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Problems Continue to Mount for Bausch & Lomb over Fungal Infections Linked to Its Contact Lens Solution, ReNu with MoistureLoc

Apr 20, 2006 | Newsinferno News Staff

In less than two weeks, Bausch & Lomb has taken quite a tumble from one of the most respected companies specializing in consumer eye-care products to one that has been rocked by a major embarrassment and potential liability for injuries involving its popular contact lens solution, ReNu With MoistureLoc.

The 153-year-old company based in Rochester, New York, had gradually become a highly visible and respected healthcare brand worldwide with annual revenues of over $2 billion from sales in over 100 countries where it employs some 13,700 people. Currently its core businesses include soft and rigid gas permeable contact lenses, lens care products, and ophthalmic surgical and pharmaceutical products.

Now, however, Bausch & Lomb is faced with class-action lawsuits, an enormous amount of negative publicity, and an FDA investigation into just went wrong with its product.

The latest revelation that has further tainted the company’s formerly pristine image is the report that FDA inspections in May and June 2002 at Bausch & Lomb's Greenville, South Carolina, plant found paint chips in rooms where containers of eye care products were filled.

In a warning letter from July 17, 2002, the FDA cited  the company for its failure to adequately investigate the cause of the paint chips "which directly related to product quality." The warning also expressed concern over the company’s ability to test for the appropriate amount of preservative/disinfectant "used in the majority of your eye care products."

The company maintains that the problem was cleared up and that no eye care product’s quality or sterility was ever in question.

The current problem, however, is far more serious and several crisis management experts have expressed amazement that the company has mismanaged the situation to the extent that it has thereby causing itself financial harm and potential loss of business with respect to its other products.

In cases of  adverse reactions, serious side-effects, or contamination, a manufacturer’s immediate reaction to the problem is often the most critical factor in assessing whether the “crisis” was managed correctly.

A company’s perceived concern (or lack thereof) for the safety of the public in general, and its own customers in particular, will be largely defined by the speed and scope of its reaction to the crisis.

Quick and decisive reactions usually serve to boost confidence and trust in a company, while slow or evasive actions only generate mistrust and second-guessing.

Immediate steps to address the crisis will also unquestionably save additional injuries or deaths.

Prompt voluntary recalls, although costly, are always seen as responsible gestures, while forced recalls dictated by government agencies or court orders are extremely damaging to a company’s image.

Any perceived delay or deception in dealing with a product-related crisis can seriously damage a company’s reputation and sales and have a spillover effect on the company’s other products even though they are not involved and remain perfectly safe.

A company’s initial reaction to a crisis will unquestionably find its way into any subsequent litigation related to it. Quick, decisive, and thoughtful actions will serve as strong defensive statements, while a slow, evasive, and self-serving approach will provide the plaintiffs with a powerful weapon against the company involved.

Unless there has been some illegal or otherwise improper conduct, an immediate response that effectively addresses the problem will usually stave off monetary penalties and punitive measures by regulatory authorities.

In the case of Bausch & Lomb, crisis management experts and business analysts have pointed out that, while the company’s actions have all been exemplary, the delay in their implementation was inexcusable and therefore highly damaging to the company’s overall image, stock value, and sales of other unrelated products.  (Bausch & Lomb’s stock value dropped 17.3% on the day after it voluntarily suspended shipments.)
 
Although the infection issue is serious enough in terms of finding out why it has occurred, the perceived failure by Bausch & Lomb to take immediate corrective action in terms of a recall or warning blitz is becoming even more of a problem for the company. While the company maintains that it reacted quickly and decisively in the matter, the perception is that it did not.

Bausch & Lomb claims it contacted the Centers for Disease Control as soon as it learned the infection had appeared in Singapore, and suspended sales of ReNu With MoistureLoc in Singapore and Hong Kong in February.

The company also notes that on March 31, it issued a press release advising of the testing it was doing to ensure that quality had not been compromised at its South Carolina plant.

Crisis management consultants, however, see the facts a bit differently. They believe Bausch & Lomb would have been well-served by recalling the product immediately upon release of the CDC warning.

