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Loophole Leaves Patients Who Take Generic Drugs With Limited Legal Options

By Mark Ackerman

FREDERICK, Colo. (CBS4) - Jennifer Fisher didn't think twice about taking a generic medication instead of the brand name. She said her insurance preferred the generic, "because it was cheaper."

But the Colorado woman would soon learn that generic drugs aren't viewed the same way as brand name drugs by the legal system. If patients are harmed by a generic, they have little or no recourse in a court of law.

Fisher learned that after her son, Benjamin, who is now 3 years old, was born with a closed heart valve.

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Jennifer Fisher with Benjamin (credit: CBS)

"He looks like a normal boy, but his heart is far from normal," she said.

Four hours after Benjamin was born he had emergency surgery to help open the valve. At six months he had a second surgery to open the valve further.

His mother was devastated to learn the condition may be connected to a drug she took for morning sickness. When Fisher was pregnant she took Ondansetron, the generic equivalent of Zofran, to treat her morning sickness. Both drugs are approved by the Food and Drug Administration to treat nausea in chemotherapy patients, but they had never been approved for use in pregnant women, but such use was common at the time.

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(credit: CBS)

Attorney Kimberly Dougherty represents clients who have been affected by both drugs. She says only those who took the brand name have a reasonable chance of winning a lawsuit against the manufacturer. She says most people are unaware that if they take a generic and something goes wrong, they are legally out of luck.

"People who took the generic drug have absolutely no recourse against the generic drug manufacturer," said Dougherty.

That means even though recent studies have linked Zofran to an increased risk of birth defects including heart problems and cleft palate, the manufacturer of the identical generic drug is legally immune.

The same is true for any generic medication.

Benjamin Fisher
Benjamin Fisher (credit: CBS)

The idea that little can be done legally about Benjamin's suffering makes his father, Robert, angry.

"They are profiting off Zofran's success," he said. "Because they have a loophole, they are protected, they are above reproach."

That's why he's hoping their story will convince a judge that brand manufacturers should be held responsible for their generic copies, which is an argument that has been successful in a limited number of states.

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(credit: CBS)

The maker of Zofran, GlaxoSmithKline, takes no responsibility for the generic drug. As for the lawsuits against Zofran, the company said:

"GSK supports having a multi-district litigation (MDL) process in place under the facts and circumstances of these cases, with a goal of giving both plaintiffs and defendants an efficient process for handling the pre-trial issues. Litigation over prescription medicines, particularly when the alleged injuries have many causes, requires resolving complex scientific questions, understanding the benefit-risk balancing inherent to each medicine, and applying the intricacies of pharmaceutical products law. We believe the allegations in these lawsuits are entirely unfounded and that when the Federal District Court in Massachusetts looks into these issues it will be established that Zofran has proper labeling, was marketed appropriately, and did not cause the injuries alleged."

Doctors still prescribe both Zofran and the generic for morning sickness. The FDA proposed a rule change that would give patients more legal rights when they take generic drugs, but the drug industry is fighting it. A decision is expected early next year.

Mark Ackerman is a Special Projects Producer at CBS4. Follow him on Twitter @ackermanmark

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