Archives: Products Liability

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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Back in August, we wrote about the FDA’s controversial plan to release draft guidance on a new regulatory framework for Laboratory Developed Tests (LDTs) —  diagnostic tests developed by and used within individual laboratories across the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

Federal Jury Sides with J&J’s DePuy In First Pinnacle Hip Implant Trial

Johnson & Johnson secured a sweeping victory last week in the first bellwether trial in the multidistrict litigation relating to DePuy’s Pinnacle system metal-on-metal hip implant device.  The plaintiff argued that the components of the device could grind together causing pain, swelling, and the introduction of toxic metal fragments into the bloodstream, and that DePuy’s defective … Continue Reading

Major Damages Award in Pelvic Mesh Case Underscores the Critical Role of Internal Email in Jury Trials

Last week, a state court jury in Dallas awarded the plaintiffs in a pelvic mesh device litigation against Boston Scientific approximately $23.5 million in compensatory damages and $50 million in punitive damages. In the bellwether case, Salazar v. Lopez, plaintiffs Martha Salazar and her husband Felix Salazar sued Boston Scientific alleging she was injured by … Continue Reading

Recent Decision in Device Products Liability Case Highlights Key Strategic Issues for Removing Cases to Federal Court

A decision by a federal district court in Allen v. Bayer Healthcare Pharms., Inc., 2014 WL 655585 (E.D. Missouri Feb. 20, 2014), demonstrates key complexities in a common strategy used by device companies in product liability lawsuits — removing the case from state to federal court.  In the case, twenty-five plaintiffs from eleven states (including Delaware) … Continue Reading

Avoiding the Forum-Defendant Rule through Pre-Service Removal

As we have previously discussed, removal of a medical device case to federal court can be an important strategic advantage for a defendant manufacturer.  Even when proper diversity jurisdiction exists, there are several restrictions that limit a defendant’s ability to remove a case to federal court.  One such limitation, set forth in 28 U.S.C. § … Continue Reading

Pennsylvania Appeals Court Strengthens Standard for Expert Opinions, Requires Experts to Cite Scientific Authority

When medical device companies are faced with product liability lawsuits, often one of the most critical issues is whether the court will permit expert testimony on key issues, such as whether the device caused the alleged injury.  While the Daubert standard, which governs the admission of expert testimony in federal courts, has been adopted by … 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

Florida Adopts Daubert Standard for Expert Testimony

On June 4, 2013, Florida’s Governor signed into law a bill amending Florida’s evidence code,  replacing the Frye standard, which had previously governed the admissibility of expert testimony in Florida, with the Daubert standard.  Florida’s new rules closely track Federal Rules of Evidence 702 and 703.  One major implication of the new evidence rules is … 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