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Stainless Steel Cookware Sets Recalled Due to Burn Hazard

Fri, 20 Nov 2009 00:00:00 -0800

Cost Plus World Market has recalled about 300 Stainless Steel Cookware sets due to burn hazard, the U.S. Consumer Product Safety Commission (CPSC) just announced.

The recalled Stainless Steel Cookware sets were made in India by Kraftwares of Mahalaxmi, Mumbai and were distributed by Cost Plus Inc., of Oakland, California

The recall was implemented because the handles on the cookware can break, posing a burn hazard to consumers. To date, no incidents or injuries have been reported.

This recall involves three Stainless Steel Cookware sets; a 4-piece multi-cooker set, a 3-piece steamer set, and a 1.5-quart egg poacher with SKU numbers 422698, 422699, and 422700. The SKU numbers can be found on the sales receipt.

The recalled Stainless Steel Cookware sets were sold at Cost Plus World Market stores nationwide in August 2009. The 4-piece multi-cooker was sold for $30, the 3-piece steamer set sold for $15, and the 1.5QT egg poacher sold for $15.

The CPSC is advising consumers to immediately stop using the recalled Stainless Steel Cookware sets and return the sets to any Cost Plus or World Market store for a full refund. Cost Plus can be reached, toll-free, at 1-877-967-5362 between 7:00 a.m. and 12:00 p.m., Eastern Time, or at the firm’s Web site at www.worldmarket.com.

Dialysis, Kidney Transplant Patients Face Higher Risk of NSF from Gadolinium Agents

Fri, 20 Nov 2009 00:00:00 -0800

A study of patients exposed to gadolinium contrast dyes at the Mayo Clinic has revealed that hemodialysis patients had a 77-fold higher risk of developing nephrogenic systemic fibrosis (NSF), while kidney transplant patients had a 69-fold higher risk of the disease. The NSF study was published in the October issue of the Archives of Dermatology.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. There are currently five such agents sold in the U.S.: Covidien's OptiMARK; Prohance and Multihance, both by Bracco Diagnostics; Bayer Healthcare’s Magnevist; and GE Healthcare’s Omniscan.

It appears that NSF only develops in people with pre-existing kidney disease who are exposed to the gadolinium agents. In September 2007, the U.S. Food & Drug Administration (FDA) asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

The Mayo Clinic study involved 94,917 patients exposed to gadolinium agents at the Mayo Clinic between January 1, 1999 and December 31, 2006. Of that group, 3,779 patients were on hemodialysis, 1,694 patients had undergone a kidney transplant, and 717 patients had liver transplants. A total of 61 patients had a clinical diagnosis of NSF.

The study found that 1% of patients undergoing hemodialysis, and 0.8% of patients who have undergone kidney transplant were at risk of developing NSF. The risk for liver transplant patients was 0%.

The study authors advocated for the development of new guidelines for the administration of gadolinium agents.

We reported previously this week that the FDA is still looking into the association between gadolinium agents and NSF. On Wednesday, we reported that an FDA review had found that OptiMARK, Magnevist and Omniscan carried a higher risk of NSF than other gadolinium agents on the market. Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

Following the news from the FDA, Covidien announced it would be modifying the label on OptiMARK to contraindicate its use in patients with severe kidney impairment. Mallinckrodt Inc., a Covidien company, has submitted this label change to the FDA and says it is implementing the new label in the U.S. effective immediately. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK.

Salomon Alpine and Atomic Ski Bindings Recalled

Fri, 20 Nov 2009 00:00:00 -0800

About 10,000 Salomon USA Alpine and Atomic Ski Bindings have been recalled due to unexpected release and fall hazard the U.S. Consumer Product Safety Commission (CPSC) just announced.

The defective Salomon Alpine and Atomic Ski Bindings, were made in Romania, imported by Salomon USA, of Ogden, Utah, and manufactured by Salomon SAS, of France.

The toe component of the Salomon Alpine and Atomic Ski Bindings could fail to fully secure the ski boot to the ski binding, causing the binding to release unexpectedly. This could cause the skier to lose control or fall and suffer injuries. To date, the firm has received two reports of injuries, including a broken leg and a knee injury.

This recall involves the Salomon Alpine Ski Bindings with models LZ 7, LZ 8, LZ 9, LZ 7 SR, LZ 8 SR, LZ 8 SC, and J LZ 9 and the Atomic Ski Bindings with model Evox 2.8, Evox 2.8+, Evox 2.8++, and FFG 8. “Salomon” or “Atomic” and the respective model number are displayed on the ski bindings. The toe components bear a production date code ending in “8” that can be found on the center plate where the toe of a ski boot contacts the toe component of the bindings.

The recalled Salomon Alpine and Atomic Ski Bindings were sold at authorized Salomon USA and Atomic USA ski dealers nationwide from September 2008 through October 2009 for between $90 and $160.

The CPSC is advising consumers to immediately stop using these ski bindings and return the Salomon-brand ski bindings to any authorized Salomon ski dealer, or return the Atomic-brand ski bindings to any authorized Atomic ski dealer, for a free inspection and replacement of the toe component.

The firm can be contacted, toll-free, at 1-877-789-5111 between 8:00 a.m. and 4:00 p.m. MT Monday through Friday; by email at qualityinfo.usa@salomon-sports.com; or by visiting the firm’s Web sites at www.salomon.com or www.atomicsnow.com.

Chinese Drywall Test Results Due Monday

Fri, 20 Nov 2009 00:00:00 -0800

More results of Chinese drywall testing conducted as part of the U.S. Consumer Products Safety Commission's (CPSC) massive investigation are expected to be released next week. The highly anticipated report will arrive just days before an important lawsuit deadline arrives for some Chinese drywall homeowners.

The next round of test results will address the corrosion of copper wires and other metals in homes with Chinese drywall – whether this is being caused by fumes from the wallboard, and whether the corrosion of wiring poses a fire hazard. The CPSC is also expected to release results of tests done on indoor-air samples collected from about 50 U.S. homes with Chinese drywall.

The CPSC has received about 1,897 reports from residents in 30 states, the District of Columbia, and Puerto Rico concerning Chinese drywall. Gases emitted from Chinese drywall are being blamed for significant property damage, including damage to HVAC systems, smoke detectors, electrical wiring, metal plumbing components, and other household appliances. These gases also produce a sulfurous odor that permeates homes, and cause metals, including air conditioning coils and even jewelry, to corrode. People living with Chinese drywall have also suffered eye, respiratory and sinus problems that may be linked to the gases.

Chinese drywall poured into the U.S. between 1999 and 2007 because of the high demand created by the housing boom. Imports accelerated when the rebuilding that followed Hurricane Charley in Florida in 2004, and Hurricane Katrina along the Gulf Coast in 2005, created a drywall shortage. According to an earlier Wall Street Journal report, some 500 million pounds of Chinese drywall was imported to the U.S. during the housing boom. That means as many as 100,000 homes throughout the country could have been built with the material.

Late last month, the CPSC release the initial results of three studies that compared Chinese and domestic wallboard. Those tests revealed that samples from China emit volatile sulfur compounds at a higher rate, and contain higher levels of sulfur and strontium, than the American-made product. However, the CPSC still could not say if there was a direct link between the Chinese drywall and the health problems homeowners are reporting.

It is hoped that test results scheduled for release Monday will clarify that issue. If health risks are found, some avenues of financial aid could open up to Chinese drywall victims. According to Scripps News, the report might begin the process to allow homeowners with toxic drywall to become eligible for a significant tax write-off for a "casualty loss." Such a deduction applies to the destruction associated with a sudden or unexpected event.

The report could also help spur the availability of disaster-related funds from the Federal Emergency Management Agency and the U.S. Small Business Administration. To do that, the report would have to link the drywall to homes built as a result of hurricanes in 2004 and 2005, Scripps News said.

If the CPSC does release its Chinese drywall test results on Monday as expected, the report will have arrived less than two weeks before some Chinese drywall homeowners face an important legal deadline. By December 2, victims whose homes were built with wallboard made by Knauf Plasterboard (Tianjin) Co., Ltd. must sign onto an omnibus class action lawsuit against the company if they want to avoid some onerous international requirements. Knauf has agreed to waive its rights under The Hague Convention for the Service of Process Abroad for claimants who join this lawsuit by December 2. This offer will greatly streamline the litigation process for plaintiffs who make the deadline.

The December 2 deadline is a hard deadline, and the omnibus complaint will not be amended at a later date to add more people. To be eligible for the omnibus lawsuit, claimants must submit pictures or other proof that they have wallboard made by Knauf Plasterboard in their homes by December 2, 2009. Any Chinese drywall homeowner interested in becoming a party to this lawsuit must start now by contacting an attorney and arranging to have their home inspected. Parker Waichman Alonso LLP, the first law firm to file a federal Chinese drywall lawsuit, is offering assistance to any homeowner interested in joining the Knauf Plasterboard lawsuit. Free consultations are available through the firm’s website at www.yourlawyer.com, or by calling 1-800-LAW-INFO (1-800-529-4636).

Puerto Rico Explosion Investigation Points To Defective Fuel Monitor

Fri, 20 Nov 2009 00:00:00 -0800

The U.S. Chemical Safety Board (CSB) announced that a malfunctioning fuel monitoring system probably led to the massive explosion at a Caribbean Petroleum Corporation facility near San Juan, Puerto Rico.

The October 23 blast endangered the lives of thousands and ignited an immense blaze that fed on jet fuel, bunker fuel, and gasoline stored at the facility. Plumes of thick, black smoke filled the air with hazardous contaminants, including carbon monoxide and sulfur; winds spread the toxins throughout San Juan and adjacent municipalities, exposing thousands and displacing over 1,500 people. The situation was no better for those forced to remain inside with windows closed to keep out the toxins.

It seems that one of the depot’s 40 tanks was accidentally overfilled with gasoline from a ship docked in the San Juan harbor, reported Reuters. The error appeared to have been a result of a faulty monitoring system, which led to the explosion, said CSB officials. Depot employees did not notice the problem because the depot’s computerized level monitoring system was not working properly, explained Reuters. Gasoline spilled from the tank, evaporated, spread across the facility, and resulted in a 2,000-foot vapor cloud, said Reuters. Once the vapor reached an “ignition source,” the blast occurred and the flames followed, added Reuters.

The Puerto Rico Seismic Network reported that the blast produced a shock wave equivalent to a 2.8 magnitude earthquake and was so strong that it tore up a highway, and shattered windows on nearby homes. Twenty-one of 40 tanks at the facility used to store jet fuel, bunker fuel, and gasoline were destroyed or damaged by the fire. There were no reported fatalities, but two people were injured, and many evacuees suffered from respiratory illnesses. The explosion decimated homes and businesses and the toll on environmental damage is still being assessed, said Reuters. Firefighters worked to stop the fire for three days, reported Reuters. It may be years before the health consequences become completely apparent.

"The filling of a tank without a functioning monitoring system is the type of activity the CSB will be examining very closely," Investigator-in-Charge Jeffrey Wanko said, quoted Reuters. "The CSB will conduct a thorough and comprehensive investigation of this accident. Our team will uncover exactly what events led to an explosion of this magnitude. Our goal is to determine not only what happened, but why it happened," CSB board member William Wright said, quoted Reuters.

In 2000, a Caribbean Petroleum refinery was shut down as well as a tank farm where gasoline, diesel fuel, jet fuel, and crude oil were stored. Also, we recently wrote that Caribbean Petroleum has a spotty environmental record. According to The Miami Herald, over the last ten years, Caribbean Petroleum Corp. has been cited for major environmental violations that have cost it a total of $1.3 million in penalties and fines. And, according to a prior Miami Herald report, the Occupational Safety and Health Administration (OSHA) had not inspected the facility since 2000. Since 1990, the National Response Center, an entity that reports oil, chemical, radiological, and biological spills, recorded at least 25 oil spills at Caribbean Petroleum facilities.

Despite its long record of environmental violations involving penalties and fines for leaking hazardous waste in the water, air and soil, Caribbean Petroleum has been allowed to run for nearly a decade without safety inspections or an emergency community disaster plan, in violation of federal law, the Herald said.

Vicks Sinex Nasal Spray Recalled Over Bacterial Contamination

Fri, 20 Nov 2009 00:00:00 -0800

Vicks Sinex nasal spray is being recalled in three countries because of potential bacterial contamination. According to a recall notice issued by Proctor & Gamble, the recall includes three lots of Vicks Sinex nasal spray sold in the United States, United Kingdom and Germany. The bacteria, B. cepacia, has been found in a small amount of Vicks Sinex nasal spray from the recalled lot sold in the States, the notice said.

The three lots of Vicks Sinex nasal spray being recalled are:

United States: Lot # 9239028831; Product Name: Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray
United Kingdom: Lot # 9224028832l; Product Name: Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml
Germany: Lot # 9224028833; Product Name: Wick Sinex Schnupfenspray Dosiersystem, 15 ml

The lot number is listed on both the outer carton and the bottle.

Proctor & Gamble is recalling the Vicks Sinex products after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals.

Proctor & Gamble said that it detected this problem during routine quality control at the plant, The company’s analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product.

The recall notice also said that B. cepacia was found in a small amount of product from U.S. lot 9239028831. Proctor & Gamble is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Proctor & Gamble is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. Consumers have been advised to discard the affected product as they would any OTC medicine.

Anyone who has these specific lots of Vicks Sinex nasal spray can call Proctor & Gamble for a replacement coupon or refund at the following numbers:

From the United States, please call: 1.877.876.7881 (Hours of operation: Monday - Friday, 9AM - 6PM US ET, Saturday - Sunday, 9AM - 4PM US ET)
From the United Kingdom, please call: 0800.5555.15 (Hours of operation: 19 November, 4PM - 9PM local time and will continue Monday - Friday, 8AM - 6PM local time, Saturday - Sunday, 9AM - 5PM local time)
From Germany, please call: 0800.111.6131 (Hours of operation: 19 November, 4PM - 9PM local time and will continue Monday - Friday, 8AM - 6PM local time, Saturday - Sunday, 9AM - 5PM local time

Children's Hooded Clothing Recalled

Thu, 19 Nov 2009 00:00:00 -0800

It seems as if we’re always writing about the issue of dangerous, deadly children’s hooded sweatshirts and jackets sold in violation of U.S. Consumer Product Safety Commission (CPSC) regulations. Sadly, another recall is being announced.

In this case, about 17,000 Youth Hooded Sweatshirts and Jackets are being recalled by Century 21 Promotions, Inc. due to strangulation hazard. The recalled Youth Hooded Sweatshirts and Jackets were manufactured and imported by Century 21 Promotions, of Seattle, Washington. To date, no reports of incidents or injuries have been reported.

