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

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. Central Medical Health Services, Inc. , In state court, Creazzo remains binding precedent. 2d 521 (Pa. 3d 1245 (N.J. Ford Motor Co. ,

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Drug & Device Law

MARCH 7, 2022

These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., 662 (2009). Greystar Management Services, L.P. , June 18, 2020); MCI Communications Services, Inc. The ruling in question was that the TwIqbal ( Bell Atlantic Corp. Twombly , 550 U.S. 2, 2020). “In

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Drug & Device Law

APRIL 21, 2022

662 (2009), which together stand for the proposition that to state a claim and avoid dismissal a plaintiff must allege facts that plausibly suggest that the defendant is liable. The court did not pay mere lip service to Twombly and Iqbal ; it actually applied them. For example, the court took judicial notice of an FDA recall notice.

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Drug & Device Law

FEBRUARY 26, 2024

Rather, it “obligate[d] only the Secretary of Health and Human Services” to create “‘conditions designed to ensure’ informed consent.” Since the FDCA didn’t “impose any obligations” on anybody but the FDA, “it cannot conflict” with anything these defendants did or didn’t do. 555, 573 (2009), and these antivaxxers didn’t come close.

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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

MARCH 13, 2023

2009) (automotive seatbelts). If “strict liability” design defect claims are allowed under Pennsylvania law, the other side hopes to use Lewis and its Pennsylvania progeny to argue that all evidence of a prescription medical product’s compliance with the FDCA and FDA regulations is completely inadmissible. Coloplast Corp. ,

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