The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. Since launch in 2008, more than 86 million patients have been treated. by Janssen Pharmaceuticals, Inc. Xarelto is marketed outside the U.S. by Bayer and in the U.S.

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Drug & Device Law

DECEMBER 21, 2023

Shikada is the first appellate decision creating a state-law warning-based duty (here, via a consumer protection claim, brought by the state rather than anyone actually claiming injury) based solely on pharmacogenomics − racially/ethnically-based genetic variations − allegedly affecting the effectiveness of FDA-approved prescription drugs.

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Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

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Drug & Device Law

OCTOBER 10, 2022

The drug at issue is the only FDA-approved pharmaceutical treatment for ATTR-CM (although off-label use of other drugs, and organ transplant, are sometimes used as treatments). ATTR-CM is a progressive heart disease that causes protein fibrils to deposit in the left ventricle of the heart, eventually leading to heart failure.

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Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. Albrecht , 139 S. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Moran , 536 U.S. Walsh , 538 U.S.

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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. See this post on one of our decisions from 2008.) Hiedeman, 694 F.3d

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Drug & Device Law

APRIL 18, 2022

at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. Wyeth Pharmaceuticals , 471 F. 2008); Herzog v. Apparently, the “no warnings” issue arose because physician in Rennick put the product to an off-label use, id. 2d 739, 747 (E.D.

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Lederle Laboratories , 2008 WL 972657 (W. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. 2d at 401.

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Drug & Device Law

SEPTEMBER 22, 2023

in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 2008), shows how the OTC express preemption provision should work. 312 (2008), and considering 21 U.S.C. 604 (2011), and Mutual Pharmaceutical Co. 379r(a)(1). An older case, Carter v. Novartis Cons.

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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. 660, 664 (1962).

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