Photo of Steven Boranian

While we are often critical of federal courts that reach out to make new state law, today we commend a far-away judge for bringing California’s learned intermediary doctrine law back to its basics.  The case is Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 U.S. Dist. LEXIS 114122 (S.D. W. Va. Aug. 18, 2014), which is one of many cases in the various pelvic mesh MDLs currently ongoing in West Virginia.  In Sanchez, the defendant surgical mesh manufacturer moved for summary judgment with mixed results, but we like the district court’s no-nonsense approach to the learned intermediary doctrine.  The district court also ruled on design defect, punitive damages, and preemption, which we will get to at the end.  For now, the focus is on our favorite topic, the LID.

The best part is the court’s rejection of the plaintiffs’ argument that the learned intermediary doctrine “does not apply when a plaintiff alleges that a manufacturer failed to adequately warn a plaintiff’s doctor of a device’s risks.”  Id. at *5.  This, of course, is a silly argument, but it is based on careless language in a number of cases applying multiple states’ laws, including California.  Some courts have said that the learned intermediary “does not apply” when the plaintiff alleges inadequate warnings, but they really mean that the defendant can be liable under the learned intermediary doctrine for an inadequate warning if all the elements of a failure-to-warn claims are established.

The district court in Sanchez was not fooled:

The learned intermediary rule is part and parcel of a failure-to-warn analysis in California. Under the learned intermediary rule, manufacturers of prescription drugs and medical devices satisfy their duty to warn if they provide adequate warnings to the prescribing physicians, rather than the patients.  A pharmaceutical manufacturer is not required to warn anybody other than prescribing physicians about the dangerous propensities of their prescription drugs and medical devices.  Period.

In order to satisfy the element of causation under the learned intermediary doctrine, a plaintiff must demonstrate that the prescribing physicians would have acted differently had he or she received adequate warnings.

Id. at *7 (Emphasis added, citations omitted).  The learned intermediary doctrine therefore regulates cases where the warnings allegedly were inadequate.  That is to say, it not only “applies,” it is the governing principle, which makes it a total non sequitur to say that it would not apply where plaintiffs alleged inadequate warnings.

For those for whom this point is not self-evident, the district court explained it this way:

To the extent that . . . cases suggest that the learned intermediary doctrine has no effect where plaintiffs allege that warnings are inadequate, I respectfully believe that these cases are incorrect. . . .  California holds that in the case of prescription drugs and medical devices, “the duty to warn runs to the physician, not to the patient.”

It does not withstand scrutiny to say that the learned intermediary doctrine suddenly becomes inapplicable when a plaintiff alleges that warnings are inadequate.  If the learned intermediary doctrine became inapplicable when a plaintiff alleged that warnings were inadequate, the doctrine would never operate in California.  Plaintiffs could simply plead around the doctrine by alleging inadequate warnings—which they must necessarily do to state a claim for failure to warn. . . .

Even where a plaintiff proves that warnings were inadequate, the learned intermediary doctrine still applies.  A plaintiff must prove that inadequate warnings altered the prescribing physician’s decision to prescribe.  Anything to the contrary would violate the California Supreme Court’s clear holding that “the duty to warn runs to the physician, not to the patient.”

Id. at **10-11 (citations omitted).  If you skipped over the long block quote, go back and read it because you’re going to want to use it the next time a plaintiff tries to argue that the learned intermediary doctrine “does not apply.”  It may be from a judge more than 2,000 miles from California, but this issue is not unique to the Golden State, and the judge’s analysis is darn persuasive.

The result was pretty good, too.  Because the treating physician did not rely on the defendant’s warnings in connection with one device, the district court granted summary judgment for lack of warnings causation in connection with that device.  Id. at **15-16.  With regard to a second device, the physician said that she reviewed the device’s instructions for use, but could not remember when.  It seems to us the defendant had a good motion, since it was plaintiff’s burden to prove that the physician reviewed the instructions before using the device to treat the plaintiff.  But the uncertainty as to timing resulted in an order denying summary judgment as to that device, leaving us to observe only that half a win is better than none.  Id. at *15.

The remainder of the court’s order provides mixed results as well, and we will keep it brief:

Design Defect:  The defendant moved for summary judgment on design defect under California law. Strict liability is easy because California law does not recognize strict liability for an allegedly defective design in prescription drugs and medical devices.  Summary judgment granted.  Id. at **16-17.  The result is different for negligent design.  Plaintiffs have been pursuing design defect under negligence theories in drug and medical device cases in California for quite some time, and while we vigorously resist, we sometimes lose that battle.  So did the defendant in Sanchez.  Id. at *17.

Punitive Damages:  The court’s order on punitive damages turned mainly on the choice of law.  The plaintiff was from California, and the defendant is based in Massachusetts.  Because the parties agreed that Massachusetts law prohibited an award of punitive damages, it is not difficult to guess which side urged which state’s law.  The district court applied California’s choice of law rules to find that California law would apply, and thus denied the defendant’s motion for summary judgment.  We have argued both side of this, depending on the applicable states’ laws and our clients’ interests.  This time, the state where the plaintiffs resided won out, which is not an uncommon result.  Id. at **19-29.

Preemption:  When we’re not writing on the learned intermediary doctrine, we can be found musing on the various forms of federal preemption.  The defendant in Sanchez raised two kinds—express preemption under the Medical Device Amendments and implied conflict preemption.  The court’s order on preemption could fill another blog post—and maybe it will someday.  For today, we will observe only that the surgical mesh at issue was not a premarket approved device.  The FDA cleared it for marketing under the 510(k) process, which makes preemption—especially express preemption—a really tough row to hoe.  The defendant in Sanchez found it to be no easier and lost this part of its motion.  There is history here, with the court observing that “I have repeatedly addressed preemption issues throughout this multidistrict litigation, and I have consistently found that federal preemption does not apply.”  Id. at *33.

With this mixed bag, we think the takeaway is on the learned intermediary doctrine, where the district court provided clear and useful analysis, if not all the results that the defendant wanted.