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Health
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December 18, 2024
Patent Limits For Biosimilar Litigation Lands In Spending Bill
Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.
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December 18, 2024
Monsanto Protests DNA Damage Argument In PCB Closings
An attorney in a toxic tort against Monsanto drew a sustained objection from the company's defense during closings Wednesday as he attempted to argue that some of the young girls allegedly exposed to PCBs "will give birth to children with altered DNA," as counsel sparred over whether the plaintiffs suffered "generational harm."
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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December 18, 2024
Pa. Nursing Home Must Face Resident's Slip-And-Fall Suit
A Pennsylvania appeals court on Wednesday reinstated a suit seeking to hold a nursing home liable for a resident's slip-and-fall injuries due to water that allegedly leaked from her room's ceiling, saying there was insufficient evidence that the home performed monthly checks for roof leaks.
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December 18, 2024
State AGs, Generic Cos. Fight Over Price-Fixing Trial Order
A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.
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December 18, 2024
Morrison Foerster Cites Tariffs As Key M&A Variable For 2025
International law firm Morrison Foerster LLP is among those citing President-elect Donald Trump's tariff plans as a key wild card that could affect mergers and acquisitions deal flow in 2025, a Wednesday report from the firm shows.
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December 18, 2024
Destroyed Docs Merit Harsher Sanctions, Mich. Panel Says
A Michigan appellate panel on Tuesday said fees awarded to the estate of a man who died after choking in an adult foster care facility were likely too low, finding a lower court erred by limiting the scope of available sanctions over the destruction of "copious amounts" of digital evidence.
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December 18, 2024
Philip Morris Sues FDA Over New Cigarette Warning Labels
Tobacco giant Philip Morris and a group of Georgia convenience store interests have sued the U.S. Food and Drug Administration over a rule that would add graphic warnings to cigarette labels, alleging the agency is exceeding its statutory authority in a move that would mark a "sea change" for the industry.
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December 18, 2024
Judge Eyes Limits To Medical Device Co.'s Poaching Verdict
A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.
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December 18, 2024
CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say
The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety.
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December 18, 2024
Amgen Hit With $50M Infringement Verdict Over Leukemia Drug
Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.
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December 18, 2024
Homeless Woman's Residency Unclear In Inter-Insurer Dispute
A Michigan state appeals court has vacated a trial court order finding the insurer for a homeless woman's parents must cover injuries she suffered after being run over by a semitruck, ruling that questions remain over whether the woman had another established residence.
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December 18, 2024
FTC Wants Express Scripts' Defamation Suit Tossed
The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.
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December 18, 2024
Medical Center Escapes COVID Outbreak Blame-Trading Suit
A Michigan state appeals panel nixed a wedding venue's defamation suit alleging it was falsely blamed after several guests at a reception contracted COVID-19, handing a win to a healthcare provider the venue pointed to as the source of the outbreak.
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December 18, 2024
Senate Sends $895B Defense Bill To Biden's Desk
The U.S. Senate on Wednesday easily passed an $895.2 billion defense policy and budget bill for 2025, despite criticism over a contentious clause effectively barring gender-affirming healthcare coverage for service members' transgender children.
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December 18, 2024
Yale Eyes Quick Win In $435M Conn. Hospital Purchase Suit
Yale New Haven Health Services Corp. has asked a Connecticut state court judge for permission to file a summary judgment motion in a feud with Prospect Medical Holdings Inc. over the sale of several hospitals in the state, saying Prospect's "stunning" failure to fund pensions and pay taxes resulted in property liens that breached the $435 million deal.
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December 18, 2024
SiteOne Gets $100M To Advance Non-Opioid Pain Treatments
SiteOne Therapeutics Inc., a biopharmaceutical company focusing on pain treatment, on Wednesday announced that it clinched a Series C funding round after securing $100 million from investors.
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December 18, 2024
Top Conn. Cases Of 2024: Kickbacks, Paybacks And Bribes
Judges and juries in Connecticut awarded several multimillion-dollar verdicts against companies big and small in 2024, socking Johnson & Johnson in a talc case in which the already substantial damages could multiply and ordering a pharmacy that paid kickbacks to cough up nearly four times the money it cost the state.
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December 18, 2024
Justices Will Decide If Medicaid Recipients Can Pick Providers
The U.S. Supreme Court on Wednesday partially granted the state of South Carolina's petition to review a Fourth Circuit decision blocking its Medicaid program from ending its provider agreement with Planned Parenthood, agreeing to determine if the Medicaid Act allows a beneficiary to choose a specific provider.
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December 17, 2024
NC Panel Revives Negligence Suit Against State Health Dept.
