US court rules to protect generic drug makers

Manufacturers of generic drugs cannot be sued for adverse side effects caused by products that they did not themselves design, the US Supreme Court ruled on Monday.

In a five-to-four decision, the justices found in favor of Mutual Pharmaceutical, overturning a $21 million award against it after a woman suffered horrific burns after taking an anti-inflammatory in 2004.

are copies of drugs already developed by other firms and approved by , and Mutual argued that any faults in the product are thus not its responsibility.

In his written opinion, conservative Justice Samuel Alito said the court had reached its finding "reluctantly", noting the "tragic" circumstances of the case which had left the victim "severely disfigured" and "nearly blind."

But he ruled it was impossible for manufacturers "to comply with both state and federal law, New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce."

" are also prohibited from making any unilateral changes to a drug label," it added.

In the case before the court, plaintiff Karen Bartlett suffered and pain and several months in a coma after using an anti-inflammatory to treat a sore shoulder.

add to favorites email to friend print save as pdf

Related Stories

Court: Can generic makers be sued for drug flaws?

Nov 30, 2012

(AP)—The Supreme Court will decide whether generic drug manufacturers can be held responsible in state courts for possible design defects that are in the brand-name medicine they are copying.

US: 'Pay to delay' generic drugs can be illegal (Update)

Jun 17, 2013

The Supreme Court ruled Monday that deals between pharmaceutical corporations and their generic drug competitors, which government officials say keep cheaper forms of medicine off the market, can be sometimes be illegal and ...

High court weighs drug companies' generics policy

Mar 25, 2013

(AP)—The Supreme Court is struggling with whether it should stop pharmaceutical corporations from paying generic drug competitors to delay releasing their cheaper versions of brand-name drugs.

Recommended for you

Xtoro approved for swimmer's ear

15 hours ago

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

16 hours ago

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

Judge halts Alzheimer's drug swap until July

Dec 16, 2014

A federal judge has ordered an Irish drug manufacturer to halt its plans to discontinue its widely used Alzheimer's medication, allegedly in an effort to drive patients to a newer patented drug.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.