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Life Sciences
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March 22, 2024
LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial
New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.
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March 21, 2024
SEC's 'Shadow Trading' Trial To Test Insider Info Boundaries
If the U.S. Securities and Exchange Commission can convince jurors hearing its first-ever "shadow trading" case next week to find a former executive in the wrong for buying up a competitor's securities while having insider information about his own company, the floodgates could open to civil and criminal prosecution of other corporate insiders under the novel legal theory, attorneys told Law360.
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March 21, 2024
Colo. Distributor Seeks $2.3M Sanction For Stryker Spoilation
A Colorado medical device distributor urged a federal judge to make Stryker and its lawyers pay $2.3 million in attorney fees as sanctions for "pervasive misconduct" throughout discovery and trial, arguing discovery violations will otherwise become the "cost of doing business" for the medical technology giant.
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March 21, 2024
Schumer Urges Texas District To Adopt Judge-Shopping Rule
Senate Majority Leader Chuck Schumer on Thursday urged the chief judge of the Northern District of Texas to quickly implement the Judicial Conference of the United States' updated policy that looks to prevent litigants from judge shopping, arguing that the district's current practices are "dangerous."
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March 21, 2024
Ill. Judge Leaves Outcome Health Execs' Convictions Intact
An Illinois federal judge said Thursday that he wouldn't disturb three former Outcome Health executives' convictions for carrying out a massive billion-dollar fraud scheme to grow their health advertising business, saying the jury heard enough evidence to support its verdict.
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March 21, 2024
MDL Claims Over Merck's Gardasil Vax Get Trimmed
Pharmaceutical giant Merck need not face many of the claims by patients who allege their autoimmune conditions were caused by its HPV vaccine, a North Carolina federal judge overseeing multidistrict litigation ruled, saying the National Childhood Vaccine Injury Act bars most claims made in the first two bellwethers.
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March 21, 2024
6th Circ. Revives McKee's Network Plan Fight With Thrifty Med
The Sixth Circuit reinstated on Thursday McKee Foods Corp.'s suit against Thrifty MedPlus Pharmacy alleging Tennessee law requiring pharmacy benefit managers to let "any willing pharmacies" participate in a network was preempted by the Employee Retirement Income Security Act, finding that amendments made to the statute didn't render McKee's claims moot.
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March 21, 2024
Calif. Panel Revives Diner's COVID Sanitization Coverage Bid
A California state appeals court revived a diner's bid for property insurance coverage of COVID-19 losses after it determined the restaurant credibly alleged direct physical losses and that the policy's language covering losses attributable to a virus applied to COVID-19 sanitization efforts.
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March 21, 2024
Tribe's Opioid Suit Can Head To State Court, Okla. Judge Says
An Oklahoma federal magistrate judge has granted the Cherokee Nation's bid to move to state court its suit accusing pharmaceuticals distributor Morris & Dickson of flooding the tribe's communities with opioids, saying the company only fulfilled one of four prongs necessary for establishing federal jurisdiction.
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March 21, 2024
CymaBay Investor Sues For Books On $4.3B Gilead Merger
A shareholder of liver disease-focused biopharmaceutical company CymaBay Therapeutics Inc. sued the company in Delaware Chancery Court to extract more information over a proposed $4.3 billion merger with Gilead Sciences Inc., saying CymaBay has refused to hand over previously requested documents regarding the valuation analyses without a legitimate excuse.
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March 21, 2024
Avoid Major Extension Of Merger Reach, EU High Court Urged
An important tool for extending European Union antitrust officials' merger scrutiny appears to be in jeopardy after a European Court of Justice advocate general effectively recommended Thursday that the bloc's high court restrict the ability to investigate transactions that don't normally trigger EU thresholds.
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March 21, 2024
Business Coalition Rebuffs Biden Plan To Seize Drug Patents
The Biden administration's proposal to exercise so-called march-in rights to seize drug patents would harm innovation in the U.S., according to an assemblage of business-focused groups.
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March 21, 2024
Home Health Cos. Stiffed Workers On OT Pay, Suit Claims
The operators of several Ohio-based home care staffing agencies have been failing to pay their employees for all the overtime hours they worked, according to a recent proposed class and collective action.
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March 21, 2024
Teleflex Catheter Patent Makes It Through Fed. Circ.
The Federal Circuit on Thursday opted to leave untouched an administrative patent board ruling that rejected a legal effort to invalidate a patent covering a type of catheter that's sold by Teleflex.
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March 21, 2024
Woman Lost Independence Due To Strattice Mesh, Jurors Told
A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.
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March 21, 2024
3rd Circ. Agrees Investors Have No Case Against Vax Maker
The Third Circuit on Thursday upheld a Pennsylvania federal judge's ruling that a putative class of investors alleging biopharmaceutical company Ocugen Inc. made misleading statements about its ability to quickly produce a COVID-19 vaccine failed to state a claim against the company.
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March 21, 2024
6th Circ. Doubtful Of Hospital Workers' Vax Exemption Claim
A Sixth Circuit panel appeared skeptical Thursday of an argument from a class of former employees of Ohio Children's Hospital that their First Amendment rights to freedom of religion were violated under the hospital's COVID-19 employee vaccination policy.
