Health Law Daily FDA approval dings claims against coronary catheter manufacturer
Thursday, November 15, 2018

FDA approval dings claims against coronary catheter manufacturer

By Leah S. Poniatowski, J.D.

A state-law based lawsuit challenging the safety of a catheter manufactured by Biosense Webster, Inc., part of the Johnson & Johnson Inc. Family of Companies, used during a procedure in which a patient’s heart had been injured was preempted by federal law, a state appellate court ruled, affirming the lower court’s decision. The court held the claims were preempted pursuant to the two-prong test established under U.S. Supreme Court precedent because the device satisfied the design and safety requirements of the FDA and the complaint did not assert any violations of federal law, of state law parallel to federal law, or that the patient’s injury arose from a violation of federal law. Additionally, the trial court properly declined the request to set aside the verdict after FDA made its premarket approval of the catheter (Russell v. Johnson & Johnson, Inc., November 9, 2018, Nickell, C.).

A patient with an irregular heartbeat condition, paroxysmal atrial fibrillation (PAF), qualified for cardiac ablation using Biosense Webster, Inc.’s THERMOCOOL® SMARTTOUCH® SF catheter in June 2016. The device had been approved by the FDA under the Investigational Device Exemption (IDE) to the Medical Device Amendments of 1976 (MDA), allowing a clinical trial to determine the safety of the device for treating PAF. Accordingly, the patient signed a "Consent to Take Part in a Research Study" agreement and underwent the procedure voluntarily. However, the ablation was aborted after his heart was torn during the procedure, requiring him to undergo emergency surgery. The patient asserted that he still has health issues from the procedure.

Trial court. The patient filed a products liability lawsuit against Biosense, alleging that the catheter was "unreasonably dangerous and defective" with respect to the design, testing, warnings, labeling, and instructions of the device. The patient’s claims were all rooted in state law: strict liability, negligence, lack of informed consent, failure to warn, breach of both express and implied warranties, fraud and fraudulent concealment, unjust enrichment, loss of consortium, and violation of the Kentucky Consumer Protection Act (KCPA). Biosense asserted that the claims were all preempted by federal law and should be dismissed. The court agreed with Biosense, holding that 21 U.S.C. § 360k(a) preempted the claims because the device was part of an FDA-approved IDE clinical trial and were subject to federally-imposed requirements vis-à-vis design, warning, and consent. Because the patient could not identify any federal law violated by Biosense, his request to amend his complaint was denied as futile. The patient filed an appeal.

Post-judgment recalls. Shortly thereafter, Biosense issued a voluntary recall of several catheters. Although the recall included the same model as the device at issue, the recall affected a different manufacturing lot. The patient requested that the court set aside the prior dismissal and to permit him to amend his complaint and allow discovery, but because the catheter had not been included in the recall, the court denied his request. The court added that the FDA granted full premarket approval (PMA) to the catheter for PAF treatment. The patient filed a second appeal.

Federal preemption. The state appellate court held that the two-part test in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), applied to the case at bar in order to determine whether state law products liability claims are preempted by federal law. The appellate court observed that the lower court closely followed Riegel when it was determined that the patient’s claims were preempted. The first prong was satisfied because the catheter had been approved by the FDA under both the IDE and PMA processes and, thus, had been subject to requirements established by the federal government. The second prong was also satisfied because the common-law claims were "different from, or in addition to" the federal requirements relating to safety and effectiveness.

Specifically, the patient did not allege a violation of federal law, a violation of an identical state law, and a link between the federal violation and his injury. The appellate court noted that there was no sufficient foundation from which a parallel state claim—or even a federal claim—could be construed in the patient’s 32-page complaint.

The case is Nos. 2017-CA-000866-MR and 2018-CA-000195-MR.

Attorneys: Jennifer L. Lawrence (The Lawrence Firm, PSC) for Clifford Russell, Jr. and Jeanene Russell, Jr. James F. Murdica (Barnes & Thornburg LLP) for Johnson & Johnson, Inc., Biosense Webster, Inc. and Johnson & Johnson Consumer Companies, Inc.

Companies: Johnson & Johnson, Inc.; Biosense Webster, Inc.; Johnson & Johnson Consumer Companies, Inc.

MainStory: TopStory CaseDecisions FDCActNews MDeviceNews PLDeviceNews SafetyNews KentuckyNews

Back to Top

Interested in submitting an article?

Submit your information to us today!

Learn More

Health Law Daily: Breaking legal news at your fingertips

Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on health legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.