Yourlawyer.com (ReNu MoistureLoc News) http://www.yourlawyer.com/topics/overview/renu_contact_solution Sat, 21 Nov 2009 05:16:00 -0800 pixel-app en Multipurpose Contact Lens Solutions May Cause Eye Damage http://www.yourlawyer.com/articles/read/16954 Tue, 08 Sep 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16954
Multipurpose contact lens solutions have caused serious eye problems for some users in the past.  For example, in May 2006, Bausch & Lomb issued a worldwide recall of ReNu with MoistureLoc solution after it was linked to an outbreak of Fusarium keratitis, a potentially blinding eye infection.  The Centers for Disease Control ultimately confirmed 180 cases of Fusarium keratitis in the U.S. that were associated with use of the recalled solution.

According to a report on Asiaone.com, in a presentation at last week's conference, Dr Gunter Wong, a regional eye expert based out of Hong Kong, said  that research has indicated that certain types of contact lens solutions may be cytotoxic - toxic to cells.  Such solutions could damage the corneal epithelium, Dr. Wong said.  This can cause corneal inflammation, a condition known as microbial keratitis.

One of the studies Dr. Wong referenced compared Complete MPS Easy Rub (AMO), Opti-free Express, Opti-Free RepleniSH (Alcon) and ReNu MultiPlus (Bausch & Lomb). According to Dr. Wong, that study found that Alcon and Bausch & Lomb solutions could damage cells in the eye.  

Dr. Lim Li, a senior consultant ophthalmologist  at the Singapore National Eye Centre, told Asiaone.com that the use of additives in some multipurpose solutions could be behind the problems seen in the study.  Dr. Lim also said that additional compounds such as cleansing agents can affect the surface of the cornea, causing toxicity, and may increase the chances of long-term damage or infection.

In response to the study's findings, an Alcon spokesperson pointed out that the testing was conducted  in a laboratory, and did not involve any actual contact lens wear, Asiaone.com said.

]]> Company Refocuses Marketing Efforts on ReNu http://www.yourlawyer.com/articles/read/16693 Tue, 30 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16693 We recently wrote that Bausch & Lomb, maker of ReNu with MoistureLoc, settled around 600 lawsuits involving the recalled contact lens solution. Now, Bausch & Lomb is focusing on ReNu marketing. According to a prior report in the Associated Press (AP), the settled ReNu with MoistureLoc claims have cost the company about $250 million, to date.

WXXI Center for Public Affairs reports that Bausch & Lomb announced a massive marketing and re-branding campaign that is expected to cost several million dollars and is geared to helping consumers understand its ReNu products.

Bausch and Lomb’s ReNu with Moisture Loc solution was taken off the marketplace in 2006 in this country and internationally after it was linked to an outbreak of a rare but serious fungal eye infection, said WXXI. Fusarium Keratitis, while uncommon, is a potentially blinding eye infection. Bausch & Lomb pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April of that year. The company would ultimately issue a worldwide recall of ReNu with MoistureLoc on May 15, 2006.

A Centers for Disease Control (CDC) report on the outbreak found that those infected with Fusarium Keratitis were 20 times likelier to have used the ReNu with MoistureLoc solution and also determined that bad hygiene habits among users were not to blame for the infections; the contact lens solution appeared to have poor disinfectant qualities. Also, as we reported last November, a study conducted by researchers at Wright State University Boonshoft School of Medicine in Dayton, Ohio found that ReNu with MoistureLoc loses much of its ability to fight fungal contamination when exposed to high temperatures for a long period of time.

We also reported previously that ReNu with MoistureLoc contained a microbial agent not found in other contact lens solutions and, according to a prior AP report, the solution also contained some novel moisturizing agents. Some researchers have theorized that the disinfectant absorbed into lenses at unusually high rates and the moisturizing agents created a biofilm (a cluster of microbes held together by a glue-like matrix) that shielded and even fostered growth of the fungus to infectious levels, said the AP.

Despite its issues, Bausch & Lomb Vice President of Brand Marketing Lisa Vandemark said the remainder of the ReNu product line does well, "We are definitely continually wanting to invest in it and build the business and move forward with the brand." Vandemark says its campaign is being developed to assist consumers in differentiating between the various ReNu products, reported WXXI.

The CDC ultimately confirmed 180 cases of Fusarium Keratitis in the U.S.; according to the AP, at least 60 more Americans needed vision-saving corneal transplants. And, while Bausch & Lomb has settled most Fusarium Keratitis cases, said the AP, it still has several dozen pending. Bausch & Lomb says it plans to defend at least 500 filed by people who claim to have suffered a variety of other eye infections allegedly because of ReNu.

]]> 3 Yrs After ReNu with MoistureLoc Outbreak, FDA Reports on Contact Lens Safety Efforts http://www.yourlawyer.com/articles/read/16649 Wed, 17 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16649 ReNu with MoistureLoc Contact Lens Solution was linked to scores of serious and potentially blinding eye infections, the Food & Drug Administration (FDA) says it is taking steps to improve contact lens safety.  Among other things, the agency has developed a new video on contact lens safety, which can be found on the FDA’s Web site, along with an in-depth Consumer Update article.

Bausch & Lomb pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April of that year, after it was linked to an outbreak of Fusarium Keratitis, a potentially blinding eye infection. The company would ultimately issue a worldwide recall of ReNu with MoistureLoc on May 15, 2006.

A Centers for Disease Control (CDC) report on the outbreak found that those infected with Fusarium Keratitis were 20 time more likely to have used the ReNu with MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. The CDC ultimately confirmed 180 cases of Fusarium Keratitis in the U.S. According to the Associated Press, at least 60 more Americans needed vision-saving corneal transplants.

Other multipurpose contact lens solutions have also been linked to eye infection outbreaks. For example, we’ve previously reported that in 2007 at least 21 cases of infections involving the water-borne acanthamoeba parasite were linked to Advanced Medical Optics (AMO) Complete MoisturePlus solution, prompting the Santa Ana, California-based company to recall the product. Roughly 170 lawsuits are pending against AMO as a result of that outbreak.

According to a posting on the FDA's website, the agency has taken several steps since the ReNu debacle aimed at improving the safety of contact lenses and solutions.  In early 2009, the FDA convened a workshop called “Microbiological Testing of Contact Lens Care Products," in collaboration with several eye care professional groups, to develop consensus on test methods for evaluating contact lens solutions. Based on discussions from this workshop and from June 2008 meeting of the agency’s advisory panel for ophthalmic devices, the FDA said it  is developing manufacturer guidance on potential labeling improvements for these products.

At the  June 2008 meeting, the advisory panel for ophthalmic devices made specific recommendations for contact lens product labeling and directions for use, including adding a discard date on their products, in addition to the usual expiration date. The discard date is the date the solution should be thrown out after opening.

The FDA also reported that last month, its Center for Devices and Radiological Health issued a letter to manufacturers of contact lens multipurpose solution products that include an option for cleaning without a step for rubbing the lenses. This letter informed these manufacturers of the panel's conclusion that there is improvement in lens care when using a rub-and-rinse regimen as compared to a rinse-alone regimen, which omits the rubbing step. The direction to rub and rinse lenses, based on the advice of an eye care professional, has always been part of the labeling for multipurpose contact lens care products.

The FDA's new contact lens safety video and article stress the importance of emptying the solution out of the contact lens case after each use and using the rub-and-rinse method for added effectiveness, the agency said Other important lens care tips in the video and article include:

  • Do not top off or reuse lens cleaning solution;
  • Use a contact lens solution to clean, rinse, and then air dry contact lens cases after each use;
  • Do not expose contact lenses or lens storage cases to any type of water or other non-sterile solutions.

]]> Hundreds of ReNu with MoistureLoc Lawsuits Settled http://www.yourlawyer.com/articles/read/16602 Mon, 01 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16602 ReNu with MoistureLoc claims have so far cost the company around $250 million.   

Bausch & Lomb pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April of that year, after it was linked to an outbreak of Fusarium Keratitis, a potentially blinding eye infection.  The company would ultimately issue a worldwide recall of ReNu with MoistureLoc on May 15, 2006.

A Centers for Disease Control (CDC) report on the outbreak found that those infected with Fusarium Keratitis were 20 time more likely to have used the ReNu with MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.   The CDC ultimately confirmed 180 cases of Fusarium Keratitis in the U.S. According to the Associated Press, at least 60 more Americans needed vision-saving corneal transplants. 

No one is exactly sure why ReNu with MoistureLoc turned out to be defective.  As we reported last November, a study conducted by researchers at Wright State University Boonshoft School of Medicine in Dayton, Ohio  found that ReNu with MoistureLoc loses much of its ability to fight fungal contamination when exposed to high temperatures for a long period of time.

As we reported previously, ReNu with MoistureLoc contained a microbial agent not found in other contact lens solutions.  According to the Associated Press, it also contained some novel moisturizing agents.  Some researchers have theorized that the disinfectant absorbed into lenses at unusually high rates and the moisturizing agents created a biofilm (a cluster of microbes held together by a glue-like matrix)  that shielded and even fostered growth of the fungus to infectious levels, the Associated Press said.

Other multipurpose contact lens solutions have also been linked to eye infection outbreaks.  For example, we've previously reported that in 2007 at least 21 cases of infections involving the water-borne acanthamoeba parasite  were linked to Advanced Medical Optics (AMO) Complete MoisturePlus solution, prompting the Santa Ana, California-based company to recall the product.  According to the Associated Press, 170 lawsuits are pending against AMO as a result of that outbreak.

Such incidents have raised concerns about the overall safety of multipurpose contact lens solution, which according to the Associated Press, have virtually replaced older lens cleansing systems since coming on the market over a decade ago.  As we reported last June, a Food & Drug Administration (FDA) advisory panel recommended that contact lens solutions be subjected to more stringent testing protocols, and the agency has been working on such standards.

But there are worries that enough still isn't being done to protect contact lens wearers from defective solutions like ReNu with MoistureLoc.  At least one expert interviewed by the Associated Press expressed concerns that the confidential nature of the ReNu with MoistureLoc settlements is preventing facts about the catastrophe - including questions of blame and clinical findings about the Fusarium Keratitis outbreak - from seeing the light of day.  But the doctor was hopeful that some of the other lawsuits still to be settled will end up at trial, thus making such facts part of the public record.

According to the Associated Press, while Bausch & Lomb has settled most Fusarium Keratitis cases, it still has several dozen pending.  And the company says it plans to defend at least 500 filed by people who claim to have suffered a variety of other eye infections because of ReNu.  A pretrial hearing is scheduled this week in New York to decide if there's a reliable scientific basis for arguing that a link between ReNu and these other infections exists, the Associated Press said.

]]> ReNu with MoistureLoc Lost Antifungal Properties When Exposed to High Temperatures http://www.yourlawyer.com/articles/read/15479 Tue, 11 Nov 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/15479 ReNu with MoistureLoc loses much of its ability to fight fungal contamination when exposed to high temperatures for a long period of time, according to a new study published in the Archives of Ophthalmology.  ReNu with MoistureLoc was recalled by Bausch & Lomb in 2006, after it was implicated in massive outbreak of the potentially-blinding  fungal infection, Fusarium Keratitis.  Following the ReNu with MoistureLoc recall, the Food & Drug Administration (FDA) cited the company's Greenville, S.C. plant for inadequate temperature control in the production, storage and transport of the contact lens solution.

Bausch & Lomb pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April, before finally issuing a worldwide recall on May 15, 2006. A Centers for Disease Control (CDC) report found that those infected with Fusarium Keratitis were 20 time more likely to have used the ReNu with MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.

Recently, researchers at Wright State University Boonshoft School of Medicine in Dayton, Ohio, tested  ReNu with MoistureLoc and five other contact lens solutions. ReNu with MoistureLoc contains a microbial agent not found in other contact lens solutions.

"Two bottles of each solution were separately stored at room temperature and 60 degrees Celsius (140 degrees Fahrenheit) for four weeks, serially diluted and then tested for their ability to inhibit growth of 11 Fusarium isolates [seven of which were associated with the keratitis epidemic]," the researchers wrote.

ReNu with MoistureLoc showed the greatest decline in antifungal activity when stored at 60 degrees C.  ReNu with MoistureLoc allowed growth of Fusarium strains associated with the outbreak in 27 of 84 combinations when stored at room temperature.  The number rose to  67 of 84 combinations when stored at 60 degrees C.

The study authors wrote that their research did not determine the exact temperature, length of  exposure to elevated temperature and extent of temperature fluctuation that would cause a reduction in the antifungal properties of any of the solutions tested.  But they concluded that their findings, "coupled with the FDA reports of Bausch & Lomb's failure to regulate the storage and transport temperatures of the products manufactured in their Greensville plant, may be significant."

]]> Tainted ReNu, AMO Contact Lens Solutions Prompt FDA Panel to Call for Better Testing http://www.yourlawyer.com/articles/read/14554 Wed, 11 Jun 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14554 ReNu with MoistureLoc and Advanced Medical Optics Complete MoisturePlus, have been linked to potentially blinding eye infections.  Now, a group of Food & Drug Administration (FDA) advisors has recommended that contact lens solutions be subjected to more stringent testing to insure their safety.  The panel also recommended that stronger safety warnings be added to the labels of multi-purpose contact lens solutions so that users can know how to avoid contaminating the products.
    
Contact lens solutions have been subjected to several recalls because of contamination problems that resulted in some users developing serious eye infections.  In 2006, Bausch & Lomb issued a worldwide recall of ReNu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. Following an investigation, the Centers for Disease Control  determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.
 
Last year, at least 21 cases of infections involving the water-borne Acanthamoeba parasite  were linked to Advanced Medical Optics (AMO) Complete MoisturePlus solution, prompting the Santa Ana, California-based company to recall the product. That AMO recall followed another issued in November 2006, when 2.9 million packets of AMO Complete MoisturePlus Multi-Purpose contact-lens solution and Active Packs were recalled after lots sold in Japan were found to have bacterial contamination. The recall included 183,000 Complete MoisturePlus units sold in the United States. AMO traced the contaminated units to a plant in China and found that Ralstonia bacteria had compromised the disinfectant in the solution and were eating away at the oxygen in the bottles.

Since the outbreaks and recalls, critics of contact lens solution makers have contended that current testing methods are not enough to insure the products' safety.    That argument gained added weight earlier this year when researchers at the Center for Medical Mycology found ReNu with MoistureLoc was unable to resist contamination because the strain of Fusarium responsible for the 2006 outbreak had the ability to form biofilms.  Biofilms are clusters of microbes held together by a glue-like matrix.   This structure made the Fusarium extremely resistant to contact lens solutions and the body’s own immune system. Unfortunately, contact lens solutions are not required to be tested against microbes with the ability to form biofilms.  In fact, RenNu with MoistureLoc and other contact lens solutions are tested against a rare type of fungus obtained from a patient in Nigeria in 1970s, which critics say has no real-world applicability.

In the case of the recalled AMO contact lens solution, there is no requirement at this time for solutions to be tested against Acanthamoeba.  Following the 2007 recall, researchers found that AMO Complete MoisturePlus had no ability to kill the parasite.  

The FDA panel strongly recommended that the agency revamp its requirements for the way companies test their contact lens solutions for safety before selling them.  The panel also recommended a variety of strong new consumer warnings for the solutions, including cautions that reusing lens solution can lead to blindness.

The FDA is not bound to follow recommendations of advisory panels, but in most cases, it does so.

]]> Bausch & Lomb Renu with MoistureLoc Tests Faulty, New Study Says http://www.yourlawyer.com/articles/read/13761 Mon, 28 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13761 Renu with MoistureLoc, the Bausch & Lomb contact lens solution that was responsible for a massive outbreak of Fusarium Keratitis in 2006, was never adequately tested to insure that it was resistant to microbial contamination.   According to a new study conducted by researchers at the Center for Medical Mycology at University Hospitals Case Medical Center in Cleveland, Ohio, the strain of Fusarium used by Bausch & Lomb to test Renu with MoistureLoc was rare and outdated, making tests with the strain a poor indicator of the contact lens solution’s effectiveness.

In 2006, Bausch & Lomb issued a worldwide recall of Renu with MoistureLoc Contact Lens Solution after it was linked to hundreds of cases of Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. Following an investigation, the Centers for Disease Control  determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.

Now, researchers led by Mahmoud A. Ghannoum, Ph.D., director of the Center for Medical Mycology, have discovered one important factor behind inability of Renu with MoistureLoc to resist contamination with  the fungus Fusarium.   A study done at the center has found the strain of Fusarium responsible for the Renu with MoistureLoc outbreak had the ability to form biofilms.  Biofilms are clusters of microbes held together by a glue like matrix.   This structure made the Fusarium extremely resistant to contact lens solutions and the body’s own immune system.

