|A recent recall of the medication Rezulin incited several diabetics around the world to look into the lingering affects of the drug. This prompted Joseph R. Santoli, an attorney and resident in Ridgewood, to take the lead in a national fight for the victims’ rights.Rezulin was taken off the market on March 21 when the Food and Drug Administration (FDA) determined that the drug is too dangerous for the patients’ liver, especially when compared to similar medications. The FDA said other drugs, such as Avandia (rosiglitazone) and Actos (pioglitazone), offer the same benefits as Rezulin without the same risk.
According to the American Diabetes Association, diabetics have too much glucose in the blood. Glucose is a kind of sugar that body cells use for fuel. When glucose builds up in the blood instead of going into the cells, it can cause the cells to be starved for energy and over time may damage your eyes, kidneys, nerves or heart.
The ADA said that Type II diabetes is the most common form of diabetes. The Type II diabetic either doesn’t make enough insulin or the body cells do not react to the insulin causing sugars to build up in the blood.
Rezulin, or troglitazone, was created for Type II diabetes to be used in combination with insulin injections and other diabetes controlling medications to help the cells absorb the sugars. The drug was distributed in the United States since 1997 by Parke-Davis Pharmaceuticals, a division of Warner-Lambert, but by December the same year, the production was suspended from production by the company’s affiliate in the United Kingdom.
Santoli, along with his co-counsel in New York, Lee Squitierri, of Abbey, Gardy and Squitierri, is reaching out to those who have taken Rezulin and show or have shown serious side effects of the medicine, particularly liver damage. He said the company acted irresponsibly when they pushed the product on the market without thoroughly testing it.
“Diabetics are sick people. That is obvious. That is where the fast-tracking came in,” he said of the rushed production. “This was supposed to be the first drug for those who couldn’t use insulin efficiently. For what it was doing, it wasn’t even effective. Some drugs more or less get pushed through without the proper scrutiny. I think this is one of those cases.”
“Some people have no reaction. Some people went immediately into liver failure. If you’re asymptomatic before taking Rezulin, and then become deathly ill after taking it, there is a problem with Rezulin. As they say, where there is smoke, there is fire.”
According to the ADA, very high levels of glucose in the blood over many can hurt your organs. Diabetes can damage eyes, kidneys and nerves. It also makes heart and blood vessel disease more likely. Santoli said his primary concern is that there is no mention of liver damage as a result of diabetes.
“Liver disease is not a symptom of diabetes. A few years back, an investigator in charge of the application for Rezulin decided to deny its production because it was very toxic to the heart. He was referring to heart complications. This investigator was eventually removed and replaced. The FDA not only rushed it onto the market, they also gave great leeway to Warner-Lambert by glossing over bad studies and by paying little or no attention to the deaths before and during the application period,” said Santoli.
Santoli and his co-counselors are handling individual lawsuits while they continue their push for a class action suit. Because there are individuals suffering from Rezulin all across the country, the possibility of a federal case is still imminent. Santoli handled a similar case in 1997 against Phen-Fen, a diet drug that was found to cause heart troubles for consumers.
He has individual suits and a class action suit pending in Bergen County Supreme Court. None of the cases have been resolved yet.
Santoli said their efforts should not stir concern among those who have taken Rezulin, but did not show any ramifications.
“We advertise specifically for injured people. There are claims being made for medical problems in the future. If you don’t have any problems so far, it is doubtful that you will have any develop in the future. There doesn’t appear to be anything to worry about if you haven’t had problems to this point,” he added.