Leslie Richter has been speaking for years on behalf of her husband, who died after taking a painkiller now linked to an increased risk of heart disease and stroke. But the Michigan Senate has yet to act on her plea to repeal a law that protects drugmakers from product-liability suits, she said at a press conference yesterday,
The Jackson Citizen-Patriot reports."They have to put the people of this state ahead of pharmaceutical companies,'' said Richter of Lansing, Michigan, whose husband, Richard, had two strokes and died in March 2003 after taking Vioxx, a drug that has since been pulled from the market. "There is nothing you can do for recourse.''
The concept, of course, is called preemption and its supports insist that FDA approval of a drug preempts state law claims challenging the safety, efficacy, or labeling. At issue is whether patients can sue a drugmaker through state law when a product has already been approved by the FDA. And critics, such as Richter, argue the notion robs consumers of due recourse. The US Supreme Court is due to review the debate. Michigan, however, is the only state that has preemption on its books.
Richter and others, including state Rep. Mike Simpson, a Democrat, spoke in several Michigan cities Monday to draw attention to the issue, one yeaer after the state House voted to repeal it. Since the House decision, Senate Majority Leader Mike Bishop, a Republican, has not brought the issue up for a vote and no hearings have been scheduled with the Senate Judiciary Committee, according to Simpson, a sponsor of the repeal legislation.
Neither Bishop nor Senate Judiciary Chairman Wayne Kuipers, both Republicans, could be reached Monday for comment. Nor could any of their staff members. Government offices were closed for Presidents Day.
The Michigan law, which was passed in 1995, provides liability protection for drug companies if their products and labeling comply with FDA standards. Some Republicans and business groups support it because they say it protects companies from unreasonable and costly lawsuits at a time when the state is struggling economically.
But Dan Farough, executive director of Progress Michigan, which is advocating for the law's repeal, tells the paper that the law "strips people of their right to protect themselves and their loved ones.'' Instead, it protects drug companies and their massive profits, he says, adding that "there is no brighter light that can shine on the special-interest-group core."
Richter, who said her husband was a healthy General Motors retiree before taking Vioxx, said she won't stop her campaign until something is done. "I would not want this to happen to anyone else's family,'' she said.
3 Comments
I have to admit, I'm a little conflicted on the preemption issue. Maybe if states want the rights, we should set up a regulatory system more like the EMEA in which countries can refuse central recognition of approval to conduct the review and approval process locally.
First of all, it would be near impossible to prove that Vioxx impacted any individual patient (or didn't for that matter). The legal system has run amok; if the FDA approves the drug, then they should be culpable as well. If it is found companies were deceptive or fraudulent, slap them silly and put them out of business. Otherwise, the consumer has to assume some risk with prescription drugs. These are bioactive chemicals, people. As an aside, I live in Michigan and there are not that many "healthy GM retirees." Just my opinion. Regarding "massive profits," are these the same critics that have drug company stocks in their retirement plans? Getting tired of being society's punching bag. Can you think of an industry that has done more good for society in the last 100 years?
There is no need here to review all the arguments that, effectively, devastate the rationale for FDA preemption. Once again, I would call people's attention to the editorial in the Jan 3rd issue of NEJM which makes many of the relevant points. See also the JAMA commentary by Kesselheim and Avorn of Jan. 2006. When the most mainstream voices of American medicine defend the work of trail lawyers, we ought to notice there may be something important going on here. NEJM, in fact, called the issue "momentous" re: its impact on patient rights and public health.
Just this addition. Until the Bush FDA, FDA's own view was that FDA regulation and civil liability provide "two complementary layers of consumer protection." Said most simply, what FDA preemption does is take one of those layers and flushes it away.
For my friend OC, civil liability is not equivalent to states creating their own regulatory agencies. It is rather holding companies accountable when they act in ways that do _not_ meet reasonable FDA complaince criteria or act in ways entirely outside the purview of FDA (intimidting researchers, squirreling with journal articles, etc.)
Re: the first point, you might say the FDA itself can hold such companies accountable. Very rarely, they do. Very rarely, indeed, as a hundred cases discussed here repeatedly demonstrate.