Third Circuit Clarifies Next Steps in Fosamax Decision

On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Third Circuit has in turn remanded the case to the district court to determine whether state law claims are preempted by federal law in the 500+ lawsuits pending regarding the medication Fosamax in Merck Sharpe & Dohme v. Albrecht. As previously discussed on this blog in May 2019, the United States Supreme Court held that the issue of federal preemption is one to be decided by the court and not a jury, while somewhat clarifying the “clear evidence” standard governing the analysis.

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Overview of Amendments to New Jersey’s Evidence Rules, Effective July 1, 2020

The increasing use of electronic discovery in litigation and the attendant high risk of inadvertent disclosures has led the New Jersey Supreme Court to adopt amendments to New Jersey’s Evidence Rule 530 (Waiver of Privilege by Contract or Previous Disclosure). The Court also adopted amendments to N.J.R.E. 608 (Evidence of a Witness’s Character for Truthfulness or Untruthfulness), and has ordered the restyling of 46 other Rules of Evidence. These amendments are effective July 1, 2020.

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Massachusetts Court Upholds Temporary Ban on the Sale of All Vaping Products

While various states and municipalities grapple with how to address the proliferation of e-cigarette or vaping product use associated lung injury (EVALI) and the related uptick in e-cigarette use among young people, Massachusetts has taken a drastic measure to protect its residents. On September 24, 2019, Massachusetts became the first state to ban the sale of all vaping products after Governor Charlie Barker issued an emergency order that took effect immediately and would remain in effect for four months. The Order states:

“The sale or display of all vaping products to consumers in retail establishments, online and through any other means, including all non-flavored and flavored vaping products, including mint and menthol, including tetrahydrocannabinol (THC) and any other cannabinoid, is prohibited in the Commonwealth.”

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FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions”

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).

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Post-BMS, Courts Grapple with the Nexus Between Stream of Commerce Activities and the Plaintiff’s Claim Required for Specific Jurisdiction over Manufacturers in Product Liability Cases

Courts have struggled for decades to define the constitutional limitations on personal jurisdiction over major product manufacturers who sell their products nationwide. The central tension has been determining the validity and potential scope of the “stream of commerce” theory in a world of advancing technology and associated evolution of business operations and practices. That tension is increasing as state courts decide what kind of nexus is required, between a defendant’s “forum-directed” commercial activities and the plaintiff’s claim, to justify the exercise of specific jurisdiction. Specifically, how purposefully forum-directed and how closely tied to the specific claim must the activities be?

Stream of commerce theory posits that a defendant that has placed a product into the nationwide channels of commerce should anticipate that its products will thereby be “swept” into any state and if it causes injury there, it will be subject to suit. In its purest form, the theory collides to some degree with the fundamental limiting requirement that a defendant may be haled into a forum to litigate only where it has “purposely availed” itself of the privilege of doing business by, for example, directing its products into the forum.

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Biotin Supplement Suit Dismissed on Preemption Grounds

A California federal judge tossed a proposed class action against allegedly “worthless” biotin dietary supplements on preemption grounds earlier this week, citing the Ninth Circuit’s recent decision in Dachauer v. NBTY, Inc., 913 F.2d 844 (9th Cir. 2019).

In Greenberg v. Target Corp., et al., the plaintiff filed a putative class action alleging that labeling for Target’s Up & Up brand of biotin dietary supplements was misleading under California’s Unfair Competition Law (UCL) and Consumer Legal Remedies Act (CLRA).

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The FDA Is in the Doghouse

An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019).

There have been numerous reports of lawsuits involving allegedly contaminated pet food filed against pet food manufacturers or distributors by pet owners claiming that they were deceived by pet food labels and suffered harm either as a result of paying a premium for the food or because their pets were sickened by the food. In contrast, on July 5, 2019, a raw pet food company, Lystn, LLC, brought a civil action against the FDA seeking declaratory and injunctive relief. The complaint challenges the FDA’s ability to enforce what Lystn characterizes as “a nationwide zero-tolerance standard for Salmonella presence in pet food that is unsupported by science and ultra vires of powers properly delegated to it by Congress.”

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There Are Two Sides to Every Product Label

As we have reported in our previous blog posts (“Beware the “Influencer”” and “The Price of Natural Cosmetics”), courts continue to wrestle with challenges to manufacturers’ claims that their products are “all natural.” Recently, California’s Central District Court added to the growing volume of decisions in this space. In Robinson v. Unilever United States, Inc., 2019 WL 2067941 (C.D. Cal. Mar. 25, 2019), the Court was tasked with resolving “100% natural” claims and “made with 100% natural” ingredients claims. The Robinson decision provides some insight into what types of “natural” claims may be permitted by trial courts and how they are reigning in consumer class actions.

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Authenticating Social Media Evidence at Trial

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).
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FDA Final Guidance Document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry”

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.
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Posted in FDA