Not all cells can form biofims, and unfortunately for Renu victims, contact lens solutions are not required to be tested against microbes with this ability.  In fact, Renu with MoistureLoc and other contact lens solutions are tested against a rare type of fungus obtained from a patient in Nigeria in 1970s.  

Scientists at the Center for Medical Mycology used three strains of Fusarium – two recent strains and the one from the 1970s used by Bausch & Lomb - to run their own tests of Renu with MoistureLoc.  While Renu was effective in deterring the 1970s fungus, it was unable to penetrate the matrix formed by the recent Fusarium samples.  The inability to penetrate these biofilms meant that Renu with MoistureLoc users had no protection against particularly virulent strains of Fusarium.  

This new study is only further evidence that Bausch & Lomb did not do enough to insure the quality of its contact lens solution.  “It’s ridiculous that a contact lens solution would only be tested against a microbe that has no real world relevance,” said Jerrold Parker, Managing Partner of  Parker Waichman Alonso LLP, a law firm representing many Renu with MoistureLoc victims.  “There is no way Bausch & Lomb could guarantee the safety of Renu MoistureLoc on the basis of these inadequate tests.”

The researchers at The Center for Medical Mycology agree.  “We recommend that solutions be tested for biofilms produced by more recent clinical isolates,” Ghannoum said.  “One of the underlying reasons for Renu with MoistureLoc not being effective against the recent outbreak of keratitis is that solution is not effective against biofilms and the organisms in biofilms.”  

]]> Bausch & Lomb CEO Steps Down, 2 Years after Renu with MoistureLoc Recall http://www.yourlawyer.com/articles/read/13747 Thu, 24 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13747 Renu with MoistureLoc recall debacle has stepped down.  Last year, under Ronald Zarella, who served as Bausch & Lomb CEO since 2001, the company was sold to private equity firm Warburg Pincus of New York City. The sale ended Bausch & Lomb's almost 70-year run as a publicly traded company.

According to the Rochester Democrat & Chronicle, Zarrella will be replaced by Gerald M. Ostrov, who most recently was group chairman of Johnson & Johnson's Worldwide Vision Care division. Ostrov left that position in 2006.

Bausch & Lomb has still not recovered from the 2006 Renu with MoistureLoc recall.  Renu with MoistureLoc had been linked to Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. The company pulled Renu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April, before finally issuing a worldwide recall on May 15, 2006.

As of June 30, 2006, the Centers for Disease Control (CDC) had confirmed 164 cases of Fusarium Keratitis. The same report said that those infected with Fusarium Keratitis were 20 time more likely to have used the Renu with MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.

In October of 2006, the FDA issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to Renu with MoistureLoc that occurred before sales of the product were suspended. The letter also cited the company for numerous violations found during a May inspection of its Greenville, South Carolina manufacturing plant.

Bausch & Lomb now faces hundreds product liability lawsuits stemming from the Renu with MoistureLoc recall. Analysts have estimated that Bausch & Lomb could face potential liabilities of as much as $1 billion over lawsuits stemming from the Renu with MoistureLoc debacle, although some have predicted that the amount will be much higher. The Renu with MoistureLoc recall also   has been blamed for a 20% percent drop in the company’s 2006 profits.

When Zarella announced the sale of Bausch & Lomb to Warburg Pincus in 2007, he said it was hoped the move would help the company “comeback from the difficulties of last year”, - he clearly meant the Renu with MoistureLoc recall.  But as a result of the acquisition, Bausch & Lomb ceased to be a publicly traded company, a status it held for over 69 years.

]]> Bausch & Lomb, Still Reeling from ReNu with MoistureLoc Recall, Announces UK Job Cuts http://www.yourlawyer.com/articles/read/13676 Tue, 15 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13676 ReNu with MoistureLoc Contact Lens Solution, announced that it would be eliminating 250 jobs at one of its plants in the United Kingdom.  The job cuts are just the latest bit of bad news for Bausch & Lomb, which has never fully recovered from the 2006 ReNu with MoistureLoc recall.

In 2006, Bausch & Lomb’s ReNu with MoistureLoc Contact Lens Solution was linked to Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. The company pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April, before finally issuing a worldwide recall on May 15, 2006. The Centers for Disease Control (CDC) determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.  As of June 30, 2006, the CDC had confirmed 164 cases of Fusarium Keratitis. The same report said that those infected with Fusarium Keratitis were 20 time more likely to have used the ReNu with MoistureLoc solution.  

In October of 2006, the Food & Drug Administration issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to ReNu with MoistureLoc that occurred before sales of the product were suspended. The letter also cited the company for numerous violations found during a May inspection of its Greenville, South Carolina manufacturing plant. Now, Bausch & Lomb faces more than 1,000 product liability lawsuits over ReNu with MoistureLoc, and some legal experts believe the company could end up paying out more than $1 billion in damages.

Last week, Bausch & Lomb said it would be cutting up to 250 positions at its West Lothian site in Scotland.   The Bausch & Lomb plant there manufactures contact lenses.  The company is to cease the manufacture of its SoftLens One Day contact lens produced at the plant in 2008, replacing it with the technologically advanced SofLens Daily Disposable contact lens.

In October 2007, Warburg Pincus, a leading private equity firm, completed a $3.67 billion buyout of Bausch & Lomb.  Bausch & Lomb’s management had hoped the Warburg Pincus acquisition would stem the bleeding from the ReNu with MoistureLoc recall.   That recall has been blamed for a 20% percent drop in the company’s 2006 profits.  Following the buyout, Bausch & Lomb ceased to be a publicly traded company, a status it has held for over 69 years. However, Warburg Pincus has indicated that Bausch & Lomb could again become a publicly traded company within five to seven year.

]]> Bausch & Lomb Goes to Court to Force Insurers to Pay for Renu with MoistureLoc Lawsuits http://www.yourlawyer.com/articles/read/13626 Mon, 07 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13626 Renu with MoistureLoc contact lens solution, is trying to force several insurance companies to help it pay for more than 1,000 lawsuits filed against the company over the tainted product.  That insurance battle is just one example of how the Renu with MoistureLoc recall is still causing problems for the company. Nearly two years later, Bausch & Lomb is still facing serious legal and financial ramifications of the Renu with MoistureLoc disaster.

In 2006, Bausch & Lomb’s Renu with MoistureLoc Contact Lens Solution was  linked to Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. The company pulled Renu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April, before finally issuing a worldwide recall on May 15, 2006. The Centers for Disease Control (CDC) determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. In October of 2006, the Food & Drug Administration (FDA) issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to Renu with MoistureLoc that occurred before sales of the product were suspended. The letter also cited the company for numerous violations found during a May inspection of its Greenville, South Carolina manufacturing plant.

Now, Bausch & Lomb faces more than 1,000 product liability lawsuits over Renu with MoistureLoc, and some legal experts believe the company could end up paying out more than $1 billion in damages.  The company recently filed lawsuits against four of its insurers to force them to help pay the costs of litigation.  So far, the companies have refused to make any payments, according to the complaint filed in federal court in Rochester, NY.  Two of the companies, Ace American Insurance and Illinois Union, have filed a countersuit. The other two, Lexington Insurance and Steadfast Insurance, are expected to respond to the Bausch & Lomb lawsuit by Jan. 15.

The Renu with MoistureLoc product liability lawsuits aren’t the only problems Bausch & Lomb faces from the recall.   The recall was the driving factor behind a more than 20 percent profit reduction in 2006 for the Rochester company.   In October, in an attempt to stem the bleeding, Bausch & Lomb was acquired by the private equity firm Warburg Pincus for $3.67 billion.  Following the buyout, Bausch & Lomb ceased to be a publicly traded company, a status it has held for over 69 years. However, Warburg Pincus has indicated that Bausch & Lomb could again become a publicly traded company within five to seven year.

]]> Renu with MoistureLoc Maker Bausch & Lomb Acquired By Warburg Pincus For $3.67 Billion http://www.yourlawyer.com/articles/read/13261 Fri, 26 Oct 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/13261 Renu with MoistureLoc Contact Lens Solution, has been acquired by the private equity firm Warburg Pincus.  Earlier today, Warburg Pincus announce that it had completed its $3.67 billion buyout of Bausch & Lomb, something that had been in the works since the spring.

Warburg Pincus has been a leading private equity investor since 1971. The firm currently has approximately $14 billion under management, and invests in a range of industries including information and communication technology, financial services and healthcare.   Bausch & Lomb’s board of directors had agreed to the buyout in May, and in September, more than two-thirds of the company’s shareholders voted in favor of the takeover.  Earlier this month, the CEO of Bausch & Lomb had voiced his hope that Warburg Pincus would be able to help the company “comeback from the difficulties of last year.”

Those difficulties stemmed from Bausch & Lomb’s Renu with MoistureLoc Contact Lens Solution recall in 2006.  Renu with MoistureLoc had been linked to Fusarium Keratitis, a rare eye infection that has the potential to cause blindness. The company pulled Renu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April, before finally issuing a worldwide recall on May 15, 2006.

As of June 30, 2006, the Centers for Disease Control (CDC) had confirmed 164 cases of Fusarium Keratitis. The same report said that those infected with Fusarium Keratitis were 20 time more likely to have used the Renu with MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities.

In October of 2006, the FDA issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to Renu with MoistureLoc that occurred before sales of the product were suspended. The letter also cited the company for numerous violations found during a May inspection of its Greenville, South Carolina manufacturing plant.

Bausch & Lomb now faces 573 product liability lawsuits stemming from the Renu with MoistureLoc recall.  Analysts have estimated that Bausch & Lomb could face potential liabilities of as much as $1 billion over lawsuits stemming from the Renu with MoistureLoc debacle, although some have predicted that the amount will be much higher.

As result of the acquisition, Bausch & Lomb will no longer be a publicly traded company, a status it has held for over 69 years.  Bausch & Lomb will be delisted from the New York Stock Exchange at the close of trading today, although  Warburg Pincus has indicated that Bausch & Lomb could again become a publicly traded company within five to seven year.

]]> Renu with MoisturLoc Lawsuits Continue to Plague Bausch & Lomb http://www.yourlawyer.com/articles/read/13242 Tue, 23 Oct 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/13242 Renu with MoisturLoc Contact Lens Solution, now faces 573 product liability lawsuits stemming from eye infections caused by the recalled product.   Those lawsuits include 550 individual lawsuits and a consolidated federal class action suit.   According to a regulatory disclosure filed by Bausch & Lomb yesterday, those lawsuits have been filed in various federal and state courts in the US, as well as in courts outside the country.

Bausch & Lomb’s legal troubles began in 2006, when Renu with MoistureLoc was linked to Fusarium Keratitis, a rare eye infection that had the potential to cause blindness.   The company pulled MoistureLoc from Asian markets in February 2006, and did the same in U.S. in April, before finally issuing a worldwide recall on May 15, 2006.

As of June 30, 2006, the Centers for Disease Control (CDC) had confirmed 164 cases of the eye infection.  The same report said that those infected were 20 time more likely to have used the MoistureLoc solution.  The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that that contact lens solution appeared to have poor disinfectant qualities.  

In October of 2006, the FDA issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to MoistureLoc that occurred before sales of the product were suspended.  The letter also cited the company for numerous violations found during a May inspection of its Greenville, South Carolina manufacturing plant.   That warning letter was similar to one issued during a 2002 inspection of that plant, when the FDA discovered paint chips in rooms where containers of eye care products were filled.    The 2002 warning letter also raised concerns that Bausch & Lomb did not have adequate procedures in place to test that the contact lens solutions manufactured at the plant contained adequate amounts of preservatives and disinfectants to insure their quality.  

Analysts have estimated that Bausch & Lomb could face potential liabilities of as much as $1 billion over lawsuits stemming from the MoistureLoc debacle, although some have predicted that the amount will be much higher.

Bausch & Lomb is also facing the potential of lawsuits on a much different front, arising from the company’s proposed merger with a private equity firm. On May 16, the company announced that it had agreed to be acquired by Warburg Pincus for about $4.5 million.  Soon after, public shareholders sued Bausch & Lomb and its directors challenging the acquisition, alleging that the price is inadequate.  The plaintiffs in each of those suits are seeking class action status.

]]> Parker Waichman Alonso LLP Files Suit Against Bausch & Lomb, Inc. on Behalf of Man Diagnosed with Fusarium Keratitis After Using Renu with MoistureLoc http://www.yourlawyer.com/articles/read/12886 Mon, 02 Jul 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12886 Parker Waichman Alonso LLP announces that it has filed suit on behalf of a man diagnosed with Fusarium Keratitis in his right eye after using Renu with MoistureLoc® Contact Lens Solution.  As a result of the infection, the man continues to suffer from a significant loss of vision.  The suit was filed in the Supreme Court of the State of New York, New York County.

If you or a loved one believe that you were injured as a result of using Bausch & Lomb’s ReNu with MoistureLoc® Contact Lens Solution, please contact our office by visiting www.yourlawyer.com.   Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

In October 2005, the injured man, a resident of Georgia, was diagnosed with injuries to his right eye including fungal keratitis, a corneal ulcer, epithelial defect, corneal edema and corneal perforation, all of which required extensive medical treatment.  In November 2005, his right eye tested positive for Fusarium.  As a result of these injuries, the victim now suffers from a significant and permanent loss of vision.

On April 10, 2006, the FDA and the CDC issued public health warnings concerning serious fungal infections associated with contact lens solution use. The CDC stated that it had interviewed 30 patients suspected of having fungal keratitis. Of these 30 patients, 28 wore soft contact lenses and 26 used a Bausch & Lomb ReNu contact lens solution in the month prior to the fungal infection diagnosis. On April 13, 2006, Bausch & Lomb, Inc. recommended that consumers switch to another lens care solution and asked all retailers to remove U.S. manufactured ReNu with MoistureLoc®  from their shelves. On May 2, 2006 the CDC announced that the number of confirmed fungal infections rose to 88 cases.  Just three days later, on May 5, 2006, the CDC revised the number of confirmed cases to 102.

On May 12, 2006, the CDC made another upward revision in the number of confirmed fungal eye infections to 122 cases. On May 15, 2006, the FDA issued a press release stating: “Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide.’’  The recall followed Bausch & Lomb’s conclusion that the product’s formula may increase the risk of fungal eye infections in certain situations.  Bausch & Lomb, Inc. and the FDA both acknowledged there is a problem in the chemical properties of ReNu with MoistureLoc® after testing confirmed that the solution allows a polymer film to form around the Fusarium fungus preventing the disinfectant in the product from killing the fungus.

Fungal keratitis is a severe infection of the cornea.  Risk factors for infection usually include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and, rarely, contact lens use.  An estimated 30 million people in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4 - 21 per 10,000 soft contact lens users.  Fungal keratitis is a condition more prevalent in warm climates.  First-line treatment includes topical and oral antifungal medications.  Patients who do not respond to treatment usually require surgical intervention, including corneal transplantation. These infections are not transmitted from person to person.

About Parker Waichman Alonso LLP:  

Parker Waichman Alonso LLP is leading the litigation against Bausch & Lomb, Inc. on behalf of people injured as a result of using ReNu with MoistureLoc® Contact Lens Solution.  Parker Waichman Alonso LLP has also filed a medical monitoring class-action suit against Bausch & Lomb, Inc. seeking compensation for medical evaluations for all people who used ReNu with MoistureLoc. 
Parker Waichman Alonso LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide.  The firm has offices in New York and New Jersey.  Parker Waichman Alonso LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective products, medications and medical devices.

For more information on Parker Waichman Alonso LLP, please visit: www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

CONTACT:    Parker Waichman Alonso LLP
                  David Krangle, Esq.
                  (800) LAW-INFO
                  (800) 529-4636
                  info@yourlawyer.com
                  www.yourlawyer.com

 

]]> Bausch & Lomb Still Feeling Backlash of Renu MoistureLoc Recall: More Than a Year Later, 400 Plus Lawsuits and Disappointing Financial News http://www.yourlawyer.com/articles/read/12870 Tue, 12 Jun 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12870 Renu MoistureLoc contact lens solution, as well as possible class action lawsuits by shareholders, Bausch & Lomb posted a disappointing financial report last month.  The earnings report, which is for the first quarter of 2006, was filed late, in part because the company needed time to assess the financial losses caused by the recall.  According to the report, the Renu MoistureLoc recall reduced Bausch & Lomb’s first quarter 2006 net income by $19.6 million dollars.  

