Dilantin Lawsuit

phenytoin

Dilantin is the brand name for phenytoin (PHT). Patients have used this drug for over a century. Since the middle of the 20th century, it has been one of the primary anti-epilepsy drugs (AED). Despite many studies showing the dangers of Dilantin, it’s still the 260th most popular drug sold in the US.

While Dilantin is an important tool for doctors fighting seizures, research over the past 35 years has continuously shown Dilantin to be a very dangerous drug. It should be a drug of last resort when nothing else works. 

It’s relatively common for long-term Dilantin patients to suffer from cerebellar atrophy, a type of brain damage. Dilantin is also associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). In a single case in Massachusetts, a jury awarded a Dilantin patient with SJS $140 million.

Since 2013, the Food and Drug Administration (FDA) has been adding to Dilantin’s warning labels to highlight recent research. As evidence mounts that Dilantin carries serious risk, victims are coming forward to hold Pfizer, its maker, accountable.

History of Dilantin

History of Dilantin

In 1908, Heinrich Biltz was the first to create Dilantin. It is a barbiturate derivative. He was looking for a drug to prevent seizures during electric shock therapy.

In 1923, Parke-Davis, an American pharmaceutical company, experimented with Dilantin. But they set it aside since it didn’t have the sedative effect they were looking for. In 1936, Parke-Davis discovered Dilantin’s anti-seizure properties. 

In 1939, the FDA approved Dilantin to treat seizures. Its advantage over other anti-seizure medications of the time was that it lacked their sedative effects. That meant patients could enjoy more normal lives.

In 1976, Warner-Lambert bought Parke-Davis. In 2000, Pfizer purchased Warner-Lambert. Today, Pfizer is the primary company behind Dilantin, but it’s manufactured and/or marketed by many companies around the world. 

Today, Dilantin is still on the World Health Organization (WHO) Model List of Essential Medicines. But its popularity in the US has been declining for several years as new evidence of its dangers becomes known.

Conditions Treated With Dilantin

Dilantin is available only by prescription. Though new safer drugs are now on the market, Dilantin is still used to treat tonic-clonic seizures and sometimes focal seizures. Dilantin is not used to treat absence seizures. Tonic-clonic seizures, also known as grand mal seizures, are what most people consider a seizure. 

Focal seizures, also known as temporal lobe seizures, are very different and much less noticeable.There may be lip smacking and unusual finger movements. The patient may experience unexplained euphoria.

PHT, in its intravenous form, goes by another brand name, Fosphenytoin. Only hospitals use this form of PHT. Doctors use it to treat status epilepticus if other drugs are unsuccessful. 

Status epilepticus is when a seizure lasts longer than five minutes or there are repetitive seizures occurring without the patient regaining conscious. It’s an extremely dangerous condition that doctors must stop by any means necessary.

Just because you’ve never had a seizure doesn’t mean you have not used Dilantin. It’s sometimes prescribed to fight a broad range of conditions, including irregular heartbeat. Doctors have recently tested it as a breast cancer drug

How Does Dilantin Work?

Sodium channels in the nervous system conduct electricity. These electrical impulses can cause neurotransmitters to fire more often than normal. This higher than normal activity in the neurotransmitters causes seizures.

Dilantin is part of a class of drugs called hydantoin. These drugs slow activity in the sodium channels. This is how they prevent seizures. Dilantin is the oldest hydantoin. 

How Effective Is Dilantin?

Dilantin is a very effective drug. Otherwise, it wouldn’t still be available considering the many dangerous side effects. But there are other drugs that are similarly effective with far fewer risks. 

Keppra (generic name: Levetiracetam) is similarly effective without the dangers of Dilantin. For this reason, many doctors are changing their patients’ Dilantin prescriptions to Keppra. Other drugs replacing Dilantin include:

  • Klonopin
  • Lamictal
  • Depakote
  • Neurontin
  • TEGretol
  • Vimpat

Side Effects and Precautions With Dilantin

If you count the number of side effects experienced by Dilantin patients and compare it to the number of side effects from other anti-seizure medications, Dilantin doesn’t look so bad. What sets Dilantin apart is how common the side effects are, along with the severity of the conditions these side effects indicate.

The following are the more common side effects of Dilantin, according to the Mayo Clinic:

  • Decreased coordination
  • Mental Confusion
  • Nervousness
  • Slurred speech
  • Difficult breathing
  • Trouble swallowing and/or speaking
  • Problems with muscle control or coordination

You’ll notice these symptoms are similar to cerebellar atrophy, cerebellar ataxia, or cerebellar degeneration. These terms essentially mean the same thing. An easier term to use is brain damage.

Long-term use of Dilantin is associated with irreversible cerebellar atrophy. One study shows an incredible 40% of patients who have used Dilantin long-term suffer from cerebellar atrophy. 

We know long-term use severely affects a high percentage of Dilantin patients. But there have also been severe reactions almost immediately upon taking Dilantin. We will go into these in more detail in a special section on the research findings below.

