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.

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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.”

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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.”

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DOUBLE SNAP! Second Circuit follows Third Circuit to Endorse Snap Removal

Last fall we wrote about the Third Circuit’s opinion endorsing the snap removals, making it the first circuit opinion in the country to approve such practice. This week, the United States Court of Appeals for the Second Circuit followed the Third Circuit’s lead and affirmed snap removals.

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Reliance Remains a High Hurdle in Establishing Third-Party Payor Claims

Third-party payor (TPP) claims against pharmaceutical companies are nothing new. The arguments are common – TPP insurers claim financial injury arising out of payments made for alleged medically unnecessary prescriptions written for numerous insureds/ beneficiaries. In some instances, the TPP plaintiffs point to evidence or allegations of off-label promotional activity to support the claims of lack of medical necessity; and sometimes the TPP plaintiffs attempt to bolster their allegations of “medically unnecessary” prescriptions by advancing a variation of the garden variety failure-to-warn narrative:

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Alternative Medical Cause Arguments Require Supporting Defense Expert Testimony in Illinois

A recent Appellate Court opinion in a premises liability case alleging back pain has the potential to be a pain in the neck for defense lawyers seeking to argue for possible alternative causes of plaintiff’s injuries in a personal injury cases in Illinois. In Campbell v. Autenreib,  109 N.E.3d 332 (2018), the Fifth District held that testimony about the potential alternative causes of plaintiff’s injuries elicited through cross-examination of the plaintiff’s treating physician was too speculative to be admitted in the absence of any defense expert testimony supporting the alternative causes. This opinion expands on the Illinois Supreme Court’s opinion in Voykin v. Estate of DeBoer, 192 Ill. 2d 49 (2000), which held that in most cases defendants must present expert testimony about the relevance of a prior injury or medical condition in a personal injury case.

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