No. 22-2610
United States Court of Appeals For the Seventh Circuit
August 11, 2023
ARGUED JUNE 1, 2023
Before EASTERBROOK, WOOD, and PRYOR, Circuit Judges.
WOOD, Circuit Judge. Hoping to minimize her risk of suffering serious complications from future blood clots, plaintiff Natalie Johnson underwent
Johnson sued the manufacturers of the Meridian filter—C.R. Bard, Inc., and Bard Peripheral, Inc. (together, “Bard“)—claiming that they defectively designed the Meridian filter and failed to warn medical providers about the device‘s risks, in violation of Wisconsin law. A jury cleared Bard on most of Johnson‘s theories, but it returned a $3.3 million verdict in her favor on her strict liability failure-to-warn count. Bard moved for a new trial on a host of issues, but the district court denied the motion. We affirm.
I
Johnson‘s case is one of several that were remanded for further proceedings following the conclusion of multidistrict litigation related to alleged defects in Bard‘s intravascular filters. See In re Bard IVC Filters Prod. Liab. Litig., No. MDL 15-02641, 2019 WL 3928657 (D. Ariz. Aug. 20, 2019). At trial, she argued that Bard was liable for her injuries under several Wisconsin-law theories: negligent defective-design, strict liability defective-design, negligent failure-to-warn, and strict liability failure-to-warn. Johnson‘s main contention was that Bard‘s Meridian filter was defectively designed because it had an unacceptably high risk of migration or fracture, or both, and that Bard failed properly to warn users about these risks. Bard‘s central defense (as relevant to this appeal) was that Johnson‘s problems came about because her surgeon, Dr. Irina Goncharova, had placed the filter too high (i.e. toward the heart) in the wall of the vein. Bard contended that Johnson‘s injuries were caused by that improper placement, not any problem with the device.
Among Johnson‘s witnesses was Dr. Darren Hurst, a vascular and interventional radiologist. In his expert report and deposition testimony, Hurst stated that CT scans taken a few days after Goncharova implanted Johnson‘s filter showed that the filter had migrated down by 3 millimeters. At trial, however, he testified that the scans showed that the filter had migrated upward by 2.5 or 2.3 centimeters. This led Bard to object at variоus times on nondisclosure grounds, an issue that we discuss in more depth in Part II.A, infra.
Johnson also called Goncharova to testify, but securing her appearance turned out to be difficult. On day one of the trial, Johnson informed the court that she was “concerned that the two physicians that have been subpoenaed have not responded.” The district court replied that the trial would proceed, but that it might be possible “to take them out of turn” or “have them appear by videoconferencing.” The district court also stated that “if you want some relief in an effort to get them to appear in some way ... you need to let me know and I‘ll do what I can.”
As Johnson suspected, Goncharova failed to appear as required by the subpoena at the scheduled time on day two of the trial. On day four, Johnson rested her case. But on the morning of day five of the trial, Johnson informed the court that she intended to file a motion to request that
One final aspect of the trial requires a word. Bard sought a jury instruction stating that it was entitled to a rebuttable presumption that the Meridian filter was not defective. Under Wisconsin law, manufacturers are entitled to such a presumption if the product “complied in material respects with relevant standards, conditions, or specifications adopted or approved by a federal or state law or agency.”
The jury returned a verdict for Bard on both of the defective-design theories and on the negligent failure-to-warn theory, but it returned a $3.3 million verdict for Johnson on the strict liability failure-to-warn theory. For the latter, it concluded that the “foreseeable risks of harm posed by the [Meridian filter] could have been reduced or avoided by the provision of reasonable instructions or warnings by [Bard] and the omission of the instructions or warnings render[ed] the [Meridian filter] not reasonably safe.”