The sweatshirts have a drawstring through the hood, which can pose a strangulation hazard to children. In February 1996, the CPSC issued guidelines to help prevent children from strangling or becoming entangled on the neck and waist by drawstrings in upper garments, such as jackets and sweatshirts. In 1997, industry adopted a voluntary standard for drawstrings that incorporated the CPSC guidelines. In May 2006, the CPSC’s Office of Compliance issued an announcement that such outerwear with drawstrings at the hood or neck would be regarded as both defective and a substantial risk of injury to young children.

Unfortunately, the CPSC guidelines are routinely ignored by the clothing industry, and that attitude has had deadly consequences for some children. From January 1985 through January 1999, the CPSC received reports of 22 deaths and 48 non-fatal entanglement incidents involving drawstrings on children’s clothing.

This recall involves children’s sweatshirts and jackets sold in sizes XS–XXL in navy blue, black, brown, pink, red, white, green, grey, blue, yellow, and orange. The recalled garments contain the following embroidered logos: “Montauk,” “Avalon,” “Stone Harbor,” “Cape May,” “Sea Isle,” “Ocean City,” “Alaska,” “Nantucket,” “Maine,” “Long Beach Island,” “Lavallette,” “Seaside Park,” “Newport,” “Monterey,” “Carmel,” “Skaneateles,” “1000 Islands,” “Block Island,” and “Seattle.”

The recalled Youth Hooded Sweatshirts and Jackets were sold at Montauk Clothing, Riptide East, Shirt Shops of Cape May, Summer Sweats, Rip Current Sportswear, B&B Department Stores, Trapper Jack’s, Annie & The Tees, Emporium, Inc., The Trading Company, Mackerel Jack’s, Carmel Classics, Rolands, The Ship Gift Shop, Star Department Store, Seattle Shirt, and Simply Seattle from September 2005 through September 2009 for between $25 and $35. Most stores are located in New England with two stores each in Seattle, Washington, and Alaska.

The recalled Youth Hooded Sweatshirts and Jackets were made in China and are just one of many recalls and issues on which we have written concerning defective products, food, and medicines imported into this country from China. Such defective imports have been making headlines in recent years; the recalled Youth Hooded Sweatshirts and Jackets recall is just another of many such issues. In 2008, nearly 80 percent of all product recalls in the U.S. involved imports from China. Products such as dog food, baby formula, toys with lead paint, and even pharmaceuticals like heparin have been found to have been made with toxic materials and other counterfeit ingredients that have long put American consumers at significant risk. Also making news is the ongoing and massive Chinese drywall disaster involving imports from that country.

The CPSC is advising consumers to immediately remove the drawstrings from the sweatshirts to eliminate the hazard, or return the garment to the place of purchase for a full refund. Century 21 Promotions can be reached, toll-free at 1-800-935-2100 between 9:00 a.m. and 5:00 p.m., Pacific Time, Monday through Friday.

2 Dead in Minnesota Casino Bus Crash

Thu, 19 Nov 2009 00:00:00 -0800

A fatal bus crash on I-90 in Minnesota killed two women and injured more than a dozen others. According to a report on StarTribune.com, it could be weeks before the cause of the bus accident is known.

According to the Minnesota Department of Public Safety, the bus crash occurred about 3:20 p.m about2 miles west of Austin. The bus crossed the median and the westbound lanes. It ended up in the ditch, where it flipped over, landing with the door side down. There was no construction going on in the area of the accident and weather was not a factor.

The bus, which was owned by Strain Tours bus company of Rochester, Minnesota, was headed back from a casino in Northwood, Iowa. The casino trip was a weekly event.

StarTribune.com is reporting that the driver of the bus suffered a ruptured aneurysm in his chest, causing him to lose consciousness. However, the Minnesota State Patrol has not confirmed this. The driver has been interviewed by police, but they aren't saying yet what he told them.

Pamela S. Holmquist, 56, of Kasson, and Rhonda R. Hill, 52, of Plainview died as a result of the crash. Ten passengers were hospitalized with non-life-threatening injuries, and eight were treated and released at area hospitals. Only one passenger escaped injury.

According to StarTribune.com, I-90 was shut down in both directions immediately after the crash.. Eastbound traffic resumed about 8 p.m., while the westbound lanes reopened before 10 p.m.

Commercial vehicle inspectors and reconstruction specialists will begin an investigation today, but it likely will be several weeks before it is known what caused the accident.

According to the Federal Motor Carrier Safety Administration, Strain Tours has reported no crashes in the past 24 months. But StarTribune.com is reporting that Bold Lines, the corporate name of the bus company, paid $20,000 to settle an enforcement case over drug testing for drivers. It also paid $300 to settle a case over driver duty times and recordkeeping. The Federal Motor Carrier Safety Administration has also advised roadside inspectors to inspect the company's vehicles because of safety concerns, StarTribune.com said.

Gas Grills Sold at Lowe's Recalled

Thu, 19 Nov 2009 00:00:00 -0800

A large recall of Perfect Flame SLG Series Gas Grills has been initiated over fire and burn hazards, the U.S. Consumer Product Safety Commission (CPSC) just announced. The recall involved about 663,000 Perfect Flame SLG Series Gas Grills in the United States and about 1,700 in Canada.

The Perfect Flame SLG Series Gas Grills were imported by L G Sourcing, Inc., of North Wilkesboro, North Carolina and were manufactured by Lucas Innovation Inc., of China. The recall was implemented because the burners can deteriorate, causing irregular flames and the lids of some models to catch fire, posing fire and burn hazards to the consumer. To date, the firm has received about 40 reports of fires from the burners deteriorating and about 23 reports of the lids catching fire. The firm is aware of one report of an eye injury requiring surgery and 21 incidents of minor burns to the hands, arms, or face.

The recalled grills are SLG series “Perfect Flame” brand outdoor propane or natural gas grills. The grills are stainless steel and painted black or gray metal. The model numbers affected by this recall are listed below. The model number can be found in the compartment under the cooking chamber. No other Perfect Flame model numbers are included in this recall. All of the grills in this recall were sold with replacement burners:

No replacement lid, model numbers:

SLG2006B
SLG2006BN
SLG2006C
SLG2006CN
SLG2007D
SLG2007DN

With replacement lid, model numbers:

SLG2007A
SLG2007B
SLG2007BN
SLG2008A

The recalled Perfect Flame SLG Series Gas Grills were sold exclusively at Lowe’s retail outlets nationwide from September 2005 through May 2009 for between $200 and $550 (U.S.) and in Canada from December 2007 through May 2009 for between $200 and $250 (CAN).

The CPSC is advising consumers to immediately stop using the product and contact L G Sourcing to receive free replacement burners and, depending on the model of the grill owned, a free replacement lid. L G Sourcing can be reached, toll-free, at 1-888-840-9590 anytime, or at its Website at www.lowes.com

Of note, this is just one of many recalls and issues on which we have written concerning defective products, food, and medicines imported into this country from China. Such defective imports have been making headlines in recent years; the Perfect Flame SLG Series Gas Grills recall is just another of many such issues. In 2008, nearly 80 percent of all product recalls in the U.S. involved imports from China. Products such as dog food, baby formula, toys with lead paint, and even pharmaceuticals like heparin have been found to have been made with toxic materials and other counterfeit ingredients that have long put American consumers at significant risk. Also making news is the ongoing and massive Chinese drywall disaster involving imports from that country.

First MRGO Hurricane Katrina Flood Trial A Big Win For Plaintiffs

Thu, 19 Nov 2009 00:00:00 -0800

A major Hurricane Katrina flooding trial ended with a win for plaintiffs yesterday, as a federal judge ruled that the U.S. Army Corps of Engineers' failure to properly maintain the Mississippi River Gulf Coast Outlet (known popularly as MRGO) was partly to blame for the flooding that followed the historic storm.

Judge Stanwood R. Duval, Jr's. landmark decision awarded over $719,000 to four different sets of plaintiffs. However, the ruling could set a precedent for over 400,000 other residents of New Orleans and St. Bernard parish who have filed similar damage claims against the Corps.

MRGO was built to allow ships easier access between New Orleans and the Gulf of Mexico. In order to build it, the Army Corps of Engineers cut through 76 miles of swamp and wetlands that had once served to protect the Crescent City from destructive storm surges, like the one that accompanied Katrina. Flood victims had claimed that during the storm, the MRGO acted as a funnel, and pulled much of Katrina’s storm surge into the New Orleans and St. Bernard.

The Corps had argued that the federal Flood Control Act shielded the government from liability for defective flood-control projects. But Judge Duval did not agree, ruling that the Corps was not protected from liability in the case of MRGO because it was built for navigation, not flood control.

Judge Duval said the Army engineers are liable for the “negligent operation and maintenance” of the canal and not for faulty design or construction. “When the corps designed the MRGO, it recognized that foreshore protection was going to be needed, yet the corps did nothing to monitor the problem in a meaningful way," he wrote in a 156-page opinion.

According to Bloomberg.com the judge had said at the trial's start that his finding would be used as a guide for other claims. An attorney for other MRGO plaintiffs said lawyers will be seeking a global settlement with the U.S. to cover residents and businesses in New Orleans' Lower Ninth Ward, east New Orleans and St. Bernard Parish.

Following Katrina, the U.S. Congress ordered the closure of MRGO, and it was officially closed to boat traffic in April.

Colorado Salmonella Outbreak Blamed on Animal Waste

Thu, 19 Nov 2009 00:00:00 -0800

It looks like the Salmonella outbreak in Alamosa, Colorado last year was the result of a faulty drinking water storage tank and animal waste.

A report from the state of Colorado’s Department of Public Health and Environment indicates that the city of Alamosa neglected to act on a long-standing recommendation to inspect a deteriorating drinking water tank, said 9News. The recommendation was made years prior to the 2008 Salmonella outbreak that caused hundreds to fall ill and resulted in one death. The report was released yesterday.

According to the report, said 9News, animal waste was the likely culprit in an in-ground storage tank contamination that was “identified as a problem in 1997.” In addition to the fatality, the outbreak in 2008 sickened 442, according to reports; however, state health officials believe the number was closer to 1,300 residents—of the some 8,900, residents, said 9News.

Ron Falco, manager of the Safe Drinking Water program at Colorado’s state health department, said “animal waste contamination in the concrete storage tank” was the likeliest culprit, according to 9News. Also, Falco indicated that state health investigators were never advised of the 1997 inspection that was made available to the “city by a private company,” said 9News. Of note, the state inspection report recommended regular inspections to keep track of the "cracking and problem with the corners of the tank," quoted 9News.

According to state inspections cited by 9News, the reviews "did not focus on storage tanks and distribution piping," and, now, Falco wants know why the report was not provided to the state and why there is no indication that follow-up inspections never occurred in the 11 years from the inspection to the massive outbreak. Had Alamosa submitted records outlining the issue, said Falco, then the state inspection could have included either a recommendation or a mandate to conduct a repair, according to 9News.

"If we'd had those records, we would have reviewed them," Falco said, quoted 9News. "Hindsight is 20-20 … it's easy to say now we would have required that," Falco added.

To compound matters, at the time of the tank’s ongoing deterioration, Alamosa did not chlorinate its water. "... only a small quantity of bird or animal feces contamination may have led to the Salmonella outbreak," reported 9News, citing the report. "This kind of outbreak may have been very difficult to prevent in a system that did not chlorinate its water," the report continued. It seems, said 9News, that Alamosa’s public drinking water system had a disinfection waiver enabling it to bypass chlorination mandates. Chlorination in Alamosa was initiated immediately following the outbreak at which point Colorado’s state health department withdrew 72 of 126 disinfection waivers in the state, reported 9News; however, many cities still operate under a disinfection waiver.

Salmonella, which is usually found in food and water contaminated with animal feces, is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstance, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis. Salmonella poisoning can lead to Reiter’s Syndrome, a difficult-to-treat reactive arthritis characterized by severe joint pain, irritation of the eyes, and painful urination.

Medtronic Cardiac Rhythm Disease Management Site Gets FDA Warning Letter

Thu, 19 Nov 2009 00:00:00 -0800

Device maker giant, Medtronic, Inc., just announced that it received a warning letter from the U.S. Food & Drug Administration (FDA).

According to the Twin Cities Business Journal, the letter came after an inspection of Medtronic’s Mounds View Cardiac Rhythm Disease Management site and concerned: “Corrective and preventative action and field-action timeliness, review and documentation of field action recommendations, supplier qualification and controls, and medical-device reporting timeliness,” said the Business Journal. Medtronic has 15 days to respond to the warning letter.

Medtronic said it will respond to the letter within the mandated timeframe and stated that it is in the process of implementing revised processes in response to the letter, said the Business Journal. Medtronic also said that, according to the FDA’s letter, the agency wrote that the firm’s proposal “appear to be adequate to address the concerns raised in the letter and will be confirmed upon re-inspection,” quoted the Business Journal.

In a statement, Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic said, quoted the Business Journal, “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible.”

This is not the first warning letter Medtronic has received in recent months. In June we wrote that Medtronic received a warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. In the letter, the FDA cited Medtronic for taking too long to recall the SynchroMed pumps. The letter also said that an inspection conducted last year at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing. SynchroMed II pumps are implantable devices used to deliver medicine to the spine. The devices have been recalled on several occasions.

According the FDA warning letter, some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the letter said.

The pumps were recalled for this problem in May 2008, after Medtronic received two reports of SynchroMed pumps being removed from patients because of a lack of propellant. “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner,” the warning letter, dated June 1, states. “It took almost two years from when the missing propellant was initially identified to conduct a recall.”

The FDA letter also criticized Medtronic for failing to notify the agency within 30 days of at least two reports of potentially serious patient issues with MiniMed Paradigm Insulin Pumps, and for failing to have a person qualified to make a medical judgment determine if reported problems had anything to do with a patient’s death or serious injury. According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.

OptiMARK Gadolinium Contrast Agent Label Changed Over NSF Risk

Thu, 19 Nov 2009 00:00:00 -0800

The maker of OptiMARK gadolinium contrast agent is modifying the product's label to contraindicate its use in patients with severe kidney impairment because of its association with nephrogenic systemic fibrosis (NSF). Mallinckrodt Inc., a Covidien company, has submitted this label change to the U.S. Food and Drug Administration (FDA) and says it is implementing the new label in the U.S. effective immediately.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnostics, Bayer Healthcare's Magnevist and GE Healthcare's Omniscan.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death.

