Products Liability
Onglyza (saxagliptin) is a drug used by people with type 2 diabetes to help regulate their blood sugar levels. Kombiglyze XR is saxagliptin combined with metformin. The defendants, including Bristol-Myers Squibb, AstraZeneca, and McKesson, market FDA-approved type 2 diabetes treatments containing saxagliptin, an inhibitor of dipeptidyl-peptidase-4 (DPP-4).
An Onglyza class action lawsuit alleged these drugs may also cause cardiac failure which can lead to death. But believing that and proving it are two different things as plaintiffs have discovered in the MDL in Kentucky. This lawsuit has not… gone well.
Onglyza Lawsuit February 2024 Update (Bad News)
In a death knell to the federal litigation the Sixth Circuit upheld a decision favoring AstraZeneca, Bristol Myers, and McKesson Corp. The court found the plaintiffs’ expert testimony unreliable, particularly criticizing their sole causation expert, Dr. Parag Goyal, for basing his opinion on a single study and ignoring others, as well as using animal data without the necessary expertise.
The panel supported the Kentucky federal court’s exclusion of Goyal’s testimony and its summary judgment for the drugmakers, emphasizing the necessity of expert testimony to establish general causation in complex medical cases. The plaintiffs’ inability to provide credible expert testimony on causation led to the dismissal of their claims.
How about more time for a new expert? No. The court also denied the plaintiffs’ request for additional time, highlighting a failure to identify reliable experts despite ample time for discovery and the potential for significant delays and costs to the defendants if the process were to restart. This is a hard argument to contest, to be honest.
My take? This litigation is going nowhere.
Onglyza Lawsuit July 2023 Update
Onglyza lawsuits are now on appeal. Pharmaceutical manufacturers AstraZeneca and Bristol-Myers Squibb, alongside distributor McKesson, have implored the federal appeals court to uphold the dismissal of lawsuits alleging that their diabetes drugs, Onglyza and Kombiglyze XR, led to heart failure in patients.
Their argument is that the plaintiffs’ 250 lawsuits do not have a viable expert. They argue that the sole expert, cardiologist and epidemiologist Parag Goyal, who linked the drugs to heart failure, was rightfully excluded as his methodology was deemed unreliable. In a drug case like this, no expert means no case.
Why did the court find the expert unreliable? The court found that Goyal’s opinion was unqualified because he relied on a singular study for causation while ignoring all other relevant human data. Plaintiff’s attorneys argue that Goyal’s opinion was scientifically sound.
Onglyza Lawsuit January 2023 Update (Bad News)
The class action litigation alleging that the diabetes drug Onglyza causes heart failure is essentially over. Earlier this year, MDL Judge Karen Caldwell excluded the plaintiff’s expert witness on causation because his reliance on a single clinical study was not consistent with the accepted methodology.
Judge Caldwell simultaneously rejected the plaintiffs’ motion to bar the defense rebuttal experts. These rulings eventually set the stage for the Judge’s ruling late last year granting the defendants summary judgment on all claims. Judge Caldwell explained that without expert testimony to support their claims that Onglyza causes heart failure, the plaintiffs could not be allowed to move forward unless plaintiffs are successful.
The reality is when you can only develop one expert in a class action lawsuit, you are probably working uphill. On top of that, your single expert is relying upon a single clinical study to show that the Onglyza causes heart failure.
How Onglyza Works
Onglyza works by inhibiting the proteolytic activity of DPP4. This increase the action of Glucagon-like peptide-l (GLP-I) which is an antihyperglycemic hormone known as an incretin. This causes glucose-dependent stimulation of insulin secretion while suppressing glucagon secretion, which may patients on Onglyza users to lower their HAle.
DPP-4 (dipeptidyl peptidase-4) inhibitors are used in combination with other drugs to normalize blood sugar by causing the pancreas to produce more insulin after meals. This insulin boost blocks the liver from producing excessive blood sugar. Onglyza is a very popular medication for people with type 2 diabetes because unlike other blood sugar drugs, Onglyza does cause weight gain.
