Depo Shot Brain Tumor Resulted in Need for Bifrontal Craniotomy: Lawsuit

A California woman has filed a product liability lawsuit against various pharmaceutical companies involved in the development and sale of Depo-Provera, as well as generic versions of the birth control shot, alleging that they failed to adequately warn that users may develop meningioma brain tumors.

The complaint (PDF) was brought by Kathleen Fazio in the U.S. District Court for the Central District of California on October 28, indicating that she continued to receive Depo shots even after undergoing a bifrontal craniotomy to remove the brain tumor, since her doctors had no idea the birth control injection had any connection to her meningioma.

Depo-Provera is a hormonal birth control shot that contains medroxyprogesterone acetate, a synthetic form of the hormone progesterone. It was approved by the U.S. Food and Drug Administration (FDA) in 1992, and has been advertised as a safe means of preventing pregnancy, by inhibiting ovulation, thickening cervical mucus to block sperm, and thinning the uterine lining to prevent a fertilized egg from implanting.

The injection is administered every three months by a healthcare provider, typically in the upper arm or buttock, making the Depo shot a popular birth control choice for approximately 70 million women. However, recent studies have linked Depo Provera to an increased risk of meningioma brain tumors, which can be life-threatening and often require surgical intervention.

Fazio now joins a growing number of women throughout the U.S. pursuing Depo shot brain tumor lawsuits, indicating that they only recently learned about the cause of their meningioma, since the drug makers failed to provide adequate warnings for users and the medical community.

Fazio states that she began receiving Depo shots in 1999, and continued to receive them regularly for 19 years. These included both the brand name drug and a number of authorized generics.

“Over time, Plaintiff developed alarming symptoms, including disorientation, lethargy, issues with memory and persistent headaches,” the lawsuit notes. “After a particularly concerning event wherein Plaintiff became disoriented while driving, Plaintiff reported to the Emergency Room. Following testing, Plaintiff was diagnosed with an intracranial meningioma.”

That was December 2017, which led to an MRI that discovered a large lesion in her brain. This brain tumor was also causing edema, which is an excessive accumulation of fluid in the brain.

In January 2018, Fazio underwent a brain surgery procedure known as a bifrontal craniotomy, which involved a neurosurgeon drilling holes in her skull to remove a section of bone to access her brain and the lesion. The surgeon had to retract the frontal lobes of Fazio’s brain, then surgically remove as much of the tumor as possible. After the procedure, a plate was used to secure the section of skull back in place.

However, after the surgery, Fazio experienced complications including blurred vision and double vision. It was later discovered she suffered obstructed blood flow to parts of the brain following the operation.

Continued To Receive Depo Shots After Brain Tumor Surgery

Although warning labels for the Depo-Provera shot in Canada contained information about the potential brain tumor risks since at least 2015, Fazio points out in the lawsuit that the manufacturers decided not to give women or doctors in the U.S. the same warnings. As a result, most medical providers were unaware about the potential link between meningioma and Depo shots.

Following her surgery in early 2018, Fazio specifically asked her doctors if she should continue taking Depo-Provera, and they said yes, likely unaware that Canadian warning labels included information on potential brain tumors just like the one they extracted from her, according to the lawsuit.

Fazio received two more Depo shots that year before ending her use of the drug, and did not learn that the Depo shots may have caused her  brain tumors until a study was published in the British Medical Journal (BMJ) in March 2024.

As a result of the brain tumor, Fazio indicates that she continues to suffer multiple impairments, including issues with memory, increased anxiety, diminished sense of taste, and loss of her sense of smell. She also uses a wheeled walker and takes medication to prevent seizures. In addition, Fazio must undergo a yearly MRI to look for the tumor’s potential return.

The Depo shot lawsuit involves claims for failure to warn, design defect, negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, fraudulent misrepresentation and breach of warranty.