It appears that NSF only develops in people with pre-existing kidney disease. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

Yesterday, we reported that an FDA review had found that OptiMARK, Magnevist and Omniscan carried a higher risk of NSF than other gadolinium agents on the market. Though the agency’s drug safety unit said the risk associated with the gadolinium contrast dyes “does not compel removal of specific (imaging agents) from the U.S. market”, it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

In a statement released by Covidien yesterday, the company said it is implementing its OptiMARK label change in all countries where OptiMARK contrast agent has been approved for sale, in accordance with local regulatory requirements. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK

“For the small percentage of the U.S. population – less than 0.5 percent – with severe renal impairment, we believe it is prudent to act now, rather than wait for a causal link between GBCAs (gadolinium based contrast agents) and NSF to be established. Although the label already advises caution when using GBCAs with these patients, we are voluntarily taking this next step to help ensure this small, at-risk population does not receive administration of a contrast agent that could pose a risk of NSF.” said Dr. Herbert Neuman, Vice President, Medical Affairs and Chief Medical Officer, Pharmaceuticals, Covidien.

E. coli Worries Prompt Another Ground Beef Recall

Wed, 18 Nov 2009 00:00:00 -0800

Fairbury Steaks, Inc. a Fairbury, Nebraska, establishment, is recalling approximately 90 pounds of fresh ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) just announced. The products subject to recall include 10-pound packages of "BULK FRESH GROUND BEEF."

This recall has been classified as a Class I Recall, which means this is a health hazard situation in which there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

The packages were placed in boxes and bear the establishment number "EST. 5726" inside the USDA mark of inspection on a label. The products were produced on November 16, 2009, and were distributed to a restaurant in Ruskin, Nebraska.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify its customers, including restaurants, of the recall and that steps are taken to make certain that the product is no longer available to consumers. In this case, the problem was discovered through FSIS microbiological sampling. To date, the FSIS has received no reports of illnesses associated with consumption of these products. Individuals concerned about an illness should contact a physician.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea, dehydration, and—in the most severe cases—kidney failure. The very young, seniors and persons with weak immune systems are the most susceptible to food borne illness.

FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef or ground beef patties that have been cooked to a temperature of 160° F. The only way to be sure ground beef is cooked to a sufficiently high temperature to kill harmful bacteria is to use a food thermometer to measure the internal temperature.

Consumers with questions regarding this recall should contact Fairbury Steaks’ Media Representative, Nicole Brown at 1-402-729-3364.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0:00 a.m. to 4:00 p.m., Eastern Time, Monday through Friday. Recorded food safety messages are available 24 hours a day.

Magnevist, Omniscan and OptiMARK Have Highest Risk of NSF, FDA Says

Wed, 18 Nov 2009 00:00:00 -0800

Three gadolinium contrast dyes - Bayer Healthcare's Magnevist, GE Healthcare's Omniscan, and Covidien 's OptiMARK -carry a higher risk of nephrogenic systemic fibrosis (NSF) than other agents on the market, according to the U.S. Food & Drug Administration (FDA). Though the agency's drug safety unit said the risk associated with the gadolinium contrast dyes "does not compel removal of specific (imaging agents) from the U.S. market", it has recommended that the drug labels note the varying levels of risks with each product. An outside panel of experts will take up the issue in December.

Gadolinium contrast dyes are approved for use in MRI procedures, and are sometimes used off-label in MRA studies. These agents were first introduced in the 1980s, and there are currently five such dyes on the market. In addition to Omniscan, Magnevist and OptiMARK, other agents on the market include Prohance and Multihance, both by Bracco Diagnotics.

NSF is a debilitating disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. NSF is a relatively new disease. In fact, the first known diagnosis of NSF only occurred in 1997, but it wasn’t until September 2000 that details of the disease were published in the medical journal Lancet.

It appears that NSF only develops in people with pre-existing kidney disease. In 2006, Dutch researchers were the first to link NSF with the use of gadolinium contrast dyes. In September 2007, the FDA asked the manufacturers of all gadolinium contrast dyes to add a black box warning to the product labels about its association with NSF. The FDA also warned that patients with kidney disease should avoid gadolinium contrast agents, and that the lowest possible dosage should be administered to such patients if use of the dyes cannot be avoided.

According to documents released yesterday by the FDA, the highest risk of NSF was associated with Omniscan, Magnevist and OptiMARK. The lowest risk was associated with Prohance and Multihance. However, the agency said "the data do not appear to rule out an NSF risk for each of the agents." FDA reviewers said the extent of risk from any of the agents was unknown. One study of Omniscan estimated the chances of developing NSF was 4 percent among patients with severe kidney impairment.

According to a Reuters report, Covidien has already decided to modify the labeling of OptiMARK. A spokesperson for the company told Reuters that "it was prudent to act now, rather than wait for a causal link... to be established" between the imaging drugs and NSF.

Gardasil No Longer Requirement For Immigrants

Wed, 18 Nov 2009 00:00:00 -0800

Gardasil or other HPV vaccination will no longer be a requirement for immigrant girls and women seeking a green card, according to the Associated Press (AP). Currently, the U.S. Centers for Disease Control and Prevention (CDC) requires that all immigrants filing for a green card must receive a variety of shots; the HPV vaccine is currently among those required.

Effective December 14, the HPV vaccination will not be required, said the AP, in an effort to not single out immigrants. The requirement to receive at least the first dose of the HPV vaccine, which is administered in three doses, was implemented by the CDC for female immigrants between the ages of 11 and 26 in July 2008.

"More than half of the immigrants who come to the U.S. seeking opportunity are women," said Silvia Henriquez, executive director of the National Latina Institute for Reproductive Health, in a statement, quoted the AP. "We thank the CDC for restoring their dignity and reproductive justice."

There are currently two HPV vaccines approved for use in the U.S. Gardasil prevents four strains of HPV, two of which cause 70 percent of all cervical cancers. The other two HPV strains are responsible for about 90 percent of genital warts. Cervarix, approved by the Food & Drug Administration (FDA) just last month, protects against two strains of HPV that cause more than 70 percent of cases of cervical cancer in women.

HPV is the most widespread of sexually transmitted diseases in the U.S.; however, a small percentage of people infected with HPV will develop cervical cancer and other dangerous diseases, citing the AP. Also, cost efficacy has long been an issue with the Gardasil vaccine, said the AP. The shots run about $400-to-$1000 and insurers do not cover such health services for immigrants, said the AP.

The CDC's decision comes at a time when the safety and effectiveness of HPV vaccination is being questioned. Recently we reported that Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, noted that, to date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane-Barre syndrome, lupus, seizures, paralysis, blood clots and brain inflammation. Dr. Harper also said that the CDC acknowledged 44 reported deaths following Gardasil administration.

Dr. Harper played a role in the development of both Gardasil and Cervarix and recently asserted that neither HPV vaccine would do much to reduce cervical cancer rates in the U.S. According to an earlier report on chattahbox.com, Dr. Harper also said the HPV vaccines should not be administered to girls under 15.

Dr. Harper also warned that Merck & Co., the maker of Gardasil, had not tested Gardasil on girls younger than 15, chattahbox.com said. “It is silly to mandate vaccination of 11 to 12 year old girls. There also is not enough evidence gathered on side effects to know that safety is not an issue,” warned Harper.

Lead Found in Barbie, Disney Toys

Wed, 18 Nov 2009 00:00:00 -0800

We have long been writing that exposure to lead in children can cause brain and nervous system damage, behavioral and learning problems, slowed growth, hearing problems, headaches, mental and physical retardation, and behavioral and other health problems. Now, the Associated Press (AP) is reporting that some toys bearing Barbie and Disney logos have tested with high lead levels, citing the Center for Environmental Health, an advocacy group located in California.

The Center tested some 250 children’s products that were purchased at popular retailers, said AP. Lead levels were found to exceed federal limits in seven of the toys tested, including a Barbie Bike Flair Accessory Kit and a Disney Tinkerbell Water Lily necklace. The Center also found “excessive lead” levels in a “Dora the Explorer Activity Tote, two pairs of children's shoes, a boys’ belt, and a kids' poncho,” said the AP. In response, California’s Attorney General, Jerry Brown, wrote to the retailers of the seven products, which include Target and Wal-Mart, issuing a warning that children’s products sold in their stores contained lead levels in violation of federal standards and should be immediately removed, reported the AP.

Lead is also known to cause cancer and reproductive harm. Once poisoned by lead, no organ system is immune. Of particular concern is the developing brain because negative influences can have long-lasting effects and can continue well into puberty and beyond. Lead is considered by many experts to be one of the most important chronic environmental illnesses affecting children today. Unfortunately, despite efforts to control lead exposure, serious cases still occur.

According to the World Health Organization (WHO), about half of all urban children world-wide and under the age of five test with blood lead levels higher than the Center for Disease Control and Prevention’s (CDC) safe limit. In the United States, the CDC dropped its “level of concern for blood” lead levels to 10 micrograms per deciliter, according to the BBC previously.

The Center for Environmental Health stated that the Barbie toy was purchased at Tuesday Morning and the Tinkerbell jewelry from Walgreens; other products with high lead levels were purchased form TJ Maxx, Sears, Wal-Mart, and Target, said the AP. Meanwhile, Mattel said it did not manufacture or sell the bike accessory kit and that, in that case, the Barbie name was licensed to Bell Sport. According to Bell Sport, the kit passed safety tests two years prior when lead level requirements were not as stringent; Bell claimed it was unaware the product was still being sold, said the AP. According to Disney, the Tinkerbell necklace was tested by Playmates Toys—its licensee—prior to distribution and was allegedly in compliance with all required regulations reported the AP.

The Consumer Product Safety Commission (CPSC) is apparently looking into the situation, said the AP.

With the implementation of the Consumer Product Safety Improvement Act (CPSIA), it is illegal to sell children’s products containing lead in specific amounts. The CPSC explained by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead; sale of those products can result in significant civil and criminal liability. After August 14, 2009, the level decreases to 300 ppm and, again decreases to 100 ppm on August 14, 2011.

Chinese Drywall Insurance Bill Proposed, Lawsuit Deadline Nears

Wed, 18 Nov 2009 00:00:00 -0800

A Chinese drywall bill just introduced in the U.S. Congress would prohibit insurers from dropping or changing policies on homes built with tainted Chinese drywall. According to The Bradenton Herald, the Chinese drywall insurance bill is being sponsored by Rep. Charlie Melancon, D-La.

The U.S. Consumer Products Safety Commission (CPSC) has received about 1,897 reports from residents in 30 states, the District of Columbia, and Puerto Rico concerning Chinese drywall. Gases emitted from Chinese drywall are being blamed for significant property damage, including damage to HVAC systems, smoke detectors, electrical wiring, metal plumbing components, and other household appliances. These gases also produce a sulfurous odor that permeates homes, and cause metals, including air conditioning coils and even jewelry, to corrode.

People living with Chinese drywall have also suffered eye, respiratory and sinus problems that may be linked to the gases. The drywall problems have forced many people out of their homes, and some families are dealing with the heavy financial burden of paying both rent and mortgage payments. Those unable to afford additional rent have no choice but to stay in their smelly – and possibly hazardous – homes.

As if they didn't already face enough issues, some homeowners have reported that their insurance company dropped, altered or refused to renew coverage on their homes because of Chinese drywall. According to The Bradenton Herald, the proposed "Drywall Victim Insurance Protection Act" would make it illegal for insurers to cancel or not renew policies on single-family homes and condominium units based on the fact they contain or are suspected of containing drywall with certain characteristics, including wallboard that was manufactured in China from 2004 to 2007 or has elevated levels of sulfur or strontium.

Unfortunately, some experts told Bradenton Herald that the "Drywall Victim Insurance Protection Act" would not be very effective, even if it is passed and signed into law. That's because state, not federal, governments regulate insurance companies.

On another front, Chinese drywall victims whose homes were built with wallboard made by Knauf Plasterboard (Tianjin) Co., Ltd. are running out of time to sign onto the omnibus Chinese drywall lawsuit against the company that will be filed on December 9. Knauf has agreed to waive its rights under The Hague Convention for the Service of Process Abroad for claimants who join this lawsuit by December 2. The Hague Convention for the Service of Process Abroad requirements were a huge obstacle to claimants, and Knauf’s offer to waive them will greatly streamline the litigation process for plaintiffs who make the deadline.

The December 2 deadline is a hard deadline, and the omnibus complaint will not be amended at a later date to add more people. Claimants will also face a second deadline – December 14 – by which time they must have filled out a profile form.

To be eligible for the omnibus lawsuit, claimants must submit pictures or other proof that they have wallboard made by Knauf Plasterboard in their homes by December 2, 2009. Any Chinese drywall homeowner interested in becoming a party to this lawsuit must start now by contacting an attorney and arranging to have their home inspected. Parker Waichman Alonso LLP, the first law firm to file a federal Chinese drywall lawsuit, is offering assistance to any homeowner interested in joining the Knauf Plasterboard lawsuit. Free consultations are available through the firm’s website at www.yourlawyer.com, or by calling 1-800-LAW-INFO (1-800-529-4636).

CSI Says ViperSheath Sheath Introducer Could Break, Recall Issued

Wed, 18 Nov 2009 00:00:00 -0800

Cardiovascular Systems Inc (CSI) has initiated a recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical. According to the recall notice, Thomas Medical has received reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in use.

The ViperSheath Sheath Introducer is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device. The device was developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI.

It In the event of a device fracture, separated segments of the ViperSheath Sheath Introducer may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

To date, CSI is aware of three instances where a ViperSheath Sheath Introducer encountered the issues related to this recall. No permanent patient injuries have been reported. In these instances, successful surgical interventions were performed to retrieve a portion of the sheath

The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

Lot range: S28117 through S29174
Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

CSI has notified all customers by FedEx about the recall and is arranging for the return of all products. Customers with questions may contact CSI at 1-877-274-0360.

The ViperSheath Sheath Introducer recall was first announced on November 2, and CSI's recall notice was posted on the Food & Drug Administration's Web site yesterday.

Plavix Users Warned Not to Take Prilosec, Nexium

Wed, 18 Nov 2009 00:00:00 -0800

Prilosec and Nexium reduce the anti-clotting effects of Plavix, according to a Public Health Advisory issued by the U.S. Food & Drug Administration (FDA). As a result, patients at risk for heart attacks or strokes who use Plavix to prevent blood clots will not get the full effect of this medicine if they are also taking Prilosec or Nexium. The agency warned yesterday that patients who take Plavix should use different medications to treat acid reflux, such as Mylanta or Zantac.

Prilosec inhibits the drug metabolizing enzyme (CYP2C19) which is responsible for the conversion of Plavix into its active form (active metabolite), the FDA said. New studies compared the amount of Plavix's active metabolite in the blood and its effect on platelets (anti-clotting effect) in people who took Plavix and Prilosec versus those who took Plavix alone. A reduction in active metabolite levels of about 45 percent was found in people who received Plavix with Prilosec compared to those taking Plavix alone. The effect of Plavix on platelets was reduced by as much as 47 percent in people receiving Plavix and Prilosec together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the agency said.

