The Health Law Firm

JUNE 20, 2012

(KV) for making false or misleading statements to the US Food and Drug Administration (FDA). The ruling was reached on June 4, 2012. Appeals Court Ruling Revives Securities Fraud Class Action Lawsuit. To view the appeals court ruling in Public Pension Fund Group v. KV Pharmaceutical Company, click here.

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Drug & Device Law

FEBRUARY 20, 2024

In 2012, Plaintiff underwent laparoscopic surgery to repair an inguinal hernia that included implanting defendant’s hernia mesh product. The court did not address that the product was cleared by the FDA, but that fact alone should defeat the extreme mental state required of defendants in intentional infliction of emotional distress cases.

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 2d 279, 287 (Mich.

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Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief.

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Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. We saw more of the same with the discussion of consumer fraud claims in CPAP II. Plaintiffs Legal Committee , 531 U.S. 341 (2001). 2023 WL 7019287, at *7.

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Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

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Drug & Device Law

FEBRUARY 2, 2023

2012 WL 956192, at *5 (S.D. March 19, 2012); Holland v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. 2012) (applying Texas law).

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