The case concerns Ms Karen Bartlett, who suffered a rare hypersensitivity reaction, which caused burn-like lesions on two-thirds of her body and left her with permanent near-blindness. She sued Mutual Pharmaceutical for alleged design defects under New Hampshire law and was awarded a US$21 million jury award.

Mutual Pharmaceutical appealed to the Supreme Court, which ruled in 2011 that patients could not sue generics manufacturers for failing to warn them adequately about drug risks because, under existing laws and regulations, generics makers must have the same labels as their brand-name counterparts [1]. Ms Bartlett’s case is due to be heard before the US Supreme Court during March 2013.

FDA plays an important role by approving drugs based on reduced clinical trial data and then monitoring what happens when the drugs are widely used. However, lawsuits are important too, as deterrents to negligence or wrongdoing. If the Supreme Court insists on shielding generics manufacturers from consumer lawsuits, then maybe Congress ought to amend the laws.

Another option would be for patients who use generic drugs to sue the brand-name drugmaker responsible for the drug’s labelling. This scenario has already been tested in the US Supreme Court of Alabama, which ruled that Pfizer could be sued by a patient who had only used generic versions of its gastric reflux medicine Reglan (metoclopramide) [2].

Editor’s comment
What do you think? Please feel free to share your thoughts via email or in the comments section below. What are your views on generics pre-emption? Do you think that patients taking generic drugs should be able to sue the generics manufacturer? Or is it right that the brand-name drugmaker should be held responsible for the drug labelling?

Related articles

Pfizer asks US Court to reconsider generic Reglan ruling

Generic pre-emption raises its ugly head again

Generics will not have to change their labelling

References

1.  GaBI Online - Generics and Biosimilars Initiative. Generics manufacturers do not have to change drug safety labels in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 29]. Available from: www.gabionline.net/Generics/News/Generics-manufacturers-do-not-have-to-change-drug-safety-labels-in-the-US

2.  GaBI Online - Generics and Biosimilars Initiative. Brand-name drugmaker can be sued for harm caused by generic drug [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 29]. Available from: www.gabionline.net/Pharma-News/Brand-name-drugmaker-can-be-sued-for-harm-caused-by-generic-drug

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