Law

Last week's "breaking news" post on West Virginia's statutory restoration of the learned intermediary rule started us thinking about how every state now has pro-learned intermediary precedent.  That's a big change even from when we started this blog.  It's also a stunning repudiation of the other side's rhetoric.

We remember, back in 1999, when the New Jersey Supreme Court went off on a tangent and recognized a novel "DTC advertising" exception to the learned intermediary rule in Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999).  The plaintiff-side Greek chorus in legal academe – always looking to foment more litigation so ever-more law school graduates would have ever-more jobs – was quick to declare the Perez exception the wave of the future.  E.g., C. Nadal, "The Societal Value of Prescription Drug Advertisements in the New Millennium: Targeted Consumers Become the Learned," 9 J.L. & Policy 451 (2001); Y. Fushman, "Perez v. Wyeth Laboratories, Inc.:  Toward Creating A Direct-to-Consumer Advertisement Exception to the Learned Intermediary Doctrine," 80 Boston U.L. Rev. 1161 (2000); J. Karns, "Direct Advertising of Prescription Drugs:  The Duty to Warn & the Learned Intermediary Rule," 3 DePaul J. Health Care L. 273 (2000).  There were many more.

That didn't happen.

Despite over a decade and a half of trying, plaintiffs have been unable to convince any other state to recognize New Jersey's DTC exception.  "[W]e decline to recognize a DTC advertising exception, which has been adopted only in New Jersey."  Watts v. Medicis Pharmaceutical Corp., ___ P.3d ___, 2016 WL 237777, at *5 (Ariz. Jan. 21, 2016).  "In the more than twelve years since Perez, many courts have declined to follow the New Jersey Supreme Court's sweeping departure from the learned intermediary doctrine."  Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 161 (Tex. 2012).  See Larkin v. Pfizer, Inc., 153 S.W.3d 758, 766 (Ky. 2004) (DTC exception "recognized only by New Jersey"); Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp.2d 222, 228-29 (D.P.R. 2008) ("this approach has not been widely accepted"); Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1376 (S.D. Fla. 2007) ("no court" other than Perez has allowed a DTC exception).

Wellllllll, not entirely.

Back to West Virginia.  Early in this blog's existence, in 2007, the West Virginia Supreme Court in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), cited to Perez a lot in reaching an even more radical departure from prior law – abolishing the learned intermediary rule altogether.  Of course, we lambasted the Karl decision ourselves (and made Karl #1 in our inaugural worst decisions of the year post).  The plaintiffs' Greek chorus, however, had other ideas, and once again spewed forth more "scholarship" predicting the coming demise of the learned intermediary rule.  E.g., A. Porter, "Old Habits Die Hard:  Reforming the Learned Intermediary Doctrine in the Era of Direct-to-Consumer Advertising," 43 McGeorge L. Rev. 433 (2012); H. Harrell, "Direct-To-Consumer Advertising of Prescription Pharmaceuticals, The Learned Intermediary Doctrine,& amp; Fiduciary Duties," 8 Ind. L. Rev. 69 (2010/2011); R. Friedman,  "Take Two Of These & Sue Me In The Morning:  Efficacy of the Learned Intermediary Doctrine in Prescription Drug Failure To Warn Cases," 22 St. Thomas L. Rev. 278 (Winter 2010); T. Hall, "Regulating Direct-to-Consumer Advertising with Tort Law:  Is the Law Finally Catching Up with the Market?," 31 W. New Eng. L. Rev. 333 (2009).

Didn't happen.  Not hardly.

Not a single state's high court (or any other court, for that matter) has followed Karl down the path to perdition.  And now Karl itself is history.  As we posted last week, the West Virginia legislature has passed, and the governor has signed into law, a bill creating W. Va. Code §55-7-30, adopting the learned intermediary rule, largely as it appears in the Third Restatement of Torts, but without any exceptions.  So now, as our learned intermediary headcount post describes in detail, there is precedent following the learned intermediary rule in every state in the country – ranging from high court or statutory authority in 38 states (and DC), to a Vermont state trial court at the other extreme.

