Posted on March 4, 2009 by LaBovick Law

Supreme Court rejects Pharma giant Wyeth's FDA pre-emption claims in Wyeth v. Levine

Interesting turn of events today in the U.S. Supreme Court.  The Supreme Court issued a decision  regarding pre-emption in  the Wyeth v. Levine, product liability case. This was an overwhelming victory for Americans. The 6-3 decision explicitly upheld the ruling that FDA  approvals do not provide a defense to pharmaceutical manufacturer Wyeth in product liability tort claims, in the Wyeth v. Levine, No. 06-1249 (slip op., 03/04/09).

According to the 80 page decision that was delivered by Justice Stevens,

Directly injecting the drug Phenergan into a patient’vein creates a significant risk of catastrophic consequences-quences. A Vermont jury found that petitioner Wyeth, the manufacturer of the drug, had failed to provide an Adequate-quate warning of that risk and awarded damages to re-spondent Diana Levine to compensate her for the amputation of her arm. The warnings on Phenergan’s label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth’s new drug application in 1955 and when it later approved changes in the drug’s labeling .The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not.

The majority decision, authored by Justice Stevens, unequivocally rejected the pharmaceutical defendant’s arguments that the FDA regulatory scheme preempted state law failure-to-warn claims and outlined the real world limitations of FDA powers. This decision will have implications in pharmaceutical product liability claims for decades to come. Also joining Justice Stevens were Supreme Kennedy, Sorter, Ginsberg, Beyer, and Thomas. It was not surprising that the three dissenters included, Chief Justice Roberts, Ali to and Scalar. 

It is important to note that this Br yer and Thomas clarified their vote by also writing an opinion in addition to Justice Stevens.  This solidified their strong belief in their sentiments that manufacturers can't hide behind the FDA approval and not be vigilant in issuing necessary warnings and safety precautions. The Supreme Court held: (1) the FDA’s regulatory scheme exists in harmony with state law failure-to-warn claims; (2) the controversial 2006 FDA preamble regarding preemption is entitled to no deference; and (3) it is the manufacturer, not the FDA, which has the duty to warn consumers about side effects. As the Supreme Court reasoned, “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.” (Slip op., at 23.)

One does not have wonder too long as to whose side C.J. Roberts and Alito are  on after reading the dissenting opinion.  Alito states in his dissenting opinion that :

This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs. That result cannot be reconciled with Geier v. American Honda Motor Co., 529 U. S. 861 (2000), or general principles of conflict pre-emption.

Alito goes on to pose the hypothetical question:  "is it the FDA or a jury in Vermont— that has the authority and responsibility for determining the “adequacy” of Phenergan’s warnings?"

There is so much to discuss in this 80 page decision.   Over the next few days we will go into the decision more on this blog, to highlight more important points in this opinion. As Civil Justice Prosecutors, we are pleased with the Court's decision in Wyeth v. Levine.

 
Tags: , , , ,
Posted on November 8, 2008 by LaBovick Law

Big Pharma, FDA and Preemption: Who should be held liable?

The Supreme Court Case, Wyeth v. Levine  (06-1249), the Supreme Court Justices are sharply divided over whether FDA regulations of labeling can prevent consumers from suing. Wyeth and the FDA presented the case before the Supreme Court involving Diana Levine, an amputee, whose bodily injury resulted from the use of the drug, Phenergan.

The debate among Supreme Court Justices is in the matter of whether consumers have the right to sue drug companies when the FDA has approved a drug for use. The strength of the argument presented by Levine's lawyers is that Wyeth is attempting to use FDA labeling to deny her a Consumer’s right to hold a Pharma company liable.

This is not the first case of involving a Pharma company being sued for harmful and deadly side effects of their drugs. A few notable instances include, Glaxo for their drugs Paxil and Avandia, Purdue Pharma for Oxycontin, Merck & Co. for Vioxx. In some cases, deficient research led to serious risks that was overlooked. In others, misleading advertising that omitted possible risks was the basis of these lawsuits.

The issue of FDA labeling as insurance to preempt lawsuits by consumers is an important aspect of the Wyeth v. Levine case. The issue of preemption is supported by the current Bush Administration in its attempts to reduce lawsuits by consumers against drug companies. Pharmaceutical companies argue that stiffer regulations and standards inhibit their research of newer, more effective drugs.

In the Levine case, Wyeth's argument reduces the lawsuit to a simple case of medical malpractice. Surprisingly, the FDA stands with Wyeth in the argument. The Federal Agency that is supposed to be on the side of Consumers, feels that once the FDA approved the drug for use, extraordinary risks that may appear as a result of use at some later point should not be a consideration for lawsuits against drug companies that have received FDA approval and are labeled as such. This begs the question: Who should be liable and held accountable if the FDA and the pharmaceutical maker fails to catch something in trials or overlooks a deadly side effects, because of the rush to get a drug on the market?

Another valid point of the argument by Levine’s lawyers is that Wyeth did not advise physicians or consumers of the danger of using the "push" method of injection of Phenergan. It is safe to say, that maybe more people would have had second thoughts about using this drug, if they would have known about the additional dangers. Moreover, in another case, Pfizer's anti-nausea drug, Vistrol, caused gangrene when injected into the arteries and Wyeth should therefore have requested an FDA to change the label warning of this on their Phenergan label.

The State of Vermont awarded Levine $6.8 million. In preemption arguments, federal law supersedes state law. Justices Scalia, Alito and Roberts argued in favor of Wyeth while Bader-Ginsberg argued in favor of Levine.

It would be simple to view Wyeth's position as one of preemption vs. adequacy of disclosure. Ultimately, the Supreme Court must address the potential for future lawsuits of this nature. They must also address the issue of what happens if the drug company gives the FDA false or misleading information about a drug that later proves to be harmful to consumers. Consumer advocates everywhere are following this case closely. Let’s see if the Supreme Court can do the right thing and tell Wyeth and the FDA that they do not get a free pass in this case. They are responsible for the safety of drugs that are put on the market, even if the FDA gives the drug a stamp of approval.

Jacob Goldstein, Writer and Blogger for the WSJ Health Blog, shares a few insightful comments from Diana Levine in his blog post "Wyeth v. Levine: The Mother of All Preemption Cases". He also includes a nice candid photo of the woman who Wyeth is going after for fighting for her rights to hold them accountable for taking their migraine drug that caused her to have her arm amputated. All eyes are on the Supreme Court regarding the decision of this case.  Let's see if they can get it right and hold the Pharmaceutical companies liable for unreported risks and dangers associated with their drugs.
 

Tags: , , , , , , , , , , , , , ,