Zofran (ondansetron) and its dissolvable sister drug Zuplenz are drugs originally developed to treat nausea in cancer patients. GlaxoSmithKline, the drug company responsible for Zofran, in an effort to capitalize on another segment of the market, encouraged the prescription of this medication for nausea in pregnant women.

However, this usage was not approved by the Food and Drug Administration (FDA), and serious side effects have come to light. Off-label use of Zofran has been connected to several types of birth defects, most commonly: Craniosynotosis (premature fusing of bones in the skull), heart defects, club foot, and cleft lip/palate. Babies born with these conditions can require extensive medical treatment and endure a great deal of suffering. Many of those affected have successfully pursued legal action in order to hold the drug companies responsible.

If the child of you or your loved one was born with a birth defect, and Zofran was taken during the pregnancy, the child and its family may be entitled to compensation. Contact our dedicated legal team at Iannella & Mummolo to learn more.

  • An inferior vena cava (IVC) filter is a small cage-like medical device that can be inserted by doctors to stop dangerous blood clots from traveling to the blood vessels of the lungs. Their structure allows them to catch fragments of clots that form in the legs or pelvis before these blockages run the risk of causing a pulmonary embolism (PE). These metal filters are surgically implanted in patients who cannot tolerate blood thinners or have seen little success with those drugs.

  • Ketek (telithromycin) is a ketolide antibiotic to enter clinical use. It is used to treat community acquired pneumonia of mild to moderate severity.

    Ketolides are a developing type of antibiotic that are designed to be more potent and capable of working against resistant bacteria. They are targeted to improve upon traditionally marketed antibiotics and make up for some of their limitations.

    Originally, this medication was also approved by the FDA to treat some lesser bacterial infections, but after some serious risks came to light, it was determined the the pros no longer outweighed the cons in terms of those less severe conditions.

  • Menactra is a vaccine approved for the prevention of meningitis. Meningitis is a disease in which the protective membranes covering the brain and spinal cord, known collectively as the meninges, become inflamed. It can be very serious and even deadly. Though meningitis is relatively rare, it can be devastating and doctors recommend that those at particular risk be vaccinated.

  • Mifeprex (mifepristone), also known as RU-486, is a pharmaceutical drug primarily used as an abortifacient in the first months of pregnancy, and in smaller doses as an emergency contraceptive.

    Though it is generally considered a safe drug, a number of young women who took this drug for its intended use died from unforeseen side effects.These cases involved otherwise healthy young women who contracted a Clostridium sordellii bacterial infection. In each case, the women became very ill within days of their medical abortion and died of toxic shock syndrome related to the infection.

  • Mirapex (pramipexole) is a drug prescribed for Parkinson's patients and those with Restless Legs Syndrome. It works by interacting with dopamine receptors in the brain to help control the symptoms of these conditions. It has also been tested for use with other illnesses that stem from dopamine receptor issues, including bipolar depression.

  • Morcellation surgical tools are used to during laparoscopic gynecological surgeries to remove tissue. However, it was discovered that these tools are capable of spreading cancerous cells in patients who have an undetected form of cancer. Spreading cancerous cells to other areas of a patient’s body can reduce the patient’s chances of surviving a fight against cancer.

    In July, 2014, the market leader of morcellators issued a worldwide recall. Additionally, the FDA discouraged health care providers from using morcellators during gynecological procedures such as hysterectomy, myomectomy, or any other gynecological surgery.

  • Natrecor (nesiritide) is a drug for heart failure that is typically administered intravenously in a hospital setting when a patient comes in exhibiting symptoms. The medication dilates blood vessels, reduces stress on the heart, and relieves such frightening symptoms as shortness of breath.

    However, some researchers have challenged the safety of this drugs. Study results have been conflicting, but some data have shown the this medicine could raise mortality rates of patients withing one to two months of treatment. Reports have shown increased risk of kidney failure, among other problems.

  • Neurontin (gabapentin) is a drug used primarily in the treatment of seizures and nerve-based (neuropathic) pain. It is also prescribed by doctors for a variety of off-label uses such as anxiety disorders and bipolar disorder.

    While there is anecdotal evidence to show that Neurontin may help with these conditions, little research has been done into the scientific basis of such claims, let alone the potential side effects from this powerful medication being prescribed for non-approved uses.

  • Neutrospec is an imaging agent that was formerly approved by the Food and Drug Administration (FDA) and used to diagnose appendicitis.

    After reports of life-threatening adverse events and even a small number of deaths, the makers of Neutrospec gave in to pressures to withdraw this product from the market. It was deemed unsafe after it was determined to be related to a number of serious side effects. This decision was also made in light of the fact that there are other means to diagnose appendicitis that do not carry such serious risks.

  • Ortho Evra is a birth control patch approved for use in the United States as an alternative to 'the pill'. It is applied to the skin and releases synthetic estrogen and progestin hormones to prevent pregnancy.

    However, this method of birth control has been associated with an especially high risk of blood clots. This is true even in populations thought to be at lower risk for such events. A number of women in their late teens and early twenties have died from blood clots or survived life-threatening strokes and other clot-related problems after being prescribed Ortho Evra.