U.S. Supreme Court Now Considering Protecting Drug Manufacturers From Lawsuits

Following up on our blog “U.S. Supreme Court Deals Blow to Lawsuits Against Defective Products“, the Court heard arguments on February 25 in Warner-Lambert v. Kent, to determine whether drug manufacturers should receive similar protection from lawsuits that the Court handed out to medical device makers earlier in February. Judge Breyer, normally one of the Court’s most liberal justices, gave a strong indication that the Court is heading in the direction of protecting drug makers when he stated: “Who should make the decisions that will determine whether a drug is on balance, going to save people or, on balance, going to hurt people?… An expert agency, [The Food and Drug Administration] on the one hand or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them.”

Seemingly forgetting about the thousands of injured victims of Vioxx, for example, who used a dangerous drug which had been approved by the F.D.A. and nevertheless suffered numerous deaths, heart attacks, and other complications, and without question needed the courts to redress their grievances, it appears that the Supreme Court is now ready to bar lawsuits against drug makers.

The Warner-Lambert case involves 27 Michigan plaintiffs who claim that they were injured as a result of taking a Warner-Lambert diabetes pill, Rezulin, which has since been removed from the market. The plaintiffs claim that the company did not disclose evidence of Rezulin’s risks of liver damage to the F.D.A., which likely would have led the agency to deny approval of the drug. In Michigan, a statute bars personal injury lawsuits against drug makers unless injured patients can show that the manufacturer deliberately withheld information from the F.D.A. that would have caused the government to block the sale of the drug.

Prior to the the Bush administration, the F.D.A. always held the position that lawsuits provided patients with additional protection besides the agency’s scrutiny. Now, in the clearly pro-business 7 years since George Bush appointed the members of this critical governmental body, the administration states that lawsuits conflict with the agency’s ability to do its job, and several justices of the Supreme Court apparently agree. We will keep our readers apprised of developments in this vital case in the era of weakened consumer protection.