{"id":353286,"date":"2016-04-04T10:46:59","date_gmt":"2016-04-04T15:46:59","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-law\/injury\/product-liability\/janumet-and-januvia-lawsuit-information.html"},"modified":"2025-09-02T16:43:11","modified_gmt":"2025-09-02T21:43:11","slug":"janumet-and-januvia-lawsuit-information","status":"publish","type":"page","link":"https:\/\/www.findlaw.com\/injury\/product-liability\/janumet-and-januvia-lawsuit-information.html","title":{"rendered":"Janumet and Januvia: Legal Information"},"content":{"rendered":"\n
\n

Janumet and Januvia: Legal Information<\/h1>\n\n
\n
\n By Natalie Moritz<\/a> | Legally reviewed by Jordan Walker, J.D.<\/a>\n | Last updated\n
\n \n <\/i>\n Legally Reviewed\n <\/summary>\n\n
\n

This article has been written and reviewed for legal accuracy, clarity, and style by FindLaw\u2019s team of legal writers and attorneys<\/a> and in accordance with our editorial standards<\/a>.<\/em><\/p>\n\n <\/div>\n <\/details>\n\n

\n \n <\/i>\n Fact-Checked\n <\/summary>\n\n
\n

The last updated date refers to the last time this article was reviewed by FindLaw or one of our contributing authors<\/a>. We make every effort to keep our articles updated. For information regarding a specific legal issue affecting you, please contact an attorney in your area<\/a>.<\/em><\/p>\n\n <\/div>\n <\/details>\n<\/section>\n\n\n

\n

Patients have taken legal action against Merck & Co. regarding the diabetes medications Janumet and Januvia. Some developed serious side effects, like pancreatitis and pancreatic cancer, after taking these medications. Product liability lawsuits alleged a failure to warn about potential risks and focused on holding the company accountable for defective drug design, inadequate warnings, and breaches of product warranties.<\/p>\n\n <\/div>\n\n\n\n

Type 2 diabetes medications Janumet and Januvia and manufacturer Merck & Co. have been the subject of extensive litigation. Claims focus on serious health risks like pancreatitis and pancreatic cancer, and the manufacturer\u2019s failure to adequately warn users of these risks. Some families of deceased patients also filed wrongful death lawsuits.<\/p>\n

This article outlines the legal grounds for these lawsuits, the types of compensation available, and how to seek legal help if you’ve been affected. You’ll also learn about FDA action regarding these drugs.<\/p>\n

If you have suffered serious side effects or adverse health effects after using a type 2 diabetes drug, speak to an attorney\u00a0about your legal options. An expert\u00a0product liability attorney<\/a>\u00a0can 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.<\/p>\n

Diabetes and Diabetes Drugs<\/h2>\n

Diabetics struggle to control their blood sugar levels. Patients with\u00a0<\/a>type 2 diabetes<\/a>\u00a0develop 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.<\/p>\n

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.<\/p>\n

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\u00a0incretin mimetics<\/a>.<\/p>\n

What Is in Janumet and Januvia?<\/h2>\n

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.<\/p>\n

Janumet is a combination of sitagliptin (same as Januvia) and\u00a0metformin<\/a>. Metformin is a biguanide that reduces glucose production in the liver and improves insulin sensitivity.<\/p>\n

A key distinction between Janumet and Januvia is that Janumet carries a black box warning\u2014the FDA’s most serious type of warning\u2014because it\u00a0may cause lactic acidosis<\/a>, an illness that can cause respiratory and abdominal distress. The metformin\u00a0Janumet contains\u00a0can accumulate in the blood, causing lactic acid to build up in the bloodstream.\u00a0Janumet is often\u00a0used when metformin alone isn’t enough to control blood sugar.<\/p>\n

Risk of Pancreatitis and Pancreatic Cancer<\/h2>\n

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.<\/p>\n

The\u00a0U.S. Food and Drug Administration<\/a>\u00a0(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.<\/p>\n

Increased Risk of Pancreatitis<\/strong><\/h3>\n

In September 2009,\u00a0the FDA warned<\/a>\u00a0that 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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Increased Risk of Pancreatic Cancer<\/strong><\/h3>\n

Serious concerns\u00a0continued to surface. In 2013, the FDA announced it would be investigating whether incretin mimetic drugs such as Janumet and Januvia\u00a0increase the risk for pancreatitis and pancreatic cancer<\/a>.<\/p>\n

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\u00a0requested the researchers’ methodology and tissue samples for independent verification.<\/p>\n

While the research study’s sample size was relatively small, it garnered\u00a0much attention.\u00a0Pancreatic cancer is among the deadliest forms of cancer, with\u00a0the\u00a05-year relative survival rate<\/a>\u00a0for diagnosed patients at\u00a013%.<\/p>\n

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.<\/p>\n

Janumet and Januvia Lawsuits<\/h2>\n

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\u00a0other manufacturers of incretin mimetic drugs, Byetta and Victoza.<\/p>\n

Product Liability Lawsuits<\/strong><\/h3>\n

Product liability<\/a>\u00a0lawsuits\u00a0are private lawsuits that can:<\/p>\n