Florida Products Liability Attorneys

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

A defective product recall has been issued for about 3,150 new General Motors Chevrolet Captiva automobiles. According to the U.S. Department of Transportation (DOT), there is a problem with the power assist/power steering fluid. Vehicles made from October 2, 2009 to April 21, 2011 are affected by the problem, described by the recall notice as a high running pump speed in first gear which generates additional and excess heat transferrable to the power steering fluid. Prolonged exposure to the higher temperatures can cause power steering fluid to leak which has the potential to ignite a fire. Beginning in January, General Motors will begin notifying owners and automobile dealers of the problem and customers will be able to bring the vehicle in to have the necessary repairs performed. The number for Chevrolet is 1(800) 630-2438. To learn more, the hot line number for the National Highway Traffic Safety Administration (NHTSA) at 1(888) 327-4236.

When a vehicle does not comply with the Federal Motor Vehicle Safety Standards, or there is a defect relating to those standards (such as with seat belts, brakes, tires, or a steering wheel), the car must be recalled. Since 1966, there have been almost 300 million vehicles of all kinds on the road recalled because of safety defects.

A vehicle can become defective during the manufacturing process or because of an overall design flaw. If that defect leads to injuries or death, the auto product liability lawyers in Jacksonville of Farah & Farah will offer you a complimentary consultation to discuss your product liability action against the manufacturer, the designer, or possibly everyone in the line of distribution. Our number is 1(800) 533-3555.

Source: http://www-odi.nhtsa.dot.gov/recalls/results.cfm?rcl_id=11V591&searchtype=quicksearch&summary=true&refurl=email

The U.S. Food and Drug Administration (FDA) has issued a recall for some herbal supplements that may be contaminated with Salmonella. The supplements are made by the Eclectic Institute of Sandy, Oregon. The FDA news release issued Tuesday, December 20, has the lot numbers of the supplements which contain the herbs Gotu Kola and Bladderwrack in freeze-dried capsules.

Salmonella is a serious contamination known to cause serious illness and even death among young children and people with weakened immune systems. Even in the healthy, a Salmonella infection can cause nausea, vomiting, diarrhea, fever, and abdominal pain. Salmonella can also get in the bloodstream and cause heart infections, endocarditis (inflammation of the heart chamber or valves), and arthritis. The supplements were sold from mid-September to mid-December of this year to health care practitioners, retailers, and individuals. The company reports in a news release that it has received no reports of anyone being infected or who has become ill, but that routine micro-testing found Salmonella in one batch while another test was negative. The company is required to report contamination of its product to the FDA.

Anyone in possession of these supplements can get a full refund from the company and should not consume them.

Defective Product Recall

A product infected with Salmonella is considered defective, and if it harms a user, it can be the subject of a product liability action. While no one wants to be sickened, you can receive compensation for your medical costs, lost wages, and any long-term consequences. Defective product lawsuits have been responsible for taking many dangerous products off the market, and just the threat of a product liability lawsuit keeps many manufacturers on their toes to produce products that are safe for the public. If you have been injured or become ill from a defective or unsafe product, the Jacksonville product liability lawyers of Farah & Farah can help. Call (800) 670-1464 for a free review of your case.

Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284711.htm?source=govdelivery; http://www.fda.gov/Safety/Recalls/ucm284454.htm

The consumer group Public Citizen frequently calls for the recall of dangerous drugs or medical devices. Now a former FDA director is joining them.

Larry Kessler used to work for the U.S. Food and Drug Administration (FDA) as director of the Center for Devices and Radiological Health (CDRH), a section of the FDA that oversees medical devices. He is joining Public Citizen in asking that the Stryker Wingspan brain stent be withdrawn from the market because of a concern that it may lead to death in users. Kessler has joined a product recall petition filed by Public Citizen on December 21, asking the FDA to also revoke Stryker’s 510(k) clearance, a way that medical devices are fast-tracked onto the market without clinical studies.

Device manufacturers like the 510 (k) because it costs them less money in research and a reduced application fee, however, many devices have later been found to be defective after they are marketed without studies for safety and efficacy. Kessler said that the stents add no benefit to patients but have an enormous downside in an elevated risk of strokes and death.

