Alaska Injury Law BlogRichard E. Vollertsen of the Alaska Personal Injury Law Group has been selected for inclusion in the “Best Lawyers In America” 2009 publication. He is now in a distinguished group of attorneys listed in the publication for over 10 years. Selection to the “Best Lawyers In America” listing is based on exhaustive and rigorous peer-review evaluations by the top attorneys in the country.
Independent Scientists Find FDA Report on BPA Defective
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
FDA Career Staff Objections Ignored–Again
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.”
Blood Thinners and Diet Supplements Don’t Mix–Especially For Kids
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.
Corporations Granted Preemption Immunity for Defective Products and Wrongful Acts
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
Prescription Drug Maker Moves Toward Transparency Re: Payments to Doctors
Eli Lilly and Co. has announced that it will now begin disclosing information about the money it pays to individual doctors for advice, speeches, and other services. The company is riding out ahead of legislators at the state and federal levels who have pushed disclosure bills that would impose a legal mandate upon drug manufacturers to make such payments public. Lilly will disclose payments above $500 made in 2009, but will not make disclosure about payments in past years.
A handful of states have legislated disclosure from drug manufacturers: Minnesota, Vermont, West Virginia, and Maine. No disclosure requirements have been imposed on medical device manufacturers, although the obvious ethical concerns apply there as well. ( See our previous posts here, and here.
Source:
The FTC And FDA Take On Peddlers Of Fraudulent Herbal Cancer Cures
The Federal Trade Commission announced today 11 law enforcement actions taken against firms deceptively advertising bogus cancer cures. The companies have been charged with making unsupported claims that their products have treated or cured various cancers, and some were charged with falsely stating that they had clinical or scientific proof of their products’ efficacy. The FTC’s Director of the Bureau of Consumer Protection stated that, “There is no credible scientific evidence that any of the products marketed by these companies can prevent, cure or treat cancer of any kind.”
Of the 11 complaints, six were resolved by proposed settlements with the remainder to be litigated by the FTC. The companies will all be required to notify consumers that there is little to no scientific evidence demonstrating the efficacy of the products to treat or cure cancer. The complaints arose out of a year-long effort by the FTC, the FDA, and a corresponding Canadian agency in which 112 websites were targeted. Of those, over 30% responded to the governmental warnings and closed their websites or altered the fraudulent claims. Warning letters were then sent to 23 companies.
To identify the companies and products targeted, follow the links below.
PTSD: Can It Be Caused By Medical Treatment?
Most readers know that PTSD can be caused by intense trauma from accidents and injuries, but the question whether medical intervention itself can cause PTSD has not been extensively studied. Dr. Dimitry Davydow of the University of Washington’s School of Medicine reports in the Sept.-Oct. issue of General Hospital Psychiatry that as many as 22% of ICU patients will later suffer PTSD. This conclusion arose from the review of 15 medical studies and 1,745 ICU patients. The symptoms of PTSD include nightmares, sleep problems, flashbacks, irritability and anger, as well as emotional numbness. The risk of suffering PTSD increased if the patient had underlying mental illness, such as anxiety or depression, or was treated with certain sedatives that cause disorientation, confusion, or psychotic experiences.
Sources:
General Hospital Psychiatry, Vol. 30, at 421-34, Sept. Oct. 2008
Arthroscopy and Knee Arthritis: No Proven Benefit
Two studies in the New England Journal of Medicine have concluded that arthroscopic surgery doesn’t improve patient outcome for those suffering from arthritis of the knee. In the first study, 200 patients with moderate to severe knee arthritis and no meniscal tears were placed randomly into surgical and nonsurgical groups. At two years, the complaints of pain, stiffness, and physical function did not differ between the two groups.
These findings comport with those of a 2002 study reported in the NEJM. There, 180 patients were studied using a placebo procedure, an arthroscopic lavage, and arthroscopic lavage with debridement. Again, at two years, there were no significant differences between the groups on scores for pain and physical functioning.
The conclusion is that arthroscopic surgery is ineffective for most patients with knee osteoarthritis.
Spiked Chinese Herbal Pills: Is Weight Loss Worth Having A Heart Attack?
We have learned the lesson repeatedly, with drugs like Fen-Phen, Ephedra (see our litigation here), and similar magic pills, that there is no free lunch when it comes to weight loss. If drugs are being used to amp up the engine of the body’s metabolism, something is eventually going to seize up. Yet, the pharmaceutical industry and the unregulated diet supplement industry keep trying.
Here’s a case report concerning their latest victim, reported in the September 11, 2008, issue of Clinical Toxicology. A 37-year-old woman suffered a heart attack after using an herbal weight loss product for just 3 days. A urine screen, however, disclosed the presence of sibutramine. (The article doesn’t disclose this fact, but one would assume that the herbal product was spiked with sibutramine, and the drug was not listed on the label as an ingredient.) Sibutramine is a serotonin-norephinephrine reuptake inhibitor that is structurally related to amphetamine, although its mechanism of action is distinct. Sibutramine is the active incredient in Abbott Labs’ Meridia, a prescription weight loss product. The patient was not obese, did not smoke, and was not known to have hypertension or diabetes. No other stimulants were found in her blood stream. The author reports a similar case involving a young woman in their clinic who had also suffered myocardial infarction after using sibutramine for 30 days.
There have been 397 adverse events reported to the FDA concerning sibutramine between 1998 and 2001. There were 152 hospitalizations. Of the 29 patients who died, 19 suffered cardiac problems that led to their deaths. Sibutramine is one of drugs Dr. David Graham, the FDA whistleblower, and Public Citizen, have warned the public about.