Natalie Johnson v. C. R. Bard, Inc., 77 F.4th 641

Background:

Natalie Johnson had a retrievable Meridian inferior vena cava (IVC) filter implanted; the device migrated and fractured, leaving fragments in her heart and elsewhere.
Johnson sued Bard (manufacturer) under Wisconsin law for defective design and for negligent and strict-liability failure-to-warn; Bard defended largely by blaming alleged improper placement by Dr. Goncharova.
A jury found for Bard on defective-design and negligent-failure-to-warn theories but awarded Johnson $3.3 million on strict-liability failure-to-warn.
Bard moved for a new trial arguing (1) plaintiff’s expert Dr. Hurst offered an undisclosed, changed opinion at trial about filter migration, (2) treating surgeon Dr. Goncharova was permitted to testify belatedly and without an expert report, and (3) the court should have instructed the jury that 510(k) FDA clearance creates a rebuttable presumption of non-defectiveness under Wis. Stat. § 895.047.
The district court denied the new-trial motion; the Seventh Circuit reviewed the nondisclosure and witness-admission rulings for abuse of discretion and the 510(k) instruction de novo, and affirmed.

Issues:

Issue	Plaintiff's Argument	Defendant's Argument	Held
1) Undisclosed change in expert opinion (Hurst) under Fed. R. Civ. P. 26(e)/37	Hurst’s new opinion was disclosed at trial and any discrepancy was addressed; plaintiff did not call him in rebuttal.	Hurst flipped from 3 mm downward migration to ~2.3 cm upward migration without supplementation—warranting exclusion/new trial.	Court: Defense raised objections during trial, court sustained many; plaintiff didn’t call Hurst in rebuttal; failure to seek stronger curative relief at trial forfeited the claim of entitlement to automatic exclusion; no abuse of discretion.
2) Reopening plaintiff’s case to allow treating surgeon (Goncharova) to testify belatedly	Reopening was warranted; plaintiff had subpoenaed her and took reasonable steps to secure appearance.	Court abused discretion by allowing late testimony, prejudicing Bard’s trial strategy.	Court: District judge permissibly exercised discretion to reopen, after attempts to enforce subpoena; no abuse of discretion.
3) Treating physician offering opinions without an expert report	Goncharova’s testimony was limited to her treatment decision-making and what she knew at the time—falling within the treating-physician exception to Rule 26(a)(2)(B).	Allowing opinions beyond treatment (e.g., general expert conclusions) required expert report and should have been excluded.	Court: Testimony stayed within treating-physician scope (patient-specific knowledge/decision-making); no reversible error.
4) Whether 510(k) FDA clearance creates Wisconsin rebuttable presumption of non-defectiveness	510(k) clearance shows device complied with relevant federal standards and therefore warrants the presumption under Wis. Stat. § 895.047(3)(b).	510(k) substantial-equivalence review does not assure that FDA judged the device’s specific safety; special-controls guidance is too general to be a ‘‘relevant standard.’'	Court (de novo): 510(k) clearance based on substantial equivalence does not establish compliance with material federal safety standards for the Wisconsin presumption; special-controls guidance was too general—instruction properly refused.

Key Cases Cited

Kaiser v. Johnson & Johnson, 947 F.3d 996 (7th Cir. 2020) (explains 510(k) substantial-equivalence process and limits on inferring FDA safety approval)
David v. Caterpillar, Inc., 324 F.3d 851 (7th Cir. 2003) (Rule 37(c)(1) exclusion is mandatory unless violation is justified or harmless; district court discretion in assessing harmlessness)
Salgado v. Gen. Motors Corp., 150 F.3d 735 (7th Cir. 1998) (standards for sanctioning discovery violations)
Mid-America Tablewares, Inc. v. Mogi Trading Co., Ltd., 100 F.3d 1353 (7th Cir. 1996) (district court discretion in Rule 26/37 matters)
Jones v. Lincoln Elec. Co., 188 F.3d 709 (7th Cir. 1999) (timeliness of objections at trial must allow district court opportunity to cure error)
E.E.O.C. v. AutoZone, Inc., 707 F.3d 824 (7th Cir. 2013) (treating-physician exception to expert-report requirement)
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (discusses FDA premarket approval regime and classifications of medical devices)
In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab. Litig., 810 F.3d 913 (4th Cir. 2016) (510(k) clearance does not necessarily equate to safety findings for preemption/presumption questions)
Eghnayem v. Boston Sci. Corp., 873 F.3d 1304 (11th Cir. 2017) (similar treatment of 510(k) limits)
In re Bard IVC Filters Prod. Liab. Litig., 969 F.3d 1067 (9th Cir. 2020) (special-controls guidance insufficient to establish device-specific FDA requirements for preemption or presumption)