FDA Tag Archives — Georgia Injury Law Blog

Published on: February 7, 2012

FDA’s Poor Oversight of Disposable Wipes Makers Poses Safety Risk to Consumers

The Food and Drug Administration has failed in its responsibility to maintain oversight over companies that manufacture disposable wipes.As a result, sanitation and hygiene standards at these facilities have dropped, and the result has been several fatalities and infections across the country caused by contaminated wipes.An investigation by the Milwaukee-Wisconsin Journal Sentinel found poor hygiene standards at a facility operated by yet another Wisconsin-based company that manufactures wipes.

Product liability claims are likely from any serious infection or wrongful death which arises due these wipes. A personal injury arising out of a serious infection often results in long-term hospitalization and continuing issues for the individual. Product liability claims which arise out of the improper manufacturing of a product can be very difficult to prove. However, personal injury lawyers have developed a variety of techniques of attacking these types of cases. The work of government agencies is often an important component in establishing civil liability in these matters.

That company, Rockline Industries manufactures baby wipes and other wipes that are used in hospitals and homes.According to the investigation, at least 5 years ago, employees of the company acting as whistleblowers wrote a letter to the Food and Drug Administration warning that thousands of contaminated wipes were being manufactured at the company’s Arkansas facility.The whistleblowers alleged that the company was aware of the contamination of these wipes, but failed to take action, and continued to ship these wipes across the country.

Published on: October 12, 2011

FDA Likely to Declare Surgical Mesh Devices as High-Risk Because of Injury Hazards – Product Liability Claims Likely

by Robert N. Katz, Esq.

Under pressure from consumer safety advocates and product liability attorneys, the Food and Drug Administration is likely to soon limit access to surgical mesh devices because of the high risk of personal injury and complications resulting from the use of these. The Food and Drug Administration has confirmed that it will soon review the safety of the devices, which are used to treat pelvic organ prolapse in women.In this condition, the uterus and other organs shift from their position, and protrude through the body.The condition is frequently seen in women after childbirth.A surgical mesh device is used to keep the protruding organs in place.These devices are implanted transvaginally.

However, the Food and Drug Administration has been aware of complaints involving complications in women who had been implanted with surgical mesh products, for a while now.According to the Food and Drug Administration, between January 2008 and December 2010, it received more than 1,500 complaints of complications associated with the use of surgical mesh products.In July, the agency issued a safety warning about the products.Most of the complaints alleged chronic pain after the insertion of the surgical mesh.Women have also reported complaints about painful sexual intercourse.

What has seemed really outrageous to Atlanta product liability attorneys is that many women, who have had these surgical mesh products implanted and now face chronic and consistent pain, could have been treated even without the use of these devices.Doctors now believe that an unknown number of women may have had surgical mesh produces implanted to treat pelvic organ prolapse, when there are noninvasive techniques that can help treat the condition. In fact, the Food and Drug Administration believes that the use of surgical mesh product exposes patients to more severe injury risks, compared to traditional non-mesh repairs.The increased risk from the use of the surgical mesh does not translate into higher benefits for these patients.The Food and Drug Administration says that it has not seen any evidence to indicate that the use of the surgical mesh treats the condition any better than non-mesh procedures.

Published on: May 8, 2009

FDA Warns Against Using Weight Loss Supplement Hydroxycut After Reports of Liver Injuries

by Robert N. Katz, Esq.

In a month in which at least 34 weight loss products of a New York-based company were recalled by the FDA, the agency has issued another warning, this time to consumers who use popular weight loss supplement Hydroxycut, to stop using these immediately. The warning comes because of reported liver injuries in persons who took these products, including at least one death.

Hydroxycut has a lion’s share of the weight loss supplement market with close to 9 million bottles reportedly sold last year alone. The supplement is popular with people on a diet because of its appetite suppressing properties. Besides, it is used widely by bodybuilders to define muscle tone. According to the FDA, some of the Hydroxycut products also have a serious side effect – they cause liver injuries. At least one person’s death has been linked to the weight loss supplement. A 19-year-old man reportedly died in 2007 from liver injuries. Also one person has had to undergo a liver transplant procedure after he suffered liver damage from using the product. According to the FDA, it has received at least 23 reports of liver injuries caused by the supplement.

The company that makes Hydroxycut, Canada based-Iovate Health Sciences has agreed to recall all Hydroxycut products, even though the FDA has linked only about 14 Hydroxycut products to liver injuries. The company however denies that the sole death was linked to its product in any way.

