Possible Learned Intermediary Showdown in Michigan

On its face, Osos v. Nuvasive, Inc., 2024 WL 3585092 (E.D. Mich. July 30, 2024), is a fairly routine medical implant product liability lawsuit, involving allegations of metallosis that have already been around the block quite a few times in hip implant cases.  Osos involves a somewhat different device, but the legal principles are no different.

But Osos involves Michigan law, and Michigan (as we first mentioned at the end of last year, and discussed more thoroughly here) only recently repealed a longstanding conclusive presumption of non-defectiveness based on FDA drug approvals.  That presumption, which “functionally foreclosed” most product liability claims against, such products, White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023, 1029 (W.D. Mich. 2008), undoubtedly reduced litigation by Michigan plaintiffs.  See Our “Michigan Diaspora” post.  The repeal will equally undoubtedly cause Michigan prescription medical product litigation to rebound.

Which brings us back to Osos.  That decision pointed out – correctly − that the Michigan Supreme Court hasn’t addressed the learned intermediary rule since 1984, and that even Michigan intermediate appellate reliance on the rule is rather old.  2024 WL 3585092, at *3 (citing Brown v. Drake-Willock International, Ltd., 530 N.W.2d 510, 516 (Mich. App. 1995)).  Our constantly updated learned intermediary rule post, “Headcount:  Who’s Adopted the Learned Intermediary Rule?” says pretty much the same thing:

Michigan: Smith v. E.R. Squibb & Sons, Inc., 273 N.W.2d 476, 479 (Mich. 1979).  To be fair, the statement in Smith was characterized as “dictum” in In re Certified Questions, 358 N.W.2d 873, 877 (Mich. 1984), but it has been followed by lower Michigan courts.  E.g., Mowery v. Crittenton Hospital, 400 N.W.2d 633, 637 (Mich. App. 1986).

That just goes to show, that, while the Blog is unequivocally pro-defense in outlook, we’re dead honest in our research.

As a result Osos has certified to the Michigan Supreme Court the following questions:

1.         Whether the Michigan Supreme Court in In re Certified Questions held that the learned intermediary doctrine does not exist in Michigan and will not exist until the legislature creates it, or left it for another time to decide whether Michigan follows the doctrine.

2.         Whether, in the event the Michigan Supreme Court reserved for itself the decision to rule on the learned intermediary doctrine, the doctrine exists in Michigan and under what circumstances it applies.

2024 WL 3585092, at *5.

That’s fine with us.  Only one state high court in history has rejected the impeccable logic behind the learned intermediary rule, and that decision was promptly overridden by the legislature.  Bexis, alone, has written briefs that helped produce high court decisions in seven states, either adopting or reaffirming the learned intermediary rule.

But we’re not so fine with the Osos decision’s truncated discussion of Michigan federal district court decisions addressing the learned intermediary rule.  That discussion cited only three cases for the proposition that federal judges are “unsure of whether the [learned intermediary] doctrine applies in Michigan.”  Id. at *4 (citing Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867 (E.D. Mich. 1985); Grainger v. Sandoz Pharmaceuticals, No. 79-40075 (E.D. Mich. 1979) (a slip opinion we’ve never seen before); and Reaves v. Ortho Pharmaceutical Corp., 765 F. Supp. 1287 (E.D. Mich. 1991)).

That discussion paints an incomplete and biased picture of Michigan federal precedent concerning the learned intermediary rule.  Every more recent court decision has concluded that Michigan would adopt the rule.

Michigan has adopted and follows the learned intermediary doctrine, which holds that a manufacturer has no duty to warn the ultimate consumer if the product is provided for use by a sophisticated consumer.  This doctrine has been expressly applied in the medical device context, with the result that adequate warnings are owed to physicians and surgeons and not to their patients.  Under the learned intermediary rule, the physician is the proper recipient of necessary information or warnings, not plaintiff.  Thus, under Michigan law, any duty in this case would be one owed to [plaintiff’s] physicians, not [plaintiff] herself, and not the FDA.

Hill v. Bayer Corp., 485 F. Supp.3d 843, 854–55 (E.D. Mich. 2020) (citations omitted).

