Duane Morris Products Liability

September 27, 2023September 27, 2023 by Will Heaston

FDA Releases New Draft Guidance Documents to Modernize the 510(k) Process

On September 6, 2023, the FDA released three draft guidance documents that seek to “modernize” the 510(k) premarket notification process. Ever since the FDA first proposed “transformative new steps” to the program in 2018, the agency has promised to further update the 510(k) clearance pathway in an effort to better balance technological innovation and patient safety. In issuing these draft guidance documents, the FDA has followed through on that promise.

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FDA Draft Guidance Recommends Info to Include in Patient-Matched Guides to Orthopedic Implants

This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in the execution of a pre-surgical plan concurred upon by the patient’s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 In the draft guidance, FDA recommends information to include in pre-market submissions for patient-matched guides to orthopedic implants.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.

June 7, 2023June 8, 2023 by Robert Kum

Explosion of Silica Exposure-Related Lawsuits in California

Silica is an abundant mineral found in materials including sand, stone, and concrete. While serving as a principal component of glass, cement, and ceramics, silica also presents an increasingly pertinent issue for those with interests in toxic torts, as well as businesses involved in the manufacturing or distribution of silica products: occupational exposure to airborne silica, a leading cause of silicosis and lung cancer.

Silicosis is a severe, incurable lung disease that is often fatal. Upon inhalation of fine particles created through workers’ manipulation of the material, small amounts of silica become trapped in the lungs, causing the scarring of lung tissue. Resulting effects are severe, often requiring lifelong care and a possible lung transplant.

Cases commonly appear among those working in construction or mining, and symptoms can present after only a few years of occupational exposure. More often than not, workers use little to no protective equipment, leaving them vulnerable to inhalation of the harmful substance. With the number of silicosis cases on the rise, the issue has been denoted an “emerging epidemic” constituting a “public health problem of great urgency.”[1]

California has recently seen a large cluster of occupational-related silicosis cases, with its Department of Public Health identifying at least sixty-nine confirmed cases since 2019. And the primary victim? Fabricators and installers of artificial-stone countertops. Continue reading “Explosion of Silica Exposure-Related Lawsuits in California”

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.

September 17, 2021 by Nicholas M. Centrella, Jr.

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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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.