CASE LAW UPDATE
by Dennis E. Merkley
Manufacturers Win One and Lose One in Recent Products Liability Cases
In Hernandez v. Schering Corporation, the Illinois Appellate Court held that expert testimony is necessary to proceed on a claim against a drug manufacturer for failure to provide adequate warnings. Mr. Hernandez tested positive for hepatitis C as well as exposure to hepatitis A and hepatitis B. He underwent a course of drug therapy that included medication manufactured by Schering Corporation. Mr. Hernandez went to an educational course regarding his medication. At that course neither the doctor nor nurse teaching the course told him about vision related side effects. Mr. Hernandez was provided a booklet about the medication he was taking that warned of serious or clinically significant adverse effects including retinal hemorrhages and cotton wool spots. Mr. Hernandez stated that neither he nor his wife understood the package insert which specifically warned of blindness. The trial court granted summary judgment to Schering Corporation.
To recover in a products liability action a plaintiff must plead and prove that the injury resulted from a condition of the product, that the condition was an unreasonably dangerous one, and at the condition existed at the time the product left the manufacturers control. A product may be unreasonably dangerous because of the manufacturer's failure to warn of a danger or instruct on the proper use of the product as to which the average consumer would not be aware. In a strict liability case, the adequacy of the warning usually presents a jury question. The sufficiency of the warning can become a question of law where the warning is clear, accurate and unambiguous.
Plaintiff presented an expert to testify about the adequacy of the warning. In the expert’s opinion the manufacturer should have drawn attention to the blindness side effect by placing the warning about the blindness in a “Black Box." Expert testimony is necessary and proper where a drug manufacturer’s liability for a prescription drug is based upon its failure to provide adequate warnings. This requirement is limited to those situations where the adequacy of the label was not so obvious that a lay person could not readily understand the insufficiency of the warning.
Plaintiff’s expert witness was a medical school graduate who practiced as an anesthesiologist for one year. He then worked in the areas of advertising, medical education and marketing for several drug companies. The expert was presented as an expert in the area of pharmaceutical marketing. The court determined that the expert did not have specialized knowledge to qualify him to testify as an expert on the adequacy of side effects warnings to prescribing physicians. Without the expert testimony the plaintiff could not prevail on his product liability claims.
While Hernandez was a victory for manufacturers, the appellate court dealt a loss to manufacturers in the case of Mitsias v. I-Flow Corporation. In Mitsias, plaintiff appealed the dismissal of her products liability suit as time-barred by the two-year limitations period. Plaintiff originally filed a medical malpractice action for her injuries following a left shoulder surgery. After surgery she was diagnosed with glenohumeral chondrolysis. During discovery, plaintiff’s expert testified that the use of a pain pump could have caused her condition. Plaintiff voluntarily dismissed her lawsuit and re-filed adding products liability counts. Plaintiff had her surgery on October 24, 2001 and her expert testified that the pain pump may have been a cause of her injury as early as August 9, 2006. Plaintiff filed her product liability claims on February 11, 2009.
At issue on appeal was the timeliness of her products liability claims. After a lengthy discussion on the discovery rule, the appellate court held that where a plaintiff knows or should reasonably know that her injury was caused by one source, but remains unaware of another source that could not be discovered through the exercise of diligent inquiry, the statute of limitations does not begin to run with regard to that second source until such time as that second source would become discoverable through diligent inquiry. The court went on to explain that the question of what a party knew or reasonably should have known that she was injured and that her injury was wrongfully caused is a question of fact unless the facts are undisputed and only a single conclusion maybe drawn from them. Essentially, in Mitsias, the court held that the unavailability of science to support a potential cause of action tolls the statute of limitations in a product liability claim involving a drug manufacturer until the science becomes available. The court justifies this holding because the products liability statute of repose is still a viable defense to these claims if the facts support it.