Tag: 2021 News

Over the weekend, the 5th U.S. Circuit Court of Appeals granted an emergency stay of the requirement by the federal Occupational Safety and Health Administration that those workers be vaccinated by Jan. 4 or face mask requirements and weekly tests.

The White House expects the new regulation created last week to “impact over 80 million workers in private sector businesses.”

Texas’ Republican Attorney General Ken Paxton tweeted Saturday “Yesterday, I sued the Biden Admin over its unlawful OSHA vax mandate.” He then added “WE WON. Just this morning, citing “grave statutory and constitutional issues,” the 5th Circuit stayed the mandate. The fight is not over and I will never stop resisting this Admin’s unconstitutional overreach.”

His case was joined by the court into a master case which included several other states in the 5th Circuit, as well as a long list of large employers who also filed several separate actions seeking the same relief.

The Judge who issued the order wrote “Because the petitions give cause to believe there are grave statutory and constitutional issues with the Mandate, the Mandate is hereby STAYED pending further action by this court. The Government shall respond to the petitioners’ motion for a permanent injunction by 5:00 PM on Monday, November 8. The petitioners shall file any reply by 5:00 PM on Tuesday, November 9.”

Louisiana Attorney General Jeff Landry said the action stops Democratic President Joe Biden “from moving forward with his unlawful overreach.”

“The president will not impose medical procedures on the American people without the checks and balances afforded by the constitution,” said a statement from Landry, a Republican.

Solicitor of Labor Seema Nanda said the U.S. Department of Labor is “confident in its legal authority to issue the emergency temporary standard on vaccination and testing.”

OSHA has the authority “to act quickly in an emergency where the agency finds that workers are subjected to a grave danger and a new standard is necessary to protect them,” she said.

The brief filed by the Burnett Companies Consolidated, Inc. Choice Staffing, LLC and Staff Force, Inc., in a companion case, lays out the essential theory supporting the Order. “Of the nine emergency temporary standards published prior to this year, three were not challenged. The six that were challenged, only one was fully upheld, and most were stayed prior to enforcement. OSHA has once again acted illegally because, as shown below, the subsection that gives it authority issue an ETS violates the nondelegation doctrine under Article I, Section 1 of the U.S. Constitution.”

Such circuit decisions normally apply to states within a district – Mississippi, Louisiana and Texas, in this case – but Landry said the language employed by the judges gave the decision a national scope.

The Occupational Safety and Health Administration (OSHA) has issued an emergency temporary standard (ETS) to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 by strongly encouraging vaccination. They have issued a shorter “Fact Sheet” to help employers understand the requirements.

Covered employers must develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID-19 testing and wear a face covering at work in lieu of vaccination.

This ETS applies to employers with a total of 100 or more employees at any time the standard is in effect. The ETS is effective immediately upon publication in Federal Register. To comply, employers must ensure provisions are addressed in the workplace by the following dates:

– – 30 days after publication: All requirements other than testing for employees who have not completed their entire primary vaccination dose(s)
– – 60 days after publication: Testing for employees who have not received all doses required for a primary vaccination

The ETS requires employers to:

– – (1) require employees to promptly provide notice when they receive a positive COVID- 19 test or are diagnosed with COVID-19;
– – (2) immediately remove any employee from the workplace, regardless of vaccination status, who received a positive COVID-19 test or is diagnosed with COVID-19 by a licensed healthcare provider;
– – (3) keep removed employees out of the workplace until they meet criteria for returning to work.

In light of the unique occupational safety and health dangers presented by COVID-19, and against the backdrop of the uncertain economic environment of a pandemic, OSHA is proceeding in a stepwise fashion in addressing the emergency this rule covers.

OSHA needs additional time to assess the capacity of smaller employers, and is seeking comment to help the agency make that determination. Nonetheless, the agency is acting to protect workers now in adopting a standard that will reach two-thirds of all private-sector workers in the nation, including those working in the largest facilities, where the most deadly outbreaks of COVID-19 can occur.

OSHA intends the ETS to address comprehensively the occupational safety and health issues of vaccination, wearing face coverings, and testing for COVID-19. Thus, the standard is intended to preempt States, and political subdivisions of States, from adopting and enforcing workplace requirements relating to these issues, except under the authority of a Federally-approved State Plan.

In particular, OSHA intends to preempt any State or local requirements that ban or limit an employer from requiring vaccination, face covering, or testing. Additional information on the preemption of State and local laws is found in Section VI.A. of the ETS preamble.

