Edwards v. Thoratec LLC

Background

Thoratec LLC manufactures the HeartMate 3, an implantable Class III medical device used for mechanical circulatory support. The device was implanted in Arvid Herrman at the Mayo Clinic on June 25, 2019. Shortly after it was activated, air repeatedly entered Herrman’s left ventricle and ascending aorta. The surgeon observed that the device could rotate despite being locked into place and that one locking arm was bent and asymmetrical. The surgeon replaced the device, but Herrman never regained consciousness and died on July 12, 2019. The complaint attributed his death to multiple air emboli caused by an air leak at the interface between the device’s inflow cannula and the heart’s apical cuff.

The complaint alleged that the device violated FDA-approved design specifications requiring the locking arms to be symmetrical and to secure the inflow cannula tightly enough to prevent air leakage. It asserted two state-law claims against Thoratec: negligence and strict liability for a manufacturing defect. Abbott Laboratories, Inc., which had also been named as a defendant, was voluntarily dismissed from the case before this order.

Motion and governing law

Thoratec moved to dismiss under Rule 12(b)(6), arguing that the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempted the state-law claims. Rule 12(b)(6) permits dismissal when a complaint does not state a legally sufficient claim. The court accepted the complaint’s factual allegations as true for purposes of the motion. The court also granted Thoratec’s unopposed request for judicial notice of five publicly available FDA documents.

The court applied Minnesota law at this stage because Minnesota and Wisconsin law were the same for purposes of the preemption analysis. It explained that the federal Medical Device Amendments expressly preempt state requirements that are different from or additional to federal requirements concerning a device’s safety or effectiveness. But state-law claims that impose requirements equal to, or substantially identical to, federal requirements may proceed as parallel claims. The court also considered implied preemption, under which private parties may not enforce the Food, Drug, and Cosmetic Act itself because enforcement authority belongs to the federal government.

Analysis

The court held that the HeartMate 3’s premarket approval created applicable federal requirements. It nevertheless concluded that express preemption did not apply because the plaintiff alleged that Thoratec manufactured a device with asymmetrical locking arms that failed to meet a specific federal requirement and also violated state manufacturing-defect and negligence law. The state-law claims therefore did not seek safety requirements different from or additional to the federal requirements.

The court rejected Thoratec’s argument that the plaintiff had to identify exactly what went wrong in Thoratec’s proprietary manufacturing process. At the pleading stage, the allegations were sufficient because they identified a specific federal requirement, alleged that the device deviated from that requirement, connected the deviation to the injury, and alleged that the defect existed when the device left Thoratec’s control.

The court also concluded that implied preemption did not apply. The plaintiff was suing for conduct that allegedly violated federal requirements and would also support recovery under state law, but the plaintiff was not suing solely because the conduct violated federal law. Instead, the claims alleged that manufacturing the device with asymmetrical arms made it unreasonably dangerous under state tort law.

Disposition

The court held that the plaintiff’s claims were not preempted. It granted Thoratec’s unopposed request for judicial notice and denied Thoratec LLC’s motion to dismiss. The order did not decide whether the plaintiff would ultimately prevail on the negligence or strict-liability claims.