MEMORANDUM OPINION AND ORDER
(.Motion in Limine No. 9)
Pеnding before the court is Boston Scientific Corporation’s (“BSC”) Motion in Limine to Preclude Any Evidence or Argument That Boston Scientific Owed 'or Breached a Duty to Warn Plaintiffs Directly (“Motion in Limine No. 9”). (See BSC’s Initial Mots, in Limine [Docket 374], at ¶ 9). For the reasons set forth below, BSC’s Motion in Limine No. 9 is GRANTED.
I. Background
This consolidated case resides in one of seven MDLs assigned to me by the Judicial Panel on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ prolapsе and stress urinary incontinence. In the seven MDLs, there are over 60,000 cases currently pending, over 13,000 of which are in the Boston Scientific Corporation MDL, MDL 2326. In this particular case, the four consolidated plaintiffs were surgically implanted with the Obtryx Transobturator Mid-Urethral Sling System (“the Obtryx”), a mesh product manufactured by BSC. (See Pretrial Order # 78 [Docket 9], at 1-2).
BSC has submitted twenty-five motions in limine, all of which I have ruled on except for the motion at bar. (See Mem. Op. & Order (Def.’s Mot. in Limine re: MSDS) [Docket 443]; Mem. Op. & Order re: Motions in Limine [Docket 464]). In its remaining motion in limine, BSC asks the court to prеclude evidence that BSC owed or breached a duty to directly warn the plaintiffs about the risks associated
BSC asserts two arguments to support its position. First, BSC contends that the plaintiffs did not rely upon'warnings provided by BSC, instead depending entirely on the medical judgment of their treating physician when deciding to undergo pelvic implant surgery. Thus, according to BSC, whether BSC owed a duty to directly warn the plaintiffs is “irrelevant to whether they would havе undergone the Obtryx procedure.” (Id. at 23-24). Because the plaintiffs have demonstrated that questions of fact exist regarding information they received prior to implant surgery, as explained in my summary judgment rulings, I am not persuaded by this reasoning. (See, e.g., Mem. Op. & Order re: Campbell [Docket 445], at 6). BSC’s second argument, however, requires further consideration.
BSC next claims that its duty to directly warn the plaintiffs is irrelevant because West Virginia courts have not eliminated the learned intermediary doctrine in the context of medical device manufacturers. BSC maintains that while the West Virginia Supreme Court of Appeals rejected the learned intermediary doctrine in State ex rel. Johnson & Johnson v. Karl,
II. Discussion
In reviewing this motion, I face a novel question of West Virginia products liability law. Karl unequivocally rejects the learned intermediary doctrine as applied to drug manufacturers, a ruling that departs from the law of forty-eight states by most recent count.
A. Determining the Scope of Karl
In Karl, the Supreme Court of Appeals confronted a motion in limine very similar to the оne in this case. Facing various products liability claims, the defendant drug manufacturer, Janssen Pharmaceutical (“Janssen”), asked the court to exclude evidence or argument by the plaintiff suggesting that Janssen had a duty to provide warnings about its manufactured drug to the plaintiff personally. Id. at 901. In other words, relying on the learned intermediary doctrine, Janssen contended that by providing adequate warnings about the drug to the plaintiffs treating physician, Janssen satisfied its duty to warn such that any direct communication with the plaintiff, or lack thereof, was irrelevant. Id. The circuit court denied the motion in limine, observing that West Virginia’s highest court had not yet adopted the learned intermediary doctrine. Id.
On petition for writ of prohibition, Jans-sen asked the Supreme Court of Appeals to join the majority of states and “adopt the learned intermediary doctrine as an exception to the general duty of manufacturers to warn consumers of the dangerous propensities of their products.” Id. at 900-01. In three separate opinions, a majority of the court denied the writ of prohibition, declining to adopt the learned intermediary doctrine. See id. at 901 (majority opinion by Chief Justice Davis); id. at 917 (Maynard, J., concurring); id. at 918 (Starcher, J., concurring). The two remaining justices dissented to the decision. See id. at 914 (Albright, J., dissenting, joined by Benjamin, J.). Left with these four puzzling opinions that have few common aspects, I must discern a concrete рrinciple on which three out of the five justices agreed in order to determine Karl’s application in this case.
To facilitate this endeavor, I borrow the United States Supreme Court’s approach for instances in which the Justices have entered multiple opinions on various grounds:
When a fragmented Court decides a case and no single rationale explaining the result enjoys the assent of [a majority] of Justices, the holding of the court may be viewed as that position taken by those members who concurred on the narrowest grounds.
Marks v. United States,
First, Chief Justice Davis’s majority opinion directs the following ruling: “[W]e now hold that, under West Virginia products liability law, manufacturers of prescription drugs are subject to the same duty to warn consumers about the risks of their products as other manufacturers.” Karl,
Second, while the justices discuss numerous rationales for rejecting the learned intermediary doctrine, their concern with the emergence of DTC advertising stands out among the opinions as the primary justification for Karl. Chief Justice Davis provides the most detailed analysis of this matter. She begins by enumerating the “primary justifications” that led to the creation of the learned intermediary doctrine:
(1) the difficulty manufacturers would encounter in attempting to provide warnings to the ultimate users of prescription drugs; (2) patients’ rеliance on their treating physicians’ judgment in selecting appropriate prescription drugs; (3) the fact that it is physicians who exercise their professional judgment in selecting appropriate drugs; (4) the belief that physicians are in the best position to provide appropriate warnings to their patients; and (5) the concern that direct warnings to ultimate users would interfere with doctor/patient relationships.
