Product Liability Litigation Update—April 2016
In This Issue:
- West Virginia Adopts Learned Intermediary Rule
- Several Courts Apply Bartlett to Find Preemption of Design Defect Claims
- Federal Court Dismisses Claims That Did Not Involve Off-Label "Promotion"
For years, West Virginia was one of a small minority of states that rejected the learned intermediary doctrine--a key doctrine in pharmaceutical product liability litigation holding that a drug manufacturer's duty runs to the prescribing physician and not the patient. That is no longer the case. The West Virginia legislature recently passed S.B. 15, adopting the learned intermediary doctrine as a defense to civil actions based upon inadequate warnings or instructions.
Generally, manufacturers have a duty to warn consumers of the risks of using their products. The learned intermediary doctrine serves as an exception to that rule, by acknowledging that the learned intermediary (typically the prescribing physician) has primary responsibility to warn patients of the risks of prescription drugs. The principle operates to shift drug manufacturers' duty to adequately warn to the prescribing physician, and relieves them of most obligations to warn the consumer directly of the risks. Up until now, West Virginia has been the only state in the nation to broadly reject the learned intermediary rule. See State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 903-05 (W. Va. 2007).
By adopting the new Code of West Virginia § 55-7-30, West Virginia will now limit civil liability for manufacturers or sellers of prescription drugs or medical devices who provide warnings to a learned intermediary. The Act provides in relevant part that a "manufacturer or seller of a prescription drug or medical device may not be held liable in a product liability action for a claim based upon inadequate warning or instruction unless the claimant proves" that: (1) the "manufacturer or seller . . . acted unreasonably in failing to provide reasonable instructions or warnings regarding foreseeable risks of harm to prescribing or other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings"; and (2) the "[f]ailure to provide reasonable instructions or warnings was a proximate cause of harm" to the claimant. § 55-7-30(a)(1)-(2).
S.B. 15 will become effective on May 17, 2016. However, there is currently an open question as to whether § 55-7-30 applies retroactively to existing litigation.
In Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013), the Supreme Court held that federal law preempted a design defect claim against a generic drug manufacturer. Branded manufacturers have since argued that this holding applies equally to branded companies who lack authority under federal law to change the formulation of FDA-approved drugs. Several recent cases have found this argument persuasive and dismissed design defect claims against branded companies.
The leading case so far on this issue is Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir. 2015). The plaintiff in Yates alleged that she suffered a stroke caused by the ORTHO EVRA® birth control patch. Plaintiff brought, among other claims, a New York state strict liability claim based on the patch's allegedly defective design. A district judge in the Northern District of Ohio granted summary judgment as to all of plaintiff's claims, including design defect.
A Sixth Circuit panel unanimously affirmed summary judgment. The panel found that Bartlett's framework applied here, even though a brand-name drug was at issue. First, plaintiff's argument that defendants had a post-approval duty to institute an alternative design was preempted because defendants could not have made such a change unilaterally. While plaintiff argued that a reduction in the drug's estrogen level "'would be minimal,'" the panel finely parsed FDA regulations and found this to be a more significant change requiring FDA pre-approval. Second, the panel rejected as "too attenuated" plaintiff's argument that defendants had a pre-approval duty to design the drug differently in the first instance because it required too many assumptions: (i) that "the FDA would have approved the alternate design"; (ii) that plaintiff "would have selected this method of birth control"; and (iii) that the alternate drug would not have caused plaintiff's alleged injury. Plaintiff was "essentially argu[ing] that defendants should never have sold the FDA-approved formulation of ORTHO EVRA® in the first place," and this "never-start-selling rationale" was akin to the "stop-selling rationale" rejected by Bartlett.
Since the Yates decision, district courts in other circuits have reached similar conclusions. In March of this year, United States District Judge Michael P. Shea of the District of Connecticut granted summary judgment on a claim that Motrin was defectively designed on the basis of preemption. In Batoh v. McNeil-PPC, Inc., __ F. Supp. 3d __, 2016 WL 922779 (D. Conn. Mar. 10, 2016), the court quoted Bartlett for the proposition that, "[o]nce a drug--whether generic or brand name--is approved, the manufacturer is prohibited from making any major changes to the 'qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.'" Thus, because the defendants could not have unilaterally substituted dexibuprofen for ibuprofen (presumably plaintiff's suggested change), plaintiff's defective design claim was preempted.
Only eleven days later, United States District Judge Madeline Hughes Haikala issued a memorandum opinion finding claims that Serophene, a brand-name fertility drug, was defectively designed were also preempted. In Barcal v. EMD Serono, Inc., No. 5:14-cv-01709, 2016 WL 1086028 (N.D. Ala. Mar. 21, 2016), the court converted defendant's motion to dismiss into a summary judgement motion and granted summary judgment as to the defective design claim. This grant was based on two independent grounds: (i) prescription drugs are "unavoidably unsafe" under Alabama law, and so it is their warnings that determine whether these products are defective; and (ii) the defendant could not have unilaterally changed the drug's composition without the FDA's permission, so the defective design claim was preempted.
As courts continue to apply the Bartlett framework to defective design claims, branded drug manufacturers may find preemption an increasingly powerful defense.
On February 8, 2016, Judge Gray H. Miller of the Southern District of Texas granted summary judgment on the relators' remaining claims against pharmaceutical manufacturer Solvay S.A. United States ex rel. King v. Solvay S.A., No. 06-2662, 2016 U.S. Dist. LEXIS 14804 (Feb. 8, 2016 S.D. Tex.). Relators and governmental plaintiffs have increasingly pressed a "formulary influence" theory of liability, alleging that off-label promotion or kickbacks caused states to wrongfully include a drug on their formularies or give them preferred formulary status. King provides an excellent example of how putting plaintiffs to their proof can dispense of such claims.
In King, the relators filed suit against Solvay related to its promotion of three prescription drugs. Among other allegations, the relators contended that Solvay pushed off-label information on members of states' pharmaceutical and therapeutical (P&T) committees to obtain placement of its drugs on state Medicaid formularies or Preferred Drug Lists and "wined and dined" P&T members to influence their decisions. In a careful and detailed opinion, Judge Miller parsed the evidence plaintiffs could muster on summary judgment as to each specific state at issue and ended up dismissing each of the claims.
For example, the relators claimed that Solvay engaged in off-label promotion when it (1) sent dossiers that included off-label information to P&T committees, and (2) distributed a supplement to an American Journal of Managed Care article that similarly included off-label information. But the district court noted that relator had offered no evidence that these actions constituted off-label promotion based on the specific facts. Rather, Solvay had sent the dossiers to the committees at their request when they asked for all available data about the drug. Second, the court held that the relators lacked evidence that Solvay violated any promotional regulation with regard to a supplement to a medical journal containing off-label information. Relator alleged that the supplement was written by a Solvay consultant but failed to back up that claim with evidence. Moreover, Solvay expressly warned its sales representatives not to use the supplement in promoting their drugs.
The court also dismissed claims that the defendant improperly "wooed" several states' P&T committees due to lack of causation. The relators pointed to a number of call notes showing visits between doctors who served on P&T Committees and company sales representatives. But the court surveyed the evidence and found that no reasonable jury could conclude that the visits caused states to put the drug on their preferred drug lists. In many cases, for example, the temporal connection between the visits and the P&T committees' decisions was just too tenuous.
The court's ruling shows the potential vulnerabilities of the "formulary influence" theory. Even if such allegations are able to pass muster at the motion to dismiss phase, proving them can be a harder task.For questions or comments on this newsletter, please contact the Product Liability group at email@example.com.