The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said.
Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. bowed out of an opioid trial set for June 28 in New York by reaching a last-minute settlement with the state.
In denying cert to Abbvie Inc. v. FTC June 21, the U.S. Supreme Court may have strengthened an FTC tool for going after biopharma companies that try to protect their patents. The high court’s refusal to hear the case reinforces a September decision by the U.S. Court of Appeals for the Third Circuit that the biopharma industry has said will make it more difficult for drug companies to pursue patent infringement cases in keeping with Hatch-Waxman.
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
A lawsuit filed last year challenging a federal rule and certification allowing certain drugs to be imported from Canada should be dismissed because no drug companies have been harmed yet, nor are they likely to be any time soon, the Biden administration said in a motion seeking dismissal of the suit.
Claiming that convicted felon Martin Shkreli continues to exert control over Vyera Pharmaceuticals LLC from prison, the U.S. Federal Trade Commission (FTC) is seeking sanctions against the former hedge fund manager for intentionally destroying text and WhatsApp messages on his company-issued phone and a contraband phone years after he was instructed to preserve all documents potentially relevant to an ongoing antitrust investigation and litigation.
The FDA’s premarket review mechanisms for class II medical devices may strike some as little more than so much regulatory esoterica, and several courts have ruled that information about the 510(k) process is inadmissible during jury trials due to the possibility of sowing confusion among jurors. An appellate court in New Jersey has ruled that such an exclusion of evidence is prejudicial in a case involving surgical mesh manufactured by two device companies, however, opening a larger debate about the propriety of such exclusions in product liability litigation for medical devices.
The so-called pharma bro Martin Shkreli’s trials are far from over. The former hedge fund manager, biopharma CEO and now convicted felon is facing a class action lawsuit led by Blue Cross and Blue Shield.
The U.S. Court of Appeals for the Seventh Circuit grappled with whether so-called patent thickets and certain global patent settlements constitute antitrust behavior as it heard arguments Feb. 25 in UFCW Local 1500 Welfare Fund v. Abbvie Inc.
The Washington Legal Foundation’s (WLF) webinar on False Claims Act (FCA) litigation highlighted several developments in case law, including that non-relator FCA cases were up significantly in fiscal year 2020. However, Jay Stephens, an attorney with Kirkland & Ellis LLP, noted that Sen. Chuck Grassley (R-Iowa) has taken aim yet again at the materiality standard for false claims as spelled out in the Supreme Court’s Escobar, a move which if successful could amplify the federal enforcement focus on life science companies.