Id. at 905. Chief Justice Davis then concludes that the “recent initiation and intense proliferation of .direct-to-consumer advertising,” accompanied by “the development of the internet as a common method of dispensing and obtaining prescription drug information,” id. at 907, has “obviate[d] each of the premises upon which the [learned intermediary] doctrine rests.” Id. at 910.
Specifically, the practice of advertising directly to patients “suggests that consumers are active participants in their health care,” invalidating the paternalistic role of
These two points of agreement result in the narrowed reading of Karl set forth above. Other federal district court judges have also assumed this tailored interpretation of Karl. In Roney v. Gencorp, Chief Judge Chambers stated, “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.”
Having exercised Marks’s directive and determined Karl’s narrow holding — that the learned intermediary doctrine does not protect drug manufacturers who engage in DTC, advertising — I now turn to the present matter.
B. Distinguishing This Case from Karl
Based on Karl’s majority ruling, I conclude that Karl does not govern this case. The learned intermediary doctrine is appropriately applied here because (1) BSC did not directly advertise the Obtryx to the consumer; and (2) the Obtryx is an implanted medical device rather than a consumed prescription drug.
1. Absence of DTC Advertising
DTC advertising, according to the Karl court, eliminates the premises underlying the learned intermediary doctrine. BSC, however, did not advertise the Obtryx directly to customers. (See Def.’s Mem. [Docket 375], at 24 (asserting that the Obtryx “has never been advertised on television by the manufacturers”)). Indeed, the deposition testimony of BSC sales representative Arthur Butcher demonstrates that BSC predominantly, if not entirely, marketed its product to physicians. (See Butcher Dep. [Docket 395-8], at 33:2-22 (discussing Butcher’s efforts to market BSC products to physicians and the content of Butcher’s “sales pitch”)).
Without DTC advertising, the premises of the learned intermediary doctrine rema-terialize. For example, lacking an advertising forum, BSC, unlike the defendants in Karl, cannot easily communicate with end-consumers. See Karl,
2. Implanted 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 failurе to warn claims. See, e.g., Hurley v. Heart Physicians, P.C.,
The Obtryx sling is analogous to the knee replacement device that the Beale court considered. Patients cannot obtain the Obtryx sling 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.
III. Conclusion
In sum, without the presence of end-consumer advertising, the rationale for rejecting the learned intermediary doctrine is not persuasive. At the same time, when the product involved is a medical device rather than' a drug, the rationale for applying the learned intermediary doctrine is compelling. The present case lies at the intersection of this reasoning. BSC, the manufacturer of a medical device and a company that markets to physicians rather than patients, is not subject to the Karl ruling, and as a result, the learned intermediary doctrine applies to the plaintiffs’ failure to warn claims. Accordingly, BSC only had a duty to warn the plaintiffs’ treating physicians of the risks involved with the Obtryx implant. Any evidence or argument that BSC owed or breached a duty to warn the plaintiffs directly is therefore irrelevant.
In reaching the conclusion that the learned intermediary doctrine would apply in West Virginia where a device manufacturer has not participated in DTC advertising, the court was encouraged by the nearly unanimous national recognition of the doctrine’s value. Applying the learned intermediary doctrine — -as forty-eight states currently do — fosters the uniformity
The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any unrepresented party. The court further DIRECTS the Clerk to post a copy of this published opinion on the court’s website, www.wvsd.uscourts.gov.
Notes
. I originally consolidated the cases of eleven plaintiffs implanted with the Obtryx. (See Pretrial Order # 78 [Docket 9], at 1 (naming Canterbury, Billings, Sexton, Hendricks, Moore, Tyree, Campbell, Blankenship, Pugh, Workman, and Wilson as consolidated plaintiffs)). Four plaintiffs now remain in this action. (See Pretrial Order # 94 [Docket 67], at 1 (removing Sexton case from the consolidated West Virginia cases); Stipulation of Dismissal [Docket 104] (dismissing the claims of Donna Billings with prejudice); Order Dismissing Canterbury Plaintiff [Docket 107], at 1 (dismissing the claims of Karen Canterbury with prejudice); Stipulation of Dismissal [Docket 123] (dismissing the claims of Neasha Workman with prejudice); Stipulation of Dismissal With Prejudice[Docket 426] (dismissing with prejudice the claims of Sharon Pugh, et al.); Stipulation of Dismissal With Prejudice [Docket 433] (dismissing plaintiff Tammy Hendricks with prejudice); Stipulation of Dismissal With Prejudice [Docket 427] (dismissing plaintiff Dreama Moore with prejudice)).
. DTC advertising is a marketing technique employed by pharmaceutical manufacturers in which “[plharmaceutical remedies for varied problems. such as allergies, nail fungus, hypertension, hair loss, and depression are placed directly before the consumer in magazines, television, and via the Internet.” Perez v. Wyeth Labs., Inc.,
. In 2012, the Texas Supreme Court counted thirty-five states, including the District of Columbia, in which the high court has "adopted some form of the learned intermediary doctrine within the prescription drug products-liability context” or that has at least "cited favorably to its application within this context.” Centocor, Inc. v. Hamilton,
. Curiously, in her decision to eliminate the learnеd intermediary doctrine, Chief Justice Davis relies heavily on the analysis in Perez v. Wyeth Laboratories, Inc., wherein the New Jersey Supreme Court merely created an exception to the learned intermediary doctrine for cases in which the manufacturer participated in DTC advertising. Perez,
. The plaintiffs point to this court's previous opinion in Woodcock v. Mylan, Inc.,
As an initial matter, Woodcock addressed a choice-of-law issue, an entirely different legal subject matter than that presented in the case at bar. See Woodcock,
