In the long saga of generics pre-emption, The New York Times is adding its opinion to the argument of whether generics makers are liable for injuries caused by their products. The newspaper believes that ‘manufacturers should bear responsibility for making sure their drugs are safe and effective’ and is urging US Congress to amend laws to allow patients to sue generics manufacturers.
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. 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).
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?
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