A Topamax lawsuit is being filed by a couple who grew up without knowing the drug caused serious side effects. The mother took the anti-seizure drug in 2005 and 2007 before becoming pregnant. But when she learned she was pregnant, she stopped taking the medication. The baby died shortly after being born. The couple filed a Topamax lawsuit in 2011.
Off-label uses of Topamax
Topamax is a drug that was approved by the FDA for certain conditions, including the treatment of epilepsy. But, the drug was also being sold for off-label uses. According to the US Department of Justice, manufacturers were paying doctors kickbacks to prescribe Topamax for unapproved uses. This illegal behavior has serious consequences for patients’ health. Read on to learn more about the lawsuit filed against Johnson & Johnson.
Some of the off-label uses of Topamax have not been approved by the FDA, but the drug has been used by people who suffer from alcoholism. Because it reduces alcohol cravings and helps people stop drinking alcohol, it is sometimes prescribed to people with this condition. Other off-label uses of Topamax include treating chronic low back pain and nerve pain. These uses aren’t approved by the FDA but may be worth exploring.
Illegal marketing of the drug
A new lawsuit filed against Ortho-McNeil Pharmaceuticals has revealed that the company unlawfully marketed Topamax for off-label uses. The company allegedly paid physicians to speak at its meetings and promote the drug for unapproved uses. In addition to paying doctors, the company made claims that were untrue and misleading to patients. The False Claims Act allows people with knowledge of fraud to file civil suits on behalf of the government.
A recent court ruling found that Ortho-McNeil Pharmaceuticals violated the Food, Drug, and Cosmetic Act by illegally marketing the drug for unapproved psychiatric uses. In addition to paying doctors to speak at meetings, the company also invited them to participate in a program in which outside physicians were paid to promote the drug. Several of these physicians were not doctors at all. As a result, patients who were prescribed Topamax were unaware of the drug’s unapproved uses.
Failure to warn of serious side effects
Many lawsuits filed against Janssen Pharmaceuticals, the makers of Topamax, are based on the drug’s failure to warn about the potential danger of the drug to humans. While the drug’s manufacturers have argued that the risks are unrelated, juries have concluded otherwise. In some cases, the drug can even cause suicidal thoughts. Many of the lawsuits allege that the drug’s failure to warn about these risks made Topamax unsafe for a pregnant woman. The companies were aware of the risks and failed to disclose them to the medical community.
While the initial prescribing information of Topamax did not list these life-threatening or serious side effects, the drug’s manufacturer has since mandated the inclusion of warnings on topiramate labels and medication guides. The warnings were first issued in 2004 and include a greater risk of hyperthermia and metabolic acidosis, two serious side effects that can cause injury or death.
Ortho-McNeil-Janssen Pharmaceuticals Inc. has agreed to pay more than $75 million in damages in a Topamax lawsuit. In addition to this, the company has agreed to pay a $6.1 million criminal fine. This settlement is because Ortho-McNeil-Janssen Pharmaceuticals LLC improperly promoted the drug for off-label uses. The company hired outside physicians to serve as sales representatives and speak at meetings and dinners.
In some cases, children may suffer serious complications due to the drug. One example is an incomplete fusion of the mouth area. This condition can lead to speech and eating difficulties. Treatment of this defect can be expensive and the parents should not be forced to shoulder the financial burden alone. Financial compensation for Topamax lawsuits is possible to help parents pay for their child’s medical bills and other expenses. Additionally, these lawsuits can help parents recover compensation for emotional distress and pain.