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Clinical drug trials are triggering an increasing number of lawsuits, ranging from wrongful death claims to the right to continue receiving drugs, according to attorneys on both sides of the litigation. Also, plaintiffs have expanded their targets to include just about anyone associated with a clinical trial: doctors, universities, research institutions, drug companies, clinical trial review boards-even patent holders of certain medical devices. And it’s a big target to start with: There are about 50,000 clinical trials currently under way in the United States, mainly used to test experimental drugs and medical devices. “I’m getting more and more calls from clients about it,” said Nancy Sher Cohen, a shareholder in the Los Angeles office of Heller Ehrman who has resolved a number of clinical trial lawsuits on behalf of biotech companies in the last year. “It’s become a much more fertile area than it was two to three years ago.” Some believe that public mistrust of the medical community is driving the litigation. “For many years there weren’t a lot of challenges to clinical trials. They were seen as truly good, as kind of mom-and-pop-and-apple-pie, and that scientists were here to help people . . . but people don’t see the truly good anymore,” said Jan Murray, partner in the Cleveland office of Squire, Sanders & Dempsey, who counsels more than a dozen biotechnology drug sponsors and clinical trial sites like hospitals. “[The public is] questioning the motives of the pharmaceutical companies. And they’re questioning if the FDA is seeking to protect the companies.” Mark Gately, a partner in the Baltimore office of Washington-based Hogan & Hartson, said that in the last four months alone he’s handled three major clinical trial lawsuits on behalf of Thousands Oaks, Calif.-based Amgen Inc., a biotech company that was sued over a Parkinson’s drug experiment and a blood-disorder drug. “I’m starting to feel like I know more about clinical studies than anything else,” Gately said. “I think this is just the tip of the iceberg. “I think you’re going to get patients coming in like this: ‘We don’t care what the risk of the drug is, we’ll take a chance.’ And then you’ll get the other side saying, ‘You should have stopped this earlier,’ ” Gately added. ‘Mere guinea pigs?’ Most recently, Amgen sparked national attention in the medical community when it won two back-to-back drug lawsuits in Kentucky and New York involving an experimental drug for Parkinson’s disease. In a twist from the typical clinical trial lawsuits-where patients sue because something goes wrong-the plaintiffs in these cases sued because they were denied continued access to an experimental drug they felt was beneficial.
Avoiding a lawsuit In the course of a year, attorney Natasha Leskovsek, a Food and Drug Administration specialist at Heller Ehrman, counsels more than 100 pharmaceutical companies on how to to avoid getting sued. In particular, she aims to help them establish solid consent forms that companies hope will be lawsuit-proof.It’s these consent forms, she noted, that often get researchers and drug companies into trouble.”The most basic rule of the consent form is it has to be written at a fifth-grade level. You have to think about the ordinary patient you’re trying to recruit to your study,” said Leskovsek, noting that none of her clients has thus far been sued, but they’re constantly on guard for it.Attorney John Serio, senior counsel to Brown Rudnick Berlack Israels of Boston, also advises the clinical research community on regulatory matters. He represents both drug companies and medical-device companies, both of which, he said, have been put on guard by the plaintiffs’ bar.Like Leskovsek, Serio believes a concrete consent form will help keep companies out of legal trouble. He offers four tips to establishing a strong informed consent document:

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