Posted on: 6/2/2011
Melissa Foster Bird, Jeremy C. Hodges
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The reports of my death have been greatly exaggerated. – Mark Twain
Like the reports of Mark Twain’s death that circulated while he was abroad in Europe, the learned intermediary doctrine has also been reported as dead in West Virginia. Unlike Mark Twain, however, the reports of the learned intermediary doctrine’s demise were well-founded, at least at the time, given the Supreme Court of Appeals of West Virginia’s decision in State of West Virginia ex rel. Johnson & Johnson Corp. v. Hon. Mark A. Karl, 220 W. Va. 463, 647 S.E.2d 899 (2007), which specifically declined to adopt the doctrine. Fortunately for drug and device companies, and the attorneys who represent them in West Virginia, the learned intermediary doctrine has made something of a comeback since 2007, based on a well-reasoned decision from the federal judiciary and the recent enactment of Senate Bill No. 474 by the West Virginia legislature.
Before the Supreme Court of Appeals’ 2007 decision in Karl, the learned intermediary doctrine had been discussed by West Virginia federal courts in several cases involving both prescription drugs and medical devices, including Rohrbough, v. Wyeth Labs, Inc., 719 F.Supp. 470 (N.D. W. Va. 1989), which recognized the doctrine (although it was not central to the court’s holding), in a case involving a vaccine that immunized infants and children against diphtheria, tetanus and pertussis. The doctrine played a much more significant role in Pumphrey v. C.R. Bard, Inc., 906 F. Supp. 334 (N.D. W. Va. 1995), where Judge Keeley discussed it at length and relied on it in granting summary judgment in favor of a device manufacturer. In doing so, Judge Keeley recognized the lack of reported cases from West Virginia courts addressing the doctrine, but predicted that West Virginia would adopt the doctrine for two reasons. First, the doctrine was based on the idea that physicians exercise their medical judgment in selecting devices and prescription medications for patients based on their individualized knowledge of the patient. Second, a then-tentative draft of the Restatement (Third) of Torts included a section that provided prescription drug and device manufacturers with a learned intermediary defense to claims of defect based on a product’s warnings, if adequate warnings and instructions were provided to prescribers and other health care providers who were in a position to reduce risks associated with the use of the product. Additionally, Judge Keeley noted that this draft section, which later became § 6 of the Restatement (Third) of Torts, “reflect[ed] the law in an overwhelming number of jurisdictions. Id. at 338.
A pair of cases from the Southern District of West Virginia followed Rohrbaugh and Pumphrey, and applied the learned intermediary doctrine in prescription drug cases to bar failure to warn claims against pharmacies. The first decision was in Baker v. Purdue Pharma, L.P., No. 1:01-0553, 2002 U.S. Dist. LEXIS 28129 (N.D. W. Va. March 28, 2002), where Judge Faber agreed with Judge Keeley and opined that West Virginia would adopt the learned intermediary doctrine if asked, but would not impose a duty to warn of the risks of prescription drugs on pharmacists. Judge Copenhaver reached a similar conclusion in Ashworth v. Albers Medical, Inc., 395 F. Supp. 2d 395 (S.D. W. Va. 2005), where unbeknownst to the pharmacy, it dispensed and plaintiff ingested counterfeit prescription medication. There, the court specifically held that the learned intermediary doctrine applied to discharge the pharmacy of any duty to warn customers of the risks of possible counterfeit drugs where the pharmacy received the drugs from the manufacturer and did not alter them before dispensing them to its customers. 395 F. Supp. 2d at 407.
Thus, as of 2005, the learned intermediary doctrine appeared to be gaining favor in West Virginia, particularly in the federal courts. Any momentum that the doctrine may have been gaining, however, came to an abrupt halt in 2007, when Janssen petitioned the Supreme Court of Appeals for West Virginia for a writ of prohibition to prevent the Circuit Court of Marshall County from enforcing an order that declined to apply the learned intermediary doctrine. Karl, 220 W. Va. 463, 647 S.E.2d 899. Not only did the Supreme Court of Appeals decline to grant the writ of prohibition, but it took the opportunity to address the learned intermediary doctrine head on despite the fact that the case was before the court on a factual record that had not been “conclusively determined." Chief Justice Davis began the decision by noting the court’s disagreement with commentators and authorities (and perhaps Judge Keeley’s opinion in Pumphrey) who suggested that an “overwhelming majority” of jurisdictions had adopted the learned intermediary doctrine. According to the court, this conclusion was not accurate because it counted lower state and federal circuit court cases and not just decisions from the highest state courts. The court found that “only twenty-two” of the highest state courts had adopted the learned intermediary doctrine, while six others had referred to the doctrine favorably in dicta or adopted it in a case that did not involve prescription drugs. Id. at 467-69, 647 S.E.2d at 903-05.
