Drug & Device Law

JANUARY 31, 2024

Plaintiff’s fraud claims in Collyer allege that the packaging of four keto-friendly cereals was misleading because the cereals do not contain an ingredient pictured on the package. 2013) (state law claims preempted where they are dependent on a violation of federal law). 4th 1040 (9th Cir. And now one has – Collyer v. 4 th at 1048).

Fraud 52

Fraud FDA 52

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. 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. Monsanto Co. ,

FDA 105

FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. 2013 WL 5406628, at *3 (D. 25, 2013) (the rule applies to both “inadequate warning” and “no warning at all” cases). Plaintiffs Legal Committee , 531 U.S.

Fraud 52

Fraud FDA Hospitals Doctors 52

Drug & Device Law

OCTOBER 13, 2023

2466, 2471 (2013). It makes no difference in our view that the FDA ultimately approved TAF-based drugs. It is undisputed that, at the time the FDA approved the first TDF-based drug, the plaintiff’s proposed “alternative” was not approved, and would not be approved for another 10+ years. Gilead Sciences, Inc. ,

FDA 59

FDA Fraud 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. 472 (2013), but that hinged largely on the duty of sameness—that is, the generic manufacturer cannot change the formulation of its drug to be different from the branded drug on which its ANDA approval depended.

FDA 64

FDA Fraud Compliance 64

Drug & Device Law

FEBRUARY 21, 2023

Plaintiff conceded that court did not have general jurisdiction over the three defendants but as to two of them argued that specific jurisdiction existed based on defendants marketing and distributing the device in North Carolina, even if those activities did not take place until after Plaintiff’s 2013 surgery.

FDA 72

FDA Fraud Doctors 72

Drug & Device Law

FEBRUARY 2, 2023

2013); Massa v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. Novartis Pharmaceuticals Corp. , 2d 898, 909-10 (W.D. Genentech Inc. & Rem.

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

JANUARY 30, 2023

472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. 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. Kent , 552 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

NOVEMBER 28, 2022

2013) (Painter); McClellan v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II) , 341 F. 3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co. ,

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our Plaintiff also offered a claim based directly on failure to report adverse events to FDA. Our posts go back for more than six years.) 2022 WL 4536240, *3.

FDA 59

FDA Fraud Doctors Public Health 59

Drug & Device Law

MAY 13, 2022

472 (2013), as readers of this blog are aware, the United States Supreme Court held that a state law design defect claim against a generic drug manufacturer was pre-empted because the manufacturer could not “redesign” a drug to comply with state law tort duties without first obtaining FDA approval. Bartlett , 570 U.S.

Fraud 59

Fraud FDA Nurses Hospitals 59

Drug & Device Law

MARCH 22, 2022

15, 2022), was 15 years old in 2013 when her mother consented to plaintiff receiving the Gardasil vaccine. Her current lawsuit brought claims under the Connecticut Product Liability Act (CPLA) and for common law fraud. The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval.

Fraud 59

Fraud FDA Doctors 59

Drug & Device Law

MARCH 7, 2022

Here, Plaintiffs fail to supply factual support showing Defendant acted with “oppression, fraud, or malice,” relying instead upon conclusory allegations. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., at *8 (agreeing with Bouncing Angels, Inc. 2, 2020). “In

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

MARCH 3, 2022

12-cv-734, 2013 WL 1739580 (D.D.C. March 21, 2013). That discussion did not, for instance, tout a non-existent presumption against preemption or suggest that Buckman only limited claims titled as “fraud-on-the-FDA,” mistakes we have seen from other judges. Medtronic, Inc. , 3d at 167-73. at 174.

FDA 59

FDA Fraud Governance 59

Drug & Device Law

FEBRUARY 24, 2022

One tack they take is to argue that Buckman is limited to its facts and thus applies only to state-law fraud-on-the-FDA claims. Still, the Chong court should be commended for taking “a fresh look at the governing FDA regulations” and acknowledging that it had previously “incorrectly decided” a “nearly identical” case.

FDA 72

FDA Governance Fraud 72