Drug & Device Law

DECEMBER 28, 2023

In addition, although we generally do not speak of judges, we note that the judge overseeing this MDL took the federal bench in 1994—a year after Daubert —and had a, shall we say, interesting history with issues of preemption and the FDA over the first year or so of the MDL. 2011), which might have been our third example above.

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Drug & Device Law

SEPTEMBER 22, 2023

Constitution’s Supremacy Clause, it strikes a balance between state and federal power on issues of public health and safety, and raises questions about whether our country’s approach to regulation and litigation makes sense for pharmaceuticals and medical devices (spoiler alert: it doesn’t). 604 (2011), and Mutual Pharmaceutical Co.

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Drug & Device Law

MARCH 30, 2023

The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health. IMS Health, Inc. , Instead, the Missouri law clearly picked a side. Reagan Nat’l Adver. of Austin , 142 S.

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Drug & Device Law

MARCH 2, 2023

Commentators beyond this Blog have described how this bent affects contraceptive choice and public health. As to one defendant, the court looked solely to whether plaintiffs’ claims “arise out of or relate to” contacts with Georgia that began in 2019, even though the implants were in 2011 to 2013. 2023 WL 2111346, *6.

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Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. at 226 (footnote and quotation marks omitted). 300aa-22(b)(1).

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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

JUNE 28, 2022

Jackson Women’s Health Org. , 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.

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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.

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