Prilosec is one of a class of drugs known as Proton Pump Inhibitors (PPIs). PPIs are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. According to the FDA, the level of inhibition among other PPIs varies, so it is unknown to what extent other PPIs may interfere with Plavix. However, Nexium, a PPI that is a component of Prilosec, also inhibits CYP2C19 and should also be avoided in combination with Plavix.

The FDA also advised that other drugs that are potent inhibitors of the CYP 2C19 enzyme would be expected to have a similar effect and should be avoided in combination with Plavix. These include: Tagamet, Diflucan, ketoconazole (sold as Nizoral, Extina, Xolegel, Kuric), VFend, etravirine (known as Intelence or TMC125), Felbatol, Prozac, Luvox, and Ticlid.

The manufacturers of Plavix have agreed to look at other possible drug interactions with Plavix. In the meantime, the Plavix label will be updated with new warnings on Prilosec and other drugs that could interact with Plavix in the same way. When more information becomes available, the FDA will communicate any additional recommendations or conclusions on the use of Plavix.

Finally, the FDA advised patients taking Plavix to consult their healthcare provider if they are currently taking or considering taking Prilosec, Prilosec OTC or Nexium. It is also very important that patients talk with their healthcare professional about any over-the-counter drugs they are taking before starting or while using Plavix. Patients should always consult with their healthcare professional before starting or stopping any medication.

FDA Says Shire, Eisai Drug Promotions Misleading

Tue, 17 Nov 2009 00:00:00 -0800

News media are reporting that the U.S. Food and Drug Administration (FDA) has issued warning letters to Shire PLC and Eisai Co Ltd about drug promotions for Dacogen and Fosrenol. The warning letters state that the Dacogen (Eisai) and Fosrenol (Shire) promotions understate the risk and overstate the benefits of the medications.

The FDA said that a customer-intended promotional card created by Eisai "presents numerous claims that misleadingly overstate the efficacy" of Dacogen, reported Reuters. Dacogen is a medication used in the treatment of the blood disorders myelodysplastic syndromes. The letter, dated November 6, also stated that Eisai’s campaign "omits material risks associated with Dacogen treatment."

According to the FDA, the promotional card was, among other violations, “misleading because it omits and minimizes important risks associated with the use of Dacogen, overstates the efficacy of Dacogen, and omits material facts about Dacogen.” Because of this, said the FDA, “the card misbrands the drug in violation of the Federal Food, Drug and Cosmetic Act.” The FDA went on to explain that, “promotional materials are misleading if they suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience,” and cited examples in which this was done on the card.

The FDA also stated that, “promotional materials are misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.” In just one of the cited examples, the agency said that the “12-page Patient Profile Card” presents claims about the drug’s efficacy prominently, utilizing large lettering and colorful graphics” in the initial pages, and “relegated … limited risk disclosure” information “to the middle of the back cover” in “small font type and single spaced paragraph format.”

In the warning letter sent on November 5 to Shire, the FDA said a Shire brochure for Fosrenol, a chewable tablet kidney medication—among other violations—omitted information on the medication’s risks and also included “unsubstantiated claims” that Fosrenol was more efficacious than its rival medications, reported Reuters.

According to the agency, Shire listed a number of the medication’s benefits; however, said the FDA, its “brochure fails to communicate any of the risk information associated with Fosrenol, including the numerous precautions and adverse reactions listed in the Background section above.” The FDA also cited another example in which it found that Shire’s presentation of Fosrenol “is more effective than other” medications of its kind, but that it is “not aware of any substantial evidence or substantial clinical experience to support” Shire’s implications.

Shire was also cited for suggesting its medication was “useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience,” which the agency said the brochure did in terms of Fosrenol’s use in treating hyperphosphatemia.

Both companies were asked to “immediately cease the dissemination of violative promotional materials” and respond back to the agency in writing by November 20.

A listing of FDA warning letters for 2009 can be accessed at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM055773

Negative Pressure Wound Therapy Warning From FDA Following Death, Injury Reports

Tue, 17 Nov 2009 00:00:00 -0800

The use of Negative Pressure Wound Therapy systems have been associated with deaths and serious complications, the U.S. Food & Drug Administration (FDA) warned yesterday. In a health alert posted on its Web site, the FDA said it will continue to monitor adverse events associated with Negative Pressure Wound Therapy systems, and will make available any new information that might affect their use.

Negative Pressure Wound Therapy helps various types of open wounds heal by creating a negative pressure (vacuum) at a well-sealed wound site. The vacuum helps remove fluids and infectious materials and draw wound edges together. Negative Pressure Wound Therapy is most commonly used with burns, flaps, ulcers and grafts, but it is contraindicated for several types of injuries, including wounds where there are exposed nerves, organs and vasculature.

In the last two years, the FDA has received six death and 77 injury reports associated with Negative Pressure Wound Therapy systems. Most of the deaths reported to the FDA occurred at home or in a long-term care facility.

Bleeding was the most serious complication and was reported in six death and 17 injury reports. Extensive bleeding occurred in patients with vascular grafts (such as femoral and femoral-popliteal grafts), in sternal and groin wounds, in patients receiving anti-coagulant therapy, and during removal of dressings that adhered to or were imbedded in the tissues. Patients with bleeding required emergency room visits and/or hospitalization and were treated with surgical procedures and blood transfusions.

According to the FDA, 27 reports indicated infection from original open infected wounds or from retention of dressing pieces in the wound. Retention of foam dressing pieces and foam adhering to tissues or imbedded in the wound were noted in 32 injury reports. The majority of these patients required surgical procedures for removal of the retained pieces, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy.

The FDA has advised healthcare professionals to carefully consider patient risk factors before employing Negative Pressure Wound Therapy. They should assure that the patient is monitored frequently in an appropriate care setting by a trained practitioner. In determining the frequency of monitoring, the patient’s condition, including the wound status, wound location and co-morbidities, should be considered.

If a patient is considered a candidate for in-home Negative Pressure Wound Therapy, healthcare providers should:

Instruct the patient and/or caregiver about how to use the system, potential complications and their signs/symptoms, and what to do if complications occur.
Request that the patient and/or caregiver demonstrate use of the system, and document his/her proficiency.
Assure that the patient and/or caregiver understands the warnings associated with NPWT system use.
Provide the patient with a written copy of the patient labeling from the NPWT system manufacturer, if available. Encourage the patient to keep these materials and instructions for use readily accessible.

TVA Says 2/3rds of Coal Ash from Last Year's Spill Cleaned Up

Tue, 17 Nov 2009 00:00:00 -0800

The Tennessee Valley Authority (TVA) is stating that most of the coal ash “deemed critical” following last year’s historic spill, has been cleaned up, said WDEF. The authority said some two-thirds of the “critical” spill has been cleaned out of the Emory River

The catastrophic fly ash spill took place last December and released an unimaginable 5.4 million cubic yards of toxic coal sludge, dumping toxins into Tennessee’s Emory and Clinch rivers and the 300 acres surrounding the TVA’s Kingston plant. An Environmental Protection Agency (EPA) report states that some “potentially toxic pollutants,” such as mercury and arsenic, found in coal ash, could present serious problems.

Mike Scott, the recovery project’s operations manager said, speaking to Chattanooga's Engineers club, "We had some heavy rains earlier after the spill had occurred which put some of the ash and washed it further down river which is one of the reasons why we're trying so hard to get it out before the Spring come next year," quoted WDEF. According to Scott, three million cubic yards of the 5.4 million cubic yards of fly ash were labeled "critical," and should be fully cleaned up by spring 2010, reported WDEF.

Earlier this year we wrote about how information pointing to “significantly higher cancer risks” for those living near coal-fired power plant ash dumps was allegedly covered up by the recent Bush Administration, citing a report by EnvironmentalIntegrity.org. The massive TVA spill involved over one billion gallons of toxic coal sludge and ravaged the environment, the economy, and the lives and health of the families, wildlife, and aquatic life living in the area. KnoxNews previously noted that the toxic sludge destroyed three homes and damaged about two-dozen others. The report also states that the pollutants can converge in considerable quantities, which are released into waterways or groundwater, said the Tennessean.

Numerous studies have concluded that coal dumps leach dangerous toxins into the environment that can cause cancer, birth defects, and other serious health outcomes in water and wildlife populations, including frightening guarantees of developing cancer from drinking contaminated water and suffering damage to the liver, kidney, lungs and other organs from toxic metal exposure, such as cadmium, cobalt, lead, and other pollutants far above levels considered safe,” said Environmental Integrity. The group noted that the danger to wildlife and ecosystems is “off the charts, with one contaminant—boron—expected to leach into the environment at levels two thousand times thresholds generally considered to be safe.”

The report also discusses cases in which the toxin has killed aquatic wildlife, contaminated wells, and adversely affected wildlife, reported the Tennessean, with the causes linked to coal ash wastewater. The waste has been both accidentally and “routinely” released as a result of coal-fired plant daily operations, the Tennessean noted. “Many of the common pollutants found in coal combustion wastewater (e.g., selenium, mercury, and arsenic) are known to cause environmental harm and can potentially represent a human health risk,” said the report, quoted the Tennessean.

Cruise Ship Norovirus Study Points Finger at Dirty Public Bathrooms

Tue, 17 Nov 2009 00:00:00 -0800

A norovirus outbreak has ruined more than one cruise vacation. Now a new study suggests that keeping public restrooms on cruse ships clean could go a long way in preventing norovirus among passengers and crew.

Unfortunately, the study, which was published in the journal "Clinical Infections Diseases" found that public bathrooms on cruise ships are not being cleaned properly. What's more, the U.S. Centers for Disease Control and Prevention (CDC), which runs a cruise ship sanitation program, is not doing a very good job of detecting the dirty cruise ship bathrooms.

The study used trained health care professionals to covertly evaluate the "Thoroughness of Disinfection Cleaning" of 6 standardized objects (toilet seat, flush handle or button, toilet stall inner handhold, stall inner door handle, restroom inner door handle, and baby changing table surfaces) with high potential for fecal contamination in cruise ship public restrooms. To do this, the investigators used an easily removable solution visible only under ultraviolet light to mark the objects. Then they monitored them for five to seven days to see if the solution had been removed by cleaning or disinfecting.

Over the course of the study, the investigative team evaluated 56 cruise ships (less than 30 percent of the vessels operated by 9 large cruise lines) from July 2005 through August 2008. There were 19 outbreaks of intestinal illness during the 3-year study period. While the survey was not designed to detect norovirus or establish the cause of any illness, the restroom cleanliness scores were slightly lower on ships that had outbreaks than on those that had none.

The investigators found that 37 percent of 8,344 objects in 273 randomly selected cruise ship public restrooms were cleaned daily. The "Thoroughness of Disinfection Cleaning" did not differ by cruise line and did not correlate with the CDC's Vessel Sanitation Program inspection scores.

According to the study, more than half the cruise ships had overall "Thoroughness of Disinfection Cleaning" scores under 30 percent, although several of these low-scoring ships had near-perfect CDC sanitation scores. The mean "Thoroughness of Disinfection Cleaning" score of the three ships evaluated within four months of an norovirus outbreak (10.3%) was substantially less than the mean "Thoroughness of Disinfection Cleaning" score of the 40 ships that did not experience such an outbreak (40.4).

Norovirus, which can survive for weeks on surfaces at room temperature, can be difficult to eliminate, and can only be killed with chorine bleach. Alcohol-based hand sanitizers and other preparations are not too helpful.

Norovirus outbreaks occur frequently in closed populations, such as cruise ship passengers According to The New York Times, there have been more than 60 outbreaks of norovirus on cruise ships since 2005.

Phthalate Exposure Affects Boys' Behavior

Tue, 17 Nov 2009 00:00:00 -0800

Phthalates, chemicals that enable flexibility in plastics and vinyls, are again, being linked to adverse health outcomes, this time in boys. According to WebMD, women exposed to high phthalate levels during pregnancy may give birth to boys who express behaviors that are less typically masculine.

For instance, said WebMD, boys born by women who were exposed to high phthalate levels, tend to play less with “trucks and other male-typical toys or to play fight,” citing an emerging study. Phthalates are known in testing to cause reproductive disturbances such as decreased sperm count, infertility, and reproductive tract malformations.

Ubiquitous in a wide array of consumer products and industry, phthalates are found in cosmetics, personal care products, pharmaceuticals and medical devices, food packaging, and cleaning and building materials, noted the National Academy of Sciences previously. Phthalates can also be found in pacifiers and rubber ducks, and are turning up in all sorts of foods. The compound is also found in, said Science Daily, flooring, cables, and packaging materials and, because of the toxin’s broad use, can be introduced quite easily into the food chain and the human body. A study recently out of ETH Zurich also stated that even when adopting a healthy eating lifestyle, phthalates are difficult to avoid, reported Science Daily.

Phthalates have been linked with male genitalia deformities, diabetes, excess weight, and premature births said Science Daily. No small problem given that synthetics are virtually everywhere. Phthalates—phthalate ester and alcohol—is an organic compound mixed with synthetic rubber for about five million tons annually, said Science Daily.

In the recent study, researchers looked at two phthalates that have been particularly worrisome to environmentalists—DEHP and DBP—said WebMD. The researchers conducted urinalysis on expectant mothers in their 28th week of pregnancy; the women were divided into four groups based on phthalate metabolites and product, said WebMD. Their 145 children and their play behavior was also assessed at three and six years of age, added WebMD. The study appears in International Journal of Andrology.

There was a correlation between mothers in the high concentration groups and boys with lowered masculinity scores, which were increased five-fold over mothers in the lowest concentration group, said WebMD, citing study researcher Shanna Swan, PhD. Swan is a professor of obstetrics and gynecology at the University of Rochester Medical Center's Center for Reproductive Epidemiology, and is also a phthalate expert, said WebMD. ''I'm not saying these boys are feminized … they are less likely to play in a male-typical manner," Swan told WebMD. Girls did not exhibit an effect, Swan added.

''We now suspect that the phthalate [exposure] affects the entire body, not just the reproductive tract,'' Swan said, quoted WebMD. Swan added that phthalate exposure might decrease testosterone production in embryos during the eighth and 24th week of gestation, considered a particularly significant time in development, reported WebMD, because it is at this time when testes are beginning to “function,” which alters “sexual differentiation in the brain.”

Thyroid Cancer Rates Near Indian Point Among Highest in U.S

Tue, 17 Nov 2009 00:00:00 -0800

Communities around the Indian Point nuclear power plant in Westchester, NY have higher-than-normal rates of thyroid cancer, according to a study released Monday. The study found that rates of thyroid cancer in the four counties surrounding the Indian Point nuclear plant - Orange, Putnam, Rockland and Westchester - were the highest in New York state, and among the highest in the United States.