Published on: March 26, 2009

Calls for FDA to Split Grow Louder

by Robert N. Katz, Esq.

Food and drug safety advocates and Georgia product liability attorneys have long called for a division of the Food and Drug Administration into separate agencies, each in charge of food and drug safety.These calls have gotten louder since the salmonella poisoning scandal earlier this year that’s been linked to contaminated peanut butter. It’s obvious that the agency is over burdened, over stressed, and simply unable to handle the responsibilities of making sure that the food and medical products that Americans consume are completely safe to use.

Hopes for a split of the agency into separate divisions for food and drug safety received impetus last week when President Barack Obama named two health experts to top positions at the FDA. The President has tipped former New York City Health Commissioner Margaret Hamburg to be the agency’s new commissioner. Joshua Sharfstein, a pediatrician has been picked by the President to be deputy commissioner. Sharfstein has long been a strong critic of health issues, including the safety of children’s cold medicines. FDA insiders believe that the President’s choice of 2 respected health experts points to his being in favor of dividing the agency into two. The President has also appointed an advisory group which will be re-evaluating archaic American food safety laws, many of which are several decades old.

The FDA has traditionally focused on drug safety as its primary responsibility, and critics have complained that the issue of food safety comes up at the agency only when there is a crisis like the recent salmonella epidemic. It has been apparent even to a casual observer that the FDA has too many responsibilities and too few resources. The drug industry is reportedly in favor of a split agency because it would lead to quicker drug approvals. Besides, having a single drug safety agency will mean better oversight over drug approvals, and more stringent following of approval processes.

Published on: January 30, 2009

FDA Reviewing Drug Labeling Charges

by Robert N. Katz, Esq.

Product and pharmaceutical liability lawyers have been seriously worried about the impending outcome of Wyeth vs. Levine and the preemption doctrine.

In December, this blog discussed the case of Wyeth and Levine and federal/state preemption issues. We await the United States Supreme Court’s decision on this issue. Meanwhile, the FDA is having to answer to these problems.

The New York Times is reporting that the U.S Food and Drug Administration may be launching criminal investigations into complaints made by several scientists against agency officials. The complaints go back to November of 2008 when the House Energy and Commerce Committee received a letter from scientists at the FDAs Center for Devices and Radiological Health division. The letter made serious allegations that management at the CDRH had been interfering with the process of approving medical devices. The scientists complained that they were being "forced" into rushing ahead to approve devices, bypassing standard procedures. The letter galvanized the ECC committee to launch an enquiry. Now, nine scientists who had made that complaint have written a letter to President Obama alleging that FDA officials may launch criminal investigations into those complaints. The letter states that it is "an outrage that our agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."

Published on: January 22, 2009

FDA Continues to Sleep Over Food Safety

by Robert N. Katz, Esq.

Seattlepi.com has an interesting story about how well we can expect our federal agencies to ensure that the food that makes it to our tables is safe to eat. The focus of the story is but naturally, the salmonella food poisoning crisis that has engulfed the country with 6 deaths connected to the epidemic so far.

The biggest source of concern to American consumers in this latest crisis, the report says is the manner in which the Food and Drug Administration dragged its feet for more than three months before confirming an outbreak. The latest crisis that has involved the agency’s food safety protocol has had consumer safety advocates, food poisoning lawyers as well as the public, wondering how the FDA which found out weeks ago that the Georgia plant of Peanut Corporation of America was the source of the particular strain of Salmonella found in the contaminated peanut butter, could have waited so long before they even confirmed the source. The FDA continued to mouth the same line – that the peanut butter in question was only sold to restaurants, nursing homes and food companies, but they still have not released a list of all Peanut Corporation of America clients who may have received the contaminated butter. The FDA’s outdated practices mean that manufacturers are rarely forced to recall their products. The agency prefers to rely on voluntary recalls by companies, and in many cases, these are too late to prevent severe illnesses.

More companies meanwhile are queuing up to announce recalls of their products that contain peanut butter. General Mills has recalled 2 varieties of snack bars because butter used in the snacks came from the Peanut Corporation of America. Other companies including Perry’s Ice cream Company, Food Lion Cookie, Hy-Vee Inc, have all removed their products containing peanut butter from store shelves as a precautionary measure because of the fear that these could contain traces of the contaminated butter.