Defective Products

The New York Times has done a special series of reports on products that escape U.S. Food and Drug Administration (FDA) regulation and are sold to the unsuspecting public, wrapped in promises of weight loss, muscle, and sexual enhancements. Often these are sold in health food stores or ethnic grocery stores.

In one case, Pai You Guo, was advertised as a natural weight loss supplement from China but federal investigators found it contained a suspected carcinogen. That product was recalled in 2009 but the damage left behind by unchecked supplements cannot be. Kidney failure, addiction, and heart problems are seen from some dietary supplements, according to Dr. Cohen, an internist and assistant Professor of Medicine at Harvard Medical School interviewed for this story.

There’s no doubt supplements are big business. Legal supplements, multivitamins and herbs cost Americans $28.1 billion last year, according to The Nutrition Business Journal. Most supplements are made by reputable companies and self-regulate according to the Council for Responsible Nutrition, a trade group for supplement makers. However millions more are spent on supplements containing amphetamines, steroids and even prescription drugs. And sometimes these find their way into the major chains such as GNC which carried for a short while a weight-loss product, StarCaps, which contained a powerful diuretic drug. The weight loss drug, sibutramine, which is the appetite suppressant in Meridia has been found in other supplements even though it was removed from the market in the U.S. because of a link to an increased risk of stroke and heart attack.

It’s the growing availability of tainted products overseas that is the biggest problem. The FDA does not inspect overseas raw ingredients suppliers. All a manufacturer has to do to import into the U.S. is to claim theirs is a supplement.

The picture may be improving. The industry closely regulates itself and three years ago new federal rules required supplement makers to certify each ingredient in their supplement and to test the finished good to make sure they match the label. The buyer needs to beware and buy from respected established brands and stay away from a quick fix, which may be someone’s ticket to a quick buck. Should an injury occur or serious adverse effects be suffered, consumers are advised to consult with a dangerous drug lawyer in Florida to learn more about their legal options.

Source: http://www.nytimes.com/2011/08/28/business/supplement-drugs-may-contain-dangerous-ingredients.html?_r=1

Synthetic and non-absorbable surgical meshes used in female pelvic surgery to correct pelvic organ prolapse (POP) offers no measurable benefits and may present an unnecessary risk to patients, so the consumer advocacy group Public Citizen has petitioned U.S. Food and Drug Administration (FDA) to have the mesh products recalled and banned. Also, Public Citizen wants the mesh to be considered a Class III medical device, which represents the highest risk, so that it must undergo stringent premarket testing before it is approved for use. At the present time, surgical synthetic mesh, which is prolene, a petroleum product, is allowed into the market after the filing of 510 (k) paperwork, which approves it for marketing, not safety. It does not have to undergo any clinical studies or premarket testing for safety, unbelievable for something that is permanently implanted in the body.

The Public Citizen petition follows a July 13th FDA Safety Notification alerting the public that complications are “not rare” and can include vaginal mesh erosion, pain, incontinence, infection among other problems. In a two year period, the FDA noted there were more than 1,500 reports of complications. Another complicating factor is that it takes often repeat surgeries to remove mesh once it has been placed in the body and in some cases it can never be removed. Co-petitioners include a professor of obstetrics and gynecology at Washington University in St. Louis and a urologic surgeon at the Mayo Clinic in Rochester, Minn.

This urgent message is needed as about 300,000 women receive this type of mesh every year for pelvic floor weakness which results from multiple births, age, and genetics. Men also receive the same type of mesh for hernia repair, though the notice does not include that information. As the baby boomer generation ages, no doubt, more of these procedures are being suggested by doctors who are sold on the product by sales representatives who offer pre-cut mesh in kits.

The surgical mesh injury attorneys in Jacksonville at the Farah & Farah law firm are hearing from many women who are suffering as a result of synthetic mesh surgery, and we will listen to your story and see if you can receive some compensation for your costs and suffering. Patients are suffering needlessly and let’s hope the petition is taken seriously by our federal regulators, who are convening an expert panel in September to consider what should happen next with this controversial medical device. Call us so we can begin helping you with this most personal problem at 1-800-533-3555.

Sources: http://www.outpatientsurgery.net/news/2011/08/19-Group-Urges-FDA-to-Recall-Surgical-Mesh and http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3405

The U.S. Food and Drug Administration (FDA) is reviewing the safety of antibacterial soaps that contain the active ingredient, a chemical known as triclosan. It was created more than 40 years ago to be used in hospitals as a surgical scrub. Today, consumers find it in many products, such as Dial Complete hand soap, which advertises that it kills more germs than any other brand, and in Colgate Total toothpaste. The Centers for Disease Control and Prevention (CDC) found triclosan in the urine of 75 percent of Americans over the age of 5.

