Alaska Injury Law Blog

The Alaska Personal Injury Law Group recently posted an article about how the FDA and other federal agencies have systematically attempted to use preemption to make manufacturers immune from suit for injuries caused by their defective products. One point of discussion was how the FDA has weakened regulatory protection of consumers from dangerous, defective drugs. Now, just a few days later, an independent group of objective scientists has issued a new report chastising the FDA for its approval of bisphenol A, commonly referred to as BPA.

The new report was issued by the Science Board, a group of independent scientists that provides advice to the Commissioner of the FDA. The Science Board provided peer review of the FDA’s draft assessment of use of BPA in food contact applications. The Science Board concluded that the FDA position was seriously flawed.

BPA is an industrial chemical used to make polycarbonate plastic and an epoxy resin used in many consumer products. The FDA approved it for use in baby bottles and as a liner in food containers like baby formula cans. It is also used extensively in other food containers, in sport bottles such as Nalgene bottles, and as a liner in soda cans. In mid-2008, the National Toxicology Center issued an extensive report addressing the health risks resulting from exposure to BPA, including effects on brain and behavioral development in infants and small children, and the potential to cause cancer. In response, the FDA steadfastly maintained its position that BPA was safe.

The Science Board has now found multiple flaws in the FDA assessment. First and foremost, the FDA assessment failed to provide ``reasonable and appropriate scientific support'' for its finding that the public wasn't at risk from BPA. Second, the FDA ignored many peer reviewed studies that found BPA presents serious health hazards. Instead, the FDA relied upon two studies funded by the chemical manufacturers’ association, only one of which was peer reviewed. The studies ignored by FDA show multiple risks, including impaired neural development, developmental changes in children, impaired reproductive tract development and diabetes. Third, the FDA assessment improperly analyzed the margin of safety (MOS) provided by the FDA standard for BPA exposure. The Science Board found extensive evidence that the FDA standard for allowable exposure levels was at least an order of magnitude too high, particularly for children.

Continue reading " Independent Scientists Find FDA Report on BPA Defective " »

The House of Representatives Committee on Oversight and Government Reform has released its report about the Bush Administration's imposition of new preemption policies within the FDA. Historically, the FDA viewed litigation brought by those harmed by medical devices or medications as a complement to the agency's regulatory efforts to protect against the effects of unsafe devices and drugs. The agency recognized that these cases help to uncover the risks that were unknown to the agency (or hidden from the agency by the manufacturer) at the time the product and its labeling were approved, thereby providing another layer of consumer protection against unsafe products. In 1997, former FDA Chief Counsel Margaret Jane Porter stated: "FDA's view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct layer of consumer protection. FDA regulation of a device cannot anticipate and protect against all safety risks to individual consumers....Preemption of all such claims would result in the loss of a significant layer of consumer protection." This position was uncategorically reversed in the Bush Administration in favor of overt advocacy by the agency in support of preemption of litigation, effecting essentially a grant of immunity to the manufacturers of medical devices and drugs.

Internal agency documents obtained by the Committee now show that these regulatory changes were made by the FDA over the objections of key career officials who repeatedly warned that the central factual justification offered for the agency's new directives was false.

For example, the preamble to the 2006 labeling rule asserted that the FDA has the ability to "carefully control" drug labeling and to continuously monitor the safety of pharmaceutical products, incorporating information into the labeling when appropriate. Dr. John Nenkins, the highest official in FDA's new drug review process, strongly disagreed with these assertions, writing: "[M]uch of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false....We know that many current approved drug labels are out of date and in many cases contain incorrect information."

Remarkably, the preamble to the 2008 labeling rule claims that the preemption revision merely conforms the language of the rule to the agency's settled interpretation, a statement that is manifestly not the case. Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research, advised that, "[t]he rule is not, as it purports to be, consistent with the agency's role in protecting the public health," and was not, in fact, reaffirming the FDA's long-standing interpretation.

