Pfizer asks US Court to reconsider generic Reglan ruling

Generics/News | Posted 22/02/2013 post-comment0 Post your comment

Pfizer has asked the US Supreme Court of Alabama to reconsider its decision of 4 January 2013, which would allow generics patients to sue brand-name drugmakers.

picture25

The company filed for a rehearing on 19 February 2013, after Alabama’s Supreme Court ruled that Pfizer could be sued by a patient who had only used generic versions of its gastric reflux medicine Reglan (metoclopramide) [1].

Federal law requires that generic drugs have the same labels as their brand-name equivalents. Therefore, in its decision, the Alabama Supreme Court ruled that ‘an omission or defect in the labelling for the brand-name drug would necessarily be repeated in the generic [drug] labelling, foreseeably causing harm to a patient who ingested the generic [drug] product’ [1].

Pfizer, however, disagrees, and states in its application for a re-hearing that ‘the court’s ruling is inconsistent with rulings in the overwhelming majority of state and federal courts around the nation’. Pfizer has previously pointed out that more then 70 similar cases have taken the opposite view. Its petition also argues that ‘a brand-name drug manufacturer cannot be held liable for injuries caused by its competitors’ generic drug products’.

The request for a re-hearing has been backed by the US Chamber of Commerce, the Business Council of Alabama and four other groups, who believe that the court’s decision could also affect other industries such as car manufacturing.

Editor’s comment
What are your views on the decision taken by the Alabama Supreme Court? Do you agree that patients taking generic drugs should be able to sue brand-name drugmakers?

Please feel free to share your thoughts via email or in the comments section below.

Related articles

Generics will not have to change their labelling

Generic pre-emption: what are the implications

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Brand-name maker can be sued for harm caused by generic drug [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 22]. Available from: www.gabionline.net/Pharma-News/Brand-name-drugmaker-can-be-sued-for-harm-caused-by-generic-drug

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010