Rivers v. B Braun Interventional Sys.

Docket Number19-CV-988
Decision Date31 October 2023
CourtU.S. District Court — Eastern District of Wisconsin


WILLIAM E. DUFFIN, U.S. Magistrate Judge.

1. Background

Jeannine Janet Rivers was 49 years old and morbidly obese when she underwent gastric bypass surgery on July 12, 2011. (ECF No 77-2, ¶¶ 69-70.) In part because she had suffered a pulmonary embolism in 2006 (ECF No. 77-2, ¶ 69), her bariatric surgeon ordered the placement of an inferior vena cava (IVC) filter (ECF No. 77-2, ¶ 71) in preparation for the gastric bypass surgery. The filter is placed in the inferior vena cava, the largest human vein (ECF No. 77-2, ¶ 1), and is intended to capture a blood clot before it can reach the patient's heart or lungs and cause potentially fatal complications (ECF No. 77-2, ¶¶ 4, 7). The surgeon did not specify what kind of filter should be placed (ECF No. 77-2, ¶ 73), and the implanting physician used a Braun VenaTech LP filter (ECF No. 76, ¶ 1), although he does not recall if he chose that filter or if that was the only type of filter available at the hospital (ECF No. 77-2, ¶ 84).

The physician implanted the filter without any problem and Rivers underwent gastric bypass surgery the same day. (ECF No. 77-2, ¶¶ 81-82.) Rivers was discharged from the hospital two days later. (ECF No. 77-2, ¶ 82.)

A couple of weeks later, on July 29, 2011, Rivers went to the emergency room complaining of leg pain. (ECF No. 77-2, ¶ 92.) An ultrasound ruled out a blood clot. (ECF No. 77-2, ¶ 92.) On July 31, 2011, Rivers again went to the emergency room, this time complaining of chest pain after passing out. (ECF No. 77-2, ¶ 93.) Rivers underwent a CT scan and a radiologist identified multiple pulmonary emboli. (ECF No. 77-2, ¶ 94.) However, the radiologist did not recognize that the CT scan showed that the filter had migrated to the right atrium of Rivers's heart. (ECF No. 77-2, ¶ 94.) Rivers was admitted to the hospital, treated for the blood clots, and discharged on August 3, 2011. (ECF No. 77-2, ¶ 96.)

Rivers continued to complain of palpitations, and an X-ray on August 8, 2011, again did not lead to identification of the migrated filter in Rivers's heart. (ECF No. 77-2, ¶ 97.) Likewise, the filter was not identified following a CT scan on August 17, 2011, after Rivers continued to complain of shortness of breath and chest pain. (ECF No. 77-2, ¶¶ 98-99.) The radiology report following another CT scan over two years later, on December 23, 2013, stated that the filter “appears normal.” (ECF No. 77-2, ¶ 100.) A chest X-ray on February 17, 2014, and a February 18, 2014, echocardiogram and cardiac catheterization did not mention the filter. (ECF No. 77-2, ¶¶ 101, 103.) Nor was the filter identified in a November 19, 2014, CT scan. (ECF No. 77-2 at 105.)

It was not until July 20, 2016, five years after the filter was implanted, that an echocardiogram finally recognized that the filter had migrated to Rivers's heart. (ECF No. 77-2, ¶ 106.) Two days later Rivers underwent open-heart surgery to remove the filter, a procedure that also required the replacement of her tricuspid valve. (ECF No. 77-2, ¶ 107.) Rivers suffered an infection following the surgery, which required treatment. (ECF No. 77-2, ¶ 112.)

On July 11, 2019, Rivers brought this action against B Braun Interventional Systems, Inc. and B Braun Medical. Because the defendants are indistinct for present purposes, the court refers to B Braun Interventional Systems, Inc. and B Braun Medical together in the singular as Braun.

Rivers brought claims for negligence, strict products liability - failure to warn, strict products liability - design defect, strict products liability - manufacturing defect, breach of the implied warranty of merchantability, and negligent misrepresentation. (ECF No. 1 at 12-23.) She also presented a seventh cause of action for punitive damages (ECF No. 1 at 24), but punitive damages are a remedy, not a claim, Estate of Wobschall v. Ross, 488 F.Supp.3d 737, 755 (E.D. Wis. 2020). Rivers subsequently withdrew her claims for manufacturing defect and breach of implied warranty. (ECF No. 77-1 at 7.)

All parties have consented to the full jurisdiction of this court pursuant to 28 U.S.C. § 636(c). (ECF Nos. 3, 11, 18.) The court has subject matter jurisdiction based on the diversity of the citizenship of the parties under 28 U.S.C. § 1332(a)(1).