Having determined that the learned intermediary doctrine was not universally accepted, the Supreme Court of Appeals next found that it was “not a modern doctrine” since its origins could be traced back to 1925. Id. at 470, 647 S.E.2d at 906. According to the court, various aspects of the physician/patient relationship had changed since 1925, including the initiation and rise of direct-to-consumer (DTC) advertising for prescription drugs, which the court discussed and analyzed in detail despite the apparent lack of any evidence in the record that suggested that the drug at issue (Propulsid) was the subject of a DTC marketing campaign or that DTC marketing affected the underlying physician/patient relationship in any way. Even so, the court went on to outline the dramatic rise in pharmaceutical DTC marketing, and noted that in 1997, the amount of money pharmaceutical companies spent on DTC marketing increased sharply. The court also noted that since 1997, only four high courts had adopted the learned intermediary doctrine and apparently none of them considered the effects that DTC marketing caused on the physician/patient relationship when adopting the doctrine. Id. at 472-73, 647 S.E.2d at 908-09.
In contrast to those other high courts, the West Virginia court was concerned with these changes to the patient/physician relationship and, in particular, how those changes affected what the court believed were the four premises that form the basis for the intermediary doctrine:
- a reluctance to undermine the physician/patient relationship;
- absence of the need for the patient’s informed consent in the outdated era of “doctor knows best”
- inability of manufacturers to communicate with patients; and
- the complexity of the subject matter.
Id. at 474, 647 S.E.2d at 910 (quoting Perez v. Wyeth Labs. Inc., 161 N.J. 1, 18-19, 734 A.2d 1245, 1255-56). Ultimately, the Supreme Court of Appeals found itself in agreement with the New Jersey Supreme Court’s Perez decision, and declared that all of the premises for the learned intermediary doctrine had been “obviated” by the rise in DTC marketing. Moreover, it saw no use in adopting a doctrine that was supposedly subject to “numerous” exceptions. Id. at 477, 647 S.E.2d at 913. Finally, in what seemed like an afterthought at the time, the court also declared that because prescription drug manufacturers are aware of the potential risks of their products and they profit from the sales of those products, then it was not unreasonable to expect manufacturers to provide warnings about the risks of their products to the ultimate users. Id. The court did not specifically state that it reached this conclusion based on “public policy” considerations, although the issue was framed as a public policy consideration in a law review article that was extensively quoted in the court’s opinion.
Although the West Virginia Supreme Court’s Karl decision cast significant doubt about the future of the learned intermediary doctrine in West Virginia, it did not kill the doctrine off entirely, in part because of the specific context that was central to the court’s reasoning in declining to adopt the doctrine. Specifically, the court went to great lengths to explain the effects of the rise in DTC marketing on the patient/physician relationship as it pertained to prescription pharmaceuticals and the court’s belief that these changes rendered the learned intermediary doctrine obsolete—leaving open the possibility that the doctrine might apply in nonprescription drug cases and cases that involve products that are not marketed directly to end users (e.g., prescription medical devices), and at least one court has reached this conclusion since 2007. In a case from the Southern District of West Virginia, Judge Chambers was asked to determine whether the closely related sophisticated user defense was available to a manufacturer of a potentially dangerous chemical which it sold to the decedent’s employer. Roney v. Gencorp, 654 F. Supp. 2d 501 (S.D. W. Va. 2009). The sophisticated user defense is closely related to the learned intermediary doctrine, both having their origins in section 388 of the Restatement (Second) of Torts (the sophisticated user defense at comment n, and the learned intermediary doctrine at comment k). Like the learned intermediary doctrine, the sophisticated user defense provides that if the manufacturer of an inherently dangerous product supplies the product through a third person (e.g., an employer) for use by others (e.g., the employees), then the manufacturer may discharge its duty to warn by informing the third party of the dangers associated with the product and of any precautions that must be exercised to use the product safely. Id. at 503.
