Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. OTC drugs also have an express preemption provision, but it contains an exception for Prop 65.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

NOVEMBER 9, 2023

552 (2011); Thompson v. If unfettered truthful off-label promotion is permissible, then the incentives for regulated entities to spend the large amounts of time and money now required to submit new uses of already approved FDA-regulated products for additional approvals would be reduced. E.g. , Sorrell v. IMS Health Inc. ,

FDA 64

FDA Nurses Production Regulations 64

Drug & Device Law

AUGUST 3, 2023

604 (2011), were still playing out. Instead, they argued below that the generic manufacturer should have sent out Dear Doctor letters to emphasize some aspect of the package insert and should have somehow corrected something about “third-party physician sources” on the drug. Mensing , 564 U.S. Its companion decision in Mutual Pharm.

Doctors 52

Doctors Packaging FDA FDA Approval 52

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. 2011), aff’d , 741 F.3d Ogden , 22 U.S. Wisconsin , 228 U.S. 115 (1913), and Savage v. Jones , 225 U.S.

Regulations 59

Regulations Production FDA FDA Approval 59

Drug & Device Law

MAY 19, 2023

In 2011 (during the Obama Administration), the FDA completed the REMS for mifepristone, mandating that it “only be prescribed by certified physicians, dispensed in certain healthcare facilities, and taken in the provider’s clinic.” That argument contravened the standing holdings of just about every other abortion case in history.

FDA Approval 111

FDA Approval Pharmacy FDA Production 111

Drug & Device Law

MARCH 13, 2023

It’s not like plaintiffs in prescription medical product liability litigation need strict liability to avoid problems with comparative fault, since doctors, not the plaintiffs, are usually the decision makers. Coloplast Corp. , 3d 448 (W.D. So why do they care? Bell Sports, Inc. , 3d 357 (3d Cir.

FDA 59

FDA Compliance Production Government 59

Drug & Device Law

OCTOBER 7, 2022

Plaintiff had the device implanted in 2011 and explanted more than seven years later, apparently not because of any symptoms or known injury. The purported misrepresentations to doctors “flow factually from her allegations of fraud-on-the-FDA,” so they were also preempted. The facts of Garcia are sparse. 2022 WL 4536240, *1.

FDA 59

FDA Doctors Production Government 59

Drug & Device Law

AUGUST 22, 2022

She also tried to sue three new defendants – a doctor, a medical society and the FDA itself. 2011 WL 8879258 (Mag. 20, 2011), adopted , 2011 WL 8879259 (W.D. 9, 2011); Williams v. 2011). . . . [U]nlike The medical claims were time-barred, and the FDA won on sovereign immunity. 23, 2014); Malonzo v.

FDA 59

FDA Regulations Production Doctors 59

Drug & Device Law

JUNE 28, 2022

In enacting the FDCA, Congress created the FDA and charged it with “promot[ing] the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.” 393(b)(2)(B). 1, 16-22 (2016) (collecting examples). Massachusetts was enjoined in Zogenix, Inc.

FDA Approval 116

FDA Approval FDA Drugs Regulations 116

Drug & Device Law

MAY 10, 2022

The second part of the Act is likewise geared toward preventing confusion or misleading the public but by requiring certain disclosures accompany all ads concerning drugs and devices approved by the FDA: Such advertisements must include the warning: “Do not stop taking a prescribed medication without first consulting with your doctor.

Doctors 52

Doctors Government Regulations FDA 52