I-Team: Generic Drug Legal Loophole Puts Patients At Risk
BOSTON (CBS) - Most insurance companies require us to take cheaper, generic drugs when they are available, but the I-Team discovered a major drawback to these medicines that doctors and pharmacists don't warn their patients about. If patients are harmed by the drugs, they have little or no recourse in a court of law. The Steele family of Foxboro is hoping their story will help make a meaningful change for thousands of Massachusetts residents who take generic drugs.
Rowan Steele was born last November, two-and-a-half months early. But that wasn't the biggest hurdle she would face. She had a congenital heart defect; a condition her mother was devastated to learn may be connected to a drug she took for morning sickness. "It will be with me for the rest of my life that I made that choice, because look what it did to her," a teary Alisa Steele said.
Alisa took Ondansetron, the generic form of Zofran. The drugs are chemically identical and are approved by the FDA to treat nausea in cancer patients receiving chemotherapy and radiation treatments. It's also used for post-operative nausea. The drugs have never been tested on or approved for use in pregnant women but are commonly prescribed off-label to treat severe morning sickness.
Boston attorney Kimberly Dougherty believes the drugs can be dangerous. "We've seen horrible amounts of different types of injuries," she said. Dougherty has clients who have been affected by both drugs, but only those who took the brand name, Zofran, are allowed to file suit against the manufacturer. "The current law does not allow generic manufacturers to be held liable when their drug injures someone. That means that even though several recent studies have linked Zofran to an increased risk of birth defects, including heart problems and cleft palate, them manufacturer of the identical drug cannot be touched in court.
This is not just about Zofran, the same is true for any generic.
The idea that Rowan's suffering doesn't matter to our legal system makes Alisa angry. That's why she's hoping their story will help Dougherty convince a judge that brand manufacturers should be held responsible for their generic copies. It is an argument that has worked in other states. "It's called innovator liability. California and Vermont allow for the brand to be held responsible in those cases," Doughtery explained.
The maker of Zofran, GlaxoSmithKline, takes no responsibility for the generic drug. As for the lawsuits against Zofran, the company told the I-Team:
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 Zofran and its generic, but the drugs are not the first line of treatment.
The FDA proposed a rule change that would also give patients more legal rights when they take generic drugs, but the drug industry is fighting it. A decision is expected early next year.