Pliva v. Mensing

In PLIVA, Inc., the Court’s 5-4 conservative majority immunized generic drug manufacturers, whose drugs comprise 75 percent of the market, from state tort liability when their labels inadequately warn consumers of health risks.

Brand name drug manufacturers have the ability and the duty to change warning labels based on newly-discovered risks without consulting the Food and Drug Administration, but generic drug manufacturers need only copy brand name warnings. The Court concluded that it was impossible for generic-drug makers to meet both the federal requirement that they copy brand name labels, and state law duties to provide adequate warnings, and therefore gave no effect to FDA’s position that the generic drug makers should have taken steps to warn the agency of problems with the generic version of the drug Reglan. The majority acknowledged that, from the perspective of plaintiffs, its ruling “makes little sense” because brand name drug manufacturers can be held liable while generic drug manufacturers cannot.

This decision has already had broad effects, resulting in the dismissal of scores of lawsuits brought by injured individuals…not to mention those cases that were never brought because attorneys accurately assessed that in the wake of PLIVA v. Mensing, their would-be clients have no chance for justice.

UPDATE, MARCH 2013: We are deeply saddened to report that early in 2013, a few months after her ninth surgery, Camille Baruch, who is featured in this portion of the documentary, and pictured below, died.  The cause of death is not yet known, but her mother notes that Camille’s immune system was compromised by the drugs she had to take as a result of the illnesses described in the video.  Ms. Baruch was 19.

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