Several plaintiffs have filed lawsuits against Pfizer Inc. and other pharmaceutical companies in California, alleging that an injectable form of birth control causes or contributes to a higher risk of developing brain tumors.
In the most recent case, plaintiff Taylor Devorak, a Crestline resident, alleges in a federal lawsuit filed Nov. 4 in the Central District of California that the drug Depo-Provera, the trade name for medroxyprogesterone acetate (MPA), caused or significantly contributed to Devorak’s intracranial meningioma, a type of brain tumor. The science behind the claims, however, is in dispute, with Pfizer noting that the prescription drug has gone through the Food and Drug Administration’s review process.
“Depo-Provera has been an FDA-approved medication for more than 30 years and has been a safe and effective treatment option for millions of patients during that time,” Pfizer said in a statement emailed to the Southern California Record. “The company will vigorously defend these lawsuits.”
Other defendants named in the lawsuit are Viatris Inc., Greenstone LLC, Prasco Labs, Pharmacia and Upjohn Co. LLC.
Several studies have shown that progesterone, progestin and Depo-Provera can increase the risk of developing intracranial meningioma, according to the lawsuit. But the risk has been characterized by the American College of Obstetricians and Gynecologists (ACOG) as five out of 10,000 for women who use the drug compared to one out of 10,000 for nonusers.
The Miller & Zois law firm, however, notes that this risk represents a 5.5-fold increase for users of Depo-Provera, which is given intramuscularly every three months.
Devorak began taking the injections in 2015 and continued doing so for about nine years, receiving a total of 36 injections, according to the lawsuit. She was diagnosed with a brain tumor earlier this year, the complaint states, after suffering from symptoms such as blurred vision. Such tumors can also lead to seizures, difficulty speaking and death, the complaint says.
“Defendants failed to warn, instruct, advise, educate or otherwise inform Depo-Provera users and prescribers about the risk of intracranial meningioma or the need for monitoring for resultant symptoms,” the lawsuit says.
The complaint points out that the U.S. label for Depo-Provera does not inform users of any increased risk of intracranial meningiomas, though the labels for the drug used in the United Kingdom and the European Union list meningioma in their “special warnings and precautions for use” section.
The label used in Canada for the drug also lists meningioma among its adverse reactions, according to the lawsuit.
The plaintiff is seeking compensatory and punitive damages in an amount to be calculated during a jury trial, general damages for physical pain and mental suffering, special damages including medical expenses and loss of earning power, and reasonable attorneys’ fees and court costs.
No class action lawsuits over Depo-Provera have been filed as yet, according to Miller & Zois, due to the relatively small number of claims that have been taken up. But the law firm suggested that more claims, potentially in the thousands, may eventually be filed and such cases could be consolidated into a unified proceeding through so-called multidistrict litigation (MDL), potentially in the federal court in the Central District of California, where four lawsuits over Depo-Provera have been filed.