Mass Device reports the Wingspan system was cleared by the FDA in 2005 under a humanitarian device exemption (HDE). Stents serve to open up narrowed arteries that deliver blood to the brain. Since then, studies have shown that the risks of injury outweigh the benefits. Public Citizen’s research shows that blood thinners and lifestyle changes reduce the risk of stroke and death better than receiving medication and the Wingspan stent. A New England Journal of Medicine study reported the death rate from stroke rose 12.2 percent in the group of patients without stents and 20 percent for the patients receiving the stent medical device. In addition, Public Citizen recently called for a recall of synthetic surgical mesh for transvaginal placement.

Product Liability

If a person is injured or killed by a medical device or any defective product marketed to the public, that individual or his survivors may be able to file a product liability action against the manufacturer who knew or should have known that injuries were likely to occur. Farah & Farah has a team of Jacksonville defective medical device attorneys who can offer you guidance in this area. Remember, you may have a limited time period within which to file a case so call us at (800) 533-3555 and we can start the conversation.

Sources: http://www.massdevice.com/news/former-cdrh-director-joins-public-citizen-demanding-recall-strykers-brain-stent; http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3489

So far, there are more than one hundred lawsuits concerning transvaginal surgical mesh filed in various state courts around the country and now three separate but related motions have been filed to consolidate those cases before a judge in the Southern District of West Virginia.

Plaintiffs from 83 different cases are suing American Medical Systems, 41 cases are suing Ethicon, and 30 cases are suing Boston Scientific – all makers of synthetic surgical mesh used to treat stress urinary incontinence and pelvic organ prolapsed (POP). Unfortunately, the complication rate is unusually high and many women experience devastating pelvic pain, infections, erosion of the mesh through organs, degrading and hardening of the mesh, and nerve damage.

According to the FDA, the adverse events for POP implants had increased five-fold in the two year period ending December 31, 2010, when compared to the three previous years. But the FDA’s database of complications, known as “adverse events” is known to represent only a fraction of real-world injuries from defective medical devices.

Mesh Complications Unknown

According to the Government Accountability Office (GAO), 99 percent of complications associated with medical devices were not reported to the FDA. The more serious the complication, the less likely it was to be reported.
Bottom line, no one really understand how often these defective products fail.

If the U.S. Judicial Panel on Multidistrict Litigation grants the motions, the lawsuits would be moved to Chief Judge Joseph R. Goodwin. He is already familiar with mesh issues since he’s overseen the Avaulta Pelvic Support mesh cases since October 2010.

Farah & Farah Florida transvaginal mesh injury lawyers understand that, unlike a class action, a multidistrict litigation allows similar complaints to join forces, thereby reducing the cost of litigation and sharing discovery gathered from the other side. The cases are still considered individually and generally any settlement is determined sooner, depending on the degree of injury and the number of people in the multidistrict litigation.

Read more: http://www.digitaljournal.com/pr/530346#ixzz1hJsjPMfk

The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall concerning a defibrillator lead that can lead to death from a defective heart rhythm. The device is made by St. Jude Medical and the FDA notified health care providers of the most serious recall of the Riata and Riata ST Silicone Endocardial Defibrillation Leads. The problem is that the silicone that insulates the covering is defective and may cause the leads to come out of the insulation. This is when a lead has the potential to misfire. The implantable cardioverter defibrillator, or ICD, is connected to the patient’s tissue through the leads whose job it is to monitor the heart rhythm. In the case of an irregular heart rate, the defibrillator, if connected properly, will deliver a jolt to encourage a regular heart rate.

The particular defibrillator leads listed in the Recall Notice says they were distributed from June 2001 to December 31, 2010, so the recall could affect thousands of patients.

St. Jude has notified physicians by certified mail of the failure rate, which the FDA does not include in this Safety Notification. As far as patients who are living with the implanted leads which could be faulty, the FDA reminds doctors that they must manage patients with this particular implant and that the doctor can report any adverse events to the FDA’s MedWatch program, which may give patients with a potentially defective implanted lead little peace of mind.

A Class 1 recall is conducted when the defective device has the potential to cause serious harm or death to a patient.

Product Liability and Medical Devices

A responsible drug or medical device manufacturer should understand their product fully before it is put into the marketplace, including any defect in the manufacturing and design, including materials used, or in a failure to adequately warn users of the product. When a company fails to do so and patients are injured, that company needs to be held accountable. Product liability litigation may ultimately be the reason a dangerous device is removed from the market.

The defective medical device lawyers in Jacksonville of Farah & Farah will offer a complimentary consultation to anyone harmed by a drug or medical device that was defective. Call us at 1(800) 533-3555 to get started.

Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284390.htm?source=govdelivery; http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm284360.htm