CIVIL ACTION NO. 4:20-CV-00817-SDJ
REPORTED BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, JOSEPH SOLVO ESQ., REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., BRAHM FISHER ESQ., JOSEPH WEBSTER MD., ESTHER HYATT PHD., BRAHM FISHER ESQ., MICHELE ALEXANDER, CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
___The Chamber of Commerce of the United States of America the world’s largest business federation:
“Free enterprise and sound policymaking depend on the regularity of the agency process. And fundamental fairness requires that liability attaches only to violations of clearly established rules”
DOJ Opioid Leader Flays Pharmacies In Enforcement Vow
ARTICLE
BY
Jeff Overley
From Law360 (December 15, 2020, 10:40 PM EST) –” Many pharmacies have ignored their legal duty to prevent the diversion of narcotic painkillers for illicit uses, and related enforcement actions are likely in 2021, one of the U.S. Department of Justice‘s top opioid attorneys said Tuesday.
Daniel Feith, a deputy assistant attorney general overseeing the DOJ’s Consumer Protection Branch, made the comments during a keynote address at the Food and Drug Law Institute‘s annual enforcement conference for the pharmaceutical industry. The remarks signaled that the federal government will continue to broaden its opioid enforcement beyond drug manufacturers and distributors.”
______THE CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA:
“Free enterprise depends on a stable and predictable regulatory environment, in which businesses can operate and invest without unwittingly running afoul of the law.”
“The Consumer Protection Branch is also going after unlawful actions by others in the opioid supply chain, including pharmacies. Pharmacies are the last line of defense against prescription opioid diversion,” Feith, whose branch helps to lead a DOJ task force on opioid enforcement, told attendees via videoconference. “But too many pharmacies [for] too long abdicated that responsibility.” (3)
“In response to those failings, DOJ lawyers in Washington, D.C. — in cooperation with U.S. attorney offices and the U.S. Drug Enforcement Administration — are pursuing “aggressive enforcement under the Controlled Substances Act to secure injunctions and penalties against pharmacies that have helped flood communities with opioids,” the deputy assistant attorney general said.
As one example, Feith singled out a DOJ complaint that accused a North Carolina pharmacy and its owner of systematically ignoring red flags for opioid diversion, including prescriptions that came from doctors who didn’t work nearby or had been cut off by other pharmacies. A federal court in February permanently barred the pharmacy and its owner from dispensing opioids.”
____the DEA master Pharmacy Plan 15DDHQ20R00000021, 9/20/2020, by Amanda Vanderveen
” Yes, we would expect that pharmacies that have an established mechanism to expose their business data to be incorporated with the provided data. “
“You can expect to see additional developments in the opioid arena in the coming year,” Feith said immediately after concluding his discussion of the North Carolina pharmacy. “We encourage everyone in [the] prescription opioid supply chain to work with us to identify wrongdoing, fix it and stem the damage this epidemic is causing.”
“WE ARE PHARMACIST NOT DRUG DEALERS”
“Feith didn’t name any specific pharmacy corporations on Tuesday, but his remarks came as the focus of a nationwide wave of opioid lawsuits increasingly shifts toward pharmacies. In general, pharmacies are accused of profiting immensely by dispensing vast amounts of addictive painkillers that clearly weren’t for legitimate medical needs. Unlike manufacturers and distributors, they have shown little interest publicly in settling. (1)
Most of the lawsuits against pharmacies have been brought by local governments in multidistrict opioid litigation, but there have been signs that greater federal involvement could be looming. Perhaps most notably, retail giant Walmart Inc. — which operates roughly 5,000 in-store pharmacies in the U.S. — recently launched a preemptive lawsuit seeking to sharply limit any legal liability for opioid sales.”
“DOJ and DEA have stated they will file a civil complaint against Walmart for not going far enough in blocking doctors by refusing to fill their prescriptions,” the company wrote in October. “This threat is based on legal theories that have no basis in statute or regulation.”
Walmart and other pharmacy chains — including CVS Health Corp., Walgreen Co., and Rite Aid Corp. — are facing hundreds of lawsuits in the MDL, which could produce its first bellwether trials next year. The pharmacies have publicly vowed to fight the cases, but have lost key legal disputes and are increasingly becoming the MULTIDISTRICT LITIGATION (MDL’s) top remaining targets as drug manufacturers and distributors work toward finalizing global settlements. (1)
In a court filing this month, the DOJ averred that Walmart’s purported preemptive lawsuit — filed in Texas federal court — was in fact an attempt “to relitigate, in what it perhaps believes is a more-friendly forum, the questions of law already resolved against it in the MDL,” which is centralized in Ohio federal court.”
In recent earnings reports, CVS, Rite Aid and Walgreens have all described receiving subpoenas or civil investigative demands from the DOJ regarding their sales of prescription opioids.
Feith emphasized Tuesday that decisions to bring cases depend heavily on whether anyone was harmed by unlawful business practices, saying that “consumer harm is the lodestar for our exercise of prosecutorial discretion.”
That comment brought to mind the DOJ’s announcement last year of a “first-of-its-kind” enforcement action against pharmacies. In that announcement, the government stressed that unlawful opioid dispensing by the pharmacies in question had been linked to two deaths and many “serious overdoses” that required hospital treatment.
