Physician Conflicts of Interest in Court: Beyond the 'Independent Physician' Litigation Heuristic

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 “independent physician”litigation heuristic. In personal injury cases, courts can do this by engaging in a fact-based analysis of not just whether a financial relationship affected a physician’s decision to prescribe a drug or device but also whether the defendant drug or device company intended the relationship to have such an effect. The latter inquiry is more straightforward than the former, which could work to plaintiffs’ advantage, and it is equally relevant to the question whether the learned intermediary doctrine should apply. In economic injury cases, courts can move beyond the heuristic 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 bring closer the goal of ensuring that patients and payers are fairly compensated for the harms caused by conflicts of interest. It would also provide an additional incentive to drug and device companies to ensure that the payments they make to physicians are legitimate.

Keywords: Physicians, Conflicts of Interest, Tort Litigation, Failure-to-Warn, Learned Intermediary, Racketeer Influenced and Corrupt Organizations Act,RICO, Aggregate Proof