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Suicide, Drug Makers, and the FDA – Will You Be Next?

(by Kim Witczak, )

Last week, a Federal Appeals Court in Philadelphia ruled the makers of Paxil and Zoloft cannot be sued for failing to warn of a risk of suicide because the FDA had explicitly refused to order such explicit warnings. The case involved two families whose loved ones committed suicide in 2003 aftertaking an SSRI antidepressant.

This decision was a victory for the drug makers and the FDA who want their scientists, not the common people sitting on a jury, to decide what the drug labels should say and should preempt stronger state consumer protection laws.

Obviously, this issue is very near to my heart as we had to fight Pfizer’s attempt to use this same argument in my case, Witczak v. Pfizer, in US District Court. Fortunately, Chief Justice James Rosenbaum saw through this argument and ruled against Pfizer.

Honestly before my husband’s death, I never really gave much thought to lawsuits and consumer’s right to hold a company legally accountable. However, this has all changed and every consumer should be concerned about federal pre-emption in these types of cases. Federal pre-emption is the ability of the federal government (federal laws) to overrule state and local regulations.

Personal injury/wrongful death/failure-to-warn lawsuits against drug makers provide justice for patients and keep pharmaceutical companies accountable for the drugs they produce as well as call attention to undisclosed side effects that would otherwise remain unknown. It was through our lawsuit against Pfizer, we were able to get confidential drug company and FDA documents made public that Pfizer knew about the suicide risk since the late 1980s.

This fall the US Supreme court is going to be taking up federal pre-emption in another drug product liability case (Levine v. Wyeth).

If federal pre-emption prevails and Supreme Court sides with the drug industry, it will take away our right to hold drug companies accountable for injury or even death caused by their product. We will no longer be able to seek retribution in court. We will be deprived a vital tool for policing drug companies and unearthing internal company documents showing they misled the public.

Drug companies would be given a free pass. It’s unimaginable to think that they couldn’t be sued because the drug and its label were approved by the FDA, the presumed authority on drug safety even if the company misled the FDA. The FDA can not fully monitor the safety of every drug on the market. They are understaffed and underfunded. Even if the FDA wanted to get inside the drug company files, they do not have the authority. If a company buries important information deep in the bowels of a report, the FDA may not detect it or even appreciate its significance like the company would.

Without the threat of lawsuits, how do you hold pharmaceutical companies responsible for problems with their drugs, motivating them to test their products rigorously even after they are on the market or come clean when they learn of a potential safety issue — like Vioxx, Avandia, and others?

Injured patients should not lose the right to sue if they are harmed by deceitful manufacturers. This is clearly a patients right issue and not about trial lawyers like the drug industry is portraying it.


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1 comment

    • Kerry OConnell on August 20, 2008 at 12:17 pm

    The manufacturors,the FDa, and The Bush Administration always frames adverse drug problems as a risk/benefit issue. As long as a few more people are helped than harmed they support the manufacturors. But what is an acceptable number of deaths? Even Soloman in all his wisdom can’t answer that question? To victims and their families even one death is unacceptable while some people with dire conditions would still take the drug even knowing that their chances of harm are very high. The debate needs to get out of clinical and legal processes and focus on the simple moral issue that it really is. Inventors and manufactors of drugs and medical devices make hundreds of millions of dollars fropm those people that they help it is only right that a portion of those profits get used to help those people who are harmed.

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