{"id":73082,"date":"2025-10-14T02:47:10","date_gmt":"2025-10-14T02:47:10","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/73082\/"},"modified":"2025-10-14T02:47:10","modified_gmt":"2025-10-14T02:47:10","slug":"lawsuits-claim-pfizer-failed-to-warn-of-brain-tumor-risk-from-birth-control-shot","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/73082\/","title":{"rendered":"Lawsuits Claim Pfizer Failed to Warn of Brain Tumor Risk From Birth Control Shot"},"content":{"rendered":"

Truthout is a vital news source and a living history of political struggle. If you think our work is valuable, support us with a donation<\/a> of any size.<\/p>\n

This article was originally published by The Lever, an investigative newsroom. If you like this story, sign up for The Lever\u2019s free newsletter<\/a>.<\/p>\n

It was early 2012 when doctors found a tumor in Kim Franzi\u2019s brain. <\/p>\n

It was a meningioma \u2014 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.<\/p>\n

\u201cI was at work one day, the next day I was at the doctor, and my whole life changed,\u201d said Franzi. \u201cI just thought, who\u2019s going to take care of my kids?\u201d <\/p>\n

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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<\/a> sexually active women in the United States, bringing in hundreds of millions in profits annually<\/a> for the pharmaceutical behemoth Pfizer, which manufactures and distributes the drug. <\/p>\n

But according to more than 1,200<\/a> 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\u2019s behalf, plus more than 9,500 cases<\/a> that have yet to be filed.<\/p>\n

Related Story<\/p>\n


\n \"Close-up
\n <\/a><\/p>\n

\n Pharmacy benefit managers have massive control over people\u2019s medications, but a growing movement is pushing for reform.\n <\/p>\n

To avoid liability, Pfizer is leaning on a legal strategy called preemption<\/a>, 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<\/a> invalid. However, critics argue that Pfizer influenced the FDA\u2019s decision-making process on the matter, potentially even manipulating a warning-label application to achieve the results the drugmaker preferred.<\/p>\n

If Pfizer is successful in its use of preemption, this decision could further solidify a legal precedent that limits consumers\u2019 ability to hold drug manufacturers accountable for inadequate warning labels. And as the Trump administration rolls back longstanding<\/a> government<\/a> protections<\/a>, companies may have more legal ammunition than ever to argue that federal negligence preempts state safety rules.<\/p>\n

This is not the first time<\/a> that pharmaceutical manufacturers have tried \u2014 and succeeded \u2014 to get cases dismissed on the grounds of preemption. <\/p>\n

In 2011, the Supreme Court ruled<\/a> 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<\/a> alleging they hid evidence suggesting their antipsychotic drugs cause breast cancer.<\/p>\n

In cases like these, it\u2019s 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. <\/p>\n

\u201cIf preemption is successful, then there is no case,\u201d Davis said. If the company has proof that they think establishes preemption, they\u2019re \u201cgoing to pursue that at the earliest possible opportunity.\u201d <\/p>\n

This August, Pfizer argued<\/a> 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\u2019s request to add a warning about meningiomas to Depo-Provera\u2019s label. <\/p>\n

The FDA said the data submitted did not indicate that such a warning was necessary, and Pfizer argued this decision effectively prevented them \u201cfrom changing the Depo-Provera label,\u201d according to<\/a> a spokesperson.<\/p>\n

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, \u201cour argument is that Pfizer did not do so,\u201d said Bryan Aylstock, an attorney at Aylstock, Witkin, Kreis, & Overholtz who is co-leading the Depo-Provera litigation. \u201cThey omitted a variety of scientific evidence,\u201d including critical studies, when they applied for the label change, he alleged. <\/p>\n

Pfizer did not respond to a request for comment.<\/p>\n

Decades Of Research <\/p>\n

Research on the relationship between meningiomas and synthetic progesterone<\/a> \u2014 the main ingredient in Depo-Provera, which prevents ovulation and hinders sperm from reaching the eggs \u2014 is extensive. <\/p>\n

In the 1930s<\/a>, an American neurosurgeon noted that women, who have higher progesterone levels than men, are more likely to develop these types of brain tumors than their male counterparts. As early as 1989<\/a>, scientists found that drugs that block the absorption of progesterone significantly reduce the growth of meningioma cells, and since then, a number<\/a> of studies<\/a> have found<\/a> a link between medications containing synthetic progesterone and the development of these tumors. <\/p>\n

