Senator Patrick Leahy (D-Vt.) with Senators Al Franken (D-Minn.), Jeff Bingaman (D-N.M.), Sheldon Whitehouse (D-R.I.), Sherrod Brown (D-Ohio), Christopher Coons (D-Del.) and Richard Blumenthal (D-Conn.), introduced legislation Wednesday to address the recent Supreme Court decision (Mensing v. PLIVA, Inc.) that threatens to undermine the safety of consumers taking generic drugs. ClassLawBlog previously outlined the Mensing decision and the unfairness it poses to consumers in the market. The end result is that while consumers of brand drugs have rights in court against the manufacturers who cause them harm, consumers of generic drugs do not. The discrepancy is further exacerbated by the fact that many health plans will only cover generic drugs and nearly 80% of the drugs on the market are generics. The Patient Safety and Generic Labeling Improvement Act introduced Wednesday will address this discrepancy and reverse the effects of the Mensing decision.
The Senators all stressed the importance of this new bill: “Right now generic drug manufacturers are prohibited from updating their labels to accurately reflect all of the side effects or risks associated with their drugs,” said co-sponsor Sen. Franken. “ “While essential to the treatment of many illnesses, prescription drugs can pose risks and have health-threatening side effects. For this reason, prescription drug warning labeling is an important part of ensuring consumer safety,” Bingaman said. “By giving generic drug manufactures the ability to update their labeling, this bill will help individuals make an informed decision about the medications they take.” “Consumers of generic prescription drugs should have the same rights as those who are prescribed brand-name drugs,” said Whitehouse. “This legislation would ensure that generics and brand-names are held to the same labeling standards, which is critical given that approximately 75 percent of prescriptions filled in theU.S.are generics.” Brown said.
“According to the Supreme Court’s decision last year in Mensing, however, federal law actually prevents generics from warning customers when they discover a new risk. I applaud Chairman Leahy for his work in drafting legislation that will fix this, keeping generic medicines safe, effective, and a key component of affordable health care.” Coons said. “Generic drug manufacturers must clearly warn patients of known possible life threatening drug side effects – and be held accountable when they fail.” said Blumenthal.
Disgruntled litigators have begun to fight back. Debbie Schork gave an extensive interview to the New York Times and compared her amputation caused by the generic promethazine with Diana Levine’s amputation by the branded version of the same drug, Phenegran. Ms. Schork was thrown out of court while the Supreme Court upheld Ms. Levine’s claims. Roberta Dunn’s husband was killed by taking propoxyphene, a generic form of Darvon or Darvocet. When her wrongful death suit was thrown out of court, she wrote a letter to the presiding Judge and copied it on President Obama and the National Association of Insurance Commissioners.
