Legal


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    Courtesy of EOFlow
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    Insulet awarded $452M in EOFlow patent fight

    A jury found that competitor EOFlow and former executives misappropriated trade secrets for Insulet’s Omnipod insulin pumps.

    By Dec. 5, 2024
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    Courtesy of GuardantHealth
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    Guardant awarded nearly $293M in false ad trial against Natera

    Natera allegedly made “false and misleading statements” to convince people to use its Signatera cancer test rather than Guardant’s rival product Reveal.

    By Dec. 2, 2024
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    Win McNamee/Getty Images via Getty Images
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    Advamed CEO congratulates Trump, stresses need for public policy support

    Donald Trump’s election victory comes weeks after the FDA named a new leader for the medical device center and as the agency’s contentious LDT final rule is challenged in court.

    By Nov. 11, 2024
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    Wavebreakmedia via Getty Images
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    Medtronic settles pulse oximetry lawsuit alleging inaccuracies

    Roots Community Health has sued 12 other firms, including GE Healthcare, CVS and Walgreens, and called for manufacturers and the FDA to ensure the devices work for everyone.

    By Nov. 4, 2024
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    GussWilder for iStock via Getty Images
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    Exactech files for Chapter 11, agrees to investor buyout

    The filing follows Exactech’s failure to settle product liability claims from about 2,600 patients in response to recalls of orthopedic devices.

    By Oct. 30, 2024
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    RiverNorthPhotography via Getty Images
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    FTC increases premerger reporting requirements over provider objections

    Companies will be required to disclose more information about minority investors and past M&A activity. Provider groups said the new requirements would be burdensome for hospitals.

    By Susanna Vogel • Oct. 16, 2024
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    Patrik Stollarz / Staff via Getty Images
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    Independent lab fires back after Philips sues over testing results

    PSN Labs called for a jury trial, claiming Philips is attempting to deflect attention away from its own “failures, negligence, concealment and recklessness.”

    By Oct. 3, 2024
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    Permission granted by Becton Dickinson
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    BD agrees to settle most of its hernia mesh litigation

    The settlement terms are confidential, BD said. The company disputes the lawsuit’s allegations and backs its product designs.

    By Oct. 3, 2024
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    Stock Photo via Getty Images
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    Jury sides with Axonics in Medtronic patent dispute

    Meanwhile, Boston Scientific is still waiting for antitrust regulators to conclude their review of its proposal to buy Axonics, which was announced in January.

    By Sept. 19, 2024
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    Courtesy of BusinessWire/Masimo
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    Masimo proxy fight nears end as shareholder vote looms

    Chairman and CEO Joe Kiani’s board seat is on the line at today's shareholder meeting.

    By Sept. 19, 2024
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    Samuel Corum via Getty Images
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    Illumina court ruling limits EU regulators’ merger review power

    The European Commission lacked oversight authority to examine the proposed sale of a cancer-detection company to biotech company Illumina, the court found.

    By Justin Bachman • Sept. 9, 2024
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    Mario Tama via Getty Images
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    Judge orders J&J to pay Auris investors more than $1B for merger violations

    J&J did not provide Auris Health with resources to achieve regulatory milestones after acquiring the robotics company in 2019, the judge found.

    By Sept. 6, 2024
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    Courtesy of Grail
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    Illumina avoids fine for Grail purchase in European court victory

    Illumina will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.

    By Sept. 3, 2024
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    andresr via Getty Images
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    Pathology group sues to block FDA lab test rule

    The Association for Molecular Pathology is the second lab trade group urging the courts to void an FDA policy expanding oversight of diagnostic tests.

    By Aug. 30, 2024
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    Retrieved from Masimo on August 20, 2024
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    Masimo’s consumer audio brands attract more suitors

    Negotiations with a potential joint venture partner will continue while Masimo initiates discussions with new parties that have expressed interest in the consumer audio business.

    By Aug. 21, 2024
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    Karen Ducey/Getty Images via Getty Images
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    Experts fear patient harm from FDA’s lab developed test rule

    Decreased access to diagnostic tests, worsening patient care and practice closures are among the concerns the AMA and others have raised as the regulation takes effect.

    By Aug. 5, 2024
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    Courtesy of Philips
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    Philips sues independent lab, alleges ‘numerous egregious errors’ in CPAP foam tests

    Philips claimed PSN Labs overestimated the potential threat to patients, saying it “would have pursued a different and more focused recall” if not for the results.

    By Aug. 2, 2024
  • A lab technician runs Guardant Health's Shield blood test for colorectal cancer screening in a lab.
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    Courtesy of Business Wire
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    Guardant settles allegations it violated the False Claims Act

    The settlement resolves claims that an oncologist ordered significantly more tests after Guardant hired two people the physician recommended for jobs at the company.

    By July 23, 2024
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    The image by Ramsey Cardy/Collision/Sportsfile is licensed under CC BY 2.0
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    Masimo sues activist investor Politan, postpones annual meeting

    The latest turn in the recent drama comes days after proxy advisory firms ISS and Glass Lewis backed two Politan nominees for Masimo’s board.

    By July 16, 2024
  • Loper decision ending Chevron deference doctrine
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    Anna Moneymaker / Staff via Getty Images
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    Deep Dive

    FDA’s lab developed test rule could be first check on agency’s power post-Chevron

    The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.

    By , July 11, 2024
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    Courtesy of Roche
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    Roche sues Foresight and Stanford, alleging use of trade secrets

    Roche said Stanford applied for patents relating to cancer detection and monitoring technology using its confidential information.

    By July 3, 2024
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    Retrieved from Dermtech on June 20, 2024
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    Dermtech files for Chapter 11, lays off 20% of staff

    The diagnostic test maker will continue to hunt for a buyer for its skin cancer detection patch.

    By June 20, 2024
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    David McNew via Getty Images
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    Former Stimwave CEO gets 6 years in prison for fake device scheme

    The case centered on allegations that Stimwave marketed a dummy piece of plastic as a receiver of radiofrequency energy.

    By June 20, 2024
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    Kevin Dietsch / Staff via Getty Images
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    Masimo embroiled in dual DOJ, SEC probes

    Masimo will have to juggle the government inquiries while also dealing with an activist investor-led proxy battle.

    By June 13, 2024
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    GussWilder for iStock via Getty Images
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    Vyaire Medical files for Chapter 11 bankruptcy

    CEO John Bibb said the move gives Vyaire “breathing room” as the ventilator manufacturer looks to sell its businesses.

    By June 11, 2024