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We have written a number of posts about pelvic mesh cases over the years.  Some of us have also worked on a number of cases.  At this point, many cases have gone from MDL to local district court to judgment to appeal.  Over time, the tide seems to have turned.  That could be because the local courts have taken a different approach than the MDLs did, because it is hard to prove a design defect when your experts criticize every device in the class, or because the prescribing doctors in later cases were aware of the risks.  In any event, we have not tired of writing about pelvic mesh wins and we still find some new twists.

Donaldson v. Johnson & Johnson, __ F.4th __, 2022 WL 2145276 (7th Cir. June 15, 2022), affirmed summary judgment for the manufacturer in a case alleging injuries from a stress urinary incontinence sling and pelvic organ prolapse mesh.  We are not discussing it just because the defendant won below and on appeal.  Or because the win below was in a district with a reputation for being plaintiff-friendly.  It also played out some recurring themes in these cases and presented a quirk of Illinois law we have not discussed much previously.

The pre-litigation facts of Donaldson are fairly simple:  Implant in 2010 of the two devices and treatment in 2014 for “injuries resulting from erosion of the mesh into her bladder, vagina and adjacent tissues, causing scarring, bladder stones and abdominal pain, among other problems.”  Her implanter gave testimony that would have ended her warnings claim—he was aware of all the relevant risks and stood by his decisions—but she dropped it.  Instead, she proceeded under a design defect theory predicated on “non-specific defects,” which is that Illinois quirk we referenced.  Under a case called Tweedy, in certain circumstances that sound quite a bit like res ipsa loquitur, a design defect claim can be established without identifying a specific defect.

We pause here to return to pelvic mesh litigation in general.  One of the two central allegations of the plaintiffs has been that the synthetic mesh devices are defective because, well, they are made of mesh.  That may be dressed up with allegations about pore size, alleged in vivo degradation, and other things, but using permanent synthetic mesh in a soft tissue repair near sensitive organs (especially if placed through the vaginal wall) is a bad idea, or so plaintiffs have alleged.  If, for instance, a plaintiff alleged vaginal erosion and her experts agreed that every mesh device sold in the United States for the same indication had a similar risk of vaginal erosion, then plaintiff was not really alleging a specific defect with the device.  The classic design defect claim requires proof that changing some aspect of the product, while retaining its basic nature and efficacy/usefulness, would have avoided the alleged injury.  You cannot claim a permanent synthetic pelvic mesh would have been safer if it had not been a permanent synthetic pelvic mesh any more than you can claim a car’s brakes would have been safer if the car had been a horse-drawn carriage.  Over time, the courts have caught on to this and more and more design claims have failed because plaintiffs cannot identify a specific design defect that proximately caused the plaintiff’s injuries.

Illinois, though, has this Tweedy line of cases that allows claims for design defect without identifying a specific defect and the plaintiff in Nicholson put all her eggs in the Tweedy basket.  She also built her case around Dr. Nayak, a treating physician who signed an attorney-drafted affidavit that offered a bunch of boilerplate allegations about both devices at issue in the case and that the devices caused all of plaintiff’s injuries.  When deposed, however, he retracted just about every opinion, except that he kept an opinion that the pelvic organ prolapse mesh caused certain injuries (even though he did not even perform prolapse repair surgeries).  (The ins-and-outs of the affidavit and retractions in deposition are discussed at length in the opinion and we can imagine the joy and angst of the counsel during the deposition.)  It appears that the plaintiff named no experts other than Dr. Nayak and, when the defendant moved for summary judgment, the plaintiff relied on Dr. Nayak’s pre-deposition affidavit in opposition.  We do not know why Dr. Nayak signed the affidavit with all those opinions he could not support or why plaintiff had no experts even after Dr. Nayak tanked, but we do have some educated and jaundiced guesses.  The district court largely disregarded the affidavit, relied on the testimony, and ruled that the Tweedy doctrine did not apply in cases involving complex medical devices.  That meant summary judgment.

The Seventh Circuit took a different route to get to the same result.  First, it found no abuse of discretion in the district court’s striking the affidavit.  The repeated contradiction in deposition and the circumstances of the affidavit were enough to invoke the sham affidavit rule or, as we have called it, the reverse sham affidavit rule.  Id. at *3  Next up was whether the Tweedy doctrine could be applied in cases involving complex medical devices.  The court ruled that it could because it had been before, including in a case we discussed here.  Because this is purely a matter of state law, we will not dwell on it, but this is a bad exception to the usual design defect requirements in Illinois and elsewhere, which require a specific defect and proof of proximate cause.  Res ipsa does not make sense in cases against manufacturers of implantable medical devices.  They do not implant themselves, are not under the manufacturer’s control when implanted, and existing product liability causes of action are sufficient for relief for plaintiffs who have the facts and expert testimony to sustain them.  It is not like a malpractice claim over a sponge left in a patient during surgery.  We have railed against res ipsa in mesh and other device cases before.  We will save some breath on it here, because it did not matter to the result.

The criteria for the Illinois exception are:

[T]he 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 the failure.

Id. at *4.  When we said Dr. Nayak’s affidavit contained boilerplate, we mean that it repeated these criteria with some words swapped in and maybe some detail added.  Once the affidavit was out of the picture, the court’s conclusion that the plaintiff had to prove these criteria through expert testimony meant the focus was on Dr. Nayak’s deposition testimony.  Id. at **5-6.  That was a problem for plaintiff.

His testimony could not carry plaintiff’s burden as to eliminating “reasonable secondary causes” of each of the claimed injuries.  Obviously, he did not implicate the sling at all.  His testimony on the prolapse mesh was not much stronger.  As to vaginal erosion, Dr. Nayak agreed with defendant’s expert that vaginal atrophy could be a cause (after being informed of the atrophy in deposition). *6.  He also agreed an intervening surgical procedure to repair posterior prolapse (whereas the prior surgery was for the anterior compartment) could be the plaintiff’s pelvic pain.  His opinion that it was possible—not likely—that the defendant’s prolapse mesh caused the plaintiff’s bladder erosion and stones was not enough to rule out other causes, especially where he had reviewed a small subset of the medical records.  Id. at *7.

He also could not establish that the prolapse mesh “failed to perform in the manner to be expected in light of its nature and intended function.”  First of all, the anterior prolapse remained repaired after the implant.  Second, as someone who did not perform prolapse repairs, he could not weigh in on the risk-profile of the defendant’s device versus “other surgical options.”  Id.  (We think this is an overly generous framing of the question, because the comparison should be to other then-available mesh devices for anterior prolapse repair not to all options for repair of anterior prolapse.)  That added up to an affirmance of summary judgment even though the Tweedy doctrine applied.  The erstwhile expert—or at least overly generous affiant—could not get plaintiff to clear two relatively low bars.  For states where no res ipsa end run on design defect is available, proof like this would not have a chance to get the plaintiff past summary judgment.