2012 January Archive

A group of parents has filed a lawsuit against Pfizer, the maker of Zoloft, an antidepressant, which they say caused severe birth defects in babies born to women who took the drug while pregnant. The nine-count complaint that was filed December 2 in St. Clair County Michigan Circuit Court says the babies were born with major medical defects, including heart damage. At the time, studies showed the risks associated with Zoloft were known, such as the doubling of chances for heart damage in the unborn. The plaintiffs say Pfizer knew or should have known about the risks to users and their unborn children yet did not adequately warn parents and doctors about birth defects, which also include lung problems, neural defects, congenital birth defects, and limb malformation.

Zoloft is an SSRI (selective serotonin reuptake inhibitor) antidepressant.

Pfizer is accused of negligence, defective design, fraud, and a breach of warranties. The product liability lawsuit asks for damages to cover medical costs and for compensation, as well as a disgorgement of profits or the forced return of profits gained through illegal or unethical acts.

Defective Drugs

A defective drug is one that harms the user who was not adequately warned about the potential for harm. A manufacturer has a responsibility to put a safe product on the market. But if there is some risk involved, the manufacturer needs to inform the user about the potential risk of harm so that he or she can make an informed decision about whether the risk is worth the benefit. To fail to do so may make the manufacturer liable for the victim’s injuries.

A Jacksonville dangerous drug lawyer at Farah & Farah understands how to represent you fairly and adequately in a product liability action. Call us at (800) 533-3555 so we can begin a conversation about your defective drug injury.

Source: http://ageorgialawyer.blogspot.com/2012/01/parents-sue-claiming-zoloft-cause-birth.html; http://www.We madisonrecord.com/news/240766-parents-sue-pfizer-over-birth-defects-allegedly-caused-by-zoloft

In a highly unusual move, the U.S. Food and Drug Administration (FDA) announced on Wednesday, January 4, it is considering upgrading the classification of surgical mesh used in woman to hold up pelvic organs or to treat incontinence. Synthetic transvaginal mesh is currently Class II. A Class III designation would mean clinical studies would have to be conducted for safety and efficacy before the product is introduced to the market.

What does that mean? You may have heard all of the controversy about the way the FDA allows some permanently implanted medical devices to be approved for marketing without any scientific assurances for safety and efficacy. There is a little known loophole within the FDA called the 510(k) process that allows just that. Manufacturers of medical devices love 510(k) because they can get a device into the hands of doctors and consumers faster and with less cost.

But the serious injuries and deaths that have resulted from synthetic transvaginal mesh failure have the FDA reevaluating whether the implanted and permanent devices should be approved without scientific studies. A reclassification from Class II to Class III would no longer allow it to pass only 510(k) scrutiny; manufacturers would now have to conduct clinical trials to prove mesh is safe for patients. Most consumers assume that this is already happening. They would be wrong.

This is just the latest in a long list of problems with synthetic surgical mesh.

On July 13, 2011, the FDA issued its strongest worded warning about the medical device, just short of issuing a recall, that said “serious complications associated with surgical mesh for transvaginal repair of POP (pelvic organ prolapse) are not rare.” The FDA also said it’s not clear whether synthetic mesh offers any advantages over traditional non-mesh repairs.

The Institute of Medicine concluded in a report issued the next month that the 510(k) process was “fatally flawed” in that it let thousands of defective medical devices onto the market without any assurances of safety.

Still thousands of these medical devices are implanted every year to unsuspecting women despite the fact that the FDA noted a five-fold increase in complications, such as mesh erosion into the vagina, pelvic pain, and nerve entrapment, among other problems.

The Florida transvaginal mesh lawyers of Farah & Farah are talking to women who may have had defective transvaginal mesh surgery and are now suffering the complications. The sooner you contact our office, the sooner we can help you retrieve your medical records to discover what type of mesh you had so a complication report can be lodged with the FDA and we can hold the manufacturers accountable for this defective product. You have a limited time within which to act, so call us at 1(800) 533-3555 at no cost to you unless we receive an award in your favor.

Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

The Enfamil infant formula has unofficially been linked to cases of four infant infections but there is not enough evidence to issue a recall, according to federal and state health officials. The Cronobacter infection was found in the infants who all had consumed Enfamil. The formula was removed from store shelves by some major retailers after infants died in Missouri and Florida. Those states, along with Illinois and Oklahoma, all had recent cases. The infants in the two other states are recovering.

