Articles Posted in Product Liability

Recent medical research suggests that certain type 2 diabetic medications, known as Incretin Mimetics, including Januvia, Janumet, Byetta, Bydureon and Victoza, are potentially linked to an increased risk of pancreatic cancer side effects when compared to other diabetes treatment.

Incretin Mimetic Investigation Timeline

April 18, 2013 – Institute for Safe Medication Practices (ISMP) released a disturbing report. ISMP, monitors FDA MedWatch reports, focused on Byetta, Victoza, Januvia, Onglza and Tradjenta. Based on the report, ISMP is calling for stronger alerts on the prescribing information, as well as new studies on the long-term effects of these diabetes treatment drugs and the association with thyroid and pancreatic cancer.

The California state court judge has tossed last week’s Actos bladder cancer verdict and has reversed the $6.5 million damage award. The judge issued a post-trial ruling rejecting key expert witness testimony.

Last week, the Los Angeles County jury awarded plaintiff Jack Cooper $6.5 million for his bladder cancer injuries from Actos side effects. The trial lasted more than 2 months and Cooper argued that Takeda Pharmaceuticals, the manufacturer of Actos, failed to adequately warn about the Actos cancer risk and claimed that use of the medication for more than two years resulted in his November 2011 diagnosis of bladder cancer.

Superior Court Judge Kenneth Freeman issued an Order tossing the jury verdict after determining that expert testimony was inadmissible. Judge Freeman determined that causation was not established in Cooper’s case. Judge Freeman said the medical expert (Dr Smith) relied on unreliable studies and did not give enough weight to Cooper’s risk factors. Cooper aged 60 and was a former smoker, a major risk factor which Takeda says probably played a larger role in his risk of bladder cancer than Actos.

According to the Institute for Safe Medication Practices (ISMP)’s Quarter Watch report, the number of pancreatic cancer cases are increasing involving lethal side effects of Byetta, Januvia, Victoza and other diabetes drugs known as incretin mimetics.

ISMP evaluates adverse event reports submitted to the FDA, and the report, Perspectives on GLP-1 Agents For Diabetes, evaluated adverse event reports for exenatide (Byetta and Bydureon), liraglutide (Victoza), sitagliptin (Januvia and Janumet), saxagliptin (Onglyza) and linagliptin (Tradjenta).

The yearly adverse event report data ending June 2012, demonstrated that there were at least 1,723 serious adverse events submitted through the FDA’s MedWatch program. There were at least 105 pancreatic cancer cases and 831 reports of pancreatitis. Pancreatitis or inflammation of the pancreas gland is an important risk factor for the development of pancreas cancer.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has received a request to consolidate all federal pancreatic cancer lawsuits. These were filed by patients using Januvia, Janumet, Byetta and Victoza incretin mimetic diabetic drugs and they allege that they developed pancreatic cancer.

The injured pancreatic cancer plaintiffs have requested that all cases be centralized before U.S. District Judge Battaglia in the Southern District of California for coordinated proceedings as part of multidistrict litigation. The plaintiffs would like one single MDL be created for all Byetta, Januvia, Janumet and Victoza lawsuits, as opposed to having four separate MDLs established.

What are Incretin Mimetic Class of Drugs?

Merck & Co. (MRK) is defending a woman’s claim that its osteoporosis drug Fosamax weakened her femur, causing her leg to break when she fell in her driveway. This is the second Fosamax femur fracture injury claim going to trial. The first trial, in state court in Atlantic City, New Jersey, was called off after plaintiff Christina Su suffered a “sudden illness” that was unrelated to her use of Fosamax.

A three-week jury trial has started before U.S. District Judge Joel Pisano in Trenton, New Jersey. The plaintiff, Bernadette Glynn fell and injured herself in April 2009. Merck claimed that Glynn, 58, tripped over a chainsaw in her garage and that the fracture is typical of women with osteoporosis.

Fosamax and Femur Fracture Allegations

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has issued an order to consolidate all Mirena IUD injury perforation injury lawsuits. This order applies to all cases filed throughout the federal court system. All Mirena IUD injury cases will be centralized before one judge as part of an MDL, or multidistrict litigation.

According to the JPML order, all defective Mirena IUD product liability lawsuits will be transferred to U.S. District Judge Cathy Seibel in the Southern District of New York for coordinated handling during pretrial proceedings.

What is Mirena IUD?

Can You Die From Januvia Pancreatic Cancer? The short answer is; it depends. Some 25 to 30 million people in the United States have diabetes, and 80 million folks have medical condition known as pre diabetes.

And the numbers are increasing slowly but surely. And Type 2 or adult onset diabetes is generally considered a man made problem (excluding Type 1 diabetes which occurs in childhood and usually as a result of genetic factors, autoimmune disease and or environmental problems).

Januvia is a drug manufactured by Merck, and it is used to treat adults with type-2 diabetes. In September 25, 2009 the FDA issued a revision to the warning label of the drug Januvia or Janumet, a combination drug comprised of Januvia and Metformin, regarding Januvia side effects, including Januvia pancreatic cancer and Januvia thyroid cancer.

As a Texas medical doctor and Dallas Januvia/Byetta/Victoza dangerous drug Pancreatic Cancer attorney I am providing this latest information and investigation from the FDA.

According to the FDA notice, posted on March 14, the agency is:

“Evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.”

According to a recent medical study, patients taking the newer diabetes drugs were affected by pancreatic cell growth and damage that may turn cancerous. The study, by UCLA Medical Center, provides evidence of increased pre-cancerous changes in diabetic patients using incretin mimetics drugs such as Januvia, Byetta and Victoza.

FDA Investigates Incretin Mimetics

According to the U.S. Food and Drug Administration, it was reviewing unpublished data by medical researchers which suggest that pre-cancerous cellular changes may be associated with Type 2 diabetes drugs known as incretin mimetics, including Bristol-Myers Squibb’s Byetta and Novo Nordisk’s Victoza.

The jury finally rendered a verdict today, in a hotly contested Johnson & Johnson defective hip lawsuit, being tried in California state court, Los Angeles. Johnson & Johnson (J&J)’s DePuy subsidiary unit was found liable for defectively designed metal-on-metal hip implant, in the first of 10,750 lawsuits over the device to go to trial.

Jury: Clear Message

The California jury sent a clear message today that Johnson & Johnson and DePuy put profit over safety by awarding Loren Kransky, the plaintiff in the California case of Kransky v. DePuy Orthopedics, $ 8.3 million for damages caused by Mr. Kransky’s implantation and revision of the recalled DePuy ASR XL hip implant.