Bard moved for a new trial on a host of issues, but the district court denied the motion in its entirety. On appeal, Bard renews three of its post-trial arguments. First, it asserts that Hurst‘s flip-flop violated the expert witness disclosure requirements of
II
A
1
Bard asserts that we must grant a new trial “because of Dr. Hurst‘s undisclosed and contradictory expert opinions offered for the first time at trial.” Although Hurst‘s expert report and deposition testimony stated that the filter migrated down by 3 millimeters, he testified at trial that the filter migrated upward by 2.5 centimeters or so. This change in opinion was significant, according to Bard, becаuse one of its defenses was that Johnson‘s injuries were caused by Goncharova‘s placement of the filter in a spot that was too high. It would have needed an entirely different
Before we delve into this part of the appeal, we need to assurе ourselves that Bard‘s objections to Hurst‘s testimony have something to do with Johnson‘s failure-to-warn theory. If they pertain only to her defective-design theories, there is nothing left to say—Bard prevailed on all of those theories before the jury, and Johnson did not file a cross-appeal. Hurst‘s testimony addressed the flaws in the device rather than any warnings that went along with it, and so at first glance one might think that any errors in admitting or denying it were harmless for purposes of the failure-to-warn theory. On the other hand, the Supreme Court of Wisconsin has held that “the likelihood of an accident‘s taking place and the seriousness of the consequences are always рertinent matters to be considered with respect to the duty to provide a sufficient warning label, and ... there is a particular need for a sufficient warning where there is a representation that the product in question is not dangerous.” Schuh v. Fox River Tractor Co., 63 Wis. 2d 728, 739 (1974); Tanner v. Shoupe, 228 Wis. 2d 357, 368 (Wis. Ct. App. 1999). The jury might well have relied on Hurst‘s testimony in its consideration of the seriousness of the consequences that attended the alleged failure to warn. That is enough, we think, to support the continued relevance of Bard‘s arguments about him.
2
Several provisions of the Federal Rules of Civil Procedure govern the pretrial disclosure of expert opinions. Under
We have held in the context of
We agree with Bard that Johnson‘s failure to disclose Hurst‘s new opinion regarding
Hurst initially testified at some length about the placement of the filter, with no objection from Bard regarding nondisclosure. Bard‘s first objection came when Johnson‘s lawyer, James Johnson, attemptеd to present a demonstrative aid that Bard had not received in advance and that Bard believed was inconsistent with Hurst‘s previous disclosures. The court sustained Bard‘s objection, admonishing Attorney Johnson that “you should have cleared this in advance. And you‘ve put yourself in this position, so he‘ll have to testify without it, Counsel.” The demonstrative was not shown to the jury, and Bard did not request any further remedial action from the court.
Bard‘s next objection was also sustained. When Attorney Johnson attempted to show an exhibit to Hurst (though not to the jury), Bard objected. A lengthy sidebar ensued, during which the parties disputed whether Hurst‘s intended testimony about the filter‘s location and its upward movemеnt was consistent with his expert report and deposition. Given the uncertainty about whether Hurst‘s intended testimony had previously been disclosed, the court told Attorney Johnson that he was “going to have to lay a foundation then, before you ask him about any movement, as to the placement of the apex of the filter after three days in relation to the inferior cortical margin.” Counsel‘s questioning immediately following the sidebar respected that limitation. And when Attorney Johnson requested permission to publish the exhibit at issue, the court refused: “No. You didn‘t disclose it in advance. There‘s problems with it and you‘re not going to be showing it to the jury.”
Bard‘s last nondisclosure objection during Hurst‘s testimony came shortly thereafter, when Hurst stated that the filter had moved 2.3 centimeters. Bard objected, citing Hurst‘s deposition testimony that the filter had moved only 3 millimeters. The district court asked Hurst about the discrepancy, and Hurst replied that he “was asked to reevaluate” one of the images by the plaintiff. At that point, the following exchange took place:
Court: There‘s a procedure for someone to correct their deposition transcript. Did you do that, did you review your transcript and change it?
Hurst: I did not review my transcript, but I did not make the change because this change—I was asked to review the IVC venacavogram later.
Court: And was this change ever disclosed to the defendants?
Attorney Johnson: No, sir.
Court: I‘m sorry?
Attorney Johnson: No, sir.
Court: Then we are where we are, Counsel.
