This page is about Dilantin birth injuries which was the focus of mass tort litigation over 10 years ago. Active litigation involving Dilantin appears to have waned, with no new mass torts emerging related to the drug. We are unaware of lawyers handling Dilantin lawsuits in 2024.
What is Dilantin?
Phenytoin, popularly known as Dilantin, is a drug used to manage and prevent seizures. It is classified as an anti-epileptic and anticonvulsant drug that treats seizures and epilepsy by slowing down runaway brain impulses. It was the first the modern drug used to treat seizures and was approved by the FDA for treating seizures in 1953.
Since 1939, Pfizer, Pharmacia LLC (formerly Pharmacia Corporation), Parke, Davis & Company, and Warner-Lambert Company (and/or their predecessors) have been responsible for the design, development, manufacture, advertisement, and distribution of Dilantin (phenytoin), an anti-seizure medication.
Over the years, the global epilepsy market has grown into a multi-billion-dollar enterprise for pharmaceutical companies. These companies have generated hundreds of millions of dollars in sales from their blockbuster drug in recent years alone. Throughout the decades after its launch, Dilantin has been sold in billions of dollars worldwide.
Most of the lawsuits being filed against the manufacturers of Dilantin are associated with the development of SJS and TEN. This is not new – cases of SJS related to Dilantin use was reported as early as the 1930’s. SJS is estimated to affect 1,400 out of 1 million children and 900 out of 1 million adults. SJS and TEN are always caused by the use of drugs. Asian and African Americans are at greater risk.
Further medical studies in the 80s show an overwhelming correlation between Dilantin use and the development of SJS and TEN in adult and pediatric patients. This was widely publicized in many medical textbooks, which prominently displayed the high risk of developing SJS with continued use of Dilantin treatment. A study conducted in the 1980s also showed that most of the people who developed Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome were using phenytoin
It is estimated that 15 percent of all SJS cases are fatal. SJS is managed through good medical care, but like many diseases, the prognosis is much better when SJS is diagnosed sooner rather than later. This is why immediately discontinuing the administration of Dilantin for patients suffering from SJS is advised. If SJS is diagnosed and there is a delay in discontinuing Dilantin, there are also potential medical malpractice and product liability lawsuits.
Dilantin and Birth Injuries
Dilantin is a medication prescribed to treat epilepsy. If taken by a pregnant woman during the first trimester, it can increase the chance of the baby developing a combination of birth defects known as Fetal Hydantoin Syndrome. Dilantin can pass through the placenta to the developing fetus. This means the baby can get an even higher dose of the medication for the baby compared to what the mother is taking.
This can cause heart defects, cleft palate, growth deficiency, developmental delay, certain facial characteristics, genitourinary abnormalities, and other long term abnormalities. Dilantin can cross the placenta so that the developing fetus receives a higher dose of the medication than the mother. Despite the risks, controlling seizures during pregnancy is crucial, so women with epilepsy should consult with their neurologist and obstetrician before conception to determine the best treatment plan.
How risky is If a pregnant woman takes phenytoin during the first trimester – before many women even know that they are pregnant – there is a 5 to 10 percent chance that her baby could be born with a group of birth defects called Fetal Hydantoin Syndrome. Babies with this syndrome may have various health problems, including growth deficiency, developmental delay, heart defects, cleft palate, and a number of other abnormalities.
Despite these risks of phenytoin, it is crucial to control seizures during pregnancy. So it is tough issue. The key is for women with epilepsy who are planning to become pregnant to consult both their neurologist and obstetrician before conception. They need to discuss the appropriate treatment options to effectively manage seizures while being pregnant.
Cerebellar Atrophy and Dilantin
Cerebellar atrophy is a permanent and severe side effect of Dilantin that results in the deterioration and death of neurons in the cerebellum. There is no cure for Dilantin-induced cerebellar atrophy. The more exposure to Dilantin, the greater the risk.
This severe and permanent long term effect of Dilantin involves the deterioration and death of neurons in the cerebellum, which is responsible for coordination, balance, speech, cognition, and emotions. This process leads to the shrinking of the cerebellum and results in irreversible deficits in balance, speech, memory, and potentially even death.
