Diverging from other courts’ decisions in 2014, the Ninth Circuit in 2015 held that a state law failure to warn claim was not preempted by the Medical Device Amendments of 1976 (MDA) to the Food, Drug & Cosmetics Act (FDCA) (therefore, a jury instruction on negligence per se was proper). This decision runs counter to a California appellate court decision that held the FDCA preempted a state law failure to warn claim and a Third Circuit decision which held that the FDCA preempted state law design defect claims.
Earlier in 2014, California’s Second District Court of Appeal, Division 5, held that a patient’s failure to warn claim for promoting off-label uses was expressly preempted. The patient claimed that the manufacturer of a device used in surgery to strengthen the spines of individuals with degenerated vertebral discs promoted off-label uses of the device without adequately warning of the associated risks. In holding this particular claim preempted by the FDCA, the court explained that strict liability failure to warn under California law imposed a requirement to warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. Federal regulations prevented device manufacturers from promoting off-label use of FDA-approved devices. Any duty of the medical device manufacturer to warn the patient and the patient’s doctors about the risks of off-label use would be different from, and in addition to, federal requirements. See: Coleman v. Medtronic, Inc., 2014 WL 286096, 14 Cal. Daily Op. Serv. 1001 (Cal.App. 2 Dist., January 27, 2014) (not designated for publication).
Midway through 2014, the Third Circuit United States Court of Appeals held that consumers’ state-law strict-liability design-defect claims against generic drug manufacturers were pre-empted by the FDCA. The consumers claimed that generic drug manufacturers of alendronate sodium, a generic form of Fosamax, a drug used for treating bone conditions such as osteoporosis and Paget’s disease, were strictly liable for design defect because alendronate sodium made bone highly mineralized, homogenous, brittle, and more susceptible to fracture. The court explained that the consumers’ state-law strict-liability design-defect claims were pre-empted by the FDCA, where, short of exiting the market, there was nothing the manufacturers could have done to reconcile their conflicting duties under state and federal law. Under the FDCA a generic drug manufacturer may not unilaterally change its labeling or change its design or formulation, and cannot be required to exit the market or accept state tort liability. Thus, to the extent it is impossible for a generic drug manufacturer to comply with its duty under a state tort law unless it takes one of those actions, that law is pre-empted by the FDCA. See: In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2014 WL 1687811 (C.A.3 (N.J.), April 30, 2014) (not designated for publication).
Conversely, the Ninth Circuit United States Court of Appeals recently explained why state law claims for negligent failure to warn and strict liability based on lack of adequate warnings were not preempted by the FDCA. In McClellan v. I-Flow Corp., 2015 WL 294292 (C.A.9 (Or.), January 23, 2015) (not designated for publication), after undergoing shoulder surgery, a woman was prescribed continuous infusion of a painkiller, delivered through a continuous infusion pump device, known as a pain pump, to her shoulder joint. Subsequently, the woman’s physician diagnosed her with chondrolysis of the shoulder. The woman suffered complete loss of articular cartilage in her main shoulder joints, resulting in a spontaneous fusion of her shoulder due to the ball and socket growing together into a single bone.
The woman sued the manufacturer and distributors of the pain pump for negligence and strict products liability. The complaint alleged that the manufacturer negligently failed to warn that its pain pump should not be used in intra-articular spaces such as the shoulder joints and that the manufacturer was strictly liable for selling a product that was unreasonably dangerous due to a lack of adequate warnings. The woman requested that the court give instructions to the jury on negligence per se and reasonable care. Specifically, Oregon Uniform Civil Jury Instruction 20.03 regarding negligence per se stated:
The plaintiffs have alleged that the defendants violated federal statutes and regulations that require or prohibit certain conduct. I will instruct you regarding these statutes and regulations.
A violation of any of these statutes or regulations by a defendant constitutes negligence unless the defendant proves by a preponderance of the evidence that it was acting reasonably carefully in the circumstances.
Oregon Uniform Civil Jury Instruction 20.04 regarding the consideration of a statute, rule, or standard as evidence whether defendant acted reasonably stated:
You may also consider these statutes and regulations, in determining whether the defendants acted as reasonably careful corporations in the circumstances of this case.
As with other evidence, give it the weight, if any, to which you consider it is entitled.
The United States District Court for the District of Oregon refused to issues these two instructions to the jury reasoning that the FDCA preempted state law negligence claims. Following a jury verdict, the district court entered judgment in favor of the manufacturer and distributors of the pain pump.
