Wednesday, March 27, 2013

Supreme Court hears key case on generic drug-maker's liability.

The Supreme Court heard arguments on Tuesday in a closely watched case that could decide the legal liability of generic drug manufacturers for drug design flaws even though the company did not actually design the drug. Print and broadcast coverage of the arguments was substantial, with more than four-and-a-half minutes of coverage on the network newscasts.
        ABC World News (3/19, story 4, 1:50, Sawyer, 7.43M) reported, "We learned today that for the first time in half a century, Americans are spending less on prescription drugs. A small drop due in part to have the switch away from brand names toward cheaper generic pills. Tonight, more than 80% of all prescriptions are generic drugs. But one patient has taken her story all the way to the Supreme Court."
        The CBS Evening News (3/19, story 7, 2:45, Schieffer, 5.58M) recounted the story behind the case, noting that in 2004 Karen Bartlett, "suffering shoulder pain, took an anti-inflammatory drug known by its generic name as Sulindac and suffered a reaction so severe her life, as she knew it, was over," and " legally blind and needs near constant assistance." CBS added, "Bartlett sued the manufacturer of the generic drug, Mutual Pharmaceutical, and a jury awarded her $21 million." However, "at the Supreme Court...the company's lawyer, Jay Lefkowitz, argued it can't be held responsible since by law it was merely copying a brand name drug." The Washington Post (3/19, Barnes, 489K) quotes Lefkowitz as saying, "Federa; law required generic sulindac to have the same ingredients, the same warning and the same safety profile as the branded version."
        In fact, the AP (3/20, Holland) reports, the court "seemed skeptical" 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 AP continues,"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," Lefkowitz said. "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."
        The Los Angeles Times (3/20, Savage, 692K) reports that Justices Antonin Scalia and Stephen Breyer "questioned whether juries of ordinary citizens are qualified to decide whether a drug's benefits outweigh its risks. A lawyer for the drug maker and one for the Obama administration urged the court to throw out the verdict and rule that juries cannot decide an approved drug is too dangerous to be on the market. But Justices Sonia Sotomayor and Elena Kagan appeared to disagree," suggesting "the FDA's approval of a drug meant only that it could be sold," but "did not necessarily prevent a jury from finding it was unreasonably dangerous."
        The Wall Street Journal (3/20, Bravin, Subscription Publication, 2.29M) reports that previous court rulings have held that brand-name drug maker may be sued under state law for failing to provide adequate warning labels, but that in 2011, the court carved out an exception for generic drug makers because they are required to provide the same labels the FDA approves for branded versions of the drug. The Journal notes that some justices' questions suggested concern about denying Bartlett any remedy for her injuries.

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