FIRM MAKES NEW LAW IN DRUG LIABILITY LITIGATION

In a case of first impression the firm won a major victory against a bio- statistical company that acted in conjunction with a medical device developer to obtain approval for a medical device. This was the first recorded case in the United States to hold a bio-statistical company which was acting as a consultant to a medical device/drug manufacturer liable for its conduct . The complaint filed by the firm states that the bio-statistical company, Statprobe, acted in conjunction with a medical device manufacturer in fraudulently obtaining approval by the FDA of a medical device.

The firm after going through an exhaustive review of hundreds of thousands of documents determined that when a study (run by the bio-statistical company, Statprobe, to show the product was effective) was completed it showed the product was not effective. Rather than submit these study results to the FDA as it was required to by a conditional approval, Statprobe, the bio-statistical company, permitted the manufacturer to substitute new data. When the new data was used the statistical analysis showed the product to be effective. Statprobe then prepared a report of this study and submitted it to the FDA withholding information that the original accurate data did not support effectiveness. Relying on the accuracy of the study, the FDA permitted this product to be marketed in the U.S.

The product in question was ADCON-L, a gel which was developed to be used by surgeons to prevent the formation of scar tissue in lower back surgeries. Not only did the product not work, it contributed to leaks of spinal fluid and infections.

The broadening of drug liability resulting from this litigation ensures that in the future, statistical companies that act in concert with drug manufacturers and mislead the public will have to answer for their misdeeds.

FIRM ACHIEVES JURY VERDICT OF $7 MILLION IN A MEDICAL MALPRACTICE ACTION

A Philadelphia jury returned a verdict of $7 million on behalf of the firm’s client (name withheld at the request of the client) in a medical malpractice action against the medical practice of Kominsky & Kubacki Medical Associates, Ltd. Plaintiff, then a 39-year-old married father of one young daughter, died as a result of diabetes and arteriosclerosis. Plaintiff came under the care of Drs. Kubacki and Kominsky in January of 1991. He was morbidly obese which was the primary focus of his management. Between 1991 and 2001 there were a total of 98 visits to the physicians’ office. Over the course of those years, the physicians ignored clinical signs and laboratory tests which indicated the plaintiff had diabetes and cardiovascular disease.

In discovery it was learned that the practice was primarily a diet clinic. Drs. Kominsky and Kubacki passed away in the late 1990s. However, the practice continued to operate by hiring per diem physicians to staff it. Diet pills would be dispensed freely to the patient sometimes without the per diem doctor’s knowledge. The focus of the case was that the practice was more interested in selling diet pills than in attending to a patient’s medical condition.

The plaintiff was a general manager in a Wawa store. His early death left his 36-year-old wife without her beloved husband and his 11-year-old daughter without her best friend.

The jury returned a total verdict of $7 million. After the addition of delay damages, the total verdict is $7,727,808.20.

FIRM ACHIEVES RECORD SETTLEMENT IN EXCESS OF $9 MILLION

After 3½ weeks of trial the defendants in this New Jersey medical malpractice case agreed to pay in excess of $9 million to settle this action. The exact amount of the settlement and identity of the parties cannot be revealed because of the confidential nature of the settlement. It was, however, the largest recorded settlement of a medical malpractice action in Camden County and one of the largest settlements of a personal injury action ever recorded in the State of New Jersey.