Wednesday, August 21, 2013
Professor Kate Greenwood (Seton Hall) has posted to SSRN her article, 'Litigant Regulation' of Physician Conflicts of Interest, Ga. St. L. Rev. (forthcoming). Here's the abstract:
While physicians’ financial relationships with pharmaceutical and medical device manufacturers are increasingly of concern to legislators and regulators, plaintiffs have had only limited success pursuing private law remedies for the harms that result from conflicts of interest. Courts have long channeled individual patients’ claims against their conflicted doctors into the medical malpractice cause of action, where patients have difficulty establishing that their physicians’ conflicts caused them to suffer concrete and compensable injuries. With recent notable exceptions, courts have also blocked patients’ claims against drug and device manufacturers. Courts apply the learned intermediary doctrine to dispose of failure-to-warn personal injury suits, without regard to whether the plaintiff’s physician had a financial relationship with the defendant manufacturer. Third-party payers, such as employers, insurance companies, and union health and welfare funds, have similarly struggled to overcome a strong presumption of physician independence. Courts routinely find that a physician’s prescribing decision breaks the chain of causation between a manufacturer’s illegal promotional efforts and a payer’s obligation to pay for a prescription, even when those promotional efforts include the payment of kickbacks.
Courts can and should move beyond the often counterfactual presumption of physician independence. In personal injury cases, this can be achieved through a nuanced analysis of alleged conflicts of interest that distinguishes between kickbacks, on the one hand, and legitimate financial relationships between manufacturers and physicians, on the other. Limited early discovery would allow plaintiffs to develop their claims about the influence of conflicts on their physicians’ decision-making without putting an undue burden on defendants. In economic injury cases, courts can move beyond the presumption of physician independence by allowing plaintiffs to use standard statistical methods to demonstrate that physicians’ prescribing decisions were not independent in the aggregate. If the doctrine were to evolve in these ways, it would amplify the role “litigant regulation” plays in the regulatory structure governing physician-industry relationships and bring closer the goal of ensuring that patients and payers are fairly compensated for the harms caused by conflicts of interest.