The Indian Point nuclear power plant is located just north of New York City. The two nuclear reactors there went online in1973 and 1976. The plant, originally run by Consolidated Edison, is now owned and operated by Louisiana-based Entergy, a $13 billion company which runs nuclear plants in four other states. Entergy is awaiting renewal of the licenses for Indian Point's two reactors, one of which expires in 2013 and the other in 2015.

According to an article published by anti-nuclear activist Joseph Mangano in the International Journal of Health Services, before the Indian Point reactors began operating, the thyroid cancer rate in the four surrounding counties was 1.5 percent below that of the state. Now they are 54 percent higher.

At a news conference yesterday, Mangano called for the facility to be shut down. “Indian Point shouldn’t be allowed to keep unless it proves that it’s safe and it should only address issues such as this,” he said.

To reach his conclusions Mangano analyzed data from the U.S. Centers for Disease Control and Prevention, which he says showed that from 2001-2005, the thyroid cancer rate for the four counties was 66% above the U.S. average The rate of the disease in Rockland County is 106 percent above the national average; 102 percent above in Putnam; 87 percent higher in Orange and 42 percent higher than average in Westchester, Mangano said.

Mangano asserted that a major risk factor for thyroid cancer is exposure to radioactive iodine, which is produced only in nuclear weapons and nuclear reactors.

Mangano heads the nonprofit Radiation and Public Health Project. Yesterday's event was also attended by representatives of the Indian Point Safe Energy Council, the Hudson River Sloop Clearwater, and the Atlantic chapter of the Sierra Club.

Chinese Drywall Repair Fraud Prompts Call for Crackdown

Tue, 17 Nov 2009 00:00:00 -0800

The number of firms offering Chinese drywall "solutions" has exploded in recent months, prompting a group of U.S. Senators to ask the Federal Trade Commission (FTC) to crack down on such scams. It's important to remember that no Chinese drywall remediation or testing protocols have been established as yet, so any claims that a particular company has found a fix for the Chinese drywall problem are questionable at best.

In a letter to FTC Chairman Jon Leibowitz, Senators Mary Landrieu, (D-La), Bill Nelson (D-Fla.), David Vitter (R-La.), Thad Cochran (R-Miss.), Roger Wicker (R-Miss.) and Jim Webb (D-Va.), raised concerns about deceptive practices that prey on consumers with defective drywall and asked the Commission to fully investigate and prosecute companies engaging in these activities.

"Homeowners in our states are already struggling to deal with the health and property issues related to the defective drywall," the Senators wrote. "We believe that these impacted homeowners should not be further victimized by spending additional funds on remediation or preliminary testing not approved or endorsed by the Federal government or any State agency. As we work together with the designated Federal and State agencies to develop real solutions to the problems created by contaminated drywall, it is important that the FTC ensure that homeowners are protected from companies seeking to make fast money off the misfortune of these homeowners."

The U.S. Consumer Products Safety Commission (CPSC) has received about 1,897 reports from residents in 30 states, the District of Columbia, and Puerto Rico concerning Chinese drywall. Gases emitted from Chinese drywall are being blamed for significant property damage, including damage to HVAC systems, smoke detectors, electrical wiring, metal plumbing components, and other household appliances. These gases also produce a sulfurous odor that permeates homes, and cause metals, including air conditioning coils and even jewelry, to corrode.

People living with Chinese drywall have also suffered eye, respiratory and sinus problems that may be linked to the gases. The drywall problems have forced many people out of their homes, and some families are dealing with the heavy financial burden of paying both rent and mortgage payments. Those unable to afford additional rent have no choice but to stay in their smelly – and possibly hazardous – homes.

While it is understandable that Chinese drywall victims want the problem resolved quickly, it is important to note that remediation protocols have not been established, and cross-contamination could occur if repairs are not done correctly. Even after Chinese drywall has been torn out and replaced, out-gassing of sulfur compounds and other elements continues to occur. Remediation will only further jeopardize public health when it is done without adequate safeguards or by unqualified individuals.

If Chinese drywall repairs are performed before effective methods are developed, homeowners may be without recourse should they find that repairs do not confirm with the protocols that eventually will be established. For that reason, it is in the best interests of homeowners to delay any Chinese drywall repairs until a remediation protocol has been formulated.

Zinc in Fixodent, Super PoliGrip Linked to Nerve Damage By Another Study

Mon, 16 Nov 2009 00:00:00 -0800

Super PoliGrip, Fixodent and other denture creams have been associated with nerve damage and the development of neurological problems, according to a study published earlier this fall in the journal "NeuroToxicology." The study, conducted by researchers at Vanderbilt University and the University of Michigan, involved 11 patients, all of whom had a history of ill-fitting dentures, and used large amounts of products like Super PoliGrip and Fixodent, resulting in significant zinc exposure.

Super PoliGrip, Fixodent and other denture creams are made with zinc. A small amount of zinc is necessary for a balanced diet. However, being exposed to an excessive amount of zinc can result in copper depletion and serious negative adverse neurological effects.

The11 patients detailed in the "NeuroToxicology" article all had suffered from significant injuries and neurological disorders for a period of years. The study authors discovered that all 11 patients had used a zinc-containing denture cream, such as Fixodent or Super PoliGrip, to keep their dentures in place. Blood test confirmed that each suffered from zinc poisoning and copper deficiency.

After the 11 patients stopped using denture creams, their zinc and copper levels normalized. This led the study authors to conclude that: "Inappropriate use of denture cream appears to be the sole source of excessive zinc in these patient." Sadly, even after they stopped using denture cream, the neurological condition of the 11 patients did not improve, and was seemingly irreversible.

This "NeuroToxicology" study is not the first to point to a link between products like Super PoliGrip and Fixodent, and neurological disorders. In August 2008, the peer reviewed journal “Neurology” reported on four patients suffering from neuropathy and other neurological symptoms typical of zinc poisoning and copper depletion. All of the patients had been using excessive amounts of denture cream for many years. It was determined that excess use of denture cream could have been responsible for their symptoms.

Over the past year or so, hundreds of victims of zinc-containing denture creams have filed suit against the makers of Super PoliGrip and Fixodent. These lawsuits allege that the manufacturers of these products failed to warn about their risks and failed to provide adequate warnings about the zinc in their products, or adequate instructions to prevent deviation from accepted use. Earlier this year, Super PoliGrip and Fixodent lawsuits were consolidated for centralized and coordinated pre-trial proceedings in the Denture Cream Products Liability Litigation in the United States District Court for the Southern District of Florida, Miami Division, before the Honorable Judge Cecilia Altonaga (MDL No. 2051).

Vytorin, Zetia Disappoint Again

Mon, 16 Nov 2009 00:00:00 -0800

Vytorin and Zetia, Merck & Co.'s anti-cholesterol medications, are coming under fire again. A new study has found that a much older - and cheaper - drug reduced artery plaque much better in eight months than ezetimibe, the active ingredient in both Vytorin and Zetia.

According to USA Today, this latest study was released Sunday at an American Heart Association meeting and published online by the New England Journal of Medicine.

Vytorin, developed and marketed jointly by Merck and Schering-Plough, is a combination of cholesterol-lowering Zetia and the statin Zocor. Vytorin was approved by the Food & Drug Administration in 2004 to treat both sources of cholesterol – absorption in the intestine of both biliary and dietary cholesterol, and production in the liver and peripheral tissues. It was believed that the treatment of cholesterol from both sources would likely result in lower cholesterol levels. It was likewise theorized that this reduction in cholesterol would in turn reduce the amount of plaque buildup in the arteries, thus reducing the risk of heart attack and stroke.

According to USA Today, the latest Vytorin and Zetia study compared ezetimibe with prescription Niaspan, made by Abbott Laboratories. Niaspan is a slow-release form of niacin, a drug which has been around for 50 years. The Abbott-sponsored study involved 363 patients who had heart disease or a high risk of heart problems. All had been taking statins and had relatively low levels of bad cholesterol. Half of the patients were given Niaspan, and half were given Zetia, USA Today said.

The study found that Niaspan reduced plaque in neck arteries by 2%,while Zetia did not. Two people in the Niaspan group had heart attacks or other major cardiac events, compared with nine in the Zetia group.

While the study did have some limitations, - a small size, and the fact that it was stopped after 14 months because patients in the niacin group were doing better - it is not the first to question the supposed benefits of Vytorin and Zetia. The drugs have been the subject of controversy since the ENHANCE study was released in January 2008. ENHANCE found that the Vytorin was no better than a cheaper, generic statin in preventing clogged arteries, and raised serious questions about the effectiveness of both Vytorin and Zetia. What’s more, Merck and Schering-Plough delayed releasing ENHANCE for more than a year, even though the trial was actually completed in 2006.

The ENHANCE controversy spawned scores of lawsuits against Merck and Schering-Plough. Many accused the companies of marketing Vytorin and Zetia in a misleading fashion and failing to disclose the results of ENHANCE in a timely manner. Earlier this year, Merck and Schering-Plough agreed to pay $41.5 million to settle class-action lawsuits stemming from that debacle.

FDA Orders Safety Review Of Alcoholic Energy Drinks

Mon, 16 Nov 2009 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) just notified about 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs. According to the FDA, of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food, such as caffeine in alcoholic beverages, is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). The agency has not approved the use of caffeine in alcoholic beverages; therefore, such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.

For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that it is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or was “prior sanctioned.” To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA's letter informed each company that if it determines use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, it will take appropriate action to ensure that the products are removed from the marketplace.

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use.

In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.

Genzyme Drugs Found To Be Tainted With Steel Fragments, Other Foreign Matter

Mon, 16 Nov 2009 00:00:00 -0800

The U.S. Food and Drug Administration and Genzyme Corporation are advising endocrinological and genetics medicine healthcare professionals that Genzyme products marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen are potentially tainted with foreign particles. The medications are used to treat rare, serious, and life-threatening diseases.

The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process and could potentially cause serious adverse events in patients. Cerezyme, Fabrazyme, Myozyme, and Thyrogen are supplied as lyophilized powders requiring reconstitution before administration; Aldurazyme is supplied as a liquid solution.

Potential adverse events from IM administration of a contaminated product could include local pain, swelling, and inflammation. Potential adverse reactions from IV administration of a product contaminated with foreign particles could be more serious, including damage to blood vessels or embolic events, and anaphylactic, allergic, and immune-mediated reactions. It is also possible that the foreign particles could affect how well these products work.

Boston.com reported that Genzyme, located in Cambridge, Massachusetts, recently suffered another blow when a virus was found at its Allston plant. Two of the medications indicated in the recent particle contamination warning—Cerezyme and Fabrazyme—were also recently rationed because of the viral contamination. Combined, the five impacted medications amount to about half of Genzyme’s annual sales, some $4.6 billion.

Globally, about 5,500 people depend on Cerezyme and about 2,500 use Fabrazyme, said Boston.com. Cerezyme treats Gaucher disease, a disorder that caused the build-up of fatty substances in the liver, spleen, and other organs; Fabrazyme treats Fabry disease. Fabry disease does not allow the body to break down oils and fats that accumulate in the eyes and kidneys, explained Boston.com.

Myozyme treats the muscular disorder, Pompe disease; Aldurazyme treats the metabolic disorder mucopolysaccharidosis; and Thyrogen treats thyroid cancer and all three are produced in Framingham Massachusetts and sent to Allston for finishing, according to Boston.com. Cerezyme and Fabrazyme are manufactured in Allston.

The FDA’s warning to physicians urges careful examination of the product vials prior to administration to patients, standard industry operating procedure, said Boston.com. If particles are discovered, the vials should be returned to the manufacturer.

The FDA began its investigation of the Allston plant in October to review Genzyme’s production operations, Boston.com reported. The Allston Landing plant is located on the Charles River. Because the issue is not considered wide scale and because of the rarity of the diseases involved, a drug recall was not initiated, according to Boston.com

Genzyme stated that the particle contamination issue is unrelated to the viral contamination issue.

Reports Of Cartilage Damage Associated With Local Anesthetics, Pain Pumps

Mon, 16 Nov 2009 00:00:00 -0800

Orthopedic and anesthesia healthcare professionals and hospital risk managers are being advised by the U.S. Food and Drug Administration (FDA) of 35 reports of chondrolysis—cartilage necrosis and destruction—in patients given continuous, intra-articular infusions of local anesthetics with elastomeric pain pumps used to control pain after joint surgery. The anesthetics in question are marketed under the names bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine

The 35 reports occurred between 2006 and 2008 primarily in the shoulder (97%) and were received via the agency’s Adverse Event Reporting System (AERS). The remaining reports occurred in the knee. Four additional reports of chondrolysis in patients administered continuous intra-articular infusions of lidocaine in the shoulder were reported after the initial 35 bupivicaine-related cases were reported from 2006 to 2008, said the FDA.

Thirty-two (91%) patients received bupivacaine (with or without epinephrine) as an intra-articular infusion after undergoing arthroscopic and other surgical procedures. Two patients received ropivacaine in addition to bupivacaine and two received bupivacaine as a single injection along with an intra-articular infusion of lidocaine. The average infusion time was between 48 and 72 hours and the most commonly reported site of infusion was the glenohumeral (glenoid) space (46%). The most common manufacturer of elastomeric infusion device mentioned was Stryker; other manufacturers mentioned were I-flow, Donjoy, and Breg.

The local anesthetic was infused using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after infusion. In more than half of the reports, patients required additional surgery, including arthroscopy or arthroplasty. Arthroplasty is the medical term for joint replacement. Chondrolysis symptoms occurred as early as two months after the infusion and was diagnosed about eight and a-half months following infusion. Patients averaged about 25 years of age—the range was 16-to-58 years of age—with six involving pediatric patients between 16 and 18 years.

Sixteen of the 32 (50%) bupivacaine-associated AERS reports included the dose administered; 10 of 16 received 500mg over 48 hours or 250mg/day. While within the maximum dose listed in the drug label (400mg/day), the maximum labeled daily dose was determined for the approved, not off-label uses such as continuous intra-articular infusions with elastomeric infusion devices. Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps.

The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are urged to follow instructions for elastomeric infusion devices, and not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery. The FDA is also advising patients that, if, after an orthopedic surgical procedure, a prolonged infusion of a local anesthetic was administered into a joint using a disposable elastomeric pump or other infusion pump, to pay attention to joint pain, stiffness, and a decrease or loss of motion and contact a healthcare professional if symptoms persist.

The FDA is now requiring the manufacturers of local anesthetics and of pumps that may be used to infuse local anesthetics to update labels to warn healthcare professionals about this potential serious adverse effect. The reported cases involved significant injury to otherwise healthy young adults and the agency wants to advise healthcare professionals that elastomeric infusion devices or any other infusion pump are not cleared by FDA to deliver intra-articular infusions of local anesthetics and should not be used for this purpose.

