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Expert Analysis

• Federal Regs Order May Spell Harsher FDCA Enforcement

  

  A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.

• Series

  Law School's Missed Lessons: Practicing Self-Care

  

  Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard​​​​​​​ at MG+M.

• New Laws Show How States Are Checking AI Developers

  

  Recent state consumer protection legislation shows Utah, Colorado and Texas are primed to impose controls on artificial intelligence, and exemplifies the states' unwillingness to accord strong deference to developers and deployers of AI tools, say attorneys at Polsinelli.

• ABA Opinion Makes It A Bit Easier To Drop A 'Hot Potato'

  

  The American Bar Association's recent ethics opinion clarifies when attorneys may terminate clients without good cause, though courts may still disqualify a lawyer who drops a client like a hot potato, so sending a closeout letter is always a best practice, say attorneys at Thompson Hine.

• IRhythm IPR Denial Raises Key PTAB Discretion Questions

  

  By giving the passage of time a dispositive role in denying institution of five inter partes review petitions filed by iRhythm Technologies, the U.S. Patent and Trademark Office has upended the strategic considerations for filing and defending against IPRs, disclosing prior art during prosecution, and engaging in licensing negotiations, say attorneys at Dentons.

• Plan For Increased HSR Info Sharing With Wash. Antitrust Law

  

  Washington's merger notification requirements, effective later this month, combined with the Federal Trade Commission's new Hart-Scott-Rodino Act rules, will result in greater information sharing among state and federal agencies, making it important for merging parties to consider their transaction's potential state antitrust implications early on, say attorneys at McDermott.

• Canadian Suit Offers Disclosure Lesson For US Cannabis Cos.

  

  A Canadian class action asserting that Aurora Cannabis failed to warn consumers about the risk of developing cannabinoid hyperemesis syndrome may spawn copycat filings in the U.S., and is a cautionary tale for cannabis and hemp industries to prioritize risk disclosure, says Ian Stewart at Wilson Elser.

• Opinion

  IPR Denial In IRhythm Should Not Set A Blanket Rule

  

  Though the Patent Trial and Appeal Board's discretionary denial in iRhythm v. Welch Allyn last month raised concerns that mere knowledge of a patent could bar inter partes review institution, a closer look at the facts and reasoning reveals why this case's holdings should not be reflexively applied to all petitioners, says David McCombs at Haynes Boone.

• What High Court's Tenn. Trans Care Ruling Means Nationally

  

  The U.S. Supreme Court's decision in U.S. v. Skrmetti, upholding a Tennessee ban on gender-affirming medical care for minors, is fairly limited in scope and closely tailored to the specific language of Tennessee's law, but it may have implications for challenges to similar laws in other states, say attorneys at Hall Render.

• Series

  My Opera And Baseball Careers Make Me A Better Lawyer

  

  Though participating in opera and the world of professional baseball often pulls me away from the office, my avocations improve my legal career by helping me perform under scrutiny, prioritize team success, and maintain joy and perspective at work, says Adam Unger at Herrick Feinstein.

• High Court ACA Ruling May Harm Preventative Care

  

  The U.S. Supreme Court's decision in Kennedy v. Braidwood last week, ruling that the U.S. Department of Health and Human Services secretary has authority over an Affordable Care Act preventive care task force, risks harming the credibility of the task force and could open the door to politicians dictating clinical recommendations, says Michael Kolber at Manatt.

• 8 Ways Lawyers Can Protect The Rule Of Law In Their Work

  

  Whether they are concerned with judicial independence, regulatory predictability or client confidence, lawyers can take specific meaningful actions on their own when traditional structures are too slow or too compromised to respond, says Angeli Patel at the Berkeley Center of Law and Business.

• Is SEC Moving Away From Parallel Insider Trading Cases?

  

  The U.S. Securities and Exchange Commission's apparent lack of follow-up in four recent criminal cases of insider trading brought by the Justice Department suggests the SEC may be reconsidering the expense and effort of bringing parallel civil charges for insider trading, say attorneys at Dentons.

• Rising Enforcement Stakes For Pharma Telehealth Platforms

  

  Two pieces of legislation recently introduced in Congress could transform the structure and promotion of telehealth arrangements as legislators increasingly scrutinize direct-to-consumer advertising platforms, potentially paving the way for a new U.S. Food and Drug Administration policy with bipartisan support, say attorneys at Sheppard Mullin.

• Series

  Law School's Missed Lessons: Communicating With Clients

  

  Law school curricula often overlook client communication procedures, and those who actively teach this crucial facet of the practice can create exceptional client satisfaction and success, says Patrick Hanson at Wiggam Law.