Important Preemption Decision

Last week the Sixth Circuit issued a significant opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals Inc., No. 15-3104, 2015 WL 8538119 (6th Cir. Dec. 11, 2015), upholding impossibility preemption of design defect claims against brand-name drug manufacturers.

Yates alleged she experienced a stroke while using the ORTHO EVRA® birth control patch, and sued the manufacturers of the patch.  Yates alleged five causes of action against defendants: (1) strict liability in tort—failure to warn; (2) strict liability in tort—manufacturing defect; (3) negligence; (4) breach of implied warranty; and (5) breach of express warranty.  The district court granted summary judgment as to Yates's failure to warn claim. 2014 WL 1369466 (N.D.Ohio Apr. 7, 2014). Thereafter, the district court granted summary judgment as to Yates's remaining claims and entered final judgment dismissing the case. 76 F.Supp.3d 680 (N.D.Ohio 2015). Yates timely appealed the district court's dismissal of all five of her causes of action.  The Sixth Circuit affirmed.

Failure to warn.

To establish a claim against a drug manufacturer for failure to warn under New York law, a plaintiff must demonstrate that the warning was inadequate and that the failure to adequately warn of the dangers of the drug was a proximate cause of his or her injuries. Krasnopolsky v. Warner–Lambert Co., 799 F.Supp. 1342, 1346 (E.D.N.Y.1992) (quoting Glucksman v. Halsey Drug Co., 160 A.D.2d 305, 553 N.Y.S.2d 724, 726 (1990)). The manufacturer's duty to warn extends to the treating physician, and not directly to the patient. Glucksman, 553 N.Y.S.2d at 726. It has long been the law in New York that prescription medicine warnings are adequate when information regarding the precise malady incurred was communicated in the prescribing information. Alston v. Caraco Pharm., Inc., 670 F.Supp.2d 279, 284 (S.D.N.Y.2009) (quoting Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95, 96–97 (1979)).  In this case, the “precise malady incurred” was a stroke, and the risk of stroke was communicated in the prescribing information. Defendants mentioned the risk of stroke several times in the package inserts. The label specifically stated there was an increased risk of several serious conditions including stroke. Thus, there was no genuine issue of material fact for a jury on the issue of whether defendants failed to adequately warn Yates, through her prescribing medical provider, of the risk of stroke associated with the product. 

Preemption

Readers know that state law claims can be preempted expressly in a federal statute or regulation, or impliedly, where congressional intent to preempt state law is inferred.  Congress may intend federal law to occupy the field,  or state law may conflict with a federal statute.  Conflict preemption exists where it is impossible for a private party to comply with both state and federal law, or when the state law is an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. A court needs to ascertain whether federal law expressly prohibits the defendant from complying with state law, or there is sufficient, sometimes termed clear evidence, that the FDA would have prohibited the defendant from taking the necessary steps under state law.

The next issue in this case was whether defendants could have complied with their alleged duty under New York law to have designed a safer drug, given FDA approvals of the design. The court reviewed Supreme Court guidance in three recent opinions on federal preemption in pharmaceutical products liability suits: LevineMensing, and  Bartlett, in which plaintiff argued that the manufacturers could comply with both federal and state law by choosing not to make the drug at all. The Supreme Court reversed, holding that impossibility preemption barred the plaintiff's claims. As for drug redesign, the Court found that was impossible for two reasons: (1) the FDCA requires generic drugs to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based; and thus the drug was “chemically incapable” of being redesigned. 

New York law provides that a product is defectively designed if  the product, as designed, was not reasonably safe because there was a substantial likelihood of harm and it was feasible to design the product in a safer manner. Doomes v. Best Transit Corp., 17 N.Y.3d 594, 608, 935 N.Y.S.2d 268, 958 N.E.2d 1183 (2011). New York follows a “risk-utility” approach to determining whether a product is not reasonably safe, which calls for consideration of several factors: (1) the utility of the product to the public as a whole and to the individual user; (2) the nature of the product—that is, the likelihood that it will cause injury; (3) the availability of a safer design; (4) the potential for designing and manufacturing the product so that it is safer but remains functional and reasonably priced; (5) the ability of the plaintiff to have avoided injury by careful use of the product; (6) the degree of awareness of the potential danger of the product which reasonably can be attributed to the plaintiff; and (7) the manufacturer's ability to spread any cost related to improving the safety of the design.

The court concluded that Yates's post-approval design defect claim was clearly preempted by federal law. FDA regulations provide that once 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 inactive ingredients, or in the specifications provided in the approved application. 21 C.F.R. § 314.70(b)(2)(i). Moderate changes must be reported to the FDA at least 30 days prior to distribution of the drug product made using the change. Id. § 314.70(c).  Based on the plain meaning of the regulation,  defendants could not have altered the dosage of estrogen without submission to the FDA and the agency's approval prior to distribution of the product made using the change. Changing the dosage level of the active ingredient of ORTHO EVRA® constituted a “major change."  Quite simply, federal law prohibited defendants from decreasing the dosage of estrogen post-approval.

Readers should note the Sixth Circuit going out of its way to state that the FDA pre-approval requirement for design changes applied to all prescription drugs, with a reference to “branded or generic” drugs.  The court also rejected plaintiff's contention that there is no federal law that would have prohibited defendants from designing a different drug in the first instance, as opposed to altering an approved design. Yates's argument regarding defendants' pre-approval duty was too attenuated. To imagine such a pre-approval duty exists, a court would have to speculate that had defendants designed ORTHO EVRA® differently, the FDA would have approved the alternate design. Next, the court would have to assume that Yates would have selected this method of birth control from all the choices, and in the face of whatever warnings were on the label. Further the court would have to suppose that this alternate design would not have caused Yates to suffer a stroke. "This is several steps too far".  The argument was contingent upon whether the FDA would approve the alternate design in the first place, and this “never start selling” claim was also preempted because it mirrored the “stop selling” claim rejected in Bartlett.   

The Sixth Circuit affirmed the district court’s grant of summary judgment on all claims ( the others on fact-specific issues we won't get into here).

 

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