With other anti-seizure medications, doctors lessen the side effects by combining those medications with other drugs. With Dilantin, the side effects indicate underlying damage so severe that the only treatment is to discontinue Dilantin. Often, stopping Dilantin isn’t enough, as the damage is irreversible.

All Names Dilantin Goes By

Dilantin is the brand name for Phenytoin. As Phenytoin was first synthesized in 1908, it has had a lot of time to accumulate different names. Its primary brand names in North America include:

  • Dilantin
  • Dilantin-125
  • Dilantin Infatabs
  • Phenytek
  • Cerebyx
  • Dilantin-30 (Canada)

Overview of Dilantin Research Findings

Overview of Dilantin Research Findings

There’s a considerable body of research showing that Dilantin causes cerebellar atrophy (brain damage) and SJS/TEN. The research showing brain damage extends back as far as the 1930s, as shown in this 1968 report

Over the decades, the evidence of brain damage caused by Dilantin grew stronger. In fact, a 2017 study showed that 40% of Dilantin patients develop cerebellar atrophy. A smaller study in 2000 showed the number was closer to 50%.

Though much rarer, the evidence is also strong that Dilantin causes SJS and TEN.

FDA Warnings About Dilantin

FDA Warnings About Dilantin

There have been recalls of contaminated batches of Dilantin in the past. Those recalls are unrelated to the serious issues covered in this article. 

Dilantin is still on the market, but the FDA issued warnings about cerebellar atrophy in 2016. See Section 5.14 in the linked report. The FDA investigated Dilantin induced SJS/TEN as early as 2008. A warning related to Dilantin induced SJS/TEN has existed since at least 2012. See Section 5.3 in the linked report.

What Do Doctors Think of Dilantin?

What Do Doctors Think of Dilantin?

For several years now, doctors have been switching their patients to new safer drugs. You can see this trend by looking at the chart supplied by ClinCalc. Dilantin usage has decreased by over 60% since 2013.

Patients have commented on their doctors replacing Dilantin with other drugs since the mid-2000s. The Epilepsy Foundation’s Forum is full of comments on the changes. Mostly, patients are happier with the new safer replacement medications.

The consensus among doctors is not to use Dilantin as a first choice for seizure treatment.

Brief Lawsuit History of Dilantin

Brief Lawsuit History of Dilantin

There are many ongoing lawsuits against the makers of Dilantin for both cerebellar atrophy and SJS/TEN injuries. Patients filed most of the cerebellar atrophy lawsuits in the mid to late 2010s. The SJS/TEN lawsuits have been constant for the past 25-30 years.

The most notable case was in 1998 when a jury awarded $140 million to a Massachusetts woman who went blind after having TEN cover 90% of her body. 

There were several other multi-million dollar SJS/TEN verdicts before Pfizer changed its strategy toward settling cases instead of fighting through trial. Now, of the reported settlements, they still involve several million dollars but aren’t as high as the jury verdicts were.

There are no verdicts to report from the cerebellar atrophy cases and only one major settlement. Billy Dennis, et al., v. Pfizer Inc., et al. was a bulk settlement of 81 separate cases from across the nation. The plaintiffs filed most of these cases in 2018, and the parties announced the settlement in December 2021. 

Though there was no published amount in the Dennis v Pfizer case, the judge issued an opinion that noted “Even adjusting for inflation, the settlement amount will provide long-term financial security sufficient to fund the plaintiffs’ medical care and provide for other necessities throughout their lives.”

Consider that inflation was already 7% in December 2021 and that medical expenses are often extremely high for patients with brain damage. The total amount for these cases was probably far higher than any other case in the long history of Dilantin lawsuits.

The only known cases Pfizer has won against a plaintiff claiming SJS/TEN or cerebellar atrophy is where the statute of limitations expired before the plaintiff sued. If Dilantin has injured you and you fear the statute of limitations has expired, it’s critically important that you consult with an expert attorney.

Though statutes of limitations look simple, they are anything but. There are extremely complex technical issues with most statutes of limitations. Attorneys must determine when the statute of limitations started to run, what triggered the statute of limitations to run, and if any event stopped the statute of limitations. 

Dilantin’s makers have fought the cases along other procedural grounds such as claiming the plaintiff filed their case in the wrong court. They are attacking on a procedural basis because they don’t have any substantive defense.

Should You Join the Many Against Dilantin’s Makers? 

While they kept you in the dark about Dilantin’s dangers, Pfizer knew about those dangers for decades. The law requires companies to warn users about dangerous products. That Pfizer didn’t adequately warn the patients about dangers it had known about for decades is part of the basis of the many lawsuits against it.

If you believe Dilantin is responsible for your health issues, you may be entitled to a settlement. Join the Many and get the money you deserve. No amount is enough to make up for what has happened to you, but some justice can help make your life easier.

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