- Supreme Court blocks bankruptcy deal for OxyContin maker Purdue Pharma (foxbusiness.com)
The U.S. Supreme Court voted to block a controversial bankruptcy deal for Purdue Pharma, the drug company at the center of the opioid crisis, on Thursday...The narrow 5-4 ruling rejected a nationwide bankruptcy settlement from proceeding with the company, and it potentially exposes the company's owners--the Sackler family--to civil consequences...READ MORE
- Ex-B. Braun regulatory specialist pleads guilty to forging FDA clearance documents (fiercebiotech.com)
A regulatory affairs specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light to put their medical devices on the market...Peter Stoll III created counterfeit letters that copied the FDA’s letterhead and the digital signature of an agency official. He said two products developed by his employer Aesculap, a B. Braun company, had received 510(k) clearances—when, in fact, they had never been submitted for review in the first place...“Not obtaining this required clearance is bad enough, but impersonating FDA to cover up this failure is truly egregious and puts patients at risk,”...Stoll pleaded guilty to one felony count under the Federal Food, Drug, and Cosmetic Act, for causing the introduction of misbranded and adulterated medical devices into interstate commerce. According to the DOJ, he faces a maximum of three years in prison and a $250,000 fine...READ MORE
- After nationwide deal, Teva reaches $193M opioid settlement with holdout Nevada (fiercepharma.com)Nevada reaches $193M settlement in latest opioid lawsuit (reviewjournal.com)
When Teva proposed its sweeping $4.25 billion opioid settlement to resolve thousands of claims across the country, all U.S. states except for Nevada and New Mexico jumped on board. Now, the company has worked out a separate $193 million deal with one of the holdouts...Under the deal, the generics giant will make annual payments to Nevada on a sliding scale starting next July and lasting through July 2043. The payouts will start at $7 million and rise to $9 million through 2037, then increase to $27 million in 2042...The cash will be divvied between Nevada and members of the One Nevada Agreement on Allocation of Opioid Recoveries, a group formed to distribute opioid-related funds to local governments...READ MORE
- California files suit against PBMs over insulin prices (healthcaredive.com)
California is suing major drug manufacturers and pharmacy benefits managers for allegedly leveraging their market power to overcharge patients for insulin...The state filed suit...against drug manufacturers Eli Lilly, Novo Nordisk, and Sanofi, along with major PBMs CVS Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx...The lawsuit alleges that the drugmakers and PBMs worked together to drive up the price of insulin through illegal and deceptive business practices in violation of California’s Unfair Competition Law...READ MORE
- Nevada Stands to Receive $6.1 Million in $700 Million Settlement Against Johnson & Johnson (2news.com)
Nevada Attorney General Aaron Ford announced that he and 42 other attorneys general have reached a $700 million nationwide settlement with Johnson & Johnson...This settlement is related to the marketing of Johnson & Johnson’s baby powder and body powder products that contained talc...As part of this settlement, which is pending judicial approval, Nevada will receive $6,131,236.22... "This case shows the danger of deceptive trade practices and their potential impacts on the heath and safety of consumers,” said AG Ford. “My office will always stand up against corporations who value their bottom line over their duty to the public. We will always work to hold such actors accountable.”...READ MORE
- Grail sued by 3 women over alleged ‘frat house’ culture, harassment and retaliation (fiercebiotech.com)
Three women are suing the cancer blood test developer Grail claiming that, during their time as high-level sales employees, they suffered harassment, discrimination and ultimately retaliation under “a fraternity house” type of toxic work culture led by senior staff...the three separate lawsuits said that Grail failed to properly respond to the plaintiffs' complaints of a “sexually charged” and hostile work environment, including racist remarks made by a coworker in one case. They also each claim they were denied equal pay under California law...READ MORE
- Ahead of high-stakes California trial, GSK notches Zantac win in Canada (fiercepharma.com)GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg (fiercepharma.com)
As GSK's July court date nears for a key Zantac trial in California, the company can wipe its hands of at least one Canadian class action suit...The company said in a Friday statement that it “welcomes the decision” of the British Columbia Supreme Court to dismiss a proposed class action suit on behalf of Canadian Zantac users...A Vancouver man filed the lawsuit in 2020, alleging that his use of the heartburn med from 2018 to 2019 caused him to develop cancer. His complaint named more than a dozen companies as defendants, including Sandoz Canada and GSK...But the court dismissed the case due to “the uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk,” GSK said in its statement...READ MORE
- Nevada pharmacy board’s regulatory role over cannabis in limbo (lasvegassun.com)
Nevada Supreme Court justices are weighing arguments in a lawsuit that seeks to remove the Nevada Board of Pharmacy from its administrative role in regulating cannabis...The ACLU of Nevada originally filed the case in 2022 on behalf of the Cannabis Equity & Inclusion Community, a nonprofit group that advocates for policies beneficial to Nevada’s legal cannabis community, in Clark County District Court arguing the pharmacy board’s classification of cannabis as a Schedule I drug was unconstitutional...District Judge Joe Hardy ruled in favor of the ACLU, determining the pharmacy board’s classification as unconstitutional, but the board appealed the decision to the state’s top court. Arguments were heard Tuesday; it’s unknown when a decision will be handed down...READ MORE
- Merck, insurers advance fight over cyberattack-related coverage to New Jersey Supreme Court (fiercepharma.com)
That didn't take long. About a month and a half after Merck & Co. scored a legal win in the insurance case tied to the 2017 "NotPetya" cyberattack, the case is in appeals—again...The case, Merck & Co., Inc. v. Ace American Insurance Company, is heading to the New Jersey Supreme Court...This development follows a lower court's ruling in May rejecting the insurers' argument that the “hostile/warlike action” exclusion clause should apply in this case. In making that ruling, the New Jersey appellate court said the exclusion shouldn’t be applied to a cyberattack on a non-military company—even if it originated from a government or sovereign power...After the 2017 cyberattack, tens of thousands of computers in Merck's global network were infected, leading to a significant disruption in the pharma company's business...READ MORE
- All Nevada counties will see proceeds from opioid settlements (thenevadaindependent.com)
After receiving more than $320 million so far from settlements with opioid companies, the state has created a process to divide it across all Nevada counties...the attorney general’s office debriefed members of the Assembly Committee on Revenue on the One Nevada Agreement on Allocation of Opioid Recoveries...“We included all counties — whether or not they were litigating or non-litigating — so that they all are receiving something because frankly, this opioid epidemic does not care about county lines or city lines,” said Chief Deputy Attorney General Mark Krueger...One of the more recent settlements was $32 million the state received through opioid litigation with Walmart...READ MORE