Attorney Johnson: I‘ll ask about other features that were disclosed.
Court: Fine.
Bard did nоt make any further relevant objections during Hurst‘s testimony. At the conclusion of the testimony, Bard filed a motion “seeking the exclusion of plaintiff‘s expert Dr. Hurst‘s undisclosed opinions.” On appeal, Bard claims that “the district court never ruled on that request.”
Bard‘s motion did not focus on the damage that had already been done by Hurst‘s trial testimony during the plaintiff‘s case-in-chief. Instead, the motion requested that the court exclude Hurst‘s prospective testimony as a rebuttal witness. For example, Bard explained:
[T]he Court, sua sponte, stated that Dr. Hurst could return as a rebuttal witness to testify about his new opinion ... . If Dr. Hurst was allowed to offer his entirely new оpinion about where the filter was placed and how far and in what direction it moved following the placement, he would not be rebutting anyone except himself ... . Furthermore, Plaintiff did not offer a rebuttal expert report for Dr. Hurst by the Court mandated August 11, 2020 deadline.
After Bard filed its motion, the court asked Attorney Johnson if he intended to call any rebuttal witnesses. He expressly declined: “We are not planning on calling Dr. Hurst in rebuttal, and, therefore, we have no rebuttal expected, Your Honor.” Thus, Bard‘s motion to exclude Hurst‘s rebuttal testimony was moot and there was no need for a ruling by the court.
Nowhere in the motion did Bard ask the court to reconsider rulings it had made оn Bard‘s objections during Hurst‘s testimony. Never did Bard suggest that it was seeking additional curative measures to remedy the harm done by Hurst‘s testimony in the case-in-chief. To the contrary, the motion stated that “[f]ollowing Bard‘s objection, the Court sustained Bard‘s objection to the introduction of this new opinion and excluded it,” and that this “refusal to allow” the testimony was “proper.” This stands in stark contrast to Bard‘s position on appeal to the effect that the district court “did not squarely address Bard‘s myriad objections.” We decline to accept this revisionist account.
The record shows that the nondisclosure-related objections Bard made to Hurst‘s testimony were all addrеssed to its satisfaction by the district court. We appreciate the challenges that parties face when attempting to respond to unanticipated issues arising in the heat of trial. For this reason, we have explained that “an objection [need not] be perfectly contemporaneous with the challenged testimony in order to ... be considered ‘timely.‘” Jones v. Lincoln Elec. Co., 188 F.3d 709, 727 (7th Cir. 1999). But objections still must be “raised within a sufficient time after the proffer of testimony so as to allow the district court an adequate opportunity to correct any error.” Id. Although Bard could have asked the court for a stronger sanction, such as striking Hurst‘s testimony from the record, a curativе instruction, or even a mistrial, it chose not to do so. Bard cannot, only after losing a jury verdict, repackage its earlier acquiescence as a bid for much stronger measures.
B
Bard also argues that it is entitled to a new trial because the district court mishandled Dr. Goncharova‘s appearance. It accuses the court of abusing its discretion by “sua sponte” reopening the plaintiff‘s case-in-chief to allow Goncharova to testify, and of similarly erring by permitting her to opine on matters outside her role as Johnson‘s treating physician without providing an expert report. Once again, we can see the potential relevаnce of this testimony to the failure-to-warn theory of liability. As the treating physician, Goncharova was just the person who needed to see an adequate warning, and her testimony was capable of shedding light on this issue.
Bard first accuses the district court of abusing its discretion because (according to Bard) it acted on its own initiative to secure Goncharova‘s attendance. But that is a misleading portrayal of what happened. Johnson informed the court during the trial that she was attempting to secure Goncharova‘s testimony after Goncharova disregarded a trial subpoena and failed to appear on day two of the trial. On the morning of day five of the trial, Johnson stated that she intended to file a motion to request that the U.S. marshals escort Goncharova to testify on the next trial date. At that point, the court e-mailed the hospital group‘s attorney in an attempt to enforce its subpoena. This effort was successful; Goncharova indicated that same afternoon that she would appear to testify on day six. The most one could say is that the court anticipated Johnson‘s motion and sought to avoid dispatching U.S. marshals by sending a warning first. That does not amount to unprompted or inappropriate activism.
