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.

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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.

28 Comments

  • TanishaJuly 9, 2022 at 4:29 pm

    I have had multiple procedures and health problems due to Seasonique

  • VickiJune 27, 2022 at 3:32 pm

    I took Seasonique from 2006 (?) to 2011. I got pregnant in 2015 with my daughter. There was an 11" cyst on my right ovary not allowing her head to come down the birth canal. I was taken in for an emergency C section upon which she and the cyst were removed when I was cut opened. Five days late, due to the estrogen in my body I started to bleed out in my liver. After extensive MRI's, it was found[Show More]I took Seasonique from 2006 (?) to 2011. I got pregnant in 2015 with my daughter. There was an 11" cyst on my right ovary not allowing her head to come down the birth canal. I was taken in for an emergency C section upon which she and the cyst were removed when I was cut opened. Five days late, due to the estrogen in my body I started to bleed out in my liver. After extensive MRI's, it was found that I had a tumor in my liver caused by my birth control pills. It was monitored and removed 6 months later. I was then told it was best not to get pregnant again because the estrogen might cause another tumor in my liver. In which that time my husband went through the process and had a Vasectomy. I hope that this information helps!!

  • MeganFebruary 9, 2022 at 6:11 pm

    I have hepatic adenomatosis from this drug.

  • KathyNovember 3, 2021 at 1:10 pm

    Developed over 20 tumors in both lobes of my liver on seasonale only took for less than 2 years in 2005. Can a claim be filed? Was never aware this could happen

  • HafzaOctober 19, 2021 at 9:48 am

    I was birth control for 17 years and took seasonable and seasonique for close to 10 years. I ended up having 10 tumors all over my liver, which 5 were cancerous. I was diagnosed in 2017 with heptocellular carcinoma. I had a liver transplant.

  • TanishaOctober 4, 2021 at 4:44 pm

    I was on seasonique for a couple of years, and it caused hepatic adenomas, as well as numerous other health issues. I never had any health issues, until I started taking seasonique. Since then I've had a huge adenoma removed with part of my liver. I've had a biopsy, ablations, countless scans, kidney problems, that I did not have before. I have constant pain, nausea, vomiting, etc... This company [Show More]I was on seasonique for a couple of years, and it caused hepatic adenomas, as well as numerous other health issues. I never had any health issues, until I started taking seasonique. Since then I've had a huge adenoma removed with part of my liver. I've had a biopsy, ablations, countless scans, kidney problems, that I did not have before. I have constant pain, nausea, vomiting, etc... This company needs to be held accountable.

  • MeganSeptember 11, 2021 at 11:57 pm

    I was on seasonique for a couple years and then nearly died, due to a hepatic adenoma that had ruptured and caused significant internal bleeding. This was in 2013 when I was 22. I can now never take OC or anything that will cause estrogen to be absorbed by my liver. This is something that I should have never gone through, as Teva should have taken measures and precautions.

  • ChaneeJuly 27, 2021 at 10:05 pm

    I developed a mass/lesion on my liver and diagnosed with a hepatic adenoma. I recently had a liver resection and my gallbladder removed in June 2021. I had no idea that this was even a diagnoses until I was diagnosed. Had I known this I certainly would not have continued taking OCs. I was on Seasonique/Camrese for 10 plus years.

  • AmandaJanuary 12, 2021 at 12:57 am

    Was put on seasonique right before Thanksgiving. My insurance would not cover the brand name, but covered the generic at 100%. A few days before finishing my first month, I noticed an unexplained pain in my left lower leg. The pain increased over the next few days. I went back to the doctor that prescribed the BC. I was told to stop taking the pills due to the number of side effects I had had over[Show More]Was put on seasonique right before Thanksgiving. My insurance would not cover the brand name, but covered the generic at 100%. A few days before finishing my first month, I noticed an unexplained pain in my left lower leg. The pain increased over the next few days. I went back to the doctor that prescribed the BC. I was told to stop taking the pills due to the number of side effects I had had over the past month. The doctor claimed that I did not need to worry that he did not think I had to worry about the pain being a blood clot. He then told me to go see my primary doctor if it continued to bother me, and told me to schedule an appointment in two months to come back. The next morning, I could not put any weight on my leg, and less than 24 hours after I was told I didn't have a DVT, I was diagnosed with a DVT and have been on blood thinners for almost 3 weeks now. I was never told that a blood clot was something I needed to worry about, and I was later told by a close friend who is in the medical field, that considering I had only quit smoking a few weeks prior and the fact that I am in my 40s, I never should have been put on that BC. Who knows what could have been. All I know is I asked for a hysterectomy for Christmas and I got a blood clot instead.

  • KimberlyNovember 4, 2020 at 1:08 am

    I was diagnosed with 12 liver tumors in 2016 according to my liver doctor it was caused by oral contraceptives (I was on Seasonale). The largest ones 7- 11 cm. were found to be positive for heptocellular carcinoma. I had 70% of my liver resected, removing 7 of the tumors. I still have 5 tumors left in the remaining portion of my liver. If the grow at at I may need a liver transplant

  • SharonAugust 15, 2020 at 11:36 pm

    I was given Jolessa by seasonaile for ovarian cyst. My OB said it would help to reduce the size of the cyst. This was about 10 years ago. I developed a severe DVT. I needed wayfarin for 2 years. Had a Vena Cave filter inserted. I later had to have a full hysterectomy which I almost bled to death in the operating room. I now suffer from a compromised vascular system in my leg. I have severe swell[Show More]I was given Jolessa by seasonaile for ovarian cyst. My OB said it would help to reduce the size of the cyst. This was about 10 years ago. I developed a severe DVT. I needed wayfarin for 2 years. Had a Vena Cave filter inserted. I later had to have a full hysterectomy which I almost bled to death in the operating room. I now suffer from a compromised vascular system in my leg. I have severe swelling and pain. I was never informed of the side affects. I now am on SSDI.

  • ChristineApril 29, 2020 at 7:19 pm

    I have FNH with now 5 masses. I was also taking seasonique. I am one of the few that have discomfort and pain as most are asymptomatic.

  • TanishaApril 5, 2020 at 2:35 pm

    I was also taking seasonique, but it only took a couple of years before symptoms showed. I've had multiple procedures, as well as constant pain, nausea, and vomiting. I still have multiple lesions throughout my liver and kidney damage.

  • RavenMarch 9, 2020 at 3:03 pm

    I was taking seasonique/ camrese as well

  • TangyMarch 4, 2020 at 9:25 pm

    I have 4 tumors on my liver from taken birthcontrol pills i was not aware of this

  • NichelleOctober 20, 2019 at 3:54 am

    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.

  • DeniseOctober 1, 2019 at 1:00 pm

    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.

  • MeganJuly 30, 2019 at 3:02 pm

    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?

  • Maria EvansSeptember 9, 2018 at 5:53 am

    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'[Show More]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.

  • ShelbyAugust 27, 2018 at 11:03 am

    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.

  • ChristineMay 13, 2018 at 1:47 am

    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.

  • CamishaApril 5, 2018 at 5:22 am

    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

  • DebMarch 1, 2018 at 7:34 am

    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 .

  • dorinaSeptember 20, 2017 at 6:27 am

    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.

  • TeshaAugust 10, 2017 at 1:36 am

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

  • JamellaJuly 31, 2017 at 12:53 am

    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.

  • JamellaJuly 30, 2017 at 4:08 am

    Seasonique caused liver adenomas.

  • MicheleJuly 7, 2017 at 4:56 pm

    Seasonique caused my Massive Ischemic Stroke May 24, 2015.

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