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Life Sciences
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November 15, 2024
Natera Exec Calls Guardant's Cancer Test Claims 'Dangerous'
Natera's president of clinical diagnostics testified at trial Friday in a California federal false advertising case that Guardant Health's claims about Guardant's competing colorectal cancer test were "false and misleading" and also "dangerous."
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November 15, 2024
SEC-Sanctioned Accounting Firm Sued Over Pre-IPO Work
The former public company accounting firm BF Borgers is facing a California state lawsuit by an ex-client that says it was forced to scuttle its plans for an initial public offering after the U.S. Securities and Exchange Commission accused the firm of being a "sham auditing mill."
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November 15, 2024
PBMs Denied Breakup Of Combined FTC Insulin Price Trial
The Federal Trade Commission's allegations that pharmacy benefit manager giants Caremark Rx, Express Scripts and OptumRx are artificially inflating insulin prices through unfair rebate schemes will forge ahead as a single case following an in-house agency judge's refusal to break them into separate proceedings.
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November 15, 2024
Despite Vaccine Spotlight, RFK Jr. A Health Policy 'Unknown'
Robert F. Kennedy Jr., President-elect Donald Trump's pick to be the nation's top health official, has made clear his unorthodox and often false views on public health issues like vaccines. But there's still plenty of policy under his potential control where his stance remains opaque, attorneys say, which could stymie their efforts to prepare for the next four years.
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November 15, 2024
Ariz. Judge Will Decide Proper Venue For CVS Antitrust Suit
A federal judge concluded Thursday that he must decide whether a proposed class action accusing CVS of exploiting a Medicare loophole to charge independent pharmacies exorbitant fees belongs in arbitration, after scolding CVS's attorneys for failing to adequately develop their arguments defending an underlying delegation clause.
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November 15, 2024
DEA Judge Nixes Vet Group's Bid To Take Part In Pot Hearings
An administrative law judge with the U.S. Drug Enforcement Administration on Friday denied a veterans group's bid to participate in upcoming hearings on a proposal to loosen federal restrictions on marijuana.
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November 15, 2024
Abbott Inks $8M Deal With Healthcare Fraudster In TM Suit
A New York federal judge on Thursday green-lit a trademark infringement settlement in which Abbott Laboratories will receive $8 million from a Florida businessman who recently pled guilty to healthcare fraud for his role in a sprawling gray market scheme to profit off of Abbott's line of diabetic test strips meant to be sold internationally.
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November 15, 2024
Ayahuasca Church Urges Justices To Hear Discovery Case
An Arizona church that uses a psychedelic substance in its ceremonies has asked the U.S. Supreme Court to reconsider lower courts' rulings directing the church to turn over members' personal information to federal drug enforcement authorities.
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November 15, 2024
Teva Defends Mifepristone Antitrust Case Against Corcept
Teva Pharmaceuticals has asked a California federal judge to reject a bid to dismiss its lawsuit against the maker of a brand-name drug used to treat a rare cortisol disorder, contending its complaint plausibly alleges an illegal scheme to suppress generic competition.
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November 15, 2024
Attys Get 'Final Warning' In Tepezza Hearing Loss MDL
A magistrate judge has chastised attorneys on both sides of multidistrict litigation involving claims that a thyroid eye disease treatment manufactured by Horizon Pharmaceuticals Inc. causes hearing loss, calling for an end to their "improper" conduct during depositions.
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November 15, 2024
HOA's Insurer Says Pool Chemical Injury Suits Aren't Covered
A homeowners association's insurer told a Virginia federal court it needn't cover underlying lawsuits alleging a lifeguard employed by the association's contractor allowed hazardous chemicals to spread and hurt pool patrons, arguing that its commercial general liability policy excluded bodily injury as a result of pollutants.
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November 15, 2024
Orrick Trial Partner Joins Morgan Lewis In Boston
Morgan Lewis & Bockius LLP announced that an experienced litigator from Orrick Herrington & Sutcliffe LLP joined the firm's Boston office as a partner, enhancing its capacity in areas such as life sciences and regulatory compliance.
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November 15, 2024
Pharma Biz To Pay $47M To Settle Feds' Kickback Claims
A Florida pharmaceutical company and its chief executive have agreed to pay $47 million to settle claims that their practice of paying for certain patient tests crossed the line into being an illegal kickback to increase prescriptions of an enzyme replacement therapy, Boston federal prosecutors said on Friday.
