Perhaps no case in the 8+ year history of the blog (well, maybe Wyeth v. Levine, 555 U.S. 555 (2009)), invoked greater ire from us than the atrocity in State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), making West Virginia the only state in the nation (still) not to apply the learned intermediary rule.  We excoriated Karl, of course, but even more, the decision prompted two of our early research-heavy posts, “In Defense of the Learned Intermediary Rule” (going over the rule’s justifications) and “Headcount: Who’s Adopted the Learned Intermediary Rule?” (one of our first 50-state surveys).  Needless to say, Karl also led our inaugural list as the worst drug/device decision of 2007.  

In the wake of Karl, we followed a federal court’s attempt to assertKarl as West Virginia “public policy” and refuse to apply the learned intermediary rule to non-West Virginia plaintiffs who brought suit in West Virginia courts.  See Woodcock v. Mylan, Inc., 661 F. Supp.2d 602 (S.D.W. Va. 2009).  The West Virginia legislature squelched that initiative by passing W. Va. Code, §55-8-16, which explicitly provided otherwise.

We also pointed out that the West Virginia Supreme Court seemed to be having second thoughts about this whole learned intermediary thing in White v. Wyeth, 705 S.E.2d 828 (W. Va. 2010), since it cited learned intermediary principles as one reason for precluding actions under the state’s consumer protection statute against manufacturers of prescription medical products.

The intervention by a physician in the decision-making process necessitated by his or her exercise of judgment whether or not to prescribe a particular medication protects consumers in ways respecting efficacy that are lacking in advertising campaigns for other products.

Id. at 141 (citation and quotation marks omitted).

Now, we’re pleased to report that the federal judge supervising the mesh MDLs in West Virginia (interestingly, the same judge who five years earlier authored Woodcock) has clipped Karl’s wings considerably, holding that Karl doesn’t apply to medical device companies that never engaged in direct-to-consumer (“DTC”) advertising, as opposed to the prescription drug in Karl.  Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23, 2014).  Rather the rejection of the learned intermediary rule in West Virginia extends only to “drug manufacturers that engage in DTC advertising.  Id. at *3.

Here’s how the court in Tyree reached that result.

Tyree first observed that Karl “departs from the law of forty-eight states by most recent count.”  2014 WL 5431993, at *2 & n.3.  The footnote cites, first, the Texas Supreme Court’s count of 35 states (including DC) in which the highest court has adopted the learned intermediary rule.  Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 158 n.17 (Tex. 2012).  We particularly enjoy that because, as we noted at the time, the Texas court excised that list from an amicusbrief filed by Bexis.  Tyree then adds lower courts from various other states to reach 48.  2014 WL 5431993, at *2 n.3.  You can find the same cases (and others) in our “Head Count” post (which we maintain).  Tyree found “exceptions” for Vermont and New Mexico.  As we list in “Head Count,” a Vermont trial court has adopted the learned intermediary rule.  Estate of Baker v. University of Vermont, 2005 WL 6280644 (Vt. Super. May 5, 2005).  In New Mexico, the state’s intermediate appellate court has followed the learned intermediary rule no fewer than five times. Silva v. SmithKlineBeecham Corp., 2013 WL 4516160, at *2-3 (N.M. App. Feb. 7, 2013); Serna v. Roche Laboratories, Division of Hoffman-LaRoche, Inc., 684 P.2d 1187, 1189 (N.M. App. 1984);Jones v. Minnesota Mining & Manufacturing Co., 669 P.2d 744, 748 (N.M. App. 1983); Perfetti v. McGahn Medical, 662 P.2d 646, 650 (N.M. App. 1983); Richards v. Upjohn Co., 625 P.2d 1192, 1195 (N.M. App. 1980); Hines v. St. Joseph’s Hospital, 527 P.2d 1075, 1077 (N.M. App. 1974).  The most recent of these (Silva), along with the prediction in In re Trasylol Products Liability Litigation, 2011 WL 2586218, at *4 (S.D. Fla. June 23, 2011), that New Mexico applies the learned intermediary rule, both come after theRimbert decision cited in the Tyree footnote as casting doubt on the learned intermediary rule in that state.  So while Tyree places the count at 48, we believe that 51 United States Jurisdictions (counting DC and Puerto Rico) have adopted the learned intermediary rule, either by decision or statute.  That still leaves West Virginia.

