Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

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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. 662, 684-85, 686 (2009) (citations, including to Twombly , omitted). Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , Ashcroft v. Iqbal , 556 U.S.

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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

MARCH 13, 2023

Unlike almost every state in the country, since 1987, Pennsylvania law has prohibited defendants from introducing evidence of their compliance with government and/or industry standards in strict liability design defect cases – generally. 2009) (automotive seatbelts). Coloplast Corp. , 3d 448 (W.D. E.g. , Lewis v. 2d 590, 593-94 (Pa.

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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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Drug & Device Law

JANUARY 30, 2023

555 (2009), and rated only a “ cf. 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. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. Levine , 555 U.S.

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Drug & Device Law

JANUARY 16, 2023

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. at *4 (“plaintiffs focus their appeal on the three Japanese studies not originally submitted to the FDA”). quoting 73 Fed. 22, 2008)).

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Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. The rulemaking process governing monographs was replaced with an administrative order process. 14, 2022), leaves us scratching our heads.

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Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

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Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § Plaintiffs’ Legal Committee , 531 U.S. Plaintiffs constantly try to evade Buckman. Medtronic, Inc. , 3d 1026, 1034 n.22

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