Plainly, reports of the death of the learned intermediary rule have, in the words of Mark Twain, have been greatly exaggerated.  If anything, the learned intermediary rule has been enjoying a distinct renaissance.

That renaissance has become more pronounced in recent years.  Just in the first couple months of this year, in addition to the West Virginia statute, the Supreme Court of Arizona – as we've gleefully reported – unanimously adopted the learned intermediary rule, overturning an odd intermediate court decision that had effectively abolished the rule:

Manufacturers generally have a duty to warn consumers of foreseeable risks of harm from using their products.  But under the LID [learned intermediary doctrine], if the manufacturer provides complete, accurate, and appropriate warnings about the product to the learned intermediary, it fulfills its duty to warn the consumer.  The premise for the LID is that certain types of goods (such as prescription drugs) are complex and vary in effect, depending on the end user's unique circumstances, and therefore can be obtained only through a qualified intermediary like a prescribing physician, who can evaluate the patient's condition and weigh the risks and benefits. . . .  Although the court of appeals has embraced the LID, this Court has not yet addressed the doctrine.  In our view, the Third Restatement properly states the LID, and therefore we adopt §6(d) as our expression of it.  Adopting the doctrine places us with the majority of jurisdictions that have considered the matter.

Watts, 2016 WL 237777, at *3 (numerous citations, and the text of Restatement §6(c) omitted).

Watts cited repeatedly to another unanimous state supreme court decision in Centocor v. Hamilton, 372 S.W.3d 140 (Tex. 2012).  Before Hamilton, Texas had been the largest state left in the country where its highest court (or legislature) had not adopted the learned intermediary rule (Indiana is now), but no longer:

Until now, we have not considered a case that squarely presents the applicability of the learned intermediary doctrine within the context of prescription drug products-liability cases.  . . .[W]e hold that a prescription drug manufacturer fulfills its duty to warn end users of its product's risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly. . . .  Our decision to apply the learned intermediary doctrine in the context of prescription drugs, prescribed through a physician-patient relationship, not only comports with our prior references to the doctrine and many years of Texas case law, but it places us alongside the vast majority of other jurisdictions that have considered the issue.  Our sister states have overwhelmingly adopted the learned intermediary doctrine in this context. . . .  The underlying rationale for the validity of the learned intermediary doctrine remains just as viable today as stated by Judge Wisdom in 1974:

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect.  As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers.  The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.  Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a "learned intermediary" between manufacturer and consumer.

Because patients can obtain prescription drugs only through their prescribing physician or another authorized intermediary and because the "learned intermediary" is best suited to weigh the patient's individual needs in conjunction with the risks and benefits of the prescription drug, we are in agreement with the overwhelming majority of other courts that have considered the learned intermediary doctrine and hold that, within the physician-patient relationship, the learned intermediary doctrine applies and generally limits the drug manufacturer's duty to warn to the prescribing physician.

Hamilton, 372 S.W.3d at 157-59 (numerous citations and a long footnote largely borrowed from Bexis' amicus brief omitted).  Between Watts and Hamilton, that's sixteen state supreme court justices in favor of the learned intermediary rule and zero against.

The learned intermediary renaissance has been particularly noticeable in the Mountain West.  Just since Karl was decided in 2007, appellate courts in every single one of those states have either adopted or reaffirmed their adherence to the learned intermediary rule.  In addition to Arizona (Watts) there are:  Klasch v. Walgreen Co., 264 P.3d 1155, 1157-58 (Nev. 2011); Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244, 257 (Mont. 2010); Downing v. Hyland Pharmacy, 194 P.3d 944, 946-47 (Utah 2008); Rohde v. Smiths Medical, 165 P.3d 433, 436 & n.5 (Wyo. 2007); Silva v. SmithKlineBeecham Corp., 2013 WL 4516160, at *2-3 (N.M. App. Feb. 7, 2013) (unpublished); O'Connell v. Biomet, Inc., 250 P.3d 1278, 1281-82 (Colo. App. 2010) (Colorado); and Adams v. United States, 449 F. Appx. 653, 659 (9th Cir. 2011) (applying Idaho law).

