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OPINION: Generic drug liability issue needs action

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The Alabama Supreme Court's ruling in Wyeth Inc. v. Weeks that says brand name drug makers can be held liable for injuries caused by drugs produced by generic manufacturers presents a quandary. In the case, a patient who had taken only generic forms of the heartburn drug Reglan and developed a muscular disorder, sued the brand name manufacturer, contending Wyeth had a duty to warn the physician treating Danny Weeks and his wife about the risks associated with the drug's long-term use.

Litigation against generic drug manufacturers, though, is pre-empted by the U.S. Supreme Court's 2011 ruling in PLIVA Inc. v. Mensing, in which the high court held generic drug makers cannot be held liable in these cases because they are required to use a warning label identical to what's approved for the brand name manufacturer.

This left the Alabama Supreme Court with the unpalatable choice between finding the brand name manufacturer liable, or leaving Mr. and Ms. Weeks without any possibility of compensation for their suffering. The court chose the latter, although it remains one of only a handful of courts to rule this way.

We are left with a situation, on one hand, in which brand name manufacturers are not only being found liable for the harm caused by a drug they never made, but in many cases they are losing profits to the generic drug makers. On the other hand, they were the ones to develop the allegedly dangerous drug to begin with. And it seems only fair that patients who suffer from this terrible condition should have some recourse.

What to do? Fortunately, just as this is not a black-or-white issue, a black-or-white solution is not necessarily called for. In other words, it seems only right that the brand name and generic drug manufacturers should contribute to a solution in cases where it can be established their drugs caused harm.

This is an issue that Congress should address, perhaps by developing some sort of formula, under which the brand name and generic drug makers each assume some liability.

Only then, we believe, can justice truly be served.