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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Texas Senate Passes Bill Regulating Attorney Advertising Regarding Prescription Medication and Medical Device Litigation
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.”
Drafting 502(d) Orders to Provide Maximum Non-Waiver Protection
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).
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First-Ever Criminal Indictments for Failure to Report a Potential Hazard to the U.S. Consumer Product Safety Commission
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.”