Bausch & Lomb’s troubles began in 2006, when Renu MoistureLoc was linked to Fusarium Keratitis, a rare eye infection that has the potential to cause blindness.   The company pulled MoistureLoc from Asian markets in February 2006, and did the same in U.S. in April, before finally issuing a worldwide recall on May 15, 2006.

As of June 30, 2006, the CDC had confirmed 164 cases of the eye infection.  The same report said that those infected were 20 time more likely to have used the MoistureLoc solution.  The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that that contact lens solution appeared to have poor disinfectant qualities.  

In October of 2006, the FDA issued a warning letter to Bausch & Lomb, criticizing the company for not reporting nearly three dozen infections linked to MoistureLoc that occurred before sales of the product were suspended.  The letter also cited the company for numerous violations at its Greenville, South Carolina manufacturing plant.  Whether or not the company has addressed those problems remains to be seen.  In March 2007, Bausch & Lomb issued a voluntary recall of another contact lens product, its Renu Multiplus Solution, for having trace amounts of iron.  The Multiplus Solution is also manufactured at Greenville.  The iron could lead to a shortened shelf life for the solution.

Analysts have estimated that Bausch & Lomb could face potential liabilities of as much as $1 billion over lawsuits stemming from the MoistureLoc debacle, although some have predicted that the amount will be much higher.

Bausch & Lomb is also facing the potential of class lawsuits on a much different front, arising from the company’s proposed merger with a private equity firm. On May 16, the company announced that it had agreed to be acquired by Warburg Pincus for about $4.5 million.  Soon after, public shareholders sued Bausch & Lomb and its directors challenging the acquisition, alleging that the price is inadequate.  The plaintiffs in each of those suits are seeking class action status.

]]> Recalled solution could trigger eye infections, Health Canada warns http://www.yourlawyer.com/articles/read/12665 Tue, 13 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12665
Bausch and Lomb on March 6 issued a recall of the solution, which is used to store and clean soft contact lenses. The recall involved ReNu Multi Plus Club Packs and ReNu MultiPlus Vision Packs, in lots GC6038 and GC6052.

The company began an investigation after three customers complained of discoloured solution.

Certain lots were found to contain high levels of iron that may weaken the cleanser's effectiveness, making the user susceptible to eye infections.

Chris Thatcher, vice-president and general manager for Bausch and Lomb Canada, said Monday that it's unlikely the product is still on store shelves, as it was distributed last June.

People who have used the affected lots may experience symptoms of an eye infection, suffering from redness, swelling, discharge, pain, itchiness and increased sensitivity to light or a change in vision. The federal agency advises these consumers to seek medical attention.

Consumers who have the recalled solution should stop using the product and contact the company for a replacement.

For more information, consumers may call Health Canada’s public enquiries line at (613) 957-2991, or toll-free at 1-866-225-0709.]]> Health Canada warns consumers not to use certain lots of ReNu MultiPlus contact lens solution due to potential health risk http://www.yourlawyer.com/articles/read/12666 Mon, 12 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12666
ReNu MultiPlus is used for the cleansing, rinsing and storage of soft contact lenses. Bausch and Lomb has advised Health Canada that it began an investigation into the product after receiving three customer reports of discoloured solution. This discolouration is caused by higher than expected levels of iron, and indicates that the solution may be losing effectiveness.

People who used the affected lots and experience symptoms of eye infection such as redness, swelling, discharge, pain, itchiness, increased sensitivity to light or change in vision should seek medical attention.

The affected lots were packaged in ReNu MultiPlus Club Packs and ReNu MultiPlus Vision Packs, each of which contain two 480 mL bottles of solution. Lot numbers can usually be found on the front panel of the bottle. If any bottle of this product has either of the Lot numbers GC6052 or GC6038, then it is part of this recall and consumers should immediately stop using the product and either dispose of it or contact the Bausch and Lomb consumer affairs line (1-866-259-8255) to arrange for a replacement. However, consumers should not discard these products until they have received guidance from their Municipal Government regarding their safe disposal. The Drug Identification Number (DIN) for this product is 02230538. The DIN can be found on the front panel of the product label and outer packaging.

Health Canada continues to monitor the effectiveness of this recall.]]> ReNu MultiPlus Contact-Lens Solution Recalled http://www.yourlawyer.com/articles/read/12637 Wed, 07 Mar 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12637
The recall affects 12 lots of the product, which were produced at the company’s Greenville, S.C., plant and sold in the U.S., Canada, Latin America, Korea, and Taiwan. “The company initiated an investigation after receiving three customer reports of discolored solution,” Bausch & Lomb said in a statement. “The root cause of the discoloration was determined to be an elevated level of trace iron in a single batch of raw material sourced from an outside supplier. The elevated level of trace iron could combine with other compounds in the solution to cause discoloration, which signals that the solution may be losing effectiveness over time.”

The company stressed that the latest recall was unrelated to the earlier recall of ReNu with MoistureLoc, which was associated with an outbreak of the severe fungal eye infection known as Fusarium keratitis. The company suspended Asian sales of ReNu with MoistureLoc in February of 2006 and U.S. sales in April of that year, although it wasn’t until the following month that Bausch & Lomb announced a full global recall and permanent withdrawal of the product from shelves in the face of mounting evidence from the U.S. Centers for Disease Control and Prevention (CDC) and others that the product carried a significant risk of the infection, which can cause permanent damage including blindness.

However, the tainted ReNu MultiPlus supply was made at the same South Carolina facility where ReNu with MoistureLoc was made. That plant was cited by the U.S. Food and Drug Administration (FDA) for numerous violations last fall, after the FDA undertook a two-month investigation of the facility following the Fusarium keratitis scare.

In a warning letter sent to Bausch & Lomb on October 31 of last year, the FDA said, “Although the March - May 2006 inspection focused primarily on the MoistureLoc contact-lens solution, the inspection, nonetheless, identified and documented significant QS [Quality System] regulation violations that were systemic and are relevant to all products manufactured at the Greenville, S.C., facility.”

Among the facility’s violations listed in that letter: “failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance”; “failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality”; “failure to establish and maintain procedures to adequately control environmental conditions”; and “failure to ensure that all equipment used in the manufacturing process meets specifications and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.”]]> Bausch & Lomb Recalling MultiPlus Lots http://www.yourlawyer.com/articles/read/12631 Tue, 06 Mar 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12631
The company recalled 12 lots of its ReNu MultiPlus contact lens solution after three reports of discolored solution. No adverse events were reported.

Bausch & Lomb determined the discoloration was caused by trace amounts of iron found in a single batch of raw material from an outside supplier. The company said the affected lots could have a shorter shelf life than the two-year expiration date as a result.

Bausch & Lomb said about a million bottles of solution from nine of the 12 lots were distributed in the United States, with the other lots going to Canada, Latin America, Korea and Taiwan. The company has notified the Food and Drug Administration and regulators in the other affected countries of the recall.

Separately, the company said revenue for 2006 dropped 3 percent to about $2.29 billion following a recall and eventual discontinuation of ReNu with MoistureLoc after the product became associated with an eye fungus that could blind users if left untreated.]]> Bausch & Lomb Initiates Limited Voluntary Recall of Twelve Lots of ReNu MultiPlus Solution Due to Potential for Shortened Shelf Life http://www.yourlawyer.com/articles/read/12632 Tue, 06 Mar 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12632
About a million bottles of solution from nine of the 12 lots were originally distributed in the United States. Product from the 12 affected lots was also distributed in Canada, Latin America, Korea and Taiwan, where it is also being recalled.

The company initiated an investigation after receiving three customer reports of discolored solution. The root cause of the discoloration was determined to be an elevated level of trace iron in a single batch of raw material sourced from an outside supplier. Iron is an element present at trace levels measured in parts per billion in many compounds used in manufacturing food, drug, medical device and cosmetic products for human use. The elevated level of trace iron could combine with other compounds in the solution to cause discoloration which signals that the solution may be losing effectiveness over time.

“The health and safety of consumers is our top priority,” said Angela J. Panzarella, vice president and head of Bausch & Lomb’s global vision care business. “With detailed and specific information about the distribution of the affected product, and good information about consumer use patterns, we are highly confident that virtually all of the affected product was used before it began to lose effectiveness. We’re now in the process of confirming with distributors and retailers that there is no product still available for sale anywhere.”

“We are confident we have identified the source of the problem and we are taking appropriate measures designed to avoid a recurrence,” Panzarella said.

Bausch & Lomb does not expect the costs associated with this limited recall will have a significant impact on its financial results.

If consumers notice that their lens care solution appears to be discolored, they should discard it, as it may be losing effectiveness. The recalled lots all carry the expiration date “2008 – 03” on the bottle. Consumers who have bottles from the lot numbers listed below should check the Company’s web site at www.bausch.com/productrecall or call the consumer affairs line (1-866-259-8255) to arrange for a replacement.

LOT NUMBERS SUBJECT TO RECALL: GC6030 – GC6037 – GC6038 – GC6045 – GC6048 – GC6052 – GC6061 – GC6063 – GC6072 – GC6073 – GC6080 – GC6085
]]> Bausch & Lomb recalls 1.5 million bottles of ReNu MultiPlus contact lens solution http://www.yourlawyer.com/articles/read/12633 Tue, 06 Mar 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12633     
The optical products maker also reported a modest drop in fourth-quarter and full-year sales in 2006, citing sluggish contact lens sales a slower-than-expected recovery from last spring’s worldwide recall of its ReNu with MoistureLoc solution, which was blamed for an outbreak of severe fungal eye infections.
    
The company said it has carried out a limited voluntary recall of 12 lots of its ReNu MultiPlus solution after getting three customer reports of discolored solution. No one was reported hurt.
    
About a million bottles of the popular brand were distributed in the United States and another 500,000 in Canada, Korean, Taiwan and Latin American. The company has notified the Food and Drug Administration and regulators in the other affected countries of the recall.
    
”I want to emphasize that this is completely unrelated to and different from the MoistureLoc recall,” company spokeswoman Barbara Kelley said.
    
”There have been no serious adverse events associated with this occurrence, and the possibility of a serious adverse event is remote. There is an extremely low risk to consumers, as virtually all of the product has already been used.”
    
Bausch & Lomb determined the discoloration was caused by trace amounts of iron found in a single batch of raw material from an outside supplier. As a result, it said, the affected lots could have a shorter shelf life than the two-year expiration date.
]]> Bausch & Lomb eye infections, lawsuits, surface in Nashville http://www.yourlawyer.com/articles/read/12538 Tue, 13 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12538
In early January, John Richardson of Clarksville brought a civil lawsuit against Bausch & Lomb, the maker of the soft contact lens solution “ReNu with MoistureLoc Multi-Purpose Solution,” alleging his use of the solution led directly to his development of “Fusarium Keratitis,” a serious eye condition that can cause permanent vision loss.

Last week, a second similar suit was also filed in U.S. District Court in Nashville on behalf of Kathy Binkley of Nashville. Like Richardson, Binkley claimed her contraction of fusarium keratitis was linked to her use of the ReNu solution.

Although these two lawsuits are the first to hit Middle Tennessee courts, they are far from the first to be levied against Bausch & Lomb, which is facing potentially years worth of litigation as a result of the ReNu with MoistureLoc solution.

In May of last year, Bausch & Lomb removed ReNu with MoistureLoc from the market after the Centers for Disease Control (CDC) linked the solution to the fungal eye infection fusarium keratitis.

After more 100 confirmed cases of the eye fungus were reported, the CDC study found that the fungus likely originated in the company’s Greenville, S.C. plant.

Local experts say the number of known Middle Tennessee cases was in the single digits.

But for Richardson and Binkley, the cases were serious, according to their lawsuits.

Richardson, who was diagnosed with Fusarium Keratitis in February of 2006, underwent a surgical procedure known as a corneal transplant “in an attempt to save his eye and restore some useful vision.”

He has suffered permanent vision loss as a result of his condition and procedure, Richardson’s lawsuit says.

Binkley contracted the fungus in the form of a “Fusarium corneal ulcer” in November 2005, and underwent a penetrating keratoplasty two months later.

Binkley has suffered decreased vision, distorted and blurred vision, eye pain, headaches, light sensitivity and possible permanent vision loss, her lawsuit claims. She is 44 years old, said her attorney.

Dr. Jeffrey Sonsino, an Optometrist at the Vanderbilt Eye Institute, said his hospital has only seen one case of Fusarium Keratitis.

But Sonsino said the CDC study was “pretty compelling” in showing at least a correlation between use of the ReNu with MoistureLoc solution and the fungus.

And Sonsino, who is also the Chair of the Anterior Segment Committee of the Cornea and Contact Lens section of the American Optometric Association, said the condition that many ReNu patients developed is a very serious one.

“Fusarium Keratitis is a very severe ocular condition where a fungus actually invades the cornea. And one of the reasons it is so serious is because it is very difficult to treat,” Sonsino said.

“A very high proportion of the patients who have this kind of infection will end up losing some vision. In fact, one third of the patients who had Fusarium keratitis in this outbreak required a surgical procedure called a corneal transplant,” he continued. “That’s not a simple procedure and it’s one that’s fraught with complications.

“This is a very serious condition,” Sonsino said.

It is perhaps for that reason that a tremendous number of private attorneys have already begun soliciting clients who developed this condition in the hopes of filing a class action lawsuit against Bausch & Lomb.

Currently, the litigants against Bausch & Lomb have not been awarded “class” status.

But the company’s immediate future is already proving to be less than auspicious.

Just last week, the the Associated Press reported that Bausch & Lomb lowered its 2006 revenue forecast, citing a “slower-than-expected recovery” from the ReNu with MoistureLoc recall and “sluggish” contact lens sales.

The good news, Sonsino said, is that with the faulty solution off the shelf, the fungal outbreak has likely vanished.

“It’s pretty conclusive that this outbreak was due to this product,” Sonsino said. “But my best guess is that from a medical standpoint this has blown over since they’ve stopped all the shipments of this product.”]]> Suits Piling Up in Eye-Fungus Outbreak http://www.yourlawyer.com/articles/read/12371 Wed, 13 Dec 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12371
Both women underwent eye-saving, cornea-transplant surgery this year. They lost months away from their jobs, wear sunglasses to avoid stares and battle a toxic mix of anger, fatigue and frustration.

"Some days I get a little down, but I cope with it. I hang on to some hope that I'm going to see again out of that eye," said McConnell, 57, a job-program coordinator in Frazer, Pa.

The culprit, a fungal infection so rare that most eye doctors had never seen a case, sent a cold shiver through contact lens wearers around the world. Hundreds of people said they contracted the dangerous microbe while using a new multipurpose lens solution made by Rochester-based Bausch & Lomb Inc.

Consumer lawsuits against Bausch & Lomb have been piling up in U.S. courts, and the debacle could drag down the optical products company's finances for years. Lawyers now expect 500 to 700 people will seek damages for Fusarium keratitis infections in trials beginning as early as next summer.

Lawsuits could wind up costing Bausch & Lomb $1 billion in damages, analyst David Maris of Banc of America Securities estimated. Losing its dominance in the lucrative lens care market 34 million Americans wear contact lenses could prove even more draining.

Already beset by accounting irregularities at its Asian subsidiaries, the company slashed its 2006 profit forecast by 78 percent. Its share of U.S. lens care kits plunged from 31 percent to 8 percent before rebounding to 21 percent in the July-September quarter, according to Health Products Research in Whitehouse, N.J.

Of the 180 infection victims confirmed so far in 35 states, 59 needed cornea transplants, the Centers for Disease Control and Prevention in Atlanta said. At least 120 more lens wearers were stricken with the infection in the fall of 2005 in Hong Kong, Singapore, Malaysia and China, health officials and lawyers in those countries reported. It later appeared in the U.S.

Several people allege the MoistureLoc solution caused them to lose an eye.

"There were days that I thought I was going insane," said Macchia, 49, a financial broker's assistant in Jackson, Mich.

Questions abound over whether Bausch & Lomb reacted quickly enough.

The company stopped selling MoistureLoc in Hong Kong and Singapore in February but only halted U.S. shipments in April. It permanently withdrew the $100-million-a-year product from all markets in mid-May when the Food and Drug Administration called it the "potential root cause."

After months of testing, the company determined that MoistureLoc's unique disinfectant and moisture-retention agents, in combination with poor hygiene habits, could in some cases create a thin film that sheltered the fungus from the solution's sterilizer.

An analysis by leading eye doctors and the CDC concluded that MoistureLoc was the only cleaner implicated, noting the spike in infections rapidly subsided after its worldwide recall.

In the company's view, spokeswoman Barbara Kelley said, the outbreak was caused by various factors including the ingredients in the solution and how the patients used it.

"The issue is, what is that unique combination of factors that led some people to get the infection and others not?" Kelley said.

