Galveston Bay Personal Injury Lawyer - Defective Products

FDA Recalls Cantaloupes For Salmonella Risk

Scott Kappes — Mon, 24 Mar 2008 15:48:14 GMT

Over the Easter weekend the FDA issued an alert to consumers and grocers about a possible risk of salmonella associated with cantaloupes imported by Agropecuaria Montelibano, a Honduran grower and packer. Research has lead health authorities to believe that cantaloupes imported by this company may be associated with over 50 reported cases of salmonella. All cantaloupes imported by this company are being detained to prevent further contamination and greater risk to the public.

In addition, the FDA has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove from their stock any cantaloupes from this company. The FDA also advises consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from this specific grower and packer. If so, consumers should throw away the cantaloupes.

The FDA has received reports of 50 illnesses from 16 states and nine additional reports have come out of Canada. Hospitalization has been required in 14 cases but no fatalities have been reported.

Symptoms of salmonella infection include nausea, vomiting, fever, diarrhea, and abdominal pain. Salmonella can infiltrate the blood stream leading to a potentially fatal infection. Anyone who has recently eaten cantaloupe and has experienced these symptoms should immediately contact a physician.

Originally posted at InjuryBoard by Scott Kappes

Wrongful Death Lawsuit Filed Over Nuva Ring Contraceptive

Scott Kappes — Thu, 20 Mar 2008 14:42:07 GMT

This week a wrongful death lawsuit was filed on behalf of the family of a New Jersey mother of two who tragically died after suffering a seizure on December 7, 2007. Jackie Kelly Bozicev, 32, had recently moved into a new home with her husband, Robert, and two young children Mary Kelly and Matthew. Jackie and Robert planned two have more children in the future, but wanted to hold off for a little while. Jackie decided to try a relatively new form of birth control, NuvaRing, which promised to be a low maintenance and effective contraceptive. She began using the NuvaRing in May and within eight months Jackie suffered a seizure, allegedly caused by the contraceptive, that would end her life.

An autopsy concluded that Jackie Kelly Bozicev died as a result of a massive pulmonary thromboemboli, or an obstruction to the arteries in the lungs, the lawsuit said. The fatal condition was caused by a blood clot in the pelvic veins, it said.

Blood clots have been a common problem with several types of birth control. The lawsuit alleges that the manufacturers of NuvaRing failed to provide adequate warnings detailing the risks associated with their product. No long long-term studies have been completed concerning the risks related to NuvaRing. The lawsuit claims that the manufacturers' marketing gives a false sense of security to patients considering using and those using the product.

The lawsuit alleges that the drugmaker presented data to the FDA claiming that the side effects of NuvaRing are comparable to those of oral contraceptives "despite no studies confirming these statements."

Originally posted at InjuryBoard by Scott Kappes

Another Magnetic Toy Recall

Scott Kappes — Mon, 17 Mar 2008 14:24:50 GMT

Today MEGA Brands in conjunction with U.S. Consumer Products Safety Commission issued a voluntary recall of two magnetic toys that could pose a serious risk to children. The Magnastik and Magnetix Jr. Pre-School Magnetic Toys were recalled due to the risk that small magnets contained in some parts may become dislodged from their housing and can cause severe, even fatal, injury if ingested. If ingested the magnets can become stuck together through the walls of different parts of the intestines causing blockages and perforations, which can be fatal.

MEGA Brands and CPSC have received 19 reports of magnets coming loose, including one report of a 3-year-old boy receiving medical treatment to remove a magnet from his nasal cavity and one report of an 18-month-old boy with a magnet in his mouth, which was not swallowed.

About 1.1 million various magnetic toys are included in this recall. The toys range cars and helicopters to dinosaurs and other animals. The toys were sold at Wal-Mart, Target, Toys-R-Us, and other major retail outlets and toys stores throughout the country. The toys were sold from January 2005 to December of 2007 for between $10 and $40. The CPSC urges parents to immediately stop using recalled toys. The toys can be returned to MEGA Brands for a free replacement toy. A full list and pictures of the recalled toys can be seen here.

Originally posted at InjuryBoard by Scott Kappes

Denture Cleansers Linked to Allergic Reaction

Scott Kappes — Mon, 25 Feb 2008 16:05:21 GMT

Today the FDA issued a warning to consumers about the safety of denture cleaning products. The warning was prompted by the death of one person and allergic reactions experienced by at least 72 others. The FDA said that some but not all of the reactions resulted from improper use of the products. The likely culprit is a bleach called persulfate, an allergen found in nearly every denture cleanser on the market. The FDA advised doctors and patients to use the products as directed and be on the lookout for possible allergic reactions.

