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Onglyza and Kombiglyze XR Lawsuits

Onglyza and Kombiglyze XR are being blamed for causing cardiac injuries. Patients are suing the manufacturers, Bristol-Myers Squibb and AstraZeneca. There have not yet been any publicized settlements or verdicts.

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If you took Onglyza or Kombiglyze XR and suffered one of the following side effects, you may be entitled to compensation.

  • Cardiac Failure
  • Congestive Heart Failure
  • Heart Failure
Suffering from heart failure related to Onglyza or Kombiglyze XR?

Number of Lawsuits Approximately 100

Plaintiff Injuries Heart failure, congestive heart failure, heart attack, pancreatitis and death

Defendants Bristol-Myers Squibb and AstraZeneca

Class-Action Status None

Litigation Status Active

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Fast Facts:

  • People who suffered major heart problems linked to Onglyza and Kombiglyze XR are suing drug makers Bristol Myers Squibb and AstraZeneca for compensation.
  • Hundreds of lawsuits are expected to be filed accusing the manufacturers of not adequately studying drug risks and failing to warn the public.
  • Attorneys are seeking to consolidate dozens of current cases focusing in state and federal courts in California.

Diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended release) are the focus of lawsuits now being filed alleging they caused patients to suffer serious cardiac complications and sometimes death. Judges in state and federal courts in California may consolidate the cases filed around the country against drug makers Bristol Myers Squibb and AstraZeneca.

Cardiac Issues Focus of Lawsuits

Recent lawsuits allege saxagliptin can cause heart failure, congestive heart failure, cardiac failure and death. According to these claims, Bristol Myers Squibb and AstraZeneca failed to warn doctors and patients of the risk.

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Attorneys are currently accepting lawsuits from people who suffered heart failure or congestive heart failure, cardiac failure before April 5, 2016. Lawsuits may also be filed by people whose loved ones died before that date and were taking Onglyza or Kombiglyze XR at the time.

If you or a loved one were diagnosed with Type 2 diabetes and started taking Onglyza or Kombiglyze XR between July 2009 and April 5, 2016, you may be able to seek compensation through a lawsuit if you or your loved one developed the following complications:

  • Heart failure
  • Death due to unspecified causes not related to trauma
  • Cardiac failure
  • Congestive heart failure

Pancreatic Cancer Cases Dismissed

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.

“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. No similar claims remain actively pending in any U.S. jurisdiction.”

- AstraZeneca wrote in its 2016 annual report

Some lawyers may still be taking cases for pancreatic cancer or pancreatitis, but the primary focus for Onglyza and Kombiglyze XR litigation involves heart failure.

Lawsuits Focus on Lack of Studies and Hidden Risks

In various lawsuits, plaintiffs allege the manufacturers of Onglyza and Kombiglyze XR didn’t tell doctors and patients about dangerous side effects and didn’t properly test the drugs before selling them.

Specifically, the lawsuits allege drugmakers:

  • 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.
  • Filing a claim and obtaining a settlement can be a painstaking process of documenting decades of exposure, potentially to different companies’ products, particularly if a plaintiff worked in the construction industry or something similar.
  • 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

Saxagliptin Brands Being Litigated: Onglyza and Kombiglyze XR

Plaintiffs filing lawsuits say Type 2 diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin extended release) made by Bristol-Myers Squibb and AstraZeneca caused serious side effects including heart failure, heart attack and death.

Bristol-Myers Squibb and AstraZeneca Named in 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 allege the companies failed to adequately study the drugs and then hid risks of serious side effects from the public.

Verdicts and Settlements in Other Diabetes Drug Cases

There have been no verdicts or publicized settlements in cases involving Onglyza and Kombiglyze XR because the cases alleging their link to serious cardiac injuries are still making their way through the early stages of litigation.

Suffered from heart failure due to Onglyza? We can help.

But Onglyza and Komgiglyze XR are only the latest of a number of diabetes drugs that have been the focus of lawsuits. Other companies have been forced to pay hundreds of millions to settle similar litigation.

