News & Resources
Legislation Introduced to Challenge Pliva v. Mensing Ruling on Generic Drugs
The U.S. Supreme Court ruling in June of 2011 in the case of Pliva v. Mensing had devastating consequences for a vast number of consumers injured by generic drugs. As a result of the ruling, consumers are not able to sue generic drug manufacturers for complications or side effects that are not listed on the label, even though manufacturers of brand-name drugs are still liable for similar claims. The Pliva Court held that since generic drug labels must be identical to the brand name label, generic manufactures could not be liable for failure to warn. The Pliva decision deviated from the Supreme Court’s ruling in Wyeth v. Levine where the Court held brand name drug manufacturers may be held liable for failure to warn if the label’s warnings are inadequate.
Recently, in response to the fears about Pliva’s effect on consumer safety, Sen. Leahy (D-Vt.) has proposed the Patient Safety and Generic Labeling Improvement Act. The bill permits generic drug manufacturers to change their labels in the same manner as brand name drug manufacturers, so that they would also be liable for failure to warn if labeling issues arose. Sen. Leahy has stated the bill promotes accountability and ensures generic drug manufacturers take steps to enhance their warnings to physicians and patients. The bill addresses what Sen. Leahy calls a “troubling inconsistency” in letting Plaintiffs sue brand-name drug manufacturers while not being able to hold their generic counterparts liable. Obviously, generic drug manufacturers oppose this new legislation.
Since the Pliva ruling last Summer, an untold number of lawsuits for citizens injured by generic drugs have been dismissed by courts all over the United States. Patients should not be barred from seeking legal recourse just because they took the generic version of the drug and not the brand name. A legislative solution, similar to the bill proposed by Sen. Leahy, is necessary to provide patients with adequate protection from faulty generic drug labeling.