One of the first things we learn in law school is the term res ipsa loquitur — "the thing speaks for itself," a legal theory embraced by courts for a long time.
Courts in other states have used the phrase "malfunction doctrine" to describe a res ipsa theory involving the malfunction of a product. That doctrine permits a plaintiff to establish a prima facie strict products-liability claim on the basis of circumstantial evidence when direct evidence or the product is unavailable.
A petition for leave to appeal before the Illinois Supreme Court is pending on this very issue in DiCosolo v. Janssen Pharmaceuticals Inc., __ Ill.App.3d __ (No. 1-09-3562, 1st Dist., decided June 30, 2011), where the defendant-petitioners allege that the appellate court improperly expanded res ipsa in Illinois.
Janice DiCosolo died in 2004 at 38 as a result of a fatal overdose of fentanyl from the defendant's recalled Duragesic fentanyl pain patch that was prescribed for severe nerve root problems in her neck. In the days before her untimely death, she was properly using the pain patch as designed, manufactured and distributed.
The Cook County medical examiner's office conducted an autopsy and found her blood level of fentanyl to be more than 16 times the average level expected from a properly functioning patch. DiCosolo's patch came from a lot that had an extraordinary number of "leaker complaints" and five "adverse event" reports that ultimately led to an "urgent Class I drug recall" of the lot in 2004, the day after DiCosolo died.
The recall notice stated that the lot "may leak medication along one edge" leading to "potentially life-threatening complications." According to the Health Hazard Analysis performed by the manufacturer at the time of the recall, a leak in its fentanyl patches could "lead to drug overdose, the effects of which can include hypoventilation, respiratory depress and, at worst, death."
DiCosolo left behind three young children and a husband who learned of the defective, leaking patches when they received the 2004 recall notice after her death. He discarded the patches from the defective lot. The defendants knew of the "classic stringer leaker" defect as early as 2000, according to DiCosolo's lawyers. The FDA ultimately found that the manufacturer's in-process and quality control checks were inadequate to prevent the release of defective patches.
All of these were facts for the jury to decide, which found in favor of the plaintiff and returned a $16.5 million verdict to her estate. The Illinois Appellate Court upheld the verdict and found that despite the unavailability of the patch, it did not preclude the plaintiff from proving its defectiveness through circumstantial evidence.
The appellate court held in DiCosolo that a plaintiff in a products-liability action is not required to present expert testimony that the product contained a specific defect, citing Tweedy v. Wright Ford Sales, Inc. 64 Ill.2d 570, 574, 357 N.E.2d 449 (1976). There the Illinois Supreme Court said "[a] prima facie case that a product was defective and that the defect existed when it left the manufacturer's control is made by proof that in the absence of abnormal use or reasonable secondary causes the product failed 'to perform in the manner reasonably to be expected in light of [its] nature and intended function.' [Citations.]"
The court went on to say "a plaintiff need not show a malfunction such as an 'exploding coffee pot, collapsed ladder or brake pedal that goes all the way to the floor' in order to prove a products-liability claim involving a nonspecific defect," the DiCosolo court wrote, Id. at 8. The appellate court in DiCosolo stopped short of embracing the malfunction theory, although recognizing it has been applied in other states.
Instead, what the Illinois Appellate Court did articulate is more accurately described as the "failure to perform" doctrine that allows courts to infer a nonspecific defect from the product's failure to perform as reasonably expected. That is what DiCosolo's lawyers alleged — that the fentanyl patch failed to perform as expected and that such failure caused her death.
Illinois law clearly permits any fact, including a malfunction, to be inferred from circumstantial evidence. In Hampton v. Sears Roebuck & Co., 252 Ill.App.3d 744 (1993) and its progeny, the court found, "Like any fact, the defective nature of a product may be proved by circumstantial evidence." Id., at 748.
Defendants/petitioners, however, have argued that while a defect may be inferred from a malfunction, a malfunction itself may never be inferred. Petitioners' novel reformulation of the law would lead to a wholesale change in Illinois product-liability law, effectively overturning Tweedy and the cases that have followed it.
The DiCosolo opinion by the appellate court merely applied long-standing principles of product-liability law, including the nonspecific defect theory first articulated in Tweedy , to a case involving a prescription drug. There was nothing unique or novel in its holding. If the Illinois Supreme Court declines the PLA, it can confirm that Tweedy remains the law in this state and applies to all products, including prescription drugs.