Opinion ID: 2981562
Heading Depth: 1
Heading Rank: 3

Heading: factual allegations of the amended complaint

Text: The plaintiffs below included Sandy Sykes individually and as administrator of the estate of David J. Muir, Katherine Muir, Margaret Muir, Robert Muir, Eric Muir, and Paul Muir. Represented by counsel, the plaintiffs initially filed suit on October 4, 2010. According to the amended complaint filed on December 29, 2010, plaintiffs’ relative, David J. Muir, died on February 6, 2004. An autopsy revealed the cause of natural death was peritonitis due to a perforated sigmoid colon and peritoneal adhesions. The autopsy confirmed that Muir suffered from hepatitis C and cirrhosis of the liver. Before 2000, Muir was severely injured in a house fire. He suffered third-degree burns over sixty-five percent of his body, which required skin grafts, amputation of one hand and amputation of the fingers on the other hand. Because of these injuries, Muir took methadone for continuous 3 pain. He also suffered from severe depression and had attempted suicide. Between 2000 and his death in February 2004, Muir received medical treatment at the Cincinnati Veterans Administration Medical Center and its affiliated locations (VA), and at the University of Cincinnati Medical Center and its affiliated locations (UCMC). The plaintiffs alleged that, between May 2000 and February 6, 2004, Muir was enrolled in human research studies or clinical drug trials at the VA and UCMC for the treatment of hepatitis C in veterans, and was enrolled to participate in the studies even though he did not qualify due to his pre-existing physical and mental conditions. The plaintiffs further alleged that the studies were administered or supervised by Charles L. Mendenhall, M.D., the study doctor; Gary Roselle, M.D., Medical Director of the VA; and Judith M. Harrer, BS Pharm., Ph.D., the investigational drug pharmacist for the Cincinnati VA Medication Development Research Unit. Although plaintiffs also named as defendants Jeffrey Goldsmith, M.D., Robert Weesner, M.D., and Joseph Morelli, M.D., the amended complaint lacked specific factual allegations concerning these physicians. The plaintiffs alleged that all of the individuals acted within the scope of their employment. The complaint further alleged that, as a participant in the studies, Muir was subjected to the use of certain medical testing devices and was prescribed certain pharmaceuticals and pharmaceutical test kits contrary to the standards or dosages approved by the U.S. Food and Drug Administration for these products. It alleged that the manufacturers of the pharmaceuticals and devices sponsored the studies and allowed their products to be used for purposes outside FDAapproved indications, and Muir was not advised by the VA, UCMC, or the drug manufacturers about any adverse warnings applicable to the pharmaceuticals that were administered to him. Muir signed at least two consent forms agreeing to participate in studies, but the plaintiffs asserted that the forms 4 were defective in that they did not disclose alternative and safer courses of treatment, did not include proper witness signatures, and did not include adequate descriptions of the compensation or treatment that the VA would provide Muir for any injury he sustained as a result of the studies. According to the plaintiffs, Muir ingested orally or was injected with approximately ten drugs over a four-year period, including Epogen, Neuprogen, Procrit, Peginterferon, Pegasys, Copegus, Bupriopion, Intron A, Rebetol, Rebetron Combination Therapy, and Gabapentin. Muir suffered adverse reactions to one or more of these pharmaceuticals, which the plaintiffs alleged ultimately led to his death. After Muir died, the plaintiffs repeatedly requested complete copies of Muir’s medical records from the VA, UCMC, the U.S. Department of Veterans Affairs, and the University of Cincinnati Institutional Review Board, but the plaintiffs claimed that their requests were denied.