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reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 2d 279,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 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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Drug & Device Law

DECEMBER 5, 2022

at 462-63; FDA §510(k) clearance of the defendants’ instructions for use did not “actually bar” or “clearly permit” the IFU statements so as to create a safe harbor that precluded the Attorney General’s claims, id. 239, 253 (2012) (which the Blog discussed here ). The bounds of statutory compliance are created entirely after the fact.

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Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2012) (citing Smith–Haynie v.

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Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. This internal FDA decision was one of the reasons that preemption prevailed in Pfaff. T]he FDA responded. However, the FDA concluded that. . . [it

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Drug & Device Law

AUGUST 8, 2022

So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. 2012 WL 3265002, at *5 (N.D. 8, 2012) (“For claims against trade associations in particular, public policy is ‘part of the legal mix’ and favors not imposing a duty.”); Lockman v.

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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. 2012), abrogated on other grounds by McCarrell v. 2012), and Garcia v. Boston Scientific Corp. 2022 WL 1261318 (3d Cir.

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