Drug & Device Law

SEPTEMBER 19, 2022

555 (2009) , and PLIVA, Inc. 604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. Under Wyeth v. Levine, 555 U.S. c)(6)(iii)(A).

Regulations 10

Regulations FDA Approval FDA Drugs 10

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” ? 555 (2009). Such a letter reflects the “FDA’s complete review of the data submitted.” 314.110(a)(3).

FDA 52

FDA Regulations Science Drugs 52

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 flimsy decision in In re Acetaminophen − ASH-ADHD Products Liability Litigation , 2022 WL 17348351 (S.D.N.Y. at *7, in Wyeth v. Levine , 555 U.S.

Regulations 59

Regulations Nurses FDA FDA Approval 59

Drug & Device Law

JANUARY 30, 2023

555 (2009), and rated only a “ cf. 280 (1995), decision that he joined in 1995 He joined a decision that found no preemption by virtue of a governmental decision not to regulate in Myrick and did not object to boilerplate description of obstacle preemption as an accepted preemption category Then in the 5-4 Geier v. Bartlett , 570 U.S.

FDA 72

FDA Regulations Production Government 72

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. Preemption turns on the availability of the FDA’s changes being accepted (“CBE”) regulation, 21 C.F.R. 12 (citation and quotation marks omitted).

FDA 59

FDA FDA Approval Regulations International 59

Drug & Device Law

APRIL 14, 2023

The only cases the defendant cited in support of its preemption argument were cases in which courts held that plaintiffs’ labeling claims related to Class II devices were preempted because the FDA “had specifically defined the content required to the devices label through a regulation or a specific requirement in a special controls document.”

FDA 59

FDA Doctors Regulations FDA Approval 59

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. Saigh , 769 N.W.2d

Production 52

Production FDA Approval Compliance FDA 52

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.

FDA 59

FDA Regulations FDA Approval Production 59

Drug & Device Law

AUGUST 31, 2023

b)(2) not to make such a change without first obtaining FDA approval.” As construed by the court, the complaint alleged that the biologic approved by the FDA is defective as a matter of state law. Bartlett , 570 U.S. 2023 WL 5437356 at *7­. Note, however, the caveat. 2023 WL 5437356 at *7­. Courts are divided.

FDA Approval 59

FDA Approval FDA Production Pharmaceuticals 59

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. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. 3d 281 (6th Cir.

FDA Approval 64

FDA Approval FDA Regulations Production 64