Some people who reported allergic reactions used the cleaners properly, the FDA said. Allergic reactions happened quickly in some people and after years of use in others, the FDA said. The agency didn't say how long it had been collecting reports of side effects.

The agaency has also recommened that all denture cleansers now be labelled with additional warning to advise patients of possible allergic reaction risks.

Originally posted at InjuryBoard by Scott Kappes

Woman Files Lawsuit For Asbestos Exposure From Husbands Laundry

Scott Kappes — Fri, 22 Feb 2008 15:26:00 GMT

A Texas housewife has filed a lawsuit against DuPont, Union Carbide and others alleging that she was exposed to asbestos over a 27-year period from washing her husband's work clothing. The plaintiff, Frances Barras, who suffers from an asbestos related illness, claims that her sickness results from the washing of her husband's contaminated clothing. The lawsuit claims that Barras inhaled great quantities of asbestos fibers from the clothing, body, and hair during her husband's time of employment with Dupont

Naming 10 different industrial companies as defendants, Barras and six members of her family filed their $30 million suit in the Jefferson County District Court on Feb. 11.

The plaintiffs are seeking $15 million in compensatory damages and $15 million in punitive damages, in addition to damages for mental anguish, medical expenses, and loss of services.

The suit alleges that the defendants were negligent in failing to protect against the transportation of asbestos from the jobsite to the home. They are also accused being negligent in not providing offsite laundry facilities and providing safe working apparel. The lawsuit also charges that the defendants failed to provide adequate warnings of the dangers of asbestos exposure.

Originally posted at InjuryBoard by Scott Kappes

Supreme Court Backs Medical Device Makers

Scott Kappes — Thu, 21 Feb 2008 14:52:50 GMT

On Wednesday the Supreme Court sided with medical device makers; delivering an 8-1 decision in favor not allowing patients injured by an FDA approved medical device to file lawsuit against the manufacturer. The Court cited a 1976 law that they say bars state-law claims challenging the safety and efficacy of medical devices that have been received pre-market approval from the FDA. The ruling only applies to the more sophisticated and riskier devices that require FDA approval before being introduced to the market; however, these types of devices seem to be the likely culprits for product liability litigation.

The ruling could benefit other device makers, who have argued that the FDA's judgment that a product is safe and effective should protect companies from being sued for liability in state court.

Justice Scalia wrote the majority opinion justifying the Court's decision. He says "Congress' concern for those injured by FDA-approved devices was outweighed by its 'solicitude for those who would suffer without new medical devices if juries were allowed to apply the (injury) law of 50 states to all innovations." He also noted that the FDA spends and average of 1,200 hours reviewing each medical device application. During this process devices undergo rigorous testing by the FDA and are approved only when providing reasonable assurance of safety and effectiveness.

The implications of this case could reach beyond the medical device industry and into the pharmaceutical litigation. A similar case to be argued this fall with define how this type of logic applies to FDA approved drugs.

Plaintiffs' lawyers see the ruling as being "potentially dangerous for patients." The threat of a product liability lawsuit can persuade device makers to ensure product safety and keep public safety at the top of their interests.

Originally posted at InjuryBoard by Scott Kappes

Woman Sues Over Non-Disinfecting Contact Solution

Scott Kappes — Wed, 20 Feb 2008 18:11:16 GMT

Kimlyn Cline of Kilgore, Texas has filed a product liability lawsuit against Advanced Medical Optics, the makers of Complete Moisture Plus Multi-Purpose disinfectant contact lens solution, alleging that the solution did not disinfect as advertised causing her to develop an eye infection. Cline's infection even with treatment worsened and she is now in need of corneal transplant surgery. The lawsuit, filed on February 13, claims that despite proper use of the product Cline developed an infection in March of 2007 that is still not resolved almost a year later.

Cline states that Advanced Medical Optical knew of the defects with the product but continued to design, manufacturer, market and sell the defective product. The suit states that the defendant failed to warn, or inadequately warned of the dangerous characteristics of the product. Further, the plaintiff states the defendant failed to adequately provide safe and proper instructions on the use of the contact lens disinfectant.

