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When the Supreme Court's Ruling is All Wrong: Generic Drugs and the Doctrine of Preemption

Imagine: You're ill. Your doctor has prescribed you a brand-name drug. You read the warning label and directions. You take the medication. All seems well. Soon, though, you begin to feel horrible. You are rushed to the hospital. Diagnosis: Adverse medication reaction. You are hospital ridden for weeks, missing family time and work. Worst of all, your kidneys are now failing. You bring a lawsuit to recover your damages. You prevail.

Now, let us change the hypothetical.

Imagine: You're ill. Your doctor has prescribed you a generic drug. You read the warning label and directions. You take the medication. All seems well. Soon, though, you begin to feel horrible. You are rushed to the hospital. Diagnosis: Adverse medication reaction. You are hospital ridden for weeks, missing family time and work. Worst of all, your kidneys are now failing. You bring a lawsuit to recover your damages. You do not prevail.

If you are perplexed and looking for a deviation that would lead to such disparate results, your confusion is thoroughly justified. The only difference in the above hypotheticals is that the patient in the first hypothetical took the brand-name drug while the patient in the second hypothetical took the genetic form of the same drug. It's a small difference, and it's a ridiculous difference, but it's the difference between whether you recover or not.

This absurd result stems from the Supreme Court's latest interpretation (and dare I say faulty interpretation) of a doctrine known as the doctrine of preemption. This doctrine holds that if there is a conflict between state and federal law, federal law trumps state law.

The latest and most horrific preemption case is Mutual Pharmaceutical Co. v. Bartlett. In this case, the plaintiff, Karen Bartlett, suffered from shoulder pain and was prescribed Clinoril, the brand-name version of a nonsteroidal anti-inflammatory drug known as sulindac. The pharmacist, however, provided Karen with the generic form of sulindac instead. As a result of taking this drug, Karen developed toxic epidermal necrolysis that caused her to be burned over the majority of her body, resulting in serious disfigurement, permanent disabilities, and almost complete blindness.

When Karen was prescribed sulindac, the label did not list toxic epidermal necrolysis as a risk. Karen then sued the generic drug manufacturer based on a design-defect claim. However, the federal law prohibited the generic manufacturer from changing it's label on it's own. As a result, the Court held that it was impossible for the generic drug manufacturer to comply with both it's federal law duty not to change the generic's label without there first being a change in the brand-name's label and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design. In other words, the state law was preempted by the federal law, leaving Karen, who suffered such horrific injuries, without a remedy.

Now, I am not a Supreme Court basher by any means. In fact, I'm a huge Ruth Bader Ginsburg fan (did you know she has her own ice cream flavor?). In this case, though, I cannot agree with the Court's decision. This absurd interpretation of preemption does nothing more than shield Big Pharm and cause endless harm to the consumer.

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