Child Injuries

June 28, 2016

Did GlaxoSmithKline Use Pregnant Women as Guinea Pigs to Test the Effects of Zofran?

Having a baby is supposed to be a joyous time for new parents. Unfortunately, when a baby has birth defects, that joy is often replaced with sadness, fear, and anger. In some situations, birth defects are hereditary, but birth defects related to prescription drugs and physician error are increasingly common. Although compensation alone cannot heal your child, it may help you obtain the necessary care and treatment your child needs to have a healthy, normal life.

When we are ill, we usually go to the doctor. This is just as true for pregnant women. If a doctor prescribes a medication to help us feel better, we put our trust in this advice. After all, why would a physician prescribe medications that hurt us? Unfortunately, just as we rely on doctors for sound medical advice, they rely on pharmaceutical companies to provide safe medications. When drug companies fail to properly test new drugs, or fail to warn about risks associated with those drugs, they should be held accountable.

GSK Only Tested Zofran in Pregnant Animals

The drug Zofran is used to treat nausea in patients undergoing chemotherapy. Pregnancy-related nausea has plagued expectant mothers since the beginning of time. With Zofran, pharmaceutical giant GlaxoSmithKline claimed to have a solution to this problem. In addition to treating chemotherapy-related nausea, Zofran can also decrease the effects of morning sickness.

Zofran is a Category B Drug

Unfortunately, new lawsuits claim that GlaxoSmithKline never got proper FDA approval for the drug’s use in pregnant patients. It was classified as a Category B pregnancy drug, meaning it was only ever tested on pregnant animals. For this reason, use in pregnant patients is considered “off-label” use. Although doctors are allowed to prescribe medications for off-label use, pharmaceutical companies are not allowed to market them for these purposes. It seems as though GSK did not follow these guidelines.

New lawsuits allege that GSK was “using expectant mothers and their unborn children as human guinea pigs” to test Zofran. Unfortunately, Zofran use in pregnant women has been linked to several life-threatening and life-altering conditions, including orofacial and septal defects, congenital heart problems, kidney malformation, and even death. Following an investigation by the Department of Justice, GSK has pled guilty and agreed to pay $3 billion in fines and compensation. Continue reading

October 13, 2014

Paxil Birth Defect Lawsuit Is Sent Back to State Court

by Altman & Altman

The United States Court of Appeals for the Third Circuit has ordered that a drug defect lawsuit against GlaxoSmithKline LLC over its Paxil antidepressant medication be sent back to a state court. The three-judge panel ruled that the second removal to federal court was not timely. They said that Pennsylvania’s Eastern District Court made a mistake when it denied the plaintiffs motion to remand.

The Paxil birth defect lawsuit was brought by Sallee Miller and her child. They claim that the boy was born with congenital defects because Miller took the SSRI antidepressant while she was expecting. Because of this, she contends, her son was born with a ventricular septal defect and coarctation of the aorta.

Their dangerous drug complaint contends that GSK should have known these risks were involved with its drug but failed to warn about the birth defects. Miller said that she did not know such serious side effects could happen to her child from taking the medication.

June 27, 2014

Parents, Doctors Warn of Prescribing Adderall to Toddlers

by Altman & Altman

Attention Deficit Disorder, or ADD (ADHD in some children includes hyperactivity) generally becomes evident when children and young adults are in school and start to experience difficulties in class or concentrating on homework. Diagnosis and treatment of this complex disorder is extremely difficult, and there has been heated debate on the medications used to treat ADD and ADHD for as long as these drugs have been on the market. The strong steroid medications often produce a lengthy list of side effects that can significantly alter a child’s quality of life. Doctors must weigh the positive effects of the treatment with negative side effects before making the decision to prescribe the medication to children.

