Past Lawsuits

Lupron

Prostate Cancer
Prostate cancer is the most common type of cancer found in American men, other than skin cancer. The American Cancer Society estimates that there will be about 230,900 new cases of prostate cancer in the United States in the year 2004. About 29,900 men will die of this disease. Prostate cancer is the second leading cause of cancer death in men, exceeded only by lung cancer. About 70% of all diagnosed prostate cancers are found in men aged 65 years or older. In addition, African-American men are more likely to have prostate cancer and to die of it than are white or Asian men.

About Lupron
The hormone testosterone, naturally produced by men, promotes the growth and spread of prostate cancer. One method of treatment of prostate cancer has been the suppression or elimination of testosterone in men suffering from the disease. Testosterone can be eliminated through the surgical removal of the testicles. Alternatively, a man's production of testosterone can be suppressed through the administration of either Lupron or Zoladex (a direct competitor of Lupron). Lupron is manufactured, marketed, and sold by Abbott Laboratories, Takeda Chemical Industries, and TAP Pharmaceuticals (a wholly owned joint venture of Abbott and Takeda). Lupron has been marketed as a treatment for prostate cancer since the 1980s. Lupron is administered to patients in liquid form by intramuscular injection. It is available in daily, one month, three month and four month doses. It is typical for a patient whose prostate is being treated with Lupron to receive regular injections for the remainder of his life.

PAL Member Litigation
In September 2001, PAL filed suit against Abbott, Takeda and TAP (collectively, Defendants) alleging a wide-ranging scheme to defraud patients using Lupron. The PAL suit was brought under the Racketeer Influenced and Corrupt Organizations Act (RICO) and was filed in federal court.

The suit alleges that during the period from 1993 through the present, Defendants created and implemented a fraudulent marketing and sales scheme to substantially increase the sale of Lupron and reap unlawful profits at the expense of Medicare patients. As part of this scheme, Defendants:

• deliberately overstated the average wholesale price ("AWP") for Lupron, the rate upon which Medicare reimbursement and Medicare beneficiary co-payments are set, causing Medicare and Medicare patients to pay artificially inflated rates for Lupron;
• provided free samples of Lupron to medical providers and instructed them to bill Medicare and Medicare patients for the free samples; and
• provided other unlawful financial inducements to medical providers to prescribe Lupron, causing artificial inflation in the price for Lupron.

The above scheme enabled Defendants to control how much reimbursement is made under Medicare for Lupron. They deliberately marketed and promoted the sale of Lupron based on the availability of inflated payments made by Medicare and Medicare beneficiaries. Twenty percent of the inflated Medicare payments come directly from co-payments and deductibles paid by Medicare beneficiaries.

In separate criminal cases, several urologists have pled guilty to charges that they conspired with TAP to defraud Medicare and Medicare beneficiaries regarding the usage of Lupron. The federal government also brought charges against TAP, seeking to recover its portion of the fraudulent charges, which constitute 80% of the overpayments. TAP agreed to settle this case, pleading guilty and agreeing to pay $875 million. This was the largest health care fraud settlement in history.

PAL's suit seeks to recover the other 20% of the overpayments paid by individual Medicare beneficiaries.

In January 2003, the Court ruled on one defendant's (Takeda's) motion to dismiss for lack of personal jurisdiction. This motion was denied in part and granted in part. Ultimately, the case against Takeda survived the motion and will remain before Judge Stearns.

In December, 2003, almost a year since oral argument on the matter, Judge Stearns issued his ruling on Defendants' Motions to Dismiss. The ruling was a very good one for Plaintiffs. In upholding most of the claims against Defendants and allowing the litigation to proceed, Judge Stearns - in reference the Defendants' arguments that the prices published by Defendants were analogous to "sticker prices" and Defendants therefore cannot be held liable for fraud - observed that "[t]here is a difference between a 'sticker price' and a 'sucker price.'" As a result of this ruling, Plaintiffs have moved ahead with additional document discovery as well as numerous depositions of TAP, Abbott and Takeda.

Update: On November 15, 2004, the parties entered into a proposed settlement agreement. Defendants agreed to pay a total of $150 million dollars to settle this litigation.  After a payment of $55 million to private health insurers who had brought suit separately against the defendants, the remaining $95 million will be made available for distribution to the class - $40 million has been allocated to satisfy consumer claims and $55 million to satisfy the claims of third-party payors. The deadline for Lupron consumers to submit claims was on May 15, 2005.  The parties anticipate that the claims will be made in early 2006.

Court: U.S. District Court, District of Massachusetts (Judge Stearns)

Lupron Plaintiff Class
Plaintiffs in the class action: (1) have taken Lupron during the time period from January, 1985, to March 31, 2005; (2) have been responsible for all or part of a 20% copay.

Press Releases:
	TAP Pharmaceuticals to Pay $150 Million to Settle With Victims of Lupron Scheme
Resources:
	Lupron Settlement Final Approval Order
	Lupron Settlement Agreement
	Lupron Complaint