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FDA Rule Change Would Affect Liability of Generic Prescription Drug Manufacturers


The Food and Drug Administration recently proposed new rules to close a loophole in prescription drug regulations. Currently, companies that create generic drugs must follow labeling requirements to match the warning label used by the brand manufacturer whose drug they are copying. This can severely limit their liability for adverse reactions that patients experience while taking the drug. The new rule would aim to close that loophole.

Injured Patient Loses Case Against Generic Drug Manufacturer

A New Hampshire woman took the drug sulindac, a generic form of Clinoril, an anti-inflammatory drug, for shoulder pain. She suffered Stevens-Johnson syndrome, which left her disfigured and blinded. The drug warned of severe skin reactions, but not this particular condition. These drugs now require warnings for Stevens-Johnson syndrome.

The patient sued the generic drug manufacturer for damages and her case became the subject of a Supreme Court ruling. The Supreme Court ruled that the patient could not hold the generic drug manufacturer liable because it was bound by federal law to use the same formula and warning labels as the branded product.

How the New Rule Would Hold Generic Drug Manufacturers Liable for Damages

Generic drug manufacturers cannot alter the warning label unless they obtain approval to do so. The new rule would allow generic drug manufacturers to change labeling without getting approval if they become aware of new risks associated with the drug.

The rule change can strengthen patients’ rights to pursue compensation from the generic drug manufacturer for failure to warn of risks. If a patient is harmed by a generic drug then he or she would be able to hold the drug manufacturer liable for the damages suffered, which is currently not an option under current rules.

Legal Options after a Severe Drug Reaction

Patients harmed by branded prescription drugs may bring a product liability claim against the manufacturer. Manufacturers are strictly liable for the effects of their products and any defects in the design or manufacturing, or failure to warn about these defects.

This means that a defendant doesn’t have to prove the manufacturer was negligent, or failed to use reasonable care to prevent harm to others, to win a lawsuit against the manufacturer. Only that the patient’s condition is the result of taking the drug.

Injured patients may hold a medical professional liable under certain circumstances. This may be the case if the doctor or another professional negligently prescribes a medication that interferes with another medication the patient is taking. Under other circumstances, patients may hold a doctor liable for prescribing a medication that is unsafe to take given the patient’s current health status, such as during pregnancy or while breastfeeding.

Patients thinking about filing a product liability or medical malpractice lawsuit should contact an attorney. There can be many challenges to these cases, and an attorney can help injured patients present a case. Contact Hensley Legal Group at (317) 472-3333 to set up a free consultation and to speak with a lawyer about your case.