Michigan Drug Industry Immunity Must End, or It Could Start Catastrophic Nationwide Trend

David Mittleman
Attorney
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Posted by David MittlemanApril 25, 2008 2:57 PM
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As has been widely reported, Michigan has granted a shield of immunity to drug manufacturers whose products have been approved by the Federal Food and Drug Administration (FDA).  This absolute defense against liability may soon spread across the nation, putting consumers everywhere at risk.  If pharmaceutical companies are not to be held accountable for their wrongdoing, who is left to bear the burden of defective drugs?  The answer is simple: 1) Big Pharma's victims and 2) the taxpayers.

Simply put, the FDA was not built to police multi-billion dollar companies.  The FDA has a broad and unenviable mission.  Its mandate is to "protect[] the public health by assuring the safety, efficacy, and security" of the nation's drugs, medical devices, food, and cosmetics.  In addition, it is directed to "speed innovations that make medicines and foods more effective, safer, and more affordable."  This one little agency is asked to regulate a one trillion dollar industry that accounts for about 25% of all consumer spending in this country.

Recent, well-pubicized failures in FDA oversight have driven home the point: pharmaceutical companies are acting recklessly and the FDA does not have the resources to stop them.  If consumers are barred from asserting their rights in court by FDA immunity statutes, legislatures will have effectively put the fox in charge of the henhouse.

Drug company practices are starting to backfire.  As patents on many popular drugs are set to expire, the search is on for the next billion-dollar miracle pill.  Unfortunately, drug companies will undoubtedly focus on inventing and promoting drugs that sell rather than drugs that actually cure people.  As Melody Peterson noted in her L.A. Times editorial, why cure the disease when you can treat the symptoms?

Legislatures enable and embolden pharmaceutical companies by granting absolute immunity for FDA approval.  This policy cannot be effective if the FDA is unable to fulfill its mission.  The victims of dangerous drugs deserve better. 

2 Comments

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HG
Posted by HG
April 28, 2008 5:09 PM

Unfortunately, this post comes much too late. The Supreme Court has already upheld FDA preemption in the Riegel case (voting 8-1). That was a medical device case.

In the Levine case, which the Court will hear in October, the issue is preemption in the arena of drugs.

So it will not take individual state legislatures. The Court can eliminate civil liability of drug companies - and probably will - this Fall.

Below a recent letter of mine that was published in the NYT on this matter:

April 13, 2008
LETTER

Drug Makers’ Advantage

To the Editor:

Re “Drug Makers Near Old Goal: A Legal Shield” (front page, April 6):

There is a kind of Alice-in-Wonderland quality as the Supreme Court comes closer to affirming Food and Drug Administration pre-emption.
Every few months, another study concludes that the F.D.A. cannot fulfill even its basic responsibilities.

Until the Bush administration, the F.D.A. itself viewed civil liability and its own regulation as complementary systems of consumer protection. And yet we are about to throw one of those systems away.

Like the doctrine of pre-emptive war that led to Iraq, F.D.A. pre-emption is a policy concocted in oblivion, an ideology without connection to the ways the agency and industry actually work. The editors of The New England Journal of Medicine recently wrote that that policy would have cataclysmic consequences for patients’ rights, industry accountability and public health.

It is not often that doctors defend trial lawyers. Having now heard what the most respected voice in American medicine has to say, we should have no illusions where we are headed.

Henry Greenspan
Ann Arbor, Mich., April 7, 2008

The writer is a faculty scholar in integrative medicine, University of Michigan.

Amanda
Posted by Amanda
April 28, 2008 6:08 PM

In February 2008, the Center for Justice & Democracy (CJ&D) released the report, A Tragic Blunder: Michigan's Drug Industry Immunity Law. As the report states, the Michigan Drug Industry Immunity Law is unprecedented and it prevents Michigan residents harmed by dangerous drugs from gaining access to the civil justice system. This law has been devastating for Michiganders while failing to accomplish any promised economic benefits for the state. Since the law went into effect in 1996, numerous unsafe drugs have been marketed with approval by the Food and Drug Administration that have killed or injured Michigan residents. Unlike victims in any other state in the country, Michigan residents are barred from seeking compensation for these deaths or injuries. Meanwhile, contrary to what the law's proponents promised, thousands of good paying jobs in the pharmaceutical industry have left the state.

What Michigan lawmakers accomplished with this law is exactly what the pharmaceutical industry has been trying to accomplish unsuccessfully for the last three decades in Congress and state legislatures around the country – eliminating their liability for marketing unsafe drugs, and shielding them from responsibility when their harmful products hurt or kill. This law is especially harmful since the FDA has fallen down on its job of protecting the public.
Every legislative session since the drug industry immunity law was passed, Michigan legislators have introduced legislation to repeal the law. Michigan residents have been reaching out to their elected officials, the House of Representatives passed repeal legislation in January 2007, and Governor Jennifer Granholm expressed support for repeal in her recent State of the State address.

For more information and a copy of the report visit the blog The Pop Tort More ...

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