We write a lot about the learned intermediary rule. There are 50 state surveys and summaries of helpful decisions, as well as numerous posts on state-specific decisions. We tracked the development of the rule in jurisdictions like West Virginia and Arizona, and we’ve generally been pleased to report positive developments. At the end of 2024, though, we flagged the Himes case from California as one of the ten worst decisions of the year based on its novel approach to warnings causation. Given our criticisms of Himes, we found it both bizarre and troubling to see the case cited recently by an MDL court in Massachusetts applying Pennsylvania law. Our colleagues in the plaintiffs’ bar are clearly advocating to expand Himes into other jurisdictions, and the defense bar should be ready to counter those efforts.
Today’s decision is from the BioZorb MDL. In re BioZorb Device Prods. Liab. Litig., 2025 WL 27628 (D. Mass. Jan. 3, 2025). The MDL involves claims relating to an implantable, absorbable device used to mark sites for radiation treatment of breast cancer. Plaintiff claimed that the device did not properly absorb, became infected, and required surgery for removal. The defendant moved for summary judgment on plaintiff’s claims for failure to warn, negligence and breach of implied warranty of merchantability.
We previously noted that Pennsylvania has been one of the strongest states on learned intermediary rulings, and the court’s review of applicable Pennsylvania precedent exemplified that. After deciding that Pennsylvania law should apply under the Massachusetts conflicts of law rules, the court reviewed the following aspects of Pennsylvania learned intermediary law:
- In a pharmaceutical or medical device warning claim, the issue to be determined is whether the warning that was given to the prescribing physician was adequate.
- Physicians rely on their independent medical judgment, taking into account the information provided by the manufacturer, medical literature, and other available sources in making the prescribing decision.
- Once a manufacturer has provided a proper warning to the prescribing physician, the manufacturer has discharged its duty to the patient.
- Pennsylvania courts do not apply a heeding presumption.
See id. at *4. Although not referenced by the court, Pennsylvania also has standard jury instructions that apply the learned intermediary rule (note that there have been some very minor changes to the instructions since our post on them, so pull the current versions).
The court then turned to the implanting physician’s deposition testimony. The doctor had ceased using the device and offered testimony adverse to the defendant, so the court found a fact question on warnings adequacy. That would have been sufficient to address the motion, but the court went further and, with a “Cf.” cite to Himes, stated that the facts could let a jury conclude that the plaintiff would not have agreed to implantation of the device if stronger warnings had been presented to her by her physician, even if her physician recommended it. Himes is of course not the law in Pennsylvania, the court cited no Pennsylvania law to support that proposition, and there’s nothing in the facts suggesting any reason that California law would have any bearing on the decision. So we’re troubled by the inclusion of the citation to Himes. We’ve discussed the fact that Himes will create confusion, lead to speculation, and erode the physician patient relationship that the learned intermediary rule was created to preserve. It should not be followed by other states.
On a brighter note, the court granted summary judgment on the plaintiff’s breach of implied warranty of merchantability claim. It is settled law in Pennsylvania that there is no implied warranty of merchantability in the sale of prescription drugs, and federal courts have predicted the Pennsylvania Supreme Court would extent that holding to medical devices. The court had no trouble dismissing this claim.