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March 21, 2024
Fed. Circ. Upholds Edwards' PTAB Win On Heart Valve Patent
The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that various parts of medical technology maker Cardiovalve's patent on an artificial heart valve implant were invalid as obvious.
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March 21, 2024
6th Circ. Zeroes In On CBA In Vax Bias Preemption Battle
A Sixth Circuit panel pressed on Thursday a cargo airline and pilots who say they were unlawfully fired for refusing COVID-19 vaccinations about the pilots' union contract, with one judge asking whether the open questions about their collective bargaining agreement meant the discrimination case was preempted.
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March 21, 2024
Chancery Denies Icahn Midcase Appeal In Illumina Board Suit
Carl Icahn can't interrupt his Chancery Court lawsuit against biotech Illumina Inc.'s board to appeal a decision about redactions to the Delaware Supreme Court, a vice chancellor ruled Wednesday, saying there are no "exceptional circumstances" that call for a midcase review.
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March 21, 2024
Greenberg Traurig Adds Jackson Walker FDA Pro In Houston
Greenberg Traurig LLP's most recent Houston addition is a shareholder who came aboard from Jackson Walker LLP, where he established and led its U.S. Food and Drug Administration practice.
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March 20, 2024
4th Circ. Backs Rockefeller Group in Guatemalans' Syphilis Suit
A group of Guatemalans who sued The Rockefeller Foundation over venereal disease experiments conducted on prisoners and psychiatric patients in the 1940s did not show an American doctor involved in the gruesome activities acted on behalf of the organization, a Fourth Circuit panel ruled Wednesday.
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March 20, 2024
Endo Plan To Trim $5B In Debt Confirmed By NY Judge
Drugmaker Endo International got a New York bankruptcy judge's approval for its Chapter 11 plan that aims to cut more than $5 billion in debt and hand over ownership to its lenders, roughly a month after it finalized a $465 million deal to resolve criminal and civil opioid claims.
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March 20, 2024
PTAB To Analyze Moderna COVID Vaccine Patents
The Patent Trial and Appeal Board has agreed to review two Moderna COVID-19 vaccine patents challenged by rivals Pfizer and BioNTech as having "unimaginably broad claims directed to a basic idea that was known long before."
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March 20, 2024
Jenner & Block-Led Lonza To Buy Roche's $1.2B US Facility
Swiss healthcare company Lonza said on Wednesday that it has agreed to acquire one of the largest medicine manufacturing facilities in the world from biotech giant Roche for $1.2 billion to increase its manufacturing capacity.
Expert Analysis
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Opinion
Life Sciences Regulators Must Write Cloud-Specific Guidance
As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.
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Fed. Circ. Elekta Holding May Make Patent Prosecution Harder
The Federal Circuit's recent analysis of obviousness in its Elekta v. Zap Surgical Systems decision will make prosecuting patents harder, as parties will now need to consider whether to argue that cited patents are nonanalogous, say Sean Murray and Jeremiah Helm of Knobbe Martens.
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Attorneys, Law Schools Must Adapt To New Era Of Evidence
Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.
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Series
ESG Around The World: The UK
Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.
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Boeing Opinion Strikes Blow Against Overpayment Theory
The Fifth Circuit's decision in Earl v. Boeing Co. casts doubt on consumers' standing to bring claims of overpayment for products later revealed to have defects — and suggests that it's more likely that those products would have been removed from the market, driving up the price of alternatives, say attorneys at Bush Seyferth.
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Tips For Litigating Against Pro Se Parties In Complex Disputes
Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.
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What Pharma Cos. Must Know About FDA Off-Label Guidance
The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.
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It's Time To Prescribe Frameworks For AI-Driven Health Care
As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.
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The Murky World Of IP Protection For Gene-Edited Plants
The recently filed Corteva v. Inari lawsuit, which accuses a plant trait developer of using a front company for commercial development, underscores the legal challenges in protecting and determining the ownership of new, genetically edited plant varieties, and emphasizes why joint development arrangements must be carefully navigated, say Andrew Zappia and Tate Tischner at Troutman Pepper.
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New Initiatives Will Advance Corporate Biodiversity Reporting
Two important recent developments — the launch of the Taskforce on Nature-related Financial Disclosures' framework on nature and biodiversity reporting, and Nature Action 100's announcement of the 100 companies it plans to engage on biodiversity issues — will help bring biodiversity disclosures into the mainstream, say David Woodcock and Maria Banda at Gibson Dunn.
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Opinion
Alternative Patents Would Solve Many Inventor Woes
A fundamental reform that gives inventors the option of alternative patents tailored to the value of an invention offers a potential solution for resolving patent-system problems, says John Powers of The Powers IP Law Firm.
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Class Action Defense: Don't Give Up On Bristol-Myers Squibb
Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.
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Pro Bono Work Is Powerful Self-Help For Attorneys
Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.
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FDA Proposals Clarify Rules For Devices With Predicates
As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.
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State Regs Sow Discord Between Cannabis, Hemp Industries
Connecticut, Maryland and Washington are the latest states choosing to require intoxicating hemp products to comply with the states' recreational marijuana laws, resulting in a widening rift between cannabis and hemp as Congress works on crafting new hemp legislation within the upcoming 2023 Farm Bill, say attorneys at Wilson Elser.