The U.S. Consumer Product Safety Commission (CPSC) recently found Amazon to be a “distributor” with product liability responsibility for products sold on its website. In a July 29, 2024, ruling, the CPSC said Amazon is legally responsible for over 400,000 allegedly hazardous items sold by third-party sellers on its site. Amazon.com, Inc., CPSC Dkt. No. 21-2 (July 29, 2024). This decision and order adopted many, but not all, of the determinations made by an administrative law judge during an administrative proceeding in 2023, highlighting public safety as paramount. Read the full Alert on the Duane Morris website.
Plan Ahead to Protect Your Innovation: Product Liability Risks for Medtech Startups
A medtech startup typically focuses on two key legal needs: (1) ensuring that its technology has proper and thorough intellectual property protection, and (2) outlining a detailed pathway for FDA clearance. Those two priorities are understandable. The areas of intellectual property protection and a regulatory pathway are threshold issues that every potential investor wants addressed before funding a company. The hypothetical risk of future product liability litigation is not as high a priority for startup companies who have yet to commercialize. However, with the recent surge in such litigation pursuing the life sciences industry, companies are on notice to start prioritizing product liability risk management.
Read the MD+DI article by Sean Burke, vice chair of Duane Morris’ Products Liability and Toxic Torts division.
Court’s Decision Affects Evidence Involving Industry & Gov’t Standards
By Alan Klein, Duane Morris LLP
A recent Pennsylvania Supreme Court decision has reaffirmed the applicability of strict liability standards under Restatement Second’s §402(a) in products liability cases filed in the State, and has barred evidence of compliance with industry or governmental standards to demonstrate that a product was safe and not defective. While clarifying these issues for trial courts and litigants, the Court’s plurality decision creates a potential unbalanced playing field for defendant manufacturers relying upon such standards in the design of their products.
Continue reading “Court’s Decision Affects Evidence Involving Industry & Gov’t Standards”
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.
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.
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.
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.
Order Requires Disclosure of 3rd Party Funding Information in Zantac MDL
On April 3, 2020, the United States District Court for the Southern District of Florida issued an order in the pending Zantac multidistrict litigation (”MDL”) requiring disclosure of funding arrangements and funding documentation between plaintiffs’ counsel and third-party litigation financiers. This order represents some increased traction in favor of arguments seeking to require disclosure of third-party funding arrangements in MDLs.
The Zantac MDL, In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924, was originally formed by the Judicial Panel for Multidistrict Litigation on February 6, 2020. The plaintiffs sued various defendants, including manufacturer Sanofi and its distributors, alleging that the active ingredient in the heartburn medication Zantac breaks down to form a carcinogen that caused personal injuries. Included in the MDL are also six putative classes of consumers who sought refunds and economic damages based on their purchase of Zantac. Due to a number of actions already pending in the Southern District of Florida, the Panel transferred the remaining actions to that court to be assigned to the Honorable Robin L. Rosenberg.
Continue reading “Order Requires Disclosure of 3rd Party Funding Information in Zantac MDL”
Contaminated Cosmetics: Recalls, Lawsuits And Legislation
In recent months, reports of asbestos-contaminated cosmetics[1] have illustrated the enduring challenges of manufacturing and marketing cosmetics as safe for consumers, particularly teens, children and expectant mothers. This is especially true where still-developing science, emotion and rapidly disseminated information (and misinformation) all play critical roles in shaping public perception, even influencing jury outcomes.
This article explores the potential legal challenges for supply chain participants arising from contaminated cosmetics, as well as significant proposals to change the way the U.S. Food and Drug Administration regulates cosmetic safety.
To read the full text of this article by Duane Morris attorney Kelly Bonner, please visit the firm website.
Supreme Court Rules That Judges, Not Juries, Must Decide Preemption of Failure-to-Warn Claims
On May 20, 2019, the Supreme Court of the United States issued a rare unanimous decision in Merck Sharp & Dohme Corp. v. Albrecht, et al., holding that judges, not juries, must decide whether state law failure-to-warn claims against brand-name drug manufacturers are preempted by the FDA’s labeling regulations. In so holding, the Court further clarified the preemption standard set forth in an earlier decision, Wyeth v. Levine, concluding that such claims are preempted where a drug manufacturer can show “that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”