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Inadequate Drug Warnings: Two Classes of Consumers

In Pliva v. Mensing, the U.S. Supreme Court deter­mined that patients injured or killed by dangerous generic drugs have no legal recourse in those situa­tions where the manufac­turer failed to warn consumers about dangerous side effects. This is in stark contrast to consumers injured or killed by name brand drugs with inade­quate warnings, who still have the right to seek compen­sation in the courts. This New York Times article explains the case, and how the ruling essen­tially created two classes of consumers: those entitled to legal recourse through the court system and those who have none.

Defective Drugs and Devices: Legal Remedies Still Available

The Supreme Court’s ruling in Pliva (generic drugs) dealt with lawsuits that alleged manufac­turers failed to provide adequate warnings about drugs. Patients injured by drugs, whether brand name or generic, that were defec­tively manufac­tured or produced still have the right to seek compen­sation in the courts because preemption does not apply to these types of cases. Also, in some situa­tions a patient’s injury or death after taking a drug occurs not because the drug itself was defective, but because the decision to prescribe the drug was negligent; in those instances, patients have the right to seek compen­sation in courts in medical malpractice lawsuits.

Finally, there are also instances when patients are harmed not by drugs, but by defective medical devices such as implantable defib­ril­lators, pain pumps, hip implants, and surgical mesh. In such cases, people can pursue compen­sation in the courts for defective medical devices, although there are some limita­tions to the kinds of medical device cases that can be pursued.

Potential Steps to Protect Consumers

Responding to this inade­quate warning discrepancy, the consumer advocacy group, Public Citizen, filed a petition with the FDA calling for a regulation change that would force generic manufac­turers to update their labels when new potential dangers become known. If passed, the rule change would provide a means to hold generic manufac­turers accountable to consumers when they fail to warn about new dangers. Consumers would be able to seek justice in court. Filed in August 2011 after the Supreme Court’s ruling in Pliva v. Mensing, the petition is being considered by the FDA; however, whether a new regulation is adopted will ultimately be deter­mined by the presi­dential election in November. The Obama Admin­is­tration has done away with many federal regulatory roadblocks to recovery by injured consumers, and, if the Admin­is­tration continues in office, it increases the likelihood of a pro-consumer reversal of the odd generic drug warning result in Pliva.

In another effort to address the discrepancy created by Pliva v. Mensing, Sen. Patrick Leahy (D-VT) intro­duced the Patient Safety and Generic Labeling Improvement Act, a bill with the express purpose of giving victims of defective generics the same rights to compen­sation as those enjoyed by the victims of defective name brands. Describing the proposed legis­lation, Sen. Leahy stated it “will promote consumer safety by ensuring that generic drug companies can improve the warning infor­mation for their products in the same way that brand manufac­turers can under existing law.” Intro­duced in April, the bill remains pending in the Senate Judiciary Committee with no action expected until after the election.

What It Means for Consumers

Given the status of the proposed rule change and legis­lation, the only way for patients to protect their right to recover for injury or death because of inade­quate warnings on FDA approved drugs is to insist that physi­cians write prescrip­tions for name brand drugs only. While doing this may result in a patient’s health insurance company refusing to pay for a prescription, it is only by refusing to accept generics that patients can ensure that they will have any legal rights if they are injured by dangerous drugs with inade­quate warnings.