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Preventable Adverse Drug Reactions

Over 2 MILLION serious ADRs yearly

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ADR rate 350,000 yearly

Institute of Medicine, National Academy Press, 2000

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

Article by: JESSE J. HOLLAND , Associated Press | Updated: March 19, 2013 2:10 PM

WASHINGTON - The Supreme Court seemed skeptical Tuesday of allowing generic drug manufacturers to be sued in state court for a drug's design defects if federal officials approved the brand-name version the generic drug copied.

The justices heard arguments from generic manufacturer Mutual Pharmaceutical Co, Inc., which wants a $21 million judgment dismissed. A New Hampshire jury gave that to Karen L. Bartlett after she took sulindac, the generic form of the drug Clinoril, in 2004. It caused her outer skin layer to deteriorate and burn off, leaving at least 60 percent of her body as an open wound. She is also now legally blind.

The federal appeals courts upheld her verdict, but the company wants the Supreme Court to overturn it.

Justices ruled in 2011 that makers of generic drugs cannot be sued for failing to warn consumers of the possible side effects of their products if they copy the exact warnings on the brand-name equivalents of the medicines as required by federal law. Mutual and the Obama administration want that protection extended to the design of the drug, since the generic is an exact copy of the brand-name drug that has already been approved by the federal government.

To allow Bartlett's verdict to stand would cause a conflict between state liability law and federal law requiring the two drugs to be the same, Mutual lawyer Jay P. Lefkowitz said.

"Federal law required generic sulindac to have the same ingredients, the same warning and the same safety profile as the branded version, but a New Hampshire jury imposed liability because sulindac didn't have a different safety profile, meaning a different ingredient or a different warning," he said.

The Food and Drug Administration approved sulindac in 1978, and Mutual got approval to sell its generic in 1991 after the FDA said it was "safe and effective for use." A warning that the side effects that Bartlett suffered was associated with the drug was added in 2002, and updated in 2006 to specifically refer to toxic epidermal necrolysis, a form of Steven-Johnson Syndrome or SJS/TEN.

Supreme Court ponders whether to allow generic drug makers to be sued over drug design

"What we are trying to do is preserve the FDA's role here, not have juries second-guess on a case-by-case and state-by-state basis imposing different safety obligations on manufacturers when Congress has established a regime for FDA to control this," said Anthony Yang of the solicitor general's office.

David C. Frederick, Bartlett's lawyer, argued that New Hampshire didn't require Mutual to change sulindac, just compensate Bartlett for her injuries. "All New Hampshire is imposing here is a duty to pay compensation if your unreasonably dangerous product harms a patient," he said.

But the jury "didn't say that yes, you can market this drug, it benefits, you know, 99.9 percent of the people but there is that 0.1 percent, and you're going to have to compensate that person," Chief Justice John Roberts said. "They said the risks outweigh the benefits, period. So you should not market this at all. And it does seem inconsistent with the federal regime."

A jury somewhere could rule that chemotherapy couldn't be used anymore because one person somewhere was horribly injured, said Justice Stephen Breyer, which is why he said he thought the FDA should be in charge instead of juries. "What I do in my mind is I say, beware, because it's also true potentially of some of these life-saving drugs and that's what's worrying me," Breyer said.

A win for Mutual would give carte blanche to drugmakers in state court because any state law that would force them to change the drug's composition would conflict with federal law, Frederick argued. "And so that applies to brand name drugs as well as generic drugs," he said. "We don't see a principal difference, unfortunately, to distinguish them."

Sulindac is still on the market, he added. Justice Ruth Bader Ginsburg said that in 2005, Mutual said the drug only produced $7 million. "If they are only making $7 million, they ought to withdraw from the market, because their product causes such horrific injuries it ought not to be sold," Frederick said.

The court will rule later this year.

The case is Mutual Pharmaceutical Co. v Bartlett, 12-142.


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Motrin can cause SJS & TEN, which can cause blindness, kidney failure, and death. What McNeil & J&J Have Never Told Parents.

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