The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” This document provides information on how the FDA evaluates uncertainty and the appropriate extent of uncertainty in the benefit-risk determination for medical devices that are subject to premarket approval (PMA).
Social media is ubiquitous in our cyber-connected world. For many, the first thing a person does when they wake up, and the last thing that person does when they go to bed is read, post, or otherwise interact with platforms such as Facebook, Twitter, Instagram, LinkedIn, and the like. For litigants in a lawsuit the potential to unwittingly post something online that is not thought through or carefully composed can be a trap. Attorneys look at social media presence in their quest for evidence, and discovery requests for social media posts are commonplace in deposition notices, preservation requests, fact sheets, interrogatories, and requests to produce.
Social media is subject to Rules of Evidence principles, including relevancy, authenticity, hearsay, and the probative value of evidence in light of its potential for unfair prejudice. Lorraine v. Markel Am. Ins. Co., 241 F.R.D. 534 (D. Md. 2007). Of these, authentication at trial is thought to be the “greatest challenge.” Hon. Paul W. Grimm, et al., Authentication of Social Media Evidence, 36 Am. J. Trial Advoc. 433, 439 (2013). Authentication of social media evidence is more complicated than showing a witness a printout with an account name and photo alongside the commentary − and for good reason. As the Third Circuit has recognized, social media evidence presents special challenges because of “the great ease with which a social media account may be falsified or a legitimate account may be accessed by an impostor.” United States v. Browne, 834 F.3d 403 (3d. Cir. 2016).
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information regarding “changes to approved risk evaluation and mitigation strategies (REMS),” the application process for proposed changes to REMS, and “how the FDA will process submissions.”
Not every pharmaceutical product approved by the FDA requires a REMS. “A REMS is a required risk management plan that uses tools beyond the prescribing information (the package insert) to ensure that the benefits of certain drugs outweigh their risks.” Following a REMS submission, an application holder might be inclined to submit proposed changes, or the FDA might require the submission of proposed changes. Application holders who find themselves in either position may turn to this final guidance document for direction.
The Third Circuit Court of Appeals has held that online retailers such as Amazon could be held liable for allegedly defective third-party products sold through its website.
In a 2−1 panel decision in Oberdorf v. Amazon.com, Inc., — F.3d —, 2019 WL 2849153 (3d Cir. July 3, 2019), the Third Circuit Court of Appeals reversed the district court’s ruling that Amazon was not a “seller” under § 402A of the Restatement Second of Torts, and therefore could be held strictly liable under Pennsylvania products liability law.
Pennsylvania has adopted Restatement Second of Torts § 402A, which “specifically limits strict products liability to ‘sellers’ of products.” Because the Pennsylvania Supreme Court has not yet addressed whether an online sales listing service such as Amazon Marketplace qualifies as a “seller” under § 402A, the district court was tasked with predicting what the Pennsylvania Supreme Court would decide under Pennsylvania law.
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.”
Government and regulatory agencies have recently provided guidelines regarding the importance of transparency in Direct-to–Consumer (DTC) advertising through proposed regulation and guidance documents.
The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.