While Bausch & Lomb said it acted swiftly to unlock a bewildering medical riddle, the timeline is the crux of the legal battle, said Carl Tobias, a law professor at the University of Richmond in Virginia who specializes in product liability disputes.

"What did they know, when did they know it, and did they move quickly enough once they had information that would lead them to believe people were being hurt by the product?" Tobias asked.

McConnell bought a bottle of MoistureLoc in September 2005, thinking its touted moisturizers might solve the drying of her eyes in wintertime. She was at work in mid-November when she suddenly felt a searing pain as if "a piece of sharp glass" was caught under her lens.

The eye turned beet red. She couldn't stand the light. She stayed home with the curtains drawn for nearly two weeks, taking antibiotic drops hourly. The pain got so severe, she was rushed to Wills Eye Hospital in nearby Philadelphia and finally diagnosed with the fungal infection.

By January, "the fungus had broken through the cornea, started eating the eye," McConnell said in a trembling voice. "They dug deep into the eye to get it out."

The invasive transplant surgery created a blinding cataract that was eventually removed in August. But with her vision deteriorating again, she recently found out she'll need a new cornea implant. As for the scarred iris, she said, "I'm at the point, I don't ever care if it turns brown again."

Robbed of depth perception, McConnell drives only on familiar roads but not at night because "headlights are doubled." She's embarrassed by her clumsiness. "I bump into people because I can't focus," she said.

In one case, an Oklahoma teenager whose eye infection disseminated through her bloodstream almost died, said Dr. Arthur Epstein, chairman of the American Optometric Association's contact lens and cornea section. "Some of these patients were terrifically harmed," he said.

In addition, said the CDC's medical epidemiologist, Dr. Benjamin Park, "there were some cases that were so severe that they did require" removal of the eye.

Macchia's attorney, Jason Mark of Parker & Waichman in Great Neck, N.Y., said one client in West Virginia "has to wear a prosthetic shell in her socket because her eye became so deformed from the treatment."

Macchia's cornea operation in March lasted 6 1/2 hours.

The doctors "Roto-Rootered my retina," she said, laughing grimly. "If I keep this cornea, the doctor will fit me with a contact lens as a cosmetic so it'll look like my other eye. That'll probably help. Like I told him, I'll wear anything as long as it's not Bausch & Lomb."]]> An eye for an eye, literally http://www.yourlawyer.com/articles/read/12242 Wed, 08 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12242
As a result of the outbreak, several people received cornea transplants to save their eyesight, while many more narrowly escaped the same fate. However, the most troubling aspect of this incident isn't a few cornea transplants - it's that Bausch & Lomb waited several months before doing anything about it. The rise of infections in the United States was preceded by dozens of infections in other countries. Singapore, Malaysia and Hong Kong all reported similar outbreaks in connection with the MoistureLoc product. And surprisingly, months before the product was pulled from the shelves in the United States, it was pulled from the shelves in each of these three countries. Then, after the infections received attention here, Bausch & Lomb decided to halt shipments of the product and recall it entirely.

Would they have pulled the product at all if our country hadn't uncovered the problem? The thought is troubling enough. Three discrete instances of the outbreak weren't sufficient to warrant this action, so it's no stretch to imagine that similar outbreaks would have occurred in other countries without our intervention.

Luckily for those affected, there is a way to seek justice. And as much as we love to bash lawyers in this country, they're the people delivering it. The number of lawsuits prompted by this incident will provide enough punishment so that this company and others will rethink their crisis response strategies. We can only hope that if Bausch & Lomb was responsible, then the litigants who lost their eyesight or nearly did take this company to the bank.
]]> FDA warns Bausch & Lomb on contact lens solution linked to infections http://www.yourlawyer.com/articles/read/12237 Tue, 07 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12237
Bausch & Lomb didn’t report the 35 serious injury reports by April 7, as required by law, after Singapore health officials had alerted the Rochester, N.Y. company, the Food and Drug Administration said in the letter. The reporting failure occurred after the company had suspended sales of its ReNu with MoistureLoc solution in Singapore.

It also came after the FDA had begun an investigation of the Greenville, S.C. manufacturing plant where Bausch & Lomb made the now-withdrawn MoistureLoc solution.

Bausch suspended sales of MoistureLoc in Singapore and Hong Kong in February and U.S. sales in April. It initiated a global recall in May. The company later acknowledged the brand of solution was the potential “root cause” of increased risk of the fungal infection, called Fusarium keratitis.

Ultimately, health official reported several hundred cases of Fusarium keratitis in parts of Asia and the United States.

The FDA warning letter refers in part to the inadequacy of a previous company response to FDA concerns about its reporting of the Singapore cases.

“Your response states that this information did not reasonably suggest that the ReNu with MoistureLoc multi-purpose solution device caused or contributed to the Fusarium infections. FDA disagrees. This information suggested that your ReNu product may have caused or contributed to the event,” the letter reads in part.

In a statement, Bausch said it has completed more than two-thirds of the corrective actions it pledged in response to the FDA’s concerns. The issues stem from the March-to-May inspections of the Greenville, S.C. plant. Bausch said it should be ready for a reinspection before March 31.

The 11-page letter, redacted in parts, largely details previously disclosed manufacturing problems at the plant. The FDA said it found no problems at the plant with any other company products.]]> FDA to B&L: Fix violations at lens solution plant http://www.yourlawyer.com/articles/read/12244 Mon, 06 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12244
In an 11-page letter to B&L dated Oct. 31, the Federal Drug Administration outlines a series of violations at the company’s Greenville, S.C. plant that it feels have not yet been adequately addressed. The alleged violations include a range of operating practices, including record keeping, cleanliness, inspection and environmental control.

If the violations are not addressed, according to the letter, B&L could face a range of sanctions, including a fine or delays in regulatory approvals of “reasonably related” products. The FDA also said that other federal agencies are advised of the warning letters to evaluate when awarding contracts.

The affected plant made ReNu with MoistureLoc, a contact lens solution tied to reports of Fusarium keratitis involving contact lens wearers in the United States and several foreign countries.

The FDA’s inspection did not link any conditions at the plant to the outbreak of Fusarium, but it did order corrective actions in record-keeping and other operating conditions.

A related investigation by the Centers for Disease Control concluded that ReNu with MoistureLoc was probably not contaminated during the manufacturing process. Instead, the CDC said it was likely the solution has “unique properties” that may have triggered the outbreak. B&L recalled MoistureLoc worldwide earlier in May.

The CDC’s report was based on a controlled study following reports of 164 confirmed cases of Fusarium infections in 33 states and one U.S. territory. Almost 60 percent of the patients reported using ReNu with MoistureLoc.

The outbreak has hovered over B&L for several months. The company earlier this year projected that pre-tax earnings for 2006 would probably be about $80 million, down from initial forecasts. B&L cited costs of the recall and related brand-rebuilding efforts.

In a release today, B&L said the FDA letter contains no new observations; rather, the company says it summarizes the agency’s assessment of B&L’s progress as of June 30.

At an update in mid-August, B&L reported to the FDA it had completed more than half the action items, the company said in its release. That number had increased to two-thirds by early last month, B&L also said, with the remaining items either in process of implementation or assigned new completion dates.

“Of the unfinished actions itemized in the warning letter, the great majority were reported as complete in the Oct. 12 update,” B&L said in its release. Those items cannot be considered closed until the FDA has had an opportunity to review or inspect them, B&L said.]]> FDA: Bausch & Lomb failed on reporting http://www.yourlawyer.com/articles/read/12234 Mon, 06 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12234
Bausch & Lomb didn't report the 35 serious injury reports by April 7, as required by law, after Singapore health officials had alerted the Rochester, N.Y. company, the Food and Drug Administration said in the letter. The reporting failure occurred after the company had suspended sales of its ReNu with MoistureLoc solution in Singapore.

It also came after the FDA had begun an investigation of the Greenville, S.C. manufacturing plant where Bausch & Lomb made the now-withdrawn MoistureLoc solution.

Bausch suspended sales of MoistureLoc in Singapore and Hong Kong in February and U.S. sales in April. It initiated a global recall in May. The company later acknowledged the brand of solution was the potential "root cause" of increased risk of the fungal infection, called Fusarium keratitis.

Ultimately, health official reported several hundred cases of Fusarium keratitis in parts of Asia and the United States.

The FDA warning letter refers in part to the inadequacy of a previous company response to FDA concerns about its reporting of the Singapore cases.

"Your response states that this information did not reasonably suggest that the ReNu with MoistureLoc multi-purpose solution device caused or contributed to the Fusarium infections. FDA disagrees. This information suggested that your ReNu product may have caused or contributed to the event," the letter reads in part.

In a statement, Bausch said it has completed more than two-thirds of the corrective actions it pledged in response to the FDA's concerns. The issues stem from the March-to-May inspections of the Greenville, S.C. plant. Bausch said it should be ready for a reinspection before March 31.

The 11-page letter, redacted in parts, largely details previously disclosed manufacturing problems at the plant. The FDA said it found no problems at the plant with any other company products.
]]> Bausch & Lomb Receives FDA Warning Letter related to Inspection at Greenville, S.C. Solutions Manufacturing Plant conducted in March-May 2006 http://www.yourlawyer.com/articles/read/12238 Mon, 06 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12238
Although the inspection did not identify any conditions at the manufacturing facility that contributed to or caused the reported adverse events, it identified some important issues that the Company is addressing through a series of corrective actions.  The Warning Letter contains no new observations, but rather documents those corrective actions still in process.  Bausch & Lomb voluntarily initiated a global recall of its ReNu with MoistureLoc lens care solution on May 15, 2006.

In response to the FDA’s report on the inspection observations (FDA Form 483), the Company immediately initiated a series of corrective actions and submitted a comprehensive plan summarizing those actions on June 30, 2006.  The Warning Letter summarizes the agency’s assessment of the corrective actions completed as of the Company’s June 30, 2006 response.  Since that time, the Company has continued to keep the FDA updated on its progress toward completing the corrective actions outlined in its response to the Form 483.

At an update with agency representatives in mid-August, the Company reported having completed more than half of the action items.  In a report submitted on October 12, which the agency has yet to finish reviewing, the Company reported that more than two-thirds of the action items had been completed; that the majority of the outstanding items were in the process of implementation according to schedule; and that a handful had been assigned new completion dates.  Of the unfinished actions itemized in the Warning Letter, the great majority were reported as complete in the October 12 update, although, of course, they cannot be considered closed until the FDA has had the opportunity to review or inspect them.

Bausch & Lomb said today that it has taken very seriously its responsibility to respond with appropriate speed and thoroughness to the FDA’s observations.  The Company has confidence in the products it manufactures at the facility based on the processes and systems in place.  Bausch & Lomb is committed to completing the remainder of the action items in its corrective plan according to schedule, and expects to be ready for a re-inspection in the first quarter of 2007.
]]> Bausch & Lomb Receives Warning from FDA over Handling of ReNu with MoistureLoc http://www.yourlawyer.com/articles/read/12437 Mon, 06 Nov 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12437
The letter also cited numerous violations stemming from a two-month investigation of Bausch’s Greenville, South Carolina, facility this past spring. Referring to Bausch’s contact lens solutions, the FDA said that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements.”

According to the October 31 warning letter, the company failed to inform the FDA of “35 serious injury reports of Fusarium keratitis from Singapore’s Minister of Health in February 2006 relating to ReNu with MoistureLoc Multi-Purpose Solution. None of the complaints were reported to the Agency as of April 7, 2006,” as required by law.

The company suspended Asian sales of ReNu with MoistureLoc in February and U.S. sales in April before eventually issuing a global recall on May 15. The spring FDA inspection did not directly connect any of the violations with the spread of Fusarium keratitis. However, the letter claimed that Bausch failed to thoroughly investigate the issues related to Fusarium keratitis. Bausch “did not include sterility or biocidal testing for ReNu with MoistureLoc Multi-Purpose Solution product lots implicated in complaints received from Hong Kong” and “had not performed sterility testing on the returned/retain samples in conjunction with the Fusarium investigation for complaints received from Malaysia and Singapore.”

Bausch has 15 days from the date of the letter to respond to the allegations. “Failure to promptly correct these violations,” says the FDA, “may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.”
]]> Recalled ReNu Lens Solution Still on the Market http://www.yourlawyer.com/articles/read/12438 Tue, 24 Oct 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12438
In their announcement of Bausch and Lomb’s decision in April, the FDA said that the company was “voluntarily stopping shipment of the ReNu MoistureLoc product while they are continuing to investigate the cause of these infections. Soft contact lens users who have existing supplies of the Renu Moisture Loc should use the product with caution and report any signs and symptoms of eye infection to their doctors.” The following week, the company issued what they called a “voluntary market withdrawal,” which requested that retailers temporarily suspend sales while research was ongoing.

It wasn’t until the following month that Bausch and Lomb announced a permanent withdrawal of the product from shelves, in the face of mounting evidence that the product carried the significant risk of Fusarium keratitis, which can cause permanent damage including blindness. This permanent recall came only after the Centers for Disease Control had confirmed more than 100 cases of the condition around the country. In more than two thirds of those cases involving contact-lens users, the sufferer had used ReNu with MoistureLoc.

Bausch and Lomb has encountered a great deal of criticism for their handling of the situation. Many researchers allege that the company had reason for concern about the product’s safety well before they announced any action in April. Many critics believe that the company had been alerted by medical officials in Hong Kong about the potentially dangerous side effects as far back as November of 2005.

In addition, the company has failed to do enough to inform users and doctors of the risks involved. Observers have found that the product can still be found on the shelves of some retail outlets, perhaps indicating that Bausch and Lomb hasn’t adequately reached out to its retailers to inform them of the recall.
]]> Bausch Lomb Warning Letter http://www.yourlawyer.com/articles/read/12243 Sun, 01 Oct 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12243 Department of Health and Human Services' logoDepartment of Health and Human Services
    
Public Health Service
Food and Drug Administration
      
Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309

October 31, 2006

VIA FEDERAL EXPRESS

WARNING LETTER
(07-ATL-01)

Ronald L. Zarrella, Chairman and CEO
Bausch & Lomb
One Bausch & Lomb Place
Rochester, NY 14604

Dear Mr. Zarrella:

During an inspection of your facility located at 8507 Pelham Rd., Greenville, SC 29615, on March 22, 2006 through May 15, 2006, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures contact lens solutions. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We reviewed and considered the responses from Mr. Michael Santalucia, VP Regulatory Affairs, dated June 30, 2006, concerning our investigators' observations noted on the FORM FDA 483, Inspectional Observations, that was issued to Mr. Thomas H. Eggleton, VP of Operations. We also acknowledge the recent receipt of your quarterly update dated October 12, 2006, which we will continue to review to help us determine the adequacy of your firm's corrections.

Based on the information we have reviewed, we acknowledge your efforts to address the outstanding inspection deficiencies noted during our March 22 - May 15, 2006 inspection. Also, we acknowledge that Bausch and Lomb has recalled all MoistureLoc contact lens solution worldwide to eliminate the serious risk to health associated with an outbreak of Fusarium keratitis. Although the March - May 2006 inspection focused primarily on the MoistureLoc contact lens solution, the inspection, nonetheless, identified and documented significant QS regulation violations that were systemic and are relevant to all products manufactured at the Greenville, SC facility. However, during the inspection we did not find problems with the other products currently manufactured at this facility that would warrant product recall or field correction.

Violations noted during the inspection include, but are not limited to, the following:

1. Failure to establish and maintain design plans that describe or reference the design and development activities, and identify and describe the interfaces with other groups or activities, as required by 21 CFR 820.30(b). Specifically, the initial design plan shows Project R0151 began in 2001 and resulted in product [redacted]. The formulation contains a different preservative [redacted] and was cleared by the Agency in 2003. The product was not commercialized by your firm. Project R0324 is an alternate product project ReNu with MoistureLoc Multi-Purpose Solution containing Alexidine, which was added to the same original design and development plan in 2004. Initial feasibility and risk assessment show the two products with two preservative agents [redacted] Alexidine) under one design project . The design plan provided to our investigators dated October 25, 2001 - February 4, 2003, does not include any activities relating to the [redacted] solution, ReNu with MoistureLoc Multi-Purpose Solution.

A discussion of your response to this observation is combined with the review of item # 3 below.

2. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).

