Duane Morris – Page 2 – Duane Morris Products Liability

October 13, 2023 by Duane Morris

Why Talc Claimants’ Experts Should Fear New Jersey Courts

Sharon Caffrey, co-chair of Duane Morris’ Trial Practice Group, is quoted in the Law360 article “Why Talc Claimants’ Experts Should Fear New Jersey Courts.”

From the article:

Cleavage fragments, or mineral particles that are found in rocks, can look like asbestos chemically, but they don’t have the same cancer-causing fibrogenic characteristics that asbestos does, Duane Morris LLP partner Sharon Caffrey told Law360.

“It’s not asbestos, and it’s … never been established as a cause of mesothelioma,” Caffrey said.

Visit the Law360 website to read the full article.

August 16, 2023 by Duane Morris

FDA Draft Guidance Recommends Info to Include in Patient-Matched Guides to Orthopedic Implants

This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s healthcare professional to position an orthopedic implant in a way consistent with the implant’s indicated use. In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants. FDA also suggests information for manufacturers to consider when creating the design process for patient-matched guides.

View the full Alert on the Duane Morris LLP website.

August 10, 2023 by Duane Morris

FDA Issues New Nitrosamine Impurities Guidance

By Alan Klein, Patrick Gallagher and Michael Fox

On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the abbreviated version.)

Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency’s Federal Register request for and receipt of extensive comments on these issues, including scientific data furnished to the agency by NDA and ANDA sponsors over the past year and a half, FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. This comes on the heels of setting similar exposure limits for these products late last month by the European Union’s chief drug regulator, the European Medicines Agency. In its current Guideline, FDA has ranked impacted prescription drugs into 5 categories depending upon their carcinogenic potency, with “1” being the most potent, and “5” the least. Instructing the industry on their responsibility to minimize or eliminate nitrosamine impurities in their products to the extent feasible, the agency has extended the timeline for this task to August 2025, recognizing the complexity of this process and the need to avoid recalls and market disruptions of widely prescribed and important medications.

April 11, 2023 by Duane Morris

Pa. Supreme Court Can Finally Set Proper Venue Standards

In March, the Pennsylvania Supreme Court heard oral argument in Hangey v. Husqvarna on the standards governing venue in a product liability case.

The court’s decision, expected by the end of the year, may provide important guidance on just how much business a corporate defendant must undertake in a plaintiff’s chosen forum for venue to attach.

This article will describe the case on appeal, the venue issues it raises and the precedential context in which it finds itself. We will also suggest a few important takeaways as trial courts and litigants await the disposition of the appeal.

To read the full text of this article by Duane Morris attorneys Alan Klein and Ethan Feldman, please visit the firm website.

December 2, 2022 by Duane Morris

Blocking A Second Punitive Damages Award In Product Cases

Punitive damages awards in product liability matters have reached new heights in recent years. Traditionally, product liability defendants have sought to contest liability in the first instance, and establish that the alleged conduct does not warrant punitive damages specifically

Two recent decisions highlight a perhaps lesser-known defense available in some jurisdictions that can limit or even preclude punitive damages where they have previously been awarded for the same product or conduct.

To read the full text of this article, originally published in Law360, by Duane Morris attorneys Anne Gruner and Ethan Feldman, please visit the firm website.

September 14, 2022September 14, 2022 by Duane Morris

California Appellate Court Permits Defense Expert Testimony Regarding Causation to Meet Lower Standard When Offered to Challenge Plaintiff’s Causation Evidence

Causation in personal injury actions, including product liability claims related to drugs and medical devices and toxic tort actions related to exposure to hazardous substances, must be proven within a reasonable degree of medical probability based upon competent expert testimony. That’s typically the plaintiff’s burden of proof. Do the defendants bear the same burden? In Kline v Zimmer, the California Court of Appeal recently held that, in challenging the plaintiff’s causation evidence, defense expert testimony should be held to a standard of “less than a reasonable medical probability.”

Kline involved the plaintiff’s claim that the Durom Cup hip implant, manufactured by defendant Zimmer, Inc. and utilized in his first hip replacement surgery, was defective and caused him to require an additional surgery, which resulted in further injury. Evidence presented by the plaintiff at trial included an expert who testified to a reasonable medical probability that the Durom Cup’s defects caused the plaintiff to need the additional surgery, which resulted in changes in his muscles and soft tissues causing him chronic pain.

To read the the full article by Duane Morris attorney Michael L. Fox, which originally appeared in the IADC Committee Newsletter, please visit the Duane Morris LLP website.

May 31, 2022May 31, 2022 by Duane Morris

Oregon Cannabis Mislabeling Spurs Investigation and Recall

The Oregon Liquor and Cannabis Commission (OLCC) is conducting an ongoing investigation into Curaleaf regarding an alleged mislabeling of a nonpsychoactive cannabidiol (CBD) product, which actually contained psychoactive delta-9 tetrahydracannabinol (THC). Curaleaf operates 101 retail cannabis dispensaries in 16 states. The OLCC investigation revealed that the alleged mislabeling resulted from an employee’s confusing the CBD bottles with the THC bottles in preparing the Curaleaf cannabis products at issue. The incident caused consumers ingesting those products to have experienced a “high” they did not anticipate, and ultimately led to the recall of approximately 500 bottles of tincture from the Oregon market. At least three of those consumers went to the emergency room due to the high, one consumer was hospitalized and one consumer’s estate brought a claim for wrongful death.

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

Seth Goldberg is a Team Lead of Duane Morris’s Cannabis Industry Group, a cannabis business advisor, and a trial attorney with experience in products liability and consumer fraud claims. Ethan Feldman is an associate in the firm’s Trial department, with experience in products liability and consumer fraud.

June 28, 2021 by Duane Morris

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.

January 12, 2021January 12, 2021 by Duane Morris

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.

October 20, 2020 by Duane Morris

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.