The Legal Challenge:
Lawsuits were filed in New York and Kentucky federal courts to force Amgen to reinstate treatment for the trial participants. Patients were represented at both pre-trial hearings by attorney Alan Milstein, whose practice focuses on medical research law. The judges in both cases considered only the contractual issues of the informed consent documents and ruled in favor of Amgen. Appeals have been filed. An interview with Mr. Milstein with more information on the legal challenges can be found at: GDNF: Interview w/Milstein
The Legal Challenge is Over
The appeal in the Kentucky case was turned down , on March 29, 2006.
The New York appeal was dismissed by Judge Kevin Castel on April 19, 2006.
The decisions were based heavily on contract law and interpretations of
the informed consent documents.
July 12, 2005 Ruling bars Parkinson's sufferers from experimental drug
www.WKYT.com Lexington, Kentucky [12/09; item no longer online]
"A federal judge has ruled against eight Parkinson's disease patients..."
Read the full story [12/09; item no longer online]
More sue for access to Amgen drug
June 23, 2005
From latimes.com
By Denise Gellene, Times Staff Writer
Patients in the latest suit say they were promised the experimental Parkinson's medicine beyond the trial period.
A second set of participants in an aborted clinical trial has filed a federal lawsuit against Amgen Inc., seeking access to an experimental Parkinson's disease drug.
Amgen withdrew the drug in September, saying it was no better than a placebo and could be harmful. The patients said the drug GDNF had helped them.
The lawsuit was filed Tuesday in U.S. District Court in Lexington, Ky., by eight patients who were treated at the University of Kentucky Medical Center.
The latest suit came two weeks after a federal judge in New York ruled that Amgen had no obligation to supply the drug in a case brought by two other clinical trial participants. Those patients, who were treated at New York University Medical Center, are appealing U.S. District Judge P. Kevin Castel's decision.
Amgen spokeswoman Andrea Rothschild said the newest suit involved the same issues that were litigated in New York.
"We look forward to presenting the case to the judge in Kentucky," she said.
June 11, 2005
Lancet Editorial: Patient choice in clinical trials Lancet; 6/11/2005, Vol. 365 Issue 9476, p1984
http://www.sskrplaw.com/publications/050611.html
May 26, 2005
Patients seek order against Amgen on Parkinson's drug
NEW YORK (AP) _ Two victims of Parkinson's disease asked a judge on Thursday to force Amgen Inc. to supply them with an experimental drug that the biotechnology company insists could harm them.
Amgen ended a clinical trial for GDNF last year after it "made the decision that the drug presented an unreasonable risk," Mark Gately, the company's attorney, told U.S. District Judge Kevin Castel at a hearing in federal court in Manhattan.
In April, trial subjects Robert Suthers and Niwana Martin sued Amgen, claiming GDNF had improved their condition. Physicians who administered the drug agreed it was working, said a lawyer for the patients, Alan Milstein.
"Everybody outside Amgen believed the drug was safe and effective, and believed the trial should go on," Milstein said.
The judge reserved decision on whether to order the Thousand Oaks, Calif.-based Amgen to supply GDNF to the plaintiffs, but said he would issue a written ruling as soon as possible.
"The decision in this case has real life consequences for two human beings," he said.
Parkinson's disease is a degenerative disorder that affects an estimated 1.2 million people in the United States, including boxing great Muhammad Ali and actor Michael J. Fox.
April 29, 2005
From Lexington Herald-Reader by staff, wire reports
3 from Kentucky back Parkinson's patients' suit
Three Kentucky Parkinson's disease patients have filed affidavits supporting a lawsuit to force biotechnology giant Amgen Inc. to provide an experimental and potentially dangerous drug that the patients and their families view as their only hope.
The suit, filed Tuesday in federal court in New York, demands that Amgen offer the Parkinson's medicine to patients who had once received it in a clinical trial that ended last year.
Ten patients at the University of Kentucky were treated with the drug, GDNF, and all "showed significant improvement in motor functions and quality of life," said Dr. Don Gash, a UK scientist.
Without the drug, Gash said, his patients "are deteriorating. We are seeing shaking, muscle cramps, hallucinations and dementia."
More news articles on New York lawsuit: May - June 2005
No trial drug for them; Patients, including a Greenlawn man, are denied further use of Parkinson's treatment used in experiment. Jamie Talan. Newsday (New York), June 14, 2005, Pg. A34.
Judge rejects appeal for Amgen drug by clinical trial patients Erin McClam. The Associated Press State & Local Wire, June 9, 2005, Business News.
Judge rules for Amgen, denies experimental drug. Andrew Pollack. Ventura County Star (California), June 8, 2005, Business, Pg. 1.
Amgen caught in dispute over drug's safety, value. Tom Kisken. Ventura County Star (California), May 29, 2005, p.1.
Patients seek order against Amgen on Parkinson's drug. The Associated Press State & Local Wire, May 26, 2005, State and Regional, NEW YORK
Patients Need to Be Heard in Drug Research. (letter-to-editor). Perry Cohen. Los Angeles Times , May 8, 2005, Business Desk; Part C; Pg. 5.
Patients sue Amgen to get drug for Parkinson's. Allison Bruce. Ventura County Star (California), April 28, 2005, BUSINESS AND STOCKS; Pg. 1.
California; Patients Sue for Amgen Drug; Participants in a former study seek access to the Parkinson's medicine. Firm says it's too risky. Denise Gellene. Los Angeles Times , April 27, 2005, Business Desk; Part C; Pg. 1.
News articles on Kentucky lawsuit: July 2005
Case inspires Parkinson's crusade. BBC NEWS . July 19, 2005.
http://news.bbc.co.uk/go/pr/fr/-/1/hi/england/bristol/4695567.stm
Parkinson's patients lose fight to regain drug. By Barbara Isaacs. Lexington Herald-Leader , July 12, 2005.
http://www.redorbit.com/news/health/172188/parkinsons_patients_lose_fight_to_regain_drug/index.html
Ruling bars Parkinson's sufferers from experimental drug, The Associated Press State & Local Wire, July 12, 2005, State and Regional, Lexington, Ky.
Parkinson's treatment works, but you can't have it, New Scientist, July 9, 2005, Pg. 18.
Withdrawn experimental drug found to reverse Parkinson’s brain damage. Medical Research News, July 5, 2005. http://www.news-medical.net/?id=1149
More Sue for Access to Amgen Drug; Patients in the latest suit say they were promised the experimental Parkinson's medicine beyond the trial period. Denise Gellene. Los Angeles Times , June 23, 2005, Part C; Pg. 2.
Related Issues
Interview with Patients' Lawyer Alan Milstein
Suthers/Martin vs. Amgen, Inc.
Dr. Hutchinson's Certification (Exhibit A) at the Suthers' Trial (part 1)
Dr. Hutchinson's Certification (Exhibit A) at the Suthers' Trial (part 2)
Perry Cohen, Ph.D.'s Certification (Exhibit C) at the Suthers' Trial
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