Specifically,

(a) Raw material specifications were not determined and firmly established prior to process validation. For example, [redacted] was used for pre-clinical and clinical studies however; the product formulation was changed to [redacted] at initial validation then back to [redacted]

(b) Your firm does not have complete validation data for ReNu with MoistureLoc Multi-Purpose Solution [redacted]. Initial scale-up activities at the Greenville plant were performed in 2003 on an unnamed similar product [redacted] utilizing [redacted] in the product formulation. [redacted] replaced [redacted] (which was used in the original product formulation for pre-clinical and clinical studies) after white particles were noted on soft contact lens while performing a lens compatibility study. The [redacted] product was formulated with and used in the validation study; however, the formulation was not commercialized In 2004 your firm performed a limited validation study on the currently marketed ReNu with MoistureLoc Multi-Purpose Solution utilizing [redacted] in the product formulation. The corrective action to avoid the appearance of white particles on the lenses was to use the [redacted] with a European Pharmacopeia clarity test. The validation data available shows that cleaning of the bulk mix tanks and filling lines, the filling process, the hold time study, and purging processes were not revalidated. Chemistry testing was limited to the compounding batches and no USP sterility testing was performed for the scaled-up batches of ReNu with MoistureLoc Multi-Purpose Solution. [redacted] validation data was accepted in lieu of performing a complete re-validation of the manufacturing processes. The validation of the product did not include an evaluation of cleaning, purging, or filling. No hold time studies or purge evaluations were done. Lastly, no tank or filter sterilizations were done for ReNu with MoistureLoc although its ingredients, Alexidine [redacted] and Poloxamine, are sterile additions.

Your firm's response to observation 6a is inadequate. Your firm has stated that it will revise SOP 90-008, Validation Program, to perform complete validation for any new product or formulation at the site. Your firm has stated that it will revise SOP 90-044, Preparation of Validation Protocols and Final Reports, to require R&D Process Development and Global Quality to approve the protocols and reports for new or transferred products. Your firm has also begun to perform audits to evaluate the effectiveness of the system. This is inadequate as your firm has not completed any of these actions and submitted documentation of them to FDA for review.

(c) The following deviations are noted in the initial validation study [redacted]

1. The European Pharmacopeia (EP) clarity test was not performed on Lot # 234068 [redacted] that was used in the 2003 validation study. Raw material specifications included a requirement for the EP clarity test in 2003.

Your firm's response to observation 6b1 is inadequate. Your firm has proposed to revise SOP 60-052, In-process, Final Product, and Raw Material Chemical Testing, to include an independent QA review and approval of the requirement before it is released for use. You proposed to revise SOP 90-074, New Product Assessment Planning, to include the requirement for effective raw material specifications prior to the start of the validation. This response is inadequate as your firm has not completed these revisions and submitted them to FDA for review.

2. Bacteriostasis/Fungistasis (B/F) testing was not performed for all validation runs as specified in the established protocol (0308-ME-0154). [redacted] runs were performed; however B/F testing was performed on only one run.

Your firm's June 30, 2006, response to observation 6b2 is inadequate. Your company has committed to write an addendum to the validation report for the bacteriostasis/fungistasis testing explaining the deviation. In addition to writing an addendum to the validation report for the B/F testing explaining the deviation, the "erroneous protocol" should be revised and updated to remove the requirement in 0308-ME-0154 for the B/F test to be repeated for each validation lot to ensure that protocols and company policy is consistent.

3. The first bottle out of filling on the third batch (PJ3004) was out of specification on the lower end for Osmolality ([redacted]mOsm/Kg). At the time of fill, the release specification was [redacted] mOsm/Kg. The release specification was subsequently lowered to [redacted]t mOsm/Kg. and this run was accepted.

Your firm's response to observation 6b3 is inadequate . Your firm states that they will develop a procedure to control specifications prior to scale up of product or manufacturing and revise SOP 90-008, Validation Program, to state that when specification changes are identified during a validation, the validation must be started from the beginning. However, this procedure has not been developed and submitted to FDA for review.

3. Failure to establish and maintain procedures for verifying the device design which confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). Specifically,

(a) Tasks for determining analytical in-process and finished product specifications were not assigned in the design plan and they were not firmly established prior to the product launch of Renu with MoistureLoc Multi-Purpose solution. for example, the Osmolality release specifications was lowered after beginning process validation. Your firm did not establish specifications prior to beginning process validation. A specification change was made after validation.

(b) Your firm does not have a test method to evaluate the degradation of Alexidine in the ReNu with MoistureLoc Multi-Purpose Solution.

Your firm's response is partially adequate. The portion of the response that addresses observation 1a-c of the FDA 483 is inadequate. Your firm states that they will develop a separate Design and Development Plan procedure that will expand and clarify Project Plan Requirements and address management and documentation when multiple designs or formulations are moved into development. The new procedures will require the appropriate tracking of multiple formulations and assess them against the new procedure. This response is inadequate as your firm has not made these changes yet and submitted these revised procedures for review.

The portion of your firm's response that addresses observation Id, appears adequate. Your finn states that you have a method for evaluating Alexidine. Your company provided TP-8230, HPLC Quantitative Determination of Alexidine [redacted] which is an assay method that quantifies the level of Alexidine in the presence of interfering degradant peaks for Alexidine and other formulation excipients. Your firm also provided the validation report for this evaluation.

4. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). Specifically, the design history file does not contain a statement of readiness from R&D as required in established procedure BL-POL-401, Product Development Management Process.

Your firm's response to observation le is inadequate. Your firm has stated that it will revise BLPOL-401, Product Development Management Process for Medical Devices, to remove the duplicative "Statement of Readiness" requirement since your firm has a signature mechanism in place that confirms that each team member is ready to move to the next phase of the process. This response is inadequate as your firm has not completed the revision of the procedure and submitted it to FDA for review.

5. Failure to establish and maintain procedures to ensure that the design requirements relating to a device include a mechanism for addressing incomplete, ambiguous, or conflicting requirements, as required by 21 CFR 820.30(c). Specifically, several design inputs for ReNu with MoistureLoc Multi-Purpose Solution [redacted] are outstanding and were not addressed by the project team before bringing the product to the market. For example, the following value added design inputs remain open: qualification of a [redacted] regimen for the [redacted]; [redacted] of cycled lenses [redacted] with [redacted] lenses [redacted] ISO/FDA 11, Regimen Test using [redacted] and [redacted] after [redacted] day soak in glass vials; laboratory cleaning study to demonstrate lipid removal with [redacted] lenses; and, a biocidal efficacy study that demonstrates efficacy against "clinically significant microorganisms" (non-ISO organisms). The value added design goals and design outputs were not completed prior to finalizing the project.

Your firm's response to observation 2 is inadequate. Your firm states that it will revise documentation and associated design control procedures to allow for only required design inputs on the Design Control matrix and provide training to all Project Managers and team members, however, these revisions have not been completed and submitted to FDA for review.

6. Failure to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development, as required by 21 CFR 820.30(e). Specifically, the post-launch product review for the ReNu with MoistureLoc Multi- Purpose Solution has not been performed as required in the formally established procedures, BLPRO-408, Project Post Launch Review. The review should occur during the first year after the product is launched. ReNu with MoistureLoc Multi-Purpose Solution was initially distributed from the Greenville site in August 2004. No post-launch has been currently done.

Your firm's response to observation 3 is partially adequate . Your firm has conducted and submitted a copy of the Post Launch Review for ReNu with MoistureLoc on June 23, 2006. Your firm has also stated that it will revise procedures to require that quality related reviews be conducted at specific post-launch time periods after product launch and train all personnel on the new procedures. Your firm also states that they will conduct reviews of quality-related information for all products that have launched within the last 24 months. This portion of your firm's response to observation 3 is inadequate as your firm has not completed these revisions and submitted them to the Agency for review . Additionally, your firm should be conducting reviews for all products lines, not only those launched in the last 24 months.

7. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements of the quality system, as required by 21 CFR 820.22. Specifically,

a) Review of the Internal Audit schedule indicated that your firm has not conducted or established a routine auditing of your complaint handling system.

b) Your firm does not have procedures defining the frequency by which supplier audits will be conducted.

c) Your firm has never audited the supplier of Polyquatemium-10 [redacted] a component used to manufacture ReNu with MoistureLoc Multi-Purpose Solution.

d) Contract laboratories/suppliers used in raw material and finished product testing have not been audited at a defined frequency. For example:

  • Lab A was last audited on December 11, 1998.
  • Supplier A was last audited on September 11, 2001.
  • The last biennial audit of Lab B was conducted on December 3, 2003.

Your firm's response to observation 11 is inadequate. Your firm has stated that it has completed audits for the supplier of polyquaternium-10 on June 2, 2006, Lab A on May 31, 2006, Lab B on May 24-25, 2006, and Supplier A on June 8, 2006, however, you did not provide documentation of these audits. Your firm has also stated that it will revise BL-PRO-1701, Global Quality System Audits, assess and modify its supplier management program, and revise metrics for the supplier management program. Your firm has not completed these revisions and submitted them to FDA for review.

8. Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality, as required as 21 CFR 820.70(e). Specifically,

a) On April 19, 2006, in the upper mix room, peeling paint and paint chips were observed on agitators located on the tops of tank [redacted], and the solenoid above tank #[redacted]. These tanks are currently used for the production of contact lens solutions.

Your firm's response to observation 7a is inadequate. Your firm has installed stainless shields in between motor housings that contain peeling paint on June 9, 2006. You have replaced painted solenoid valve housings with plastic housings on June 10, 2006, and will make other replacements by the end of 2006. Your firm will revise cleaning procedures to require periodic cleaning of stainless steel shields and revise preventative maintenance procedures to require periodic examination of agitator motor housings for condition and repair. The response is inadequate until the changes have been completed and verified by FDA.

b) The cleaning, inspection, and sanitization of fill lines #[redacted] used in the production of Opcon A, Sensitive Eyes, Boston Cleaner, and ReNu with Moisture Loc Multi-Purpose Solution were not documented as per SOP #40-102-19, "Weekly and Monthly Cleaning and Inspection of [redacted] for the monthly cleaning conducted for the month of February 2006.

Your firm's response to observation 7b is inadequate. Your firm has stated that it will retrain all site supervisors in proper change control and procedure management, however, this training has not been completed with documentation submitted to FDA for verification.

9. Failure to establish and maintain procedures to adequately control environmental conditions, as required by 21 CFR 820.70(c). Specifically, temperature conditions within the aseptic processing area are not being documented to ensure such conditions are consistently within established specifications of [redacted] degrees Celsius.

Your finn's response to observation 8 is inadequate. Your firm has stated that it has updated the Preventative Maintenance Task List to include space to record specific temperature readings on April 27, 2006. Your company has stated that it will conduct an audit to identify and enhance other temperature documentation practices and will install a continuous temperature and humidity recording system. Your firm has not provided the updated task list to FDA and the temperature audit has not been completed.

10. Failure to ensure that all equipment used in the manufacturing process meets specifications and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g) . Specifically, on March 27, 2006, clean, uncapped product transfer hoses that are used in production were observed in direct contact with a shelving unit upon which a visible layer of a white powdery residue was observed. The shelving unit was installed to prevent hoses from coming in contact with the manufacturing room floor.

Your firm's response to observation 13 is inadequate. Your firm states that it revised SOP 40-072, Routine Cleaning of the Pharmacy, Upper Mix and Lower Mix, on May 20, 2006, to require weekly cleaning of the shelving unit in the Upper Mix Area and trained personnel on the new procedures on May 23, 2006. Your firm has not submitted the revised procedures for review.

11. Failure to document maintenance activities, including the date and individuals performing the maintenance activities, as required by 21 CFR 820.70(g)(1). Specifically, integrity testing of the vent filters on the [redacted] Hot Purified Water (HPW) tanks was not conducted during the six month interval between June 2005 and March 2006 per SOP # 50-095-08.

Your firm's response to observation 14 is inadequate as your firm states that it has corrected the preventative maintenance task form to require filter testing every4Mmonths. Your firm has stated that it will revise SOP 50-001, Preventative Maintenance Program, to require that any changes to the Preventative Maintenance System go through the formal change control process as well as review changes that have been made to the Preventative Maintenance Program to ensure they are not in conflict with existing procedures . Your firm has not provided the task form and has not completed the revisions to these procedures and submitted them for review by FDA.

12. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.198(c). Specifically,

a) The Fusarium Keratitis investigation did not include sterility or biocidal testing for ReNu with MoistureLoc Multi-Purpose Solution product lots implicated in complaints received from Hong Kong.

b) Your firm had not performed sterility testing on the returned/retain samples in conjunction with the Fusarium investigation for complaints received from Malaysia and Singapore.

Your firm's response to observation 9 is inadequate. Your firm states that it has updated the complaint investigation for reports of infectious keratitis to include modified bioburden and biocidal testing for ReNu with MoistureLoc and ReNu MultiPlus on May 8, 2006. Your firm states that it will also evaluate and modify complaint investigation procedures to include modified bioburden and biocidal testing for complaint categories. Your firm has not submitted these documents for review.

13. Failure to establish and maintain procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling, as required by 21 CFR 820.140. Specifically,

a) No documentation, inspection, audit, or checklist were established or conducted to guarantee that the trucking company transporting finished product from the manufacturing plant to the distribution center is protecting materials and finished product from damage and contamination as specified in SOP #15-006-09. Additionally, the trucking company does not have a climate control system in the trailer to monitor temperature conditions.

b) There are no procedures indicating the amount of time finished products are allowed to remain stored in trailers before finding a location in the warehouse for storage. Your firm's response to observation 12 is inadequate. Your firm has stated that it will revise procedures to require transportation vehicles to be inspected before loading, after reaching the distribution center and will require them to be unloaded within [redacted] hours. However, these revisions have not been completed and submitted for review.

14. Failure to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects, as required by 21 CFR 820.150(a). Specifically,

a) On April 4, 2006, your firm was unable to locate a product lot implicated in a customer complaint, ReNu with MoistureLoc Multi-Purpose Solution, Lot# GG5055, which was identified as being part of the current inventory in your firm's validated inventory control systems [redacted] and [redacted].

b) On April 24, 2006, your firm was unable to locate sixteen (16) cases of ReNu with MoistureLoc Multi-Purpose Solution, Lot #AJ5065.

c) On May 9, 2006, your firm was unable to locate [redacted] units of ReNu MultiPlus Multi-Purpose Solution, Lot #GC6061.

Your firm's response to observation 10 is inadequate. Your firm has stated that it will revise SOP 70-126, Finished Goods Destruction Notification and Obsolete Inventory/Component Disposition, to require the tracking of lot numbers; SOP 15-057, Customer Returns Processing to clarify the documentation review process and expand the license plate numbering for customer return pallets ; SOP 15-117, Cancellation and/or Deallocation of Orders/Order Lines to include steps that will be performed by IT to modify the in-process order line status to indicate that the line item has been cancelled.

Your firm states that it will also conduct a statistical sampling of order accuracy before shipping, and modify the inventory system picking and replenishment processes to provide additional checks to ensure that only released materials are shipped, and will develop an SOP on the use and resulting actions of the Open Order Status Report in Customer Service. These tasks have not been completed and no documentation has been provided to FDA for verification.

Our inspection also revealed that your contact lens solutions are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:

Failure to submit an MDR report within 30 calendar days after receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). Specifically, a) Your firm failed to notify the Agency of 35 serious injury reports of Fusarium keratitis from Singapore's Minister of Health in February 2006 relating to ReNu with MoistureLoc Multi-Purpose Solution. None of the complaints were reported to the Agency as of April 7, 2006.

We have reviewed your response and have concluded that it is inadequate. A review of your complaint #S106000046, which concerns 26 of the cases of Fusarium keratitis reported by the Singapore MoH was conducted. The Office of Surveillance and Biometrics (OSB), CDRH, has determined that these are MDR reportable serious injuries. On April 6, 2006, your firm contacted CDRH/OSBIRSMB about the 35 cases from Singapore. Your firm was told to treat the cases as a literature report and submit a single 3500A that contained all of the information your firm had from the Singapore MoH. Your firm was also told that if it received information on new cases from Singapore MoH this information would need to be submitted as a new literature report.

The rationale provided in the file for not reporting these events at both the regulatory affairs and the corporate level is not supported by the information available to your firm.Your response states that this information did not reasonably suggest that the ReNu with MoistureLoc Multi- Purpose Solution device caused or contributed to the Fusarium infections. FDA disagrees. This information suggested that your ReNu product may have caused or contributed to the event.

Your response also states that there was insufficient information to submit MDRs. FDA disagrees. Bausch & Lomb was required to submit the 26 MDRs within 30 days of becoming aware or the events, regardless of how little information you had. Bausch and Lomb states that it did not receive adequate input from FDA as to how to submit the MDRs. However, FDA's guidance document "Medical Device Reporting for Manufacturers" has been available since March 1997 and can be accessed easily via FDA's Internet site by choosing Medical Devices, MDR reporting, and then manufacturers. This document explains that each patient event requires submission of a separate 3500A. In addition to the guidance document this site also provides contact information for OSB/RSMB.

b) Complaints #S105000240 - #S105000245 were initially reported to your firm as keratitis complaints in July 2005. These complaints have not been reported to the Agency as of May 9, 2006.

