KANSAS CITY, Mo., Aug 27 (Reuters) - Cancer patients and their families have named Eli Lilly & Co. a defendant in five lawsuits alleging that it failed to alert authorities to signs a Kansas City pharmacist was dangerously diluting its top-selling chemotherapy drug.
According to suits filed on Monday in Kansas City, the Indianapolis-based pharmaceutical giant contributed to the deaths of at least three cancer patients by not alerting authorities to the fact that a sales representative suspected in early 2000 that pharmacist Robert Courtney might have been diluting Eli Lilly's Gemzar when filling prescriptions for intravenous chemotherapy treatments.
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 on 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 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.
WIDE POTENTIAL
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.
The sales representative informed the company of the discrepancies, and it conducted an internal investigation. But it was more than a year later, in May 2001, that the sales representative notified the doctor of the alleged dilution, according to investigative documents filed in court.
The doctor then had the drugs provided by Courtney's pharmacy tested and notified federal agents.
Because Lilly did not move quickly to investigate the concerns and never notified authorities about its findings, the company has liability in the deaths and deteriorating conditions of affected cancer patients, said Kansas City attorney Michael Ketchmark, who filed the suits on Monday morning in Jackson County Circuit Court.
THREEFOLD DISCREPANCY
"The (company's) investigation confirmed that Courtney was selling up to three times the amount of drugs he was purchasing from them," Ketchmark told Reuters.
"It appears to us Eli Lilly was more interested in protecting the millions of dollars in sales it might have in 2001 from Gemzar than the lives of the patients who could have been saved," Ketchmark said.
Lilly issued a statement on Monday morning calling the allegations that it acted inappropriately "untrue and absolutely ridiculous."
"Lilly helped uncover this alleged criminal activity, and had it not acted, there's no telling how long this would have gone on," it said.
Company spokeswoman Judy Moore said she was not sure when the company was first tipped off to the possible dilution and when it conducted its investigation. But she said it was not in early 2000. Moore said that after the company discovered a sales discrepancy, it approached the treating physician, a step that ultimately led to the FBI probe of Courtney's actions.
Physician Verda Hunter, however, has been quoted in affidavits filed in the criminal investigation of Courtney as saying that she tried to contact Lilly about the concerns raised by its sales representative but got no response.
Lilly had sales of $3.033 billion in the second quarter. Gemzar sales totaled $160.9 million in the second quarter.
According to suits filed on Monday in Kansas City, the Indianapolis-based pharmaceutical giant contributed to the deaths of at least three cancer patients by not alerting authorities to the fact that a sales representative suspected in early 2000 that pharmacist Robert Courtney might have been diluting Eli Lilly's Gemzar when filling prescriptions for intravenous chemotherapy treatments.
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 on 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 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.
WIDE POTENTIAL
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.
The sales representative informed the company of the discrepancies, and it conducted an internal investigation. But it was more than a year later, in May 2001, that the sales representative notified the doctor of the alleged dilution, according to investigative documents filed in court.
The doctor then had the drugs provided by Courtney's pharmacy tested and notified federal agents.
Because Lilly did not move quickly to investigate the concerns and never notified authorities about its findings, the company has liability in the deaths and deteriorating conditions of affected cancer patients, said Kansas City attorney Michael Ketchmark, who filed the suits on Monday morning in Jackson County Circuit Court.
THREEFOLD DISCREPANCY
"The (company's) investigation confirmed that Courtney was selling up to three times the amount of drugs he was purchasing from them," Ketchmark told Reuters.
"It appears to us Eli Lilly was more interested in protecting the millions of dollars in sales it might have in 2001 from Gemzar than the lives of the patients who could have been saved," Ketchmark said.
Lilly issued a statement on Monday morning calling the allegations that it acted inappropriately "untrue and absolutely ridiculous."
"Lilly helped uncover this alleged criminal activity, and had it not acted, there's no telling how long this would have gone on," it said.
Company spokeswoman Judy Moore said she was not sure when the company was first tipped off to the possible dilution and when it conducted its investigation. But she said it was not in early 2000. Moore said that after the company discovered a sales discrepancy, it approached the treating physician, a step that ultimately led to the FBI probe of Courtney's actions.
Physician Verda Hunter, however, has been quoted in affidavits filed in the criminal investigation of Courtney as saying that she tried to contact Lilly about the concerns raised by its sales representative but got no response.
Lilly had sales of $3.033 billion in the second quarter. Gemzar sales totaled $160.9 million in the second quarter.