It is unclear whether the severe bacterial infection came from the formula or the water it was mixed with. Symptoms usually begin with a fever, crying, and a lack of energy. Cronobacter can cause bacterial sepsis or infection in infants, along with meningitis. A U.S. Food and Drug Administration (FDA) inspection of the manufacturing facility has come up negative for the Cronobacter bacteria. Mead Johnson, maker of the formula, says its tests too have come up negative. But retailers Supervalu, Price Chopper, Walgreens, and Walmart are all reportedly reluctant to return the product to store shelves. Infections are rare with only a maximum of six cases reported a year. It’s one of the reasons health officials recommend breast feeding and feel it is superior over formula.

Interestingly, Consumer Affairs reports that when the U.S. Centers for Disease Control and Prevention (CDC) checked the DNA fingerprint, the cases in Missouri and Illinois differed genetically which suggests they’re not related. Florida and Oklahoma’s cases are not yet available.

Product Liability

When a product is defective, it can injure and kill consumers. Manufacturers have a responsibility to ensure that what they sell to the public is safe for consumption or use. If not, the manufacturer, the designer, and/or the distributor can be held liable for any injuries or deaths that result. It takes an investigative team from an experienced Florida product liability law firm to uncover whether the defect is in the manufacturing or design of the product, or in its failure to adequately warn about the product’s potential for danger. For a free consultation with an Orlando child product recall lawyer at the law firm of Farah & Farah, call (800) 670-1464.

Source: http://www.consumeraffairs.com/news04/2012/01/no-need-for-formula-recall-feds-find.html

The federal U.S. Consumer Product Safety Commission (CPSC) and Health Canada issued a press release Wednesday, December 28, announcing the recall of a defective Pottery Barn Bed for Kids with a canopy that has collapsed and injured children. The defective canopy belongs to the Madeline Bedroom Collection made by Pottery Barn, a division of Williams-Sonoma. The recall extends to 7,700 beds sold in the U.S. and about 230 in Canada. The company has received reports that the connection holding the posts to the top rail can come loose allowing the canopy to fall and injure those on the bed.

There have been 3 reports of canopy failure that caused cuts, bruises, and bumps. None of the injuries were serious, and one required stitches. The defective canopy beds were sold from December 2003 until August of 2011, according to the CPSC. The canopy component was made in Vietnam and sold for $150 to $300.

Consumers are asked to stop using the canopy, remove it from the bed, and contact Pottery Barn to receive a repair. The toll free number for information is (855) 662-4114, or visit their website at www.potterybarnkids.com. It is illegal to resell any item that has been recalled.

The CPSC is asking consumers who have been injured or have experienced the canopy falling to contact the federal agency and report the experience.

Product Liability

A product can be defective in the way it was manufactured, in its basic design, or in the way it’s sold with the accompanying literature that underestimates the potential for danger. If your child has been injured by a defective product, an experienced Florida child product recall attorney can determine where the liability lies to recover the costs associated with the injuries. Farah & Farah can be reached at 1(800) 533-3555 to discuss your product injury and the avenues for recovery.

Sources: http://www.prnewswire.com/news-releases/madeline-bed-canopy-recalled-by-pottery-barn-kids-due-to-impact-hazard-136311368.html

The injuries to patients from defective all-metal artificial hips are beginning to be understood in terms of dollars and cents. The New York Times reports the most widespread medical device failure in decades involves metal hips that have a high failure rate and leave patients thousands of dollars in debt and will cost Medicare, taxpayers, and insurers billions in the coming years. The Times reports on one patient who is typical of the injured – a 55-year-old from Illinois, who had a metal-on-metal artificial hip that failed. Infection set in. His bills exceed $400,000 – all for a metal-on-metal hip that was supposed to last 15 years or longer but instead had to be removed and replaced.

The defective medical device injures patients when the metal wearing on metal creates debris that gets into the body, damaging tissue and sometimes crippling patients.

So far, about 5,000 lawsuits have been filed against Johnson & Johnson’s DePuy division and Zimmer Holdings. Zimmer has settled hundreds of patient claims over its metal implants while at the same time insisting they are safe. DePuy recalled the defective medical product known as the A.S.R. (Articular Surface Replacement) hip last year and its Pinnacle artificial hip is the subject of about 560 defective product lawsuits.

Medicare and insurance are paying the cost of the product failures and repeated surgeries. Both expect to be paid back when the cases are done.

A defective product case involves a failure during the manufacturing process or in a defective design of a product. Whether it is a medical device, a consumer product, or an automobile, if a patient or user is harmed, an experienced product liability law firm can file an action to recover the lost wages, medical expenses, and pain and suffering experienced by the user. Call the Florida hip replacement failure lawyers at Farah & Farah for a complimentary assessment of your case at (800) 533-3555.

Source: http://www.sacbee.com/2011/12/28/4148435/suits-mount-costs-soar-for-failed.html; http://www.nytimes.com/2011/12/28/business/the-high-cost-of-failing-artificial-hips.html?pagewanted=all