We’ve written quite a few posts about pelvic mesh circumstances over time. A few of us have additionally labored on quite a few circumstances. At this level, many circumstances have gone from MDL to native district court docket to judgment to enchantment. Over time, the tide appears to have turned. That might be as a result of the native courts have taken a distinct strategy than the MDLs did, as a result of it’s laborious to show a design defect when your specialists criticize each gadget within the class, or as a result of the prescribing docs in later circumstances had been conscious of the dangers. In any occasion, we’ve got not bored with writing about pelvic mesh wins and we nonetheless discover some new twists.
Donaldson v. Johnson & Johnson, __ F.4th __, 2022 WL 2145276 (seventh Cir. June 15, 2022), affirmed abstract judgment for the producer in a case alleging accidents from a stress urinary incontinence sling and pelvic organ prolapse mesh. We aren’t discussing it simply because the defendant gained beneath and on enchantment. Or as a result of the win beneath was in a district with a popularity for being plaintiff-friendly. It additionally performed out some recurring themes in these circumstances and offered a quirk of Illinois legislation we’ve got not mentioned a lot beforehand.
The pre-litigation information of Donaldson are pretty easy: Implant in 2010 of the 2 units and therapy in 2014 for “accidents ensuing from erosion of the mesh into her bladder, vagina and adjoining tissues, inflicting scarring, bladder stones and belly ache, amongst different issues.” Her implanter gave testimony that may have ended her warnings declare—he was conscious of all of the related dangers and stood by his choices—however she dropped it. As a substitute, she proceeded below a design defect principle predicated on “non-specific defects,” which is that Illinois quirk we referenced. Beneath a case known as Tweedy, in sure circumstances that sound fairly a bit like res ipsa loquitur, a design defect declare may be established with out figuring out a selected defect.
We pause right here to return to pelvic mesh litigation on the whole. One of many two central allegations of the plaintiffs has been that the artificial mesh units are faulty as a result of, nicely, they’re manufactured from mesh. Which may be dressed up with allegations about pore dimension, alleged in vivo degradation, and different issues, however utilizing everlasting artificial mesh in a smooth tissue restore close to delicate organs (particularly if positioned by the vaginal wall) is a nasty concept, or so plaintiffs have alleged. If, as an example, a plaintiff alleged vaginal erosion and her specialists agreed that each mesh gadget bought in america for a similar indication had the same danger of vaginal erosion, then plaintiff was not likely alleging a selected defect with the gadget. The traditional design defect declare requires proof that altering some facet of the product, whereas retaining its primary nature and efficacy/usefulness, would have averted the alleged damage. You can not declare a everlasting artificial pelvic mesh would have been safer if it had not been a everlasting artificial pelvic mesh any greater than you possibly can declare a automotive’s brakes would have been safer if the automotive had been a horse-drawn carriage. Over time, the courts have caught on to this and an increasing number of design claims have failed as a result of plaintiffs can not determine a selected design defect that proximately triggered the plaintiff’s accidents.
Illinois, although, has this Tweedy line of circumstances that permits claims for design defect with out figuring out a selected defect and the plaintiff in Nicholson put all her eggs within the Tweedy basket. She additionally constructed her case round Dr. Nayak, a treating doctor who signed an attorney-drafted affidavit that supplied a bunch of boilerplate allegations about each units at challenge within the case and that the units triggered all of plaintiff’s accidents. When deposed, nonetheless, he retracted nearly each opinion, besides that he saved an opinion that the pelvic organ prolapse mesh triggered sure accidents (despite the fact that he didn’t even carry out prolapse restore surgical procedures). (The ins-and-outs of the affidavit and retractions in deposition are mentioned at size within the opinion and we are able to think about the enjoyment and angst of the counsel in the course of the deposition.) It seems that the plaintiff named no specialists apart from Dr. Nayak and, when the defendant moved for abstract judgment, the plaintiff relied on Dr. Nayak’s pre-deposition affidavit in opposition. We have no idea why Dr. Nayak signed the affidavit with all these opinions he couldn’t assist or why plaintiff had no specialists even after Dr. Nayak tanked, however we do have some educated and jaundiced guesses. The district court docket largely disregarded the affidavit, relied on the testimony, and dominated that the Tweedy doctrine didn’t apply in circumstances involving advanced medical units. That meant abstract judgment.
