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PHARMACEUTICAL COMPANY LINKED TO GHOSTWRITING MEDICAL ARTICLES
Posted by: William Gentile
December 14, 2008

Wyeth, a major drug manufacturer, has been accused of paying ghostwriters to write favorable medical journal articles, according to the New York Times. Senator Charles Grasserly has been spearheading a Senate Committee investigation of drug company practices. His staff released these documents which they discovered mostly from civil lawsuits.

This is an important example of how the civil justice system exposes some of the most egregious acts of corporate malfeasance. From tobacco, to asbestos and numerous other public health issues, lawsuits have been one of the most effective ways to expose these dark tactics. The details of this particular case are disturbing. The article states:

documents show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles - all without disclosing the companies' roles to journal editors or readers.

It is important to realize that this is an industry wide practice. This issue is particularly important in the context of lawsuits against drug manufacturers. Courts look at peer reviewed articles in evaluating whether a drugs side effects can be causally related to harms alleged in lawsuits. By stuffing peer reviewed journals with ghost written pieces that call into doubt studies linking a drug to harmful side-effects, these companies greatly increase the likelihood of immunizing themselves from lawsuits.

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PRE-EMPTION REDUX
Posted by: William Gentile
November 11, 2008

The New York Times has a cautionary editorial (hat-tip TortDeform) on the Wyeth pre-emption case we addressed last week.  As we discussed, a Supreme Court decision applying the doctrine of pre-emption to FDA-approved drugs would bar injured plaintiffs from sucessfully suing the producer of an FDA-approved drug for any harm caused by that drug.  In the editorial, the Times warns that the effects of this application would be far-reaching: 

For the court to broadly endorse the concept of "implied pre-emption" in this case would show disrespect for the considered decisions of Congress and could foreclose injury suits involving not only drugs, but also motor vehicles, household products and other things. The ultimate effect would be to undermine consumer safety.

Far from usurping the F.D.A.'s power, litigation aimed at holding drug companies liable for problems like those in this case complement the agency's efforts to protect the public. For many years the F.D.A. welcomed state failure-to-warn suits as reinforcing those efforts; two former commissioners, David Kessler and Donald Kennedy, made that point in a brief in the case.

It is only during the Bush administration that the FDA leadership has viewed litigation as a hindrance to its consumer protection efforts.  In fact, the Wall Street Journal reported recently:

Bush administration officials, in their last weeks in office, are pushing to rewrite a wide array of federal rules with changes or additions that could block product-safety lawsuits by consumers and states.

The administration has written language aimed at pre-empting product-liability litigation into 50 rules governing everything from motorcycle brakes to pain medicine. The latest changes cap a multiyear effort that could be one of the administration's lasting legacies, depending in part on how the underlying principle of pre-emption fares in a case the Supreme Court will hear next month.

The good news is that the Bush administration's eight-year attack on the civil justice system is almost over.  If he chooses, Barack Obama can undo in short order much of the damage Bush has wrought.  The problem, however, is that the Wyeth case is in the hands of the Roberts Court, which has already decided in favor of pre-emption in a recent case.

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FDA DOES NOT INSPECT CHINESE FACTORIES THAT PRODUCE DRUG PRODUCTS SHIPPED TO US
Posted by: William Gentile
November 11, 2008

I just came across this New York Times article via TortsProf Blog.  It talks about how China has become a major player in the production of over-the-counter and prescription drugs.  Lately, China has been plagued by non-stop reports of incidents of contamination from toys to baby food.  The most horrifying example was when 4 babies were killed and 53,000 sickened when the chemical melamine was found in baby formula.  Could this type of contamination find its way into drugs sent to the United States?  Here is the money quote from the article:

China now produces about two-thirds of all aspirin and is poised to become the world's sole global supplier in the not-too-distant future. But are the Chinese factories safe? Who knows? The U.S. Food and Drug Administration, the European Medicines Agency and other competent government regulators rarely, if ever, inspect them.

You might want to start reading those aspirin labels...

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SUPREME COURT HEARD ARGUMENT TODAY ON CRITICAL PRESCRIPTION DRUG PRE-EMPTION CASE
Posted by: Will Gentile
November 03, 2008

The U.S. Supreme Court will hear argument today on one of the most important cases in recent history to be heard on the rights consumers. The case of Wyeth v. Levine will take up the issue of pre-emption of FDA approved prescription drugs. The pharmaceutical industry has been pushing this doctrine for years. The basic argument is that oncethe FDA has approved a drug, an injured plaintiff cannot sue the producer of the drug for any harm caused by that drug. When one considers the history of the FDA and its failure to adequately evaluate drugs before releasing them to the market, it is clear that the consequences of pre-emption for the general public are quite severe. The history of adverse side effects from prescription drugs is so long and so tragic, it is beyond the pale that the pre-emption doctrine is being considered. The reason consumer groups are so anxious about this case is the Supreme Court's recent decision upholding pre-emption for medical devices approved by the FDA in Reigel v. Medtronic.

The Center for Justice and Democracy published a report describing how the FDA often fails to adequately protect women in assessing the safety of prescription drugs. An excerpt from the report states:

"Women have been hurt many times over the years by FDA-approved drugs, whether because drug companies withheld information and lied about health risks, or because the FDA has lacked the resources or political will to keep dangerous products off the market," said Cynthia Pearson, Executive Director of the National Women's Health Network. "This report from Center for Justice & Democracy documents the devastating consequences of these regulatory failures and shows how women who have been hurt by unsafe drugs have used lawsuits to bring critical information to light, protecting other women from suffering similar harm."

If the pharmaceutical companies have their way, consumers will have no recourse to the civil justice system for defective drugs that can cause catastrophic injury.

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