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

NOVEMBER 10, 2023

That phrase echoed in our minds when we first read In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2023 WL 1818922 (D.N.J. Valsartan , 2023 WL 1818922, at *24. See Valsartan , 2023 WL 1818922, at *24 (justifying unprecedented class certifications as “promoting Class Action settlement”).

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Drug & Device Law

DECEMBER 4, 2023

2010) (citations and quotation marks omitted). “[W]e have exercised restraint” and “opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the affected state] decides differently.” 2010). “[E]ven if we were torn between two competing yet sensible interpretations of [state] law. . .,

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Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 2023 WL 6216933 (S.D. 25, 2023), no court had slid all the way to the bottom of the “parallel claim” slippery slope. 2023 WL 6216933, at *5. 2023 WL 6216933, at *6.

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Drug & Device Law

MARCH 16, 2023

We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. 2010) (Ohio law), and the Pennsylvania Supreme Court in Lance v. 1:22-cv-00141-MR, 2023 WL 2386776 (W.D.N.C.

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Drug & Device Law

DECEMBER 7, 2023

In particular, we’re not surprised to learn that AI is being used in the context of FDA-required adverse event reporting, purported problems with which have become one of the other side’s go-to preemption dodges. Yates , 2010 WL 503061, at *1 (E.D. Shinette , 2018 WL 4929736, at *5 (E.D.

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Drug & Device Law

AUGUST 25, 2023

As it became widely used off-label for morning sickness, the FDA considered, but did not require, pregnancy-related labeling. Then, over the next several years, both sides brought the plaintiffs’ allegations/evidence to the FDA’s attention, and the FDA rejected multiple proposed labeling changes regarding birth defects.

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Drug & Device Law

JANUARY 16, 2023

4th , 2023 WL 128570 (1st Cir. 9, 2023), the court unanimously affirmed the MDL-wide preemption order dismissing all claims. As we’ve also discussed previously , the FDA imposes tight restrictions about anything that a regulated entity proposes to say about off-label uses in the label. 49603, 49605-06 (FDA Aug.

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Drug & Device Law

DECEMBER 21, 2023

Speaking of cold and darkness, it is now time for us to look back upon the results of drug and medical device litigation during 2023 and to select the ten worst decisions of the year. 122 (2023) ( here ). FDA , 78 F.4th We also consider the same court’s equally politicized attack on FDA authority in Apter v. 3d 18 (Cal.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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