Failure to Disclose Increased Risk to Leqembi and Kisunla Patients

Two Alzheimer’s drugs Leqembi and Kisunla were approved by the FDA to treat mild dementia or a pre-Alzheimer’s condition called mild cognitive impairment. Data had suggested that Leqembi could slow cognitive decline in Alzheimer’s patients by five months over a period of 18 months for patients who had only mild symptoms. Two thousand volunteers had agreed to test Leqembi in clinical studies.  However, it turns out these drugs may also increase the risk for brain bleeds and swelling in patients with certain genetic profiles—and patients may not have been given enough information. If you suffered brain bleeds or swelling during a clinical trial for Leqembi or Kisunla, you may be able to recover compensation.

Call Moll Law Group About Your Claim

Investigation shows that drug manufacturers Eisai and Eli Lilly may not have disclosed to certain people in their clinical trials that they were more vulnerable to brain bleeding or swelling. The clinical trial for Leqembi had 274 volunteers without the manufacturer alerting them that they were at especially high risk to develop brain injuries. Eli Lilly also failed to tell volunteers in its Kisunla studies of increased risks, and dozens of those volunteers suffered severe brain bleeding.

Patients in the clinical studies should have received adequate information about the increased risks they faced due to their genetic profiles. Generally, patients must give informed consent before they take a medication for the study; patients cannot give informed consent if they have not been told the risks of taking a medication. In both of the trials, the volunteers were required to sign consent forms that let them know people with certain profiles faced greater risk of brain injuries while taking the drugs and that while participants would be tested for those risks, they wouldn’t be told the results.

Manufacturers Eisai and Eli Lilly did perform genetic testing on patients before giving them medications, but they didn’t give the patients the results of the genetic testing. The New York Times investigated whether risks were disclosed to participants and found that patients weren’t fully informed that they were at greater risk and that if they had been so informed, they might have elected not to participate in the study.

After three doses of the drug, one of these volunteers died and the autopsy showed that her death was partly caused by the drug’s side effects. Another volunteer at higher risk due to their genetic profile also died, and more than 100 other volunteers experienced swelling and brain bleeding. Many of these injuries were mild and the patients didn’t suffer from symptoms, but there were also those situations in which the injuries were quite serious.

Additionally, while the FDA approved the medications, not all other health authorities around the world have made the same decision. The EU, for instance, decided not to approve Leqembi. Despite the New York Times’ findings, these drugs remain approved by the FDA.

If you or a loved one was injured by Leqembi, call the seasoned Chicago-based product liability attorneys of Moll Law Group to talk about your legal options. For a free consultation, please complete our online form or call us at 312.462.1700.