Drug giant faces flood of lawsuits over Lipitor
Drug giant Pfizer is facing almost 1,000 US lawsuits over its Irish-made blockbuster drug Lipitor.
The cases have been taken by women who say that taking Lipitor gave them type-2 diabetes.
In the past five months the number of cases has shot up from 56 to almost 1,000. The cases were revealed following a review by Reuters of US federal court filings.
Lawsuits began to be filed not long after the American Food and Drug Administration (FDA) warned in 2012 that Lipitor and other statins had been linked to incidents of memory loss and a "small increased risk" of diabetes. According to plaintiffs' lawyers, women face a higher risk than men of developing diabetes from using Lipitor, and gain fewer benefits.
Statins, such as Lipitor, are a class of drugs that block the liver's production of cholesterol to reduce the risk of heart disease. Type 2 diabetes, once known as adult-onset or non-insulin-dependent diabetes, is a chronic condition that affects the way the body metabolises glucose.
The recent spike in lawsuits followed a decision by a federal judicial panel to consolidate all Lipitor diabetes lawsuits from across the US into a single Federal courtroom in Charleston, South Carolina.
The drug manufacturer opposed the consolidation, arguing it would prompt copycat filings. The first case is scheduled to be tried next July.
Pfizer is one of biggest companies in Ireland, with plants in eight locations including Dublin, Cork and Kildare. It has invested over €5m in its Irish operation and employs 4,000 workers. In a statement, the company said it would fight the lawsuits.
It is not uncommon for a drugmaker to get hit with thousands of lawsuits over its products after the FDA issues an alert. Lipitor is the best-selling prescription drug of all time with global sales of more than $130bn (€97m) since 1996.
On the other hand, potentially complicating matters for plaintiffs, the FDA emphasised the benefits of statins even as it warned of the risks.
When the labelling change was released in 2012, a top FDA official underscored that the agency still stood behind the drugs.
"Clearly, we think that the heart benefit of statins outweighs this small increased risk (for diabetes)," Amy Egan, a deputy director for safety at the agency's Division of Metabolism and Endocrinology, said in a statement.
Lawyer H Blair Hahn, who represents the Lipitor plaintiffs, said her clients contracted diabetes as a consequence of taking Lipitor, and that women with diabetes see the length and quality of their lives reduced.
He said the nearly 1,000 cases filed so far represent 4,000 women, and that the number of cases could ultimately reach 10,000 or more.
Pfizer said it believes Lipitor did not cause the plaintiffs' diabetes. Women who are prescribed Lipitor to control cholesterol may share other risk factors that make them vulnerable to the disease, such as high blood pressure or obesity, the company said. The Pfizer statement said there is an "overwhelming consensus" in the medical community about statins' benefits.
The first Lipitor trial is scheduled for next July.