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. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

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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 had the device implanted in 2011 and explanted more than seven years later, apparently not because of any symptoms or known injury. 2022 WL 4536240, *1.

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Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.”

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Drug & Device Law

FEBRUARY 10, 2022

2011 WL 3583743, at *5 (S.D. 2011), for the proposition that a “patient’s negligent misrepresentation claim based on [a] failure to warn is not barred as a matter of law by the learned intermediary doctrine.” The court cited Mardegan v. Mylan, Inc. It seems, however, that Florida has not adopted either provision as its own.

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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. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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Drug & Device Law

AUGUST 3, 2023

604 (2011), were still playing out. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. Dear Doctor letters are labeling, according to post- Mensing cases and the regulation defining what written communications can create liability for “mislabeling.”

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. T]he growing market for mifepristone. . .

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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.

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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 hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

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Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. Jackson Women’s Health Org. ,

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Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. 552 (2011); Thompson v. FDA , 119 F. E.g. , Sorrell v.

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