That numerical quibble aside, Tyree next looked at Karl itself..  TheKarl decision was fractured, with “three separate opinions” and a 2-justice dissent (on a 5-member court).  2014 WL 5431993, at *3. To construe “these four puzzling opinions that have few common aspects,” Tyree employed the analysis for such situations adopted by the United States Supreme Court in Marks v. United States, 430 U.S. 188, 193 (1977) – that the controlling “holding of the court may be viewed as that position taken by those members who concurred on the narrowest grounds.”  2014 WL 5431993, at *3.

Applying this analysis to Karl, produced a limiting result:

[T]he narrowest reading of Karl eliminates the protection of the learned intermediary doctrine only for drug manufacturers that engage in DTC advertising.  I reach this conclusion by recognizing that notwithstanding the many differences in their opinions, Chief Justice Davis, Justice Maynard, and Justice Starcher uniformly rejected the learned intermediary doctrine specifically for drug manufacturers based, at least partially, on the prevalence of drug advertisements targeted at consumers.

Id. (emphasis added).  The Davis opinion “expressly refers to drug manufacturers and does not speak to Karl’s role in other circumstances” such as medical devices.  Id.  The same was true of the concurrences by Maynard and Starcher, JJ (neither of whom remain on the bench).  Id.  The various opinions also gave various rationales for their refusal to apply the learned intermediary rule inKarl, with the unifying principle being DTC advertising.  Id. at *4 (“their concern with the emergence of DTC advertising stands out among the opinions as the primary justification for Karl”).

The court’s Marksist analysis found support in other cases that had carefully examined Karl.  “The decision in Karl [] was extremely context specific.  The reasoning is not applicable to a scenario outside of the prescription pharmaceutical context and the rise of direct-to-consumer advertising.”  Roney v. Gencorp, 654 F. Supp.2d 501, 504 (S.D.W. Va. 2009) (Karl did not preclude the sophisticated purchaser defense in a bulk supplier case).  InVagenos v. Alza Corp., 2010 WL 2944683 (S.D.W. Va. July 23, 2010), Karl did not preclude a pharmacy from raising learned intermediary principles as a “shield” from liability because Karl did not arise in “the context of a pharmacist's duty to warn.”  Tyree, 2014 WL 5431993, at *5.

Karl therefore did not preclude application of the learned intermediary rule under West Virginia in a medical device case where there was no DTC advertising. 

DTC advertising, according to the Karl court, eliminates the premises underlying the learned intermediary doctrine.  [The defendant], however, did not advertise the [device] directly to customers. . . .  Without DTC advertising, the premises of the learned intermediary doctrine rematerialize.

Tyree, 2014 WL 5431993, at *5.  Nor did the Karl holding, expressly mentioning only “drugs,” apply to medical devices:

Because Karl implicates only drug manufacturers, I am of the opinion that medical device manufacturers may continue to use the learned intermediary doctrine in failure to warn cases.  Many courts have allowed medical device manufacturers to use the learned intermediary doctrine against failure to warn claims. . . .  Patients cannot obtain the [the device] except through a physician.  Additionally, because the patient is under anesthesia during the surgery, the patient and her physician must thoroughly discuss the potential risks and benefits prior to the implantation. These factors are not present when a physician prescribes a routine drug.

Id. at *6 (citations omitted).  Thus, in a case where both of these distinctions were present – a medical device manufacturer that engaged in no DTC advertising – Karl is doubly inapplicable and “the learned intermediary doctrine applies to the plaintiffs' failure to warn claims.”  Id.  The court also cited “nearly unanimous national recognition of the doctrine’s value,” which “fosters the uniformity and predictability of the law.”  Id.

While we still remain unalterably opposed to the Karl decision, we’re nonetheless pragmatists.  We’ll take whatever we can get. We’ll certainly take Tyree.