At the Alaska Personal Injury Law Group, we commonly face the unpleasant task of explaining to prospective clients the way in which “tort reform” has dramatically taken away the legal rights they thought they possessed. One of the recent unsung accomplishments of the Bush Administration is the silent destruction of the legal rights of those hurt by the malfeasance of corporations--stealth tort reform at the FDA.
Utterly unnoticed by the American public was an unheralded aboutface at the FDA. Although it had been silent on the issue before, the FDA began taking an active role in pending private litigation espousing the proposition that, if the FDA had approved a drug or medical device, then that approval should shield the manufacturer from any liability if the product were to injure or kill. In legal terms, that shield is called “preemption, “ the argument being that the federal government, by regulating the industry, has preempted state regulation and state tort claims. Manufacturers have long sought this shield, but the courts recognized the argument for the folly that it is, and commonly rejected it. Not surprisingly, this policy reversal by the White House was implemented by Dan Troy, one of 100’s of industry lobbyists President Bush put to work in positions responsible for public advocacy. Before his appointment, Troy’s practice was based on representing drug and tobacco companies in challenging FDA regulations. It was under Troy’s guidance that the FDA flip-flopped its position on preemption, much to the delight of the industry the FDA was supposed to be regulating.
The United States Surpeme Court, its makeup another Bush Legacy, has recently breathed life into the preemption defense, with its ruling in Riegel v. Medtronic. The ruling effectively wipes out all pending medical device litigation, from faulty pacemakers to defective insulin pumps. The natural extension of the legal argument will be to apply this ruling to preemption arguments in drug claims. And from there the erosion of legal rights will spread to every area of American society touched by the FDA (and by logical extension, any federal agency), whether the injury comes from a toxic chemical exposure or tainted hamburger.
Most remarkably, these changes come at a time when the FDA has had to explain one shocking lapse after another. Why shouldn’t the FDA’s approval of a medical device or drug preempt a state tort action? Consider this:
1.) The FDA’s approval of a medical device or drug is based on only partial data, usually the limited and sometimes biased clinical studies of the manufacturer itself. It is not until a product is in wide release and used by patients with many different kinds of health histories and conditions that the product’s true clinical liabilities are disclosed.
2.) The FDA’s approval is sometimes based on bad data provided by the manufacturer seeking product approval. We’ve previously written about this. Because there are often billions at stake, the manufacturers shade what is told to the FDA, so its garbage in, garbage out.
3.) The FDA is an agency subject to political pressures, just like every other federal agency. When the message from the White House is “hands off,” then the agency is less vigilant in its oversight. Lax oversight that is the result of political pressures applied to the FDA should not be transposed by a court into a conclusion that a product is safe.
4.) The FDA approval process is rife with conflicts of interests. Medical device and medication approvals are thus not being made by those who are truly independent and objective. The clinical studies submitted to the FDA are based on research done by those who are, literally, investors in the company seeking the approval. The leadership at the FDA is often drawn from the very industry the agency is supposed to regulate. And the agency’s advisory boards should represent physicians, researchers and patient advocates—not stockholders—but a 2006 study by the Journal of the American Medical Association showed that 22% of the advisory board meetings were completed with over half of the members having direct financial interests in the products being regulated. Nowhere is the problem more clear than President Bush’s appointment of Dan Troy.
5.) Because the FDA is subject to political pressures, the work of experts within the agency is often muzzled. Dr. Lori Love’s work to make public the dangers of ephedra was stifled at the agency. Dr. Andy Mosholder was banned by the FDA from attending a public Advisory Committee meeting to make final recommendations about Paxil, but the agency later relented if he answered only from an agency approved script about the suicide danger the drug posed to teens. Dr. David Graham's work on the dangers of Vioxx was repeatedly suppressed by the agency. In his public warnings about the FDA's botch of that drug's safety evaluation, he identified five other suspect drugs: Accutane, Bextra, Crestor, Meridia and Serevent. Dr. Rosemary Johann-Liang suggested two years ago that the diabetes drug Avandia carry black box warnings about the drug’s cardiac risks, but her supervisors reprimanded her and deep-sixed her report. In a 2006 poll by the Union of Concerned Scientists, 40% of the 1,000 FDA scientists said that they could not publicly express concerns about public health “without fear of retaliation.” Remarkably, 20% disclosed theat the agency decisionmakers had asked them explicitly “to provide incomplete, inaccurate or misleading information” to the public.
6.) The fact that a product has been approved does not mean that it has been inspected. Even when a product is effective, it must still be properly manufactured. The responsibility of the FDA is enormous—it simply can’t be everywhere. It is unable to stop the illegal spiking of diet supplement products with pharmaceutical drugs. It is unable to be sure that contaminated toothpaste and Heparin from China are safe.
7.) The FDA is a lumbering beast. It cannot move quickly. The two decades it took to get ephedra off the market is one example. The FDA didn’t warn the public about the risks of high estrogen releases from the Ortho Evra birth control patch until November 2005, even though there had been 50 deaths associated with the drug beginning in 2002. Bayer knew in 1993 that Trasylol was toxic to the kidneys, but the FDA approved the drug. It wasn't until an independent research published a journal article in the NEJM in 2006 that the FDA issued a health advisory. It was not until the fall of 2007 that independent Canadian study results prompted the suspension of the drug, 14 years after the first red flags went up.
8.) The FDA does not know how to litigate. Its power over those entities it regulates is its control over whether a product can be sold in the American marketplace. It is this threat to billions in potential future profits that keeps a manufacturer in line when the FDA does seek to regulate a product already on the market that is found to be unsafe. Yet, it is with the tools of litigation that bedrock truth is most often obtained about the risks of the product and what the manufacturer knew when. The FDA cannot get this information because it is not built to do so. To think that, despite this, a manufacturer will voluntarily disclose that which is most in its economic advantage to hide, is utter naivete.
The plain fact is that the courts are part of the system needed to protect the public from the avarice of corporations. If these companies can manipulate the FDA to approve their products in the first place, and then use that manipulated approval as a shield against later liability, there will be no redress when the products we most want and need to trust instead maim and kill those we love.
Alaska Injury Law Blog, January 17, 2008 and February 15, 2008:
New York Times April 6, 2008:
The Washington Times, March 31, 2008:
The Heparin Problem:
The Journal of the American Medical Association, April 26, 2006:
The Journal of the American Medical Association, May 21, 2008:
New England Journal of Medicine, April 24, 2008:
Abuses of Science at the FDA, Union of Concerned Scientists:
Dan Troy: Bush Administration's Preemption Gang:
FDA Is Placing Corporations Above Public:
Dan Troy's Poison Pill:
When Advocates Become Regulators:
FDA Scientist Says She Was Reprimanded For Warning:
Government Accountability Project: Dr. David Graham:
Protect Consumers' Right To Sue Drugmaker:
Strong Medicine: What's Ailing The FDA?
Bush Administration Rules Limit Lawsuits: