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Health
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August 29, 2024
Ga. Health System Shakes Facebook Data Sharing Row
A Georgia federal judge has tossed a putative class action accusing Piedmont Healthcare Inc. of unlawfully sharing confidential health information with Facebook, finding that the plaintiffs failed to allege actual damages and that the "weight of authority" in similar online tracking cases supported the provider's contention that there was no privacy intrusion.
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August 29, 2024
Pa. Justices To Examine Axing Of 'Red Book' Drug Pricing
The Supreme Court of Pennsylvania has agreed to review a decision tossing the "Red Book" pricing values used by the state's Bureau of Workers' Compensation to calculate reimbursement for prescription drug costs.
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August 29, 2024
Jury Clears Ore. Hospital That Implanted FDA-Flagged Mesh
A state jury cleared an Oregon hospital system and a surgeon of liability Wednesday over a patient's claims that prolapse mesh was implanted almost two weeks after the U.S. Food and Drug Administration ordered its maker to stop selling it.
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August 29, 2024
Lannett Says Areva Reneged On Cancer-Drug Deal After Ch. 11
Lannett Pharmaceuticals hit generic-drug maker Areva Pharmaceuticals with a contract suit in Delaware's Court of Chancery on Thursday, accusing Areva of breaching their 2022 agreement that gave Lannett exclusive rights to distribute Areva's injectable anticancer drug after Lannett emerged from a prepackaged Chapter 11 bankruptcy.
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August 29, 2024
Sutter Health Kickback Fight Likely Headed To Nov. Trial
A California federal judge indicated Wednesday she's likely to send at least some claims in a whistleblower's kickback suit against Sutter Health and a surgical-practice group to a November trial, saying during a hearing there are disputes over the credibility of certain evidence and that's "the providence of the jury."
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August 29, 2024
Comer Tells PBMs To Correct Record On Role In Drug Pricing
Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.
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August 29, 2024
Seattle Biotech Can't Immediately Force Out LA Times Owner
Billionaire and Los Angeles Times owner Dr. Patrick Soon-Shiong will not be forced to recuse himself from a Seattle-based biotech research institute board while the nonprofit's breach-of-fiduciary duty lawsuit against him is pending, a Washington federal judge said on Thursday.
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August 29, 2024
Pacira To Appeal Generic's Win In Pain Drug Patent Fight
Pacira Pharmaceuticals Inc. says it is appealing a New Jersey federal judge's decision invalidating its patent on a nonopioid painkiller and opening the way for generic versions of its drug Exparel, a long-acting injectable for managing postsurgical pain.
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August 29, 2024
Convicted Drexel Prof Says Records Would've Swayed Jury
A Drexel University accounting professor convicted on charges of tax evasion and filing false tax returns after the government accused him of failing to report $3.3 million in income from a Trenton pharmacy has asked a New Jersey federal judge for a new trial.
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August 29, 2024
Conn. ER Docs Ask To Drop Harvard Pilgrim Insurance Fight
A staffing company covering six Connecticut emergency rooms has asked a federal judge to dismiss its lawsuit against Harvard Pilgrim Health Care of Connecticut Inc. after the state's highest court last week ruled in the insurer's favor on three certified questions of law regarding a surprise billing statute.
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August 29, 2024
HHS Withdraws Appeal In Hospital Web-Tracking Clash
The Biden administration on Thursday abandoned its appeal of a federal court decision that knocked down new guidance restricting how hospitals can use web-tracking tools, handing the American Hospital Association a victory in a closely watched case.
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August 29, 2024
Full 11th Circ. Won't Rehear Ala. Trans Care Ban Challenge
The Eleventh Circuit said it will not reconsider its ruling allowing Alabama to enact a ban on certain gender-affirming medical care for minors, knocking down a challenge brought by parents and those who received the treatment of the circuit's ruling, which found that the ban doesn't flout constitutional rights.
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August 29, 2024
Houston Law Firm Hit With 2nd Data Breach Suit
Houston personal injury firm Fleming Nolen & Jez has been hit with another proposed class action over a February 2023 data breach that exposed clients' personal and health information.
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August 29, 2024
GOP States Ask Justices To Undo Trans Patients' 4th Circ. Win
A group of two dozen Republican attorneys general told the U.S. Supreme Court it should review a Fourth Circuit decision barring West Virginia and North Carolina from excluding coverage of gender-affirming medical care for transgender people, arguing states need the power to control controversial nascent treatments.
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August 29, 2024
Man Gets Prison In Journalist Harassment Case
A man who pled guilty to his role in a scheme to harass two New Hampshire Public Radio journalists was sentenced to two years and three months in prison.
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August 28, 2024
CVS Can't Avoid Federal Claims In $200M FCA Suit
A former CVS Health compliance director can pursue claims the company and its subsidiaries pocketed more than $200 million in overpayments, after an Illinois federal judge on Monday tossed several other claims from a qui tam suit alleging various schemes by CVS to take money from the government.
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August 28, 2024
9th Circ. Overturns Rule Mandating Sealing Of Health Records
A Ninth Circuit panel found Wednesday that Hawaii state court rules mandating the automatic sealing of medical and health records in civil and criminal proceedings are unconstitutionally overbroad.
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August 28, 2024
Dr.'s Suit Blames Practice's Buyer For Chaos After Sale
A North Carolina doctor struck back in a lawsuit blaming him for business challenges following the sale of his practice to another physician, alleging in counterclaims that the purchasing physician lied about his intentions for the practice and ultimately led it to ruin.
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August 28, 2024
SEC Says Repeat Offenders Ran Medical Co. Investment Scam
The U.S. Securities and Exchange Commission has reached a settlement with one of two men it accused of inflating the price of a healthcare company before an initial public offering with a shell company, saying he has violated a trading bar from the agency's previous suit against him.
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August 28, 2024
Suit Against BCBS Unit Over COVID-19 Test Claims Tossed
A Florida federal judge on Wednesday nixed a laboratory's lawsuit accusing a Blue Cross Blue Shield unit of violating state and federal laws by underpaying or refusing to pay COVID-19 testing claims during the pandemic.
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August 28, 2024
Walgreens Brass Hid Pharmacy Division Woes, Suit Says
Walgreens' directors and officers have been hit with a derivative suit by a shareholder who says the company and its executives inflated stock value by publicly expressing confidence in the pharmacy division's growth while hiding its struggles adapting to industry hurdles.
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August 28, 2024
NC Hit With Class Action Over Foster Care System In 'Crisis'
North Carolina Gov. Roy Cooper and the state Department of Health and Human Services are to blame for a state foster care system in "crisis," according to a new federal class action alleging that children's rights have been trampled as the Tar Heel State struggles to keep pace with a ballooning foster care population.
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August 28, 2024
11th Circ. Trans Health Redo May Spark Supreme Court Fight
The Eleventh Circuit's recent decision to rehear Georgia county officials' appeal seeking to exclude gender-confirmation surgery from its employee healthcare coverage rekindles an appellate debate on the extent to which Title VII protects transgender workers that could soon reach the U.S. Supreme Court, attorneys say.
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August 28, 2024
Mont. Hospital Pays $11M In FCA Case For Doc's Fake Billing
Nonprofit healthcare center St. Peter's Health will pay nearly $11 million to settle alleged False Claims Act violations stemming from conduct by a former oncology doctor who submitted fraudulent claims to government programs for up-coded cancer treatment services and who double-billed office visits to boost his own salary, according to the U.S. Attorney's Office for the District of Montana.
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August 28, 2024
Del. Justices OK Mid-Case Appeal In Zantac Class Suit
The Delaware Supreme Court on Tuesday said it would hear a mid-case appeal in mass tort litigation over claims that the heartburn drug ranitidine, widely sold under the name Zantac, caused cancer.
Expert Analysis
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Motion To Transfer Venue Considerations For FCA Cases
Several recent decisions highlight the importance for practitioners of analyzing as early as possible whether a False Claims Act case warrants a change of venue, and understanding how courts weigh certain factors for defendants versus whistleblowers, say Ellen London at London & Stout, and Li Yu and Corey Lipton at DiCello Levitt.
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
After Chevron: New Lines Of Attack For FCA Defense Bar
Loper Bright has given defense counsel new avenues to overcome the False Claims Act elements of falsity and scienter, as any FCA claim based upon ambiguous statutory terms can no longer stand solely on agency regulations to establish the statute's meaning, which is itself necessary to satisfy the FCA's basic requirements, says Elisha Kobre at Bradley Arant.
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CFPB's Medical Debt Proposal May Have Side Effects
The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.
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Series
Teaching Scuba Diving Makes Me A Better Lawyer
As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.
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15 Areas That Would Change Under Health Data Rule Proposal
If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.
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3 Ways To Lower Insider Trading Risk After First 10b5-1 Case
In light of the U.S. Department of Justice's insider trading prosecution against the former CEO of Ontrack based on alleged abuse of a Rule 10b5-1 safe harbor plan — designed to allow executives to sell their companies' securities without liability — companies and individuals should take steps to avoid enacting similar plans in bad faith, say attorneys at Jenner & Block.
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Lawyers Can Take Action To Honor The Voting Rights Act
As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.
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PE Firms Should Prepare For Increased False Claims Scrutiny
The impact private equity firms may have over medical decisions and care is increasingly attracting potential liability under the False Claims Act and attention from states and the federal government, so investors should follow best practices including conducting due diligence both before and after acquisitions, say attorneys at K&L Gates.
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3 Healthcare FCA Deals Provide Self-Disclosure Takeaways
Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.
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Series
After Chevron: ERISA Challenges To Watch
The end of Chevron deference makes the outcome of Employee Retirement Income Security Act regulatory challenges more uncertain as courts become final arbiters of pending lawsuits about ESG investments, the definition of a fiduciary, unallocated pension forfeitures and discrimination in healthcare plans, says Evelyn Haralampu at Burns & Levinson.
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Opinion
Expert Witness Standards Must Consider Peer Review Crisis
For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.
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Takeaways From High Court's Tribal Health Admin Cost Ruling
The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.
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Justices' Intent Witness Ruling May Be Useful For Defense Bar
At first glance, the U.S. Supreme Court’s recent Diaz v. U.S. decision, allowing experts to testify to the mental state of criminal defendants in federal court, gives prosecutors a new tool, but creative white collar defense counsel may be able to use the same tool to their own advantage, say Jack Sharman and Rachel Bragg at Lightfoot Franklin.