Instances of medical malpractice go beyond just the stereotypical scene of a surgeon forgetting to remove a sponge from a patient on the operating table. They also include doctors who negligently miss an important diagnosis that would help someone or even save their life and even defective medical equipment or drugs that end up doing more harm than good.
One example of a defective medicine that has caused countless people serious harm is Topamax. While it was approved by the Food and Drug Administration (FDA) as an anticonvulsant drug that could help treat epilepsy and severe headaches, including migraines, it was marketed illegally by its manufacturer and Johnson & Johnson subsidiary, Janssen Pharmaceuticals, as a weight loss treatment. Topamax was prescribed to numerous young and middle-aged women in the United States as a way to lose weight, even though it was not approved for such usage. This made it even more devastating when it was discovered that Topamax caused serious childbirth injuries to unborn babies, saddling young children with costly and debilitating medical conditions at the very outset of life.
The injuries that Topamax have brought on innocent people and children throughout the United States are exactly why the personal injury attorneys at the Maryland law office of Gilman & Bedigian strive to legally represent medical malpractice and products liability victims in court. By fighting for your rights to compensation, we can make you whole, once again, and can bring justice to the companies that have played recklessly with your well-being for their profit and gain.
Topamax, also known as Topiramate, is a pill that is designed to inhibit seizures and help people who suffer from epilepsy. It was originally conceived in 1979 by McNeil Pharmaceuticals, which then merged with Ortho Pharmaceutical in 1993 to create the conglomerate Ortho-McNeil Neurologics. This company has since joined with Janssen Pharmaceutica and become a subsidiary of the giant pharmaceutical company, Johnson & Johnson. Janssen now manufactures the drug, which has become one of the most popular ways for treating seizure problems and epilepsy.
In 1986, the research and development team at McNeil applied for an investigational new drug approval for Topamax at the FDA, starting the long process of a new and experimental new drug on the road to FDA approval, which happened at the end of 1996. Topamax was approved as and was first marketed as, a drug for epilepsy because of its ability to reduce the power and number of seizures that patients faced. Later clinical trials found that Topamax could also help people who suffered from migraines. Sales of Topamax peaked at $2.7 billion in 2008, just before the U.S. patent for Topamax expired on February 28, 2009, allowing generic replacements to hit the market and reduce the cost of the drug.
However, the ability of Topamax to help the people who took it to lose weight was long known to Johnson & Johnson. Despite the fact that the drug had only been approved for epilepsy and migraine treatment, Johnson & Johnson aggressively marketed the drug as a weight loss pill to pad its profits. The practice of marketing a drug for something that it has not been approved for – called “off-label” marketing – is illegal because it can put innocent patients at great risk. After all, the drug was only tested and approved by the FDA for its intended purpose – any off-label use is done without the benefit of FDA studies and clinical trials that are meant to ensure the drug is safe to take.
Intended Use of Topamax
The FDA approval and the off-label use of Topamax makes the intended use of the drug a tricky issue.
According to the FDA, Topamax should only be used for inhibiting seizures from epilepsy and for reducing the severity of migraines for people who suffer from them. When the FDA approved the use of Topamax, those were the only situations that were considered for the drug during its testing, so any other uses could create side-effects and other complications that were not revealed in the clinical testing that only considered its use for epilepsy and migraines.
When you ask Johnson & Johnson, however, there is both an official and an unofficial answer. The official answer on the intended use of Topamax is in line with what the FDA says about the drug: It is intended to be used for epilepsy treatment and migraines.
However, Johnson & Johnson has also had an unofficial use for Topamax: Weight loss. Because of the few weight loss drugs on the market, there was a niche that Topamax could fill easily and lucratively, and Johnson & Johnson took advantage of it. Knowing that Topamax had proven effective for getting patients to lose weight, but also understanding that the official FDA approval was only for Topamax's intended use for seizures, epilepsy, and migraine headaches, Johnson & Johnson marketed Topamax for off-label use as a weight-loss pill, despite the lack of testing by the FDA for such a purpose.
This unofficial intended use as an off-label weight loss pill has exacerbated the impact of the worst of Topamax's numerous side effects.
General Side Effects of Topamax
Topamax has a long list of potential side effects. For many people suffering from epilepsy or who have consistent problems with migraine headaches, many of these are worth the risk. However, for those who are taking the drug as an off-label pill meant for weight loss, some of these side-effects might be too considerable.
Side-effects of Topamax include:
- Difficulty concentrating or paying attention,
- Memory problems,
- Spells of confusion,
- Clumsiness or physical unsteadiness,
- Sharper mood changes, including aggression, depression, irritability, or apathy,
- Dulled senses or perceptions,
- Slower mental capacity or ability,
- General nervousness or agitation,
- Loss of appetite,
- Reddened, irritated, or even bleeding gums,
- A fever, chills, sore throat, or similar flu-like symptoms,
- Issues with speaking clearly,
- Prickly sensations like tingling or burning,
- Continuous eye movements,
- Slowed and weakened physical activity,
- Fatigue and drowsiness,
- Abdominal pain,
- Increased menstrual pain or other menstruation changes, and
- Vision problems, including blurred or even double vision.
