Dorsey Health Law
coronavirus
Coronavirus Lawsuits More Than Double In 2021; Those Against Healthcare Providers Steadily Increase
Despite widespread vaccine availability and the corresponding optimism about returning to “normal,” the coronavirus pandemic continues to spawn hundreds of employment and health-related lawsuits. Many of these lawsuits have been aimed at employers in the healthcare sector and relate to workplace safety, retaliation, and wrongful termination or wrongful denial of leave. In fact, since our last update on this topic (available here), the healthcare sector has increased its relative share of coronavirus lawsuits compared to other industries. In December 2020, approximately 20 percent of lawsuits alleging labor and employment violations related to coronavirus arose from the healthcare industry; today, that number is approximately 25 percent. The total number of coronavirus lawsuits has also increased dramatically. At the end of 2020, 1,235 total lawsuits had been filed against employers related to the coronavirus. Today, that number has more than doubled; there have been 2,560 lawsuits, including 200 class actions. States with the most filings include California (666), New Jersey (293), Florida (198), New York (184) and Ohio (156). Whether brought in California, Iowa, or elsewhere, coronavirus lawsuits most commonly assert that employers violated federal and state mandates, guidelines, and regulations regarding employee safety. One such federal mandate was the Families First Coronavirus Response Act (FFCRA), passed by Congress in March 2020 (and, with certain exceptions, expired in December 2020). While operative, the FFCRA required employers with fewer than 500 workers to provide employees with a certain amount of compensated time off for various reasons linked to COVID-19, including if employees become ill. Importantly, however, the FFCRA provided that certain employees—i.e., “health care providers and emergency responders”—may be excluded from entitlement to both emergency family leave and emergency paid sick leave. In addition to FFCRA cases, employees have also filed lawsuits alleging that their employers violated the federal WARN Act (or similar state laws), which in certain circumstances requires that employers with 100 or more employees provide at least 60 days’ notice before conducting a mass layoff. Even though there are fewer lawsuits involving COVID-19 related issues in states like Iowa, the recently filed Iowa cases are representative of the types of cases occurring across the country. In one case, an employee of a hospital asserts that she was terminated after she raised concerns about the lack of available personal protective equipment and about staff failing to wear masks correctly. She also claims that she raised concerns about an social event where staff were attending without masks and without adhering to social distancing guidelines. Another case involves claims by a food manufacturer’s nurse supervisor asserting her employer’s lack of preparedness for COVID-19 and her resulting firing after she raised safety concerns. Although other employment-related cases in Iowa have been filed against employers outside the health care industry, similar cases could be filed against those in the health care industry in the future. These cases include allegations that employers denied leaves of absence for an individual with high risk conditions and failure to implement proper screening, social distancing and other protective measures, which in one case resulted in deaths from COVID-19. On the flip side, Iowa has also seen recent litigation filed with an individual asserting a civil rights violation for requiring students to wear a mask to school. A recent development that may impact future coronavirus litigation is the updated federal guidance on mask mandates. On May 13, 2021, the U.S. Centers for Disease Control and Prevention (“CDC”) revised its guidance to reflect that “fully vaccinated” individuals no longer need to wear masks, whether indoors or outdoors, except in limited circumstances. And while there is a caveat for “local business and workplace guidance,” OSHA is advising employers to follow CDC guidelines for fully-vaccinated employees. Accordingly, employers across the nation now face the practical challenge of maintaining a safe and compliant workplace in an increasingly open environment, while at the same time minimizing their risk for legal liability. While many states have enacted legislation that limits the liability of healthcare providers for actions or omissions during the pandemic, most of the legislation leaves openings for plaintiff’s lawyers to argue that their clients’ claims are not prohibited, especially with respect to employment-related claims. For example, Iowa enacted the “COVID-19 Response and Back-to-Business Limited Liability Act”. Under the Iowa Act, providers cannot be held civilly liable for various actions, which include, but are not limited to screening, assessing, diagnosing, caring for or treating individuals with COVID-19. The Act also provides protection for acts or omissions relating to non-COVID-19 patients, if those acts or omissions result from supporting the state’s response to COVID-19. This may include acts such as providing treatment outside the premises of a health care facility or using equipment and supplies outside their normal use. As seen by the lawsuits described above, the Iowa Act does not prevent the filing of employment-related claims and notably, liability can still be established even in non-employment related contexts if the provider acted recklessly or engaged in willful misconduct. Navigating the highly dynamic landscape of federal, state, and local coronavirus rules and policies presents numerous challenges for employers. But healthcare providers can still employ a number of proactive steps to reduce their potential exposure. Providers should understand their obligations under relevant federal and state law and provide employees protected leave as appropriate. When in doubt, we recommend that employers err on the side of granting the requested leave. Providers should revise company policies as necessary to incorporate the new regulations that apply to COVID-19 exposure and sick leave. To the extent feasible, providers should consider offering teleworking opportunities for eligible employees. Providers should implement a system for recording employees’ requests for leave and the reasons supporting those requests, i.e., an employee’s symptoms and the date for a test or doctor’s appointment. However, providers should not require employees to provide further documentation, such as certification that the employee sought a diagnosis or treatment from a healthcare provider. Providers should be mindful of the risks of taking personnel actions that could lead to discrimination or retaliation lawsuits by workers who requested or took applicable leave. As always, providers should properly document their termination decisions. Providers should carefully consider whether and how they will ask employees to provide proof of vaccination, and they must be aware of relevant legal considerations if making those inquires. Several jurisdictions have implemented laws banning employers from requiring so-called “vaccine passports” or other methods of requiring individuals to provide proof of vaccination to gain access, entry, or service. Providers may initially want to strongly encourage employees to get vaccinated—with the caveat that it may be mandatory in the future—and only require vaccination in the future if absolutely necessary.
