About Kenneth Murphy

Kenneth A. Murphy is a partner with the law firm Faegre Drinker Biddle & Reath LLP with over 30 years of experience. Ken is known for his defense of pharmaceutical companies in product liability and tort claims, including unfair trade practice and off-label promotion claims. Read Ken's full bio

FDA Finds Certain E-Cigarette Products “Appropriate for the Protection of Public Health” but Not “FDA Approved”

On October 12, 2021, the U.S. Food and Drug Administration (“FDA”) issued orders granting R.J. Reynolds (RJR) Vapor Company approval to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo ENDS e-cigarette and accompanying tobacco-flavored pods.  In issuing the orders, FDA found “that the marketing of these products is appropriate for the protection of public health.”  However, FDA also stated that its orders do not mean “these products are safe or ‘FDA approved.’”  See FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency | FDA.

Although ENDS products, such as e-cigarettes, have been on the market since the mid-2000s, this is the first time FDA has authorized the marketing of specific ENDS products through the Premarket Tobacco Product Application pathway.

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Preparing for In-Person Trials in the PCCP during COVID

In March 2021, the Philadelphia Court of Common Pleas (“PCCP”) released its Protocols and Guidelines for conducting in-person civil jury trials during the COVID-19 pandemic (the “Protocols”). To curb the spread of COVID-19, the Protocols outline several precautions, including mask requirements, enforced social distancing, reduced capacity, strategically placed Plexiglass, and the use of streaming technology. Now, over two months later, more Americans are fully vaccinated and the Centers for Disease Control and Prevention (“CDC”) recently stated that fully vaccinated individuals may forgo wearing masks indoors and outdoors. However, the Protocols currently remain intact. While the Commonwealth of Pennsylvania often has stated that it would follow the CDC’s most recent masking guidelines, Philadelphia has often been more restrictive than the rest of the state. Regardless, it remains unclear what impact the CDC’s guidelines will have on future civil jury trials in the PCCP. Therefore, when preparing for trial in the PCCP, attorneys must familiarize themselves with the Protocols. Below are highlights from the Protocols which attorneys should consider when preparing for trial in the PCCP.

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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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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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