Opinion ID: 6350078
Heading Depth: 1
Heading Rank: 3

Heading: Ill Dec. 574, 951 N.E.2d 1238, 1244 (Ill. App. Ct.

Text: 2011)); McKenzie v. S K Hand Tool Corp., 272 Ill.App.3d 1, 208 Ill.Dec. 918, 650 N.E.2d 612, 616 (1995); Varady v. Guardian Co., 153 Ill.App.3d 1062, 106 Ill.Dec. 908, 506 N.E.2d 708, 711–12 (1987). The plaintiff may instead resort to circumstantial evidence that supports an inference that the product was defective, by showing that the product failed to perform as expected, in light of its nature and intended function, and that the product was not being used abnormally and that there were no reasonable secondary causes of failure. Tweedy, 2 Ill.Dec. 282, 357 N.E.2d at 452; Horne, 987 F.3d at 726. Bensenberg, 31 F.4th at 535–36. See also Tweedy, 357 N.E.2d at 452 (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 14 No. 21-2028 manner reasonably to be expected in light of its nature and intended function). In assessing the defendants’ summary judgment motion, the district court first remarked: This Court does not believe that the Tweedy doctrine can appropriately be applied in complex medical device cases. These devices are not simple products that lay jurors commonly use or see and their func- tions are, therefore, beyond a jury’s common knowledge, experience or understanding. That is why expert testimony is needed to assist the jury’s understanding of whether a product is unreasonably dangerous. Without the aid of expert testimony, the jury can only speculate as to what inferences to draw. … Thus, the question of whether the devices in question were defective and caused Donaldson’s injuries is a complex issue that requires expert interpretation and proof. Donaldson, 2021 WL 1754605, . But Illinois courts have applied the Tweedy doctrine to medical devices that are arguably as complex as the mesh products at issue here. See, e.g., DiCosolo v. Janssen Pharmaceuticals, Inc., 951 N.E.2d 1238 (Ill. App. Ct. 2011) (affirming jury verdict in favor of plaintiff who proceeded under the Tweedy doctrine to prove that a transdermal Duragesic skin patch defectively delivered more fentanyl through its rate-controlled membrane than it was designed to do, resulting in the plaintiff’s death due to overdose); Weedon v. Pfizer, Inc., 773 N.E.2d 720 (Ill. App. Ct. 2002) (reversing summary judgment in favor of defendant manufacNo. 21-2028 15 turer of a venous access device implanted in plaintiff’s body to deliver chemotherapy because, although plaintiff produced no experts in the manufacture or design of the device, under the Tweedy doctrine, the plaintiff’s treating physicians and nurse provided sufficient evidence that the device did not perform as expected when it likely leaked chemotherapy drugs into surrounding tissues, and also testified to the absence of abnormal use and secondary causes). Although Illinois courts appear to approve the use of the Tweedy doctrine in cases involving medical devices, the application of that doctrine does not automatically eliminate the need for any sort of expert testimony.7 Under Tweedy, the plaintiff must present evidence 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. Tweedy, 357 N.E.2d at 452; Bensenberg, 31 F.4th at 535–36. In a case involving a medical device that is implanted in the body, proving the absence of abnormal use or reasonable secondary causes will likely require evidence from healthcare providers who have experience in the use of the device, in other words, expert testimony. For an implanted device, for example, a plaintiff will likely need medical testimony on the appropriate installation of the device in the body in order to rule out abnormal use, or 7 Donaldson argues that Tweedy obviates the necessity of expert testimony to prove a specific defect, citing DiCosolo, 951 N.E.2d at 1243 (“[a] plaintiff is not required to present expert testimony that the product contained a specific defect.”). Although that is true, expert testimony may be necessary to establish the Tweedy factors. 16 No. 21-2028 evidence from a medical professional demonstrating the absence of infection or other medical conditions that could have caused the injury. This sort of evidence is outside the knowledge, experience and understanding of jurors. The Weedon case illustrates well that expert testimony is sometimes necessary in Tweedy cases. Weedon sought to prove that his implanted venous access device injured him by leaking chemotherapy drugs into the tissues surrounding the device, a process called extravasation: Although there was no witness produced by the plaintiff to testify as an expert regarding any specific defect in the venous access device, Sarah Coveny, the oncology nurse who administered the chemo- therapy, testified that she used a specially designed “Port–A–Cath needle” and that she did not remem- ber having any problems with Weedon’s chemother- apy injections. Dr. Talamanti testified that he inspected the device prior to and immediately after implantation and testified that there was no indication of any defects. Although Dr. Dumanian, the plastic surgeon, did not see the Port–A–Cath through which the chemotherapy was given, he testified to the difference between an infection and an IV infiltration injury and, although he did not know exactly what happened, he testified that Weedon had an infiltration injury. The defendants’ expert, Mr. James Hagar, testified that a venous access device should not leak absent external forces, such as a medical mistake or use of an improper needle. No. 21-2028 17 Weedon, 773 N.E.2d at 731. Weedon methodically countered each secondary cause that the defendant presented, demonstrating that his injuries were not due to infection, a medical mistake such as improper implantation of the device, or the use of an improper needle by the person administering the drugs. Although “the doctors that treated Weedon all testified that his injury could have resulted from infection, malpositioning of the device or extravasation … each doctor testified that it was more likely that plaintiff had an extravasation injury than an injury due to infection or malpositioning of the device.” 