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A court case of vital importance

COMMENTARY | August 15, 2008

The decision in Wyeth v. Levine could determine whether documents that expose massive, lethal misconduct are accessible to reporters and the public.

By Morton Mintz

A wake-up call for journalists: We have an enormous stake in a case pending before the Supreme Court. Moreover, the wrong outcome would create a continuing threat to the lives, safety and health of huge numbers of Americans. That our interest and the public interest coincide is all the more reason why our professional organizations should at least think about filing amicus curiae briefs.

As Alicia Mundy wrote in the Wall Street Journal, for journalists the fundamental issue that arises from Wyeth v. Levine, which will be heard Nov. 3, is the steady whittling away by the Bush Administration of "the ability of consumers and other groups to sue corporations for damages related to their products." The whittling away matters to us because when liability suits cannot be brought, internal documents exposing massively lethal and harmful misconduct by pharmaceutical, medical-device and other manufacturers do not become accessible to the press and public. Instead, the documents can remain hidden forever and testimony about them never heard.

  • Two examples:

    Cigarettes kill more than 400,000 Americans annually. In 1988, after years of legal discovery, a smoker-death case went to trial in U.S. District Court in Newark, N.J., and I spent nine weeks covering the trial for the Washington Post. Day after day, plaintiff's lawyer Marc Z. Edell put into the record damning internal documents revealing what tobacco manufacturers knew, and when they knew it. About the hazards of smoking. About their campaigns to make smoking glamorous, to hook kids on cigarettes, to sell filtered cigarettes as "safe," and to create phony scientific "controversy" about smoking and health. Understand: The chances that these documents, and testimony about them, would have become publicly available absent litigation are close to zero.
  • The Dalkon Shield was an intrauterine contraceptive device that was inserted into approximately 2.8 million women in the United States and 1.8 million elsewhere and that caused large numbers of grave or even fatal injuries. [Correction: An earlier version of this story incorrectly stated that the Dalkon Shield caused grave or fatal injuries to 2.8 million women in the U.S. and 1.8 million elsewhere.] Evidence produced in an estimated 15,000 product-liability lawsuits established that the IUD owed its extreme popularity primarily to false claims made by the manufacturer about its safety and effectiveness in preventing pregnancy. The lawsuits were the basis of a series I wrote for the Post in 1985 and of a subsequent book. In the end, a federal judge approved a mandatory class settlement against the manufacturer, A.H. Robins, and its insurer, Aetna. Robins was sold for $2.475 billion, and the proceeds went to establish a trust for victims. More than 300,000 people filed claims.

Reporter Mundy could tell you about Fen-Phen, an immensely profitable weight-loss drug combination that was prescribed for nearly seven million Americans, mostly women, and that, starting in 1996, sickened thousands of them, killed some, and left others with permanently damaged hearts and lungs. Her 2001 book "Dispensing with the Truth," drew heavily on liability litigation to reveal a catalogue of outrages. To cite just a few:

Manufacturer Wyeth-Ayerst had known that Fen-Phen was not really effective and was possibly lethal as well. The company destroyed the first 13 reports of a deadly valve disease sent to it by a North Dakota physician. The Food and Drug Administration, under pressure from Wyeth-Ayerst, helped to insulate the company from lawsuits by effectively becoming part of the cover-up.

In the Journal, Mundy wrote that the pending Supreme Court case "centers on Diana Levine, a professional guitarist who lost an arm to gangrene after a receiving a shot to treat a migraine headache in 2000. Ms. Levine won $6.8 million in her lawsuit against Wyeth [yes!], which makes the antinausea drug, phenergan, that was given to her. A Vermont jury and that state's Supreme Court found that Wyeth hadn't sufficiently warned the public and doctors about the drug's dangers if improperly injected.

"Wyeth has argued that the company is protected because the Food and Drug Administration had approved its label. The government is supporting Wyeth's position, on behalf of the FDA."

The essence: Drug and medical-device manufacturers, their trade associations and lobbyists, and allied business organizations spend what it takes to install a government that will assure a weak, compliant FDA and that will fill Supreme Court and lower-court vacancies with pro-corporate ideologues. That done, these special interests and the Bush administration argue in unison that people who've been needlessly killed and harmed by a product can't sue the manufacturer because their jointly owned regulatory agency says not to worry.

Mundy, in her August 13 Wall Street Journal article:

The Bush administration has denied that it has a broad program aimed at pre-empting plaintiffs' right to sue. But it has tapped tort-reform supporters as legal advisers in several agencies.

Jay Lefkowitz, a former deputy counsel at the Office of Management and Budget under the Bush administration, said, "Product-liability lawsuits challenge FDA sovereignty, undercut having one label standard, increase costs and render drugs much less safe." Mr. Lefkowitz helped recruit Dan Troy to work as the FDA's top lawyer from 2001 to 2004. "Dan promoted a more-robust pre-emption agenda," Mr. Lefkowitz said.

The FDA began filing numerous legal briefs in state and federal courts favoring pre-emption, though it had previously supported plaintiffs' suits.

Mr. Troy, who was recently named general counsel for GlaxoSmithKline, declined to comment....

Dozens of lawsuits against drug makers could be dismissed if the justices side with Wyeth.

Do I believe all lawsuits against tobacco companies, drug companies, and other companies are soundly based? No.

Do I believe some product-liability lawyers are greedy so-and-so's interested only in lining their own pockets? Of course. But the same goes for defense lawyers.

Do I also believe that liability suits are, and must remain, an invaluable source of information for journalists, in the public interest? Absolutely.

Finally, do I believe that in Wyeth v. Levine, journalists have a dog in the hunt? How could you ask?

pharmalot, editor
Posted by ed silverman
08/15/2008, 07:01 PM

Hi Morton,

With all due respect, this journalist heard the preemption call last year and has posted about the topic regularly on Pharmalot, a site that covers the pharmaceutical industry.

Just this morning, I broke from vacation to offer links to the various amici curiae filed by a wide group of people - state attorneys general, NEJM editors, former FDA commissioners, tort law professors, economists, consumer groups and unions - in support of Vermont musician Diana Levine in her battle against Wyeth.

I also ran an interview with Levine earler this year. All this can be seen in this post...

http://www.pharmalot.com/2008/08/the-right-to-sue- ...

I have great respect for Alicia, but Pharmalot has been covering preemption for more than a year. I suggest you add Pharmalot to your official list of blogs that journalists should read.


Ed Silverman

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