While some retailers followed that path, the manufacturer did not. The hesitation allowed the product to remain on the market for a considerable length of time when it should have been already on its way back to the company.

The delay in launching an all-out media blitz containing warnings and safe eye-care procedures has also been seen as a problem for the company. While government agencies reacted to protect the public as soon as they could, Bausch & Lomb could have done so much sooner given its immediate knowledge of the Asian cluster of what is normally a very rare infection.

The warnings issued by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) were released faster and with more emphasis than anything done to that point by the company. For example, the FDA stated:

“This is to inform you of a recent increase in the number of reports in the United States of a rare but serious fungal infection of the eye in soft contact lens wearers. The infection, a fungal keratitis caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.

“Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating this situation. At this time, Bausch and Lomb has agreed to stop shipping the ReNu MoistureLoc brand contact lens solution. This Notification will be updated as more information becomes available.”

So far, 109 cases of the infection have been reported to the CDC from 17 states in the U.S. Of 30 cases already investigated, 28 involved soft contact lens wearers and 26 of those patients had used Bausch & Lomb’s ReNu or a generic version thereof also produced by the company. Most of those cases involved ReNu with MoistureLoc produced at the company’s Greenville, South Carolina, plant.  

Nine patients reported wearing their lenses overnight, “a known risk factor for microbial keratitis”, and eight required corneal transplantation.

“Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in February 2006. At that time, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong, pending their investigations, after multiple reports of Fusarium keratitis among contact lens users there.

“Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiency, and rarely, contact lens use. There are an estimated 30 million soft contact lens users in the United States; the annual incidence of microbial keratitis is estimated to be 4-21 per 10,000 soft contact lens users, depending on overnight lens use. Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, fungal keratitis comprises up to 35% of microbial keratitis cases compared with 1% in New York. The proportion of fungal keratitis due to Fusarium spp. also varies by region, from 25-62%.”

One newly filed class-action alleges Bausch & Lomb failed to disclose the possible link between ReNu with MoistureLoc and Fusarium keratitis once it learned of the problem among its users in Asia. Singapore health officials noticed an increase in reports of infection in January of this year. An investigation revealed 39 cases involving contact lens users from 2005 to February 2006. Cases of the infection have also been reported in Malaysia and Hong Kong.

The newest release by the FDA states: “FDA is continuing to work closely with the Centers for Disease Control and Prevention (CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections. The agency supports Bausch & Lomb's decision to voluntarily withdraw ReNu MoistureLoc® contact lens solution from the market until the agencies have had a chance to conclude their investigation.

“FDA started its investigation of the Bausch & Lomb manufacturing plant on March 22, 2006, and will continue inspections of the Greenville, SC manufacturing plant and other facilities through next week. While the investigation continues, FDA will work with CDC to identify and confirm cases of Fusarium keratitis reported by state health departments and from FDA Medwatch reports.”

A second class-action lawsuit filed this week in United States District Court for the Eastern District of New York, on behalf of all users of the affected lens solution seeks compensatory and punitive damages from Bausch & Lomb to Cover medical screening and medical monitoring.

Attorneys close to the litigation and familiar with pharmaceutical litigation in general have reported to newsinferno.com that calls are “pouring into” personal injury law firms concerning possible cases against Bausch & Lomb.

One firm, Parker & Waichman, which filed the federal class action in New York, also announced that “it has been retained by a 53-year-old man who was diagnosed with fusarium keratitis after using ReNu with MoistureLoc Solution. Due to the infection, the victim underwent numerous lengthy and invasive surgeries including: cornea transplant, lensectomy, capsulectomy, removal of iris, removal of vitreous fluid and the removal of the fungal infection. The victim is left with only 15% vision in his left eye and is currently awaiting FDA approval for an iris transplant.” A lawsuit on behalf of this user is planned.

For more information, please visit FDA’s Contact Lens and Eye Infections page at: http://www.fda.gov/oc/opacom/hottopics/contacts.html


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