Onglyza (saxagliptin), a type 2 diabetes drug, has faced thousands of lawsuits since gaining FDA approval in 2009. Plaintiffs allege that manufacturers AstraZeneca and Bristol-Myers Squibb were negligent and put profits above patient safety.
Core Allegations of the Lawsuits
The Onglyza lawsuits focus on a few key claims:
- Increased Heart Failure Risk: Plaintiffs contend Onglyza wasn’t adequately tested, revealing increased heart failure risk that should have prompted stronger warnings or even withdrawal.
- Pancreatic Inflammation and Cancer: Lawsuits argue the drug carries a risk of pancreatitis (inflammation of the pancreas) and that prolonged pancreatitis elevates pancreatic cancer risk.
- Deceptive Marketing: Plaintiffs claim the companies downplayed or hid the true danger associated with Onglyza, misleading patients and physicians
Onglyza (saxagliptin), a type 2 diabetes drug, has faced thousands of lawsuits since gaining FDA approval in 2009. Plaintiffs allege that manufacturers AstraZeneca and Bristol-Myers Squibb were negligent and put profits above patient safety.
Core Allegations of the Lawsuits
The Onglyza lawsuits focus on a few key claims:
- Increased Heart Failure Risk: Plaintiffs contend Onglyza wasn’t adequately tested, revealing increased heart failure risk that should have prompted stronger warnings or even withdrawal.
- Pancreatic Inflammation and Cancer: Lawsuits argue the drug carries a risk of pancreatitis (inflammation of the pancreas) and that prolonged pancreatitis elevates pancreatic cancer risk.
- Deceptive Marketing: Plaintiffs claim the companies downplayed or hid the true danger associated with Onglyza, misleading patients and physicians
Understanding the MDL and Bellwether Trials
- Multidistrict Litigation (MDL): When lawsuits share similar allegations, an MDL combines them for efficiency. Judge’s rulings often influence settlement offers to non-MDL plaintiffs.
- Bellwether Trials: Key cases are tried early. Outcomes test overall arguments. Wins for either side increase pressure to settle future cases rather than risk further trials.
Outcomes and Ongoing Legal Actions
- Mixed Verdicts: Bellwether trials lacked overwhelming victory for either side. Some favored plaintiffs, others manufacturers, likely contributing to…
- Settlement Spike: While there’s no single class-action payout, thousands of cases resolved through individual settlements, often confidential.
- Not Fully Over: Some cases may persist as individuals choose to litigate rather than take settlements offered.
Further Controversy: FDA Panel Decisions
In 2014, an FDA advisory panel debated Onglyza safety:
- Vote to Keep on Market: 14-1 vote NOT to withdraw Onglyza, arguing benefits still outweighed risks if risks were clearly stated.
- Vote for Stronger Warnings: Panel agreed manufacturers needed to strengthen heart failure warnings, reflecting increased data.
Impact on Patients and the Pharmaceutical Industry
- Heightened Awareness: Lawsuits highlight how medications thought safe have unexpected dangers emerge over time.
- Scrutiny on Data Transparency: Questions persist about how much pre-approval drug trial data companies should release, and when safety signals warrant quick action.
- Financial Cost of Litigation: Pharmaceutical giants face considerable litigation costs, even when legal battles aren’t decisively lost.
What Onglyza Users Should Know
- Medical Advice: Never stop medication solely due to a lawsuit. Discuss potential risks and alternatives with your healthcare provider.
- Monitoring Signs: Be aware of heart failure symptoms (shortness of breath, leg swelling) or pancreatitis (severe upper abdominal pain) and seek medical help.
- Legal Consultation: If you took Onglyza and experienced serious health conditions, an attorney specializing in pharmaceutical claims can assess your options.
