Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. Monsanto Co. ,

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Drug & Device Law

JUNE 19, 2023

As discussed here , the primary allegations asserted the same sort of “fraud on the FDA” claim that, when brought as a common-law tort claim, were held preempted in Buckman Co. As the earlier post discussed, the First Circuit rightly put an end to that attack on FDA authority in United States ex rel. No other causation needed.

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Drug & Device Law

MARCH 7, 2022

Here, Plaintiffs fail to supply factual support showing Defendant acted with “oppression, fraud, or malice,” relying instead upon conclusory allegations. 2017 WL 1294004, at *4 (C.D. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., Corrections Corp. ,

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Drug & Device Law

FEBRUARY 20, 2024

The mesh remained in place until plaintiff underwent a partial explant in 2017, where the explanting surgeon noted “no obvious signs of an abnormality.” In 2012, Plaintiff underwent laparoscopic surgery to repair an inguinal hernia that included implanting defendant’s hernia mesh product.

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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reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Cartridge Co. , 804, 813 (E.D.

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Drug & Device Law

FEBRUARY 16, 2023

Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible for crafting (and sometimes outright inventing, see fraud on the FDA) defenses for that then-unusual medical device-related mass tort. However, those claimed alternatives “were not yet cleared by the FDA” for the use at issue in Baksic.

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Drug & Device Law

FEBRUARY 14, 2024

In 2017, the plaintiff sued his eye doctor professionals and the manufacturer of contact lenses, claiming that the lenses caused him to suffer serious injuries, including vision loss. Nor did the plaintiff identify particular Ohio state-law duties that parallel any FDA requirement. Both show up in Groeschen v. 2024 Ohio Misc.

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Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

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Drug & Device Law

MARCH 19, 2024

Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Plaintiff was missing any “indicia of fraud, wrongdoing, domination, misuse, or subversion of corporate formalities. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements.

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. She sued in 2017 with a bunch of the typical claims for medical device cases.

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