This devastating disease impacts motor function, coordination, memory and speaking ability impactsimpacts motor function, coordination, memory and ability to speak. It is a process in which neurons (nerve cells) in the cerebellum – the area of the brain that controls coordination and balance – deteriorate and die.
The most characteristic symptom of cerebellar atrophy is a wide-based, unsteady, lurching walk, often accompanied by a back-and-forth tremor in the body’s trunk. Other symptoms include difficulty speaking and swallowing; slow, unsteady, and jerky movement of the arms or legs; slowed and slurred speech, and nystagmus.
Despite ample scientific literature (that has been around forever), internal adverse event reports, and safety signals linking Dilantin to cerebellar atrophy, the drug makers did not include any reference to this condition in the U.S. Dilantin label until December 2015. The label was changed only after Plaintiff’s counsel brought claims against Defendants on behalf of numerous individuals who had suffered similar catastrophic injuries, as Defendants did not make any changes to the label on their own initiative or through their own deficient internal product safety surveillance protocols.
There is now a good warning in place. But the Dilantin product labels was changed in foreign countries (including Australia, Germany, Switzerland, Sweden, New Zealand and others) to warn of cerebellar atrophy decades before changing the U.S. Dilantin label.
Symptoms of Stevens Johnson Syndrome/Toxic Epidermal Necrolysis
SJS/ TEN Symptoms
Stevens-Johnson Syndrome is a serious medical condition and if not diagnosed early could be fatal. The danger with SJS is that its early symptoms are very similar to the common flu. Patients suffering from SJS may be misdiagnosed until the first skin rashes and lesions appear.
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis often results from severe allergic reactions to drugs. Common drugs known to produce this effect are sulfa drugs, antibiotics and anti-epileptics. Prognosis depends on how early the medical condition is identified and treated. If drugs are suspected, in this case Dilantin, any delay in the withdrawal of the medication may result to the fast progression of the disease.
Other side effects related to Dilantin treatment also includes:
- Liver Damage
- Rash
- Hallucinations
- Irregular Heartbeat
- Decreased Blood Pressure
- Increased Blood Sugar
- Birth Defects
Settlements and Lawsuits
- In 2010, a woman who suffered from toxic epidermal necrolysis (TEN) from phenytoin was awarded $140 million by a Massachusetts jury. In addition, Pfizer was ordered to pay $10 million to a Dilantin patient suffering from Stevens-Johnson Syndrome (SJS) and cerebellar shrinkage in January 2010, and settled another Dilantin and SJS lawsuit for $4 million just 11 months later.
- In November 2010 Pfizer agreed to a $3.78 million settlement with the family of a nine-year-old girl who died less than one month after ingesting Dilantin.
- In 2008, a Dilantin case settled for $900,000. The patient had an allergic reaction to Ciprofloxacin that led to TEN and severe burns. This was a medical malpractice case.
- In 2018, ten individuals have filed a lawsuit against Pfizer Inc., claiming that the company and its subsidiaries, including Parke-Davis, Pharmacia, and Warner-Lambert, did not adequately warn about the potential risk of severe brain damage from taking the anti-seizure medication Dilantin. The plaintiffs alleged that Pfizer and its subsidiaries had knowledge of the risk of cerebellar atrophy, a motor function disease, as early as 2009, but only updated the warning label for Dilantin in the United States in 2016.
- In 2020, in Castro v. Pfizer, Inc., et al., the plaintiff sought damages for injuries allegedly caused by the generic drug Dilantin, which she claimed led to her developing Stevens-Johnson syndrome. After an automobile accident, Castro was prescribed Dilantin, which she filled with a generic version manufactured by Mylan, Inc. Her lawsuit included claims against Mylan for strict products liability, failure to warn, and breach of warranty, as well as medical malpractice claims against several medical providers. A New York trial court dismissed all claims against Mylan, citing federal law preemption, which protects generic drug manufacturers when the drug adheres to FDA-approved standards. The appellate court affirmed this dismissal, noting Castro had waived any objections to the timeliness of Mylan’s motion to dismiss by initially accepting it without protest. The case highlights the legal protections for generic drug manufacturers under federal law, which often preclude state law claims for product liability.
Please note this is posted for informational purposes. There is no Dilantin class action lawsuit pending. Our law firm is not handling these cases.