Many people are coming forward with their stories and demanding accountability from Pfizer. You can join them.
A Brief History of Dilantin
A German chemist invented Dilantin in 1908. In 1923, an American pharmaceutical company, Parke-Davis, also created Dilantin. In the 1930s, Parke-Davis became aware that Dilantin could prevent seizures.
Through a few mergers and acquisitions over the years, Parke-Davis became part of Pfizer in 2000.
The first research showing Dilantin causes brain damage is from the 1930s, as this 1968 report mentions. Pfizer and its subsidiaries knew about the dangers of Dilantin for decades, yet they never warned the patients.
Understandably, many patients injured by Dilantin were angry when they learned this. Dilantin patients have been winning major lawsuit verdicts and settlements since the 1990s.
Overview of Dilantin Research Findings
Dilantin is unusual for two reasons: the number of conditions it can treat and the number of severe side effects related to its use. Here, we will focus on brain damage and serious skin conditions. Other major concerns with Dilantin include increased suicide risks and birth defects.
Terms for the type of brain damage caused by Dilantin include cerebellar degeneration, cerebellar ataxia, and cerebellar atrophy. We will stick with cerebellar atrophy or brain damage to avoid confusion. We mention here these other terms because you will see them in the linked research material.
Saying that Dilantin can cause serious skin conditions is an incredible understatement. Dilantin is associated with Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These are both painful and deadly conditions.
The Mayo Clinic provides a great description of these conditions that, for some people, occur almost immediately after starting Dilantin. Hospitalization is a necessity as the treatment is similar to that provided in a burn center.
Dilantin and Cerebellar Atrophy
The connection between Dilantin and cerebellar atrophy has been the subject of debate among medical professionals since at least 1968. In their report, these researchers from the University of Iowa cited studies going back to 1930 — a time before the FDA approved Dilantin as a seizure medication. For the sake of brevity, we’ll limit our discussion to the last thirty years.
In 1989, doctors reported on a patient who attempted suicide by taking 7 grams of Dilantin. Since the normal dosage is 300 mg per day, this patient took over three weeks of Dilantin doses at once.
In their report, the doctors stated they had performed CAT scans four weeks after the suicide attempt and again one year later. The patient’s brain damage improved over time, but at 18 months, he was still not back to normal.
This report shows that even a single case of severe Dilantin intoxication is enough to cause long-lasting brain damage. This report raised the question about how long-term use of Dilantin affects the brain.
In 1994, the Archives of Neurology published the results of a test where researchers studied 36 patients with focal seizures. Doctors were treating these patients with Dilantin. The researchers examined their brains using MRI machines. Focal seizures, also known as partial epilepsy, are no longer treated by Dilantin.
The researchers chose these patients with partial epilepsy as their seizures are far less severe than other epilepsy patients. The idea was to determine if the seizures themselves or Dilantin caused the cerebellar atrophy. With less severe seizures, it was less likely the seizures caused the brain damage.
These researchers concluded that cerebellar atrophy was common in the patients, but weren’t sure whether the seizures caused the damage or Dilantin caused the damage.
In 2000, the results of a study in Portugal of 66 patients showed the following degrees of atrophy:
- 33 of the 66 had no cerebellar atrophy
- 15 of the 66 had mild atrophy
- 18 of the 66 had moderate-to-severe atrophy
The researchers concluded that cerebellar atrophy could occur with an overdose or through long-term use. They noted that the most severe cases were among the patients who had used Dilantin the longest.
This 2012 report from the FDA mentions rare reported cases of cerebellar atrophy. The FDA’s 31-page report on Dilantin in 2016 featured cerebellar atrophy more prominently and only irreversible cerebellar atrophy was rare in that report.
It was no longer considered rare in 2017 when the British medical journal, Seizure, reported evidence that 40% of Dilantin patients were showing signs of cerebellar ataxia (uncoordinated muscle movement), which is a sign of cerebellar atrophy. Again, let’s just call it what it is — brain damage.
Dilantin Induced SJS and TEN
In its update of warnings on Dilantin in 2012, the FDA gave Serious Dermatologic Reactions its own section. This section includes SJS and TEN warnings. See the pictures in this article from the International Medical Case Reports Journal in 2017 to get an idea of the severity of these conditions. Before looking at this article, consider that the pictures are grotesque, and the effect is indistinguishable from that of burn victims.
SJS or TEN usually occurs within 28 days of beginning Dilantin treatment. That’s far different from the incidents of severe and irreversible cerebellar atrophy that may take years unless there’s an overdose.
Patients who suffered and survived SJS and TEN are not happy about it. Patients with irreversible brain damage are similarly unhappy. Many of these patients have lost patience with the pharmaceutical companies selling Dilantin. The ones that were never warned about the risks are especially angry.
