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Clinical Trial Injuries
The plaintiff's bar has discovered an opportunity in clinical research. The deep pockets of pharmaceutical companies provide one attraction, but attorneys are seldom shy about suing anyone who might even remotely be found liable for an injury. Successful litigation is rare, but the judgments can be expensive. Because of this, many physicians who conduct clinical research are reviewing their medical malpractice insurance policies. Many others, however, have no concept of the looming risks and of whether they are protected by their medical malpractice insurance policies when taking part in clinical trials.
What Does Your Insurance Cover?
The courts (for example, Heinrich v. Sweet, 62F. Supp.2d 282, 313 (D.Mass. 1999)) generally regard clinical research injuries as regular medical injuries, but medical malpractice policies are often ambiguous on the topic of clinical research. They may refer to coverage for “medical care,” which, strictly speaking, clinical research generally is not. People in clinical trials are not “patients”; they are “subjects,” “volunteers” or “participants.” Sometimes, unapproved drugs and devices or clinical research are specifically excluded from coverage. The investigator may be able to purchase a clinical research rider on the policy, but often not.
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