Lemtrada Lawsuits

As of December 2024, there have been no major developments, trials or publicly announced settlements in Lemtrada personal injury lawsuits. Drugwatch’s legal partners are currently not accepting Lemtrada cases.

However, Sanofi paid $315 million in 2019 to settle allegations that it delayed the Lemtrada’s release to avoid paying investors. The company also agreed to pay $11.85 million in 2020 to resolve kickback allegations.

More than 21,000 patients worldwide had received Lemtrada treatment as of October 2018, according to a Sanofi Genzyme press release. These people may have been at risk of rare strokes and tears in the walls of blood vessels in the head or neck, known as cervicocephalic arterial dissection.

Sanofi Genzyme began marketing Lemtrada for relapsing multiple sclerosis in 2014, but a warning for the risk of stroke or arterial dissection did not appear in United States prescribing information until November 2018.

While Lemtrada can cause a number of side effects, ischemic stroke, hemorrhagic stroke, head or neck arterial dissection and death are the main injuries claimed in lawsuits.

In November 2018, the Food and Drug Administration warned about rare but serious risks of stroke and blood vessel wall tears with alemtuzumab.

According to the FDA’s safety announcement, most of the patients who experienced stroke or arterial dissection developed symptoms within one day of receiving the drug. In one case, symptoms started three days after treatment.

As of March 2024, the FDA Adverse Events Reporting System (FAERS) Public Dashboard showed 13 cases of strokes among people taking Lemtrada reported since 2017. The FDA also received seven reports of artery dissection, carotid aortic dissection and vertebral artery dissection. At least two cases were fatal.

An accurate number of people who actually suffered these problems is difficult to obtain because FAERS data is submitted voluntarily. The data does not necessarily mean that the use of the drug was a direct cause of the adverse event.

Lawsuits claim Sanofi Genzyme failed to warn the public that its drug could cause strokes and tears in the arteries. If doctors and patients had known, they may have chosen another treatment option and avoided serious injury.

The latest rash of Lemtrada lawsuits is not the first. In 2013, investors filed a class action lawsuit against Sanofi Genzyme for misrepresenting the safety and efficacy of the drug.

According to Solak v. Sanofi et al., “Sanofi (and Genzyme as its subsidiary) strongly touted the efficacy and safety of Lemtrada, by directing investors’ attention to two pivotal studies which the Company claimed demonstrated the safety and efficacy of Lemtrada.”

However, the FDA Advisory Committee on Peripheral and Central Nervous System Drugs found that “significant concerns exist regarding the safety profile of alemtuzumab [Lemtrada] and the adequacy of the efficacy data.”

The lawsuit, which was filed in the United States District Court Southern District of New York, claimed Sanofi also misled investors regarding the design of clinical trials for the drug. Sanofi did not disclose “trials contained high levels of placebo effect and observer bias,” which affected the FDA’s decision to approve the drug.