Bard also argues that the district court abused its discretion in permitting Goncharova‘s belated testimony because Johnson did not act “diligently” to secure her presence. The court was willing to say that Johnson “should have done a better job of pursuing [Goncharova].” But it nevertheless concluded that the “various steps” Johnson had taken were sufficient, and so it declined to exclude Goncharova‘s testimony for lack of diligence. The district court was well-situated to make this determination, and Bard has not shown that the court‘s conclusion amounted to an abuse of discretion.
Bard also argues that allowing Goncharova to testify “on the last day of all evidence” was prejudicial because it upset Bard‘s case strategy and gave “her testimony out-sized importance ... without any meaningful ability to respond.” This too is a matter that lies squarely within the district court‘s discretion, and we see nothing amiss here. The court was satisfied that Bard was not unfairly prejudiced by the timing of Goncharova‘s testimony. Bard was on notice from the outset that Johnson intended to call Goncharova as a witness. Johnson attempted to depose Goncharova (albeit unsuсcessfully) and listed her as a witness on her pretrial submissions. In addition, Bard knew that the court had expressed a willingness to permit Goncharova to testify “out of turn” after Johnson shared concerns about Goncharova‘s responsiveness. If Bard decided to rest its trial strategy on the hope that a key witness would successfully ignore a subpoena, that was a risk it accepted voluntarily.
We reject Bard‘s argument that the timing of Goncharova‘s testimony deprived it of a meaningful opportunity to respond to her. The trial court stated that it would
Alternatively, Bard argues that Goncharova‘s testimony should have been excluded because she impermissibly offered “opinions on a variety of issues that went far beyond describing her care and treatment of Plaintiff.” Typically, “[a]n expert witness must submit a written report ‘if the witness is one retained or specially employed to provide expert testimony in thе case or one whose duties as the party‘s employee regularly involve giving expert testimony.‘” E.E.O.C. v. AutoZone, Inc., 707 F.3d 824, 833 (7th Cir. 2013) (quoting
As we discussed above with respect to Hurst, we review a district court‘s decision to admit or exclude expert testimony after a nondisclosure violation for abuse of discretion. See David, 324 F.3d at 857. Here, hоwever, the underlying question is whether Goncharova‘s testimony was within the scope of her role as Johnson‘s treating physician. We have treated similar issues as legal questions that are evaluated de novo. See, e.g., Echo, Inc. v. Timberland Machs. & Irrigation, Inc., 661 F.3d 959, 963 (7th Cir. 2011) (“We review the district court‘s classification of a witness as lay or expert de novo.“).
Bard highlights three exchanges during Attorney Johnson‘s examination of Goncharova as impermissibly veering outside the scope of her treatment of Johnson and into the realm of an expert retained for litigation purposes. It failed to lodge relevant objections to Attorney Johnson‘s questions during two of these exchanges. But in any event, counsel‘s questions to Goncharova appropriately focused on her treatment of Johnson.
The three exchanges that Bard now criticizes follow a similar pattern. First, Attorney Johnson asked Goncharova whether she knew certain information regarding Meridian filters at the time she chose a Meridian filter for Johnson‘s surgery. Next, counsel asked Goncharova whether that information “would ... have been important” to her. Finally, he asked why the information would have been important, or what she would “likely have done had [she] been made aware of that information[.]”
These questions were directed at what Goncharova knew about the Meridian filter at the time she decidеd to implant that device in one particular patient—Johnson—and how that knowledge (or lack thereof) affected the doctor‘s decisions with respect to her treatment of that patient. This is not a case where the plaintiff attempted to back-door undisclosed expert testimony through the testimony of the plaintiff‘s treating physician. Goncharova did not, for example, offer a general opinion on industry standards, what other surgeons might do, or conclusions based on studies or research she conducted after Johnson‘s surgery. Nor did she engage in special preparation leading up to the litigation. To the contrary, the events leading up to her testimony show that Goncharova
C
Finally, Bard argues that the district court should have instructed the jury that Bard was entitled to a rebuttable presumption that the Meridian filter was not defective. Again, we need to ensure that these arguments continue to be relevant to the appeаl. It appears to us that they are. Wisconsin law considers a manufacturer to be strictly liable for a product that “is defective because of inadequate instructions or warnings.”