Before the court are a plethora of pretrial motions supported by extensive and often repetitive filings spanning more than 12,000 pages. Navigation of these filings has been burdened by the parties' disorganization, failure to fully comply with the court's electronic filing policies, and a seeming overuse of redactions[1](thereby requiring the filing of both a redacted and unredacted version of the same document). Rivers seeks partial summary judgment. (ECF No. 56.) Braun seeks summary judgment (ECF No. 65) and to exclude six experts (ECF Nos. 57, 59, 60, 61, 62, 63).

2. Request for Oral Argument

The parties have written “Oral Argument Requested” in the caption of nearly all of their filings related to the present motions. But at no point do they explain why they believe oral argument is necessary or would be helpful. The parties having failed to demonstrate that oral argument is necessary, the request is denied.

3. Motions Regarding Experts

3.1. Applicable Law

The admissibility of expert opinions is governed by Fed.R.Evid. 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Kirk v. Clark Equip. Co., 991 F.3d 865, 871 (7th Cir. 2021). Under Rule 702 the court acts as a gatekeeper to ensure that proffered expert testimony “is not only relevant, but reliable.” Id. at 872 (quoting Daubert, 509 U.S. at 589). “In performing this role, the district court must engage in a three-step analysis, evaluating: (1) the proffered expert's qualifications; (2) the reliability of the expert's methodology; and (3) the relevance of the expert's testimony.' Id. (quoting Gopalratnam v. Hewlett-Packard Co., 877 F.3d 771, 779 (7th Cir. 2017)).

The fact that an expert is qualified to give an opinion is not by itself a sufficient basis for admissibility. Kirk, 991 F.3d at 873. In assessing the reliability of an expert opinion, courts may consider the following non-exhaustive factors:

(1) Whether the particular scientific theory can be (and has been) tested;
(2) whether the theory has been subjected to peer review and publication;
(3) the known or potential rate of error; (4) the existence and maintenance of standards controlling the technique's operation; and (5) whether the technique has achieved general acceptance in the relevant scientific or expert community.

Id. (quoting Deputy v. Lehman Bros., Inc., 345 F.3d 494, 505 (7th Cir. 2003)) (internal brackets and quotation marks omitted); see also Gopalratnam, 877 F.3d at 779-80 (discussing additional factors outlined in the Notes of Advisory Committee on Rules to the 2000 Amendment of Rule 702).

Because there are many different kinds of experts and expertise, the test for reliability is flexible, and no one factor is dispositive. Kirk, 991 F.3d at 873; Gopalratnam, 877 F.3d at 780. Courts must be mindful that they are not assessing the correctness of the expert's opinion but merely the soundness of the expert's methods. Daubert, 509 U.S. at 595 (“The focus, of course, must be solely on principles and methodology, not on the conclusions that they generate.”); Kirk, 991 F.3d at 873; Kopplin v. Wis. Cent. Ltd., 914 F.3d 1099, 1104 (7th Cir. 2019) (“The focus is on the expert's methodology, not his ultimate conclusions.”). “The soundness of the factual underpinnings of the expert's analysis and the correctness of the expert's conclusions based on that analysis are factual matters to be determined by the trier of fact, or where appropriate, on summary judgment.” Gopalratnam, 877 F.3d at 781 (quoting Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir. 2000); citing Manpower, Inc. v. Ins. Co. of Pa., 732 F.3d 796, 806 (7th Cir. 2013)).

3.2. Derek Muehrcke

Derek Muehrcke is a cardiothoracic surgeon with decades of experience implanting and removing filters like the one at issue here. Retained by the plaintiff as an expert, he produced a report that contains 24 separately numbered opinions (some of which contain multiple opinions). (ECF No. 63-3 at 15-24.)

3.2.1. Muehrcke's Opinions

In broad terms, Muehrcke opines that various symptoms, treatments, and complications that Rivers experienced were caused by the migration of the filter. (ECF No. 63-3 at 15-16, opinions 2, 3, 4, 5, 7, and 8.) It is very unlikely that the laparoscopic gastric bypass surgery caused the filter to migrate. (ECF No. 63-3 at 15, opinion 1.) Rivers would have needed open-heart surgery even if the migration had been recognized at the first opportunity. (ECF No. 63-3 at 17, opinion 9.) Rivers will need a valve transplant-and thus open-heart surgery-again. (ECF No. 63-3 at 16, opinion 6.)

Muehrcke says that Braun manufactured a filter that had a lower migration rate and, although Braun knew that this other filter was safer, it chose to sell that filter only outside the United States and to sell in the United States the “bad” filter that Rivers received. (ECF No. 63-3 at 17, 18, 20, 24, opinions 10, 11, 12, 15, 16, 17, 18, 24.)

Braun insufficiently tested its filter (ECF No. 63-3 at 23, opinions 21, 22) and misleadingly stated that its filter had been cleared by the FDA as safe and effective (ECF No. 63-3 at 23, opinion 21). Braun underestimated the rate at which its filters migrated and inaccurately reported Rivers's migration to the FDA. (ECF No. 63-3 at 21-22, opinions 19, 20.)

According to Muehrcke, an...

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