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Expert Analysis

• In Holmes' Sentencing, Judge Has Warning For All Companies

  

  In sentencing ex-Theranos CEO Elizabeth Holmes to 11 years in prison, a federal judge issued a scathing statement about the company’s culture of fraud — revealing an important lesson about how an organization’s core values can help mitigate compliance risk, say Scott Maberry and Joseph Jay at Sheppard Mullin.

• Potential Upheaval For FDA Regulation Of Stem Cell Clinics

  

  If upheld by the Ninth Circuit, a recent California federal court ruling that a stem cell clinic's products are not subject to the Federal Food, Drug and Cosmetic Act could fundamentally alter the U.S. Food and Drug Administration's ability to regulate stem cell therapies, say attorneys at Ropes & Gray.

• Top 10 Whistleblowing And Retaliation Events of 2022

  

  From huge whistleblower bounty awards to the U.S. Securities and Exchange Commission's renewed focus on employer restrictions and adoption of new whistleblower-friendly rules, 2022 saw highly impactful whistleblower and retaliation events that will have far-reaching impact, say attorneys at Proskauer.

• Florida's Medical Marijuana Industry: 2022 In Review

  

  2022 saw the medical marijuana market in Florida continue with several measured steps forward, bringing with it a host of new business opportunities and litigation challenges — and leaving open questions about adult-use legalization, says Richard Blau at GrayRobinson.

• Medical Malpractice Settlements Shouldn't Require NDAs

  

  Hospitals and insurance companies can go to great lengths to avoid accountability — as depicted in the recent Netflix film "The Good Nurse" — and nondisclosure agreements used to settle medical malpractice cases out of court leave patients without crucial information when seeking treatment, says Andrew Barovick at Sandra Radna.

• What Really Doomed Kidney Test Patents In Fed. Circ. Ruling

  

  Following the Federal Circuit's decision in CareDx v. Natera upholding the invalidation of kidney test patents, commentary has focused on the asserted patents' use of boilerplate, even though the issues in this case can be traced back to their claiming strategy and subsequent litigation strategy, say attorneys at BCLP.

• 2022 Hurdles Failed To Deter DOJ Antitrust Enforcement Goals

  

  Some significant losses and dismissals in major criminal cases this year haven't impeded the U.S Department of Justice Antitrust Division's commitment to enforcement, including in untested areas of the law, signaling to businesses the importance of reevaluating compliance program effectiveness, say attorneys at Miller & Chevalier.

• Best Practices For Cannabis Cos. Managing A Product Recall

  

  As expanded access to legal cannabis markets increases the risk of large-scale, costly product recalls resulting from mislabeling or adulteration, companies should develop a recall plan that protects consumers, mitigates the threat of litigation and builds brand loyalty, say Joanna Borman and Amy Rubenstein at Dentons.

• What To Expect From Colo. Therapeutic Psychedelics Law

  

  Lauren Carboni at Foley & Lardner breaks down Colorado's recently passed Natural Medicine Health Act, highlighting key deadlines and next steps for regulators as they aim to prioritize social equity and affordable access to therapeutic psychedelics for adults, while also allowing the industry to succeed.

• Why States Need Clear Standards For Cannabis Testing Labs

  

  State lawmakers should emulate California’s efforts to protect consumers and create consistency in the cannabis market by implementing uniform testing standards, thereby curbing companies' practice of working with labs to misrepresent the concentrations of THC and contaminants in their products, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.

• Ky. Ruling Shows Need For Consistent Insurer Claim Replies

  

  The Kentucky Supreme Court's recent ruling in Ashland Hospital v. Darwin Select Insurance, allowing a hospital to continue seeking coverage for a medical malpractice claim, warns insurers against invoking a prior-notice exclusion to bar coverage after previously rejecting a notice of potential claim as insufficient, say Chet Kronenberg and Lindsay DiMaggio at Simpson Thacher.

• NY Panel's COVID Nursing Home Case Order Spurs Questions

  

  The New York Litigation Coordinating Panel's recent final order to coordinate the resolution of COVID-19 nursing home cases leaves critical parameters for the cases coming under the order undefined, such as time frame and injury, say Christopher Potenza and Elizabeth Adymy at Hurwitz Fine.

• 3rd Circ. 'Loss' Definition Is A Win For White Collar Defendants

  

  The Third Circuit's recent watershed decision in U.S. v. Banks — holding for the first time that the definition of "loss" in fraud cases does not include "intended" loss under the sentencing guidelines — may result in fewer white collar matters and smaller sentences, say attorneys at Sheppard Mullin.