Ask Your Doctor

Doctors are smart folks who want to do the right thing for their patients.   By and large, they want more information, not less.  By and large, they respect the wishes of their patients.  Ask any doctor if she would have wanted to know additional safety information when prescribing a medicine or medical device and the answer almost always is yes.  Ask her if she would honor a patient’s decision not to take a prescription medicine or use a medical device and the answer almost always is yes.

In a failure to warn case, plaintiffs often rely on these two obvious and easily-elicited admissions to side step the learned intermediary doctrine.  The dance goes like this.

First, the Plaintiff testifies, my word, had my doctor told me about this additional risk information, I never would have taken this drug or used this medical device.  Of course, Plaintiff invariably delivers this testimony while actively using an alternative medicine or device that carries the very same risk as the medicine or device that is the subject of the litigation.

Next, Plaintiff’s counsel turns to the prescribing physician and marches through this simple Q and A:

Plaintiff’s counsel:  “Doctor, wouldn’t you have wanted to know X, when prescribing this medicine?”

Prescriber:  “Yes, I would have wanted to know.”

Plaintiff’s counsel:  “And Doctor, if you had known X, would you have told my client prior to prescribing this medicine?”

Prescriber:  “Yes, I probably would have taken it into consideration and may have discussed it with the patient.”

Plaintiff’s counsel:  “And if my client said she did not want to take this medicine, knowing X, would you have honored her wishes and prescribed an alternative?”

Prescriber: “Yes.”

“Ah ha!” they exclaim. “We’ve established causation – in the face of a different warning, my client would not have taken the medicine/used the medical device.  We’ve defeated summary judgment and get to a jury.”

Not so fast, says the Fourth Circuit.

Earlier this month, in Lewis v. Johnson & Johnson, App. No. 14-1244, 2015 WL 860371 (4th Cir. March 2, 2105), the Fourth Circuit upheld summary judgment on Plaintiff’s failure to warn claim regarding alleged injuries associated with the use of a vaginal mesh device.  The court explicitly rejected Plaintiff’s attempt to side step the learned intermediary doctrine by arguing that a stronger warning would have caused her to withhold consent for the procedure.  The Fourth Circuit made clear that in a failure to warn case, the inquiry is into whether a stronger warning would have changed the prescriber’s decision to prescribe, not the plaintiff’s decision to give consent.

“[T]he relevant test is whether the ‘alleged inadequacy caused [the plaintiff’s] doctor to prescribe the drug’ … courts must look to the prescribing doctor’s behavior in deciding whether the inadequate warning is the ‘producing cause’ of plaintiff’s injury … the inquiry under Texas law remains whether the warning would have changed the decision of the prescribing physician.”  Id. at *1 (emphasis added and internal citations omitted).  Tripping up the plaintiff’s familiar dance steps, the Fourth Circuit held that the prescribing physician’s testimony that she might have passed additional information on to the Plaintiff and the Plaintiff’s testimony that she would not have consented to the procedure in the face of that additional information wasn’t enough to defeat summary judgment.

It’s the right result.  By attempting to shift the focus away from the physician and onto the patient, plaintiff’s side step ignores the reality of a patient’s relationship with her physician and, indeed, the entire premise of the learned intermediary doctrine.  It is the job of a physician, as the learned intermediary, to make sense of all the risk and benefit information and to use his or her independent medical judgment to apply that information to a patient’s individual medical care.  We rely on and expect our doctors to do just that.  If not, why else would anyone ever seek the advice of a doctor?

Consistent with the learned intermediary doctrine, warnings are therefore directed to physicians, not patients.  Warnings are intended to supply physicians with the information they need to make treatment decisions.  Physicians are not, as plaintiffs would like to characterize them, mere conduits of information.  The warnings are directed to them and not their patients.  What matters is whether a doctor, based upon the information at issue, would have made a different prescribing decision, not whether a patient would have made a different consent decision.  The Fourth Circuit got it right.