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Al Smith - May 13, 2008
Montana Trial Lawyers Association
Preempting Our Safety
Preemption has been used in the past where companies argued that legislation passed by Congress had preempted any claims brought under state laws. Such federal laws have been challenged on a constitutional basis, primarily arguing that the law in question did not specifically preempt state suits. Sometimes courts have held that state laws were not preempted because the legislation did not specifically provide that state suits were preempted. I've spoken before about the Bush administration's crusade to use federal administrative rules to preempt state laws that protect consumers, essentially bypassing Congress. Several agencies are attempting to use rules so that the industries that they supposedly regulate do not have to be accountable and responsible in state courts for the harms they cause.
Tomorrow, Congress will hold hearings on whether regulation by the Food and Drug Administration of drugs and medical devices should preempt lawsuits under state laws. Hearings are being held because the FDA has asserted in state law suits that its regulation of drugs and medical devices preempts state law suits against manufacturers that the FDA regulates, even if Congress has not specifically included statutory language to preempt state law claims.
The FDA and the drug companies argue that no citizen should be allowed to sue a drug maker for injuries associated with an FDA-approved drug. They claim that such lawsuits undermine the FDA's authority, and that FDA approval ought to provide the definitive word on a drug's safety.
Does it matter that all too often we hear of a drug's deadly or debilitating side effects only months to years after a drug has gained FDA approval? It doesn't seem to matter that we are told about drug company research that somehow bypassed the original FDA evaluation only after deadly side effects have taken innocent lives.
Is the FDA’s usefulness undermined by state law claims? Last year the FDA's own science advisory board concluded that the FDA was "so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety." The Government Accountability Office and the Institute of Medicine reached similar conclusions.
So who is the FDA useful to? The manufacturers of drugs and medical devices. Did you know that drug companies actually pay the FDA to evaluate new drugs as quickly as possible? Since 1992 the FDA has collected fees from pharmaceutical companies in return for promising to deliver quicker drug approvals. Drug companies provide nearly half of the FDA’s budget for reviewing new drugs. And, the FDA depends upon the drug companies to do the underlying studies to determine the efficacy and safety of new drugs.
But drug companies are not even required to hand over all of their drug research - the good, the bad and the ugly - to the FDA. It is alleged that the Ortho Evra patch has caused increased risks to women for heart attacks and strokes, and has caused at least 40 deaths. Johnson & Johnson internal correspondence uncovered in litigation show that the manufacturer knew of these risks due to elevated estrogen levels - years before it obtained FDA approval.
The company used an unsubstantiated assumption on absorption of estrogen into the bloodstream that resulted in higher levels of estrogen being delivered to a woman’s body. Did Johnson & Johnson report this to the FDA as part of the approval process? Well kind of, it included a single mathematical formula on the assumption in a 400 page report - with no explanation of the assumption. After FDA approval, adverse side effect reports started coming in - the FDA found out about these side effects some six years after manufacturer Johnson & Johnson did.
The purpose of state law claims against drug manufacturers is to make sure manufacturers are responsible and accountable for the harms they cause. It is not about banning drugs from the market, rather it is about consumers being able to make informed decisions about their healthcare. After the elevated risk of side effects of Ortho Evra caused the FDA to require new labeling and thus became public knowledge, prescriptions fell by 80%. Given more complete information, women could make their own informed decisions and many chose to avoid the risks.
Drug companies want preemption to hide behind the FDA's skirts. And the Bush administration is more than willing to use administrative preemption to extend those skirts and abolish U.S. citizens' rights to fend for themselves in court.
The preemption of state lawsuits removes a significant incentive for companies to improve the safety of their drugs. Often, big pharma agrees to safety standards only after they have been held accountable by juries in state courts for injuries and deaths that could have been prevented with full disclosure of all studies - to the FDA and the public.
This is Al Smith for the Montana Trial Lawyers Association.
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| Northwest Area Foundation Grant Funds News Reports on Poverty Issues |
Through 2008 the Montana Public Radio News Department will be presenting regular feature stories about issues of poverty in Montana. This project is made possible with a two-year, $78,500 grant from the Northwest Area Foundation. The funding will enable Montana Public Radio to add a half-time reporter to its staff for the duration of the project, as well as cover costs for field recording equipment and travel throughout western and central Montana. News Director Sally Mauk says, “I’m excited about the project and the opportunity to get our news staff out to many Montana communities to report on such an important and timely topic.”
The Northwest Area Foundation approached Montana Public Radio with this opportunity for funding coverage of poverty issues, after beginning successful projects with Minnesota Public Radio and Seattle’s KUOW. The Northwest Area Foundation’s mission is to help communities in an eight-state region (including Montana) reduce poverty. www.nwaf.org.
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