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Monday, March 18, 2013

Will originator pharma be held responsible for harm caused by taking a generic version of their drug in Australia?

By Senior Associate Ric Morgan

From recent news reports relating to a decision of the Supreme Court of Alabama in the USA, it would seem that innovator pharmaceutical companies can be held responsible for product liability even where the person harmed by the drug only took generic versions of the drug.

The person injured took a generic version of the Wyeth product Reglan, which contains the drug metoclopramide. It is a heartburn medicine and there is a risk associated with metoclopramide of tardive dyskinesia, a movement disorder. Reading the US decision, it seems clear that the generic manufacturer was aware of the particular risk and certainly did nothing to warn.

The decision of the Alabama Supreme Court in early January 2013 (Wyeth v Weeks) results in Mr Weeks being able to sue Wyeth even though Mr Weeks never took the Wyeth version of the drug. In late February 2013, Pfizer (which now owns Wyeth) requested the Alabama Supreme Court to rehear its decision, described it as creating 'tort hell'.

It is unlikely that a court would make the same decision in Australia.

Critically, the Alabama decision relied on the clear allocation of responsibility for the labeling of medicines by the FDA. In the US, brand-name manufacturers and generic manufacturers have different drug-labeling responsibilities, with only the brand-name manufacturer responsible for the accuracy and adequacy of its warnings. Manufacturers seeking generic drug approval in the US are only responsible for ensuring that their warning label is the same as the brand name's label.

The decision in Alabama seems to have turned on the fact that:

…it would have been impossible for the generic-drug manufacturers to change their warning labels without violating the federal requirement that the warning on a generic drug match the warning on its brand-name counterpart.
In Australia, the TGA does not require that a generic manufacturer slavishly copy product information and warnings (see Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) [2011] FCA 846). The TGA's guidance on this issue is that where the information is 'different in content to … the already registered brand, safety and/or efficacy data may be needed' and also that 'safety-related changes that only reduce the patient population, remove and indication or add a warning, precaution, contraindication or adverse event may be made without approval of the TGA but subject to a notification process'.

Because of this, it seems quite unlikely that a generic manufacturer in Australia would be able to hide behind the innovator's failure to warn.

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