ACTOS LAWSUIT UPDATE

Actos, a prescription drug designed to help diabetes patients manage their blood sugar levels, is one of the best selling drugs in the United States, bringing in over $2.4 billion dollars in sales. Hundreds of thousands of people worldwide have taken Actos, but many may be unaware of the increased danger of bladder cancer that long-term usages of Actos can bring.

In early testing, Actos was found to provide only a small increase in the chance of contracting Actos bladder cancer while taking the drug. However, in September 2010, the FDA announced that Takeda Pharmaceuticals, the manufacturer of Actos, provided interim data spanning five years that suggests there may be a risk of bladder cancer the longer the medication is used. After 24 months, the rate of exposure and the increased Actos cancer risk reached statistical significance. In June 2011, an Actos recall was issued in France after health authorities ordered doctors to stop prescribing the drug due to the possible risk of bladder cancer.

Germany has also pulled the drug completely off of the market. The sale of Actos is still allowed in the United States at this time, but the FDA has issued a warning about the product and the risk of bladder cancer. The FDA has also ordered the manufacturer to change the wording on the drug’s warning labels. Despite the enhanced warning labels on the drug, this does not mean that patients who have contracted Actos bladder cancer after taking Actos long-term to treat their diabetes cannot file an Actos lawsuit.

Because of these new findings, dozens of Actos lawsuits have been filed by people seeking redress for their injuries. A class action lawsuit has recently been filed in Louisiana against Takeda pharmaceuticals claiming that information about the danger of Actos bladder cancer was suppressed or hidden from the general public. The Actos lawsuit also alleges that the manufacturer had significant financial incentives to try and prevent the spread of the information.  In general, anyone who was prescribed the drug is a potential class member of the Actos lawsuit, even if they did not contract Actos bladder cancer while taking the drug.

A motion was filed by plaintiffs’ lawyers in August to centralize the federal litigation over bladder cancer from Actos into an “MDL”. An “MDL”, or Multi-District Litigation, is a powerful tool useful in mass torts litigation and I have blogged extensively about the benefits of the procedure. Pittman, Dutton & Hellums has represented many injured plaintiffs in a number of MDL’s including In re: Total Body Formula, In Re: Chinese-manufactured Drywall and In re: DePuy Orthopaedics, Inc. ASR Hip Implant.

Although Takeda Pharmaceuticals has indicated they agree the lawsuits should be consolidated for discovery and pretrial proceedings, they disagree about where the cases should be centralized. The U.S. Judicial Panel on Multidistrict Litigation heard oral arguments for a motion for centralization of the Actos lawsuits on December 1, at their hearing session at the Tomochichi United States Courthouse in Savannah, Georgia. All lawsuits allege that defendants, including Takeda Pharmaceuticals, were negligent and failed to warn of the risks associated with the medication. The motion for the MDL was filed on August 31 by plaintiffs Glen and Nina Weant. Our firm filed a brief advocating for the MDL to be located in Birmingham, Alabama.

As a patient who was prescribed Actos, either for diabetes glucose management or any other reason, you need to be aware of the increased risk of Actos bladder cancer that taking Actos brings. If you have Actos bladder cancer, or believe that you may have Actos bladder cancer, please contact me at booths@pittmandutton.com or call toll free 1-866-515-8880.

Latest Alabama Supreme Court Ruling on Experts

On November 18, 2011, the Alabama Supreme Court issued an opinion in Springhill Hospitals, Inc. v. Critopoulos, No. 10909646.  After undergoing a cardiac-artery-bypass graft, Critopoulos was placed in the cardiac-recovery unit, where a nurse noticed that he had developed a decubitus ulcer.  A med-mal lawsuit was brought against several nurses and the hospital.  One contention was that the nurses allowed the development of the ulcer because they did not properly move or rotate him while he was bed-ridden.  The trial court rejected the defendants’ challenges that the plaintiff’s nursing expert was not “similarly situated.”  The jury found for the plaintiff as to all but one nurse and awarded $300,000 in damages.  The Supreme Court found that the expert did not qualify as “similarly situated.”  The expert was amply qualified in the area of wound-care management and pressure-ulcer prevention; she was a “big wig” at Duke Hospital. 

The Supreme Court concentrated on the fact that the care was rendered in a cardiac-recovery unit and involved the concerns and/or risks associated with a fresh post-CABG patient. They also honed in on the point that the expert, “had never seen an immediate post-CABG patient for preventive measures; that she had provided hands-on treatment to fresh postoperative patients only for would care; and that, at Duke, the cardiac-recovery nurses provided pressure-ulcer-prevention care for postoperative patients in the cardiac-recovery unit.”  The expert could not evaluate how unique factors in caring for this type of patient would influence decisions as to moving or rotating a patient.

This opinion demonstrates the need to have your expert look as much like the defendant healthcare provider as possible.  Critopoulos’s expert was clearly tops in the general field of pressure-ulcer prevention; still, the Supreme Court concluded that post-CABG patients are unique enough that the expert should be familiar with caring for such unique patients.  This opinion is consistent with a trend of opinions that hold that a generalist cannot qualify as a “similarly situated” healthcare provider when the defendant was practicing a specialized area of medicine.

Merck Wins Another Bellwether Fosamax Trial

Merck, manufacturer of the drug Fosamax, has declared itself the victor in the fifth bellwether trial concerning the product and a condition known as osteonecrosis of the jaw (“ONJ”). The Whitehouse, N.J., drug maker is facing hundreds of cases in state and federal courts, generally alleging that use of Fosamax can cause a jaw-destroying condition known as ONJ and that Merck failed to properly warn of this risk.

On October 3, Merck issued a press release announcing that “a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.” Secrest v. Merck (case no. 1:06-cv-06292)—a so-called bellwether lawsuit—is the fifth lawsuit involving claims that Fosamax caused a plaintiff to suffer ONJ to go to trial. Merck, the developer and manufacturer of the brand-name drug, is currently defending thousands of Fosamax cases, including cases alleging that the drug caused users to suffer femur fractures, as well as ONJ cases. The cases involving femur fractures were recently transferred to a separate MDL.

Merck won three of the first four bellwether trials in the ONJ MDL. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck in May 2010; the second case to be tried to a verdict, Boles v. Merck, initially resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict and a retrial of that case in June 2010 resulted in a plaintiff verdict-which was later reduced by Judge Keenan and which Merck intends to appeal after the damages portion of the case is retried; the third case to be tried to a verdict, Graves v. Merck, resulted in a defense verdict for Merck in November 2010; and the fourth case to go to trial, Rosenberg v. Merck, which was tried in the Superior Court for Atlantic County, New Jersey, resulted in a defense verdict for Merck in February 2011.

The outcome is significant because bellwether trials are used to assist attorneys to evaluate similar cases for determining settlement talks and strategies. As of June 30, 2011, there were about 1,650 lawsuits, including approximately 2,050 plaintiff groups, that have been filed in federal and state courts.