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Leaders of a rural Nevada church are asking the U.S. Supreme Court to suspend the state’s 50-person cap on religious gatherings while an appellate court considers their claim that COVID-19 restrictions treating casinos and others more leniently violate their constitutional right to freely exercise their beliefs...Gov. Steve Sisolak’s June 4 directive allowing casinos, restaurants, bowling alleys and amusement parks to reopen at 50% of capacity while maintaining a hard cap for church services “simply turns the First Amendment on its head,” lawyers for Calvary Chapel Dayton Valley wrote in the request to the high court for an emergency injunction...“The Free Exercise Clause protects the exercise of religion. No constitutional provision protects the right to gamble at casinos, eat at restaurants, or frolic at indoor amusement parks,” they said...READ MORE

Bayer said...that it will pay up to $10.9 billion to settle litigation over the weedkiller Roundup, which has faced thousands of lawsuits over claims it causes cancer...The company said the settlement over Roundup, which is made by its Monsanto subsidiary, involves about 125,000 filed and unfiled claims. Under the agreement, Bayer will make a payment of $8.8 billion to $9.6 billion to resolve current litigation, and $1.25 billion to address potential future litigation, even as the company continues to maintain that Roundup is safe...READ MORE

Johnson & Johnson says it's pulling its talc-based powders from the U.S. and Canadian markets. But the move comes as the drugmaker faces thousands of personal injury lawsuits over the product's safety—and as demand has fallen due to years of publicity about the legal fight...In response to the COVID-19 pandemic, J&J stopped shipping certain products—including its iconic baby powder—back in March to allow its factories to make high-demand medicines and to allow workers to spread out for social distancing reasons, the company said in a statement...Now, it's permanently discontinuing about 100 products, including its talc-based powders...READ MORE

Doctors on the front lines of the COVID-19 fight really are heroes, but don’t forget about the tens of thousands of 'backline doctors' who are equally at risk, physically and financially...President Trump has compared the fight against COVID-19 to a war against a silent enemy. The soldiers on the front lines are the doctors, nurses, technicians, and others who are fighting it in hospitals across the United States...The untold story, however, is of the hundreds of thousands of doctors facing not only the health risks of caring for patients with undiagnosed COVID-19, but also ruinous financial calamity and professional catastrophe, self-inflicted by government...Now our health-care system is poised to implode...Many patients need care, and not just those with COVID-19. To ensure our system can recover, federal and state governments should implement a few basic provisions.

1. ...the federal government should indemnify doctors against frivolous lawsuits that result from this pandemic.
2. ...the federal government should make available interest-free loans to doctors who feel they cannot reopen offices because of financial hardship inflicted by COVID-19-related mandates. This is important to prevent wholesale migration of small practices to hospitals.
3. ...the federal government should seize this once-in-a-century opportunity to decimate the bureaucracy impeding innovation in medicine. Cutting red tape will stimulate a wave of doctor-led creativity, which is now constrained by onerous laws, such as Stark laws, which restrict collaboration.
4. ...the reprieves that have allowed telemedicine to expand during this pandemic should be made permanent. Doctors need to continue to be paid for these services just as they would for office visits, and be allowed to deliver these services across state lines.
5. ...the playing field in health care needs to be leveled, giving more control to doctors and less to hospitals. State lawmakers should repeal certificate-of-need laws, which prevent competition and the opening of new facilities in certain areas. We were underprepared for this pandemic in part because of hospital consolidation. More resources, not fewer, would provide helpful redundancy and protection against the next pandemic...READ MORE

A U.S. judge, skeptical of how Bayer plans to resolve future Roundup claims, says he's "tentatively inclined" to reject that part of the $10 billion-plus settlement...Looks like Bayer’s Roundup litigation headache may not be over after all, even after the company committed nearly $11 billion to a settlement...U.S. District Judge Vince Chhabria...said in a court filing...that he’s ready to reject part of the deal centered on potential future claims that the popular Monsanto weedkiller causes cancer...“[T]he Court is skeptical of the propriety and fairness of the proposed settlement, and is tentatively inclined to deny the motion,” Chhabria wrote...READ MORE

In the high-stakes patent fight between Biogen and Mylan over Tecfidera’s main remaining patent, Mylan has scored a major win in federal court...U.S. District Judge...said Mylan “demonstrated by clear and convincing evidence” that certain claims of Biogen’s '514 patent are invalid for “lack of written description.”...The decision threatens Biogen’s bestselling medicine with early generics; Tecfidera, a multiple sclerosis drug, generated $3.3 billion in the U.S. last year. The company's '514 patent is set to expire in 2028, meaning the decision, if upheld, could wipe out years of monopoly sales...Biogen is also facing patent challenges in Delaware federal court. That court's decision will also factor into the ongoing efforts by generics companies to launch copycats...READ MORE

Federal prosecutors turned up the heat in recent months on a generic price-fixing probe that targeted some of the industry's biggest players before COVID-19 slowed the hunt. Teva, the biggest target in that investigation, has reportedly bailed on settlement talks in a decision meant to test the government's resolve...Teva walked away from negotiations with federal prosecutors, daring the U.S. Department of Justice to pursue criminal price-fixing charges against the drugmaker at a time when it's part of the COVID-19 pandemic response...Teva is betting that its role in aiding the U.S. coronavirus response, including donating millions of doses of antimalarial hydroxychloroquine sulfate to hospitals, will put the Justice Department in a bind on its decision to file charges...READ MORE

Accused of favoring profits over patients’ lives, French pharmaceutical company Servier Laboratories is facing millions of euros in potential fines and damages after a huge trial involving 6,500 plaintiffs who say the company allowed a diabetes drug to be widely and irresponsibly prescribed as a diet pill — with deadly consequences...The popular drug, called Mediator, became one of France’s biggest modern health scandals, and the trial is wrapping up Monday after more than six months of proceedings targeting both Servier and France’s medicines watchdog. Servier says it didn’t know about the drug’s risks...Servier is accused of manslaughter, involuntary injury, fraud, influence trading and other charges. Investigating magistrates concluded that Servier for decades covered up Mediator’s effects on patients. The national medicines agency is suspected of colluding in masking its dangers...READ MORE

The Trump administration's quest for drug prices in TV ads just took another hit—and it might be a fatal blow. A U.S. appeals court agreed with a lower court ruling that found the U.S. Department of Health and Human Services didn't have the authority to require them...It was a big win for Merck & Co., Eli Lilly and Amgen along with the Association of National Advertisers, which sued last June to block the rule that would have forced drugmakers to include list prices in TV ads...Their argument? HHS has no statutory authority to create the rule in the first place, and even if it did, the rule violates the First Amendment...READ MORE

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster. A concept paper for a Cures 2.0 legislative package was recently unveiled by Reps. Diana DeGette (D-Col) and Fred Upton (R-Mich), who sponsored the Cures bill of 2016. It calls for a national COVID-19 testing and response strategy, with specifics for developing and administering vaccines and therapeutics and for modernizing and expanding US biopharma manufacturing capacity to provide needed treatments for patients on a timely basis...READ MORE