Keith Jensen obtained the largest verdict in NH history and that case is before the U.S. Supreme Court

Kimberly Atkins | Lawyers USA | March 20, 2013

WASHINGTON – Deciding where the preemptive effect of federal rules governing drug manufacturing ends and states’ ability to impose liability on drug makers begins has never been an easy task — not even for the justices of the U.S. Supreme Court.
On Tuesday, the justices wrangled once again over the preemptive reach of the federal Food, Drug and Cosmetic Act in an effort to decide whether the law prevents design defect claims against generic drug manufacturers.
The case, Mutual Pharmaceutical Co. v. Bartlett, gives the justices a chance to draw a line between two previous rulings: the 2009 holding in Wyeth v. Levine that state-law failure-to-warn drug claims are not automatically preempted by federal law; and the 2011 ruling in PLIVA Inc. v. Mensing that federal regulations governing generic drugs directly conflict with, and thus preempt, those claims.
Attorneys representing plaintiffs say that design defect suits play an important role in regulating drug manufacturers to ensure that products are safe and that victims are compensated when drugs are dangerous.
“Drug suits are complementary to the FDA’s mission in making drugs safe and effective,” said Keith M. Jensen, of Jensen Associates in Fort Worth, Texas, who has represented plaintiff Karen L. Bartlett since the trial level.
But tort defense attorneys say that design defect claims against generic drug makers, which have been on the rise since the court handed down Mensing, should be preempted just as failure-to-warn cases are. It’s up to the Food and Drug Administration, not members of juries, to decide whether a drug is safe to market, they say. As cases like this one demonstrate, they argue, it is impossible to comply with both, so federal law trumps.
“These claims are definitely an attempt to find a way around Mensing,” said James M. Beck, counsel in the Philadelphia office of Reed Smith.
And plaintiffs may be a tougher sell this time around. Unlike in Mensing, when the Justice Department backed the patient as amicus, in Bartlett it is backing the drug company — a move that confounds Jensen.
“The FDA commissioner last week said that the FDA cannot ensure safety,” Jensen said, referring to a speech Commissioner Margaret Hamburg gave in Boston warning of the effect of the federal budget sequester on the agency. “This week they are arguing they are the sole arbiter of that.”
Identical drug, competing standards?
Federal law requires that the design and labeling of generic drugs be materially identical to that of their brand name counterparts. Bartlett, who developed a degenerative skin disease after being given the generic version of the pain reliever Clinoril called sulindac, argues that she should be able to bring drug design defect claims.