Chinese Drywall Lawsuits, Investigation Gaining Momentum

Mon, 16 Nov 2009 00:00:00 -0800

The Chinese drywall crisis, and the litigation surrounding it, is set to enter a new phase this month. With potential plaintiffs in Chinese drywall lawsuits facing an important deadline in a few weeks, a federal judge will soon be scheduling the first lawsuits for trial.   And in the coming weeks, federal investigators should know more about the what, if any, safety hazards, the corrosion blamed on Chinese drywall fumes may pose.

By December 2, any Chinese drywall victim whose home was built with wallboard made by Knauf Plasterboard (Tianjin) Co., Ltd. needs to join the omnibus Chinese drywall lawsuit against the company that will be filed on December 9.   Knauf has agreed to waive its rights under The Hague Convention for the Service of Process Abroad for homeowners who sign on to this lawsuit by the deadline. The December 2 deadline is a hard deadline, and the omnibus complaint will not be amended at a later date to add more people. Claimants will also face a second deadline – December 14 – by which time they must have filled out a profile form.

The Hague Convention for the Service of Process Abroad requires claimants to pay approximately $15,000 per lawsuit, which allows for the translation of legal documents into Chinese and to have them presented to the appropriate authorities in China to obtain service on the Chinese drywall manufacturers. These requirements were a huge obstacle to claimants, and Knauf’s offer to waive them will greatly streamline the litigation process for plaintiffs who make the deadline.

To be eligible for the omnibus lawsuit, claimants must submit pictures or other proof that they have wallboard made by Knauf Plasterboard in their homes by December 2, 2009. Any Chinese drywall homeowner interested in becoming a party to this lawsuit must start now by contacting an attorney and arranging to have their home inspected. Parker Waichman Alonso LLP, the first law firm to file a federal Chinese drywall lawsuit, is offering assistance to any homeowner interested in joining the Knauf Plasterboard lawsuit. Free consultations are available through the firm’s website at www.yourlawyer.com, or by calling 1-800-LAW-INFO (1-800-529-4636).

The agreement with Knauf was announced earlier this month by Judge Eldon E. Fallon, who is overseeing the consolidated Chinese drywall litigation (MDL 2047) currently underway in federal court in New Orleans. The offer applies only to the consolidated federal litigation, not individual cases.

Sometime this week, Judge Fallon is also expected to select the first Chinese drywall lawsuits that will go to trial.    Judge Fallon has said that he wants the first Chinese drywall trial to start by January 10, 2010.

Finally, the Consumer Products Safety Commission (CPSC) is expected to issue more findings from its Chinese drywall investigation sometime this month. The next round of test results will address the corrosion of copper wires and other metals in homes with Chinese drywall - whether this is being caused by fumes from the wallboard, and whether the corrosion of wiring poses a fire hazard. The CPSC is also expected to release results of tests done on indoor-air samples collected from about 50 U.S. homes with Chinese drywall,

Late last month, the CPSC release the initial results of three studies that compared Chinese and domestic wallboard. Those tests revealed that samples from China emit volatile sulfur compounds at a higher rate, and contain higher levels of sulfur and strontium, than the American-made product. However, the CPSC still could not say if there was a direct link between the Chinese drywall and the health problems homeowners are reporting.

Gander Mountain Tree Stands Recalled Due to Fall Hazard

Sat, 14 Nov 2009 00:00:00 -0800

About 13,000 Hang-On Fixed Position Treestands, imported by Gander Mountain Company of St. Paul, Minnesota and manufactured by StrongBuilt, of Waterproof, Louisiana, have been recalled, the U.S. Consumer Product Safety Commission (CPSC) just announced.

The clasp on the Gander Mountain Hang-On Fixed Position Treestands may open unexpectedly if the strap is fastened incorrectly, causing the treestand and user to fall to the ground. To date, Gander Mountain has received two reports of consumers falling while using the treestands; one sustained unspecified injuries and a second person sustained a broken pelvis and broken arm.

Gander Mountain is recalling the 2008 model GMT101 and 2008 model GMT103 Hang-On Fixed Position Treestands. The recalled treestands have wire mesh on the base of the platform to the top of the footrest and a Gander Mountain logo on the front of the seat. In addition, the seat has a camouflage pattern that is branded “AP” and “REALTREE.” Model GMT101 has “Steel Hang-On With Foot Rest” printed in large bold print on the exterior of the box and the GMT103 has “Large Steel Hang-On With Foot Rest” printed on the exterior of the box. This recall does not affect the 2009 year models GMT101 and GMT103 Hang-On Fixed Position Treestands manufactured by Rivers Edge.

The recalled Gander Mountain Treestands were sold only at Gander Mountain stores from July 2008 until July 2009. The GMT101 was sold for about $60 and the GMT103 was sold for about $80. The recalled treestands were manufactured in China.

Of note, defective imports from China have been making headlines in recent years; this treestand recall is another of many such issues on which we have been writing. In 2008, nearly 80 percent of all product recalls in the United States involved imports from China. Products such as dog food, baby formula, toys with lead paint, and even pharmaceuticals like heparin have been found to have been made with toxic materials and other counterfeit ingredients that have long been putting United States consumers at significant risk. Also making news is the ongoing Chinese drywall disaster involving imports from that country.

The CPSC is advising consumers to immediately stop using the recalled treestands and return them to Gander Mountain for a refund, exchange for a 2009 model, or a store credit. Gander Mountain can be reached toll-free at 1-888-542-6337 Monday through Friday between 8:00 a.m. and 10:00 p.m. and Saturday and Sunday between 9:00 a.m. and 8:00 p.m., Eastern Time, or at the firm’s Web site at www.gandermountain.com

FDA Cites Red Cross for Problems with Blood Supplies

Fri, 13 Nov 2009 00:00:00 -0800

Dow Jones News just broke with information regarding blood supplied by the American Red Cross. It seems that the U.S. Food and Drug Administration said yesterday that it discovered what it described as “widespread and persistent problems with the storage and distribution” of blood supplied by the Red Cross.

The agency investigation, which took place last year, revealed a substantial amount of violations. According to Dow Jones, over 200 significant violations were discovered at 12 Red Cross facilities nationwide. The data is part of a report posted to the FDA’s Web site.

According to the agency, it is responsible for regulatory oversight of the U.S. blood supply. FDA promulgates and enforces standards for blood collection and for the manufacturing of blood products, including both transfusible components of whole blood, pharmaceuticals derived from blood cells or plasma, and related medical devices. FDA also inspects blood establishments and monitors reports of errors, accidents and adverse clinical events. CBER (Center for Biologics Evaluation and Research) works closely with other parts of the Public Health Service (PHS) to establish blood standards, and to identify and respond to potential threats to blood safety or supply.

Dow Jones reported that violations include blood components distributed with incorrect references to donor gender, and blood distributed in cases in which a donor was not properly cleared to give blood. "FDA regards the violations discussed in this letter to be significant," the agency said in its October 30 letter to the Red Cross, quoted Dow Jones. The FDA said it may levy fines of up to $5,000 for every unit of blood or blood component that was distributed and may have put the public's health at risk.

To date, Dow Jones indicated that documents do not state if there were any injuries reported or experienced as a result of the blood distributed by the American Red cross. Also, Red Cross spokeswoman Stephanie Millian said it has not received any reports of adverse events related to the blood products mentioned in the FDA report, said Dow Jones.

The FDA noted that from 2003 through 2008 the Red Cross had to recall 7,363 "unsuitable" blood components, said Dow Jones. Also, in a statement, the Red Cross said that over the last 18 months it has made system-wide change to address problems, and that most cited problems took place prior to 2008.

The Red Cross also argued, said Dow Jones, that the blood problems cited are just a fraction of the blood units it collects and processes annually, some six million unites. "The blood supply is safer today than ever before, and people should not hesitate to give or receive blood," the Red Cross said, quoted Dow Jones.

The Red Cross has been under intense scrutiny for more than a decade, and has been cited for similar violations by the FDA, most recently in 2005. A federal court in the 1990s ordered the Red Cross to correct systemic problems in tracking and distributing blood, according to Dow Jones. Meanwhile, the FDA's report said its investigation found the Red Cross has "repeatedly promised to implement and monitor corrective actions, but the corrective actions have not prevented recurrence of the problem."

Firm At Center of E. Coli Outbreak Wasn't Testing Beef Trim

Fri, 13 Nov 2009 00:00:00 -0800

An E. coli outbreak that has killed 2 people has been linked to a ground beef processor that, according to The New York Times, stopped testing its ingredients years ago under pressure from beef trim suppliers.

As we've reported previously, Fairbank Farms of Ashville, New York - owned by AFA Foods - recalled more than 500,000 pounds of ground beef because of potential E. coli contamination. At the time the recall was issued, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) said that there was an association between the fresh ground beef products subject to recall and illnesses in Connecticut, Maine and Massachusetts. It is now suspected that many as 500 cases of E. coli O157:H7may be tied to the recalled ground beef.

According to The New York Times, despite the fact that the USDA banned E. coli 0157:H7 in 1994, meat companies are only encouraged, not required, to test ingredients. Earlier this fall, a Times investigation found that many trim suppliers actually bar ground processors from testing their beef trim prior to use out of fear that the discovery of E. coli will force a recall. As a result, most ground beef is tested as a finished product, which can make it difficult to determine the original source of E. coli if contamination is found.

This is apparently how AFA handles testing, according to The New York Times. Officials with AFA confirmed that its plants - including Fairbank Farms - require slaughterhouses to test their trim and that the plants tests samples of finished ground beef as frequently as every 10 minutes. Like many processors, Fairbank Farms uses beef trim from various suppliers. According to the Times, in 2007, the plant could not determine the source of E. coli contamination when it was found in finished ground beef.

The products subject to the Fairbank Farms recall were sent to retailers including Trader Joe’s, Price Chopper, Lancaster and Wild Harvest, Shaw’s, BJ’s, Ford Brothers, and Giant Food Stores. The recall was for distribution centers in eight states, but Fairbank Farms said some retailers may have sent the affected beef to other states. According to the FSIS, the meat involved in this recall is marked with “EST. 492″ inside the USDA mark of inspection. The recalled products were packaged on September 15 and 16 and may have been labeled at the retail stores with a sell-by date from September 19 through 28. Consumers should ask at their point of purchase if the products they have purchased are subject to recall.

According to The New York Times, Trader Joe's, which has terminated its relationship with AFA since the Fairbank Farm recall, has since said it was embracing trim testing even though it has had to recall only a small amount of fresh ground beef and knew of no illnesses among its customers.

Maclaren Knew About Dangerous Strollers For 5 Years, Took No Action

Fri, 13 Nov 2009 00:00:00 -0800

This week we’ve been following the massive recall of Maclaren strollers that was finally made official following reports of children’s fingertips being amputated. Now, it seems, that information is emerging that Maclaren knew—for an unbelievable five years—that the strollers could sever children’s fingers but did nothing until forced to by the government, the New York Post has reported.

Maclaren USA, Inc., of South Norwalk, Connecticut issued a recall of about one million Maclaren Strollers because the stroller’s hinge mechanism poses a fingertip amputation and laceration hazard to the child when the consumer is unfolding/opening the stroller. To date, Maclaren has received 15 reports of children placing their finger in the stroller’s hinge mechanism, resulting in 12 reports of fingertip amputations in the United States.

The recall includes every Maclaren stroller sold in the past decade, since 1999.

Although Maclaren acknowledged that the fingers of children were amputated as a result of the stroller’s hinges, it never advised the U.S. Consumer Products Safety Commission (CPSC) at the time it was first made aware that a "potential danger," existed, said the Post. The Post, citing sources, noted that Maclaren, which is based out of Great Britain, could face, at least, upwards of $1 million in fines. Companies are federally mandated to "report to CPSC immediately on learning of a problem with a product that makes it a substantial hazard or poses a potential hazard," agency spokesman Scott Wolfson said, quoted the Post.

In this case, Maclaren was allegedly aware that its stroller hinges could sever fingers since as far back as July 12, 2004, said the Post, when a 23-month-old Connecticut child’s right pinky was lopped off by the defective Maclaren stroller hinge, said the Post, citing court papers. The accident happened when Jane DeWinter, the child’s mother, was shopping at a Right Start store near Greenwich and was looking at a Maclaren Triumph stroller, said the Post. DeWinter was testing the mechanism when her son, Carlos, put his finger on the defective hinge and experienced a "traumatic amputation," according to court papers. The pinky was not able to be reattached, although two surgeries were attempted, said the Post.

Meanwhile, both Maclaren and Right Start blame the mother’s "own negligence," according to the lawsuit, said the Post. Regardless, Robert Moro, an engineer and former CPSC compliance officer disagreed, based on his 2007 testimony in which he stated that “this stroller contains a substantial design defect when compared to other types of designs of strollers intended to be used by children," quoted the Post. Further, the design and manufacturing of the stroller—which was made in China—is in violation of federal guidelines to prevent horrific “scissoring effect,” according to Moro, said the Post. "Maclaren had a legal obligation to report this," Moro told The Post. "It's extremely unfortunate a lot of little kids had to get their fingers amputated." Maclaren and the DeWinters settled for an undisclosed sum, said the Post.

Of note, defective imports from China have been making headlines in recent years; this massive stroller recall is another of many such issues on which we have been writing. In 2008, nearly 80 percent of all product recalls in the United States involved imports from China. Products such as dog food, baby formula, toys with lead paint, and even pharmaceuticals like heparin have been found to have been made with toxic materials and other counterfeit ingredients that have long been putting United States consumers at significant risk. Also making news is the ongoing Chinese drywall disaster involving imports from that country.

Synthes USA Issues Class I Recall for Vertebrae Replacement Implants

Fri, 13 Nov 2009 00:00:00 -0800

Synthes USA is recalling all lots of the Ti Synex II Vertebral Body Replacement device.   The U.S. Food & Drug Administration (FDA) has deemed the Synthes USA Ti Synex II Vertebral Body Replacement recall a Class I recall.

The Ti Synex II Vertebral Body Replacement is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. The recall is being issued because of reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ occurring at six to fifteen months post implantation.

Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device.

The FDA has directed that surgeons and hospitals in possession of the recalled devices stop implanting them immediately. Patients who have this recalled device and have increased pain, other symptoms, or questions should contact their surgeon.