Onglyza Increases Risk of Heart Failure
Onglyza is manufactured and sold by Bristol-Myers Squibb (“BMS”) and AstraZeneca Pharmaceuticals (“AZ”). Onglyza was first released on the market in 2009. A year before its release, the FDA issued new testing guidance to companies developing diabetes drugs such as Onglyza. The new guidelines called for testing to evaluate the cardiovascular safety of drugs like Onglyza. One of the primary health dangers of type 2 diabetes is an increased risk of heart problems. So the FDA wanted to make sure that drugs used to treat diabetes did not increase this even further.
BMS and AZ did not want to delay the release of their new drug. They ignored the new FDA guidance. Instead, they opted to perform cardiovascular safety testing after Onglyza was released. So the companies did not perform studies to determine if these drugs and their drastic alterations of the natural incretin hormone cycle, increased the risks of cardiac injury. It is particularly true in this case because patients taking these drugs are already at an increased cardiovascular risk. But studies take time and time delays profits.
SAVOR Study That Triggered Litigation
Onglyza had been on the market for several years by the time BMS and AZ finally completed the recommended cardiovascular safety testing. So in 2013, the FDA required the manufacturers of Onglyza to conduct a clinical trial to evaluate the cardiovascular safety of the drug.
Following the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee’s 2008 recommendation for further clinical studies to explore the cardiovascular risks associated with diabetes medications, the SAVOR trial was initiated. This randomized-controlled trial involved 16,492 type 2 diabetes patients with a history of or risk for cardiovascular events, comparing saxagliptin to a placebo over an average of 2.1 years.
These findings were published in 2013 in the New England Journal of Medicine. This prompted the FDA to issue a safety communication in February 2014 on a possible link between Onglyza and heart failure. Based on the results of this testing, an FDA advisory committee voted 13 to 1 in favor of adding heart failure warnings to Onglyza. The 1 member who voted against believed that the drug was so unsafe that it should be recalled. BMS and AZ ignored the FDA advice and continued to market Onglyza without adding any warning about heart failure risks. In April 2016 the FDA published its official warning about the risk of heart failure associated with Onglyza.
Onglyza Lawsutis Filed
Over the last year, several Onglyza lawsuits have been filed against BMS and AZ. More than 200 Kombiglyze XR and Onglyza lawsuits pending are pending in federal court. Even more Onglyza lawsuits are on file against BMS and AZ in state courts. There have been more filed in recent months but we do not have the exact data on the total number of plaintiffs.
The premise of the Onglyza lawsuit is that the use of Onglyza or Kombiglyze causes a user to develop heart failure, or in a wrongful death case, caused the patient’s death. The Onglyza lawsuits allege that BMS and AZ knew that there was an increased risk of heart failure associated with Onglyza.
The suits allege that despite this knowledge BMS and AZ marketed and sold Onglyza without any warnings about the dangers or risk of heart failure. As a result, plaintiffs are claiming that their prescribing doctors were unaware of the health risks associated with Onglyza and that they were injured as a result.
To date, none of the Onglyza lawsuits have been settled or otherwise resolved. [2024 Update: And the prospects are very slim now.] Onglyza lawsuits may be be very difficult to defend because of some of the decisions that the drug companies made. First, there is no dispute that BMS and AZ ignored the FDA guidance and put Onglyza on the market without the recommended testing on cardiovascular safety.
Instead, they opted to this testing after the drug was on the market, only to learn that Onglyza did, in fact, increase the risk of heart failure. This looks really bad for them and could heavily influence a jury at trial. It makes it seem like BMS and AZ rushed the drug onto the market for financial reasons without regard for public safety.
BMS and AZ will also have a very difficult time defending their refusal to add warnings about heart failure risks. Plaintiffs’ lawyers contend it was apparent that Onglyza may increase a patient’s risk of heart failure. At that point, BMS and AZ should have added warnings about heart failure risks to the Onglyza label. Instead, they continued to market and sell the drug for several more years before adding a warning about heart failure. Again this decision just looks really bad and may suggest to a jury that BMS and AZ cared more about their bottom line than the lives of people who used their drug.
Our Law Firm Is Not Handling Onglyza Cases
In 2023, our law firm is not handling Onglyza lawsuits. The prospects for these claims appear grim.