In a trio of recent decisions arising out of cases alleging that an antipsychotic medication, Risperdal, and its generic, risperidone, had caused gynecomastia (breast tissue growth) in men, the United States District Court for the District of Delaware granted motions for summary judgment for defendant Janssen Pharmaceuticals, Inc. The three opinions clarify that Delaware law would not impose innovator liability on a branded drug manufacturer when the plaintiff had used only a generic drug, and addressed “but-for” warnings causation and proximate cause in prescription drug products liability cases. [Disclosure: Drinker Biddle & Reath. LLP attorneys were co-counsel of record in these cases for Janssen.]
Biometric Data Privacy: Why Illinois Regulation Is Relevant to Manufacturers Nationwide
Our federal system and the often dysfunctional nature of Congress can be vexing for cutting-edge manufacturers. Emerging technologies are rarely addressed at the federal level, leaving states to pass piecemeal regulations that can frustrate even the most attentive compliance officers. If you’re bringing a product to market nationwide, you need to be aware of which states have the most stringent regulations. When it comes to biometrics, Illinois tops that list.
The Illinois Biometric Information Protection Act (BIPA) generally is considered the most stringent in the United States, and lawmakers in Florida and New York City are currently working on passing similar measures. So just what is the current state of biometric data privacy in Illinois? The answer lies in three rather unexpected topics: roller coasters, robot dogs, and pizza.
Third Circuit Tackles Third-Party Funding Issues in In Re: National Football League Players’ Concussion Injury Litigation
Third-party litigation funding has received increased scrutiny over the past several years, particularly in the context of mass torts, class actions, and multidistrict litigation. Most of this scrutiny has focused on pre-litigation or pre-resolution commercial loans to fund the litigation, and particularly whether parties are required to disclose such funding during the course of the litigation.
For example, in February 2019, several U.S. senators reintroduced S.471, the Litigation Funding Transparency Act of 2019, which would require plaintiffs to disclose third-party litigation funding for class actions and multidistrict litigation. This came on the heels of a January 2019 letter from more than 25 major U.S. companies to the Committee on Rules of Practice and Procedure requesting an amendment to Federal Rule of Civil Procedure 26(a)(1)(A) “to require in civil actions the disclosure of agreements giving a non-party or non-counsel the contingent right to receive compensation from proceeds of the litigation.”
Beware of the “Influencer”
The proliferation of social media has transformed the world in many ways including how people communicate, becoming a preferred vehicle for political discourse and an important source of information in litigation. It has also changed the way companies market their products. Gifting “influencers” with products to promote in their posts has proven to be a successful marketing strategy for increasing brand awareness. However, companies may be held accountable for claims made by influencers about their products.
Labeling Preemption Questions are for the Court, not the Jury, Holds U.S. Supreme Court in Fosamax Decision That Clarifies the “Clear Evidence” Standard
A judge, and not the jury, is the better-positioned and appropriate decisionmaker to determine whether a failure-to-warn claim is federally preempted, the U.S. Supreme Court held today.
The Court also clarified the “clear evidence” standard governing an impossibility preemption defense to failure-to-warn claims.
FDA’s Final Guidance on “Least Burdensome” Principles for Medical Devices
The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should be least burdensome across the total product life cycle.” This means that manufacturers are expected to provide “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.” The FDA observed that this approach should “ensure that patients have access to high-quality, safe and effective medical devices.”
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