Many of us were somewhat surprised when in 2009 the United States Supreme Court upheld the jury’s determination in Wyeth v. Levine. In the Levine case, the Court determined that the Hatch-Waxman Act amending the Food, Drug and Cosmetic Act did not establish complete immunity for pharmaceutical manufacturers. The Court correctly ruled that Wyeth was responsible for providing adequate warnings for its drugs even if that meant Wyeth had to provide warnings stronger than the FDA required.

Then, just last year the High Court spoke again in PLIVA v. Mensing. This time the Court explained that manufacturers of generic drugs are required to use the same labels as their brand name equivalents. Therefore, the Court said that generics cannot be held responsible for failing to warn consumers about the dangers of their products. As the First Circuit Court of Appeals pointed out last month in Bartlett v. Mutual Pharmaceutical Co., this logic leads to the inequitable result of consumers who purchase name brand drugs being compensated when pharmaceutical companies fail to warn of a drug’s dangers, while consumers who purchase generic drugs are denied any recovery for the company’s failure to warn.

In an example of bad logic leading to more bad logic, the First Circuit, being bound by Mensing, held that the consumer could not recover against a generic manufacturer for failure to warn. The Court explained that Mensing did not address the Plaintiff’s design defect theory of liability. The manufacturer argued that legally it could not alter the design of the drug. If it did the drug would not be a generic. Instead, it would be a new drug, requiring FDA approval. It also argued the drug consisted of a single active molecule and therefore was impossible to alter. The First Circuit ruled that the manufacturer could alter the drug by refusing to produce it all together because its benefits were outweighed by its risks. Under this reasoning, while a generic manufacturer cannot be held liable for failing to warn about known dangers of a drug, it can be held liable if the Plaintiff proves that the risk of the drug is greater than its utility.

Senator Patrick Leahy has introduced legislation in the U.S. Senate to require generic manufacturers to update their labels to reflect known risks of their drugs. Considering the current climate on Capitol Hill, it is doubtful that such a logical bill will ever even be brought up for a vote. It will, however, provide a litmus test to determine which of our elected officials place Big Pharma’s interests above the interests of those citizens who actually have the right to vote. That’s why it is important to contact your Senators. Ask them to get Sen. Leahy’s bill out of committee and get it to the Senate floor for a vote. If you need more information, contact Russ Abney, a lawyer in our firm, at 800-898-2034 or by email at Russ.Abney@beasleyallen.com.