FDA agrees with Bausch & Lomb that the 6 cases of Infiltrative Keratitis included in Complaints #S105000240 - S105000245 are not reportable. It appears that your firm appropriately investigated these events and attempted to obtain additional information.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties . Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to the attention of Serene N. Ackall, Compliance Officer, at the address noted in the letterhead. If you have any questions about this letter, you can contact Ms. Ackall at 404-253-1296.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. As noted above, the specific violations noted in this letter and in the Inspectional Observations, FORM FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely,

Mary H. Woleske
Director
Atlanta District Office

]]> Clarifying the View of Contact Lens Care http://www.yourlawyer.com/articles/read/12115 Tue, 05 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12115
Recently however, Bausch and Lomb have entered the news again. The news headlines are quite attention grabbing: "Contact Lens solution eyed in fungus outbreak"; "The eye fungus among us thanks to MoistureLoc"; "Bausch and Lomb issues Renu contact lens solution doctor advisory".

As contact lens users here can confirm, buying contact lens solution in Ukraine can be a bit of a challenge. Only certain pharmacies and official optical shops sell solution, usually at higher prices than we are used to paying elsewhere. Also, Bausch and Lomb seem to have something akin to a monopoly in Kyiv. In fact, I have yet to see another brand of contact lens solution on display. Bausch and Lomb's Renu solution is considered one of the top brands of lens solution, so up until recent events, such a monopoly has been the least of our eye care worries. Now the situation seems less clear.

It turns out a naturally occurring fungus named fusarium, usually only found in plants and soil, has formed an alliance with one of the components in Renu multipurpose contact solution with MoistureLoc. The result is an eye fungus that can lead to blindness (or a necessity of cornea transplants) if not treated quickly. Symptoms of the eye fungus include blurry vision, pain or redness, increased sensitivity to light and excessive discharge from the eye, but it is not transmitted from person to person.

Interestingly, this eye fungus only occurs in users of contact solution with MoistureLoc. People who use Renu multipurpose contact solution without the MoistureLoc component are unaffected. Bausch and Lomb is still trying to determine why and how the fungus is interacting with the contact solution that contains 'MoistureLoc', but in the meantime has advised contact lens wearers to use the solution without it.

This is easier said than done around here. I went searching for Renu contact solution without MoistureLoc and found that most places are still selling the solution with the additive in question. I finally located plain multipurpose solution in a state pharmacy, and promptly bought a bottle and began to use it instead of my potentially fungus inducing MoisureLoc one. If you choose to continue using the bottle you have, I recommend being more vigilant about lens hygiene than usual and if you start to develop any of the above mentioned symptoms, get medical help immediately. Many things can be replaced, but eyesight is not one of them.
]]> ReNu with MoistureLoc Still Sold in Ukraine http://www.yourlawyer.com/articles/read/12439 Tue, 05 Sep 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12439
Last month, the CDC issued the results of a study that found that ReNu with MoistureLoc lacked the necessary sterilization qualities to prevent eye infections with normal lens use. The report found that the outbreak of Fusarium keratitis was directly associated with the use of ReNu with MoistureLoc, and that the unique properties of the solution may have contributed to the outbreak of fungal infections. The CDC study also found that suboptimal hygiene practice appeared unlikely to contribute to the outbreak, and that biofilm on the contact lenses or contact lens cases may have played a role in causing the spread of Fusarium keratitis.

Fusarium keratitis is a severe fungal infection of the cornea that can result in permanent blindness. First-line treatment includes topical and oral antifungal medications; patients who do not respond to these treatments usually require surgical intervention, including corneal transplant. While Fusarium keratitis has been primarily linked to ReNu with MoistureLoc, many doctors and researchers believe that all multi-purpose contact lens solutions may be associated with dangerous infections.
]]> Parker & Waichman, LLP Commends JAMA Study On ReNu With MoistureLoc http://www.yourlawyer.com/articles/read/12110 Thu, 31 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12110
Parker & Waichman, LLP believes the following findings in the CDC report establish that ReNu with MoistureLoc lacks the necessary sterilization qualities to prevent eye infections with normal lens use.

  • The outbreak of Fusarium keratitis was associated with the use of ReNu with MoistureLoc
  • The unique properties of ReNu with MoistureLoc formula may have contributed to the outbreak of fungal infections
  • The Fusarium keratitis was likely caused as a result of extrinsic contamination of the contact lens solution bottle or contact lens cases outside the manufacturing or storage process
  • Suboptimal hygiene practice appeared unlikely to contribute to the outbreak
  • Biofilm on the contact lenses or contact lens cases may have played a role in the outbreak
  • Some hygiene practices may have facilitated the growth of biofilms
  • Fusarium may have specific qualities promoting adherence and penetration into the contact lenses that allow survival within contact lens cases when used with ReNu with MoistureLoc

Parker & Waichman, LLP believes the CDC report did not go far enough as to some of above areas.

The report also indicated that the first report of Fusarium keratitis in the United States was made by Dr. David S. Chu, a New Jersey ophthalmologist and a specialist in cornea diseases on March 8, 2006. This contradicts what Dr. Levy, the Chief Medical Officer of Bausch & Lomb, told the Rochester Democrat Chronicle in their April 21, 2006. In this story Dr. Levy claimed that Bausch & Lomb was the first to notify the CDC of Dr. Chu's report to them. This revelation appears to demonstrate that Bausch & Lomb knew about the association of ReNu with MoistureLoc's link with Fusarium keratitis in the United States at least a month and a half before they notified any regulatory or health agency. This, on top of the notice that Bausch & Lomb had from Asia regarding the association of ReNu with MoistureLoc with Fusarium keratitis is very significant.

Fusarium keratitis is a severe infection of the cornea. Risk factors for infection usually include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and, rarely, contact lens use. An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users. Fusarium keratitis is more prevalent in warm climates. First-line treatment includes topical and oral antifungal medications; patients who do not respond to these treatments usually require surgical intervention, including corneal transplantation. These fungal infections are not transmitted from person to person.

In addition, Parker & Waichman has received thousands of inquiries from contact lens wearers who have contracted other types of microbial keratitis including bacterial, acanthamoeba and viral keratitis from other Bausch & Lomb multipurpose contact lens solutions as well as from multipurpose contact lens solutions from other manufacturers.

As the accompanying commentary to the CDC report in the August 23rd edition of JAMA noted, "The broader question that deserves further attention is whether multipurpose contact lens solutions although more convenient to use, are less effective against fungi than lens care systems that use a separate disinfection solution, such as hydrogen peroxide." We think that statement, while enlightening, needed to include the other forms of microbial keratitis.

About Parker & Waichman, LLP

Parker & Waichman, LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker & Waichman, LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medications and medical devices. Parker & Waichman, LLP was the first law firm nationwide to file a class action on behalf of victims of ReNu with MoistureLoc. The class action seeks, among other remedies, a medical monitoring fund to enable consumers to obtain medical screening and treatment services. In addition to ReNu with MoistureLoc, Parker & Waichman, LLP is currently representing victims of Guidant Defibrillators, Zyprexa, Ortho Evra Patch, Ketek, Tequin, Fosamax, DES, Mirapex and other defective medications and medical devices. For more information on Parker & Waichman, LLP please visit: http://www.yourlawyer.com or call (800) LAW-INFO ((800) 529-4636).

CONTACT:  Parker & Waichman, LLP
          Jason Mark, Esq.
          Melanie H. Muhlstock, Esq.
          (800) LAW-INFO
          (800) 529-4636 -- toll-free
          info@yourlawyer.com
          http://www.yourlawyer.com
]]> Bausch & Lomb ReNu with MoistureLoc Recall History http://www.yourlawyer.com/articles/read/12440 Mon, 28 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12440 ReNu with MoistureLoc was removed from the market after the CDC discovered numberous cases of fusarium keratitis were linked to the product. The recall has slowed the outbreak of the fungal eye infection but it is estimated that MoistureLoc still holds over 2 percent of the market, because many people are still unaware that the solution has been recalled. Below is a detailed timeline of Bausch Lomb’s ReNu with MoistureLoc.

May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution:

Description of the Device Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001 %). (emphasis added)
May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution: Description of the DeviceBausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001 %). (emphasis added)Note: This is a Multi-Purpose Solution that is essential the same as ReNu with MoistureLoc, accept it uses PHMB as a disinfectant.

May 5, 2003 – Bausch & Lomb filed a Summary 510(k) (K031646) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC03”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution”. Under “Predicate Devices”, Bausch & Lomb describe the solution: Description of the Device Bausch & Lomb Multi-Purpose Solution NRC03 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with polyaminopropyl biguanide (0.0001 %). (emphasis added)Note: This is a Multi-Purpose Solution that is essential the same as with MoistureLoc, accept it uses PHMB as a disinfectant. December 11, 2003 – Bausch & Lomb filed a Summary 510(k) (K033854) for a product they called “Bausch & Lomb Multi-Purpose Solution NRC07”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution” and “Bausch & Lomb Multi-Purpose Solution NRC03”. Under “Predicate Devices”, Bausch & Lomb describe the solution:

Description of the Device

Bausch & Lomb Multi-Purpose Solution NRC07 is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with Alexidine dihydrochloride (0.00045%). (emphasis added)

NOTE: 2 observations regarding the May 5 and December 11, 2003 entries. They are the identical product except for the preservative used. Except that the preservative used in the May 5th filing was PHMB, and the preservative used in the December 11th filing was alexidine. Both 510(k)’s were filed using the incorrect “Proprietary Name” which should have been the name of the product intended to be used in marketing.

December 14, 2003 – The Food and Drug Administration (FDA) approved Bausch & Lomb’s 510(k) (K031646) for “Bausch & Lomb Multi-Purpose Solution NRC03”.

May 19, 2004 – The Food and Drug Administration (FDA) approved Bausch & Lomb’s 510(k) (K033854) for “Bausch & Lomb Multi-Purpose Solution NRC07”.

Note: This is ReNu with MoistureLoc.

4th Quarter, 2004 – Bausch & Lomb, with much fanfare, launched ReNu with MoistureLoc.

June 29, 2005 – Bausch & Lomb filed a Summary 510(k) (K051755) for a product they called “Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution”. As a “Predicate Device”, they list among others “Bausch & Lomb MultiPlus Multi-Purpose Solution” and “Bausch & Lomb Multi-Purpose Solution NRC03”. Under “Predicate Devices” and “Description of Device” Bausch & Lomb describes the solution:

Predicate DevicesAlcon OPTI-FREE Express Multi-Purpose Disinfecting Solution and Ciba Vision AQuify Multi-Purpose Solution have been selected as the predicate devices for Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution.

Description of Device

Bausch & Lomb ReNu with MoistureLoc Multi-Purpose Solution is a sterile isotonic solution containing boric acid, sodium chloride, sodium phosphate, Hydranatee (hydroxyalkylphosphonate), poloxamer 407, polyquatemnium- 10, poloxamine 1107, purified water and preserved with alexidine dihydrochloride (0.00045%). (emphasis added)

NOTE: The only difference in this 510(k) and in the 510(k) for “Bausch & Lomb Multi-Purpose Solution NRC07” is a new indicated use was added for “silicone hydrogel lenses”.

NOTE: This 510(k) did not reference as a “Predicate Device” either of the 2 previously filed and approved devices for “Bausch & Lomb Multi-Purpose Solution NRC03” or “Bausch & Lomb Multi-Purpose Solution NRC07”. Interestingly, NRC07 is ReNu with MoistureLoc.

NOTE: About this time, reports from Asia are coming out regarding an increase in Fusarium keratitis. See: July, 2005. Is it reasonable to think Bausch & Lomb had spontaneous reports prior to the July, 2005 meeting?

July, 2005 – Ophthalmologists at the Hong Kong Hospital Authority, while holding a periodic review, voiced concern about “an unusually high yield of Fusarium from patients’ clinical specimens sent for culture” (per the authority pronouncement on May 20, 2006).

August, 2005 – Hong Kong Health Department put out a public alert about a recent outbreak of 4 cases of keratitis. They warned the public to clean contact lenses carefully. No connection to Bausch & Lomb ReNu products is mentioned.

October 20, 2005 - Hong Kong health officials formally placed Bausch & Lomb on notice of a potential link between the outbreak of keratitis and ReNu with MoistureLoc. Apparently Bausch & Lomb didn’t inform the Food and Drug Administration (FDA) of this notification, the Singapore Ministry of Health (MOH) or Malaysia health department of the Hong Kong action.

November 11, 2005 – After no response by Bausch & Lomb to the October 20, 2005 notice, Hong Kong health officials again formally placed Bausch & Lomb on notice of a potential link between the outbreak of keratitis and ReNu with MoistureLoc. Apparently Bausch & Lomb didn’t inform the Food and Drug Administration (FDA) of this notification, the Singapore Ministry of Health (MOH) or Malaysia health department of the Hong Kong action.

November 17, 2005 – The Food and Drug Administration (FDA) approves the 510(K) filing by Bausch & Lomb for ReNu with MoistureLoc, issuing a “substantially similar” letter to Bausch & Lomb regarding their Summary 510(K) application.
December, 2005 – Malaysia health department started an investigation into the spike of fugal corneal infections recently observed in Malaysia.

]]> Lens solution blamed for eye infection http://www.yourlawyer.com/articles/read/12086 Wed, 23 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12086 A U.S. agency and eye doctors reportedly agree the ReNu With Moisture Loc contact lens solution alone was responsible for an eye infection outbreak this year.

But the research led by Dr. Douglas Chang, a fungal disease specialist at the Centers for Disease Control, said it was not clear how the solution made by Bausch & Lomb caused the problem, reports The New York Times. The findings are to be published in The Journal of the American Medical Association.

In an accompanying commentary in JAMA, two academic researchers urged more study to determine the safety of various brands of "multipurpose" lens care solutions, the report said.

On Moisture Loc, Bausch & Lomb had cited as a major factor for the outbreak customer failure to properly clean their lenses and regularly replace the storage solution, the Times reported.

Bausch & Lomb withdrew Moisture Loc from U.S. markets in April and later announced a worldwide recall. The latest study said the number of confirmed new infection cases has slowed to a trickle since the recall, the report said.

It also found no evidence of unusual risks with ReNu MultiPlus, which Bausch is using as a replacement.

]]> CDC Report on ReNu with MoistureLoc May Exacerbate Legal Problems for Bausch & Lomb http://www.yourlawyer.com/articles/read/12441 Wed, 23 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12441
As of June 30, the researchers had identified 164 confirmed cases of the fungal infection fusarium keratitis. Of those, 94 percent, or 154 patients, wore soft contact lenses. Infected patients came from 33 states and one U.S. territory and about 34 percent of them required a corneal transplant. According to the study, infected contact lens wearers were 20 times more likely to have used Bausch & Lomb’s ReNu with MoistureLoc lens solution than another solution.
While the number of reported CDC cases is alarming, a prominent plaintiff attorney believes the number of infected patients could be in the thousands. Jerrold Parker, a founding partner of Parker & Waichman, LLP, said his firm has already been retained by over 600 plaintiffs and they continue to evaluate hundreds of additional cases. Mr. Parker indicated that his firm is also investigating the disinfectant qualities of other multi-purpose solutions. Some researchers believe that all multi-purpose contact lens solutions fail to effectively sterilize contact lenses.

In the meantime, CDC researchers appear happy that they’ve begun to understand what lead to the fungal outbreak. “We feel pretty confident that the outbreak is over,” said CDC researcher Benjamin Park, who has studied the outbreak since the first reports of the infection in the United States in early March. The report by Park and colleagues at the CDC in Atlanta appeared in the August 23-30 issue of the Journal of the American Medical Association.
]]> CDC: B&L methods not to blame in infections http://www.yourlawyer.com/articles/read/12074 Tue, 22 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12074
The Centers for Disease Control and Prevention have said in an article to be published tomorrow that it was “unlikely” that B&L’s ReNu with MoistureLoc solution came into contact with the fungus causing the infection during the production process.

Instead, the study to be published in the Journal of the American Medical Association, suggests that the outbreak of Fusarium keratitis, a sight-threatening infection, “may” have been caused by a complex and undetermined interaction between MoistureLoc, the Fusarium fungus and, possibly, the lens case or contact lens itself.

