Brain Tumors, Big Pharma, And A Legal Escape Hatch
By Helen Santoro
October 7, 2025
It was early 2012 when doctors found a tumor in Kim Franzi’s brain.
It was a meningioma — a typically slow-growing, non-cancerous tumor that originates in a layer of tissue between the brain and skull. Franzi underwent a risky two-day brain surgery to remove the mass, which doctors warned could leave her paralyzed or prove fatal. The operation was successful, but more than 13 years later, she still suffers from side effects, including issues with her reflexes, teeth, hearing, and vision. Franzi considers herself one of the lucky ones.
“I was at work one day, the next day I was at the doctor, and my whole life changed,” said Franzi. “I just thought, who’s going to take care of my kids?”
Before discovering the tumor, Franzi used the birth control shot Depo-Provera for more than 15 years. The shot has been used by roughly one in four sexually active women in the United States, bringing in hundreds of millions in profits annually for the pharmaceutical behemoth Pfizer, which manufactures and distributes the drug.
But according to more than 1,200 lawsuits, Pfizer has failed to properly warn the public about long-established links between Depo-Provera and meningiomas. That includes a lawsuit submitted on Franzi’s behalf, plus more than 9,500 cases that have yet to be filed.
To avoid liability, Pfizer is leaning on a legal strategy called preemption, which asserts that federal law can override conflicting state laws. In this case, Pfizer is arguing that regulations and approvals issued by the Food and Drug Administration (FDA) render stronger state consumer warnings invalid. However, critics argue that Pfizer influenced the FDA’s decision-making process on the matter, potentially even manipulating a warning-label application to achieve the results the drugmaker preferred.
If Pfizer is successful in its use of preemption, this decision could further solidify a legal precedent that limits consumers’ ability to hold drug manufacturers accountable for inadequate warning labels. And as the Trump administration rolls back longstanding government protections, companies may have more legal ammunition than ever to argue that federal negligence preempts state safety rules.
This is not the first time that pharmaceutical manufacturers have tried — and succeeded — to get cases dismissed on the grounds of preemption.
In 2011, the Supreme Court ruled that safety lawsuits against generic drug manufacturers are preempted by federal law, since generic drugs must mirror brand-name labels and cannot independently change their warnings. Additionally, both Eli Lilly and Johnson & Johnson are using preemption to challenge lawsuits alleging they hid evidence suggesting their antipsychotic drugs cause breast cancer.
In cases like these, it’s common for pharmaceutical companies to try to use preemption as a knockout strategy against liability cases, said Mary Davis, dean of the University of Kentucky J. David Rosenberg College of Law.
“If preemption is successful, then there is no case,” Davis said. If the company has proof that they think establishes preemption, they’re “going to pursue that at the earliest possible opportunity.”
This August, Pfizer argued in the U.S. District Court in Florida that Depo-Provera lawsuits against the company should be dismissed on the basis of preemption. The drugmaker contended it cannot be sued under state laws for allegedly failing to warn patients about potential risks because of a 2024 FDA decision that rejected the company’s request to add a warning about meningiomas to Depo-Provera’s label.
The FDA said the data submitted did not indicate that such a warning was necessary, and Pfizer argued this decision effectively prevented them “from changing the Depo-Provera label,” according to a spokesperson.
However, critics contend that Pfizer laid the groundwork for the FDA to reject the warning label. While the company claims it provided regulators all relevant information during the decision-making process, “our argument is that Pfizer did not do so,” said Bryan Aylstock, an attorney at Aylstock, Witkin, Kreis, & Overholtz who is co-leading the Depo-Provera litigation. “They omitted a variety of scientific evidence,” including critical studies, when they applied for the label change, he alleged.
Pfizer did not respond to a request for comment.
Decades Of Research
Research on the relationship between meningiomas and synthetic progesterone — the main ingredient in Depo-Provera, which prevents ovulation and hinders sperm from reaching the eggs — is extensive.
In the 1930s, an American neurosurgeon noted…