“FALSUS IN UNO, FALSUS IN OMNIBUS”
Feith on Tuesday also discussed recent opioid settlements with drug makers like Purdue Pharma LP, Indivior PLC and Reckitt Benckiser Group PLC. He simultaneously echoed recent remarks from Deputy Attorney General Jeffrey Rosen, who said at the time of Purdue’s settlement in October that the DOJ was looking to punish “unlawful activity involving opioids at every level” of the pharmaceutical industry. (2)
“We’re committed to holding accountable all actors at all steps in the prescription drug supply chain who have contributed to this crisis,” Feith said at the FDLI conference. “As the deputy attorney general recently said, on the prescription side, that means any unlawful actions by manufacturers, distributors, pharmacy dispensers or physician prescribers.”
The Chamber of Commerce of the United States of America
Civil Action No. 4:20-cv-00817-SDJ
INTRODUCTION AND INTERESTS OF AMICI CURIAE
The Chamber of Commerce of the United States of America is the world’s largest business federation. It represents approximately 300,000 direct members and indirectly represents the interests of more than three million companies and organizations of every size, in every industry sector, from every region of the country. An important function of the Chamber is to represent its members’ interests in matters before Congress, the Executive Branch, and the courts. The Chamber files amicus curiae briefs in cases that raise issues of concern to the nation’s business community. Washington Legal Foundation (“WLF”) is a public-interest law firm and policy center with supporters nationwide. WLF promotes free enterprise, individual rights, limited government, and the rule of law. It often appears as amicus curiae to oppose civil liability unmoored from any statute or regulation. See, e.g., Domino’s Pizza, LLC v. Robles, 140 S. Ct. 122 (2019); Merck &
Co. v. U.S. Dep’t of Health & Human Servs., 962 F.3d 531 (D.C. Cir. 2020).
The National Retail Federation (“NRF”) is the world’s largest retail trade association, representing diverse retailers from the United States and more than 45 countries. Retail is the nation’s largest private-sector employer, contributing $3.9 trillion to annual GDP and supporting one in four U.S. jobs. For over a century, NRF has been a voice for every retailer and every retail job, communicating the impact retail has on local communities and global economies. NRF
submits amicus curiae briefs in cases raising significant legal issues for the retail community. The Retail Litigation Center, Inc. (“RLC”) is the only trade organization dedicated to representing the retail industry in the courts. The RLC’s members include many of the country’s
1 Amici curiae state that no party’s counsel authored this brief in whole or in part, no party or party’s counsel contributed money intended to fund preparing or submitting this brief, and no person other than amici curiae, their members, or their counsel contributed money intended to fund preparing or submitting this brief. (2)
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largest and most innovative retailers, employ millions of workers throughout the United States, provide goods and services to tens of millions of consumers, and account for tens of billions of dollars in annual sales. The RLC provides courts with retail-industry perspectives on legal issues impacting its members and highlights the industry-wide consequences of significant cases. Since its founding, the RLC has participated as an amicus in more than 150 cases.
Businesses that face liability for purported violations of regulatory obligations have an interest in ensuring those obligations are created, refined, and enforced in accordance with law. Free enterprise and sound policymaking depend on the regularity of agency process. And fundamental fairness requires that liability attach only to violations of clearly established rules.
When trying to regulate the private sector, federal agencies have increasingly avoided notice and comment procedures under the Administrative Procedure Act (“APA”). Rather than use the APA’s procedures—which were developed to provide regulated entities with notice and an adequate opportunity to comment before the imposition of new substantive rules of conduct— agencies increasingly issue de facto regulations in the guise of interpretive guidance.
Predicating civil liability on interpretive guidance created without a transparent regulatory process goes against the requirements of the APA and due process and, here, violates binding regulations issued by the Department of Justice (“DOJ”). The Chamber, WLF, NRF, and RLC have an interest in seeing that agencies respect administrative law principles, stop unlawfully enforcing non-binding guidance, and operate consistently with due process and the rule of law.
CONCLUSION
Free enterprise depends on a stable and predictable regulatory environment, in which businesses can operate and invest without unwittingly running afoul of the law.
FOR NOW, YOU ARE WITHIN THE NORMS
END NOTES
- PETITION TO SUB-COMMITTEE ON JUDICIARY CONGRESSMAN HANK JOHNSON (D) GEORGIA: https://youarewithinthenorms.com/2020/12/16/petition-%c2%b7-house-sub-committee-on-judiciary-lead-by-congressman-hank-johnson-d-ga-expose-deas-targeting-of-black-owned-pharmacies-%c2%b7-change-org/
- DEA DIRECTOR CANDIDATES PRESIDENT-ELECT JOSEPH BIDDEN, VICE PRESIDENT-ELECT KAMALA HARRIS: https://youarewithinthenorms.com/2020/12/06/recommended-great-candidates-to-head-the-united-states-drug-enforcement-administrationdea-under-president-elect-joe-bidden/
- https://www.wsj.com/articles/walmarts-opioid-whipsaw-11604012110?reflink=share_mobilewebshare