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November 15, 2024
Sterilization Co. Cosmed Hits Ch. 11 Amid Cancer Claims
Sterilization company Cosmed Group Inc. filed for Chapter 11 protection in a Texas bankruptcy court Thursday with over $100 million in liabilities, much of it related to cancer claims over the gas that it uses for sterilization.
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November 14, 2024
Trump's RFK Jr. Pick For HHS Draws Its Share Of Critics
The nomination of Robert F. Kennedy Jr. — well-known for his opposition to vaccines — as the secretary of the U.S. Department of Health and Human Services is President-elect Donald Trump's latest controversial pick for his administration, and one that could disrupt the U.S. Food and Drug Administration and its mission.
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November 14, 2024
Senate Panel Delays Votes On Patent Eligibility And PTAB Bills
The Senate Judiciary Committee on Thursday postponed planned votes on legislation aimed at reducing decisions that inventions are ineligible for patents and setting new limits on Patent Trial and Appeal Board challenges, but approved a bill to let the patent office collect demographic data on inventors.
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November 14, 2024
Judge Finds Dexcom Infringed Abbott Patent That Hung Jury
A judge has found that Dexcom Inc. infringed a glucose monitor patent owned by an Abbott Laboratories unit, with the ruling coming after a Delaware federal jury in March said it was hung on the issue.
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November 14, 2024
Takeda Rips Cert. Order's 'Whale Of Assumption' At 9th Circ.
Takeda Pharmaceutical urged the Ninth Circuit on Thursday to reverse a ruling certifying a class of third-party payors who allege Takeda and Eli Lilly & Co. hid their anti-diabetes drug's bladder-cancer risks, arguing the lower court erroneously made a "whale of an assumption" that 56.7% of prescriptions wouldn't have been written with disclosures.
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November 14, 2024
Boehringer Says Inhaler Antitrust Suit 'Fails On Its Face'
Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim International GMBH have urged a Connecticut federal judge to dismiss a proposed class action brought by health funds accusing it of monopolizing the inhaler market with improper patent listings, arguing the suit fails to allege any competitors were actually hindered by those patents.
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November 14, 2024
Boeing Could Sell Navigation Unit For $6B, And More Rumors
Boeing is mulling a sale of its Jeppesen navigation unit at potential $6 billion price tag, Pfizer may be seeking billions for its hospital drug unit, and a U.S. gas station and convenience store business could be sold at a $1.5 billion value. Here, Law360 breaks down these and other notable deal rumors from the past week.
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November 14, 2024
Trump Picks RFK Jr. To Lead Health & Human Services
President-elect Donald Trump announced Thursday that Robert F. Kennedy Jr., a prominent anti-vaccination activist and former presidential candidate, is his nominee to lead the U.S. Department of Health and Human Services.
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November 13, 2024
Guardant Atty Accuses Natera CEO Of Dishonesty At Trial
A Guardant Health lawyer on Wednesday accused Natera's CEO of being disingenuous when he testified at trial that a Natera ad campaign was aimed at correcting misleading information Guardant promoted about its competing colorectal cancer tests, exclaiming, "It was about money, wasn't it? Can't you just be honest about that?"
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November 13, 2024
Damages Limited In AGs' Generic Drug Price-Fixing Case
A Connecticut federal judge has nixed some claims against Sandoz Inc. and other generic-drug makers in a massive antitrust and unfair trade practices case filed by state attorneys general, finding that a handful of the enforcers cannot seek damages on behalf of their allegedly injured citizens.
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November 13, 2024
Honey Pot Greenwashes 'Plant-Derived' Products, Suit Says
The Honey Pot Co. faces a proposed false advertising class action filed Tuesday in California federal court by customers who allege its line of organic feminine care products, which includes foam washes, wipes, pads and liners, contain synthetic ingredients, despite being labeled as "plant-derived."
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November 13, 2024
Ozempic MDL Plaintiffs Say Eli Lilly, Novo Nordisk Hid Risks
Patients accusing Novo Nordisk and Eli Lilly & Co. of failing to warn them about the risks associated with Ozempic and other such medications on Wednesday filed a massive master complaint in the sprawling multidistrict litigation centralized in the Eastern District of Pennsylvania.
Expert Analysis
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.
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11 Patent Cases To Watch At Fed. Circ. And High Court
As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.
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Opinion
3rd. Circ. Got It Right On Cancer Warning Claims Preemption
The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.
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Opinion
To Lower Drug Prices, Harris Must Address Patent Thickets
If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.