By Pamela C. Maloney, J.D.
Patients injured by implanted birth control device could pursue only limited manufacturing defect claims and failure to instruct claims against manufacturer.
On remand from the state supreme court, the Indiana Court of Appeals reviewed each of the claims brought against the manufacturer of a permanent birth control device and concluded that manufacturing defect claims based on nonconformity with Food and Drug Administration (FDA)-approved specifications and failure to instruct claims were not impliedly preempted; however, manufacturing defect claims based on failure to proactively change the device’s warnings and failure to warn claims based on inadequate warning labels were expressly preempted. In addition, the appellate court noted a failure to warn claim based on alleged violations of FDA reporting requirements was potentially actionable as a manufacturing defect under the Indiana Product Liability Act (IPLA) (Bayer Corp. v. Leach, August 19, 2020, Bailey, L.).
More than 30 women, who alleged that they had been injured by a medical device called Essure®, which was marketed as a form of permanent birth control, filed a nine-count complaint against Bayer Corporation, the manufacturer of the device. The complaint alleged that Bayer was liable for defective manufacturer, failure to warn, and failure to instruct under the Indiana Product Liability Act (IPLA). The complaint also set forth claims under the Uniform Commercial Code and the Indiana Consumer Sales Act. Bayer sought judgment on the pleadings, arguing that: (1) aspects of the complaint were deficient; and (2) the claims were preempted. The trial court’s denial of Bayer’s motion was affirmed on appeal. According to the appellate court, Bayer had sufficient notice of the defect-related claims, which were not expressly preempted by the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetic Act (FDCA) because they were premised on Bayer’s alleged failure to comply with federal manufacturing requirements. The claims also were not impliedly preempted, since they were derived from traditional Indiana tort law, according to the appeals court. The appellate court further noted that a jury reasonably could have concluded that Bayer’s alleged failure to comply with federal manufacturing standards rendered Essure in a defective condition unreasonably dangerous to any user or consumer.
Bayer successfully appealed to the state supreme court, which reversed the appellate court’s decision on the ground that the appeals court had addressed only the legal viability of the patient’s defective manufacturing claim. The case was remanded to the appellate court with instructions to consider the viability of each claim presented [see Products Liability Law Daily’s June 17, 2020 analysis]. On remand, Bayer again moved for judgment on the pleadings, arguing that the claims were preempted and that aspects of the complaint were deficient.
Adequacy of complaint. The appellate court reiterated its previous finding that under Indiana’s liberal notice-pleading requirement, the complaint in this case set forth sufficient allegations to put Bayer on notice of the nature of each of the claims against it.
Express preemption—proactive warning changes.The manufacturing defect claim based on the manufacturer’s failure to proactively strengthen the FDA-approved warnings on the device’s label was expressly preempted by federal law, the appellate court held, dismissing the claim. Although federal law permitted a manufacturer to proactively change the information on an approved label, it did not require the manufacturer to do so. Thus, any state law claim based on a failure to take a permitted action would constitute a state requirement "in addition to" the federal requirement and was, therefore, expressly preempted.
Express preemption—false or misleading statements. However, the appellate court refused to find that allegations that the manufacturer had violated federal requirements by making false or misleading statements were expressly preempted. The manufacturer had relied on several exhibits submitted in support of its motion to dismiss in order to show that the challenged statements had been approved by the FDA. Explaining that matters outside the pleadings could not be considered at this stage in the proceedings, the appeals court concluded that it could not find that the patients’ tort claim premised on false or misleading statements was expressly preempted.
Implied preemption—manufacturing defects.The court of appeals further determined that the patients’ manufacturing defect claim, which was based on allegations that the Essure devices were nonconforming products in that they failed to conform to the design and performance standards as described in the pre-market approval (PMA) submitted by the manufacturer and approved by the FDA, was not impliedly preempted by federal law. Under the IPLA, a fact-finder could determine that the alleged failure to comply with a federal requirement created an adulterated or misbranded product condition that resulted in the device being in a condition not contemplated by reasonable persons which was unreasonably dangerous to the expected user. This type of claim, which was derived from traditional Indiana tort law, did not conflict or interfere with the federal regulatory scheme, the appellate court found, explaining that Congress did not intend to grant medical device manufacturers civil immunity for their violations of federal law that resulted in harm to patients.
Inadequate warnings. Arguing that the patients had not alleged that the label warnings deviated, in any way, from the FDA-approved warnings and that federal law did not require the use of any labeling or packaging other than that approved by the FDA, the manufacturer moved to dismiss the inadequate warnings claim as preempted. Although the complaint alleged that the approved labeling and packaging was rendered inadequate as a result of the manufacturer’s failure to comply with federal reporting requirements, the manufacturer was correct in asserting that it was required to use the approved labeling and packaging and any state law that imposed a different or additional requirement, as the patients sought to do in this case, was expressly preempted. However, the alleged violation of reporting requirements was potentially actionable as a manufacturing defect under the IPLA, the appellate court noted, adding that such a violation would render the product to be in an adulterated or misbranded condition.
Failure to instruct. Claims that the manufacturer failed to comply with federal training requirements and that it negligently performed its self-imposed duty to train physicians were neither expressly nor impliedly preempted. With regard to express preemption, the court specifically found that the claim that the manufacturer had failed to or had negligently performed the FDA-training requirements was not expressly preempted because it was premised on a violation of federal requirements. Similarly, the physician training that the manufacturer had undertaken voluntarily went beyond FDA-imposed requirements and, thus, did not implicate the explicitly preemptive text of the MDA, nor did it assert a violation of a federal requirement.
The court rejected the claim that the failure to instruct claim was impliedly preempted because imposing a state-law duty to exercise reasonable care in complying with federal training requirements and with self-imposed training duties did not interfere with the federal regulation of medical devices.
Fraudulent misrepresentation. The patients’ claims that their injuries were a result of the manufacturer’s fraudulent misrepresentation, fraudulent concealment, and fraudulent omissions, as well as its failure to test, should have been dismissed by the trial court. All these claims had as their basis a claim for personal injuries allegedly caused by a medical device and, in fact, the patients had stated in their complaint that the IPLA formed the basis for these claims, However, the IPLA recognizes only three types of product liability claims: design defect, manufacturing defect, and a defect due to failure to adequately warn or instruct. Concluding that these claims were not recognized by the IPLA, the appellate court granted the manufacturer’s motion to dismiss them.
UCC claims. The court also found that the patients’ claims for breach of express warranty were neither expressly nor impliedly preempted. The preemptive text of the MDA only prohibited the enforcement of a different or additional state-imposed requirement. A breach of express warranty claim arose from the substantive obligations of a contract and, therefore, did not implicate any federal requirements.
The case is No. 19A-CT-625.
Attorneys: Lee C. Christie (Cline Farrell Christie Lee & Bell, P.C.) and Gregory J. Bubalo (Bubalo Law PLC) for Rene Leach. Robert A. Jorczak (Ice Miller LLP) and Erika L. Maley (Sidley Austin LLP) for Bayer Corp.
Companies: Bayer Corp.
MainStory: TopStory DesignManufacturingNews WarningsNews PreemptionNews MedicalDevicesNews IndianaNews
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