But the renaissance is hardly restricted to any particular section of the country.  Again, just limiting ourselves to what's happened since Karl, state supreme courts in seven other states have reiterated their adherence to the learned intermediary rule.  This includes the otherwise atrocious Weeks decision in Alabama.  Wyeth, Inc. v. Weeks, 159 So.3d 649, 672-73 (Ala. 2014).  See also Lance v. Wyeth, 85 A.3d 434, 457 (Pa. 2014); Nye v. Bayer Cropscience, Inc., 347 S.W.3d 686, 701 (Tenn. 2011); Kowalski v. Rose Drugs, Inc., 378 S.W.3d 109, 119-20 (Ark. 2011); Hurley v. Heart Physicians, P.C., 3 A.3d 892, 899-900 (Conn. 2010); Panag v. Farmers Insurance Co., 204 P.3d 885, 893-94 (Wash. 2009); and Hyman & Armstrong, P.S.C. v. Gunderson, 279 S.W.3d 93, 109-10 (Ky. 2008).

Those against – zero.

A couple of recent federal appellate decisions that we've discussed have relied on the learned intermediary rule in throwing out plaintiffs' warning claims.  See In re Avandia Marketing, Sales Practices & Products Liability Litigation, ___ Fed. Appx. ___, 2016 WL 574074, at *3 & n.6 (3d Cir. Feb. 12, 2016) (applying Pennsylvania law); Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 292-93 (6th Cir. 2015) (applying New York law).  If we listed all the federal courts of appeals decision applying the learned intermediary rule since Karl, we would unduly extend this post, but since the Erie doctrine does require a "prediction" of state law where the state courts have not reached a definitive answer to a particular question, we will provide federal appellate authority solely from those fourteen (mostly smaller) states where the state's highest court has not settled the issue.  See Schilf v. Eli Lilly& amp; Co., 687 F.3d 947, 949 (8th Cir. 2012) (applying South Dakota law); Greaves v. Eli Lilly & Co., 503 F. Appx. 70, 71-72 (2d Cir. 2012) (applying Rhode Island law); and Allgood v. SmithKline Beecham Corp., 314 F. Appx. 701, 702 (5th Cir. 2009) (applying Louisiana law).  There were also a couple of court of appeals decisions applying Arizona law, but we don't care about them now, after Watts.

Once again, those against – zero.  The other side has been putting up a lot of zeros in this area.  The learned intermediary rule's recent record may be the current longest winning streak this side of the UConn Huskies women's basketball team.

So the next time that you encounter the other side bleating about the learned intermediary rule being "outdated" or some similarly unrealistic adjective, rest assured that they're wrong and that recent precedent uniformly refutes that proposition.  Heck, the rule is even picking up some love from law review articles.  "Our whole medical product regulatory scheme has long depended on the physician as learned intermediary, bringing together useful but potentially dangerous products and patients who need them."  M. Riley, "An Unfulfilled Promise:  Changes Needed to the Drug Approval Process to Make Personalized Medicine A Reality," 70 Food & Drug L.J. 289, 309 (2015).  "[T]he sale of prescription drugs requires the education of prescribers, 'learned intermediaries' without which our prescription drug system would not function."  J. Herbst, "Off-Label 'Promotion' May Not Be Merely Commercial Speech," 88 Temp. L. Rev. 43, 81 (2015).  "As the FDCA's explicit endorsement of physicians' prescribing decisions and common law's 'learned intermediary' tradition suggest, doctors are sophisticated decisionmakers who engage in a multipronged analysis when evaluating medical claims."  K. Bi, "What Is 'False or Misleading' Off-Label Promotion?," 82 U. Chi. L. Rev. 975, 1012-13 (2015).