U.S.

Pharmacist Pleads Not Guilty

By CBSNews.com staff CBSNews.com staff

August 20, 2001 / 9:40 AM EDT / CBS

Lawsuits filed Monday allege that a pharmacist and drug maker Eli Lilly were responsible for several deaths stemming from the pharmacist's alleged weakening of chemotherapy drugs.

Also, pharmacist Robert R. Courtney pleaded innocent in federal court to 20 felony counts of altering the cancer drugs Gemzar and Taxol. U.S. Magistrate Robert E. Larsen set an Oct. 1 trial date.

Courtney appeared calm in his court appearance, reports CBS News Correspondent Cynthia Bowers.

Four wrongful death lawsuits were filed against Courtney, two of which also name Lilly. Five other lawsuits seeking unspecified damages for emotional harm were also filed against Courtney, including two that also name Lilly. And Lilly was added as a defendant to a wrongful death suit filed last week.

Lilly said the lawsuits were "totally without merit" and that the company "had no reason to suspect that this pharmacist was allegedly diluting Gemzar in early 2000." Lilly said it helped uncover the alleged dilutions.

But plaintiff's attorney Michael Ketchmark said, "The Eli Lilly representative started suspecting in early 2000 that the drugs were being diluted. He went to Eli Lilly with that information. It wasn't until the summer of 2001, some 18 month later, that they finally told the doctor."

Ed West, a spokesman for the company, responded by saying "Any allegation that we knew of this alleged dilution in early 2000 is totally ridiculous."

Under federal law, Lilly had no legal obligation to alert anyone, but some believe they did have an ethical obligation.

For his part, Courtney, 48, was indicted last week on 20 felony counts of product tampering, drug adulteration and drug misbranding. Federal investigators said Courtney illegally diluted Gemzar and other expensive chemotherapy drugs to boost his profits.

Courtney appeared in federal court Monday afternoon and pleaded not guilty to the charges. U.S. Magistrate Judge Robert Larsen set a trial date for Oct. 1. Courtney, who is being held without bond after being deemed a flight risk, faces as much as 196 years in prison and $5 million in fines if convicted of all the charges. He has also been named as a defendant in more than 10 lawsuits.

Potentially, hundreds of cancer patients relying on chemotherapy treatments for survival may have been harmed as a result of Courtney's dilution of cancer drugs, according to the FBI. At least one individual who received the diluted drugs has died, according to prosecutors.

Investigators have said in court documents that a Lilly sales representative became suspicious of the alleged tampering with Gemzar by Courtney's pharmacy in early 2000 when records indicated a Kansas City doctor was receiving much more Gemzar from Courtney's pharmacy than the actual amount of Gemzar the pharmacy was purchasing from the manufacturer.

Physician Verda Hunter has been quoted in affidavits filed in the criminal investigation of Courtney as saying that she tried to contac Lilly about the concerns raised by its sales representative but got no response.

Authorities say Courtney, who allegedly saved hundreds of dollars per dose, was motivated by profit. He also faced $600,000 in tax bills.

Court records said Courtney has admitted diluting cancer drugs from November 2000 through May 2001. The FBI says samples of drugs tested after being prepared by Courtney's Research Medical Tower Pharmacy generally contained less than half of the medication prescribed.

Prosecutors have said they have evidence of at least 150 instances of dilution, which could have affected hundreds of patients. But Bradshaw has said Courtney's dilutions affected only about 30 to 35 patients. Many of Courtney's patients used multiple doses.

Lilly had sales of $3.033 billion in the second quarter. Gemzar sales totaled $160.9 million in the second quarter.