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Gilberto Hernandez and Ruth Elizondo v. Schering Corporation

September 30, 2011


Appeal from the Circuit Court of Cook County. No. 04 L 9028 Honorable Marcia Maras, Judge Presiding.

The opinion of the court was delivered by: Justice Hall

JUSTICE HALL delivered the judgment of the court, with opinion.

Presiding Justice Hoffman and Justice Karnezis concurred in the judgment and opinion.


¶ 1 The plaintiffs, Gilberto Hernandez and his wife, Ruth Elizondo, filed a complaint against the defendants, Schering Corporation, Schering-Plough Corporation (collectively Schering) and Victoria McGill, R.N., (hereinafter Nurse McGill)*fn1 seeking damages for bodily injuries stemming from Mr. Hernandez's use of PEG-Intron, a drug manufactured and sold by Schering. The circuit court granted the defendants' motion for summary judgment as to six of the counts of the complaint but denied summary judgment on the remaining counts.*fn2 The circuit court granted the plaintiffs' motion for a finding pursuant to Illinois Supreme Court Rule 304(a) (eff. Jan. 1, 2006), and the plaintiffs filed a timely notice of appeal. Subsequently, this court granted the motion of the Illinois Trial Lawyers Association (ITLA) to file an amicus curiae brief in support of the plaintiffs.

¶ 2 On appeal, the plaintiffs contend that the circuit court erred in granting summary judgment to the defendants on the strict liability, product liability negligence and negligence in performing a voluntary undertaking counts. They maintain that genuine issues of material fact precluded the summary resolution of these counts of their fourth amended complaint.


¶ 4 Counts I through IV of the plaintiffs' fourth amended complaint alleged causes of action in strict liability and product liability negligence and loss of consortium claims against Schering. Counts V and VI alleged negligence in performing a voluntary undertaking and a loss of consortium claim against Schering and Nurse McGill. The following pertinent facts are taken from the materials submitted by the parties in connection with the summary judgment proceedings, as well as other relevant evidence in the record.

¶ 5 In December 2001, Mr. Hernandez tested positive for hepatitis C (HCV), as well as exposure to hepatitis A and hepatitis B. Mr. Hernandez was referred to Dr. Suleiman Hindi, a physician specializing in diseases of the liver and digestive tract.

¶ 6 In his deposition, Dr Hindi testified as follows.*fn3 After further tests, the doctor diagnosed Mr. Hernandez with HCV. The treatment for HCV with the best results was a drug combination, PEG-Intron/Rebetol, consisting of an interferon called Pegylated and Rebetron, an oral medication. While there was another interferon on the market, Dr. Hindi specified PEGIntron/Rebetol, manufactured by Schering, for his patients because it had been on the market longer and prescribed more frequently.

¶ 7 Dr. Hindi was responsible for ordering the medication for Mr. Hernandez. As part of the medication regime, Dr. Hindi also expected his patients to attend an educational class sponsored by Schering. The class was an additional way to instruct patients how to use the medication and about any possible side effects. Dr. Hindi's nurse would arrange for the classes when there were enough patients for a class to be held.

¶ 8 Dr. Hindi acknowledged that, as a physician prescribing medication, the standard of care required him to inform patients as to the potential side effects of the medication. He did not believe that Schering's class relieved him of his duty to provide information as to the side effects of the medication. He did advise his patients that the majority of individuals taking the PEGIntron medication suffered some side effects . Though Dr. Hindi had attended seminars and educational programs, he did not recall learning that there were vision-related side effects to PEG-Intron. Since he was unaware of them, he would not have warned Mr. Hernandez of the vision-related side effects of PEG-Intron. Had he been aware that there was a risk the medication could result in blindness, he would have mentioned that fact to the patient.

¶ 9 According to their deposition testimonies, on April 10, 2002, the plaintiffs attended the class taught by Nurse McGill on behalf of Schering. The class took about an hour to an hour and a half. Nurse McGill distributed a document to the class attendees entitled "Understanding the Side Effects of Interferon Therapy" and informed the class that she would discuss all of the side effects of PEG-Intron. This document did not list blindness as a side effect, and Nurse McGill did not mention any vision-related side effects. In deciding whether to go on the PEGIntron medication, Mr. Hernandez relied on the information in that document and what Nurse McGill stated in the class about side effects. Had he been aware that the side effects included blindness or other vision-related problems, he would not have taken the medication.

¶ 10 Additional documents were distributed at the class: the PEG-Intron/Rebetol package insert, the medication guide for PEG-Intron, a "frequently asked questions booklet" and a pamphlet entitled " Your PEG-Intron Dose." Among the reported adverse reactions, the package insert listed vision disorders, with blindness occurring in less than 1% of patients. The medication guide stated that persons taking PEG-Intron medication should call their doctors immediately if they experienced decreased vision. The booklet and the pamphlet warned that "serious or clinically significant adverse effects" including "retinal hemorrhages and cotton wool spots" were reported by less than 1% of the patients. The plaintiffs went through all the documents distributed at the class. According to Mr. Hernandez, neither he nor his wife understood the package insert which specifically warned of blindness.

¶ 11 In her deposition, Nurse McGill testified that her role was to educate the patients on how to mix and inject the medication, how to manage the basic side effects and the importance of follow-up visits with their physicians. Basic side effects included flu-like symptoms, fatigue, nausea and injection-site reaction. Nurse McGill did not discuss in detail other potential side effects, because that was the treating physician's role. She did emphasize the importance of following up with the patient's own doctor. The doctor would be the one to identify the side effects once the patient is on the drug therapy. Nurse McGill did not specifically mention visual problems to the patients in the class. However, the patients were instructed to read all the materials they were given.

¶ 12 Mr. Hernandez began taking PEG-Intron/Rebetol in August 2002. At the time he filled the prescription at a Walgreens Drug store, he received a standard sheet of side effects. He did not recall a warning on the sheet to contact his doctor immediately if, among other things, he experienced vision problems. In the middle of September, he was brushing his teeth when he threw up, and the vision in his right eye became blurred. Initially, he did nothing, believing it would resolve itself. After about four days, he went to the emergency room at MacNeal Hospital. It is uncontested that as a result of taking PEG-Intron, Mr. Hernandez sustained optic nerve damage and permanent vision loss.

ΒΆ 13 In granting summary judgment to Schering on the product liability counts, the circuit court found as a matter of law that the warnings Schering provided to Dr. Hindi in the product insert were adequate. The product insert "delineated the exact problems" suffered by Mr. Hernandez. The court further found that, even if the warning was not adequate, the plaintiffs could not establish proximate cause. According to Dr. Hindi's deposition testimony, had the doctor known of the ...

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