The recall applies to devices manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. The devices included are:

•   Part No. 04.808.001; Description: Ti Synex (TM) II Central Body 14 mm - 19 mm
•   Part No. 04.808.002; Description: Ti Synex (TM) II Central Body 17 mm - 25 mm
•   Part No. 04.808.003; Description: Ti Synex (TM) II Central Body 21 mm - 29 mm
•   Part. No.04.808.004; Description: Ti Synex (TM) II Central Body 25 mm - 33 mm
•   Part No. 04.808.005; Description: Ti Synex (TM) II Central Body 29 mm - 44 mm
•   Part No. 04.808.006; Description: Ti Synex (TM) II Central Body 37 mm - 52 mm
•   Part No. 04.808.007; Description: Ti Synex (TM) II Central Body 45 mm - 71 mm
•   Part No. 04.808.008; Description: Ti Synex (TM) II Central Body 58 mm - 84 mm
•   Part No. 04.808.009; Description: Ti Synex (TM) II Central Body 71 mm - 97 mm
•   Part No. 04.808.010; Description: Ti Synex (TM) II Central Body 84 mm -110 mm
•   Part No. 04.808.011; Description: Ti Synex (TM) II Central Body 97 mm -123 mm

Class 1 recalls are the FDA's most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

Chinese Drywall Aid Set Aside in Louisiana

Fri, 13 Nov 2009 00:00:00 -0800

Some Chinese drywall victims in Louisiana could eventually get a bit of financial help from the state. According to the Associated Press, the Louisiana Recovery Authority (LRA) yesterday voted unanimously to back a $5 million plan to help Road Home program recipients who have tainted Chinese drywall. The aid package still must be approved by the Louisiana legislature and federal authorities before it can begin.

The LRA was established in 2005 following hurricanes Katrina and Rita, and provided funds through the Road Home program to residents for rebuilding. Much of the rebuilding done with Road Home funding involved the use of Chinese drywall.

Earlier this summer, the Louisiana legislature had mandated that the LRA create a $5 million initiative to help drywall victims. In October, the LRA approved Action Plan Amendment No. 37, which created the initiative. Yesterday's decision sets the funding for the program aside. Only people who received aid through the Road Home program will be eligible for the funds.

According to a report on WWLTV.com, funds for the program won't be dispersed until the federal government devises protocols for how to properly test and fix homes with Chinese drywall. It's doubtful that will happen this year.

While Louisiana is the only state so far to set aside funds for Chinese drywall victims, WWLTV.com said that state officials acknowledge that the $5 million won't go very far. They are hoping that the federal government will implement a large scale program to help Chinese drywall homeowners throughout the country.

The U.S. Consumer Products Safety Commission (CPSC) has received about 1,897 reports from residents in 30 states, the District of Columbia, and Puerto Rico concerning Chinese drywall. Gases emitted from Chinese drywall are being blamed for significant property damage, including damage to HVAC systems, smoke detectors, electrical wiring, metal plumbing components, and other household appliances. These gases also produce a sulfurous odor that permeates homes, and cause metals, including air conditioning coils and even jewelry, to corrode.

People living with Chinese drywall have also suffered eye, respiratory and sinus problems that may be linked to the gases. The drywall problems have forced many people out of their homes, and some families are dealing with the heavy financial burden of paying both rent and mortgage payments. Those unable to afford additional rent have no choice but to stay in their smelly – and possibly hazardous – homes.

Forum on Silver Eagle Refinery Blasts Yields Few Answers

Thu, 12 Nov 2009 00:00:00 -0800

At a meeting to discuss last week's Silver Eagle Refinery explosion in Woods Cross, Utah, city officials said there was little they could do to regulate the facility. However, City Administrator Gary Uresk told an audience of about 200 that the city would work with the Occupational Safety and Health Administration (OSHA) or U.S. Chemical Safety Board to press for more oversight and safety.

Last Wednesday's explosion at the Silver Eagle refinery occurred shortly after 9:00 a.m. MST, sparking a fire at the 10,250 barrel-per-day refinery, located just outside of Salt Lake City in Woods Cross, that burned until later that day. The blast created a huge fireball, which sent flames as high as 100 feet in the air. At least 10 homes sustained damage, and some were knocked off their foundations from the force of the explosion. Other damage to property included smashed windows, bent garage doors and peeled siding.

A team from the U.S. Chemical Safety Board has determined that the cause of the latest accident at the Silver Eagle Refinery was a “catastrophic failure” of a 10-inch pipe that contained more than 600 lbs of pressurized hydrogen. It is not yet known why the pipe suffered such a failure. Refineries are supposed to monitor the integrity of piping, and investigators said they would inquire whether that monitoring occurred at Silver Eagle.

As we've reported previously, Silver Eagle has had other problems recently. On January 12, a large vapor cloud that was released from a petroleum storage tank ignited, causing a massive flash fire. The storage tank continued to burn for a number of hours, leading to widespread evacuations in Woods Cross. Two refinery operators and two contractors, who were standing in a shed more than 230ft from the tank, were engulfed by the flame front and suffered serious burns. The January 12 fire is still under investigation.

A current inspection report from the OSHA Web site lists four “serious” violations related to the January fire. In 2005, OSHA cited the facility for 10 “serious” violations in 2005, and assigned a “gravity” rating of 10 to one, meaning it carried the highest possible risk to workers’ safety. Silver Eagle also received two other “serious” violations in 2004, and one in 2002. OSHA records indicated that since April 2002, the facility has been cited for 23 violations overall.

According to a report in the Salt Lake Tribune, some Woods Cross residents expressed surprise during this week's meeting when they were told the city could do little to regulate Silver Eagle. At least one attendee told the Tribune that the information disseminated at the forum did not make him feel any safer.

Others in the audience questioned why the city allowed a residential development to be built so close to the Silver Eagle Refinery. Some homes in Woods Cross were separated from the refinery by only a sound wall and railroad track. The neighborhood directly east of the Silver Eagle Refinery was hardest hit by the blast

According to the Salt Lake Tribune, the city's own engineering report had recommended following Housing and Urban Development standards that would have placed homes roughly 475 to 750 feet away from potentially unsafe storage areas. But, a developer-commissioned study, which the city ultimately followed, said homes should be 175 feet away based on the International Fire Code.

Some residents suggested making a buffer area between the refinery and the adjacent subdivision larger. Others propose making a wall between the homes and the refinery taller.

Pfizer Influenced Neurontin Studies

Thu, 12 Nov 2009 00:00:00 -0800

It has been known that Neurontin is associated with a significant—80 percent, accoring to a prior LA Times report—increase in suicidal ideation and actions. Now, Reuters, is reporting that internal Pfizer Inc. documents point to the drug maker having “altered or omitted unfavorable study findings to expand its epilepsy drug, Neurontin's, market,” citing U.S. researchers looking into how drug manufacturers massage research data. Pfizer is considered, said Reuters, the world’s largest drug maker.

The research found that although clinical trials respond to a specific scientific question, when looking at Pfizer documents and published studies on Neurontin for nonepilepsy conditions, it seems that nearly half—eight of 20—of the studies did not receive medical journal publication, said Reuters. Also, eight of 12 studies that were published, were published with a significant change: Pfizer changed The main scientific question.

"There were a lot of primary outcomes that were shifted around between the planning of the protocol and the reporting of the study," said Kay Dickersin of Johns Hopkins University in Baltimore, quoted Reuters. Dickersin’s study appears in the New England Journal of Medicine. "Some primary outcomes were lost altogether. Some were brand new. Some were secondary outcomes that were upgraded to primary," Dickersin said in a telephone interview with Reuters.

The drug giant funded all of the studies and all showed how Neurontin worked off-label for migraines or pain. Once approved, any drug can be prescribed off-label; however, drug makers are not permitted to market medications for off-label uses and can only tout drugs for Food & Drug Administration (FDA)-approved uses, explained Reuters. Interestingly, drug companies can distribute study reprints from medical journals; of note given the change in focus in a number of such pieces made by Pfizer.

In 2004, Pfizer paid a whopping $430 million to settle a lawsuit over how it illegally promoted Neurontin and was sued last year for off-label marketing, neglecting to release negative study results, and changing the focus of trials to present more favorable outcomes, said Reuters. The 2004 charges stemmed from a federal whistleblower lawsuit that claimed Neurontin marketing was promoting off-label uses, including the treatment of pain and bipolar disorder.

The FDA approved Neurontin in 1983 to treat partial complex seizures. The drug quickly became a blockbuster; by 2004, sales reached $3 billion annually. Neurontin was made by Parke-Davis, a division of Warner-Lambert, which was acquired by Pfizer in 2000.

The family of Susan Bulger filed the first Neurontin suicide lawsuit; Bulger (39) took the drug before hanging herself in 2004. The lawsuit alleged the company hid the drug’s suicide risks. The plaintiffs’ case focused on last December’s decision by the FDA to order all makers of epilepsy drugs to add a suicide-risk warning to their label. As we reported at the time, the new warnings resulted from the FDA’s review of 199 clinical trials of 11 anti-epileptic drugs which showed that patients receiving anti=epileptic drugs had a nearly two-fold risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with anti-epileptic drugs instead of placebo, the agency said.

Illness Reported After H1N1 Vaccine

Thu, 12 Nov 2009 00:00:00 -0800

Less than 24 hours after being inoculated against the H1N1 Swine Flu, a young Virginia boy has come down with the dangerous, often debilitating Guillain-Barre syndrome, MSNBC is reporting.

Jordan McFarland (14), is wheelchair-bound and developed severe headaches, spasms, and leg weakness, said MSNBC, and is expected to need to use a walker for up to six weeks and will have to undergo “extensive physical therapy,” following his shot. Jordon is not the only case, and this is not the first time a swine flu vaccine has been associated with the serious disorder, noted MSNBC. In 1976, there were increased reports of Guillain-Barre connected to that year’s swine flu vaccine; to date, the U.S. Centers for Disease Control and Prevention (CDC) has received five reports of the syndrome since October 6, reported MSNBC, in addition to Jordan’s.

While less than what is expected, according to Dr. Claudia J. Vellozzi, deputy director of immunization safety, about 40 million H1N1 vaccine doses have been made available, said MSNBC. Guillain-Barre is expected to develop in about one in each one million regular flu vaccinations, with one more case of the syndrome in every 100,000 people receiving swine flu vaccinations in 1976, said the CDC, reported MSNBC.

And, while the CDC says it has received some 1,700 reports of adverse events associated with the new swine flu shot—four percent, or 68, were deemed serious—Guillain-Barre Syndrome is considered one of the most severe of the reactions, said MSNBC. Experts believe the adverse effects experienced with the H1N1 virus are more serious than the vaccine. “The H1N1 illness is making lots of children very ill," Vellozzi said. Over 4,000 have died, to date, said MSNBC, citing recent CDC estimates.

Since the implementation of the H1N1 inoculation program, the CDC has issued warnings about an array of conditions, such “miscarriage, heart attack and even GBS” that can take place with or without the vaccine and has urged the public to report any potential side effects, but not to assume the vaccine is connected, said MSNBC.

Barbara Lowe Fisher, president of the National Vaccine Information Center in Vienna, Virginia, explained that adverse events are underreported with a mere one-to-ten percent reported to the government's Vaccine Adverse Event Reporting System (VAERS), according to MSNBC. While a law implemented in 1986 mandates reactions be reported, there are no so-called sanctions for failing to report, said Fisher; the CDC confirmed that reporting is voluntary, noted MSNBC.

The Associated Press (AP) just reported that, according to federal health officials, at least 4,000 Americans have died from the swine flu, which is an increase of four-fold over what is being released in estimated figures. The AP noted that the increased figure was previously reported by The New York Times and also includes fatalities resulting from swine flu complications, such as infections and pneumonia.

The AP also said that, according to the CDC, "many millions" of Americans have been diagnosed with the pandemic virus since in April and that the World Health Organization (WHO) said physicians should not wait for lab results when dealing with pregnant women and at-risk groups who may have the swine flu.

Yaz, Yaz Litigation Progresses, Plaintiffs' Steering Committee Named

Thu, 12 Nov 2009 00:00:00 -0800

There is progress to report in the Yaz and Yasmin multidistrict litigation (MDL No. 2100) currently underway in U.S. District Court for the Southern District of Illinois. Judge David Herndon, who is overseeing the Yaz and Yasmin MDL, has appointed members to the Plaintiffs' Steering Committee. One of those appointed by Judge Herndon is Andres F. Alonso, Esq., a partner in the law firm of Parker Waichman Alonso LLP.

As we've reported previously, Mr. Alonso also serves as Co-Lead Counsel in the Denture Cream Liability Litigation (MDL No. 2051) currently pending before Honorable Judge Cecilia Altonaga in the United States District Court for the Southern District of Florida, Miami Division.

The Plaintiffs' Steering Committee was appointed by Judge Herndon in an Order dated November 10, 2009. In addition to Mr. Alonso’s appointment, Michael S. Burg, Michael London and Mark N. Niemeyer were appointed as Co-Lead Counsel to the Plaintiffs Steering Committee. Judge Herndon also appointed Roger Denton as Liaison Counsel.

The other members of the Plaintiffs' Steering Committee appointed by Judge Herndon are:

Daniel Becnel
A.J. DeBartolomeo
Thomas Girardi
Arnold Levin
Jeff Lowe
Roopal R. Luhana
Steven Maher
Trent Miracle
Mark Robinson

Appointments to the Plaintiffs' Steering Committee expire one year from the date of Judge Herndon's order. Appointees to the Committee may apply to be reappointed at that time.

The Plaintiffs' Steering Committee will, among other things, conduct and coordinate the discovery stage of this litigation with the defendants’ representatives or committee. The Committee will also act as a spokesperson for all plaintiffs at pretrial proceedings and in response to any inquiries by the Court.

More than 100 lawsuits have been filed by women across the United States who claim they suffered strokes, pulmonary emboli, deep vein thrombosis, blood clots, gallbladder disease, and other serious injuries after taking Yaz and Yasmin. Yaz and Yasmin are both made with a type of progestin called drospirenone, making them different from many other oral contraceptives. Drospirenone can elevate the body's potassium levels, which can lead to a condition called hyperkalemia in certain patients. Hyperkalemia may result in potentially serious heart and health problems. Adverse Events reported to the Food & Drug Administration (FDA) involving Yaz and Yasmin include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death.

Yaz is the top-selling oral contraceptive in the U.S. Last year, Yaz and Yasmin generated about $1.8 billion for Bayer. Yaz and Yasmin lawsuits allege that these sales were achieved through a marketing campaign that presented the medications as more than mere birth control pills, and touted them as treatments for premenstrual dysphoric disorder, premenstrual syndrome and moderate acne. Bayer Corporation and the other defendants named in the complaints have been warned at least three times by the FDA over misleading television advertisements which overstate the efficiency of Yaz or Yasmin and minimize serious risks associated with the drugs.

On October 1, 2009, all Yaz and Yasmin lawsuits pending in federal court were consolidated for centralized and coordinated pre-trial proceedings in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation in the United States District Court for the Southern District of Illinois before Judge Herndon (MDL No. 2100).