B&L said the CDC study “confirms that Bausch & Lomb took the right action in the interests of consumer health and safety by recalling the MoistureLoc product, and that Bausch & Lomb can continue to recommend its ReNu MultiPlus solution with confidence.”

The major conclusion of the study, according to its chief author, is to confirm that contact lens wearers should not use ReNu with MoistureLoc. B&L recalled the product worldwide in mid-May.

Investigators noted that MoistureLoc contains two ingredients not found in other soft contact lens solutions currently on the market, and that those unique properties “may have contributed” to fungal infection in certain instances.

The CDC’s results support both preliminary conclusions made by the Food and Drug Administration in May as well as the company’s own investigation. Executives told the Democrat and Chronicle in May that there was enough evidence to show that a polymer in the formula was an inadvertent culprit.

“This has been a very unique situation, a very unique outbreak,” said Dr. Douglas Chang, an officer with the epidemic intelligence service with the CDC.

The CDC said in its paper it had identified 164 cases of Fusarium by June 30. Those with the infection were statistically more likely than not to be users of MoistureLoc.]]> Bausch & Lomb lens debacle studied http://www.yourlawyer.com/articles/read/12076 Tue, 22 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12076
Earlier this year, the product which Bausch & Lomb withdrew from the market -- was blamed for an outbreak of the corneal infection Fusarium keratitis in contact lens wearers.

Fusarium keratitis, a fungal infection of the cornea, can lead to permanent blindness or the need for corneal transplantation.

The Centers for Disease Control and Prevention (CDC) said it has received 164 reports of Fusarium keratitis infections between March and June 30, 2006.

Fifty-five of these patients required corneal transplants.

In response, CDC researcher Douglas Chang led a group of scientists in a search to determine the specific activities, contact lens hygiene practices, or products associated with the outbreak.

Since 94 percent of the infected patients wore soft contact lenses, the team compared data on 45 of them with data on 78 healthy, lens-wearing controls. They discovered that patients were 20 times more likely than the control group to report that they used ReNu with MoistureLoc.

The use of ReNu MultiPlus solution was similar among case patients and controls and was not associated with the infection.

No infection was found at the manufacturer's factory, warehouse, or in unopened solution bottles of implicated lots, so the team has hypothesized that contamination took place in patients' homes and the solution was not able to neutralize the organism.

The researchers said they are conducting tests to confirm their theory, but have advised all soft contact lens wearers to discontinue the use of the product.

The CDC report appears in the August 23/30 issue of the Journal of the American Medical Association.]]> More Data On Lens Solution Infection http://www.yourlawyer.com/articles/read/12077 Tue, 22 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12077 Users of a recently recalled contact lens solution by Bausch & Lomb were more than 20 times as likely to develop a potentially blinding eye infection as nonusers.

The CDC study released today shows that 164 confirmed cases of the corneal infection Fusarium keratitis were reported in 33 states and a U.S. territory from June 1, 2005 to June 30, 2006. Ninety-four percent of those cases were among soft contact lens wearers.

When researchers compared the risk of infection among contact lens wearers, they found users of the recalled contact lens solution, ReNu with MoistureLoc, were more than 20 times as likely to develop the infection as nonusers.

Preliminary findings from this CDC investigation were released in May and prompted the withdrawal of ReNu with MoistureLoc from the market worldwide.

Where Did the Fungus Come From?

The complete report, published in JAMA, the Journal of the American Medical Association, provides further details of the link between a rare type of eye infection and the contact lens solution.

Fusarium is a fungus found in soil and plants. Beginning in March 2006, the CDC began to receive multiple reports of corneal infections caused by this fungus among contact lens wearers.

The condition is a serious complication that can lead to permanent vision loss or the need for a corneal transplantation. The cornea is the clear, thin layer of tissue that covers the iris (the colored part of the eye) and the pupil.

Overall, the study showed that 34 percent of the 164 corneal infection cases reported required corneal transplantation.

Researchers say it's still not clear what exactly caused the eye infections to develop. Testing of the factory where the contact lens solution is produced did not show evidence of the fungus.

The problem was likely due to outside contamination that did not occur during the manufacturing process, according to researcher Douglas C. Chang, MD, of the CDC, and colleagues.

They add it's unlikely the main cause for the outbreak could be poor contact lens hygiene habits.

"Ongoing studies may help to determine if the infections were caused by an interaction of its ingredients with Fusarium that might have permitted growth of the organism," conclude the researchers.

Meanwhile, users of Renu with MoistureLoc are urged to stop using the product; report any infections to their eye care professional; and pay careful attention to eye hygiene practices, including washing and drying hands prior to handling lenses, storing lenses in new contact lens solution after each use, and carefully following directions for use of contact lenses and contact lens solution products.
Tips for Preventing Eye Infections

Good contact lens hygiene is recommended even though this Fusarium outbreak does not appear to have been caused by poor contact lens cleaning.

In April, the FDA offered tips to help prevent eye infection in contact lens wearers:

  • Stop using Bausch & Lomb ReNu with MoistureLoc products and discard all remaining MoistureLoc solution, including partially used or opened bottles.
  • Consult your eye care professional for a recommendation for an appropriate alternative cleaning/disinfecting product.
  • Consider performing a "rub and rinse" lens cleaning method, rather than a no-rub method, regardless of which cleaning/disinfecting solution is used. That will minimize the number of germs and reduce the chances of infection.

 

Continue to follow proper lens care practices:

  • Wear and replace lenses according to the schedule prescribed by the doctor.
  • Wash hands with soap and water, and dry (lint-free method) before handling lenses
  • Follow the specific lens cleaning and storage guidelines from your doctor and the solution manufacturer.
  • Keep the contact lens case clean and replace every 3 to 6 months.
  • Remove the lenses and consult your doctor immediately if you experence symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge, or swelling.

The FDA has posted these updated recommendations for health care providers:

  • Advise patients to stop using Bausch & Lomb ReNu with MoistureLoc products immediately, discard all remaining MoistureLoc solution, and use an alternative cleaning/disinfecting product.
  • If a patient has microbial keratitis, consider that a fungal infection may be involved. Prior to initiating immediate treatment, an eye care professional should obtain a specimen for laboratory analysis.
  • Report cases of fungal keratitis in contact lens wearers to the FDA.
]]> Eye fungus culprits: solution, hygiene http://www.yourlawyer.com/articles/read/12078 Tue, 22 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12078
The report, in this week's Journal of the American Medical Association, said there were 164 confirmed cases. Users of the ReNu with MoistureLoc solution were 20 times more likely to get the infection than people who did not use that brand.

"We found that overwhelmingly MoistureLoc contact lens solution posed a high risk," said Dr. Benjamin J. Park, an epidemiologist on the investigative team at the Centers for Disease Control and Prevention. "The source of the infection was people's homes."

Park said that the "genetic diversity" of the fungus, Fusarium keratitis, they found after tests of contact lens cases, the factory and unopened bottles indicated that improper care contributed to the outbreak.

"This bug is a fungus that can be found in many different areas, including sinks and drains. The next question is why this one solution," Park said.

Dr. Marcelle Morcos, chief of the ophthalmology at the Nassau University Medical Center, said eye care experts speculate that a special disinfectant in the solution was the culprit.

"When it dries a little on the cornea it could be a good .medium for the fungus to grow," Morcos said. "There could have also been outside contamination."

Fifty-five people, or 34 percent, needed a corneal transplant, the report found.

In an accompanying commentary, other researchers called for additional study of all multipurpose lens-care solutions being sold similar to MoistureLoc to determine their safety.

In a statement on its Web site acknowledging the CDC report, Bausch & Lomb said: "We are working with eye care practitioners to create an ongoing discussion with contact lens wearers about proper care of their lenses and their eyes."

The company pulled MoistureLoc from the market in early April when the CDC announced it was investigating the outbreak.

The eye fungus infection whose symptoms include blurred vision can scar the cornea and blind its victims.

Park said that the CDC's investigation continues.]]> Eye cleanser now off the market http://www.yourlawyer.com/articles/read/12075 Tue, 22 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12075
Researchers investigated the infection outbreak and its link to the solution and found that while there was a connection, proper lens hygiene still plays an important role.

Renu with Moistureloc, a contact lens cleaning solution that was taken off the market in May after some people using it got a painful eye infection called Fusarium Keratitis.

Benjamin Park of the U.S. Centers for Disease Control and Prevention says, "This Fusarium Fungus is very common and is in fact everywhere in the environment. It's very commonly found in bathrooms and sinks and other water sources.”

Dr. Benjamin Park and his colleagues at the U.S. Centers for Disease Control and Prevention collaborated with health officials from 33 states, and with the Food and Drug Administration, to investigate the Fusarium infection outbreak.

Their findings appear in JAMA, the Journal of the American Medical Association.

Park also says, "There were 164 confirmed cases of Fusarium Keratitis and we found that users of Bausch and Lomb's Moistureloc solution were over 20 times more likely to get this infection than people who didn't use this solution."

In about 1/3 of the cases, the infection was so severe that patients required a corneal transplant to prevent blindness. Investigators found no contamination in the manufacturing process, or in any of the contact lens products they tested, so what's the link between Moistureloc solution and this infection?

Park says, "That is really the subject of more research, to figure out exactly what it is about the composition of the solution that allows the Fusarium fungus to grow."

Dr. Park says regardless of the solution, practice proper lens cleaning and care. Contact lens expert Michael Ward agrees. Ward of Emory Eye Center says,” Infections are rare and they're usually caused by a breakdown in hygienic practice. Of course the number one thing everyone needs to do is wash their hands prior to ever touching the contact lens."

He says this much is clear to see, following your doctor's instructions for usage, care and cleaning of your lenses will help protect your eyes from infection.

Bausch and Lomb took its Moistureloc formula off the market in May and since then there have been very few reported cases of this infection.]]> One-Third of Infected ReNu with MoistureLoc Users Needed Corneal Transplants http://www.yourlawyer.com/articles/read/12442 Tue, 22 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12442
ReNu with MoistureLoc, was removed from worldwide markets in May after it was linked to several cases in the United States and Asia of fusarium keratitis, a serious fungal infection that can cause blindness.Between June 1, 2005 and June 30, 2006, the CDC said it identified 164 confirmed cases of fusarium keratitis in the U.S. Of those, 94 people reported using ReNu with MoistureLoc and another 21 people reported using that solution along with others to clean their contact lenses. The May CDC report confirmed 130 cases of the eye infection in the United States. Researchers said 55 people either underwent or planned to have a corneal transplant as a result from damage caused by the infection.

“We think that there’s something about the chemical make-up of the solution that allows the fungus to grow and cause infection,” said study senior author Dr. Benjamin J. Park, medical officer with the U.S. Centers for Disease Control and Prevention. “We don’t know the exact mechanism, but it’s important that users of solution don’t use Moistureloc.”

Numerous lawsuits have already been filed against Bausch & Lomb on behalf of people injured by ReNu with Moistureloc. The number of cases is expected to rise dramatically as attorneys are able to clearly link the eye infections with the Moisureloc solution. Parker & Waichman, LLP, a New York personal injury law firm, confirmed that they have been retained by over 600 ReNu users who claim to have been injured by the products. The firm, which has already filed several cases against Bausch & Lomb, plans to file hundreds of additional cases over the next 12 months.]]> Recalled contact solution from Bausch and Lomb a source of pain for some in Grand Island http://www.yourlawyer.com/articles/read/12048 Wed, 09 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12048
"I was fortunate we were able to catch it when we did," said Branting, who lives in Shelby. "If it had gone untreated much longer, it could have done serious damage. Right now, I don't think there's any major vision loss."

Branting contracted a fungus in her eye known as Fusarium Keratitis, most likely from a recalled contact solution called ReNu with MoistureLoc distributed by Bausch and Lomb. While the company recalled the product in March because of problems with Fusarium Keratitis, Branting, who works at Annie Jeffrey Memorial Hospital in Osceola, didn't hear of the recall.

Now that her ordeal is almost over, after she painfully applied medication every hour and underwent procedures where doctors scraped her cornea, she's keen to let others who might still be using the product know of the dangers.

She's not alone. Dr. Michelle Gleason of Gleason-Janky Eye Physicians in Grand Island said she has seen patients still using the ReNu with MoistureLoc months after the recall went out.

"I had a patient (Branting) who had an infection and did OK with it, but I had a patient come in recently who was still using that solution," she said. "Sometimes people buy a lot at a time and they could be at risk. We wanted the public to be very aware of this situation."

Gleason said if you've used ReNu with MoistureLoc recently and not suffered any symptoms such as pain or intense itching, you have nothing to worry about but should throw away the rest of your supply.

If you've used it in the past and not seen any symptoms, you're similarly in the clear, though Gleason said you're at risk if you continue to use the solution.

Fusarium Keratitis begins with minor irritation but progresses quickly. In Branting's case, she first noticed a problem on a Saturday and experienced intense pain the next day while traveling to Omaha to take her daughter to Children's Hospital, where she had a surgery scheduled.

"It was so bad I walked across the street (from Children's Hospital) and went to the ER at Methodist," she said. "By that Tuesday, I couldn't even function. I couldn't tell how bad it hurt. It felt like there were razor blades in my eye."

The ER initially diagnosed her problem as "gouges in my cornea," but when the problem didn't resolve itself, Branting sought out a specialist and found Gleason. To treat the infection, Gleason prescribed drops that caused blistering on Branting's eyelids and had to be administered once an hour, every hour, even during the night.

While the disease is serious, it appears as if Branting escaped any major lasting damage to her eyes. But it's too early to be sure. More importantly, she knows of others who didn't hear about the recall and were using ReNu with MoistureLoc, unaware of the possible dangers.

Gleason says it's important for people to understand eye disease and work to prevent it.

"Any time a patient has a red eye, they need to come in and be seen," she said. "The earlier we catch this stuff, the better."]]> Experts: Lens solution still a risk http://www.yourlawyer.com/articles/read/12032 Mon, 31 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12032
And they need to stop now.

"I've just seen too many patients and too many problems with it," he said.

The product was recalled May 15 voluntarily by its manufacturer, Bausch & Lomb, but the UI Hospitals and Clinics are still experiencing MoistureLoc effects. Goins said he has approximately a dozen cases presumed to be related to use of the solution.

The company removed it from the market because of its possible link to Fusarium keratitis, a dangerous, sight-threatening fungus infection.

"(The infection) is very difficult to treat," said Goins, who specializes in corneal and external diseases. "In our series here, about 25 percent of those patients have needed cornea transplants."

The U.S. Centers for Disease Control and Prevention reported an increased risk for the infection among MoistureLoc users, although the cause of the association is not clear.

Christine Sindt, a UI clinical assistant professor of ophthalmology, noticed a problem with the solution almost two years ago when she conducted her own informal study. When MoistureLoc was released in November 2004, she was eager to create a personal assessment of it.

"I always like to test the new products test-drive them, so I can develop an opinion," Sindt said.

Contact lenses sat soaked in three different solutions overnight. The following day, Sindt examined five volunteers from her office for corneal staining, the presence of dead cells on the eye. Volunteers then wore a pair of the contacts for one to two hours and were examined again.

Sindt, also the director of UIHC's contact-lens service, said the lenses soaked in MoistureLoc produced an "unusual" amount of staining, named because of a dye's adherence to dead cells.

She immediately expressed her concern with Bausch & Lomb's public relations director, who told her he was certain the solution had undergone appropriate studies and had passed. When the director, Fred Edmunds, said the company had not conducted tests that could measure corneal damage over time, she urged him to do so.

"The eye heals itself in about eight hours," Sindt said. "So the most staining would be noticeable in one to two."

Then, she waited.

"I felt like at that time I had done my part to voice my concern, and I handled the information appropriately within my own practice when I recommended solutions to my own patients," Sindt said.

Meanwhile, contact wearers worldwide using the MoistureLoc solution began reporting cases of fungal infections.

Goins said Sindt developed the theory that a new preservative in the formula could get "trapped" in the lens, causing both the corneal staining and infection vulnerability.

"If her theory is true," he said, "the increased preservative in the lens would lead to a breakdown in corneal epithelial surface cells, thereby allowing pathogens direct access to the cornea, so they may be directly linked."

Bausch & Lomb, in a report issued May 19, stated it will continue searching for a cause of Fusarium keratitis. Representatives from the corporation could not be reached for comment Thursday afternoon.

