Generic Makers Enjoy Wide-Spread Immunity One Year After Supreme Court Ruling
Consumers have no day in court simply because they took generics
Washington, DC—Carrie Scott went in to the hospital for abnormal bleeding. Days later she returned home without her hand and forearm. The generic form of Phenergan was given improperly, apparently from an inadequate warning label. Scott has no legal recourse because a generic drug caused her injury, rather than its brand-name equivalent.
Saturday marks the one-year anniversary of the U.S. Supreme Court decision that generic manufacturers are not responsible to update warning labels, even when they learn of new safety issues associated with the drugs.
In the case, Pliva v. Mensing, the Court held that Gladys Mensing could not hold the manufacturer of metoclopramide, the generic equivalent of Reglan, responsible when she developed tardive dyskinesia. The disorder is a neurological movement disorder that is an adverse effect of the drug. In 2009, the U.S. Food and Drug Administration (FDA) ordered all manufacturers of Reglan to update their label with a warning of tardive dyskinesia.
“One year after Mensing, we are just beginning to see the real-life implications of the Supreme Court’s decision,” said American Association for Justice (AAJ) president Gary M. Paul. “While brand manufacturers can be held accountable for the safety of their drugs, generic makers continue to get a free pass, like they did in Carrie Scott’s case.”
Scott’s case is ironic. In 2008, a woman facing nearly the same set of circumstances named Diana Levine won a landmark U.S. Supreme Court case. The Court ruled the maker of Phenergan failed to properly warn about properly administering the drug in Wyeth v. Levine. Levine won a multi-million dollar settlement against the brand manufacturer, while Scott is subject to last year’s Mensing decision that awarded her nothing.
“With the expanding generic drug market, it is essential all manufacturers—brand and generic—are held fully responsible for their drugs’ safety,” added Mr. Paul.
One year after Mensing, the case has enormous implications for Americans, since more than 75 percent of all prescriptions in the U.S. are filled with generic drugs.
Senator Patrick Leahy (D-VT) and six co-sponsors introduced the “Patient Safety and Generic Labeling Improvement Act of 2012” (S. 2295), amending FDA regulations to allow manufacturers of generic drugs to initiate labeling updates. A companion bill was introduced in the U.S. House of Representatives (H.R. 4384).
This bill would allow generic manufacturers to initiate changes to their labels to reflect current health and safety information under the same circumstances that apply to manufacturers of branded drugs; ensuring brand and generic manufacturers have the same responsibility to adequately warn the public of their drugs’ risks.
Public Citizen filed a citizen petition with the FDA addressing the Mensing decision. AAJ filed comments in support of this petition earlier this year.
For more information and to see a list of the cases that have been dismissed as a result of the Mensing decision please visit www.justice.org/courts.