Generic Drug Legal Loophole Puts Patients At Risk: Morning Sickness Pill Linked to Birth Defects

In most cases, patients are required by their insurance companies to take cheaper, generic versions of prescription drugs if and when they are available. But an I-Team investigative report by CBS discovered there is an unsafe drawback to these medicines that both doctors and pharmacists don’t want patients to know about. One local family is speaking out in the hopes that their story will create change for a legal loophole that’s putting numerous patients at risk.

According to CBS Boston, Foxboro resident Alisa Steele gave birth to her daughter, Rowan, last November. Rowan was delivered more than two months prematurely and diagnosed with a congenial heart defect; a condition that Alisa was devastated to learn was most likely caused by her use of a generic version of the prescription morning sickness pill, Zofran, called Ondansetron. The drugs are currently approved by the FDA to treat nausea in cancer patients receiving chemotherapy and radiation treatments, as well as post-operative nausea. Never have either Zofran or its generic form, Ondansetron, been tested on or approved for use in pregnant women yet they are both readily prescribed off-label to treat severe morning sickness.

Kimberly Dougherty, a Boston attorney, says she’s seen countless injuries caused by generic drugs. The problem is, according to the current law, only patients who were injured after taking the brand name drug are allowed to sue 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,” Dougherty said. In light of the numerous reports linking generic drugs to injury, the FDA proposed a rule change that would also give patients more legal rights when they take generic drugs, though the drug industry continues to fight it. A decision is expected early next year.

Birth Defects and Prescription Zofran

Birth defects caused by Zofran cover a large scope and most notably include heart defects, heart failure and cleft palate defects. In an earlier post by Altman & Altman, we discussed Zofran’s pregnancy safety rating, which it purportedly received a rating of “Pregnancy Category B,” meaning that animal testing of this drug did not produce any concrete evidence that it would later become harmful in subjects who are pregnant. The ongoing influx of information about birth defect potential suggests that perhaps the rating could even go so far as being classified as “Pregnancy Category X” which would explicitly state that Zofran should not be used by women who are pregnant or may become pregnant.

Consumers should always be aware of the potential side effects of taking prescription medication, and it is critical to receive proper medical advice before taking this product while pregnant. However, for some women, warnings have come too late; or perhaps your doctor failed to properly inform you of or evaluate you for the potential harmful effects of the drug on your pregnancy.

At the law firm of Altman & Altman LLP, our seasoned Personal Injury Lawyers fully understand that illness and injury result in more than simply physical effects. Along with long-term health and quality-of-life consequences, raising a child with birth defects can be incredibly stressful and expensive for an individual and his or her family—with expenses including surgery, at-home care and transportation assistance. Financial recovery may be crucial to ensure you the healthiest and highest quality of life for you and your child.

If you believe your child has suffered birth defects as the result of a prescription medication you took during pregnancy, contact one of our personal injury attorneys who is experienced in medical malpractice mass tort litigation. Our team will aggressively advocate on your behalf, working closely with the finest medical experts in the Commonwealth to ensure that you have a strong case and receive the settlement you are entitled to. Contact our office for a free initial consultation. If you are injured and unable to come into our office, our attorneys are available to meet at your home or elsewhere. We are available around the clock, 7 days a week to answer all of your questions and concerns.


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