In April, the Food and Drug Administration (FDA) presented research about the possible link between Onglyza and heart problems. The research on Onglyza was presented as briefing materials under consideration for expert evaluation.

In a study termed “SAVOR” — Saxagliptin Assessment of Vascular Outcomes Recorded — it looked at patients with diabetes. SAVOR data indicated that patients taking Onglyza had a 27% increase in first-time hospitalizations compared to the study’s control group.

FDA researchers did qualify their statement, saying that the study could have false positives because it was not designed to treat. Still, researchers concluded that “the validity of this finding is supported by the large number of events reported in this trial, and the fact that hospitalization for heart failure was based on a pre-specified definition, and clinically adjudicated by an independent, blinded committee of specialists.”

The SAVOR study was a form of post-market surveillance on Onglyza. Under U.S. law, drug makers and the FDA are required to collect data and look for evidence that a drug could cause unforeseen side effects once it hits the market.

This is because clinical trials may include at most a few thousand people. While this sounds like a lot, once a drug like Onglyza is approved, millions may take it, possibly revealing side effects that did not show up in the initial clinical trials.

The SAVOR study’s results on Onglyza are important because they came from double-blind clinical trial data, which is one of the stronger forms of medical research. Additionally, the study included data from nearly 16,500 patients between the Onglyza and control groups.

Even as the FDA wrestles with the implications of the SAVOR study, the first Onglyza lawsuits have been filed. In one Onglyza lawsuit, Plaintiff Rochelle G. claims that her mother, Lillie R. G. suffered from heart failure stemming from Onglyza side effects.

According to this Onglyza lawsuit, Lillie began taking Onglyza in 2010. In 2011, she was hospitalized for heart failure twice, leading up to her death in October 2013. The Onglyza lawsuit alleges the drug’s makers are to blame for Lille’s heart problems.

Rochelle’s Onglyza lawsuit alleges that Onglyza side effects caused her mother’s heart failure. The Onglyza lawsuit further alleges that the drug’s makers were aware, or reasonably should have been aware, of risk of heart failure and heart attack allegedly linked to Onglyza.

The Onglyza lawsuit seeks more than $50,000 over the death of Lillie, in addition to medical costs, compensation for wrongful death, and punitive damages. Punitive damages are a special type of compensation in lawsuits.

Punitive damages are extra money above costs sought to compensate the plaintiffs of a lawsuit, intended to punish the defendant for outrageous conduct and discourage further law breaking. U.S. law only allows for punitive damages in a handful of situations, to keep from abusing it, but drug suits are one of the few situations where it is permissible to seek punitive damages.

The Onglyza Lawsuit is Case No. 2015-L-010969, filed in the Cook County Circuit Court in Chicago.