Caroselli, Beachler & Coleman, L.L.C.

Prescription drugs, generic drugs and product warnings

A manufacturer of a particular drug wants all generic brands of the same medication to display a warning that the drug causes high blood pressure and suicidal ideation. This clearly suggests that we may be dealing with a dangerous and defective drug.

AstraZeneca Plc (AZN), a UK based company, is now suing the FDA because the agency denied a prior request that such warnings be required for generic brands of a drug called Seroquel. Seroquel is an antipsychotic medication which until now has been exclusively marketed by AZN, but such exclusivity is soon to change as generic brands of Seroquel will also be sold. If such warnings are not required of the generic brands, AZN then asks that approval of marketing of the generic brands be delayed.

The motives of AZN in bringing the lawsuit and requesting such warnings be used seems to have little to do with consumer safety. Rather AZN is more likely concern that patients will be more likely to buy the generic brands of Seroquel without such product warnings and that AZN will then lose out on sales and a great deal of its market share.

Part of the reason why clients and their attorneys bring so many products liability suits is because companies often make decisions based on financial costs rather than consumer safety. Yet products liability suits often hit such companies that ignore consumer safety where it hurts the companies most: in the wallet.

Without trying to sound overly pessimistic, the best way to promote product safety in Pennsylvania and elsewhere maybe to make it as difficult as possible for companies to make profits until such companies place consumer safety first.

Source: Bloomberg, "AstraZeneca Sues FDA Over Generic Seroquel Warning Denial," March 14, 2012

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Caroselli, Beachler & Coleman, L.L.C.
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Pittsburgh, PA 15222

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