OSHA will continue to monitor trends in COVID-19 infections and death as more of the workforce and the general population become fully vaccinated against COVID-19 and as the pandemic continues to evolve. Where OSHA finds a grave danger from the virus no longer exists, or new information indicates a change in measures necessary to address the grave danger, OSHA may update this ETS, as appropriate.

Although this ETS takes effect immediately, it also serves as a proposal under Section 6(b) of the OSH Act(29 U.S.C. 655(b)) for a final standard.

Accordingly, OSHA seeks comment on all aspects of this ETS and whether it should be adopted as a final standard. OSHA encourages commenters to explain why they prefer or disfavor particular policy choices, and include any relevant studies, experiences, anecdotes or other information that may help support the comment.

The National Council on Compensation Insurance (NCCI) released its next updated Countrywide Court Case Update. The November 2021 edition provides a look at some of the key cases and decisions NCCI’s Legal Team monitors that may impact workers compensation across the states. This report contains updated information on cases previously introduced and presents new cases and decisions including COVID-19-related rulings.

“The Countrywide Court Case Update is a valuable resource that NCCI provides to insurers, regulators, and other industry stakeholders,” said Bill Donnell, NCCI’s President and CEO. “NCCI produces this robust report to inform on state and federal legal developments that can impact the workers compensation system.”

This report, provides insights on topics such as:

– – COVID-19 court cases
– – Workers compensation exclusive remedy
– – Challenges to state adoption of third-party guides
– – Developments in marijuana-including reimbursement and employment-related questions
– – Air ambulance reimbursement: state vs. federal law
– – Additional federal and state developments listed by geographic zone

In California, The California Second Appellate District will consider in See’s Candies, Inc. et al. v. Superior Court of Los Angeles County, whether WC exclusive remedy bars a lawsuit brought by an employee alleging that the employer’s failure to provide sufficient safeguards against COVID-19 caused the death of the employee’s spouse, who was infected after the employee contracted the virus at work.

And a case headed to the U.S. Supreme Court is significant to California since the state is governed by the 9th Circuit Federal Court of Appeal.

On August 19, 2020, the federal Court of Appeals for the Ninth Circuit, in United States v. Washington 971 F.3d 856 (9th Cir. 2020), as amended on April 15, 2021, affirmed a federal district court decision upholding the constitutionality of a Washington workers compensation statute that creates a presumption of compensability for certain types of diseases contracted by federal contractors working at the Hanford federal nuclear cleanup site.

The court rejected the federal government’s argument that the workers compensation statute violated the federal intergovernmental immunity doctrine, which invalidates state laws that seek to regulate the United States directly or discriminate against the federal government and those with whom it deals.

The court further concluded that the workers compensation statute falls within the scope of a federal law (40 U.S.C. § 3172) that authorizes the states to regulate workers compensation on federal land to the same extent that the states can regulate on nonfederal land.

A petition for Writ of Certiorari in this case was filed with the U.S. Supreme Court in September 2021. The essential question presented is whether a state workers’ compensation law that applies exclusively to federal contract workers who perform services at a specified federal facility is barred by principles of intergovernmental immunity, or is instead authorized by 40 U.S.C. 3172(a), which permits the application of state workers’ compensation laws to federal facilities “in the same way and to the same extent as if the premises were under the exclusive jurisdiction of the State.”

Reuters reports that Merck has signed eight deals to sell more than a total of 2 million courses of its experimental COVID-19 pill molnupiravir to governments around the world.

It has applied for approval in the United States and said it can make 10 million courses in 2021. A Food and Drug Administration advisory committee is scheduled to evaluate the safety and efficacy data of the pill on Nov. 30 and decide whether or not to approve it for emergency use authorization in the U.S.

Last week the company reached a deal with the United Nations-backed Medicines Patent Pool that will allow more companies to manufacture generic versions of the pill with a royalty-free license applying to 105 low- and middle-income countries. So far Merck has agreed to license the drug to several India-based generic drugmakers.

Merck CEO Robert Davis told CNBC on Thursday the drugmaker is ready to produce and distribute tens of millions of doses of its Covid antiviral pills if given regulatory approval.

The Merck pill forces the SARS-CoV-2 coronavirus to mutate itself to death. The drug tricks the virus into using the drug for replication, then inserting errors into the virus’ genetic code once replication is underway. When enough copying errors occur, the virus is essentially killed off, unable to replicate any further.

