Deceased treating, prescribing, and implanting physicians present special challenges in drug and device cases. Chief among those challenges is the loss of testimony about the prescribing decision, the doctor’s awareness and weighing of the risks and benefits of the product, and whether the doctor would have acted differently if given different warnings.

A recent case out of the U.S. District Court for the Middle District of Georgia, In re Mentor, illustrates the effect that the loss of this testimony has on a plaintiff’s ability to prove causation in a failure to warn case. In re Mentor involved a suburethral sling product used to treat women with stress urinary incontinence. The plaintiff alleged the manufacturer of the product failed to provide adequate warnings to her physician. The plaintiff’s treating physician died before he could testify, and there was no evidence that different warnings would have changed his prescribing decision.

“Read and Heed” Presumption

Faced with the lack of testimony from the dead physician, the plaintiff invoked the “read and heed” presumption. This is a rebuttable presumption that the prescribing physician would have read and heeded additional warnings had they been given. The plaintiff also presented expert testimony that:

  • The deceased physician likely did not know the product had risks that were not disclosed in the product data sheet
  • A reasonable physician would have told their patients about these risks if they had been known

District Court Rejects Approach

The district court observed that, at best, the “read and heed” presumption only permitted the court to presume that the plaintiff’s prescribing doctor would have considered the additional risk. But, neither the presumption, nor the proffered expert testimony permitted the Court to speculate about how the deceased doctor would have weighed the additional warnings. Even though the expert opined that the plaintiff’s prescribing physician “‘[m]ore likely than not…would have altered his clinical practice’” if he had received additional warning information, the plaintiff’s claim failed because she “did not point to any Texas authority suggesting that she may establish causation by having an expert opine about what her doctor might have done with different warnings.” In re Mentor Corp., 2016 WL 4611572, *3 (Sept. 2, 2016).

The In re Mentor decision can be found here.