The Ninth Circuit United States Court of Appeals vacated and remanded for a new trial due to the district court’s instructional error. The court held that the woman’s state law claims for negligent failure to warn and strict liability based on lack of adequate warnings were not preempted by the FDCA. The Court of Appeals analyzed the appeal using the conflict preemption framework, implicit preemption of state law that occurs where there is an actual conflict between state and federal law. Specifically, the court analyzed the appeal under the second form of conflict preemption: when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.
The Court of Appeals explained in detail why the woman’s state law failure to warn claims were not preempted by the FDCA. First, the court applied the presumption against preemption because, unlike policing fraud against the FDA, the regulation of medical devices prior to the passage of the FDCA was left largely to the States to supervise as they saw fit. The court reviewed a number of fraud-on-the-FDA cases to distinguish them from the case at bar. Most importantly, the court distinguished Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), which the District of Oregon relied on below in finding the woman’s claims were preempted. The court explained that Buckman involved state-law claims that the defendant made fraudulent representations to the FDA, resulting in improper market clearance for bone screws, and harm to patients through their use. In Buckman, the Supreme Court explained that policing fraud against federal agencies was not a field which the States have traditionally occupied and it was the FDA’s exclusive responsibility to police fraud against itself. The Supreme Court went on to hold that this type of fraud-on-the-FDA claim was preempted by the FDCA. Conversely in this case, the Ninth Circuit explained, the woman had not alleged any fraud on the FDA. Instead, the woman alleged failure-to-warn theories related to the labeling and regulation of medical devices. The court found that, unlike policing fraud against the FDA, the regulation of medical devices prior to the FDCA was left largely to the States to supervise as they saw fit. Thus, the woman’s claims were not preempted by the FDCA.
Second, the court found that, the woman’s requested negligence per se jury instruction did not conflict with the congressional intent behind the FDCA. Congress intended that the FDCA be enforced exclusively by the Federal Government. The court found that the woman’s requested instructions would not usurp the exclusive federal enforcement power over the FDCA. The court reasoned that using federal law to establish the standard of care was not an attempt to enforce the underlying federal provisions. The court noted that there was no suggestion that Congress intended to displace traditional tort law by making all policing of medical labels and warnings the exclusive province of the FDA.
Third, the court found that the failure to warn claims did not arise solely by virtue of the FDCA. The allegations at issue occurred outside the context of the regulatory process. The woman’s requested instructions had little to do with direct regulatory interaction with the FDA.
An instruction that a manufacturer’s violation of the FDCA constitutes negligence per se is a strong tool for plaintiffs in medical product liability cases. The Ninth Circuit’s decision in McClellan makes clear that trial courts need to thoroughly consider conflict preemption before refusing to give such an instruction.
Since McClellan, in Guvenoz v. Target Corp., 2015 IL App (1st) 133940 (Ill.App. 1 Dist. Mar 27, 2015) the Appellate Court of Illinois, First District, Fifth Division, also has held that a claim alleging negligence in the design, manufacture, or distribution of drug was not barred on federal preemption grounds; a strict products liability claim was not barred on federal preemption grounds; a claim for negligent misrepresentation was not barred on federal preemption grounds; a claim for fraudulent concealment was not barred on federal preemption grounds; and a claim for statutory consumer fraud was not barred on federal preemption grounds. The court noted that most courts, including Fosamax, have held claims against generic manufacturers preempted, while a substantial minority of courts have allowed claims against generic manufacturers to proceed. Preemption is a significant consideration in any of these types of claims, which counsel must carefully consider.
By Sarah Kelman, JD, and the experts and editors at Medical Law Perspectives.
For more details, see the Scalpel Weekly News, February 2, 2015.
For more details on Coleman v. Medtronic, Inc., 2014 WL 286096, 14 Cal. Daily Op. Serv. 1001 (Cal.App. 2 Dist., January 27, 2014) (not designated for publication), see the Scalpel Weekly News, February 10, 2014.
For more details on In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2014 WL 1687811 (C.A.3 (N.J.), April 30, 2014) (not designated for publication), see the Scalpel Weekly News, May 12, 2014.
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See also Medical Law Perspectives, June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability
See also Medical Law Perspectives, January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory
See also Medical Law Perspectives, March 2012 Report: Off-Label Use of Prescriptions: When is this Medical Malpractice? Is the Pharmaceutical Company Liable for Overpromotion?