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Legal News for Thurs 5/9 - Jazz Pharmaceuticals Orphan Drug Claim, Ozempic Side Effect Litigation, Allegations against Rudy and AFL vs. Red Hat

Legal News for Thurs 5/9 - Jazz Pharmaceuticals Orphan Drug Claim, Ozempic Side Effect Litigation, Allegations against Rudy and AFL vs. Red Hat

Jazz Pharmaceuticals and the FDA, side effects litigation linked to Ozempic, new allegations against Rudy Giuliani, and a lawsuit by America First Legal against Red Hat.
Rudy Giuliani, pencil sketch

This Day in Legal History: Impeachment Hearings Against Nixon

On May 9, 1974, a significant event unfolded in the political and legal history of the United States as the House Judiciary Committee, chaired by Representative Peter Rodino (D-NJ), initiated impeachment hearings against President Richard Nixon. This marked a crucial point in the Watergate scandal, an episode that had gripped the nation for two years following the break-in at the Democratic National Committee headquarters at the Watergate complex in June 1972. The scandal involved allegations of political espionage and sabotage conducted on behalf of Nixon's reelection campaign, a cover-up by high-level White House officials, and subsequent revelations of misconduct.

The decision to open hearings was based on accumulating evidence from various investigations, including testimonies provided to the Senate Watergate Committee and the revelations from the Watergate tapes. As chairman, Peter Rodino played a pivotal role in overseeing a fair and meticulous review of the allegations against Nixon, guiding the committee through extensive debates on legal and constitutional grounds for impeachment.

The committee's hearings were comprehensive, involving detailed examination of the evidence and intense deliberations on the constitutional criteria for impeachment. The proceedings were conducted with a level of transparency, broadcasted live on national television, allowing the public to witness the meticulous process of democratic oversight.

On July 30, 1974, after several months of hearings, the committee voted to impeach Nixon on three counts: obstruction of justice, abuse of power, and contempt of Congress. These charges were centered around Nixon's involvement in the cover-up of the Watergate break-in and other misuse of presidential power.

The impeachment process was a watershed moment in American legal history, emphasizing the principle that no one, not even the President of the United States, is above the law. It showcased the pivotal role of legal frameworks and congressional oversight in upholding democratic principles and integrity within the executive branch.

Peter Rodino, whose leadership was instrumental during this challenging time, was later recognized for his fairness and dedication to upholding justice. He passed away in 2005 at the age of 95, remembered as a key figure in one of the most challenging periods in American political history. This day in 1974 remains a defining moment, highlighting the robustness of legal and democratic processes in the face of political crisis.

Jazz Pharmaceuticals is set to challenge the FDA in a court case regarding the approval of a rival narcolepsy medication, Lumryz, by Avadel CNS Pharmaceuticals. Jazz argues that the FDA's approval of Lumryz violated the Orphan Drug Act because it disregarded the "clinical superiority" clause. Jazz contends that the FDA should not have approved Lumryz as it is considered the same drug as Jazz's Xywav, which has orphan drug exclusivity until 2027. The FDA, however, maintains that Lumryz is not the same because it offers clinical benefits that Xywav does not, such as not requiring a second dose during the night. The case hinges on the interpretation of the term "same drug" and whether the FDA's definition of a clinically superior drug is permissible under the Orphan Drug Act. This lawsuit could potentially reshape how the FDA interprets and applies rules concerning drug exclusivity and could have broader implications for how agencies interpret ambiguous statutory language, following the principles established by the Chevron doctrine.

By way of very brief background, the Orphan Drug Act of 1983 provides seven years of market exclusivity for drugs designed to treat rare diseases, preventing the FDA from approving similar drugs for the same condition from other manufacturers unless certain exceptions apply. This law aims to encourage the development of treatments for diseases affecting small patient populations, and thus having a small number of potential sales, by offering incentives like exclusivity to pharmaceutical companies. In the case involving Jazz Pharmaceuticals and the FDA, the dispute centers on whether the FDA can approve a drug claimed to be "clinically superior" despite existing exclusivity agreements under this law.

Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval

Prominent law firms Morgan & Morgan PA, Seeger Weiss LLP, Wagstaff & Cartmell LLP, and Motley Rice have been appointed as lead counsel for plaintiffs in litigation concerning side effect warnings for the diabetes drug Ozempic and related medications. The decision was made by Judge Gene E.K. Pratter of the US District Court for the Eastern District of Pennsylvania. This litigation involves multiple lawsuits against pharmaceutical companies including Novo Nordisk A/S, the producer of Ozempic, and Eli Lilly & Co., which manufactures Mounjaro and Trulicity. These companies are accused of underplaying serious gastrointestinal side effects associated with drugs classified as glucagon-like peptide-1 receptor agonists. 

Ozempic, known for its blood sugar regulation and unintended weight loss effects, has seen a spike in demand leading to the development of the weight loss drug Wegovy. The firms representing the defendants are DLA Piper for Novo Nordisk, and Welsh & Recker PC, Kirkland & Ellis LLP, and Redgrave LLP for Eli Lilly. The case continues to unfold in Pennsylvania.

Ozempic and Wegovy, popular diabetes and weight-loss medications, have been linked to severe gastrointestinal side effects, including gastroparesis (stomach paralysis) and cyclic vomiting syndrome (CVS). Gastroparesis causes the stomach muscles to slow down, severely delaying the digestion process, which can result in food remaining undigested in the stomach for prolonged periods. This condition can lead to symptoms such as nausea, vomiting, and abdominal pain. Cyclic vomiting syndrome is characterized by intense, recurrent episodes of vomiting, which can last several hours or days, accompanied by severe abdominal pain and nausea. These side effects significantly impact patients' quality of life, and concerns have been raised about the adequacy of warnings provided by the drugs' manufacturer, Novo Nordisk. 

Ozempic Plaintiff Attorneys Led by Morgan & Morgan, Seeger Weiss

Rudolph Giuliani, the former mayor of New York, has been accused again by Georgia poll workers Ruby Freeman and Wandrea’ Arshaye “Shaye” Moss of making false statements. Despite a previous $148 million defamation judgment against him for similar allegations, Giuliani reportedly continued to claim that these poll workers manipulated the 2020 presidential election results. This accusation came during an April livestream where he addressed a crowd in Tulsa, Oklahoma. Freeman and Moss, who recently won their defamation suit against Giuliani, responded by filing an objection to his motion for an appeal, which he had requested after declaring bankruptcy. They argue that Giuliani’s actions are not only a flawed litigation tactic but also a disregard for legal consequences. Meanwhile, a committee of unsecured creditors also opposed Giuliani's motion, highlighting that his legal maneuvers delay resolving the financial claims against him, affecting the creditors adversely. The dispute underscores ongoing legal battles involving Giuliani, who faces significant financial liabilities primarily due to the defamation award.

Giuliani Accused of New False Remarks About Georgia Poll Workers

Stephen Miller's legal group, America First Legal (AFL), has initiated a lawsuit against IBM subsidiary Red Hat Inc., alleging that the company's diversity initiatives resulted in discriminatory practices against a former White male employee, Allan Kingsley Wood. Filed in the US District Court for the District of Idaho, the lawsuit contends that Red Hat's diversity, equity, and inclusion (DEI) program, which sets hiring goals for women and minorities, led to Wood's wrongful termination. Wood, who was a senior director at Red Hat, reportedly disagreed with the DEI policies based on his religious, personal, and political beliefs, advocating for hiring based on merit. The lawsuit also claims that Red Hat's DEI goals effectively acted as "quotas," aiming to significantly alter the company's workforce demographics by 2028. Shortly after expressing his views, Wood was dismissed from his position, along with 21 other employees, predominantly White males, under the guise of role elimination. Wood is now seeking compensation and an injunction against Red Hat's DEI program. The case highlights ongoing tensions and legal challenges related to corporate diversity efforts following the US Supreme Court's June 2023 decision on affirmative action in college admissions.

Stephen Miller Group Sues IBM’s Red Hat for White Male Bias (1)

Minimum Competence - Daily Legal News Podcast
Minimum Competence
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