A federal appeals court has ruled that Medtronic must face a whistleblower lawsuit over FDA clearance of certain spinal fusion devices. The Dan Abrams Company sued Medtronic in 2015 claiming that Medtronic defrauded the FDA into granting 510(k) clearance to certain Verte-Stack cervical vertebral body replacement (VBR) devices used in spinal fusion surgeries. The lawsuit […]
Legal News
Illumina postpones $8B Grail deal amid FTC challenge
Illumina (NSDQ:ILMN) has delayed its proposed $8 billion acquisition of Grail amid a FTC challenge. The companies have agreed to postpone the planned purchase until after Sept. 20 while the FTC challenges the deal, according to a temporary restraining order issued out of U.S. District Court in the District of Columbia. News of Illumina’s agreement […]
Merit Medical must face shareholder lawsuit
A federal judge in California quashed a bid by Merit Medical to dismiss a lawsuit alleging misrepresentation of success to stockholders. The consolidated class action complaint states two claims for securities fraud, alleging that Merit CEO Fred P. Lampropoulos and CFO Raul Parra, plus the company itself, made multiple misrepresentations to investors that resulted in […]
Abbott’s St. Jude Medical wins patent spat over catheterization method
St. Jude Medical, now part of Abbott, has won a patent dispute over a method for using a double catheter in heart failure patients. Niazi Licensing’s patent, issued in 2003 for the double catheter system, describes it as better suited for “use in the coronary sinus, especially in patients suffering from congestive heart failure,” according […]
Second Sight’s merger with Pixium Vision may fall through
Second Sight‘s plans to raise $27.9 million from a private placement appear to have generated conflict with its would-be owner Pixium Vision. Pixium informed Second Sight (NSDQ: EYES) yesterday that the private placement would breach the memorandum of understanding the two companies reached in early January, according to a Second Sight filing with the SEC. […]
Federal judge won’t let Boston Scientific avoid Watchman lawsuit
A federal judge in western North Carolina has declined to dismiss a wrongful death lawsuit against Boston Scientific (NYSE:BSX) over its Watchman stroke prevention device. Boston Scientific had sought to have the suit — brought by the Jean Penland estate — dismissed based on the Supreme Court’s decade-old Riegel v. Medtronic decision. The Riegel ruling […]
Boston Scientific settles host of state pelvic mesh lawsuits for nearly $189M
Boston Scientific (NYSE:BSX) has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve claims that it deceptively marketed transvaginal surgical mesh devices, state AGs announced today. Pelvic mesh products have been one of the medical device industry’s worst failures so far in the 21st century. First cleared nearly two […]
Investors sue Decision Diagnostics over COVID-19 test
Decision Diagnostics is facing legal action after the company allegedly misled investors about developing a COVID-19 diagnostic. Licgo Partners, Sovereign Partners and Paradigm Capital, all investor companies, sued Decision Diagnostics and CEO Keith Berman in federal court under allegations that Berman had falsely stated that the company was developing an at-home COVID-19 test that was […]
Allergan must face breast implant class action
A federal judge in New Jersey has shut down part of a multi-district lawsuit against Allergan over its Biocell textured breast implants but kept most other parts of the litigation. Judge Brian Martinotti ruled on March 19 that some of the plaintiffs’ claims against Allergan (now part of AbbVie) were preempted by federal law while […]
Feds charge medical testing company with fraud
A federal grand jury has charged the uBiome co-founders with multiple federal crimes, including two fraud charges, money laundering and more. Now bankrupt, uBiome was founded by Zachary Apte, 36, and Jessica Richman, 46, in 2012 as a medical testing company that performed diagnostic analysis on fecal samples. The company offered a direct-to-consumer service called […]
Theranos founder Elizabeth Holmes’s trial delayed again — this time over pregnancy
A federal judge in San Jose, Calif. has agreed to delay Theranos founder Elizabeth Holmes’s trial until Aug. 31, according to media reports. This is the fourth delay to Holmes’ trial — which has been continually delayed because of challenges caused by the COVID-19 pandemic. This time, the trial has been delayed another six weeks […]
