A giant in the industry of pharmaceuticals is currently being presented with a growing number of lawsuits concerning one of its popular medications, Lipitor. Whatever drug someone happens to take in order to lower cholesterol levels there may be side-effects. This, of course, is true for most any health issue and drug being taken to counter-act the health issue. Now, Pfizer and its prescription medication, Lipitor, are heading for a fight in court concerning its anti-cholesterol side-effects.
Pfizer has been presented with a current count of nearly 1,000 lawsuits by women in the United States who have been taking Lipitor. They are claiming that the drug has given them type-2 diabetes. The Food and Drug Administration first came out in 2012 with a warning about a small risk of diabetes as a possible side-effect. According to statements in the lawsuits against Pfizer in this case, there is a higher risk of developing diabetes after taking Lipitor for women than there is for men.
Pfizer contends it is not liable and opposes the lawsuits. Due to the recent increase in lawsuits against Pfizer in the Lipitor case a federal panel of judiciaries is combining the Lipitor diabetes cases across the U.S. into a class action lawsuit hearing that will be held at a Federal courtroom in Charleston, South Carolina. Pfizer protested the integration of the lawsuits, maintaining the action would stir into existence copycat cases. The initial case is set to begin in July of 2015.
What sets this case apart from many other prescription drug related lawsuits is the enormous popularity of Lipitor. It has a global sales impact of more than $130 billion, making it the prescription drug with the most sales since it was introduced into the market in 1996. Lipitor has been prescribed to more than 29 million people in this country, making for an extensive reservoir of potential clients filing lawsuits against Pfizer.
The court fight against Lipitor and its cholesterol benefit properties may find a tough battle ahead. The popularity of Lipitor might mean that some of the warnings and side-effects associated with the drug may have been minimized due to its anti-cholesterol benefits.
To bolster this view, a cardiologist and professor at Scripps Research Institute, Eric Topol, spoke out in March, 2012 with a New York Times Op-Ed piece. According to Topol, the very drugs American are taking to combat cholesterol are also resulting in consumers of such drugs “overdosing on cholesterol-lowering statins.” As a result, Topol added that this overdose of cholesterol-lowering statins could lead to a marked rise in “Type 2 diabetes.”
According to Topol, large-scale objective evaluations of cholesterol lowering statin drugs have shown a definite connection with diabetes when the drugs are used at higher doses. Combined studies and the data used in them demonstrated the risk for diabetes was one in 255 persons using the medication. The information from these studies was combined in 2010 with a total of 91,000 cases where subjects were assigned a placebo or an actual drug on a random basis.
A conundrum in this type of lawsuit is the information provided by the FDA. The FDA highlights the benefits of statin drugs as being beneficial for lowering the risk of heart problems, while also releasing information of the risk of getting diabetes. A statin drug is used to block production of cholesterol in the liver, thus reducing the risk of disease in the heart. Type 2 diabetes is a chronic condition affecting the body’s glucose metabolization, and is known as non-insulin dependent or adult-onset diabetes.
This dilemma may present a difficult and contentious legal entanglement for the plaintiffs. The risk of taking Lipitor and acquiring diabetes in the process and the risk of whether or not it is beneficial due to the drug’s effectiveness with heart disease is a seeming conflict of use and may result in difficult legal wrangles. Whichever side wins this litigation in July may well chart the course for any cases to follow.
If Pfizer prevails, there may be a domino effect and all subsequent cases might face steep uphill contests in court or cause future plaintiffs to settle out of court. Pfizer may also take a different course altogether, settle out of court. By doing so, they might avoid exposure of information it does not want disclosed. The monetary settlement amount may play a major factor in the choice to settle or fight the allegations in a protracted legal battle.
It appears because of the FDA statements about Lipitor, Pfizer may have the upper hand in court. Plaintiffs may need unimpeachable evidence that the drug was the instigator in causing Type-2 diabetes. The Lipitor fight against cholesterol is now not just a medical issue but is one that is being fought in court.
By Andy Towle