Like other chemicals released into the environment without testing, triclosan has been shown to alter hormone function in lab animals or cause us to be resistant to antibiotics. Soap containing triclosan has been found to be no more effective than soap and water, according to the FDA.

The federal agency was scheduled to release results of its review several months ago and the Environmental Protection Agency (EPA) is also looking into triclosan and expected to come up with a policy statement. Industry is pushing back as these antibacterial soaps represent about half of the $750 million annual market. The manufacturer of Dial Complete says there is no real evidence showing triclosan is harmful to humans. Other manufacturers are responding to consumer preferences and have removed triclosan from face washes and hand soaps such as Softsoap. The ingredient can still be found in Colgate Total Toothpaste.

In an April 2010 announcement concerning triclosan the agency said it, “does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan at this time.” However, changes to triclosan use have been under consideration as far back as 1972.

Sources: http://www.nytimes.com/2011/08/20/business/triclosan-an-antibacterial-chemical-in-consumer-products-raises-safety-issues.html?_r=1&ref=health and http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm207833.htm

The saga of the blockbuster diabetes drug Actos continues with hundreds of lawsuits over allegations that the drug raises the risk of bladder cancer. Drug maker Takeda Pharmaceuticals stopped sales of the drug in France and Germany after regulators there took the risk seriously, and the U.S Food and Drug Administration (FDA) has issued warnings but has removed the drug from the market. Doctors are being told not to prescribe it if the patient has ever had bladder cancer. The drug became a blockbuster because it made the body more sensitive to insulin in a one-a-day pill. And when the other drug in its class, Avandia, was linked to an increase in the risk of heart attacks and its use discouraged in the U.S. (while banned in the EU), Actos jumped to the head of the class. As of last year sales had jumped to $4.3 billion up from $2.9 billion in 2006.

But these sales figures are not impressive to the thousands of plaintiffs who say Actos gave them bladder cancer, especially patients who took the drug for years. Takeda’s patent on Actos expires in 2012 so the company does not expect the blockbuster sales to continue, although today doctors would be wise to opt for prescribing Actos only if patients have no other options.

A drug company has a duty to provide drugs that are safe for use by patients and Takeda failed in that responsibility by manufacturing and delivering a drug that was defective and dangerous. The lawsuits will try to prove what the drug company knew and when it knew it.

Source: http://finance.yahoo.com/news/Lawsuits-follow-diabetes-drug-apf-2477245245.html?x=0&.v=1

The Food and Drug Administration (FDA) is taking a second look at medical devices that are cleared for the market with no premarket safety tests. The FDA clearance process is called 510 (k) and it clears a medical device for marketing if it is substantially similar to a device already on the market. It is one way that defective medical devices have been fast-tracked to the marketplace, sometimes to the detriment to patients. Manufacturers sometimes take the liberty to change or modify the medical device after it has received FDA clearance. This notice issued by the FDA on Tuesday, July 26, states that “When the changes could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510 (k) must be submitted.”

The need for a new submission will be required if there are changes to labeling, to the technology used in the device or in its performance, or in the materials used to manufacture the device.

The problem with the 510 (k) process is that a request for approval by the manufacturer is almost never denied. It is more like a shuffling of paperwork than any safety-oriented approval process. The exchange of paperwork provides a clearance to market a device bypassing the more time-consuming premarket approval and clinical trials that prescription drugs must undergo.

The 510 (k) process is intended to give a fast-track approval to low-risk medical devices, however hip implants and surgical mesh, which have been found to be defective medical devices and recalled, are both implanted in the body permanently and both fall under that classification.

The FDA’s Center for Devices and Radiological Health oversees medical device approval.

Sources: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265458.htm, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265458.htm and http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm

Reuters is reporting that the health industry is concerned that external defibrillators, usually found in emergency rooms or airports, have been the subject of 68 recalls because of defects over the last five years. The automated external defibrillators (AEDs) can potentially save the life of someone in cardiac arrest if the paddles are used within minutes of the patient’s collapse. The shock causes an arrested heart to resume back to its normal beat. Thousands of reports of malfunctions in devices from a range of manufacturers have come to the Food and Drug Administration (FDA), sometimes even malfunctioning during an emergency procedure.

In a statement, the FDA says it wants to help industry improve safety and resolve problems quickly. The review is part of the larger problem of faulty medical devices that present safety risks due to design and manufacturing shortfalls. With about 200,000 AEDs sold every year, many have been found deficient in design and manufacturing. Many people are also dissatisfied with how the company handles consumer complaints and recalls.

A multi-city AED registry will become one way to track the outcomes of the one million AEDs in use around the country.

