Janumet and Januvia: Legal Information

This article navigates the complex legal process of filing a claim against a drug manufacturer. This includes examining the statute of limitations that applies to such claims, potential compensation, and FDA action regarding these drugs and relevant legal information.

If you have suffered serious side effects or adverse health effects after using a type 2 diabetes drug, speak to an attorney about your legal options. An expert product liability attorney can determine if you have a case against the drug manufacturer. If so, they will guide you through the claims process and seek fair compensation for your injuries.

Diabetes and Diabetes Drugs

Diabetics struggle to control their blood sugar levels. Patients with type 2 diabetes develop a resistance to insulin, an important hormone that helps metabolize glucose (sugar) from food. This failure to absorb glucose leads to elevated blood sugar levels.

Elevated blood sugar levels can lead to other complications. As the organ responsible for producing insulin, the pancreas can respond to high blood sugar by ramping up its insulin production. When this fails to lower blood sugar, the pancreas may eventually stop producing insulin. The resulting drop in insulin production and continuing insulin resistance raises blood sugar levels.

Most diabetics manage their condition through diet and exercise. When this isn’t enough, diabetes drugs such as Janumet and Januvia can help. They are designed to boost the pancreas’s insulin production and reduce the body’s resistance to insulin. Combined with diet and exercise programs, these drugs can lower blood sugar levels. Janumet and Januvia are part of a group of diabetes drugs known as incretin mimetics.

What Is in Janumet and Januvia?

Januvia contains sitagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor. It works by increasing the levels of incretin hormones, which help regulate blood sugar by increasing insulin release and decreasing glucagon levels.

Janumet is a combination of sitagliptin (same as Januvia) and metformin. Metformin is a biguanide that reduces glucose production in the liver and improves insulin sensitivity.

A key distinction between Janumet and Januvia is that Janumet carries a black box warning—the FDA’s most serious type of warning—because it may cause lactic acidosis, an illness that can cause respiratory and abdominal distress. The metformin Janumet contains can accumulate in the blood, causing lactic acid to build up in the bloodstream. Janumet is often used when metformin alone isn’t enough to control blood sugar.

Risk of Pancreatitis and Pancreatic Cancer

Reports from patients who have taken Janumet and Januvia have raised serious concerns. Several research studies have concluded that these drugs may increase the risk of pancreatitis and pancreatic cancer.

The U.S. Food and Drug Administration (FDA), the federal agency responsible for regulating pharmaceutical drugs, has twice warned doctors and patients about potential pancreatic side effects from taking Janumet and Januvia.

Increased Risk of Pancreatitis

In September 2009, the FDA warned that taking Janumet, Januvia, or Byetta (another diabetes drug) could increase the risk of developing pancreatitis (an inflamed pancreas). Acute pancreatitis is inflammation in the pancreas for a short period of time. The severity can range from mild discomfort to life-threatening.

This warning came after post-marketing reports revealed that 88 patients who took these drugs developed acute pancreatitis. A warning about this risk was later added to drug labels.

The FDA also announced that it was revising the prescribing information for sitagliptin products such as Janumet and Januvia to include reports of acute pancreatitis. Pancreatitis can create conditions where the heart, kidneys, and lungs could be vulnerable to harm.

The grave nature of the situation led the FDA to advise health care professionals to carefully monitor for signs of pancreatitis after initial dosages or increases in dosage of sitagliptin. The FDA also advised health care professionals to discontinue prescribing sitagliptin for patients if pancreatitis is suspected.

Increased Risk of Pancreatic Cancer

Serious concerns continued to surface. In 2013, the FDA announced it would be investigating whether incretin mimetic drugs such as Janumet and Januvia increase the risk for pancreatitis and pancreatic cancer.

The investigation was sparked by reports from academic researchers who took pancreatic tissue samples from deceased patients who had died of unspecified causes. Some of these tissue samples linked incretin mimetics to pancreatitis and pancreatic cancer. The FDA then requested the researchers’ methodology and tissue samples for independent verification.

While the research study’s sample size was relatively small, it garnered much attention. Pancreatic cancer is among the deadliest forms of cancer, with the 5-year relative survival rate for diagnosed patients at 13%.

As of May 2014, the FDA has not yet reached any conclusions on incretin mimetics’ alleged link to pancreatic cancer. Patients are advised to continue taking them until new developments occur.

Janumet and Januvia Lawsuits

Many patients who took Janumet and Januvia later developed pancreatitis or pancreatic cancer. A growing number have sued Merck & Co., claiming that the drugs caused their injuries. Hundreds of these lawsuits have been consolidated before a federal court in San Diego, CA, along with lawsuits against two other manufacturers of incretin mimetic drugs, Byetta and Victoza.

Product Liability Lawsuits

Product liability lawsuits are private lawsuits that can:

• Compensate victims
• Hold manufacturers accountable
• Raise the public’s awareness about dangerous and defective products

Injured patients begin by filing a product liability lawsuit against the relevant manufacturer. Lawsuits must advance one or more”claims”against the manufacturer, or present other legal reasons for holding the manufacturer liable for the plaintiff’s injuries.

Common claims include that the manufacturer:

• Failed to warn doctors and patients about a known side effect
• Defectively designed a product which was unsafe for consumers
• Breached product warranties in selling a defective product

All these claims have been made in Janumet and Januvia lawsuits.

Wrongful Death Lawsuits

Some patients who took Janumet and Januvia have died. For their surviving family members, a wrongful death lawsuit can help ensure that a loved one’s death does not exact a financial toll on those they leave behind. Wrongful death lawsuits can recover compensation for:

• Funeral costs
• Hospitalization and other medical expenses
• Loss of support
• Loss of services
• Loss of consortium (loss of companionship)
• Other damages

Wrongful death suits often involve hiring experts to testify. Consider speaking with a wrongful death attorney before filing a claim.

Potential Compensation for Janumet and Januvia Lawsuits

Patients can file a Janumet or Januvia lawsuit for many reasons, but most are financial in nature. Patients who suffer from a dangerous or defective pharmaceutical drug may:

• Be hospitalized
• Require long-term medical care
• Be unable to work
• Struggle to support their family
• Experience significant pain and suffering

A product liability lawsuit can recover compensation for all of these costs from the manufacturer. If you or a loved one has been injured by Janumet or Januvia, consult a product liability attorney to learn more about your legal options.

Common Janumet and Januvia Side Effects

Common complications and side effects of Januvia and Janumet include:

• Diarrhea and abdominal pain
• Headaches/migraines
• Sore throat
• Muscle aches and cramps
• Breathing difficulties
• Runny or stuffy nose

If you suffer any of these issues while taking one of these drugs, speak with your doctor immediately.

Filing a Lawsuit Against Your Type 2 Diabetes Medication? Get Legal Help

Drug manufacturers have a legal responsibility to produce drugs that are free of defects and safe to use. If you’ve been injured by Janumet or Januvia, you have legal options under product liability laws.

If you’re considering a lawsuit against Merck & Co. for Janumet or Januvia use, consult with a products liability attorney to discuss your options. Most states have statutes of limitations (time limits) for product liability claims, so be careful about taking too long to file a claim. An attorney can evaluate your situation to determine if you have a valid claim. If so, they will advocate for your rights throughout the legal process.