The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade. Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge […]
Legal News
How medical device companies are responding to abortion bans
Days after the U.S. Supreme Court’s decision to overturn Roe v. Wade’s protection of abortion rights, medical device companies are among those reassuring workers about healthcare access. Corporate communications to employees and the public at large come as trigger laws in nearly half of the states outlaw abortion immediately. Some medtech companies are not using […]
Former SCWorx CEO indicted over alleged COVID-19 rapid tests scheme
The U.S. Dept. of Justice announced that Marc Schessel of SCWorx was indicted for charges related to an alleged COVID-19 test scheme. Schessel, the former CEO of the New York-based company, was charged with two counts of securities fraud for his alleged participation in a scheme to mislead investors about SCWorx’s procurement of COVID-19 rapid […]
iRhythm stays silent on federal grand jury subpoenas
More than one year after receiving the first of two federal grand jury subpoenas seeking information about its products and communications with the FDA, iRhythm Technologies has said little publicly about the matter. It would have been easy to miss the San Francisco-based cardiac monitor maker’s initial disclosure last summer. iRhythm (Nasdaq:IRTC) was without a […]
Medtronic must sell Intersect ENT subsidiary to satisfy FTC concerns
The Federal Trade Commission has issued a proposed order to require Medtronic (NYSE:MDT) to sell a subsidiary of Intersect ENT within 10 days of completing its $1.1 billion acquisition of Intersect ENT. The commission announced May 10 that it voted 4-0 to issue its complaint and accept the proposed consent order for public comment. Under […]
DOJ subpoenas Philips over Respironics recall; CEO addresses investigation
Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices. Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial […]
California appeals court orders Johnson & Johnson to pay $302M in pelvic mesh case
A California appeals court mostly agreed that Johnson & Johnson must pay the state hundreds of millions of dollars over misleading marketing around the risks of pelvic mesh products. The Fourth District Court of Appeals in California, in its April 11 ruling, reduced the size of the civil penalties against J&J’s Ethicon subsidiary by $42 […]
Federal Circuit deals Abbott’s St. Jude Medical a setback in catheter IP case
A Federal Circuit court ruled that Abbott (NYSE:ABT) must face patent infringement claims going back to St. Jude Medical. Abbott acquired St. Jude Medical for $25 billion in 2017. A year ago, it won a patent dispute over the method for using a double catheter in heart failure patients. Niazi Licensing sued St. Jude in […]
Surgeon wins $20M verdict against J&J’s DePuy Synthes
A federal jury hit DePuy Synthes with a $20 million verdict payable to a surgeon who said the Johnson & Johnson (NYSE:JNJ) orthopedic unit stole his patented technology. The surgeon, Dr. Gary Lynn Rasmussen of Utah, invented a device for aligning and positioning the prosthesis in knee replacement procedures, according to court records. He applied […]
Fujifilm Sonosite files patent infringement lawsuit against Butterfly Network over handheld ultrasound
Fujifilm Sonosite announced today that it filed a patent infringement lawsuit against Butterfly Network (NYSE:BFLY). Bothell, Washington–based Fujifilm Sonosite filed the lawsuit in the U.S. District Court for the District of Delaware, asserting seven patents (U.S. Patent Nos. 7,169,108; 7,867,168; 8,128,050; 8,861,822; 9,538,985; 6,901,157; and 8,360,981) pertaining to fundamental technologies for acquiring ultrasound images at the point […]
Purdue Pharma, Sacklers reach a new $6B opioid settlement deal
Purdue Pharma and the Sackler family will pay $6 billion to settle lawsuits with a host of states over their role in the opioid epidemic. Purdue Pharma and the Sackler family — the founders and owners of the company — will pay the $6 billion to victims, survivors and states as a result of their […]