With MoistureLoc pulled from store shelves, the threat of its damage remains behind medicine cabinet doors. And until the culprit causing these infections is identified and its inclusion in future solution products permanently banned, Sindt wants only to know one thing: "How long can you beat a dead horse?"
]]> de la O, Marko, Magolnick & Leyton, P.A. and Parker & Waichman, LLP to Represent Citizens of Asia Against Bausch & Lomb, Maker of Renu With MoistureLoc Contact Lens Solution - BOL http://www.yourlawyer.com/articles/read/12011 Fri, 21 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12011
One of the Asian clients, Teck-Meng Yong, was one of the first ReNu victims in Singapore to undergo a corneal transplant as a result of severe damage caused by the Fusarium fungus he contracted while using Bausch & Lomb's ReNu with MoistureLoc(r) brand contact lens solution. Another client from Asia is 19 year old Jermaine Tan, also from Singapore. In January of this year, Mr. Tan also underwent a corneal transplant as a result of severe damage caused by the Fusarium fungus contracted while using ReNu with MoistureLoc(r). Joel Magolnick, a partner at de la O, Marko, Magolnick & Leyton, stated, "According to Jermaine's doctors, the Fusarium fungus had almost eaten all the way through the cornea. One more day and it could have been too late. If Jermaine had not been treated in time, doctors would have had to remove his entire eye." Jermaine Tan has only recovered about 60 percent of the sight in his left eye, and his vision remains impaired.

Fungal keratitis is a severe infection of the cornea. Fusarium keratitis, one type of fungal keratitis, is often accompanied by symptoms of eye pain/discomfort, excessive watering or discharge from the infected eye, decrease in vision and increased sensitivity to light. Risk factors for infection usually include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies and, very rarely, contact lens use. An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users. Fungal keratitis is a condition more prevalent in warm climates. First-line treatment includes topical and oral antifungal medications; patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. These infections are not transmitted from person to person. If not timely treated, Fusarium keratitis may lead to complete destruction of the cornea and loss of the eye itself.

In February 2006, Bausch & Lomb ceased sales of all ReNu(r) solutions in Singapore and Hong Kong after many users of ReNu with MoistureLoc(r) were diagnosed with Fusarium Keratitis. As of May 2006, researchers in Singapore had found 80 cases of Fusarium keratitis among contact lens wearers, nearly all of whom used ReNu with MoistureLoc(r).

On May 15, 2006, Bausch & Lomb announced that it was permanently removing ReNu with MoistureLoc(r) from the market worldwide. That same day, the FDA issued a press release stating: "Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide." The recall followed Bausch & Lomb's conclusion that the product's formula may increase the risk of fungal eye infections in certain situations. Bausch & Lomb, Inc. and the FDA both acknowledged there is a problem in the chemical properties of ReNu with MoistureLoc after testing confirmed that the solution allows a polymer film to form around the Fusarium fungus, preventing the disinfectant in the product from killing the fungus.

More information on this and other class actions can be found on the Class Action Newsline at www.primezone.com/ca

CONTACT: de la O, Marko, Magolnick & Leyton, P.A.
         Joel S. Magolnick, Esq.
         (305) 285-2000
         Toll free: (888) 893-5723
         magolnick@dmmllaw.com
         www.dmmllaw.com
         
         Parker & Waichman, LLP
         Jason Mark, Esq.
         (212) 267-6700
         Toll free:  800-LAW-INFO
         or (800) 529-4636
         info@yourlawyer.com
         www.yourlawyer.com
         www.renulawsuit.com
]]> Consumers plan lawsuit against contact lens maker http://www.yourlawyer.com/articles/read/11972 Tue, 11 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11972 Nearly 80 Chinese citizens who claim they suffered eye infections caused by a contact lens solution made by Bausch & Lomb plan to sue the company in the United States.

They believe they contracted fungal keratitis, which can lead to blindness, after using ReNu MoistureLoc Multi Purpose Solution.

The lawyer representing the group, told China Daily yesterday that less than 10 had so far provided sufficient evidence to back up the claims.

"I have sent full medical documents of three infections to my partner in the United States," he said yesterday.

Sources with Bausch & Lomb China said they would not comment over the cases until they had been processed, China Business News previously reported.

The Chinese lawyer, said he believes the company made a mistake by not informing Chinese consumers of the quality problem after it recalled products in Singapore in February.

Where exactly to sue the US company has not yet been decided, the lawyer said.

"To sue Bausch & Lomb in New York State, where its headquarters are located, is a possibility. But we are also considering suing the company in a state where higher compensation is likely," the  lawyer said. A date has yet to be fixed to file the lawsuit, he added.

In the United States, the number of confirmed cases of the rare fungal eye infection that can cause blindness has climbed to 122. Most of them are contact-lens wearers who reported using Bausch & Lomb's ReNu MoistureLoc Multi Purpose Solution, US authorities said in May.

It is believed that some American consumers have brought lawsuits against Bausch & Lomb for compensation. No judgements have been reported yet.

Reports in April said that Bausch and Lomb found no eye infections in China linked to the cleaning solution. Company chief executive Ronald Zarrella said that in China the solution was made locally and not imported from the United States.

]]> Healthcare professionals in ReNu study honoured http://www.yourlawyer.com/articles/read/11966 Mon, 10 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11966
These professionals have been honoured for not only daring to take on a pharmaceutical giant but also for saving the sight of many contact lens users.

The team of eye doctors and researchers were the first in the world to discover the link between Bausch and Lomb's ReNu MoistureLoc contact lens solution and the rising cases of fungal corneal infections.

The discovery came after some nifty investigation work, and throughout the investigation process, high stakes were involved.

Health Minister Khaw Boon Wan said: "Certainly when you decide to do something like this, you're taking on a very big multi-national corporation and as I said, they're armed with teams of (scientists and) lawyers. And if the advisory was pre-mature or without basis, or could not be proven, I'm quite sure there'll be a legal suit on our table.

"But more than legal suits, it's also our own reputation. In this instance, the reputation of SNEC and of course Ministry of Health and Singapore. So I'm quite glad. More importantly it ended up well."

Associate Professor Donald Tan, Deputy Director of the Singapore National Eye Centre (SNEC), said: "I think it was speed which saved a lot of patients, not only in Singapore but also elsewhere. So we're very happy that we were able to do that.

"In the US, one third of the patients actually required corneal transplants. So it's very severe, and a lot of it is because of delayed diagnosis. For us, we have five transplants out of 68 cases. So the severity was much less. So our patients did not suffer as much. They had better visual outcomes because we got into it earlier."

To recognise their vigilance, professionalism, dedication and courage, the team of eye doctors and researchers were given the Health Minister Awards on Monday.

Another team of healthcare professionals also received the Minister of Health award.
]]> Stores Wipe Eye Solution Off Shelves, Finally! http://www.yourlawyer.com/articles/read/11961 Thu, 06 Jul 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11961
On June 26, Arab News reported on the selling of ReNu with MoistureLoc in pharmacies here despite announcements over a month ago by Bausch & Lomb that it was recalling the product from markets worldwide. The manufacturers announced their decision in May after an outbreak of a fungal eye infection in the US was linked to the use of the products.

The Saudi Ministry of Health also issued a precautionary note and later sent circulars to pharmacies to remove all ReNu products from their shelves, but even after removing them ReNu with MoistureLoc was still available for sale.

Pharmacies visited by Arab News last week said they were not aware of the circular or of the harm the product might cause to the eye.

The Saudi Ophthalmology Society issued a statement that its chairman, Prince Abdul Aziz ibn Ahmed, had directed the society to follow up on the international developments.

The society’s board member and joint president of the International Association for Combating Blindness in the Middle East, Dr. Abdul Aziz Al-Rajhi, said that the society sent an official letter to the company inquiring on the reports and local sales representative’s actions in the Kingdom in response to the recall.

Al-Rajhi said that the company’s initial response was that the product being sold in the Kingdom came from a European plant, and not the US plant that was linked to the outbreak of the infection. Later, the company decided to recall the entire line, regardless of where the product was manufactured.

Al-Rajhi said that the company assured the society that it is currently pulling out voluntarily ReNu with MoistureLoc from the Saudi market and sent letters and press releases to ophthalmologists not to use the product, and supplying them with ReNu Multiplus instead.

In a statement issued by the US Food and Drug Administration (FDA) on May 15, scientific and epidemiological data suggested that ReNu with MoistureLoc may increase susceptibility to Fusarium and that Bausch & Lomb has decided to permanently remove the product worldwide.

Other ReNu brand products were not found to have any problems at that time, although there have been some allegations that ReNu MultiPlus users have contracted the fungal eye infection.

Meanwhile, the FDA and the Centers for Disease Control and Prevention are investigating the multistate outbreak and have sent field officers to inspect the Bausch & Lomb plant and facilities in Greenville, South Carolina, one of the plants where the product is manufactured.

“ReNu with MoistureLoc contact lens solution, manufactured in the Greenville, SC plant, was voluntarily withdrawn from the market in the United States on April 13, 2006. To date, a majority of the confirmed Fusarium cases have been associated with the ReNu with MoistureLoc,” said the FDA statement.]]> Contact lens fungus link to blindness http://www.yourlawyer.com/articles/read/11927 Wed, 28 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11927
The infection called fusarium keratitis has prompted the withdrawal of one type of lens cleaning solution used by many of those affected.

But people with poor contact lens hygiene also appear to be at increased risk of catching the infection, which was described as "the most severe complication related to contact lens wear" by researchers.

Several of those infected in the outbreak are expected to need corneal transplants to fully restore their sight.

Experts said it was rare in Britain, but advised anyone travelling to hot and humid climates, where the fungus is more common, to switch to daily disposable contact lenses to avoid the risk associated with wearing longer-lasting lenses.

In a paper published in today's edition of the Journal of the American Medical Association, scientists at the Singapore Eye Research Institute (SERI) said the three outbreaks "suggest that this phenomenon may be part of a global problem, with serious implications for millions of lens wearers worldwide".

They said the infection rate in Singapore with 2.35 cases out of every 10,000 people wearing contact lenses was an "astounding figure".

They continued: "We believe that Singapore is facing a new and unprecedented outbreak of fusarium keratitis and that this is the first time that such an outbreak has been reported among contact lens wearers anywhere in the world.

"By highlighting this serious outbreak of fusarium keratitis among contact lens wearers in Singapore, we hope to alert physicians and other eye-care clinicians worldwide to maintain a high index of suspicion for fungal infections."

The researchers said 7.4 per cent of those infected in Singapore needed "urgent surgical intervention to treat acute corneal perforation" or to stop this from happening. "It is likely that additional cases may require subsequent corneal transplantation for residual scarring."

Nearly all patients wore soft, disposable contact lenses and just under two-thirds reported using a cleaning fluid called ReNu with MoistureLoc.

This was withdrawn from the market worldwide this year, with the manufacturer, Bausch & Lomb, saying some part of the formula "may be increasing the relative risk of fusarium infection in unusual circumstances".

However, Professor Roger Buckley, a former president of the British Contact Lens Association, has said he believes the apparent link with the MoistureLoc fluid was simply because it was so commonly used in Singapore, adding "it is likely that the cause will be found elsewhere".

To date, fungal keratitis has been rare in the UK. ISD Scotland, which collates statistics from the NHS and Scottish Executive, said it did not have any relating to the condition. Donald Cameron, a leading Edinburgh optometrist, said he had never seen a single case in 30 years, while Dr Stuart Roxburgh, a leading eye specialist at Ninewells Hospital in Dundee, said he saw about one case in every two years.]]> Pharmacies Ignore Pullout Order, Sell Harmful Ophthalmic Solution http://www.yourlawyer.com/articles/read/11919 Mon, 26 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11919
Bausch & Lomb, the manufacturers of the contact lens clearing solution ReNu with MoistureLoc, announced their decision to call back the product from markets worldwide due to a high rate of eye infection associated with it. The Saudi Ministry of Health also issued a precautionary note around the same time.

Pharmacies visited by Arab News said they were not aware of the circular or of the harm the product might cause to the eye until last week. Although many pharmacies have removed the product from their shelves, some continue to sell it.

According to a statement issued by the US Food and Drug Administration (FDA) on May 15, the multinational eye care company Bausch & Lomb, which has its headquarters in Rochester, New York, decided to permanently withdraw ReNu with MoistureLoc due to data suggesting that the liquid may increase susceptibility to Fusarium Keratitis, a fungus that causes an eye infection affecting the cornea and which can lead to total blindness.

The Centers for Disease Control and Prevention (CDCP) is investigating the multi-state outbreak of Fusarium Keratitis that may be associated with contact lens use.

However, the risk of getting the fungus from contact lenses remains extremely low. Contact lens wearers who experience unusual redness, pain, tearing, light sensitivity, blurry vision, discharge or swelling should consult their doctor immediately. The CDCP is continuing its investigation to identify specific factors that may have placed people at risk for developing the infection, including hygiene practices, overnight usage and specific solutions used.

The Saudi Ministry of Health issued warnings in the local papers a month ago about possible infections associated with the use of ReNu with MositureLoc. Last week pharmacies began receiving a circular from the ministry ordering them to remove all ReNu brand products. They were also informed of the pullout by the distribution agent.

“I only found out about the circular a few days ago from my neighbor who is an optician,” said pharmacist Mohammed Fathi.

The optician, Osama Hussein, said many pharmacists he encountered have not read the reports in the papers nor have they received the circular. “There hasn’t been any follow-up from the ministry to check on whether the product has been removed from the shelves or whether it is still being sold,” he said.

ReNu products, especially ReNu Multiplus, are the most common brands bought by contact lens users, according to pharmacists.

Manal Ahmed, 36, has been using ReNu for the past seven years. She bought ReNu with MoistureLoc last week from a local supermarket and did not know that it was harmful and was supposed to be pulled out.

“This (Fusarium Keratitis) is a very rare type of fungus and we have not received any cases here until now,” said Dr. Ihab El-Hawary, ophthalmology consultant at El-Maghrabi Eye Center on Madinah Road. “Although it might affect contact lens wearers, especially those who use distilled water to clean their lens, it mainly affects people who work in agriculture or have low immunity due to diseases such as cancer, uncontrolled diabetes or have some kind of organ transplant,” he explained.

Even if there were some cases in the Kingdom, they might not have been reported or diagnosed correctly, said Dr. El-Hawary.]]> Bausch & Lomb Renu Moistureloc Lawyer Fungal Infection Attorney http://www.yourlawyer.com/topics/overview/renu_contact_solution Mon, 26 Jun 2006 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/renu_contact_solution LATEST UPDATE:

Bausch & Lomb settles 600 eye fungus lawsuits

Daily Herald 6/1/09-- Click Here

Leading the Fight for those Injured by ReNu with MoistureLoc

Parker & Waichman, LLP is leading the fight against Bausch & Lomb, Inc. on behalf of people injured after using ReNu with MoistureLoc contact lens solution. We filed the first case against Bausch & Lomb, Inc. on behalf of a Fusarium keratitis victim and have since filed numerous cases in federal and state courts. Parker & Waichman, LLP also filed a medical monitoring class action against Bausch & Lomb, Inc. seeking compensation for medical evaluations for all people who used ReNu with MoistureLoc. There are many law firms looking for people with ReNu injuries, but don't trust your case to any firm. Trust Parker & Waichman, LLP, the leaders in defective medical product litigation.

ReNu with MoistureLoc Linked to Fusarium Keratitis
On April 10, 2006, Bausch & Lomb announced suspension of shipments of its contact solution ReNu with MoistureLoc.  Reports of fungal keratitis infections in users of the solution are surfacing in contact lens wearers who use ReNu with MoistureLoc.

Increase in fungal infections found
Just before Bausch & Lomb announced it was suspending shipments, the FDA warned of increasing numbers of the fungal infections in those who wear contact lenses.  There were 109 cases of Fusarium keratitis under investigation by public health authorities.  CDC data of 30 cases of the infections revealed that 28 wore contact lenses and that most used the ReNu saline.

Fungal keratitis
Fungal keratitis is a serious eye infection that can develop through the whole depth of the cornea.  The infection can require prolonged drug therapy with antifungals such as natamycin, nystatin, and amphotericin B. Other antifungals that may be administered include various Azoles and Fluorinated pyrimidines.  If drugs do not work and the eye is damaged, surgery may be necessary to remove fungal ulcers/lesions.  Symptoms of fungal keratitis include eye pain, eye discomfort, decrease in vision and light hypersensitivity.

FDA Recall
On May 15, 2006, Bausch & Lomb recalled its contact solution ReNu with MoistureLoc. The FDA and CDC have been investigating an increase in cases of fungal keratitis, an eye infection that affects the cornea and can cause permanent blindness.

Legal help for Renu MoistureLoc users
If you or a loved one developed an infection as a result of Bausch & Lomb Renu MoistureLoc saline solution, contact Parker & Waichman, LLP for a free case evaluation. Call 1-800-LAW-INFO (1-800-529-4636) or fill out the short form to the right.]]>