Legal
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Courtesy of GuardantHealth
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 Nick Paul Taylor • Dec. 2, 2024 -
Win McNamee/Getty Images via Getty Images
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 Ricky Zipp • Nov. 11, 2024 -
Wavebreakmedia via Getty Images
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 Elise Reuter • Nov. 4, 2024 -
GussWilder for iStock via Getty Images
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 Nick Paul Taylor • Oct. 30, 2024 -
RiverNorthPhotography via Getty Images
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 -
Patrik Stollarz / Staff via Getty Images
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 Elise Reuter • Oct. 3, 2024 -
Permission granted by Becton Dickinson
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 Susan Kelly • Oct. 3, 2024 -
Stock Photo via Getty Images
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 Elise Reuter • Sept. 19, 2024 -
Courtesy of BusinessWire/Masimo
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 Susan Kelly • Sept. 19, 2024 -
Samuel Corum via Getty Images
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 -
Mario Tama via Getty Images
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 Ricky Zipp • Sept. 6, 2024 -
Courtesy of Grail
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 Susan Kelly • Sept. 3, 2024 -
andresr via Getty Images
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 Susan Kelly • Aug. 30, 2024 -
Retrieved from Masimo on August 20, 2024
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 Susan Kelly • Aug. 21, 2024 -
Karen Ducey/Getty Images via Getty Images
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 Susan Kelly • Aug. 5, 2024 -
Courtesy of Philips
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 Elise Reuter • Aug. 2, 2024 -
Courtesy of Business Wire
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 Nick Paul Taylor • July 23, 2024 -
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 Susan Kelly • July 16, 2024 -
Anna Moneymaker / Staff via Getty Images
Deep DiveFDA’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 Susan Kelly , Elise Reuter • July 11, 2024 -
Courtesy of Roche
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 Nick Paul Taylor • July 3, 2024 -
Retrieved from Dermtech on June 20, 2024
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 Nick Paul Taylor • June 20, 2024 -
David McNew via Getty Images
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 Nick Paul Taylor • June 20, 2024 -
Kevin Dietsch / Staff via Getty Images
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 Susan Kelly • June 13, 2024 -
GussWilder for iStock via Getty Images
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 Elise Reuter • June 11, 2024 -
K-Kwanchai via Getty Images
Lab industry sues to stop FDA’s new LDT rule
The American Clinical Laboratory Association argues the agency does not have the authority to enforce stricter standards on lab developed tests.
By Susan Kelly • May 30, 2024
