All Things in Moderation

Something I’ve been keeping an eye on is the effects of the SCOTUS ruling in PLIVA v. Mensing, limiting liability of generic drug makers for side effects of the drug that are not included on the warning label from the brand-name drugs.

A couple of links.

First:

In the wake of Mensing, state courts in Pennsylvania, California, and New Jersey have been considering what to do with thousands of suits by metoclopramide users who claim they weren’t warned about the long-term risks of developing a neurological disorder. (The cases were mostly filed in state courts after the Judicial Panel on Multidistrict Litigation denied a bid to consolidate the metoclopramide litigation at a federal level.) What’s notable is that judges in those states have taken markedly different approaches to their metoclopramide dockets: In Philadelphia and San Francisco, judges have allowed thousands of personal-injury suits against the generics to move forward despite Mensing. But on Friday Superior Court Judge Carol Higbee in Atlantic City, New Jersey, ruled that generics are largely off the hook in her court.

Alison Frankel at Thomson Reuters. In addition to the Higbee decision, there was another case in NJ (in re Fosamax)

A likely case for eventual SCOTUS review, to reconcile the decisions in PLIVA v. Mensing and Wyeth v. Levine, which provided for damages to plaintiffs who suffered side effects from brand-name drugs.

On Wednesday, the Court of Appeals for the First Circuit upheld a $21 million verdict awarded to a woman who suffered grievous injuries as a result of taking a generic pain medication prescribed by her doctor. In its appeal to the First Circuit, the generic drug manufacturer, Mutual Pharmaceutical Company, argued that the design defect claims were preempted by the Hatch-Waxman Amendments to the Federal, Drug, and Cosmestic Act (“FDCA”) under the Supreme Court’s 2011 decision PLIVA v. Mensing.

Bartlett v. Mutual

A NYT article about people suffering from side effects of the generics. Included in the article is a mention of a Public Citizen petition of the FDA to allow generics to use the Changes Being Effected process to change their warning labels. The FDA has apparently postponed their decision on this petition.

And Sen. Leahy has introduced a bill to address the PLIVA/Levine discrepancy. The bill is here with its House counterpart, introduced by Rep. Van Hollen here.

Filed under: regulations, Supreme Court | Tagged: generics, pharmaceutical, PLIVA | 25 Comments »