Under the Bush Administration, the FDA has been suborned to act in a way designed to protect the manufacturers of medical devices and drugs from potential liability. It has done so by actively ignoring the objections of career FDA officials who understand the vital role the FDA plays in protecting the public in its use of food, drugs, and medical devices. The FDA's mission should be to advance medicine and science, not to serve a political agenda illicitly designed to protect corporate interests over the protection of those they have sworn to protect,

Sources:

House Committee Report, October 2008

FDA Preemption: Another Bush Legacy Wrecking The House

Stealth Tort Reform: AmBush At The FDA

Just because an herbal product is advertised to be "all natural," this does not mean that it is safe. "All natural" is a marketing term used to convince you to buy a product--it is code for "no side effects." In fact, most diet supplements are untested as to both their safety and their effectiveness in treating any particular condition, although most consumers look at the packaging (which is designed to look like pharmaceutical packaging), and assume that someone with a white coat has tested the product. Not so. Moreover, herbal medicines can cause dangerous drug interactions, many of which are unknown to science, when herbals are taken along with prescription medications. If you are taking prescription medications and mixing them with diet supplements, you are taking the risk that your medication's effectiveness may be blunted or substantially increased, either of which can cause significant injury.

The most recent warning is given to us by the Stollery Children's Hospital in a release to the Canadian Cardiovascular Congress. Noting the inherent unpredictability of Warfarin treatment itself, the hospital warned that combining such therapy with herbal remedies increases the risks of clots and bleeding in patients. Remarkably, in a study of children taking Warfarin, researchers found 37% to be taking diet supplements, yet the parents had not informed their physicians about the supplement use.

Set out helow is a list of herbal products known to interact with Warfarin (Coumadin). Be sure to talk with your doctor about combining any of these products with your blood thinning treatment.

Vitamin C--Vitamin E--Vitamin K--Glucosamin/Chonroitin--Coenzyme Q--Agrimony--Dandelion--Pau d’arco--Alfalfa--Fenugreek--Policosanol--Aloe Gel--Feverfew--Poplar
Aniseed Angelica (Dong Quai)--Garlic--Quassia--Arnica--German Sarsaparilla--Red Clover--Asa Foetida--Ginger--Senega--Aspen--Ginkgo Biloba--St. John’s Wort--Bladder Wrack (Fucus) --Goldenseal--Sweet Clover--Black Cohosh--Green Tea--Sweet Woodruff--Black Haw--Horseradish--Tamarind--Bogbean--Licorice--Tonka Beans--Bromelain--Meadowsweet--Wild Carrot--Buchu Boldo--Mistletoe--Wild Lettuce--Capsicum--Nettle--Yarrow--Cassia--Onion--Celery--Parsley--Chamomile (German & Roman)--Passion Flower

Sources:

Heart And Stroke Foundation of Canada

Warfarin Patient Handout

For the past several years, the Bush administration has pursued a covert campaign to steal the rights of victims of dangerous drugs and other defective products. Contrary to the conservative Republican mantra of "personal responsibility," federal agencies have been giving "Get Out of Jail Free” cards to irresponsible corporate wrongdoers. The goal is to deprive the injured victims of defective products of their rights to fair compensation under state law.

An in depth study just released by the American Association for Justice has documented how federal agencies have used "preemption" to try to allow corporate wrongdoers to escape justice. What is preemption? Rightly used, preemption means a federal law preempts all contrary state laws where Congress has expressed its intent to totally occupy a specific area of law.

What is the result of such language? If it is effective, consumers can be prevented from filing lawsuits in state court when the product that injured them complied with federal standards, no matter how inadequate those regulations may be. No suit may be maintained even though the product might be considered defective under state law. By this means, the federal law trumps the state law, and the corporate wrongdoer is immune from liability for the injuries its product caused.

Political appointees of the Bush administration have gutted many of the regulations that are supposed to protect us all. Compounding the wrong, they then inserted into those ineffective regulations language that purports to preempt lawsuits by victims of dangerously defective drugs, defective automobiles, and other harmful products. Since 2005, seven agencies of the United States government have issued more than 60 rules with preemption language in the preamble to the rule. These preemption provisions generally were inserted at the last minute, without notice to interested state governments, consumers or other affected groups. Often, the proposed rule stated that no preemption was intended, but the Bush bureaucrats inserted a preemption provision into the final rule after public comment had ended.

"Why," you may ask, "would the government want to keep people injured by dangerous drugs or other defective products from asserting their legal rights?" Why, indeed. Protection of the public is the mission of many of the agencies that have tried to cheat these victims and help the corporations that harmed them. Contrary to their true mission, under the Bush administration the agencies have taken up the cause of protecting corporations at the expense of public safety. A bigger perversion of the role of federal regulators would be hard to find.

Continue reading " Corporations Granted Preemption Immunity for Defective Products and Wrongful Acts " »