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.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

JULY 24, 2023

To put that in context, the Actos label also carries the FDA’s most serious type of warning – a boxed warning – but for congestive heart failure, not bladder cancer. precipitously” after the 2011 label change adding the bladder cancer language, a “significant number” of claims would not have been reimbursed by TPPs nationwide.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation , 65 F.4th They excluded bogus expert testimony under Fed. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir. Monsanto Co. ,

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 604 (2011), and Mutual Pharm. Wyeth Ayerst Pharms. , 3d 364 (1st Cir. 3d 1034 (S.D.

FDA Approval 59

FDA Approval FDA Testimonials Production 59

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA 59

FDA FDA Approval Testimonials Vaccine 59