Nicholas Malfitano Jan. 7, 2016, 9:53am


PHILADELPHIA – Pennsylvania has recently adopted a new set of suggested jury instructions related to the learned intermediary doctrine, according to attorneys from Reed Smith.

A defense doctrine used in courts throughout the United States, the learned intermediary doctrine states a product manufacturer has fulfilled its duty of care when providing all information related to the product to a “learned intermediary” who then communicates that information to a third party or consumer of that product.

It is a defense often used by drug or medical device manufacturers to guard against liability in tort cases. On a recent blog post, James Beck of Reed Smith outlined the new suggested instructions.

On the subject of reasonable care, the suggested new guidelines state, “The manufacturer has an obligation to exercise reasonable care to inform the plaintiff’s prescribing physician about the risks of its product," including risks not generally known, if the manufacturer “knew or reasonably should have known about the risks of its product.”

With respect to the learned intermediary rule, the suggestions say, “A drug or medical device manufacturer only has a duty to warn the prescribing or implanting physician about the dangers of its drugs or medical devices. It does not have a duty to warn patients directly.”

The suggestions also outlined the plaintiff’s burden of proof in drug or medical device tort cases. They explain the plaintiff must show first, “The defendant did not adequately warn the prescribing or implanting physician about the risks of its drug or medical device,” and second, “The prescribing or implanting physician would not have prescribed or implanted the drug or medical device if a different warning had been provided.”

Finally, the new suggestion guidelines also cover the subject of other sources. “A pharmaceutical or medical device manufacturer that fails to adequately warn the prescribing or implanting physician about the risks of its drug or medical device is not liable if the physician was aware of the risks from medical literature or other reliable sources,” the suggestions read.

Beck also offered his thoughts on the approval of the new learned intermediary doctrine jury instructions. 

“Pennsylvania first adopted the learned intermediary rule in 1971, in Incollingo v. Ewing, and it only took 44 years to incorporate the rule into standard jury instructions,” Beck wrote in the blog.

Beck reiterated the guidelines are only “suggested” and not “etched in stone.”

Barbara Binis, a colleague of Beck’s and partner at Reed Smith who served on the committee to approve the new suggested guidelines also lent insight on the matter.

“We’ve been talking about these instructions for many years,” Binis told the Pennsylvania Record.

“When you think of products liability cases, you tend to naturally think of strict liability, which is not applicable to pharmaceutical and medical device cases. Those are decided under a long line of published Supreme Court cases under a negligence standard.”

Binis said that to this point, specific instructions to deal with non-strict liability cases did not exist and elaborated on the differences the new instructions highlighted. 

“Under strict liability, there is no need to prove any wrongdoing. There is only a need to prove that there was an injury, and that the injury was caused by the product,” Binis said. 

“That’s very different from Pennsylvania law regarding pharmaceutical and medical device cases, where in fact you need to show that the company did something negligent and where the warnings are not directed in general to consumers, they’re directed to physicians as the learned intermediary."

Binis said the instructions, which she characterized as “well-balanced” between plaintiffs and defense, would serve to assist courtrooms that may not hear many pharmaceutical or medical device cases and make it easier for a court to evaluate the arguments on jury instructions.

“There wasn’t really any form of instructions that could be used, so now, we do have a set of form instructions that can be used. I think it’s going to help, and in fact, we’ve already gotten some positive feedback from judges and from litigants of plaintiffs and defense on the ease of using these instructions,” Binis said. 

From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nickpennrecord@gmail.com

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