Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

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Drug & Device Law

AUGUST 11, 2023

Plaintiff asserted various fraud and breach of warranty claims, and alleged that “hydrogen peroxide is ineffective in treating minor cuts and abrasions because, contrary to popular belief, it does not reduce rates of wound infection… and does more harm than good because it also destroys beneficial bacteria and healthy cells that promote healing.”

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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. 341 (2001). But the FDA has concluded just the opposite.

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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

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S.

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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. An unfortunate fiction developed post- Buckman —particularly after Riegel v. Stryker Corp. ,

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Drug & Device Law

NOVEMBER 28, 2022

2001) (Kilburn); and Wade-Greaux v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). I-Flow Corp. , 2d 1092, 1119-25 (D. 2010) (Matsen); Nelson v. Tennessee Gas Pipeline Co. 1998 WL 1297690, at *4, 7-8 (W.D. 31, 1998), aff’d , 243 F.3d 3d 244 (6th Cir. Whitehall Laboratories, Inc. ,

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Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” See 42 U.S.C. § See 21 C.F.R. 2022 WL 4305656, at *8.

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Drug & Device Law

JUNE 9, 2022

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. The court held that the presumption applied because it was “undisputed that the [device] is subject to FDA oversight.”

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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

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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Drug & Device Law

FEBRUARY 1, 2022

Her claims included negligence, strict liability, breach of implied and express warranty, and fraud. 341 (2001) as impermissible attempts at private enforcement of the FDCA. Plaintiff also failed to plead her fraud claims with the specificity required by Rule 9(b). Plaintiffs’ Legal Comm. , The court agreed.

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