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August 13, 2024
FTC Makes 2nd Request In Review Of Medical Device Co. Deal
Medical device company Surmodics Inc. disclosed Monday that federal regulators are taking a closer look at its agreement to be acquired by private equity giant GTCR in a $627 million deal.
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August 13, 2024
3 Firms Drive $3.8B Carlyle-Baxter Kidney Care Deal
Kirkland & Ellis LLP-led private equity firm Carlyle on Tuesday agreed to acquire the kidney care unit of Baxter International Inc., represented by Sullivan & Cromwell LLP and Baker McKenzie, for $3.8 billion, Baxter said in a statement Tuesday.
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August 12, 2024
WWE Accuser Says Doc's Lawsuit Threat Meant To Silence Her
A celebrity doctor with alleged ties to World Wrestling Entertainment Inc. and ex-CEO Vince McMahon should be sanctioned for filing a "vexatious" presuit discovery request in an effort to intimidate the woman who claimed the company and former executives sexually abused and trafficked her, she argued in a Monday motion.
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August 12, 2024
Accused Accounting Prof Is No Tax Expert, NJ Jury Told
New Jersey federal jurors were urged Monday to keep one word at the front of their minds as they listen to the government present its case against an accounting professor accused of failing to report $3.3 million in income from a pharmacy he co-owned with his wife: willful.
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August 12, 2024
Groups Call On IHS To End Amalgam Use On Tribal Lands
A consortium of groups, including Consumers for Dental Choice and the International Indian Treaty Council, are calling on the U.S. Indian Health Service and other governments to immediately stop using mercury-containing dental fillings on Native Americans.
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August 12, 2024
GAO Says VA Deal Awardee Wasn't Missing Key Staff Member
The U.S. Government Accountability Office has rejected Booz Allen Hamilton's protest over a U.S. Department of Veterans Affairs agreement for healthcare market assessments, saying there was no evidence that a key worker for the awardee wasn't available to work on the deal.
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August 12, 2024
States Want Teva Generic Price Fixing Case Tried 1st
A coalition of state attorneys general suing a slew of generic drugmakers are asking for a Connecticut federal court to proceed with one of the two cases before the other, saying the outcome in that case will have a "significant impact" on settlement talks with other pharmaceutical company plaintiffs.
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August 12, 2024
Conn. Toothbrush Co. Says Rival In Poland Copied Design
The manufacturer of the Autobrush automatic toothbrush said they have nothing to smile about regarding a Polish company's similar U-shaped toothbrush, claiming in Connecticut federal court that its patents have been infringed.
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August 12, 2024
Paragard IUD Makers Gearing Up For Defect Dismissal Bid
Teva Pharmaceuticals and The Cooper Cos. have five days to reach out to plaintiffs who may be included in a motion to dismiss the sprawling litigation over alleged defects in the Paragard IUD, a Georgia federal judge said Monday.
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August 12, 2024
Atrium, NC Textile Family Settle Fight Over $17M Inheritance
Half of a $17 million trust from a prominent North Carolina textile family will go to a new beneficiary as part of a settlement in which the family and Atrium Health agreed to change the terms of the matriarch's will after months of "differing contentions" about the rightful recipient.
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August 12, 2024
Pacira Patent On Surgery Pain Drug Voided In Win For Generic
Pacira Pharmaceuticals Inc.'s patent on a nonopioid painkiller is invalid, a New Jersey federal judge has ruled, opening the way for generic versions of Exparel, a long-acting injectable for managing postsurgical pain.
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August 12, 2024
NJ Health System Wants Proskauer DQ'd From Antitrust Case
Proskauer Rose LLP is facing accusations that it should be disqualified from representing one of New Jersey's largest healthcare systems in an antitrust lawsuit brought by a competitor that was once a client of the firm.
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August 12, 2024
Healthcare Co. To Pay Atty Fees In Suit Over Board Diversity
A Maryland federal judge has awarded $850,000 in attorney fees to an Omega Healthcare shareholder who filed a derivative suit against the healthcare investment trust alleging it had a discriminatory policy aimed at keeping Black individuals from being appointed to its board of directors.
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August 12, 2024
The Biggest Georgia Rulings Of 2024 So Far
From upholding a win for a transgender sheriff's deputy who challenged a county health plan's refusal to pay for gender-affirmation surgery, to ruling that a judicial emergency order issued during the pandemic can be used to toll the state's medical malpractice statute of repose, Georgia courts have been busy in the first half of 2024.
