Week Ahead in Health: Aug. 30, 2021


(Reuters) - Here are some upcoming events of interest to the health community. All times are local.

Monday, Aug. 30

1 p.m. - The U.S. Department of Health and Human Services will urge the 5th U.S. Circuit Court of Appeals to reverse a district court order holding that it cannot bypass review by an administrative law judge in recouping Medicare overpayments from providers. HHS began bypassing ALJ review because of an administrative backlog, but Texas-based Family Rehabilitation Inc successfully argued that doing so violated its due process rights.

The case is Family Rehabilitation Inc v. Becerra et al, 5th U.S. Circuit Court of Appeals, No. 20-10271. For Family Rehabilitation: Rebecca Lunceford Kolb of Arnall Golden Gregory. For HHS: Kyle Edwards of the U.S. Department of Justice.

Tuesday, Aug. 31

8 a.m. - An evidentiary hearing is scheduled before U.S. District Judge M. Casey Rodgers in Pensacola, Florida in multidistrict litigation over 3M Co's Combat military earplugs. The judge will hear expert testimony on the general scientific reliability of a diagnosis of "hidden hearing loss" that does not show up on standard hearing tests, and will also consider choice of law issues for upcoming bellwether cases. Plaintiffs in the MDL, the largest in U.S. history, allege that they suffered hearing loss or damage as a result of using the plugs.

The case is In re 3M Combat Arms Earplug Products Liability Litigation, U.S. District Court for the Northern District of Florida, No. 19-md-2885. For the plaintiffs: Bryan Aylstock of Aylstock, Witkin, Kreis & Overholtz, Shelley Hutson of Clark, Love & Hutson and Chris Seeger of Seeger Weiss. For 3M: Mike Brock of Kirkland & Ellis.

9 a.m. - Jury selection is scheduled to begin before U.S. District Judge Edward Davila in San Jose, California in the trial of Theranos founder Elizabeth Holmes, who is accused along with former Theranos chief operating officer Ramesh "Sunny" Balwani of defrauding patients and investors by falsely claiming that her company had developed technology that could run a wide array of tests on a single drop of blood. Balwani is expected to face trial separately.

The case is United States v. Holmes, U.S. District Court, Northern District of California, No. 18-cr-00258. For the government: Assistant U.S. Attorney Jeff Schenk. For Holmes: Lance Wade and Kevin Downey of Williams & Connolly.

10 a.m. - Viatris Inc will urge the Federal Circuit U.S. Court of Appeals to reverse a district court holding that AstraZeneca's patents on its asthma inhaler Symbicort were not invalid as obvious. Viatris is seeking to sell a generic version of the product.

The case is AstraZeneca AB v. Mylan Pharmaceuticals Inc, Federal Circuit U.S. Court of Appeals, No. 21-1729. For Viatris: Andrew Dufresne of Perkins Coie. For AstraZeneca: David Berl of Williams & Connolly.

Wednesday, Sept. 1

10 a.m. - U.S. District Judge George Daniels in Manhattan will hear oral arguments over former Rochester Drug Co-operative Inc Chief Executive Laurence Doud's motion to dismiss an indictment accusing him of illegally distributing opioid drugs. Prosecutors said that despite the company's obligations to not ship drugs to pharmacies it knew were dispensing the drugs unlawfully, Doud agreed to ship opioids to pharmacies even when "red flags" existed demonstrating they were diverting them. Doud, who led Rochester from 1991 to 2017, has pleaded not guilty and denied wrongdoing.

The case is U.S. v. Doud, U.S. District Court, Southern District of New York, No. 19-cr-00285. For the United States: Assistant U.S. Attorneys Alexandra Rothman, Louis Pellegrino, Nicolas Roos and Stephanie Lake. For Doud: Derrelle Janey of Gottlieb & Janey.

10 a.m. - Indivior Plc will urge the Federal Circuit U.S. Court of Appeals to revive a patent on its sublingual opioid dependence drug Suboxone, which the Patent Trial and Appeal Board ruled invalid in response to a challenge by rival Dr. Reddy's Laboratories Inc.

The case is Indivior UK Limited v. Dr. Reddy's Laboratories SA, Federal Circuit U.S. Court of Appeals, No. 20-2073. For Indivior: Richard Rainey of Covington & Burling. For Dr. Reddy's: Kevin Martin of Goodwin Procter.

2 p.m. - The 8th U.S. Circuit Court of Appeals will hear arguments over whether North Dakota can regulate pharmacy benefit managers, the intermediary companies that negotiate prescription drug prices between drugmakers, pharmacies and insurers. The Pharmaceutical Care Management Association, an industry group, previously won an order from the 8th Circuit striking down the state's law as preempted by federal law, but the U.S. Supreme Court ordered the circuit to reconsider after reviving a similar Arkansas law in a different case.

The case is Pharmaceutical Care Management Association v. Wehbi et al, 8th U.S. Circuit Court of Appeals, No. 18-2926. For PCMA: Michael Kimberly of McDermott Will & Emery. For the state: Thomas Smith of Katten Muchin Rosenman.

Thursday, Sept. 2

1 p.m. - The 9th U.S. Circuit Court of Appeals will hear a challenge to the Drug Enforcement Administration's determination in February that it lacked authority to waive any provision of the Controlled Substances Act to allow medical use of psilocybin, the active chemical in magic mushrooms. The challenge was brought by a Seattle doctor, Sunil Aggarwal, and his clinic and research institute, the Advanced Integrative Medical Science Institute, seeking to give psilocybin to terminally ill patients to treat depression and anxiety under Washington's "right to try" law, which aims to give certain patients access to experimental therapies.

The case is AIMS v. USDEA, 9th U.S. Circuit Court of Appeals, No. 21-70544. For plaintiffs: Matthew Zorn of Yetter Coleman. For the government: Thomas Pulham of the U.S. Department of Justice.

Know of an event that could be included in Week Ahead in Health? Contact Brendan Pierson at brendan.pierson@thomsonreuters.com

(CORRECTION: This article has been updated to remove an incorrect entry for a trial in litigation against Remington over the Sandy Hook mass shooting. The trial has been postponed until 2022.)

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.