Tecfidera Lawsuit Filed by Shareholder Over Biogen Ignoring Safety Signals
The makers of the multiple sclerosis (MS) drug Tecfidera face a lawsuit brought on behalf of shareholders, which alleges the company ignored safety signals about the potentially harmful side effects of Tecfidera, leading investors to believe the drug, and thus the company, was more valuable than it really was.
The shareholder derivative complaint (PDF) was filed by Mary Ann Mullaney last month in the U.S. District Court for the District of Delaware, against Biogen Inc. and a number of its top executives.
The case was filed just days before the FDA approved new warning labels about the risk of liver injury from Tecfidera, indicating that clinically signficant cases of liver problems have surfaced within a few days to several months after starting treatment.
Tecfidera (dimethyl fumarate) is the top selling oral multiple sclerosis (MS) drug in the world, with sales of $1.03 billion in the third quarter of 2016. Side effects of Tecfidera have also been linked to an increased risk of a rare brain infection known as progressive multifocal leukoencephalopathy (PML).
In November 2014, the FDA issued a drug safety communication about the risk that Tecfidera may cause PML brain infections, which may be life-threatening.
The Tecfidera lawsuit indicates that since at least 2014, Biogen has known that research indicated Tecfidera could also lower lymphocytes, a type of white blood cell that affects the immune system, to dangerously low levels. According to the complaint, researchers at the MS Institute at the Shepherd Center in Atlanta, Georgia conducted blood tests which indicated that the drug could cause such low lymphocyte levels that the condition could be mistaken for Acquired immune Deficiency Syndrome (AIDS).
The shareholder complaint indicates that Dr. Ben Thrower, the medical director at the institute and one of the doctors involved in the original Tecfidera clinical trials, tried to warn Biogen officials that the drug was not as safe as Biogen was advertising.
In the second quarter of 2014, according to the lawsuit, Biogen officials were notified that the Shepherd Center was removing patients from Tecfidera, and that new prescriptions had “plummeted,” which led to other neurologists around the nation to follow suit.
By August 2014, the center had stopped prescribing the drug altogether, and had placed about half of the 400 patients using Tecfidera onto other treatments.
“Defendants did not disclose any of these devastating developments to the public,” the lawsuit notes. “Rather, they publicly trumpeted Tecfidera’s safety profile and growing sales, and omitted any mention of the fact that the number one source of Tecfidera prescriptions in the United States, the Shepherd Center, completely stopped prescribing Tecfidera and discontinued off that drug at least half of its existing patients then taking Tecfidera because of its dangerous side effects.”
The company was forced to acknowledge some problems in October 2014 after a patient died of PML. However, the lawsuit notes that the company continued to mislead the public about the drug’s overall safety.
As more incidents occurred, and the public and experts began to doubt Biogen’s claims, it began to affect the company’s stock, until the company admitted there was a problem in July 2015.
“On this news, Biogen’s common stock plummeted from $385.05 per share at the close on July 23, 2015 to $300.03 per share at the close on July 24, 2015, a decline of more than 22% in a single day,” the lawsuit notes.
The lawsuit accuses the defendants of breach of fiduciary duties, unjust enrichment, and Securities Exchange Act violations.
9 comments
My husband has gotten colon cancer twice since taking this drug and is currently on Chemotherapy with a stage 4 diagnosis
I believe Tecfidera has caused my daughter to have JC virus and she might not be able to have surgery because of it! And she could lose her life!!! I’m tired of my daughter being a lab rat for meds that could cause more harm then good!!
I am a MS patient. I was prescribed Tecfidera in March of 2014. I tried for 2 years to go onto the full dose. I was unsuccessful. The problem was that the medication was destroying the inside lining of my stomach. In November of 2017 I had medical procedure with a camera in my stomach. This test confirmed the damage. Presently, discussions are continuing concerning surgery to repair the damage caused by Tecfidera. I stopped taking Tecfidera in May of 2017 against the advice of my Doctors. I would be interested in efforts to inform the public about the potential damage that may present to other patients.
i was diagnosed with ms september 23 1999 and i have tasken avonex and tecfidera with bad side effects from both drugs
I’m a MS patient. Started Tecfidoera May 2019 for only 6 days. The horrid side affects from day 1 and I was told by my nuerologists staff to just push threw trial pack. Again by day 6 I took myself off it for the pain around my right eye almost fully took my vision. Still having complications. Other affects I had were, massive drooling, unbalanced walking, felt drunk, slurring words, swollen tounge , wanting to fall over and more. Today finally contacted a laywer waiting to hear back because I want to sue the neurologist. Never once on any phone call did they say stop taking Tecfidoera and here we are in July- End of my rope .
I began taking Tecifidera in June 2013. I started bleeding profusely between menstrual cycles, and my appendix exploded in March 2014. I was then diagnosed with low grade stromal cell sarcoma, in November 2014, an extremely rare form of uterine Csncer , resulting in a radical hysterectomy. I stopped taking Tecifidera, I was almost 44 years when my appendix exploded, was told that it was uncommon for a woman of my age to have that happen.
I lost 8 teeth while on Tecfidera. I posted it on the Tecfidera support groups and it was amazing how many people, world wide, had severe dental problems like me. My dentist found that Tecfidera had caused the nerves in the teeth to calcify, which killed the teeth and caused them to fall out. I have advised MS patients to contact the FDA so we could hold Biogen responsible. Now I need implants and dental insurance doesn’t cover that. I no longer take any DMD’s for MS.
I started taking Tecfidera in 2013. I was immediately hit with extreme fatigue and I was unable to think, concentrate, or figure out what was going on. Many more side effects then what’s listed! I stopped taking Tecfidera on June 10, 2020, when I got onto the Tecfidera website to see if I could figure out why this “flushing” NEVER goes away and my eye balls feel like they’re on fire, the same as my chest, neck and face. That’s when I saw the “changes in personality” side affect description. I have also been diagnosed with several other things that have gone away since I quit taking it.
I started taking Tecfidera on 18th November 2019 & immediately started to experience debilitating side effects. At the time the Neurology team had assured me that the drug was safe. I was persuaded to continue by Neurology Team, but then further problems developed, leading to me stopping Tecfidera altogether by end of January 2020. It was at this point my liver started to struggle, my LFTs became ‘deranged’, leading to peripheral oedema, my TSH became erratic, I developed hypertension despite being historically hypotension, suffered excruciating abdominal & back pain, severe joint pain etc. I furthermore gained 20kg in weight in under a month & became morbidly obese. I was eventually placed on diuretics in July 2020 which resulted in me losing 5kg in just 2 days. I was referred to gastroenterologist with speciality in liver disease who was of the opinion that I may have liver failure & heart disease. It should be noted that the Neurology team were in regular contact with the medical advisor at Biogen but failed to give me any feedback. A diagnosis of ‘transient hepatitis secondary to Tecfidera’, followed in September. The Neurology team have been noticeably absent throughout the year. They were clearly negligent & in cohorts with both the gastroenterologist & Biogen, & have tried to redirect my attention/the focus by telling me that I had heart failure and that my health problems were self inflicted, based on a diagnosis of COPD many years ago. It should noted that heart failure was ruled out following extensive tests. I was relatively fit until I started taking Tecfidera but now experience poor health.