Defective Product Claim
A Florida product liability lawsuit can name the designer of the device, the manufacturer, the pharmacy, the distributor, and retailer. Additionally, your treating physicians can be sued for Florida medical malpractice if a defective medical device caused your injury.

At Farah & Farah, our Jacksonville product liability lawyers can help a victim of a defective medical device or product seek compensation for lost wages due to the illness that resulted from the device, and time out of work, both past and future. The emotional trauma of pain and suffering can also be compensated, and a jury can opt to award punitive damages to punish the device manufacturer or designer for maliciously or intentionally putting a dangerous device into the marketplace.

The federal Consumer Product Safety Commission (CPSC) along with toy maker, Fisher Price, have announced the voluntary recall of more than 10 million toy tricycles, infant activity centers, and toy cars after there were several reports of injuries among children.

Consumer Reports states that the CPSC and Health Canada, along with Fisher Price announced the recall of defective products Thursday, September 30. Among the products recalled are more than 7.2 million trikes, almost 3 million infant toys with inflatable balls, and 100,000 Little People Wheelies.

The defective child trikes have a plastic key that sticks up, presenting a hazard that has injured at least ten children. The activity centers are a defective product because the inflatable ball contains a valve that can be removed by children. Fisher Price has reports of 14 pieces that were found in children’s mouths and there were 3 reports of children choking. The toy cars have wheels that can come off, though there have been no reports of injuries.

If you have one of these defective products in your home, you can call Fisher Price at (800) 432-5437 or go to the company website for a free replacement.

Recalls are one step toward preventing future injuries, but lawsuits should deter the maker from producing dangerous children’s products in the first place. Florida child product recall attorneys Farah & Farah will offer a free evaluation of your product liability case if your child was injured by a defective product.

These are not good days for GlaxoSmithKline and its diabetes drug, Avandia. The Food and Drug Administration has decided Avandia can stay on the market but must have additional warning labels and be restricted to those patients for whom other drugs do not work. Other GSK products containing rosiglitazone also face the same limitations.

The problem with Avandia may be its link to cardiovascular risks such as heart attack and stroke.

The FDA came very close to pulling Avandia off the market last July during an advisory panel meeting. The experts meeting did stop an Avandia trial called TIDE, which compared Avandia to Actos, a rival drug.

According to an FDA news release, the restrictions allow Type 2 diabetics, who are currently taking Avandia, to continue its use while use will be restricted to new patients only if they cannot control their blood sugar while on other medications and cannot take Actos.

Avandia is in a class of drugs known as thiazolidinediones or TZDs.

GSK will have to set up the limitations and doctors will have to confirm a patients’ eligibility. GSK will also have to assemble an independent group of experts to review the clinical trial known as RECORD which is completed to determine the safety of Avandia compared to other diabetes drugs. The cardiovascular safety question will be key.

It is very possible if GSK has shown bias in its study methods or results, the FDA could remove Avandia from the marketplace. If you or a loved one has taken Avandia and suffered a cardiovascular event, you should know that an experienced Florida defective product law firm will review your case at no cost to you.

Acer Computers are getting more than their fair share of complaints over the Internet. We reported here about the bloatware that a new computer comes loaded with. Bloatware is software pre-loaded onto your new computer that is basically an advertisement for a virus software or backup program. Advertisers pay for the ads, they pop up on your computer occasionally and slow town the start up and shutdown times of your computer as well as generally slows its response and reduce battery life. Now Consumer Affairs have a whole litany of complaints from consumers about the Acer. One woman says Wal-Mart and Acer refuse to fix the problem.

Another says her new Acer Netbook has a cracked LCD screen, and the company wants to charge her $125 even though it has a factory warranty. Another Acer Aspire 3050 has been in six times for repairs. Even a computer sales consultant says he does not recommend Acer to anyone largely y because of their poor customer service.

In January, the company recalled some models of the Aspire Notebook computers. 22,000 were recalled after it was determined that an internal microphone wire can short circuit and posed a potential burn injury hazard to consumers.

On the bloatware problem, there is software that can walk you through removing the bloatware and some computer companies actually offer an option. You can purchase a custom configuration that removes bloatware on your new computer, but of course for that you pay more, or you can simply take the machine in and have the bloatware removed, again substantially raising the price of a low cost computer and fooling consumers in the process.

Florida product liability attorneys Farah & Farah, P.A., are pleased to announce the creation of Florida-ProductLiability.com—a free public information site devoted to coverage of product recalls, product liability settlements and other issues that are important to those who have suffered injuries because of defective products.

In our consumer-driven society, defective products prose a significant threat to the lives and well-being of everyday people. Almost any type of product can be poorly designed or insufficiently tested in such a way that innocent consumers are at risk.

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