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August 12, 2024
Fusion Tech Co. Finds GC In Ex-MacAndrews & Forbes Exec
Wisconsin-based SHINE Technologies has found its new top attorney in a veteran in-house leader who previously worked at billionaire investor Ronald O. Perelman's MacAndrews & Forbes Inc.
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August 12, 2024
Big Tobacco To Pay $600M In 'Historic' Mass. Deal
Philip Morris Inc. and RJ Reynolds Tobacco Co. will pay nine-figure sums as part of a $600 million settlement between Massachusetts and major tobacco companies that resolves yearslong disputes about how much the cigarette makers owe, the state attorney general announced Monday.
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August 09, 2024
Takeda Should Face Certified Antitrust Classes, Judge Says
A New York federal judge on Friday recommended certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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August 09, 2024
Split 9th Circ. Affirms Ax Of Meta Anti-Vax Censorship Suit
A split Ninth Circuit panel Friday affirmed the dismissal of Children's Health Defense's lawsuit challenging Meta's policy of censoring its anti-vaccine Facebook posts, with the majority concluding that the Robert F. Kennedy Jr.-founded nonprofit failed to show Meta was acting on the government's behalf to state viable constitutional claims.
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August 09, 2024
Delaware Jury Says Fecal Treatment Patents Are Worth $25M
A Delaware federal jury decided Friday that a Swiss drugmaker owes a smaller drug rival at least $25 million in a patent case involving an experimental enema used to treat a particularly deadly form of diarrhea.
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August 09, 2024
Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told
A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.
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August 09, 2024
Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio
The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.
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August 09, 2024
DC Circ. Pans Suit Claiming HHS Caused Health Aid Shortage
The D.C. Circuit said Friday that a judge properly dismissed a proposed class action blaming the U.S. Department of Health and Human Services for a lack of home health aides willing to assist Medicare beneficiaries with chronic illnesses, saying the private providers aren't required to accept those patients.
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August 09, 2024
Conn. Hospital Must Give Data To Competitor, Judge Says
Connecticut's Bristol Hospital must turn over a brand survey for use in Saint Francis Hospital and Medical Center Inc.'s antitrust lawsuit against Hartford HealthCare Corp., but the data can be redacted and restricted to attorneys only, a federal magistrate judge ruled Friday.
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August 09, 2024
Biotech Firms Mull Acquisition Offers Amid Shaky IPO Climate
Amid a shaky outlook for initial public offerings, more private biotechnology firms are exploring acquisition offers from larger pharmaceutical companies as a more certain exit strategy, according to experts who advise emerging drug developers.
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August 09, 2024
Wash. Hospital Patients Can't Certify 'Fail Safe' Classes
A Washington federal judge on Friday rejected a certification attempt in a proposed class action accusing a hospital system of incentivizing two of its doctors to perform medically unnecessary surgeries, but said the plaintiffs would have the chance to address the litany of defects by amending their suit.
Expert Analysis
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Unpacking NY's Revised Hospital Cybersecurity Rule Proposal
The New York State Department of Health's recently revised hospital cybersecurity rule proposal highlights increased expectations and scrutiny around cybersecurity in the healthcare sector, while adapting to both recent industry developments and public comments, say Christine Moundas and Gideon Zvi Palte at Ropes & Gray.
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Short-Term Takeaways From CMS' New Long-Term Care Rules
The Centers for Medicare & Medicaid Services' new final rule on nursing home staffing minimums imposes controversial regulatory challenges that will likely face significant litigation, but for now, stakeholders will need to prepare for increased staffing expectations and more specialized facility assessments without meaningful funding, say attorneys at Morgan Lewis.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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FDA's Data Monitoring Guidance Reveals Future Expectations
As the world of clinical research grows increasingly complex, the U.S. Food and Drug Administration's recent draft guidance on the use of data monitoring committees in clinical trials reveals how the agency expects such committees to develop, say Melissa Markey and Carolina Wirth at Hall Render.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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New OSHA Memo Helps Clarify Recordkeeping Compliance
Based on recent Occupational Safety and Health Administration guidance on whether musculoskeletal disorders are recordable injuries under the agency's recordkeeping regulation, it appears that OSHA may target active release techniques and stretching programs during its inspections, say attorneys at Morgan Lewis.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.
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To Make Your Legal Writing Clear, Emulate A Master Chef
To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.
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Circuit Judge Writes An Opinion, AI Helps: What Now?
Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.
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'Food As Health' Serves Up Fresh Legal Considerations
The growth of food as medicine presents a significant opportunity for healthcare organizations and nontraditional healthcare players to improve patient outcomes and reduce costs, though these innovative programs also bring compliance considerations that must be carefully navigated, say attorneys at McDermott.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.