Sometimes it takes an outsider to point out something that should be blindly obvious. In this case, that role was performed by a couple of our colleagues earlier this month at the annual ACI Drug and Medical Device Litigation Conference. They both told us how useful they found the new – adopted in 2015 − Pennsylvania Suggested Standard (Civil) Jury Instructions (“Pa. SSJI Civ.”) on the learned intermediary rule in prescription drug and medical device litigation. So we thought we’d introduce them to you. Here they are:
23.00 (Civ) Duty to Warn − Reasonable Care
In the case of prescription [drugs] [medical devices], the manufacturer has an obligation to exercise reasonable care to inform the plaintiff’s prescribing physician about the risks of its product. Such a manufacturer has a duty to warn about risks of its products that are not generally known, if the manufacturer knew or reasonably should have known about the risks of its product.
23.10 (Civ) Duty to Warn Physicians, Not Patients − Learned Intermediary Rule
A drug or medical device manufacturer only has a duty to warn the [prescribing] [implanting] physician about the dangers of its [drugs] [medical devices].
It does not have a duty to warn patients directly.
If you find that the defendant adequately warned the plaintiff’s [prescribing] [implanting] physician, even if the physician did not transmit that information to the plaintiff, you must find for the defendant on the failure-to-warn claim.
23.20 (Civ) Different Warning
The plaintiff has the burden of proving both of the following:
- that the defendant did not adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device], and
- that the [prescribing] [implanting] physician would not have [prescribed] [implanted] the [drug] [medical device] if a different warning had been provided.
23.30 (Civ) Physician’s Knowledge − Other Sources
A pharmaceutical or medical device manufacturer that fails to adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device] is not liable if the physician was aware of the risks from medical literature or other reliable sources.
If you find that the plaintiff’s [prescribing] [implanting] physician already knew about the risks of the defendant’s [drug] [medical device] when he or she decided to [prescribe] [implant] it [to] [in] the plaintiff, then you must find for the defendant on the negligent failure-to-warn claim.
Yeah, we know, this is fairly basic stuff, but come on, this is Pennsylvania we’re talking about. Pennsylvania first adopted the learned intermediary rule in 1971, in Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971), and it only took 44 years to incorporate the rule into standard jury instructions.
Remember, these are “suggested” instructions only, so they’re not etched in stone. While they are accurate statements of the law (see the committee notes, which we did not reproduce here), they do not have the force of law. Thus, if you have a case where instead of the “other sources” instruction, the dispute is over whether the prescriber read the defendant’s warnings at all, feel free to add an instruction to that effect.
A (Reed Smith) partner of ours, Barbara Binis, serves on the committee that approved them, and has graciously agreed to field any additional questions you may have. Bexis can answer questions about the notes.