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Expert Analysis

• High Court Underscores DOJ's Role In Policing FCA Litigation

  

  The U.S. Supreme Court's decision in Polansky v. Executive Health Resources reaffirms that the government has final say in False Claims Act cases, allowing for meaningful guardrails that deter private litigators from seeking to regulate industries that Congress has delegated to expert administrative agencies, say attorneys at Ropes & Gray.

• What The Data Says About FDA Responses To FOIA Requests

  

  A statistical evaluation of the U.S. Food and Drug Administration's response times to Freedom of Information Act requests in the last decade shows that the FDA handles the majority of requests within a reasonable time frame, but its slowest response times are somewhat concerning, says Bradley Thompson at Epstein Becker.

• Despite Its Plan Objections, UST Also Won In Purdue Ch. 11

  

  The Second Circuit’s recent decision approving Purdue Pharma’s reorganization plan is a win even for the dissenting Office of the U.S. Trustee because the decision sets extremely stringent guidelines for future use of nonconsensual third-party releases, say Edward Neiger and Jennifer Christian at Ask.

• What Courts Say About Workers' Comp And Medical Marijuana

  

  Whether employers and insurance carriers are required or allowed to reimburse employees for out-of-pocket costs for treating work-related injuries with medical marijuana has spawned a debate, and the state courts that have addressed this matter are split on a number of issues, say Alexandra Hassell and Anthony Califano at Seyfarth.

• Health Staffing Shortages May Draw More Antitrust Scrutiny

  

  Though courts have been historically hesitant to police hospital staffing under antitrust laws, recent staffing shortages in the health care industry have created a stronger need to preserve competition in the market and will likely result in crackdown efforts from courts, say Dylan Newton and Michael Horn at Archer & Greiner.

• State Laws Could Complicate Employer Pandemic Protocols

  

  If the recent wave of state bills that would prevent employers from implementing certain safety protocols in a future pandemic is signed into law, companies — especially those that operate across state lines — will be forced to completely rewrite their pandemic playbooks to avoid compliance issues and discrimination claims, says Karla Grossenbacher at Seyfarth Shaw.

• How Telemedicine Providers Can Adapt To Post-COVID Rules

  

  Telemedicine providers should pay close attention to the U.S. Drug Enforcement Administration's temporary rule extending pandemic-era flexibilities for prescribing controlled substances and utilize this brief reprieve to prepare for significant changes in the final permanent rules to come, say Chris Eades and Mayo Alao at Hall Render.

• A Watershed Moment For Microbiome-Based Therapy

  

  While there has been limited microbiome patent enforcement so far, the regulatory approvals of three microbiome-related products and the case of Ferring v. Finch indicate that microbiome patent litigation could take off, and may spur greater investment in this space, say Mark FitzGerald and Alissa Young at Nixon Peabody.

• Legal Pitfalls To Watch For When Advertising Psychedelics

  

  As psychedelic products and related therapeutic services make their way into the mainstream, companies engaged in creating or publishing ads for such products and services should consider several legal implications on federal, state and local levels, says Dorian Thomas at Frankfurt Kurnit.

• ERISA Ruling Shows Why Insurers Must Justify Claim Denials

  

  The Tenth Circuit's recent decision in D.K. v. United Behavioral Health imposed a long-overdue measure of accountability on health insurers by holding that Employee Retirement Income Security Act compliance requires responding to the medical opinions of the beneficiary's treating doctors before denying claims, says Mark DeBofsky at DeBofsky Law.

• USDA Salmonella Proposal Propels New Food Safety Journey

  

  The U.S. Department of Agriculture's recent proposed policy to declare salmonella an adulterant in breaded stuffed raw chicken products could have major implications not only for the specialized products at issue, but also the entire poultry industry and beyond, say Bob Hibbert and Amaru Sanchez at Wiley.

• What The Justices' Questions Signify For FCA Compliance

  

  Whatever the outcome of two False Claims Act cases pending before the U.S. Supreme Court, the justices' questions during recent oral arguments indicate that government contractors should take certain steps to ensure their compliance programs are demonstrably active and adaptable, say Holly Butler and Rebecca Fallk at Miles & Stockbridge.

• What Texas Misrepresentation Ruling Means For Insurers

  

  The Texas Supreme Court's recent decision in American National Insurance v. Arce, confirming that insurers must prove intent to deceive in order to rescind coverage based on material misrepresentation, solidifies additional burdens for insurers to consider during both the underwriting and claims adjudication processes, say Josh Pedelty and Javon Johnson at Husch Blackwell.