Whistleblower News: Sarbanes-Oxley, Opioids, Novartis, Boeing

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3rd Circuit revives whistleblower's Sarbanes-Oxley claim against Citigroup

A federal appeals court has revived part of a former Citigroup worker’s whistleblower lawsuit alleging that he was fired after reporting improprieties in the firm’s internal complaint system.

Former Citigroup data center employee Abdul Jaludi had sued Citigroup for alleged violations of anti-retaliation provisions of the 2002 Sarbanes Act and the U.S. Racketeer-Influenced and Corrupt Organizations Act (RICO), claims that a lower court had forced into arbitration. read more »

Opioid Distributors Propose $10 Billion to End State Claims

McKesson, Cardinal Health, AmerisourceBergen make opening bid

States demand $45 billion; Local government pursue own suits

McKesson Corp., Cardinal Health Inc. and AmerisourceBergen Corp. have proposed paying $10 billion to settle claims they helped to fuel the U.S. opioid epidemic -- the first sign of progress in resolving state lawsuits against the drug distributors, according to people familiar with negotiations.

The companies, which deliver the majority of prescription medications to U.S. pharmacies, made the verbal proposal as part of talks with a group of state attorneys general, said three people familiar with the offer who asked that their names not be used because they weren’t authorized to speak publicly. read more »

Novartis Hid Manipulated Data While Seeking Approval for $2.1 Million Treatment

The failure to report the issue has not put patients at risk, the F.D.A. said, but the drugmaker could face criminal and civil penalties.

The drug maker Novartis concealed manipulated data from the Food and Drug Administration while applying for approval of an extremely expensive gene therapy treatment and then delayed reporting the issue, the agency said on Tuesday.

Officials said the inaccurate data, which involved testing in mice of two different strengths of the treatment, did not affect the safety or efficacy of the therapy, Zolgensma, used to treat a rare, often fatal genetic disease called spinal muscular atrophy.

Approved in May, the treatment’s price — set at $2.1 million — stoked concerns about the astronomical costs of potential cures for rare diseases and upset parents who initially could not get insurance coverage for the breakthrough treatment. read more »

Boeing 737 Max Needs Full F.A.A. Review, Crash Families Say

A group of family members representing more than 50 people who died in the crash of Ethiopian Airlines Flight 302 are calling on the Federal Aviation Administration to conduct a full regulatory review of Boeing’s 737 Max before it is allowed to fly again.

The Max, which entered service in 2017, is Boeing’s most recent update to the 737, which was introduced in the 1960s. Because it was not an entirely new airplane, the F.A.A. reviewed only the parts of the Max that differed significantly from a previous version of the 737.

By certifying the plane with a so-called amended type certificate, the F.A.A. allowed Boeing to get the Max flying years sooner than it would have had the company introduced a brand-new plane that had to be certified for the first time. read more »