If you are one of these people, Join the Many who are doing something about it. You won’t only be helping yourself and loved ones. You will also help deter pharmaceutical companies from pursuing profits without regard for the well-being of their patients in the future.
History of the Dilantin Lawsuits
Though there’s a longer history of research on brain damage caused by Dilantin, lawsuits against the drug makers for cerebellar atrophy are relatively new.
There are many ongoing cases against the pharmaceutical companies for SJS/TEN and brain damage. Here, we will list some of the major jury verdicts for SJS/TEN cases before going into a special section for brain damage litigation.
In 1998, a jury in Massachusetts awarded a woman who had TEN over 90% of her body $140 million. She never completely recovered as TEN left her blind.
There were a pair of interesting cases in 2010. A jury awarded the estate of a patient who died from SJS less than a month after the patient started taking Dilantin $4 million. The other was a $10 million award for an SJS patient who also had cerebellar atrophy. As of 2018, there were over 120 pending SJS/TEN lawsuits across the US.
When Pfizer saw that going to trial with the SJS/TEN cases was too expensive, they changed their strategy to one of settling these cases. For example, in 2010, they settled a case where a nine-year-old girl had died from SJS for $3.78 million.
Legal Basis for the Lawsuits
Whether the lawsuits are for brain damage or SJS/TEN, they’re lawsuits based on a defective drug. This means they fall in the area of the law called products liability. Product liability cases are usually strict liability cases.
Strict liability means the plaintiff doesn’t have to prove careless, recklessness, or fault. If the defendant made a product that harmed the plaintiff, that’s enough for the defendant to owe the plaintiff money.
Even with strict liability, it’s better to have more, though. Plaintiffs need to prove there was some defect in the product or the product’s design. It’s much better if the plaintiff can prove the defendant knew of the danger and didn’t adequately warn the plaintiff.
That FDA warnings didn’t come out for SJS/TEN and cerebellar atrophy until 2012 and 2016 respectively means Pfizer failed to adequately warn patients before those dates.
That these warnings were on the FDA labels doesn’t mean the drug maker couldn’t have warned the patients earlier. They had known about the risk of SJS/TEN since at least the 1990s. As we pointed out in the research section, there was a paper from 1968 that referenced reports as early as 1930 about the connection between Dilantin and cerebellar atrophy.
Why didn’t Pfizer warn patients about these risks without waiting for the FDA? The probable answer is simple. Mentioning these issues hurts drug sales. With fewer drug sales, the drug makers have smaller profits. Their profits were more important than their patients’ lives.
The drug companies were right. As soon as the public learned of the risks of taking Dilantin, its sales dropped off. See the graph in this ClinCalc.com report. Dilantin sales in 2020 were roughly a third of what they were in 2013.
The Cerebellar Atrophy Lawsuits
There are ongoing lawsuits around the nation based on cerebellar atrophy caused by Dilantin. These cases aren’t class action lawsuits. Instead, they’re being brought one at a time. Pfizer is eager to settle. But the settlement amounts aren’t publically available.
In Billy Dennis, et al., v. Pfizer Inc., et al., the defendants settled 81 individual cases brought in 2018 after three years of litigation. We don’t know the settlement amount, but the judge issued an opinion that stressed that 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.
This settlement was in December 2021 when inflation had already risen to 7%. The amount needed to provide for 81 people throughout their lives, regardless of inflation, is an incredible amount of money. It’s important to know that the lead plaintiff in this settlement was a minor, so the money would need to last around 60-80 years.
In other cases where public information is available, the only times Pfizer has been successful was when a judge dismissed a case for expiration of the statute of limitations.
In a California case, the plaintiffs kept the case in state court by joining a single defendant that was based in California. It’s rare for plaintiffs to keep a case in state court in these situations, where the defendant wants the case in federal court. Pfizer and its subsidiaries and partners aren’t even able to win on the easy issues.
Should You Join the Many Against Dilantin?
It’s clear that Pfizer is eager to disentangle itself from Dilantin lawsuits brought against it across the nation. It needs to settle. Should you get in on seeking compensation from Pfizer for injuries related to Dilantin?
Research shows that Pfizer knew about potential brain damage caused by Dilantin as far back as 1930. Pfizer’s subsidiary, Parke-Davis, has controlled the distribution of Dilantin in the US since 1923. Pfizer has been losing court cases related to SJS/TEN since at least the 1990s. They’ve known about the risks of cerebellar atrophy and SJS/TEN for several decades, but they didn’t start warning you of the dangers until the last ten years.
You have the right to compensation from Pfizer and its affiliated companies if Dilantin harmed you. These compensatory damages cover items like medical bills and lost income. They also cover non-economic damages like pain and suffering.