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Are Drug Companies Liable for Side Effects?

By Ephrat Livni, Esq. | Last updated on

Medications manufacturers may be liable for injuries from dangerous drug side effects. But there are limits on liability and not all manufacturers are made equal -- makers of generic drugs approved by the FDA can't be sued under state laws.

Still, if you are injured because a drug company, doctor, or pharmacist breached their duty to warn you about a drug's side effects, you do have recourse. A lawyer can help you figure out whom to sue.

Duty to Warn of Known Dangers

Manufacturers of medications must test their products and get approval from the government to release them to the public. When approved, drug makers must warn consumers of all known drug dangers.

But they are not liable for unknown dangers. In other words, you should not expect to have been warned of what no one could have told you.

That does not mean that the duty to warn ends with a drug's release, however. The duty is continual, and companies must disclose adverse effects as they become known over time.

Recently, for example, the FDA announced that certain diabetes medications could cause severe joint pain in patients a day or years after starting on the drugs. Patients are already suing the drug maker and the authorities continue to issue updates and recommendations to doctors as more becomes known about avoiding dangerous side effects from these medications.

Learned Intermediary Liability

Drug makers also don't have to warn you directly. They do it through learned intermediaries, the people who patients contact. The drug maker's duty to warn is satisfied by telling doctors and pharmacists about side effects.

These learned intermediaries may be liable if a patient is injured due to their negligence. They have a duty to understand the drugs they prescribe, warn of side effects, and be aware of known conditions in the patient that exacerbate adverse impacts.

Not Including Unique Patients

Note, however, that drug manufacturers are not responsible for extreme reactions from unusually susceptible people, meaning they need not anticipate every adverse possibility that could occur in every possible type of plaintiff.

Consult With Counsel

Many injury and products liability lawyers will consult with you for free and even take your case on contingency. If you believe you have an injury caused by a side effect of your medication, consult with counsel.

Someone may well be liable. But only a knowledgeable attorney who has heard the facts of your case can make that assessment.

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