For example:

  • In 2015, the manufacturer of Actos, a blockbuster drug for Type 2 diabetes, agreed to pay $2.37 billion to nearly 9,000 plaintiffs who contended that the medication gave them bladder cancer. Lawsuits accused the maker, Takeda Pharmaceutical Company, of hiding the risk and failing to warn patients. That settlement announcement came after eight trials, with five concluding in wins for plaintiffs. However, two of those plaintiff awards were overturned by judges. In one case, a jury awarded a plaintiff $9 billion, but a judge later lowered that to $38.6 million.
  • GlaxoSmithKline has settled about 50,000 cases involving claims that its Type 2 diabetes drug Avandia caused injuries including heart attacks, cardiovascular death and serious issues with the liver and bones. The pharmaceutical giant has settled the cases in groupings for various amounts. In one instance, the company agreed to pay $460 million to settle 10,000 cases. In another settlement, GSK said it would pay about $60 million to settle more than 700 lawsuits.

Class Action and Multidistrict Litigation

The states with the highest numbers of lawsuits involving injuries linked to Onglyza and Kombiglyze XR are:

  • California
  • Kentucky
  • Texas
  • Illinois

There are currently no class actions or multidistrict litigations (MDL) involving Onglyza or Kombiglyze XR. But there are motions seeking to consolidate cases in California State Court and asking the Judicial Panel on Multidistrict Litigation to create a MDL in federal court in California as well.

Consolidation is a means for courts to manage large numbers of similar lawsuits filed against the same defendants. It allows a single judge to issue pre-trial rulings that apply across the board to all the consolidated cases. These orders can address a range of issues, including:

  • Expert testimony
  • Allowable defenses
  • FDA issues

Typically, in MDL and state court consolidated actions, the parties will select a few cases to go to trial first — known as bellwethers — so that both the plaintiffs and defense will gain an understanding on how other cases may play out. This information can be used to inform potential settlement negotiations.

According to the motion filed by plaintiffs in the federal Northern District of California on October 11, 2017, there are at least 44 actions pending in 24 different judicial districts in the United States, and it is likely that hundreds of more similar lawsuits will be filed across the country.

Please seek the advice of a medical professional before making health care decisions.

Author

Elaine Silvestrini is a career journalist with a strong desire to learn, explain, and help people. At Drugwatch, Elaine has reported about trials over whether talcum powder caused ovarian cancer and allegations that Androgel causes heart problems in patients who use it. She has chronicled the billions of dollars generated for big pharmaceutical companies by certain drugs and efforts to warn consumers about the dangers of specific medical problems. Elaine has received six health literacy certificates for completing courses offered by the Centers for Disease Control and Prevention. She brings more than 20 years of experience covering state and federal court systems, learning the intricacies of criminal and civil law, developing investigative pieces about how the law affects people’s lives and digging through and digesting reams of court records on a daily basis.


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  1. Gibson v. AstraZeneca. (2015, October 29). Complaint for Damages, Cook County Circuit Court, Case No. 2015-L-010969. Retrieved from: http://cookcountyclerkofcourt.org/?section=CASEINFOPage&CASEINFOPage=2400
  2. FDA.gov. (2015, August 28). FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm459579.htm
  3. FDA.gov. (2016, April 5). Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure. Retrieved from: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm
  4. AstraZeneca. (2017, February 2). Full-Year and Q4 2016 Results. Retrieved from https://www.astrazeneca.com/content/dam/az/PDF/Full_year_and_q4_2016_results/Full_Year_and_Q4_2016_Results_announcement.pdf
  5. AstraZeneca. (2017). Annual Report and Form 20-F Information 2016. Retrieved from https://www.astrazeneca.com/content/dam/az/Investor_Relations/Annual-report-2016/AZ_AR2016_Full_Report.pdf
  6. Chester v. Bristol-Myers Squibb et al. (2017, February 1). Complaint for Damages, United States District Court Southern District of Texas. Case 4:17-cv-00316. Retrieved from http://www.pacer.gov
  7. Taylor V. Bristol-Myers Squibb el al. (2016, July 13). Complaint for Damages, United States District Court Eastern District Of Kentucky Lexington Division. Case: 5:16-cv-00260-KKC. Retrieved from http://www.pacer.gov
  8. Onglyza and Kombiglyze Products Liability Litigation. (2017, October 11). Memorandum in Support of Plaintiff’s Motion for Transfer of Actions to the United States District Court for the Northern District of California. Retrieved from: https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2017-10-11-Motion.pdf

Suffering from heart failure related to Onglyza or Kombiglyze XR?
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