773 N.E.2d at 722. The court therefore concluded that the plaintiff’s evidence was sufficient to preclude summary judgment under Tweedy. Unfortunately for Donaldson, this is a case that required expert evidence. On the question of abnormal use, there was conflicting medical evidence in the record on whether the implanting surgeon placed the Prosima device in too deep a plane. The implanting physician testified that he installed the devices correctly, following all of the manufacturer’s instructions and his training. That testimony countered the claim by the defendants’ expert that the Prosima device was likely implanted in too deep of a plane, leading to the bladder erosion. If that were the only Tweedy factor in dispute, summary judgment would have been inappropriate as to the Prosima device. But on the issue of reasonable secondary causes, the record was entirely one-sided. The defendants presented expert opinion regarding several possible secondary causes for Donaldson’s injuries, factors independent of the design of the devices. In particular, the defendants presented an affidavit 18 No. 21-2028 from Dr. Douglas Grier, who examined Donaldson’s extensive medical records and concluded that there were several causes of mesh erosion and pelvic pain in Donaldson’s case that had nothing to do with the design of the mesh products. Among these secondary causes, Dr. Grier cited vaginal atrophy as a cause of vaginal erosion, and noted the posterior surgical repair and pelvic floor muscle dysfunction as the causes of her pelvic pain. R. 59-3, at 16. Donaldson’s own treating physician, Dr. Nayak, agreed that vaginal atrophy could be a cause of her vaginal erosion injury. Dr. Nayak also agreed that Donaldson’s pelvic pain could have been caused by the surgical procedure she had undergone at the Mayo Clinic. Donaldson did not counter this evidence with any direct or circumstantial evidence that would negate any of the reasonable secondary causes that are supported by the record. Instead, Dr. Nayak opined only that the Prosima “possibly caused the mesh to be eroded into the bladder and caused stones.” R. 56-4, at 68–69. Where “[t]he evidence presented by plaintiff only raised possibilities for the cause of the accident, not a probability,” the evidence is insufficient to make out a Tweedy claim. Saieve v. Budget Rent-A-Car of Rockford, 591 N.E.2d 507, 515 (Ill. App. Ct. 1992). Dr. Nayak inferred that the injuries were related to the Prosima implantation because they occurred after the surgery. But as we noted recently in a case involving another Ethicon mesh product: The FDA had approved the use of mesh implants knowing that they are not 100 percent effective. The fact that a known complication or failure occurs could reasonably be interpreted as a sign that such No. 21-2028 19 product or procedure-related failures could occur without anyone acting wrongfully. Stark v. Johnson & Johnson, 10 F.4th 823, 830 (7th Cir. 2021). See also Ralston v. Casanova, 473 N.E.2d 444, 451 (Ill. App. Ct. 1984) (finding that a Tweedy claim failed where the only evidence presented by plaintiff was his testimony that he was wearing a seat belt while operating his vehicle and that he sustained injuries during a collision, because “it cannot legally be presumed from evidence of the mere occurrence of an accident involving a product that the product was defective when it left the manufacturer’s control”). Unlike the healthcare providers in Weedon, Dr. Nayak declined to say that the design of the Prosima was the likely cause of Donaldson’s injuries as opposed to any other cause cited by the defendants’ expert. Donaldson asserts that an examination of her medical records, attached to Dr. Nayak’s affidavit, demonstrates the absence of reasonable secondary causes. That is simply not the case. First, there is no indication that these records are a complete account of Donaldson’s treatment from her many providers. In his affidavit, Dr. Nayak characterized the thirty pages of attached medical records as “portions of the medical records” that he maintained pertaining to Donaldson’s treatment. R. 40-1, at 2. Dr. Grier averred that he reviewed “several thousand pages of Mrs. Donaldson’s medical records,” and pointed out that Dr. Nayak’s records begin in 2014 and contain no record of the operation where the devices were implanted. R. 56-3, at 29–30. Obviously, a statement that there are no secondary causes apparent in a tiny portion of the medical record does not exclude secondary causes. Second, the records that Dr. Nayak attached confirm other conditions from 20 No. 21-2028 which Donaldson suffers such as vaginal atrophy and pelvic floor dysfunction, conditions that the defendants’ expert opined caused Donaldson’s injuries. Nothing in Dr. Nayak’s records indicates that any physician considered or excluded secondary causes for the erosion of the devices into either the bladder or vagina, or for her painful pelvic symptoms. And as we noted previously, Dr. Nayak expressly conceded that he had not considered the issue of secondary causes. Third, reviewing and deciphering Donaldson’s complex medical records to eliminate secondary causes is simply not a task that a jury is competent to conduct without the aid of a medical expert. Finally, on the question of whether the Prosima failed to perform in the manner to be expected in light of its nature and intended function, the record is again one-sided. Dr. Nayak conceded that the Prosima repaired Donaldson’s prolapse. He characterized the product as unreasonably dangerous because it caused complications that are not reasonable when compared with other types of surgery such as “sling” surgery. But the “sling” to which he referred was a device he employed to treat urinary incontinence, not pelvic prolapse, and that is the purpose of the Prosima device. Dr. Nayak testified that he does not treat pelvic prolapse, and he was not, therefore, in a position to offer an opinion on the risk-benefit profile of using the Prosima for that purpose. Dr. Grier, on the other hand, testified that the Prosima performed as expected, and explained that erosion is a known risk factor for all types of No. 21-2028 21 surgical repairs for prolapse, not only for mesh products such as the Prosima.8 He stated that the fact of erosion does not necessarily indicate that the product is defective and he agreed with Dr. Schultheis that the benefits of the device outweighed the risks. Donaldson presented no evidence to counter Dr. Grier’s expert opinion on the risk profile of the Prosima compared to other surgical options. She argued only that her surgeon did not warn her of the risks. But her surgeon’s failure to warn her does not counter Dr. Grier’s testimony.