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

FEBRUARY 2, 2023

2012 WL 956192, at *5 (S.D. March 19, 2012); Holland 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. 2012) (applying Texas law).

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Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2012) (citing Smith–Haynie v.

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Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. 2012 WL 3265002, at *5 (N.D. Such power rests solely with the FDA.” The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud.

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Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

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Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. The Arizona legislature passed the punitive damages exemption statute in August of 2012. Hence, the statute applied.

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Drug & Device Law

MARCH 7, 2022

These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., It does not give him license to evade the less rigid ? It does not, however, give a plaintiff “license to evade the less rigid ? 2012); Sieloff v. 2012 WL 5835396, at *1 (D. Medtronic, Inc. ,

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