The “learned intermediary” doctrine is an exception to the axiomatic principle that a manufacturer has a duty to warn the user of known dangers inherent to its product.  It applies to manufacturers of prescription drugs, who are required to warn only the prescribing physician, who acts as a learned intermediary between the manufacturer and consumer.  Generally speaking, the rationale for the rule is that a physician is in the best position to weigh the risks of using a prescription drug in a particular case and to convey the appropriate information to the patient.  To expect the average citizen to know if he or she should take the drug or when to stop taking it, or to understand the technical language so often necessary to explain the dangers of the drug, is unreasonable.  The rule also applies to prescription devices.

Tice v. Zimmer Holdings, Inc., 2015 WL 4392985, at *5 (W.D. Mich. July 15, 2015) (citations and quotation marks omitted).  See Teal v. Argon Medical Devices, Inc., 533 F. Supp.3d 535, 550-51 (E.D. Mich. 2021) (following Brown and Mich. Comp. Laws §600.2945(j)); McClarty v. C.R. Bard, Inc., 2020 WL 6075520, at *10 (E.D. Mich. Oct. 15, 2020) (“Michigan has adopted and follows the learned intermediary doctrine”); Hill v. Bayer Corp., 2020 WL 5903892, at *1 (E.D. Mich. Oct. 5, 2020) (“Michigan applies the learned intermediary doctrine”); Avendt v. Covidien, Inc., 262 F. Supp.3d 493, 521 (E.D. Mich. 2017) (“Michigan has adopted and follows the learned intermediary doctrine, which . . . has been expressly applied in the prescription drug and medical device context”); Davis v. C.R. Bard, Inc., 2012 WL 6082933, at *8-9 (E.D. Mich. Dec. 6, 2012) (plaintiff’s evidence defeated summary judgment under “learned intermediary” and “sophisticated user” doctrines); Knight v. St. Jude Medical, 2011 WL 1230819, at *10 (Mag. W.D. Mich. Jan. 11, 2011) (“The learned intermediary rule recognizes that patients rely on their doctor’s expertise and advice when using a drug or medical device and, moreover, may not appreciate or even understand any warnings provided directly by the manufacturer.”), adopted, 2011 WL 1230815 (W.D. Mich. March 31, 2011); Gillett v. Sofamor, S.N.C., 2001 WL 1135304, at *7 (E.D. Mich. Sept. 13, 2001) (“Michigan has recognized the ‘learned intermediary doctrine’ with regard to medical devices.”); Marciniak v. Miles-Cutter, 874 F. Supp. 772, 776 (W.D. Mich. 1994) (“After discussion on the record with regard to the ‘learned intermediary doctrine,’ plaintiff’s attorney stipulated . . . to dismissal of . . . claims in the complaint that defendants breached their duty by failing to warn the end-users”); Nichols v. McNeilab, Inc., 850 F. Supp. 562, 564 (E.D. Mich. 1993) (learned intermediary rule “holds true for the prescription of prescription drugs, to which the consumer has no access except through her physician”).  See also Dandy v. Ethicon Women’s Health & Urology, 2022 WL 1284735, at *18 (D.N.J. April 29, 2022) (“Michigan follows the learned intermediary doctrine in failure to warn cases involving medical devices.”) (following Brown and Avendt) (applying Michigan law).

By citing only to the earliest federal district decisions concerning the learned intermediary rule under Michigan law, Osas created a false impression of uncertainty that, over the ensuing decades, has entirely vanished.  In truth, not a single Michigan decision since Odgers has questioned the general applicability of the learned intermediary rule under Michigan law to prescription medical product liability litigation.  Sometimes plaintiffs’ warning claims have succeeded; sometimes they have failed – but they have all been evaluated in accordance with the learned intermediary rule.

It remains to be seen whether the Michigan Supreme Court will accept the certified questions.  The last time it considered a similar question, it held that the Michigan legislature, not the courts, should have the final say.  Certified Questions, 358 N.W.2d at 874; Osas, 2024 WL 3585092, at *4.  In 1996 the legislature did so act, recognizing:

“Sophisticated user” means a person or entity that, by virtue of training, experience, a profession, or legal obligations, is or is generally expected to be knowledgeable about a product’s properties, including a potential hazard or adverse effect.  An employee who does not have actual knowledge of the product’s potential hazard or adverse effect that caused the injury is not a sophisticated user.

Mich. Comp. Laws §600.2945(j) (emphasis added).  While §600.2945(j) sweeps more broadly, a learned intermediary physician is certainly a subset of such a “sophisticated user,” as defined by the statute, based on such physician’s “professional” and training and experience.

In light of the above, we feel confident that, if certification is accepted, Michigan will retain the learned intermediary rule.