Judge Chambers began his analysis by noting that the context of the Karl decision was extremely important to the Supreme Court of Appeals’ reasoning and conclusion in that case. Specifically, its holding relied on the perceived ubiquity of pharmaceutical DTC marketing whereas the factual record before Judge Chambers lacked any sort of direct marketing of the chemical in question to its end users. In stark contrast to the supposed new era of patient/physician relationships described in Karl, the plaintiff in Roney had little opportunity to influence the selection of products he would be exposed to and relied on his employer to determine how the selected products would be used. Id. at 505. Because the Karl decision was based on “reasoning entirely inapplicable” to the facts before Judge Chambers, he was able to conclude that despite Karl, West Virginia might apply some version of the sophisticated user doctrine. Although it did not specifically address the learned intermediary doctrine, Judge Chambers reasoning and analysis in Roney likely breathed some life back into the doctrine in West Virginia, especially in cases where the product in question was not marketed or advertised to its end user, including medical devices that are generally not the subjects of DTC marketing campaigns
More recently, the learned intermediary doctrine made another step in the road to recovery in West Virginia. Shortly after the 2011 regular session of the West Virginia legislature adjourned on March 18, 2011, former Senate Bill No. 474 was approved by the Acting Governor and became law. That bill created a new section of the West Virginia Code, § 55-8-16, which provides: "(a) It is public policy of this state that, in determining the law applicable to a product liability claim brought by a nonresident of this state against the manufacturer or distributor of a prescription drug for failure to warn, the duty to warn shall be governed solely by the product liability law of the place of injury (lex loci delicti). (b) This action shall be applicable proactively to all civil actions commenced on or after July 1, 2011."
Senate Bill No. 474. As a result, any non-resident plaintiff who files a failure to warn claim regarding a prescription drug in West Virginia will not be able to avoid application of the learned intermediary doctrine if the law of their home state recognizes the doctrine.
Senate Bill No. 474 was undoubtedly introduced to prevent forum shopping by prescription drug plaintiffs who might be drawn to file suit in West Virginia after July 1, 2011, in the hopes of avoiding the learned intermediary doctrine, which would otherwise apply if their suit was litigated in the courts of their home state. Although this would seem to be a narrow subset of potential plaintiffs, enactment of Senate Bill No. 474 should represent significant reform since there are currently two MDLs involving prescription products that are currently pending in West Virginia and there have been at least two cases involving this very factual scenario within the last two years. See Woodcock v. Mylan, Inc., 661 F. Supp. 2d 602 (S.D. W. Va. 2009); Vitatoe v. Mylan Pharmaceuticals, Inc., 696 F. Supp. 2d 599, No.1:08CV85, 2010 U.S. Dist. LEXIS 27038 (N.D. W. Va. Mar. 5, 2010).
The district court in both cases was sitting in diversity, and was presented with a choice of law problem because both plaintiffs were residents of states other than West Virginia. As such, the courts had to first perform an Erie analysis to determine which state’s substantive law would apply, West Virginia’s as the forum state, or the law of the state of the plaintiffs’ residence (Alabama and Louisiana), both of which happened to recognize the learned intermediary doctrine. In Woodcock, Chief Judge Goodwin found that, as a rule, West Virginia applies the law of the place of injury in tort actions, or lex loci delicti. The one notable exception to that rule, however, is that West Virginia would not apply the law of the foreign state if doing so would violate West Virginia public policy. Woodcock, 661 F. Supp. 2d at 605.
Thus, the district courts had to determine if application of the learned intermediary doctrine would offend West Virginia public policy, and the portion of the West Virginia Supreme Court’s opinion in Karl, which addressed the reasonableness of requiring manufacturers to warn patients of the risks associated with prescription drugs (and which originally seemed to be an afterthought) became critical to the district court’s decision of whether to uniformly apply the lex loci delicti rule to all of the plaintiffs’ prescription drug claims, or to apply the law of the foreign state but not the learned intermediary doctrine. In Woodcock, Chief Judge Goodwin was “convinced” that if faced with this question, the Supreme Court of Appeals of West Virginia would find that that application of the learned intermediary doctrine would violate West Virginia public policy. Woodcock, 661 F. Supp. 2d at 607-08; Vitatoe, 696 F. Supp. 2d at 609 (following Judge Goodwin’s decision in Woodcock). Thus, district courts in West Virginia applied the foreign state’s law to a plaintiff’s prescription drug claims, but would not apply the learned intermediary doctrine if it was recognized by that foreign state, raising the prospect that many more plaintiffs might attempt to bring their claims in West Virginia despite the lack of any factual connection, in the hopes of avoiding the learned intermediary doctrine.
Fortunately, for drug and medical device manufacturers, the passage of Senate Bill No. 474 by the West Virginia Legislature will halt that practice for all cases brought after July 1, 2011. Moreover, implementation of the statute also revives the learned intermediary doctrine in West Virginia law and keeps the prospect alive that the doctrine might once again gain favor and that the Supreme Court of Appeals – a majority of which has changed since the Karl decision – might eventually reconsider the doctrine in a future case. For now, however, the post-Karl federal decisions strongly suggest that the holding in Karl is now limited to only those cases where there is evidence of DTC marketing.
Melissa Foster Bird
Nelson Mullins Riley & Scarborough, LLP
Huntington, West Virginia
Jeremy C. Hodges
Nelson Mullins Riley & Scarborough, LLP
Columbia, South Carolina