Advanced Medical Optical issued a voluntary recall of 18 lots of the solution in 2006, followed by full recall of the product in May of 2007, after the Center for Disease Control and Prevention released information on a possible elevated risk of eye infection.

Cline is seeking damages for past and future medical expenses, pain, vision loss, loss of income, and loss of earning capacity among others.

Originally posted at InjuryBoard by Scott Kappes

Pain Patch Recalled for Possible Overdose Risks

Scott Kappes — Thu, 14 Feb 2008 09:59:38 GMT

Yesterday Johnson & Johnson announced a voluntary recall of a popular version of their Duragesic pain patch. About 32 million patches sold by PriCara, a unit of J & J, are being recalled due to concerns that a defect could expose patients to excess doses of the powerful opioid, fentanyl, leading to respiratory difficulties and even death. The company estimates that defects exist in two out of every one million patches, 64 in all. The recall involves the widely used 25-microgram per hour patch used to treat lower-weight and newer patients suffering from chronic pain.

In 2004 the company issued a recall of some batches of the less popular 75-microgram per hour patch. Johnson & Johnson has been sued by 72 people alleging injury from the Duragesic patch. A case last summer delivered a $5.5 million verdict.

Some plaintiffs' attorneys have argued that it may be time for the patches to be pulled from the US market, citing the prevalence of safer and more effective alternatives.

"We're acting responsibly by recalling the defective lot," says the PriCara spokesman, Mr. Panico, adding that the company can't comment on pending lawsuits. "Despite the defect, there's much unaffected product on the market and we think overall the patients have been served by this therapeutic option."

The company has said that no fatalities have been reported with the defective patches and hopes to avoid the bulk of legal issues associated with this recall by acting in a quick and preventative fashion.

Originally posted at InjuryBoard by Scott Kappes

FDA Launches Investigation into Tattoo Chemicals

Scott Kappes — Mon, 11 Feb 2008 12:01:37 GMT

For the first ever FDA scientists will be evaluating the safety of the materials used in tattooing. The investigation was incited by numerous reports of skin irritation following a tattooing session. The FDA wants to know how the chemicals break down, and if any pose a threat to the individual's safety. If the FDA finds it necessary to enact changes or limitations it could have a huge impact on the industry that usually flies below the FDA radar.

Most tattoo artists believe that bad reactions are few and far between, but with gaining popularity and over 15,000 shops in the US with an estimated $2.3 billion in annual business the once taboo art can no longer hide in the shadows and avoid federal regulation.

The tattoo industry has been ridiculed in the past for poor sterilization techniques and the spread of disease from careless artists, but nowadays almost every studio has adopted a very strict sterilization policy. While this has been a concern in the past there has been very little discussion of the actual materials used in the tattooing process.

In 2005, the FDA received over 150 reports of adverse skin reactions ranging from swelling and cracking to permanent scarring. In the end, the Texas based manufacturer recalled over 52,000 containers of pigment due to possible contamination.

The U.S. Food and Drug Administration said it is aware of more than 50 pigments used in tattoo inks, none of which have been approved for injection into the skin. The federal agency said some of these pigments are "industrial strength colors suitable for printers' ink or automobile paint."

Originally posted at InjuryBoard by Scott Kappes

Toymaker Settles Recall Lawsuit For $30M

Scott Kappes — Wed, 23 Jan 2008 10:40:48 GMT

Toymaker RC2, the makers of Thomas & Friends toy trains amongst other toys, has agreed to pay $30 million to settle a class action lawsuit resulting from last years toy recalls. Between June and September the company recalled over 1.7 million toys due to the use of lead paint in many of their toys. This was the first recall to raise substantial public awareness and concern about lead paint in toys. Dozens of other recalls would soon follow creating a considerable concern from American consumers about the safety of toys. Most of the recalled toys were made in China and this spawned a public outcry for higher quality standards for foreign made toys.

The agreement calls for cash reimbursement for recalled toys or the consumer can elect for a replacement toy and bonus toy. Coupons are being offered to affected customers with no toy or proof of purchase.

Since the recall most toymakers, including RC2, have stepped up testing and quality control standards to ensure product safety.

Mattel and other toymakers face similar lawsuits over their toy recalls. Organizations like the Toy Industry Association have asked Congress to mandate safety testing, which is now voluntary. The end goal here is to establish standards that exceed a level of toy safety that consumers would consider acceptable.

For more information on mthis subject, please refer to the section on Defective and Dangerous Products.

Originally posted at InjuryBoard by Scott Kappes