Bard argues that the fact that the Meridian filter received “510(k) clearance” from the FDA means that it “complied in material respects with relevant standards, conditions, or specifications adopted or approved by a federal ... agency,”
To see why, a brief look at that process is in order. We described it in detail in Kaiser v. Johnson & Johnson, 947 F.3d 996, 1003–05 (7th Cir. 2020), a case dealing with an analogous Indiana presumption of non-defectiveness. The FDA categorizes medical devices as Class I, Class II, or Class III. See
There are two ways to show substantial equivalence, if the new device has the same intended use as the predicate device: the new device may “(1) have ‘the same technological characteristics’ as the predicate device or (2) be ‘as safe and effective’ as the predicate and ‘not raise different questions of safety and effectiveness.‘” Id. (quoting
In Kaiser, we held that the defendants were not entitled to the Indiana presumption of non-defectiveness because there was no assurance that product safety had factored into the FDA‘s clearance decision, which was based on the substantial-equivalence exception. Id. at 1018. We also found that the district court did not abuse its discretion in refusing to allow the defendant to present evidence of the product‘s 510(k) clearance to the jury. Id. The Fourth and Eleventh Circuits have come to similar conclusions in cases dealing with 510(k) clearance. See In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab. Litig., 810 F.3d 913 (4th Cir. 2016); Eghnayem v. Boston Sci. Corp., 873 F.3d 1304 (11th Cir. 2017).
The district court in the present case concluded that the line of substantial-equivalence findings that Bard‘s filter depended on did not demonstrate compliance with relevant federal safety standards. We agree with this reasoning. Bard did not show that the 510(k) clearance of its Meridian filter was based on the FDA‘s determination that it complied with any specific safety standards, rather than its similarity to previously approved devices.
Bard finally argues that the district court failed to consider that apart from the substantial-equivalence showing, the FDA requires it to comply with three “special controls.” These “special controls,” it asserts, are sufficient to invoke the presumption. But it was vague about what these “sрecial controls” actually were, other than referring generically to “three mandatory guidance documents ... delineat[ing] the testing, labeling, etc. that must be done when developing a [sic] intravascular filter.” This is not good enough. Recall that the Wisconsin presumption applies only if Bard shows that it “complied in material respects with relevant standards.”
Even if we were to overlook Bard‘s failure to develop this argument fully (and we are not inclined to do so), we are skeptical that the special controls currently applicable to intravascular filters qualify as relevant standards as contemplated by Wisconsin law. The special controls consist of three guidance documents: (1) “Use of International Standards Organization‘s ISO 10933 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,” (2) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1),” and (3) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”
Bard does not discuss these documents in any detail, probably because they are far too general to qualify as relevant safety standards. One document enumerates “the criteria for an ideal filter,” but only at a high level of generality:
- Nonthrombogenic
- High filter efficiency without impedance of blood flow
- Secure fixation within the vena cava
- Rapid and safe percutaneous insertion
- Low rate of associated morbidity
- Magnetic resonance imaging (MRI) compatibility
We conclude that the district court did not err in holding that the evidence that Bard proffered regarding its 510(k) clearance was insufficient to show that it materially complied with relevant federal safety standards. Therefore, the district court did not err by refusing to instruct the jury that there was a rebuttable presumption that the Meridian filter was not defective for failure to warn.
III
Our decision in this appeal should not be misinterpreted as our endorsement of some of Johnson‘s counsel‘s trial tactics. But ours is an adversary system, and parties in civil litigation are held to the decisions they make. From that perspective, we find no reversible error, and we AFFIRM the district court‘s denial of defendants’ motion for a new trial.