In 2024, a large study<\/a> of more than 18,000 cases of women undergoing surgery for meningiomas found that \u201cprolonged use of\u2026[Depo-Provera]\u2026was found to increase the risk of intracranial meningioma.\u201d Specifically, the scientists found that use of Depo-Provera was associated with a more than five-fold heightened risk of developing a meningioma that required surgery, and that risk increased further if patients used Depo-Provera for more than a year. <\/p>\n

While the majority of meningiomas are benign<\/a>, they can still impact vital nerves or compress the brain, causing significant disabilities or even becoming life-threatening. Ten to 15 percent of these tumors can be cancerous.<\/p>\n

The link between synthetic progesterone and brain tumors is also dose-dependent, meaning the higher the dose<\/a>, the greater the risk of developing a meningioma. Depo-Provera contains a very high dose<\/a> of synthetic progesterone compared to other types of contraception, like daily birth-control pills and intrauterine devices. <\/p>\n

The science is so robust, in fact, that the scientific committee that monitors the safety of medicines in Europe recommended<\/a> last year that patients taking high doses of synthetic progesterone be monitored for meningioma symptoms. Drug labels for Depo-Provera in the European Union<\/a>, United Kingdom<\/a>, New Zealand<\/a>, Australia<\/a>, and Canada<\/a> also warn about these brain tumors. <\/p>\n

Yet, even though Depo-Provera\u2019s U.S. drug label has been updated at least 13 times<\/a> since 2003, Pfizer has yet to add a warning to it about the risk of meningiomas. While such a warning could potentially reduce the drugmakers\u2019 liability for adverse effects of the medicine, it could also reduce demand, leading to lower profits.<\/p>\n

Finally, in early 2024, in the face of mounting scientific evidence, Pfizer proposed adding a warning to all of its synthetic progesterone products stating that \u201cmeningiomas have been reported following long-term administration\u201d of these drugs. But by grouping Depo-Provera with low-dose synthetic progesterone birth-control pills \u2014 which have little evidence linking them to meningiomas \u2014 the company cast doubt on the connection between brain tumors and the entire class of synthetic progesterone drugs, according to a recent court filing<\/a> from attorneys representing plaintiffs in the case.<\/p>\n

Furthermore, the drugmaker omitted<\/a> six<\/a> studies<\/a> that<\/a> found<\/a> significant<\/a> links between patients taking injectable synthetic progesterone-containing contraception like Depo-Provera and brain tumors. This \u201cdeprived [the] FDA of information crucial to assessing Depo-Provera\u2019s meningioma risk,\u201d the filing reads. <\/p>\n

FDA regulators subsequently concluded the science did not support such a warning. <\/p>\n

\u201cOne would assume that if a drugmaker went to [the] FDA and said, \u2018Hey, we want to include a warning on this drug label,\u2019 that the manufacturer would submit all evidence to support the warning,\u201d said Aylstock, the attorney who is co-leading the litigation. Instead, \u201cPfizer was able to pick and choose what it gave the FDA.\u201d <\/p>\n

\u201cThe FDA Said \u2018No\u2019\u201d <\/p>\n

Now, Pfizer is arguing that the FDA\u2019s rejection \u2014 and their reasoning that the drugmaker \u201cfully informed the FDA of the justifications for the warning\u201d \u2014 preempts the 1,200-plus brain tumor lawsuits it\u2019s facing over Depo-Provera. <\/p>\n

Essentially, \u201cPfizer\u2019s argument is it\u2019s impossible to put a warning on Depo-Provera\u2019s label when the FDA said no,\u201d Alystock explained. If the Florida judge agrees with this argument, it would exempt Pfizer from liability in all lawsuits alleging it failed to adequately warn consumers. <\/p>\n

Johnson & Johnson and Eli Lilly are also relying on preemption to fight allegations that they concealed evidence linking their blockbuster antipsychotic drugs, Risperdal and Zyprexa, to breast cancer<\/a>. <\/p>\n

Both medications, which are prescribed to treat conditions like schizophrenia and bipolar disorder, are known to elevate prolactin \u2014 a hormone tied to breast development and milk production. Scientists have known about the connection between high prolactin levels and breast cancer since at least the 1970s<\/a>, and by the 1990s<\/a>, research had established that certain antipsychotics, including those sold by Eli Lilly and Johnson & Johnson, could trigger dangerous hormone spikes.<\/p>\n

