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Onglyza and Kombiglyze XR Lawsuits

Onglyza and Kombiglyze XR lawsuits blame the drugs for causing cardiac injuries. In February 2018, a federal panel consolidated lawsuits against Bristol-Myers Squibb and AstraZeneca in federal court in Kentucky. There have not yet been any publicized settlements or verdicts.

Suffering from heart failure related to Onglyza or Kombiglyze XR?

If you took Onglyza or Kombiglyze XR and suffered from heart related side effects, you may be entitled to compensation.

Onglyza and Kombiglyze XR Lawsuit Facts
  1. Number of Lawsuits 84
  2. Plaintiff Injuries Heart failure, congestive heart failure, heart attack, pancreatitis and death
  3. Defendants Bristol-Myers Squibb and AstraZeneca
  4. MDL Location U.S. District Court for the Eastern District of Kentucky
  5. Litigation Status Active

People are suing Bristol-Myers Squibb and AstraZeneca over the Type 2 diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended release). Lawsuits allege these drugs caused serious cardiac complications and sometimes death.

In February 2018, a federal panel consolidated cases from several different states into a single litigation in Kentucky. As of Feb. 15, 2018, 84 cases were pending in the U.S. District Court for the Eastern District of Kentucky.

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.

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. Get a Free Case Review

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

There are currently no known class action lawsuits for Onglyza and Kombiglyze XR. But, on Feb. 2, 2018, judges consolidated cases from 23 districts into multidistrict litigation (MDL) No. 2809.

Consolidation allows 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 to all of the consolidated cases.

These orders can address a range of issues, including:
  • Expert testimony
  • Allowable defenses
  • FDA issues
  • Preemption
  • Side-effect evidence

MDL 2809 is in the Eastern District of Kentucky. Chief Judge Karen K. Caldwell is presiding over the cases.

The MDL covers injuries such as heart failure, congestive heart failure, myocardial infarction and cardiovascular injury.

There is also a motion seeking to consolidate cases in California State Court.

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 the defense will gain an understanding on how other cases may play out. This information can be used to inform potential settlement negotiations.

No bellwether trials had been set as of February 2018.

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

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9 Cited Research Articles

  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://wayback.archive-it.org/7993/20170111133905/http://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
  9. U.S. Judicial Panel on Multidistict Litigation. (2018, February 2). In Re: Onglyza (Saxagliptin) And Kombiglyze Xr (Saxagliptin And Metformin) Products Liability Litigation; Transfer Order. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2809-Initial_Transfer-01-18.pdf
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