Tag Archives: Device Preemption

AI Update: Medical Software and Preemption

In light of the rapidly expanding field of medical software technology, and its recognition that traditional approval mechanisms for hardware-based medical devices may not be well suited to regulating such technology, FDA is piloting a new, streamlined regulatory approach for digital health technologies. The initiative, currently a “working model” and known as the Software Precertification … Continue Reading

FDA Proposal to Regulate LDTs Raises Legal Liability Questions for Labs

Back in August, we wrote about the FDA’s controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) —  diagnostic tests developed by and used within individual laboratories across the country.  As it stands now, LDTs are overseen by the Centers for Medicare and Medicaid Services under the Clinical … Continue Reading

Fifth Circuit Holds That Product Development Protocol Has Same Preemptive Effect As Premarket Approval

Discussion of the applicability of preemption doctrine in medical device product liability cases usually centers on two types of devices: (1) Class III medical devices approved pursuant to FDA’s premarket approval process, and (2) devices cleared through the less rigorous 510(k) process. A recent case reminds us of a different pathway to approval, which carries … Continue Reading

Preemption applies to 510(k)-cleared components of a PMA-approved device

We frequently post about developments in medical device preemption.  Preemption doctrine is a key issue in medical device product liability cases, and often a powerful tool for medical device manufacturers defending product liability claims.  As a general matter, under preemption doctrine, devices approved by a premarket approval application (PMA) are exempt from common law claims … Continue Reading

Indiana Appellate Court Finds No PMA Preemption for Claim Premised on Allegedly Negligent Advice Given by Manufacturer Representative During Surgery

While most product liability claims involving Class III devices subject to Premarket Approval are preempted (see our previous post), the recent case of Medtronic, Inc. v. Malander demonstrates that there are some circumstances in which preemption may not apply.  Specifically, the Malander court concluded that preemption does not apply where a representative of the manufacturer … Continue Reading

Supreme Court Seeks Solicitor General’s Views on Cert Petition in Closely-Watched Preemption Case

In January, we wrote about the Ninth Circuit’s controversial ruling in Stengel v. Medtronic, holding that the plaintiff’s product liability claims, which were premised on Medtronic’s alleged failure to report post-approval information regarding its pain pump to the FDA, were not preempted.  For a detailed discussion of the case, please refer to our previous post.  … Continue Reading

Possible Implications of Mutual v. Bartlett for Design Defect Claims Involving 510(k) Devices

On June 24, 2013, the Supreme Court issued its opinion in Mutual Pharmaceutical Co., Inc. v. Bartlett, 570 U.S. __ (2013), holding that the plaintiff’s claim that the defendant’s generic prescription drug was defectively designed was impliedly preempted.  Although in the drug context, Bartlett may have implications for cases involving medical devices, particularly design defect … Continue Reading

Biomaterials Access Assurance Act as a defensive tool for suppliers of medical device component parts

We recently came across an interesting medical device case from the Western District of Kentucky, Sadler v. Advanced Bionics, LLC, 2013 WL 1636374 (W.D. Ky. Apr. 16, 2013), involving the Biomaterials Access Assurance Act of 1998 (“BAAA”), 21 U.S.C. §§ 1601-1606.  As Sadler reminded us, the BAAA can be a useful tool for suppliers of medical … Continue Reading

Caplinger v. Medtronic: Medical device preemption and allegations off-label promotion

Supreme Court preemption doctrine leaves only a narrow sliver of claims available to plaintiffs who claim to have been injured by a Class III medical device.  (For a more detailed discussion of the application and intersection of express preemption and implied preemption in the medical device context, see our earlier post.)  As a result, plaintiffs … Continue Reading

Ninth Circuit View of Device Preemption Inconsistent with Controlling Case Law and Eighth Circuit

Parallel claims are a hot topic in medical device product liability cases at the moment.  In recent years, product liability plaintiffs have alleged parallel claims in an attempt to avoid the dismissal of their claims on preemption grounds under Riegel v. Medtronic, 552 U.S. 312 (2008).  In Riegel, the Supreme Court held that Class III … Continue Reading