Subsequent studies confirmed these risks: Prolactin levels can rise two- to three-fold<\/a> in Zyprexa users and up to ten-fold in Risperdal users. A 2022 analysis<\/a> of 11 studies covering nearly 1.5 million people found that antipsychotic exposure is \u201can independent risk factor for cancer,\u201d with high-dose users up to 39 percent more likely to develop breast cancer than low-dose users. <\/p>\n

Right now, a growing number of lawsuits<\/a> are alleging that Johnson & Johnson and Eli Lilly failed to warn consumers about potential risks from the antipsychotics. But both drugmakers are arguing that their FDA-approved labels shield them from state claims.<\/p>\n

For years, the drug labels on Risperdal and Zyprexa downplayed the risk of breast cancer. This January, the FDA added a new warning<\/a> for all drugs that elevate prolactin levels: \u201cPublished epidemiologic studies have shown inconsistent results when exploring the potential association between [abnormally high levels of prolactin] and breast cancer.\u201d <\/p>\n

These label changes came after the publication of<\/a> three<\/a> studies<\/a>, which all concluded that Risperdal, Zyprexa, and other prolactin-raising antipsychotics were not linked to increased breast cancer risk. All of these studies, it turns out, were designed and funded by a subsidiary of Johnson & Johnson. <\/p>\n

In response to a California lawsuit, both<\/a> drugmakers<\/a> pointed to these studies, claiming that the FDA\u2019s findings of \u201cinconsistent\u201d evidence override any state demand for stronger warnings of breast cancer on Risperdal\u2019s and Zyprexa\u2019s labels.<\/p>\n

\u201cOur position is [the drugmakers] have an obligation to assess these risks\u2026 to go to the FDA and request labeling changes,\u201d said Monique Alarcon, an attorney at Wisner Baum, which filed a lawsuit against Eli Lilly and Johnson & Johnson. \u201cBut they\u2019ve failed to do that.\u201d<\/p>\n

When asked for a comment on the ongoing litigation, a spokesperson for Eli Lilly wrote in an email to The Lever that \u201cPatient safety is Lilly\u2019s top priority.\u201d <\/p>\n

\u201cZyprexa has helped millions of patients with schizophrenia and bipolar I disorder since its FDA approval in 1996, and it was added to the World Health Organization\u2019s List of Essential Medicines in 2023,\u201d the email continues. \u201cWe will continue to vigorously defend against these claims.\u201d<\/p>\n

Johnson & Johnson did not respond to a request for comment. <\/p>\n

\u201cI Don\u2019t Want Any Other Woman To Have My Life\u201d <\/p>\n

This is not the first time Pfizer has faced lawsuits over Depo-Provera. In 2021, the pharmaceutical company was ordered to pay nearly $2 million<\/a> in settlements for failing to warn Canadian consumers about the risk of bone mineral density loss associated with the drug. The medicine now includes a warning on the matter. The current brain tumor claims could lead to significantly larger payouts from the company \u2014 if the plaintiff\u2019s attempts aren\u2019t derailed by Pfizer\u2019s preemption move.<\/p>\n

Taking Depo-Provera \u201cdidn\u2019t just affect my quality of life, it ruined my life,\u201d said Jane Garcia, one of those plaintiffs, who was diagnosed with multiple meningiomas in 2023 after taking the birth control shot for roughly a decade. The tumors are small, the size of erasers, so the doctors are monitoring them to see if they grow. Meanwhile, Garcia suffers from a myriad of debilitating symptoms, including balance issues, blurred vision, and extreme anxiety. <\/p>\n

\u201cI\u2019m afraid to go to bed at night because I\u2019m afraid that I\u2019m not going to wake up. I\u2019ll stay awake for days,\u201d she said, wiping away tears. \u201cI think about it all day long. Is it gonna leak, is it growing?\u201d <\/p>\n

If the attorneys representing Garcia and other plaintiffs can overcome the question of preemption that currently sits in the Florida court, the chances of being able to show the link between Depo-Provera and meningiomas are high, said Aylstock. <\/p>\n

\u201cThis case is one of the strongest drug cases we\u2019ve seen in a long time in terms of scientific literature,\u201d Aylstock said.<\/p>\n

For the people bringing these cases, though, the fight isn\u2019t just about science and legal arguments \u2014 it\u2019s about preventing others from having to go through the same ordeal.<\/p>\n

These lawsuits force Pfizer \u201cto be accountable,\u201d said Garcia. \u201cThere needs to be awareness. I don\u2019t want any other woman to have my life now.\u201d <\/p>\n

Trump is aiming to stifle and defund nonprofits.<\/p>\n

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