The Indiana Court of Appeals recently considered Bayer’s motion to dismiss the claims of more than 30 women who had suffered complications alleged to have been caused by Bayer’s Essure medical device. Bayer’s challenge was two-fold: (1) that the complaint itself was deficient and (2) that the claims were preempted by federal law, and thus did not belong in an Indiana court.
Indiana follows a liberal notice-pleading standard when it comes to legal complaints. All that is required is to put the defendant on notice of potential liability and the potential harms and losses arising out of the liability.
The women alleged manufacturing defects in the Essure device such as “the central axis was not fully adhered to the spring which can cause the [device] to fracture/break apart.” This, Bayer argued, was not good enough. The women alleged a variety of symptoms following the implantation of the Essure device including menorrhagia, extreme fatigue, abdominal pain, back pain, joint pain, and various skin rashes.” Again, Bayer claimed the women had failed to tie these injuries to any alleged defect.
The court noted that formal discovery is often necessary before a plaintiff can provide a detailed statement of the specific basis for a product defect claim, especially in a medical device case where much of the device-specific manufacturing information is kept confidential by federal law. Consequently, the court quickly disposed of the facial challenge to the complaint.
The more interesting issue was Bayer’s claim that the women’s product liability claims were preempted by federal law. First, the court considered whether the claims were expressly preempted. Federal statutes provide that enforcement proceedings under the Federal Food, Drug and Cosmetic Act (“FDCA”), including the Medical Device Amendments of 1976 (the “MDA”), as it relates to a manufacturer’s non-compliance with the regime of receiving pre-market approval (“PMA”) “shall be by and in the name of the United States.” So, an injured person would have to look to whether or not state law provides a remedy since the FDCA does not. And, where state law would conflict with federal law, state law is preempted. Consequently, a complaint by an individual would have to be founded on the federal standards of compliance.
Ultimately, the court found that because the women alleged that Bayer violated federal manufacturing requirements, the claim was not expressly preempted. Had the women alleged violations outside of federal manufacturing requirements, they would have been out of luck according to the court.
Next, the court considered whether or not the women’s claims were impliedly preempted. The court quickly dispensed with the notion that the federal government intended to preempt all state claims (known as “field preemption”), by noting that federal law only prohibits “different or additional state-law requirements.”
Finally, the court considered whether there was such a conflict between state and federal law, that state law claims could not exist separately. The court concluded there was no conflict so long as the claims were premised upon violation of federal requirements and do not exist solely under the FDCA, i.e. Indiana would have provided a remedy under its traditional tort law principles.
To make this final determination of a state remedy, the court turned to the Indiana Product Liability Act (“IPLA”). First, the court concluded the IPLA was enacted to govern all product-based claims against manufacturers. Second, the court determined a medical device, such as the Essure device, fits within the definition of a product under the IPLA. Third, a manufacturer like Bayer qualifies as a manufacturer of a product under the IPLA. Fourth, the court found the women qualified as users or consumers of products under the IPLA and that they were claiming injuries.
The IPLA imposes liability upon manufacturers who put defective and unreasonably dangerous products into the stream of commerce and those products hurt users and consumers. The court concluded that a state-law claim existed and was not preempted. Thus, the complaint should not be dismissed at this early stage.
Bayer also complained that the women had identified other legal theories that fell outside of federal law and asked the court to explicitly dismiss those theories. However, the court noted that because a complaint “need not identify theories, a court need not strike specific theories upon a motion for judgment on the pleadings.” In sum, the fact that Bayer did not like extra verbiage in the complaint was of no importance to the verbiage that mattered and stated a valid claim.
You can read the opinion here.