Seasonique and Seasonale Lawsuit Filed, Claiming Birth Control Pills Caused Liver Tumors

Teva Pharmaceuticals faces a product liability lawsuit, which alleges that inadequate warnings were provided for women and the medical community about the risk that side effects of Seasonique and Seasonale birth control pills may cause liver tumors. 

In a complaint (PDF) filed in the U.S. District Court for the Southern District of Florida on May 26, Michelle Smith indicates that she developed masses on her liver after using the birth control pills for several years.

Smith began taking Seasonale in 2003, and switched to Seasonique in 2009, before masses were found in 2013.

According to the lawsuit, Teva knew or should have known that there was a five-fold increased risk of hepatic ademomas after five to seven years of use, and a 25-fold increased risk after use longer than nine years.

“Defendants have known that there is a proved association between the use of oral contraceptives and the development of hepatic ademoma. Evidence indicates that estrogen consumption is the primary risk factor for their development,” Smith’s lawsuit states. “Defendants have also known that the longer the duration of use, the greater the risk for developing a hepatic ademona.”

According to the complaint, Teva at first downplayed the risks of hepatic adenomas in the warning labels for Seasonale and Seasonique, claiming that their occurrence is rare in the U.S. Those warnings appeared on the 2003 label of Seasonale and the 2006 label of Seasonique, stating:

“Benign hepatic adenomas are associated with oral contraceptive use, although their occurrence is rare in the United States. Indirect calculations have estimated that attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use.”

However, the labels were changed in 2010, stating:

“Studies have shown an increase risk of developing hepatocellular carcinoma in long-term (>8 years) [oral contraceptive] users. However, the attributable risk of liver cancers in [oral contraceptive] users is less than one care per million users.”

The Seasonale and Seasonique lawsuit claims that both labels are deficient, by calling the rate of occurrence rare. It also notes that the 2010 update removed the fact that hepatic-adenoma risk increased with long-term use by only mentioning hepatoceulluar carcinoma.

Smith presents claims for defective design, failure to warn, negligence, and negligent failure to warn. She is seeking compensatory and punitive damages.

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  1. Michele Reply

    Seasonique caused my Massive Ischemic Stroke May 24, 2015.

  2. Jamella Reply

    Seasonique caused liver adenomas.

  3. Jamella Reply

    I developed liver adenomas after taking seasonale/seasonique for years. I was never told of the high increase of liver rumors with prolonged use of seasonique.

  4. Tesha Reply

    Seasoniqe, also caused my ischemic stroke I have been left with severe deficits., as a result.

  5. dorina Reply

    I have multiple tumors on my liver, that burst, due to seasoniqe use. I had to have embolization, but doctors are still saying that I may need liver resection, and possible cancer transformation of tumors one day. I have daily pain, and difficulties.

  6. Deb Reply

    I had bilateral PE s from seasonique . I spent over a week in the hospital. Got pneumonia from compromised lungs from damage done by PE s. Months of missed work due to recovering. Still have issues .

  7. Camisha Reply

    Ibeen taking seasonique eight years I’m now having lots of stomach problem and pain i went to the emergency room in lots of pain

  8. Christine Reply

    I was on this BC. Went in for gallbladder removal and turns out I have FNH of my liver. Recently diagnosed. I have fatigue minor tummy pain on somedays.

  9. Shelby Reply

    I had a saddle form from this medication in a matter of 3 months (symptoms started) and 3 months after that my left middle lobe of the lung was completely occluded. I did NOT get a DVT or a simple pulmonary embolism. My entire side of my heart expanded. I was in the best shape of my life when I switched birth controls. I lost my job/career – literally everything I’ve worked for in college / ROTC.

  10. Maria Evans Reply

    I was diagnosed with hepatocellular carcinoma in April of this year. Had been on Seasonale then Seasonique since their introductions, so 15 total years on one or the other. I had a liver resection, and my latest bloodwork shows that something is back. I am most likely going to die from this. Why does nobody know about this? I have retained counsel, but I may not be here to see resolution.This can’t happen to someone else.

  11. Megan Reply

    I almost died in 2013 from an unknown hepatic adenoma that had ruptured. I had been on seasonique for roughly 10 years. I was told my statute of limitations have expired but I am wanting to do something, because I battle daily with the aftermath of this tumor. Any insight on a good direction like a class action lawsuit?

  12. Denise Reply

    I had been on Seasonique for 10 years into my early 40s non-smoker healthy exercise regularly. I developed breast cancer, estrogen and progesterone positive. No breast cancer history in my family. Three older sisters none of them have breast cancer thankfully. I know this drug was the catalyst.

  13. Nichelle Reply

    Seasonique caused a massive ischemic stroke for me in 2013. I’m left with multiple deficits. I was told theirs no recourse is this true? I practiced Family Law for 7 years prior now I’m disabled and depressed.

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