Bristol-Myers Squibb and AstraZeneca face lawsuits filed by plaintiffs who say Type 2 diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin extended release) caused serious side effects including heart failure, heart attack, pancreatitis, pancreatic cancer and death.
The U.S. Food and Drug Administration approved Onglyza in 2009 and Kombiglyze XR in 2010. These drugs belong to a class of medications known as DPP-4 inhibitors that lower blood sugar by increasing insulin output and decreasing glucose excreted by the liver.
Since the FDA approved the drugs, the agency released a number of safety communications warning about side effects. The FDA findings led plaintiffs to file several lawsuits.
Currently, the largest number of lawsuits is pending in California, according to AstraZeneca’s annual report. Several others are scattered across the country in various state courts including Kentucky, Texas and Illinois. Plaintiffs filed the most recent lawsuits for heart failure, congestive heart failure and wrongful death.
There are no class actions or multidistrict litigations (MDL) pending. But, there is a motion to consolidate cases in California State Court. If the number of Onglyza and Kombiglyze XR heart failure lawsuits continues to rise, plaintiffs or defendants may request the Judicial Panel on Multidistrict Litigation consolidate the cases into an MDL to expedite litigation.
Allegations Raised in Onglyza and Kombiglyze XR Lawsuits
The main defendants named in these lawsuits are Bristol-Myers Squibb, AstraZeneca and Amylin Pharmaceuticals, LLC — a wholly owned subsidiary of AstraZeneca. Other named defendants include IPR Pharmaceuticals and McKesson Corp., companies that may have been involved in distribution, manufacturing and marketing of Onglyza and Kombiglyze XR.
Plaintiffs are claiming damages related to negligence in the “the defendants’ design, manufacture, sale, marketing, advertising, promotion, labeling, packaging, and distribution of their drug saxagliptin,” according to court documents.
In various lawsuit complaints, plaintiffs allege defendants:
- Did not perform adequate studies to determine if Onglyza and Kombiglyze XR may increase risks of cardiovascular-related adverse events
- Failed to warn about heart failure, congestive heart failure, cardiac failure and death despite Saxagliptin Assessment of Vascular Outcomes Recorded SAVOR clinical trial findings and FDA Advisory Committee recommendations for a warning
- Overpromoted Onglyza and Kombiglyze XR and downplayed their risks in print marketing, advertising and promotional materials, blogs, websites and promotions to consumers
- Promoted Onglyza and Kombiglyze XR to doctors and other health providers as safer than other Type 2 diabetes drugs
- Failed to adequately test Onglyza and Kombiglyze XR before putting them on the market
- Sold Onglyza and Kombiglyze XR despite knowing their serious risks
- Manufactured defective and unreasonably dangerous drugs
- Negligently manufactured, designed, labeled, packaged, distributed, marketed, advertised and sold Onglyza and Kombiglyze XR
New Heart Failure Allegations Lead to More Onglyza and Kombiglyze XR Lawsuits
The newest lawsuits allege saxagliptin can cause heart failure, congestive heart failure, cardiac failure and death. According to these lawsuits, Bristol Myers Squibb and AstraZeneca failed to warn doctors and patients of the risk.
Attorneys are accepting lawsuits from people who suffered heart failure, congestive heart failure, cardiac failure or death before April 5, 2016.
In October 2016, AstraZeneca filed a motion to dismiss the claims of 14 plaintiffs alleging heart failure, cardiac failure and death. The judge granted the dismissal. As of February 2017, about 85 claims remain in active litigation, according to AstraZeneca’s annual report.
In December 2016, California plaintiffs filed a motion to consolidate similar cases for pretrial in the California Superior Court.
Chester v. Bristol-Myers Squibb
Wrendell Chester used Onglyza and Kombiglyze XR for about five years between 2010 and 2015. According to his lawsuit filed on Feb. 1, 2017 in Texas, he suffered congestive heart failure, heart failure and hypoxic respiratory failure from the two drugs. Chester’s lawsuit alleges failure to warn and negligence.
“Saxagliptin was defective in design in that the products neither bore, nor were packaged with, nor were accompanied by, warnings adequate to alert users, including Plaintiff, of the increased risks associated with using the products, including, but not limited to, the risk of heart failure, congestive heart failure, cardiac failure, death from heart failure, and other serious health conditions,” Chester alleged in his complaint.
Gibson v. Bristol-Myers Squibb
Lillie Ree Gibson’s daughter, Rochelle, filed a lawsuit on October 29, 2015 in Illinois on her behalf. Gibson began taking Onglyza in 2010 and suffered heart failure in 2011. According to the lawsuit, Gibson died two years later after being hospitalized twice because of the condition. Gibson’s lawsuit alleges failure to warn and negligence.
Onglyza and Kombiglyze XR Heart Attack Lawsuits
In addition to heart failure lawsuits, some plaintiffs also claim Onglyza caused them other cardiac injuries, such as myocardial infarction (heart attack). Studies reviewed by the FDA, however, did not reveal evidence of increased risk of heart attack or stroke in people taking Onglyza or Kombiglyze XR. These heart attack cases are still be pending.
Taylor v. Bristol-Myers Squibb
David Taylor and his wife Leatha filed suit on July 13, 2016 in Kentucky after he took Onglyza and suffered a heart attack he claims the drug caused. Taylor began taking Onglyza in April 2015 and suffered a heart attack in July 2015. According to his complaint, defendants knew of the heart problems associated with Onglyza, but failed to warn the public.
David Taylor claimed in a 2016 Kentucky suit, “Defendants acted in concert with one another in the Commonwealth of Kentucky to fraudulently convey false and misleading information concerning the safety and efficacy of Saxagliptin and Onglyza and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure and other adverse effects associated with Saxagliptin and Onglyza from the public, including Plaintiff David Taylor, his physicians, and other healthcare providers.”
Early Onglyza and Kombiglyze XR Lawsuits Claims of Pancreatic Cancer
Some of the first Onglyza and Kombiglyze XR lawsuits filed against AstraZeneca and Bristol-Myers Squibb involve pancreatitis — inflammation of the pancreas — and pancreatic cancer. The FDA issued a safety communication in 2013 linking DPP-4 drugs to possible increased risk of pancreatitis and pre-cancerous cells in the pancreas.
While drug labels contained some warnings for pancreatitis, the FDA said it did not previously communicate the potential risk of cancerous cells. In 2016, the agency required drugmakers to publish additional information from clinical studies on the risk of pancreatitis on drug labels.
“In May 2016, a federal judge in California granted AstraZeneca’s motion for summary judgment and dismissed the claims of 14 plaintiffs who alleged pancreatic injuries, including pancreatic cancer, from treatment with either Onglyza or Kombiglyze,” AstraZeneca wrote in its 2016 annual report. “No similar claims remain actively pending in any U.S. jurisdiction.”
While some lawyers may still be taking cases for pancreatic cancer or pancreatitis, the focus for Onglyza and Kombiglyze XR litigation involves heart failure.
Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.