An adult care center's constitutional claims accusing the North Carolina Department of Health and Human Services of negligently asserting bogus penalties and unfairly suspending admissions at the facility are timely, a North Carolina state appellate panel ruled Tuesday, reviving a case that previously landed before the North Carolina Supreme Court.
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December 17, 2024
UNC Doctor Can't Shield Minor Transgender Patients' Records
A University of North Carolina doctor cannot assert privilege over medical records sought from the university by state Republicans fighting a suit by the physician and others seeking to enjoin a law imposing limits on transgender care for minors, a federal magistrate judge has ruled.
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December 17, 2024
11th Circ. Urged To Block Abortion Clinic Buffer Zone Law
A Florida anti-abortion group urged the Eleventh Circuit on Tuesday to give it another shot at an injunction preventing the city of Clearwater from enforcing a buffer zone ordinance that blocks the group from getting within five feet of the driveway to the city's only abortion clinic.
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December 17, 2024
Express Scripts, OptumRx Can't Ditch LA County Opioid Suit
A California judge ruled Tuesday that Los Angeles County can keep pursuing a lawsuit claiming pharmacy benefit managers Express Scripts and OptumRx colluded with drugmakers to fuel the opioid epidemic, though the county must rework its complaint to specify how regulators were allegedly deceived.
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December 17, 2024
Sandoz Cuts $275M Deal For More Price-Fixing Claims
Swiss drugmaker Sandoz said Tuesday it has reached a $275 million settlement to end claims from consumers, insurers and others in the sprawling multidistrict litigation over alleged price-fixing in the generic-drug industry.
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December 17, 2024
House GOP Asks CVS How Its PBM Treats Smaller Pharmacies
Lawmakers on Capitol Hill are demanding documents from CVS on its pharmacy benefit manager's treatment of independent pharmacies, continuing to press the healthcare giant over potentially anticompetitive conduct.
Expert Analysis
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When Investigating An Adversary, Be Wary Of Forged Records
Warnings against the use of investigators who tout their ability to find an adversary’s private documents generally emphasize the risk of illegal activity and attorney discipline, but a string of recent cases shows an additional danger — investigators might be fabricating records altogether, says Brian Asher at Asher Research.
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3 Ways To Train Junior Lawyers In 30 Minutes Or Less
Today’s junior lawyers are experiencing a skills gap due to pandemic-era disruptions, but firms can help bring them up to speed by offering high-impact skill building content in bite-sized, interactive training sessions, say Stacey Schwartz at Katten, Diane Costigan at Winston & Strawn and Lauren Tierney at Freshfields.
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Medicare Overpayment Rules Are A Mixed Bag For Providers
The Centers for Medicare & Medicaid Services' updated rules for handling agency overpayments adopt a more reasonable definition of what it means to have "identified" an overpayment, which is a win for providers, but their new time frame for investigating related overpayments is unrealistic, says Susan Banks at Holland & Knight.
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Navigating Decentralized Clinical Trials With FDA's Guidance
The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.
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The Bar Needs More Clarity On The Discovery Objection Rule
Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.
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Expect More State-Level Scrutiny Of Noncompetes Ahead
Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.
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Series
Being A Navy Reservist Makes Me A Better Lawyer
Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.
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Cos. Should Inventory Issues To Prep For New Congress
As the legislative and oversight agendas of the 119th Congress come into sharper focus, corporate counsel should assess and plan for areas of potential oversight risk — from tax policy changes to supply chain integrity — even as much uncertainty remains, say attorneys at WilmerHale.
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Incoming Admin May Shake Up Life Sciences Regulation
Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.
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Next Steps In The $2.8B Blue Cross Payout To Providers
Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.
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Navigating DOJ's Patchwork Whistleblower Regime
In the past few months, the U.S. Department of Justice and several individual U.S. attorney’s offices have issued different pilot programs aimed at incentivizing individuals to blow the whistle on misconduct, but this piecemeal approach may create confusion and suboptimal outcomes, say attorneys at BakerHostetler.
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What To Expect From State AGs As Federal Control Changes
Under the next Trump administration, Democratic attorneys general are poised to strengthen enforcement in certain areas as Republican attorneys general continue their efforts with stronger federal support — resulting in a confusing patchwork of policies that create unintended liabilities for businesses operating in multiple jurisdictions, say attorneys at Morgan Lewis.
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So You Want To Move Your Law Practice To Canada, Eh?
Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.
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What To Expect Next From Federal Health Tech Regulation
Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.
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5 Areas Congress May Investigate After GOP Election Wins
With Republicans poised to take control of Congress in addition to the executive branch next year, private companies can expect an unprecedented uptick in congressional investigations focused on five key areas, including cryptocurrency and healthcare, say attorneys at Cahill Gordon.