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phase II clinical trial SOC and Boceprevir - Join the Suit

Lloyd Wright,
An email friend referred your site. I am currently in a federal law suit for permanent injury sustained from my participation in a clinical trial of PegIntron / Rebetol / Boceprevir. I suffer multi-system sarcoidosis with occular, renal and pulmonary involvement caused by PegIntron and Rebetol treatment.
 
Prior to my consent to the participate in the clinical trial, I was provided an informed consent agreement/contract, and advised to closely study the agreement before making a decision. The contract agreed to follow the study protocol according to FDA regulations, that I could withdraw from the study any time without losing benefits of follow up treatment, and that the sponsor would provide medical costs for any adverse event arising from the study. What did I have to loose -- I thought! Almost immediately, side effects began and continued debilitating. The investigator assured me the side effects were normal and would resolve on their own within six months after terminating drug therapy. More than 36 weeks of the treatment drugs, I woke with both eyes hemmorhaging and serious abdominal pain, blurring vision and eyes extremely sensitive to light. I stopped the treatment drugs and was diagnosed with uveitis/iritis and 30 percent loss of vision in my right eye. Seven months later my side effects were still debilitating, so I ask the investigator to provide follow up treatment, but the investigator refused my request, and said I was not eligible for follow up because I did not complete the study. I presented the agreement which sharply contradicted the response, but again, the investigator said those provisions only apply to subjects who complete the study. Five months later, I wake with extreme hypertension, dizzy and weak, shortness of breath, severe abdominal pain and back pain, and rushed to the hospital. The admission doctor said I had critical levels of blood calcium, renal failure, anemia, and unusual mass of infiltrates on both lungs, and warned my condition could be malignant and infectious, and placed me in an isolated medical unit. I was in extreme distress and great fear of losing my life. After ten days of extensive testing and treatment, I was diagnosed with stage III pulmonary sarcoidosis, renal failure, hypercalcemia secondary to sarcoidosis, and vascular calcification secondary to hypercalcemia. 
 
I immediately notify the investigator and sponsor of the clinical trial, and demand they honor their agreement/contract entered into for my consent to administer their dangerously toxic drugs, and pay my $80,000 medical expense and provide treatment for the permanent injury I sustained. Despite the fact that sarcoidosis is listed as rare side effect of PegIntron, the investigator said my sarcoidosis was not from the study drugs. After numerous attempts, consulting the Sponsor, IRB, and the FDA, I decide to collect evidence to support my complaint, and request all my medical records prepared during the clinical trial. The record reveals that I was given overdoses of Pegintron that were 30 micrograms higher than the dose specified by the study protocol (120 mcg). I believe the sponsor and investigator authorized the overdoses to yield more favorable results of their clinical research and constitutes a breach of their legal and fiduciary duty, wilfull, wanton, and intentional disregard of my legal rights, my health and future well being.
 
March 2010, I see a sarcoidosis specialist, and provide the specialist my medical records. After extensive testing and review of my medical records, the specialist said I have multi-system sarcoidosis with occular, renal and pulmonary involvement as complications of PegIntron and Rebetol treatment. Despite clear and convincing evidence, the sponsor and investigator continue to claim my incurable disease was not a result of their study drug therapy and denied any liability.
 
October, 2010, I filed a civil conspiracy complaint against the sponsor, investigator, IRB, and the FDA for their non-complinace to federal regulations, common law fraud for their intentional misrepresentations of material fact, and strict liability for abnormally dangerous activities, medical negligence and battery for unwarranted administration of dangerously toxic drugs. I believe this is not an isolated incident, but a common design by the perpetrators to yield more favorable results and FDA approval of their study drug, and substantially affects interstate commerce, and more than 400 human subjects who also participated in the clinical trial.
 
FDA regulation set forth the essentials of an adequate and well-controlled clinical investigation. 21 CFR 314.111(a)(5)(ii). According to 21 CFR 312.60, "An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, investigational plan, and applicable regulation; for protecting the rights, safety, and welfare of subjects under the investigator's care..." 
 
If YOU or ANYONE you know has suffered adverse effects of PegIntron/Rebetol/Boceprevir and have been denied medical follow up treatment leading to a more serious condition, I would like hear from you. I am not an attorney of law and can not provide you legal advice, but we can discuss the facts and issues which may provide a resolution, and exercise your legal rights
  
Kind Regards,
 JerryK.

If anyone was a participant in this study and wish to join this law suit
please send Lloyd an email with your information
and he will be happy to forward it.