The Seventh Circuit took a distinct path to get to the identical consequence. First, it discovered no abuse of discretion within the district court docket’s hanging the affidavit. The repeated contradiction in deposition and the circumstances of the affidavit had been sufficient to invoke the sham affidavit rule or, as we’ve got known as it, the reverse sham affidavit rule. Id. at *3. Subsequent up was whether or not the Tweedy doctrine might be utilized in circumstances involving advanced medical units. The court docket dominated that it may as a result of it had been earlier than, together with in a case we mentioned right here. As a result of that is purely a matter of state legislation, we is not going to dwell on it, however this can be a dangerous exception to the standard design defect necessities in Illinois and elsewhere, which require a selected defect and proof of proximate trigger. Res ipsa doesn’t make sense in circumstances towards producers of implantable medical units. They don’t implant themselves, should not below the producer’s management when implanted, and current product legal responsibility causes of motion are adequate for aid for plaintiffs who’ve the information and skilled testimony to maintain them. It isn’t like a malpractice declare over a sponge left in a affected person throughout surgical procedure. We’ve railed towards res ipsa in mesh and different gadget circumstances earlier than. We are going to avoid wasting breath on it right here, as a result of it didn’t matter to the consequence.
The factors for the Illinois exception are:
[T]he product did not carry out as anticipated, in gentle of its nature and meant operate, and that the product was not getting used abnormally and that there have been no affordable secondary causes of the failure.
Id. at *4. After we mentioned Dr. Nayak’s affidavit contained boilerplate, we imply that it repeated these standards with some phrases swapped in and possibly some element added. As soon as the affidavit was out of the image, the court docket’s conclusion that the plaintiff needed to show these standards by skilled testimony meant the main focus was on Dr. Nayak’s deposition testimony. Id. at **5-6. That was an issue for plaintiff.
His testimony couldn’t carry plaintiff’s burden as to eliminating “affordable secondary causes” of every of the claimed accidents. Clearly, he didn’t implicate the sling in any respect. His testimony on the prolapse mesh was not a lot stronger. As to vaginal erosion, Dr. Nayak agreed with defendant’s skilled that vaginal atrophy might be a trigger (after being knowledgeable of the atrophy in deposition). Id.at *6. He additionally agreed an intervening surgical process to restore posterior prolapse (whereas the prior surgical procedure was for the anterior compartment) might be the plaintiff’s pelvic ache. His opinion that it was doable—unlikely—that the defendant’s prolapse mesh triggered the plaintiff’s bladder erosion and stones was not sufficient to rule out different causes, particularly the place he had reviewed a small subset of the medical data. Id. at *7.
He additionally couldn’t set up that the prolapse mesh “did not carry out within the method to be anticipated in gentle of its nature and meant operate.” To begin with, the anterior prolapse remained repaired after the implant. Second, as somebody who didn’t carry out prolapse repairs, he couldn’t weigh in on the risk-profile of the defendant’s gadget versus “different surgical choices.” Id. (We expect that is an excessively beneficiant framing of the query, as a result of the comparability must be to different then-available mesh units for anterior prolapse restore to not all choices for restore of anterior prolapse.) That added as much as an affirmance of abstract judgment despite the fact that the Tweedy doctrine utilized. The erstwhile skilled—or not less than overly beneficiant affiant—couldn’t get plaintiff to clear two comparatively low bars. For states the place no res ipsa finish run on design defect is out there, proof like this may not have an opportunity to get the plaintiff previous abstract judgment.