Children suffering from the symptoms of ADD/ADHD may:
• Be easily distracted, miss details, forget things, and frequently switch from one activity to another • Have difficulty focusing on one thing • Have trouble completing or turning in homework assignments, often losing things (e.g., pencils, toys, assignments) needed to complete tasks or activities • Have difficulty processing information as quickly and accurately as others • Talk nonstop • Have trouble sitting still during dinner, school, and story time • Blurt out inappropriate comments, show their emotions without restraint, and act without regard for consequences • Have difficulty waiting for things they want or waiting their turns in games (Source: National Institute of Mental Health)
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April 28, 2014

Lundbeck Pharmaceuticals Hit With Stevens Johnson Syndrome Lawsuit

by Altman & Altman

A Texas family has filed suit against the European drug company Lundbeck Pharmaceuticals for the injuries their son sustained after taking Onfi, an anti-seizure medication. The parents of the 11-year-old allege that the drug caused their son to develop Stevens Johnson Syndrome, a rare and extreme disorder of the skin and mucous membranes.

After developing SJS, the boy incurred serious skin and hair loss, as well as the loss of his fingernails. His parents, Madeline and Rogelio Escareno, said in the lawsuit that Onfi has caused their son to be permanently disfigured and traumatized, and are demanding that Lundbeck pay them compensation for the boy’s injuries.

DEFECTIVE MEDICATIONS AND DRUGS

Onfi (Clobazam) is an anti-seizure medication which falls into the category of drugs called benzodiazepines. Onfi is often prescribed with other medications to help prevent seizures associated with a severe form of epilepsy called Lennox-Gaustaut syndrome. The drug was approved by the FDA in October 2011, for treatment of patients aged 2 years and older. Since being approved, the medication has been prescribed to more than 30,000 patients in the United States. Sadly it has been linked to at least 20 reported cases of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis worldwide.

While the Escarenos’ son did not suffer from Lennox-Gaustaut syndrome, which the drug was specifically formulated to treat, he was prescribed Onfi for the off-label use to treat his epilepsy. However, shortly after beginning this treatment, the boy began developing severe skin lesions, causing skin to detach from various parts of his body including inside and outside of his mouth, throat, and genital areas. According the lawsuit, the condition eventually manifested into SJS’s deadlier and latent cousin, Toxic Epidermal Necrolysis.

Though badly injured, the boy was able to survive the disease after undergoing nearly a month of treatment at Fort Worth’s Cook Children’s Medical Center in March 2013. The proof of his injuries is still clear-the Escarenos say that their son is both physically and psychologically scarred. According to the Escarenos’ lawsuit, there were no warnings or indications printed on the drug’s label of the possibility of SJS or TEN developing from its use. The family said that had they known about those side effects, that they would never have put their son on the medication. In the lawsuit, it was confirmed that no warnings of SJS or TEN were available by March 2013, and that warnings were announced by the FDA in December 2013. In the lawsuit, the family accuses Lundbeck of knowing these warnings, and intentionally withholding the information to protect their profit margins.

Additionally, the family also alleged Lundbeck of illegally promoting Onfi for uses not approved by the FDA. Because the company had marketed the drug to treat a much broader range of epilepsy conditions, the Escarenos say that is why their son was prescribed the drug for off-label use. Doctors are permitted to prescribe medications for any reason deemed medically relevant, however it is illegal for drug companies to promote drugs for off-label uses.
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February 27, 2014

New Study Links Tylenol to ADHD in Kids

by Altman & Altman

According to a new study, the children of moms who took acetaminophen while pregnant may have a 40% greater risk of being diagnosed with attention deficit hyperactivity disorder than kids whose moms didn’t take the drug. Acetaminophen is found in Panadol, Tylenol, Excedrin, Midol, NyQuil, Alka Seltzer Plus Cold Medicine, and Theraflu. The findings were reported this month in the JAMA Pediatrics journal.

While a cause-effect link between Tylenol (and other meds with acetaminophen) and ADHD has been identified, it is not confirmed. That said, the findings should be noted and serve as a warning to pregnant moms to take the drug conservatively if at all. It is also a good idea for expectant mothers to consult with their doctors about taking any medication with acetaminophen. Injury from Tylenol can be reason for a Massachusetts drug defect lawsuit.

Acetaminophen also lowers fever, which his why a pregnant woman may take Tylenol. Infection and fever can be dangerous for the fetus. It is an endocrine disrupter that has been linked to undescended testes in baby boys. The authors of the study say there is a chance that acetaminophen may interrupt the development of the brain.