3rd Party Litigation Funding Must Be Disclosed Under Recent New Jersey Local Rule

On June 21, 2021, the U.S. District Court for the District of New Jersey announced that it would amend Local Rule 7.1.1 to require disclosure of any third-party litigation funding received by any party. The rule requires that, within 30 days of filing an action or of transfer into the district, all parties file a statement identifying “any person or entity that is not a party and is providing funding for some or all of the attorneys’ fees and expenses” in exchange for either “a contingent financial interest based upon the results of the litigation” or “a non-monetary result” not in the nature of a monetary loan.

The statement must contain the identity of the funder, including the name, address, and (if the funder is a corporate entity) its place of incorporation. Parties must also disclose whether the funder’s approval is necessary for “litigation decisions or settlement discussions.” If the funder’s approval is necessary, the nature of the terms and conditions of approval must also be disclosed.

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The Importance of 510(k) Evidence to Ensuring a Fair Trial

Since the onset of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) has received more attention than perhaps ever before. While Americans anxiously awaited for approval of a COVID-19 vaccine, the FDA and its regulatory scheme were ever-present topics on the news and in social media. The American population’s newfound familiarity with the FDA is especially pertinent in a medical device litigation context.  As litigators well know, jurors already enter a courtroom with preconceived notions of medical device companies, the FDA and the relationship between the two. So how will this newfound knowledge of the FDA influence juror opinions? Put another way, what would happen if a jury participating in a medical device trial failed to hear any reference to the FDA at all?  Potentially, the results would be catastrophic to device manufacturers.

To read the full text of this article co-authored by Duane Morris partner Sean Burke, please visit the AdvaMed website.

510(k) Clearance Evidence Gains New Life After $83 Million Verdicts Overturned

On March 2, 2021, a New Jersey appellate court overturned two pelvic mesh jury verdicts totaling over $83 million dollars, holding that the trial courts committed reversible error by excluding all evidence related to the FDA clearance process.  This decision represents a substantial victory for medical device manufacturers, particularly in light of the staggering jury verdicts that have been handed down over the past few years.

This ruling represents two separate cases that were consolidated for purposes of appeal.  See Hrymoc et al., v. Ethicon Inc. et al., Docket No. A-005151-17, and McGinnis et al. v. C.R. Bard Inc. et al., Docket No. A-001038-18.  In both cases, the respective juries found the medical device defendants liable for design and failure-to-warn defects that caused injuries to plaintiffs. In Hrymoc, the jury awarded the plaintiff and her husband $5 million in compensatory damages, and $10 million in punitive damages.  Conversely, in McGinnis, the jury awarded the plaintiff and her husband $33 million in compensatory damages, and $35 million in punitive damages. Continue reading “510(k) Clearance Evidence Gains New Life After $83 Million Verdicts Overturned”

Parallel or Preempted? The Massachusetts Supreme Judicial Court Highlights the Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices

The Massachusetts Supreme Judicial Court recently addressed the question of what pleading standard is required in Massachusetts to allege parallel state law claims involving medical devices to avoid preemption under the federal law regulating medical devices.  The Court’s decision sheds light on the lack of consensus among state and federal courts on this issue, which may impact the time and resources that litigants and the courts expend on claims that may later prove to be meritless.

Background

As background, the Food and Drug Administration (“FDA”) must approve or clear medical devices before they can be marketed or sold to the public.  The approval process employed depends upon the category of the medical device.  Under the Medical Device Amendments of 1976 (the “MDA”) to the Federal Food, Drug, and Cosmetic Act (the “FDCA”), devices are separated into three categories depending on the potential risks they present: Class I, Class II, and Class III.  Class I devices “are those that present no unreasonable risk of illness or injury and therefore require only general manufacturing controls; Class II devices are those possessing a greater potential dangerousness and thus warranting more stringent controls; Class III devices ‘presen[t] a potential unreasonable risk of illness or injury’ and therefore incur the FDA’s strictest regulation.”  Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343-44 (2001) (citation omitted); see also 21 U.S.C. § 360c.  Class III devices include replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators, among other devices.  Riegel v. Medronic, 552 U.S. 312, 316 (2008). Continue reading “Parallel or Preempted? The Massachusetts Supreme Judicial Court Highlights the Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices”

FDA Issues Long-Awaited Action Plan for Artificial Intelligence/Machine Learning-Based Software As a Medical Device

On January 12, 2021, the FDA issued its long-awaited action plan concerning the regulation of artificial intelligence (AI) and machine learning (ML)-based Software As a Medical Device (SaMD).  The plan comes on the heels of an April 2019 FDA white paper, which provided an initial proposed regulatory framework for SaMD, as well as an open comment period in which the FDA solicited stakeholder feedback.  The action plan outlines five primary goals and commitments to advance the FDA’s interest in facilitating the innovation of SaMD while developing proper oversight, as follows. Continue reading “FDA Issues Long-Awaited Action Plan for Artificial Intelligence/Machine Learning-Based Software As a Medical Device”

3D Printing and its Implications for the Auto Industry

For as long as cars have existed, three fundamental truths appeared to be eternal. First, every car contains safety critical components, second these components are mostly metal and third, they are manufactured by one of two methods—stamping or cold forming. These eternal truths always led to an equally durable legal reality, that if the safety critical component fails the manufacturer will be liable to the injured party. It’s hard to think of a more trite and dependable set of principles. But these timeless precepts are about to become disrupted as the automotive industry continues to explore the innovation of 3D printing.

To read the full text of this article by Duane Morris partners Sean Burke and Alex Geisler, please visit the 3DPrint.com website.

Mitigating Litigation Risks with 3D Printing in Life Sciences

With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality.  Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked. […]

Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing.

To read the full text of this article by Duane Morris partner Sean Burke, please visit the 3DHeals website.

New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers

On June 4, 2020, the U.S. Food & Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products—led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health—that include both (i) drug and device; or (ii) biological product and device constituent parts. In addition, because the underlying 2017 Guidance was issued by OPD, CBER, CDER and CDRH collectively, the same principals would like apply to inspections  in which CBER is the lead center.

To read the full text of this Duane Morris Alert, please visit the firm website.

Third Circuit Seeks Help Deciphering Pennsylvania Strict Liability Law

On June 2, 2020, the Third Circuit, sitting en banc, took the unusual step of asking the Pennsylvania Supreme Court to decide a novel question of state law on strict liability for defective products sold through e-commerce websites in a case that will shape the future of products liability and online sales.

To read the full text of this Duane Morris Alert, please visit the firm website.

Two New Guidances from FDA for Investigational New Drug Applications and Clinical Trial Expectations for Drugs and Biological Products Proposed for Use Against COVID-19

On May 11, 2020, the FDA issued two new guidances for industry and investigators of drugs and biological products proposed for use against COVID-19. These two guidances, “COVID-19 Public Health Emergency: General Considerations for Pre-IND Meetings Requests for COVID-19 Related Drugs and Biological Products” and “COVID-19: Developing Drugs and Biological Products for Treatment of Prevention,” provide insight into the expectations of the FDA regarding new treatment drug development programs in the fight against COVID-19.

To read the full text of this Duane Morris Alert, please visit the firm website.