June 7, 2021
coronavirus
False Claims Act Exposure for Beneficiaries of the Public Health and Social Services Emergency Relief Fund: Mitigating Risks of Ambiguous Terms & Conditions
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Andrew Brantingham, Ross C. D'Emanuele, and Alex Hontos for the following post from Dorsey's FCA Now blog: The CARES Act allocated $100 billion in relief funds to hospitals and other healthcare providers, to be distributed by the Department of Health and Human Services (“HHS”) through the Public Health and Social Services Emergency Relief Fund (or “Provider Relief Fund”). Many healthcare providers across the country have received payments from the Fund...[Continue Reading]
May 7, 2020
Opioids
Untimely Dispensing Allegations Against Pharmacies Stricken in Opioid Litigation
As the world grapples with the health crisis caused by COVID-19, litigation regarding a different health crisis—the opioid epidemic—continues to progress (see our previous posts on this topic here and here). In a major development last week for the multidistrict litigation, the Sixth Circuit concluded that key bellwether cases against twelve large pharmacy chains may not include untimely dispensing allegations. The multidistrict litigation (“MDL”) includes claims by numerous plaintiffs arising out of the nation’s opioid crisis. Two of those plaintiffs—Cuyahoga County and Summit County of Ohio—brought claims against certain pharmacies that sold prescription opioids (in addition to their claims against other defendants like distributors and manufacturers). The Counties’ claims against the pharmacies are scheduled for trial in November 2020. The Counties’ claims against the pharmacies originally related to the pharmacies’ capacity as “distributors” of drugs to their own retail pharmacies. The Counties expressly declined to bring any claims against the pharmacies as “dispensers” of prescription opioids. This is an important distinction. Distributors ship pharmaceuticals wholesale; dispensers fill prescriptions. Discovery against the pharmacies proceeded with respect to their alleged role as distributors. For all parties, discovery included more than 600 depositions and the production of tens of millions of documents. However, nearly ten months after the close of discovery, the Counties reversed course and moved to amend their complaints to add dispensing allegations against the pharmacies. On November 19, 2019—i.e., almost 19 months after the court’s deadline for amendments to the Counties’ complaints—the court granted the Counties’ motion. The court did so based on perceived efficiencies, reasoning the dispensing claims were better considered by the district court now rather than later “in front of some other Court that does not have the expertise I have developed over the past two years.” The court also allowed discovery on the recently-added dispensing claims. The pharmacies were ordered to produce data on every prescription that their pharmacies had filled for any opioid medication, anywhere in the United States, for a period of 13 years—including data on prescriptions outside Ohio, which the district court intended to make available for future cases, but which would be inadmissible in the Ohio-focused case in which it was to be produced. Following the district court’s order, the pharmacies petitioned the U.S. Court of Appeals for the Sixth Circuit for a writ of mandamus. The primary issue before the Sixth Circuit on the pharmacies’ petition was the district court’s decision to allow the Counties to amend their complaints 19 months after the court’s deadline for doing so. The Sixth Circuit granted the writ in a strongly-worded order. Stating that an “MDL court may not . . . distort or disregard the rules of law applicable” to each individual case consolidated in the MDL, the Sixth Circuit concluded there was no “good cause” for the Counties’ failure to timely amend their complaints to add the dispensing allegations. In fact, the Sixth Circuit recognized that the Counties’ express decision to omit those claims earlier “arguably amounts to an outright waiver of them.” According to the Sixth Circuit, “[n]ot a circuit court in the country, so far as we can tell, would allow a district court to amend its scheduling order under these circumstances.” The Sixth Circuit’s ruling once again highlights how the unprecedented scope of the opioid litigation—with more than 2,700 cases consolidated in the MDL—deeply strains ordinary structures and procedures of litigation. In the orders at issue, the district court appeared to value efficiency and the collective interests in managing the MDL as a whole over the individual rights of the parties in the specific case at hand. Stipulating that the “district judge in this case is notably conscientious and capable, and we fully recognize the complexity of his task in managing the MDL here,” the Sixth Circuit nevertheless concluded the district court had gone too far: “Respectfully, the district court’s mistake was to think it had authority to disregard the Rules’ requirements in the Pharmacies’ cases in favor of enhancing the efficiency of the MDL as a whole.” That decision should have been based, but was not, on the record in the individual case before the court. Even in an MDL as complex as the opioid litigation, the district court’s authority to manage it is not without limit. Cases within an MDL retain their separate identities and the parties in those individual cases have rights that cannot be impinged merely to create efficiencies in the MDL generally. Particularly with respect to issues that can be dispositive, e.g., motions for summary judgment or to amend pleadings, it remains important for district courts to articulate and apply the traditional standards governing such issues. The Sixth Circuit’s decision also means that important liability questions in the opioid litigation will remain unanswered for now. Had the dispensing claims been allowed, the trial set for November 2020 may have answered whether a pharmacy could or would be held liable for filling prescriptions issued by someone else. Because those claims are no longer part of the Counties’ complaints, the full extent of potential liability large pharmacies face for the opioid epidemic is still unclear. And unlike other categories of defendants like drug manufactures and large distributors, pharmacies have largely declined to settle the claims against them. The MDL is In re: National Prescription Opiate Litigation, case number 1:17:md-02804, in the U.S. District Court for the Northern District of Ohio.
