Problems continue to mount around the massive respiratory device recall at Royal Philips (NYSE:PHG). Reuters reported today that French prosecutors have opened a preliminary investigation into the recall, citing a text message from a Paris public prosecutor’s office spokesperson. In the U.S., the FDA and federal prosecutors are increasingly scrutinizing how Philips has handled the […]
Search Results for: legal
Conformis appoints chief legal officer, corporate secretary
Conformis (NSDQ:CFMS) this week announced that Denise Pedulla was appointed chief legal officer and corporate secretary. Prior to joining the Billerica, Massachusetts-based company, Pedulla served as the general counsel and corporate secretary for NeoGenomics. She has also held numerous leadership roles at Berkeley Research Group, Orthofix and Fresenius Medical Care. “We are pleased to announce […]
Frequency Therapeutics faces growing legal challenges
Hearing loss drug developer Frequency Therapeutics (NASDAQ: FREQ) is the subject of a growing number of security fraud accusations on behalf of investors. Earlier this year, things were looking up for the company’s lead product candidate, FX-322. But on March 23, Frequency Therapeutics announced that interim results suggested that FX-322 was not effective at improving […]
AdvaMed launches campaign against ‘misleading’ legal advertising
Medtech trade group AdvaMed this week debuted a website that tracks law firm TV advertisements aimed at patients who have had certain medical devices implanted. The “Responsible Advertising for Patient Safety” site says that such ads mislead patients into legal action against the manufacturers of devices that are “non-faulty” and may jeopardize patient safety. Get the full […]
Varian appoints chief legal officer and interventional solutions president
Varian Medical Systems (NYSE:VAR) this week announced it appointed Michael Hutchingson as SVP and chief legal officer and Francis Facchini as president of interventional solutions. Prior to joining Varian, Hutchinson most recently served as VP and advisor to the chairman and CEO at Stryker. He also previously served as general counsel, VP and chief legal officer […]
Sterigenics’ legal troubles mount in Illinois
Nearly two dozen new lawsuits were filed against Sterigenics this week over its now-shuttered ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., according to a law firm representing some of the plaintiffs. That brings the total of such lawsuits to nearly 75, noted Chicago personal injury lawyer Antonio Romanucci, court-appointed lead counsel from among five firms involved in the […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
Plaintiff’s lawyers seek legal fees in $12m Thoratec settlement
Attorneys representing investor Bradley Cooper are seeking approximately $3 million from Abbott (NYSE:ABT) owned Thoratec in legal fees and $392,445 in expenses for a lawsuit that the company settled in February for $11.9 million. In the original case, plaintiffs claimed that Thoratec and some of its officers hid facts about its Heartmate II heart pump’s thrombosis rate […]
Wright Medical loses bid for legal fees in Spineology patent spat
The U.S. Court of Appeals for the Federal Circuit this week shot down an appeal by Wright Medical(NSDQ:WMGI) seeking to obtain legal fees related to a patent infringement case against Spineology which was decided in Wright’s favor this summer. Wright appealed after the U.S. District Court for the District of Minnesota ruled that Wright could […]
CEL-SCI wins $2.9M in CRO legal battle
Score one for the little guy. After a four-year legal battle, immunotherapy maker CEL-SCI Corporation has won the first-ever breach-of-contract case against a contract research organization, or CRO. In a final and binding decision, an arbitrator concluded that CRO inVentiv knowingly and fraudulently misled CEL-SCI with regard to enrollment projections for a clinical trial of […]
Here’s how FDA officials think you can legally promote off-label device, drug uses
The FDA has issued final guidance clarifying what it considers permissible off-label information for devicemakers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the agency […]