Chinese Drywall Omnibus Lawsuit Deadline Just Weeks Away

Thu, 12 Nov 2009 00:00:00 -0800

Chinese drywall victims whose homes were built with wallboard manufactured by Knauf Plasterboard (Tianjin) Co., Ltd are just weeks away from a make-or-break deadline. They have until December 2, 2009 to join an omnibus class action lawsuit that will be filed against Knauf on December 9. Knauf has agreed to waive its rights under The Hague Convention for the Service of Process Abroad for homeowners who sign on to this lawsuit by the December 2 deadline.

The December 2 deadline is a hard deadline, and the omnibus complaint will not be amended at a later date to add more people. Claimants will also face a second deadline – December 14 – by which time they must have filled out a profile form.

To be eligible for the omnibus lawsuit, claimants must submit pictures or other proof that they have wallboard made by Knauf Plasterboard in their homes by December 2, 2009. Any Chinese drywall homeowner interested in becoming a party to this lawsuit must start now by contacting an attorney and arranging to have their home inspected.

Parker Waichman Alonso LLP, the first law firm to file a federal Chinese drywall lawsuit, is offering assistance to any homeowner interested in joining the Knauf Plasterboard lawsuit. Free consultations are available through the firm’s website at www.yourlawyer.com, or by calling 1-800-LAW-INFO (1-800-529-4636).

The Hague Convention for the Service of Process Abroad requires claimants to pay approximately $15,000 per lawsuit, which allows for the translation of legal documents into Chinese and to have them presented to the appropriate authorities in China to obtain service on the Chinese drywall manufacturers. These requirements were a huge obstacle to claimants, and Knauf’s offer to waive them will greatly streamline the litigation process for plaintiffs who make the deadline.

The agreement with Knauf was announced earlier this month by Judge Eldon E. Fallon, who is overseeing the consolidated Chinese drywall litigation (MDL 2047) currently underway in federal court in New Orleans. The offer applies only to the consolidated federal litigation, not individual cases.

Appeals Court Revives Cell Phone Cancer Cases

Wed, 11 Nov 2009 00:00:00 -0800

Cell phone lawsuits alleging that radiation from the devices can cause brain cancer have been given new life. According to Law.com, the Washington D.C. Court of Appeals has reversed a lower court decision that found that cell phone cancer lawsuits were preempted by federal law.

The decision came in a case called Murray v. Motorola, and involves Verizon, Motorola, AT&T, Sprint, Nokia and other cell phone providers. The plaintiffs had claimed that they or their loved ones suffered illness, including brain cancer, as a result of the use of cell phones manufactured, sold or distributed by the defendants. They also alleged that defendants have long been aware of numerous studies revealing that radio frequency radiation from cell phones can cause tissue destruction, a precursor to cancer.

According to Law.com, in 2007, Judge Cheryl Long of the Superior Court of the District of Columbia dismissed the suits, reasoning that the claims, which were made based on D.C. law, were pre-empted by the Federal Communications Act of 1996.

Last month, the D.C. Court of Appeals overturned part of Judge Long's ruling While the appeals court ruled that plaintiffs could not pursue claims that they were injured by phones which met the Federal Communications Commission's (FCC) emissions standards, it ruled that personal injury claims were not pre-empted if they were based on phones that were either built before 1996, when the FCC purportedly began applying its radiation limits to cell phones, or failed to meet the commission's requirements. According to Law.com, the ruling also allows plaintiffs to continue their claims under the D.C. Consumer Protection Procedures Act that the companies had lied or omitted information about potential safety issues.

According to Law.com, the ruling could lead to the filing of even more suits against cell phone companies in Washington's trial court.

The ruling comes at a time when concerns over the possible health consequences of cell phone use are growing. Last month, we reported that the World Health Organization (WHO) would soon be publishing the results of its groundbreaking Interphone study. A preliminary analysis of the WHO study’s data found a “significantly increased risk” of some brain tumors “related to use of mobile phones for a period of 10 years or more.” The Interphone project conducted studies in 13 countries, interviewing tumor sufferers and people in good health to see whether their use phone use differed. Interviews were conducted with 12,800 people between 2000 and 2004.

Gehl Sauce Dispensers Recalled Due to Fire and Burn Hazard

Wed, 11 Nov 2009 00:00:00 -0800

Gehl Foods just issued a recall of about 115,000 of its HOT TOP2 Nacho Cheese and Chili Sauce Dispensers due to fire and burn hazard. Manufacturer Gehl Foods Inc. is located in Germantown, Wisconsin.

The recall was implemented because the HOT TOP2 Nacho Cheese and Chili Sauce Dispenser’s fan blade can come into contact with the heater coil, posing fire and burn hazards to consumers. To date, Gehl Foods has received 12 reports of the dispenser’s fan blade malfunctioning and coming into contact with the heater coil, including one report of a fire that caused property damage. No injuries have been reported.

This recall includes Gehl Food’s commercial Nacho Cheese and Chili Sauce Dispensers, which were manufactured in the United States, bearing model numbers HT2-04 Single, HT2-04 Dual, and HT2-03 APS with serial numbers HT2 164500 through HT2 299689. The model and serial numbers are located on the back of the dispensers. “Gehl’s” is printed on the front of the dispensers.

The recalled HOT TOP2 Nacho Cheese and Chili Sauce Dispensers were leased to commercial customers nationwide, including concession and food service establishments, from December 2003 through September 2009.

The Consumer Products Safety Commission (CPSC) is advising food establishments and consumers to immediately stop using the recalled HOT TOP2 Nacho Cheese and Chili Sauce Dispensers and contact the firm for a free repair by Gehl, or to receive a free repair kit to be installed by the customer. Gehl Foods can be reached, toll-free, at 1-877-440-4008 between 8:00 a.m. and 4:30 p.m. Central Time, Monday through Friday or at the firms’ Web site at www.gehls.com

Company in Puerto Rico Oil Explosion Has Record of Environmental Violations

Wed, 11 Nov 2009 00:00:00 -0800

Caribbean Petroleum Corp., the company at the center of a massive explosion and fire in Puerto Rico last month, has a spotty environmental record. According to The Miami Herald, over the last ten years, Caribbean Petroleum Corp. has been cited for major environmental violations that have cost it a total of $1.3 million in penalties and fines.

The Caribbean Petroleum Corp. explosion occurred around 12:30 a.m. on October 23 at the company’s gasoline warehouse and distribution center in Catano, just outside of San Juan. According to the Puerto Rico Seismic Network, the blast produced a shock wave equivalent to a 2.8 magnitude earthquake. The explosion was so strong that it tore up a nearby highway, and shattered windows on nearby homes. Twenty-one of 40 tanks at the facility used to store jet fuel, bunker fuel and gasoline were destroyed or damaged by the fire.

Two people were injured as a result of the explosion. The fire, which burned for nearly three days, produced plumes of thick, black smoke that filled the air with hazardous contaminants, including carbon monoxide and sulfur. Prevailing winds spread these contaminants to several areas of San Juan and adjacent municipalities, including Catano, Levittown, Toa Baja and Bayamon, exposing thousands to toxic fumes.

More than 1,500 people were evacuated. Many evacuees, some of whom were suffering from respiratory illnesses, were unable to return for several days. Many businesses were also forced to close. Residents of San Juan and the surrounding area were advised to keep windows shut and to stay indoors.

According to The Miami Herald, the Caribbean Petroleum facility in last month's explosion had not been inspected by the Occupational Safety and Health Administration since 2000. Since 1990, the National Response Center, an entity that reports oil, chemical, radiological, and biological spills, has recorded at least 25 oil spills at Caribbean Petroleum facilities. Yet despite its long record of environmental violations involving penalties and fines for leaking hazardous waste in the water, air and soil, Caribbean Petroleum has been allowed to run for nearly a decade without safety inspections or an emergency community disaster plan, in violation of federal law, the Herald said.

The U.S. Chemical Safety and Hazard Board is still investigating last month's explosion. A criminal act has been rule out as a cause, and the probe is now focusing on possible negligence and human error.

FDA Investigating Problems With External Biphasic Defibrillators

Wed, 11 Nov 2009 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J. The agency indicated that it has received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion.

The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia, as well. FDA is seeking additional information in order to interpret the significance of these events, and to determine if agency activities are advised.

The FDA addresses this advisory to the clinical community and specific health care professionals including Electrophysiology Labs, code teams, Cardiac Catheterization Labs, Operating Rooms, Intensive Care Units, Emergency Rooms, Risk Managers, Quality Managers, Patient Safety Coordinators, Directors of Nursing, Medical Directors, Biomedical/Clinical engineers, and Emergency Medical Services Professional Organizations, including the American Heart Association, American College of Cardiology, Heart Rhythm Society, American Hospital Association, American Nurses Association, American Medical Association, and Electrophysiology physicians

The cardiac devices include external biphasic defibrillators that deliver energy levels ≤ 200 Joules (J), including monitor/defibrillators and automated external defibrillators (AEDs).

To date, the FDA analysis of the 14 cases does not suggest the need for any change to current clinical practice. As FDA continues its evaluation, it encourages compliance with American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and compliance with manufacturers’ instructions for defibrillator use.

The FDA stated that it has reviewed its adverse event report database and explored the literature on defibrillation effectiveness and said it recognizes that there can exist multiple contributors to defibrillation and cardioversion success. Patient attributes, such as the size and shape of a person’s body, presenting rhythm; defibrillator attributes, such as energy level and waveform, and treatment conditions such as drug therapy and oxygenation, all affect defibrillation and cardioversion outcomes, said the FDA.

The FDA advises that if an event is experienced similar to those reported above, to report the incident to the FDA by filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm. Healthcare personnel employed by facilities subject to FDA’s user facility FDA's user facility reporting requirements at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/default.htm and should follow the reporting procedures established by their facilities.

The FDA asks that the following information be included in adverse event reports regarding external biphasic defibrillators: Energy level/intensity, waveform (biphasic truncated exponential or biphasic rectilinear), acute vs. chronic cardiac rhythms, drug therapy, oxygenation, paddles vs. pads, delay in therapy, device make and model, and time from collapse to shock.

Florida Insurance Commissioner Says Chinese Drywall Not Covered Under Homeowners' Policies

Wed, 11 Nov 2009 00:00:00 -0800

Chinese drywall is not a covered peril under homeowners' insurance polices, according to the Florida Insurance Commissioner. Speaking to state legislators, Kevin McCarty warned that insurers have no obligation to cover defective Chinese drywall.

The U.S. Consumer Products Safety Commission (CPSC) has received about 1,897 reports from residents in 30 states, the District of Columbia, and Puerto Rico concerning Chinese drywall. Gases emitted from Chinese drywall are being blamed for significant property damage, including damage to HVAC systems, smoke detectors, electrical wiring, metal plumbing components, and other household appliances. These gases also produce a sulfurous odor that permeates homes, and cause metals, including air conditioning coils and even jewelry, to corrode.

People living with Chinese drywall have also suffered eye, respiratory and sinus problems that may be linked to the gases. The drywall problems have forced many people out of their homes, and some families are dealing with the heavy financial burden of paying both rent and mortgage payments. Those unable to afford additional rent have no choice but to stay in their smelly – and possibly hazardous – homes.

Florida has long been deemed "ground zero" in the drywall disaster. More than 1,300 reports to the CPSC have come from that state, and it is estimated that as many as 35,000 Florida homes could be impacted.

According to McCarty, having Chinese drywall in a home is "a malfunction based upon a defective material that was installed in the building. And that historically has been excluded from a homeowner's policy." He also warned that homeowners could lose coverage altogether if they move out of their homes for extended periods of time under an "underwriting standard" that allows companies to drop coverage of unoccupied dwellings.

In McCarty's view, drywall manufacturers are liable to the damage their wallboard has done to homes in Florida. Hundreds of Chinese drywall homeowners in the U.S. have already filed lawsuits hoping to recover restitution from Chinese manufacturers for the damage done to their homes, but the process is proving difficult.

For instance, one of the companies suspected of manufacturing tainted drywall, Taishan Gypsum Co. Ltd., is controlled by the Chinese government. As we reported previously, Taishan was recently hit with a default judgment by U.S. District Court Justice Eldon E. Fallon, who is overseeing the massive Chinese drywall litigation in federal court in Louisiana, for failing to respond to lawsuits.

Recently, another Chinese firm, Knauf Plasterboard (Tianjin) Co., Ltd., offered to waive its rights under The Hague Convention for the Service of Process Abroad for homeowners who sign on to an omnibus class action lawsuit against the firm by December 2, 2009. The Hague Convention for the Service of Process Abroad requires claimants to pay approximately $15,000 per lawsuit, which allows for the translation of legal documents into Chinese and to have them presented to the appropriate authorities in China to obtain service on the Chinese drywall manufacturers. These requirements were a huge obstacle to claimants, and Knauf’s offer to waive them will greatly streamline the litigation process for plaintiffs who make the deadline.

To be eligible for the omnibus lawsuit, claimants must submit pictures or other proof that they have wallboard made by Knauf Plasterboard in their homes by December 2, 2009. Any Chinese drywall homeowner interested in becoming a party to this lawsuit must start now by contacting an attorney and arranging to have their home inspected.

Parker Waichman Alonso LLP, the first law firm to file a federal Chinese drywall lawsuit, is offering assistance to any homeowner interested in joining the Knauf Plasterboard lawsuit. Free consultations are available through the firm’s website at www.yourlawyer.com, or by calling 1-800-LAW-INFO (1-800-529-4636).

The offer applies only to the consolidated federal litigation, not individual cases. The December 2 deadline is a hard deadline, and the omnibus complaint will not be amended at a later date to add more people. Claimants will also face a second deadline – December 14 – by which time they must have filled out a profile form.

Hospira Propofol, Liposyn Recalled Over Particulate Matter

Wed, 11 Nov 2009 00:00:00 -0800

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30%, as well as 73 lots of Propofol Injectable Emulsion 1% products that begin with lot numbers 79 and 80. The recall has been implemented, said the U.S. Food and Drug Administration (FDA), because some of the containers may contain particulate matter.

The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall.

Hospira is undertaking this recall in consideration of the potential for safety issues if the products are administered to patients. Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack, and/or death.

To date, Hospira has not received any reports of adverse events related to this issue. Hospira has identified the root cause and corrective actions have been implemented.

The FDA is advising anyone in possession of an existing inventory to quarantine the product immediately and call Stericycle, toll-free, at 1-866-654-0725 to arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications, also toll-free, at 1-800-615-0187 between 8:00 a.m. and 5:00 p.m. Central Standard Time, Monday through Friday.

Any adverse reactions experienced with the use of these products and/or quality problems may also be reported to the FDA’s MedWatch Program by telephone, toll-free at 1-800-FDA-1088; by fax, toll-free, at 1-800-FDA-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch Website at www.fda.gov/medwatch.

Hospira is currently manufacturing both products and has begun to ship replacement product. Please contact Hospira Customer Care, toll-free, at 1-877-946-7747 for further details.