April 21, 2020
Opioids
Drug Companies Preview Trial Defenses for Bellwether Opioid Trial
In the last several years, thousands of cities and counties, as well as most states, have sued various combinations of pharmaceutical manufacturers, retailers, and distributors for damages allegedly caused by the opioid epidemic. Nearly 2,000 of those cases have been consolidated into a multi-district litigation (“MDL”) in the Northern District of Ohio. Until very recently, defendants in the MDL had not revealed how they intended to argue against the charge that they caused or contributed to the opioid crisis. But with the first trial set to begin on October 21, 2019, the defendants recently submitted their trial briefs, which provide a sneak peek at the factual and legal arguments they intend to raise at trial. Among other alleged causes, defendants have pointed to corrupt doctors, criminal cartels, and even local governments. For example, one drugmaker stated that it “fully recognizes the opioid crisis that exists in this country” but suggested that alternative causes such as public policy failures and illicit drug use drove the opioid crisis. More specifically, the defendant stated: [P]ervasive diversion and abuse of oxycodone and hydrocodone pills, unscrupulous doctors and internet pharmacies operating as drug-trafficking organizations, foreign criminal cartels that flooded the country with heroin and fentanyl illegally made in clandestine labs, and state and federal governments that struggled to ensure patients had access to necessary medications while addressing long-known problems of abuse, misuse, diversion, and overdose. (Doc. No. 2633 at 8.) Another drugmaker alleged that rather than blaming defendants, the plaintiffs—i.e., two counties in Ohio—“should be examining their own actions and inaction—which directly contributed to the opioid abuse problem in the United States.” (Doc. No. 2669 at 9.) As an example, the defendant argued that “the Counties continue to reimburse for opioid prescriptions for chronic pain today, thereby influencing what gets prescribed and dispensed to patients—and confirming (against their very own foundational theory in this case) that opioid prescriptions may be appropriate for chronic pain.” (Id.) Similarly, an opioid distributor believes the opioid crisis was caused by “innumerable actors not before the Court, ranging all the way from well-intentioned prescribing doctors to criminal drug dealers and heroin traffickers.” (Doc. No. 2643 at 4-5.) Another distributor suggested that plaintiffs in the MDL overlook the “role of criminal drug cartels and other actors in the illegal opioid market.” (Doc. No. 2659 at 4.) Finally, yet another distributor argued that alternative causes of the opioid crisis preclude recovery in the MDL. This defendant argued that under City of Cleveland v. Ameriquest Mortg. Secs., Inc., 615 F.3d 496 (6th Cir. 2010), the presence of “independent actors between the alleged misconduct and the alleged injury” compel the conclusion that plaintiffs’ claims here are “too indirect to warrant recovery.” Ameriquest, 615 F.3d at 506. The defendant attempted to distance itself from defendants occupying other roles in the chain of distribution by stating that it “does not make opioids available to patients,” and instead, a “patient can obtain opioids only after a doctor makes an independent decision to write a prescription and a pharmacist makes the independent decision to fill the prescription.” (Doc. No. 2667 at 8.) All the finger-pointing between and among plaintiffs and defendants emphasizes what has been increasingly clear as the first MDL cases approach trial; it will take a Herculean effort by the courts (and juries) to sort through the medical, social, political, and economic issues that are intertwined with the opioid crisis. The breadth of the problem even raises the question of whether jury trials are the right tools to address social crises of this magnitude and complexity. Indeed, some studies place the national economic burden of the opioid crisis at $78.5 billion, with over 35,000 people dying annually for drug overdoses related to opioids. U.S. District Judge Dan Polster, who presides over the MDL cases, bluntly emphasized these complex challenges in recent comments: [E]veryone shares some of the responsibility, and no one has done enough to abate it. That includes the manufacturers, the distributors, the pharmacies, the doctors, the federal government and state government, local governments, hospitals, third-party payers and individuals. Just about everyone we’ve got on both sides of the equation in this case. The federal court is probably the least likely branch of government to try and tackle this, but candidly, the other branches of government, federal and state, have punted. So it’s here.
October 16, 2019