Judge Dave Hylla
The country's first ever trial over a controversial acne medication was continued Tuesday by Madison County Circuit Judge David Hylla so he could schedule a hearing on whether punitive damages will be allowed in the case.
Jason Christopher Peipert of Godfrey sued Roche Laboratories and his physician Daniel Goran, M.D. on Dec. 16, 2003, claiming Accutane caused him to sustain severe and permanent injuries.
Accutane or its generic form, Isotretinoin, is an oral drug used to treat severe acne that is resistant to more conservative treatments such as creams and topical or oral antibiotics.
Peipert claims Goran prescribed Accutane to him in 1999 for general care and treatment of acne.
The Food and Drug Administration approved Accutane in 1982.
Peipert claims Goran was negligent because he failed to recognize that Accutane is a difficult drug to manage in patients and failed to run diagnostic tests to confirm he was not developing the severe side effects of Accutane.
The most common side effects of Accutane are dry skin, itching, dry nose, nosebleeds cracks in the corners of the mouth, dry mouth and inflammation of the whites of the eyes. Joint aches also are common.
Rare side effects include skin infections, peeling, sun sensitivity, hearing impairment and hepatitis. Rarely, Accutane can cause brain swelling which produces nausea, vomiting, headache, and changes in vision.
Psychiatric problems such as depression, hallucinations and suicidal behavior also have been reported.
Peipert also claims Goran prescribed Accutane to him more frequently and for periods longer than has been approved by the FDA and failed to advise him of the risks and side effects associated with Accutane.
According to court records, Peipert claims Accutane caused him to develop Crohn's Disease, an ulcerative or inflammatory disease of the bowel.
He also claims once he began to experience certain side effects, Goran still prescribed the medication after failing to recognize Accutane was causing the problems.
Peipert claims Roche either knew or should have known that Accutane was causally related to and associated with severe and life threatening complications and side effects.
He alleges the medication was defective and contained unreasonably dangerous design defects and was not reasonably safe subjecting users to risks that outweigh the benefits of the drug.
Peipert also claims that Accutane was insufficiently tested and that it caused harmful side effects which outweighed any potential utility.
He further claims Roche failed to adequately instruct on the length of time an individual should be allowed to continue using Accutane.
On Feb. 20, Goran filed a motion for summary judgment claiming that none of Peipert's witnesses have disclosed opinions critical of his standard of care.
Goran, represented by Jeffrey Reel of Belleville, also claims that Peipert did not develop symptoms associated with Crohn's until two years after he stopped taking Accutane.
He argues that there is no evidentiary basis from which the jury could conclude that he failed to properly advise Peipert of the risks and side effects associated with Accutane.
On April 13, Peipert voluntarily dismissed Goran from the suit.
Peipert is represented by John Papa of Granite City and Michael Hook of Pensacola, Fla.
Roche is represented by Dana Tucker of Fox Galvin in St. Louis.
Once the trial begins, Peipert plans to call 36 witnesses including live and video testimony from the current and former CEO of Roche.
The trial is expected to last four-to-six weeks once it resumes.
A panel of 80 jurors was set aside for the trial.