In addition to this laundry list of side-effects, Topamax has also been found to be especially risky for patients who are pregnant, particularly in the early portion of their pregnancy. The impact of the drug on the developing fetus has been found to be the cause of serious birth defects, including a huge increase in the chance of a cleft palate or lip.
Topamax Side Effects That Cause Birth Injuries
While Topamax has a long list of potentially serious side-effects, by far the most severe is the increased risk that pregnant women face of giving birth to a child with a cleft palate or cleft lip.
In 2011, data from a medical report indicated that infants who were exposed to Topamax during the first trimester of their mother's pregnancy were 21.3 times more likely to have an oral cleft on birth than infants who were not exposed to Topamax. These clefts can range from minor splits in an infant's lip to a deep groove that runs from their lip, through their mouth, and even into their nose. These clefts can create problems with eating and speech development and can create ear problems, as well. They often require surgery to correct, something that is far more dangerous on newborns than it can be on adults.
Other reports compared the risk of birth defects from Topamax to the risk from other anti-seizure medication and found that Topamax was three times more likely than these other, similar drugs to create the birth defect.
None of these reports or the clinical trials that produced them, moreover, were beyond what Johnson & Johnson and Topamax manufacturer Janssen Pharmaceuticals could have done before pushing their drug as seizure and headache treatments. Additionally, the steep increase in the rates of oral clefts in newborns exposed to Topamax – over 21 times the likelihood of a non-exposed newborn – highlights the lack of care or interest that Johnson & Johnson and the manufacturer Janssen had in making sure Topamax was safe for its official intended use.
Off-Label Marketing of Topamax as Weight Loss Pill Makes Injuries Worse
However, these sharp increases in the chances of a birth injury with expectant mothers were only exacerbated by the fact that Topamax was marketed for off-label use as a weight loss pill. Even those who were not getting the primary seizure or headache benefit of Topamax were still putting their unborn children at severe risk of a significant birth injury. Worse, the Topamax exposure that damaged the developing fetus could happen as soon as the first trimester of the pregnancy, before women are even aware that they are carrying a child. This made it impossible for women to know that they were at risk of exposing their unborn child to Topamax and a potentially devastating childbirth injury.
Nevertheless, Johnson & Johnson's aggressive off-label marketing for Topamax recklessly put this dangerous drug in the hands of the people who were most likely to be at risk of suffering from a defective birth: Young and middle-aged women.
This kind of off-label marketing is illegal because it promotes a drug for uses that it was not clinically tested for and for which it was not approved by the FDA, increasing the likelihood of something going drastically wrong through side-effects or unforeseen medical complications. Nevertheless, Johnson & Johnson and its subsidiaries saw the potential profit in marketing their epilepsy drug as a weight loss pill and took the initiative.
Using their “Doctor-for-a-Day” program, which hired outside physicians to shadow and help sales representatives as they marketed Johnson & Johnson products to healthcare professionals, Johnson & Johnson pushed for the use of Topamax to help patients lose weight. This is illegal under the Federal False Claims Act, and Johnson & Johnson and its subsidiaries were caught by the Department of Justice after private citizens sued them to enforce the law in a qui tam lawsuit. In 2011, Johnson & Johnson and its subsidiaries pled guilty to a misdemeanor violation of the Act, which carried a criminal fine of $6.14 million. They also agreed to pay $75.37 million to resolve civil lawsuits that they promoted Topamax for use in weight loss problems.
Topamax Recall Based on Entirely Different Reason
Despite the substantial likelihood of a birth injury from taking Topamax, the drug has not been recalled for any health-related reason. Instead, the only recall that Topamax has gone through was back in April 2011, when the Johnson & Johnson subsidiaries behind the manufacture and marketing of the drug issued a recall that impacted 57,000 bottles of Topamax. The bottles, when opened, had a musty smell that raised concerns about the drug enough to warrant a limited recall. The source of the smell was likely trace amounts of the chemical 2,4,6 tribromoanisole which, while it has not been linked to any serious medical condition, should nevertheless raise concerns about the safety of the drugs. Only Topamax bottles that were shipped between October 19, 2010, and December 28, 2010, were affected.
Maryland Medical Malpractice and Birth Injury Attorneys at Gilman & Bedigian
Medical malpractice issues are often the results of doctors or other healthcare professionals acting negligently and making a mistake. However, they can also be caused by drug manufacturers like Johnson & Johnson recklessly or even deliberately putting innocent patients at risk so they can maximize their profit selling their medicine and drugs. That was the case, in the situation surrounding the Topamax drug. Now, innocent newborn babies are left severely hurt and in need of costly and dangerous medical attention to fix the problems that Topamax caused, and which could not have been avoided by anyone.
If you have been impacted by the adverse complications associated with the drug Topamax and want to get the compensation that you need and deserve to overcome this setback, call the law office of Gilman & Bedigian at (800) 529-6162 or contact us online for a free consultation.