But according to an article in Forbes the drug raises two key concerns. The first is the drug’s potential mutagenicity, and the possibility that its use could lead to birth defects or cancerous tumors. The second is a danger that is far greater and potentially far deadlier: the drug’s potential to supercharge SARS-CoV-2 mutations and unleash a more virulent variant upon the world.

The company claims the antiviral pill it’s developing can cut hospitalizations and deaths among people with COVID-19 by half. The results haven’t yet been peer reviewed. But if the drug candidate is authorized by regulators, it would be the first oral antiviral treatment for COVID-19. By contrast, the other currently authorized drugs must be delivered intravenously or injected.

A pill could make treating patients earlier on in their infection much easier – and more effective. It could also keep hospitals from overflowing, especially in places where vaccination rates are still low.

The other therapies on offer against COVID-19, Gilead Science’s antiviral remdesivir and a monoclonal antibody cocktail from biotech firm Regeneron, must be administered intravenously or by injection. That makes it difficult for people to access the therapies before they are sick enough to land in hospital. And remdesivir is approved only for those who are already hospitalized with COVID-19.

Molnupiravir was so effective in a phase 3 trial involving COVID-19-positive people at risk of severe illness that clinicians halted enrollment early.

An Orange County Superior Court Judge ruled late Monday that four drug companies can’t be held liable for that state’s opioid epidemic. Communities had hoped for tens of billions of dollars in compensation to help ease the addiction crisis.

It marked the first trial win for any drug companies in the more than 3,300 lawsuits filed by states and local governments over a drug abuse crisis that the U.S. government says led to nearly 500,000 opioid overdose deaths over two decades.

Attorneys representing four California counties argued the drug companies used false and misleading marketing to push up the sale of prescription opioids. The Sixth Amended Complaint asserted causes of action for False Advertising , Unfair Competition and Public Nuisance against the companies. The companies denied any wrongdoing.

Phase I of this case regarding liability was tried to the Court between April 19, 2021 and July 27, 2021 . No party requested trial by jury on any claim or issue. The entire trial was conducted remotely, via the Zoom platform. All parties rested on July 27, 2021. The Court set a briefing schedule for closing briefs, and closing arguments were heard on September 30, 2021 and October 1, 2021.

In his 41-page ruling, Superior Court Judge Peter J. Wilson said it was unclear the drug industry’s marketing efforts led to directly to a rise in illegal use of prescription opioid painkillers.

He also acknowledged that his Court is aware of the toll being taken on society by what has been variously referred to as the “opioid crisis” or the “opioid epidemic” and that the defendants do not dispute that there is an opioid crisis.

However he noted that “the California Legislature has approved, and continues to approve, the availability of opioid medications, through prescriptions, by passing the laws described” in the opinion.

The ruling went on to say “As the Historical and Statutory Notes to Business & Professions Code section 2241.5 state, “it is the intent of the Legislature to encourage physicians to provide adequate pain management to patients in California consistent with Section 2241.5.” And the California Legislature made clear its intention to expand, rather than restrict, the appropriate prescribing of opioid medications.“

“In addition to its relevance to proof of the “unreasonableness” element of a public nuisance claim as discussed above, the absence of evidence concerning medically inappropriate prescriptions also breaks the chain of causation between Defendants’ alleged wrongful conduct and the harms complained of.“

The ruling reviewed documents presented during the trial against each defendant in great detail, and concluded that none of the identified statements, within the applicable statute of limitations periods, to be false or misleading. An allegedly false or misleading statement in an internal company document, that was in no way published or disseminated before the public, would not qualify as “false advertising” under the statute or applicable cases.

The ruling concludes that “There will accordingly be judgment for Defendants on all claims.”

The ruling came as J&J and the three largest U.S. drug distributors – McKesson Corp, Cardinal Health Inc and AmersourceBergen — work to finalize a proposed deal to pay up to $26 billion to settle the thousands of cases against them. And a bankruptcy judge in August approved a settlement by OxyContin maker Purdue Pharma and its wealthy Sackler family owners of the claims against them that the company values at more than $10 billion.

In a statement, the lead lawyers overseeing related federal lawsuits against the companies — Jayne Conroy, Paul Farrell and Joe Rice — said they strongly disagreed with the ruling and stressed that it did not impact related cases nationally.

The only other opioid trial to reach a verdict resulted in an Oklahoma judge in 2019 ordering J&J to pay $465 million to the state. J&J is appealing that decision.

Trials are currently underway a New York case against Teva and AbbVie and in Ohio against three pharmacy chain operators. A West Virginia federal judge recently finished hearing evidence in a trial involving the distributors.