Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 2370 (2022), which the Blog recently wrote about here. United States HHS , 42 F.4th 4th 67 (2d Cir. A little background is in order. Pfizer , 42 F.4th

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52

Drug & Device Law

DECEMBER 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. GlaxoSmithKline PLC , 2022 WL 17338047 (E.D.N.Y. 29, 2022), which (if allowed to stand) imperils everything that Congress and the Supreme Court accomplished through the Vaccine Act. Merck & Co.

FDA 115

FDA Public Health Fraud Hospitals 115

Drug & Device Law

JUNE 8, 2022

A couple of weeks ago on this blog we recalled a lobster dish in Paris. 2022 WL 1750462 (N.D. May 31, 2022), case showed how standing can be a double-edged sword. Judge DDL Blog would likely grant the defense motion to dismiss. Anybody can make a fine steak. Think of sweetbreads, tripe, or liver. No, really.

Fraud 59

Fraud FDA 59

Drug & Device Law

DECEMBER 29, 2023

2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted.

FDA 105

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

Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. 2022 WL 610276 (C.D. 31, 2022), fell into our laps. Here, Plaintiffs fail to supply factual support showing Defendant acted with “oppression, fraud, or malice,” relying instead upon conclusory allegations.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

JUNE 22, 2022

This is called the Drug and Device Law blog, but every once in a while we discuss cases that involve neither drugs nor devices. failure to test) or fraud or the usual ‘dollars over lives’ canard, the truth is that drug and device companies are careful, conscientious, and heavily regulated. 2022 WL 1787160 (N.Y. June 2, 2022).

Fraud 59

Fraud FDA Governance 59

Drug & Device Law

JANUARY 19, 2023

This post is from the non-Reed Smith side of the blog. That is because the well-reasoned decision in question, In re Allergan PLC Securities Litigation , 2022 WL 17584155 (S.D.N.Y. 2022), has major implications for the parallel Textured Breast Implant MDL now pending in the District of New Jersey. 2022 WL 17584155, at *11.

FDA 52

FDA Fraud 52

Drug & Device Law

MAY 13, 2022

2022 WL 1415031 (W.D.N.Y. May 4, 2022), the plaintiff alleged that the defendant’s osteoporosis drug, Fosamax, caused her to suffer serious injuries, including osteonecrosis of the jaw and atrial fibrillation. MacSwain , 2022 WL 1415031 at *4 (citations to Complaint omitted). In MacSwain v. Merck & Co. Bartlett , 570 U.S.

Fraud 59

Fraud FDA Nurses Hospitals 59

Drug & Device Law

FEBRUARY 23, 2022

2022 WL 468051 (W.D. 15, 2022), a case with a bizarre procedural posture and a mixed bag of rulings. Or perhaps this case is another example of why the exclusion of FDA clearance is so unfair and unworkable. Consider Terry v. Ethicon, Inc. Then it comes down to arguing to your court which opinions are closest or smartest.

FDA 59

FDA Fraud 59

Drug & Device Law

APRIL 21, 2022

2022 WL 1076173 (C.D. 2022), illustrates why defendants and plaintiffs have contrary views of Twombly and Iqbal. The plaintiff asserted all the usual claims and then one: manufacturing defect; failure to warn; breach of warranty; and fraud. 2022 WL 1076173, at *2 (quoting Twombly , 550 U.S. 2022 WL 1076173, at *4.

FDA 59

FDA Fraud 59

Drug & Device Law

FEBRUARY 2, 2022

2022 WL 204360 (N.D. 24, 2022), does not involve any physical injuries. Rather, parents filed class actions alleging that the smaller dose and higher priced “infants” version of OTC acetaminophen-based pain relievers, when compared to the “children’s” version with the same formula, violated Illinois and Texas consumer fraud statutes.

Fraud 59

Fraud FDA 59

Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. 2022 WL 4237528 (D. 14, 2022), is an even stranger claim, with the plaintiff seeking to hold the defendant liable for not manufacturing a prescription drug.

FDA 72

FDA Doctors Fraud 72

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. 3d —-, 2022 WL 464149 (N.D. 2022), rejected that sophistry. 2022 WL 464149, at *1. 2022 WL 464149, at *4. 2022 WL 464149, at *4. Plaintiffs constantly try to evade Buckman.

FDA 72

FDA Governance Fraud 72

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 both the blog and many of us defense practitioners can attest, the statute before repeal, Mich. . 2022 WL 5265300 (D.N.J.

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

JUNE 9, 2022

2022 WL 1261318 (3d Cir. 2022 WL 1261318 (3d Cir. 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. 2022 WL 1261318, at *2. Boston Scientific Corp.

Compliance 59

Compliance FDA Fraud 59

Drug & Device Law

DECEMBER 1, 2022

22-cv-10220, 2022 U.S. 21, 2022), reminded us of another of our post- TwIqbal pet peeves: when courts treat sweeping legal conclusions as if they were plausible factual assertions. Even more authoritative sources than this Blog agree with us. The decision in Corrigan v. Covidien LP , No. LEXIS 210296 (D.

FDA 59

FDA Fraud Hospitals 59

Drug & Device Law

JUNE 5, 2023

April 21, 2023), became the latest decision to follow what used to be (before the Pelvic Mesh litigation used the law in this area as a settlement tool) the overwhelming majority rule, that FDA decisions to allow products to be marketed – including §510(k) clearance – were routinely admissible. 2022 WL 17887527, at *3-4 (M.D.

FDA 59

FDA Regulatory Compliance Compliance Fraud 59

Drug & Device Law

AUGUST 24, 2022

If we advertised our blog as being non-drowsy, would that be false advertising? 2022 WL 3357575(M. August 15, 2022), the plaintiff claimed that a cough syrup was falsely advertised as non-drowsy. He filed a putative class action based on various state consumer fraud laws, breach of contract, breach of warranty, etc.,

Fraud 119

Fraud Overpayments Overpayment FDA 119

Drug & Device Law

MAY 25, 2022

May 19, 2022), which is an interesting food decision and apparently only the latest of several vanilla class actions. FDA law is also implicated, thereby supplying us with an excuse to write about ice cream in a drug and device law blog. . And that gets us to today’s case, Wach v. Prairie Farms Dairy, Inc. LEXIS 90233 (N.D.

Fraud 105

Fraud FDA 105

Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. FDA litigation that is now before the Supreme Court. FDA , 78 F.4th quoting FDA appellate brief ). See Alliance for Hippocratic Medicine v. 3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). See Alliance for Hippocratic Medicine v.

FDA 59

FDA Fraud Pharmaceutical Industry Doctors 59