For some long-awaited events, a little time and distance can add a measure of clarity. Not always – many still are processing the Game of Thrones finale, with no end in sight. But over the past few weeks pharmaceutical products liability lawyers have had the opportunity to acquire some Zen and enlightenment about the Supreme Court’s highly anticipated preemption decision in Merck Sharp & Dohme, Inc. v. Albrecht, 2019 WL 2166393 (U.S. May 20, 2019). An initial description of the decision is here.
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.]
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-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.
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.
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.
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.”
On April 11, 2019, the Texas Senate passed by a vote of 20-10 bipartisan Senate Bill 1189 regulating attorney advertising relating to prescription medication and medical device litigation.
The bill prohibits certain advertisements for legal services that use the phrases “medical alert,” “drug alert,” “public service announcement,” or other language to suggest that “the advertisement is offering professional, medical, or government agency advice about medications or medical devices rather than legal services.”
Counsel drafting an order under Federal Rule of Evidence 502(d) or an agreement under Rule 502(e) generally expect to supplant the uncertainty of the privilege waiver analysis under Rule 502(b) and assure near-absolute protection against inadvertent waiver. But two recent decisions frustrate such expectations and offer lessons on how to better assure strong anti-waiver protection. Absolute Activist Value Master Fund Ltd. v. Devine, 262 F. Supp. 3d 1312 (M.D. Fla. 2017); irth Solutions, LLC v. Windstream Communications, LLC, 2018 WL 575911 (S.D. Ohio 2018) (appeal pending).
Two individual former corporate officers of Chinese appliance manufacturer Gree Electric Appliances have been criminally indicted in the first-ever criminal prosecution for failure to report under the Consumer Product Safety Act (CPSA).
The CPSA grants the U.S. Consumer Product Safety Commission (CPSC) the authority to pursue both civil and criminal penalties for violations of the statutes it enforces. As summarized in a Department of Justice press release, Section 15 of “[t]he Consumer Product Safety Act requires manufacturers, importers, and distributors of consumer products to report ‘immediately’ to the CPSC information that reasonably supports the conclusion that a product contains a defect that could create a substantial product hazard or creates an unreasonable risk of serious injury or death. This duty also applies to the individual directors, officers, and agents of those companies.”