In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litig.
| Decision Date | 11 June 2021 |
| Docket Number | Master Docket No. 1:17-md-2775,MDL No. 2775 |
| Parties | IN RE: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING (BHR) HIP IMPLANT PRODUCTS LIABILITY LITIGATION |
| Court | U.S. District Court — District of Maryland |
THIS DOCUMENT RELATES TO THE FOLLOWING CASES:
Paula and Jace Redick v. Smith & Nephew, Inc., No. 1:17-cv-00944
Now pending are a host of motions in limine filed by Ms. Paula Redick ("Ms. Redick") and Ms. Phyliss Mosca ("Ms. Mosca") (collectively, "the plaintiffs") and by Smith & Nephew ("S&N") in this multidistrict litigation. The motions are fully briefed and oral argument was heard on April 28, 2021. Though it will not be possible to rule on many of the motions until specific evidence is proffered in the context of trial, the court endeavors herein to set appropriate boundaries on the admissibility of the challenged evidence. In this memorandum, the court will address twelve of the pending motions in limine; a subsequent memorandum will resolve the remaining motions.
A motion in limine seeks to "exclude anticipated prejudicial evidence before the evidence is actually offered." Luce v. United States, 469 U.S. 38, 40 n.2 (1984). Such motions are "designed to narrow the evidentiary issues for trial and to eliminate unnecessary trial interruptions." Louzon v. Ford Motor Co., 718 F.3d 556, 561 (6th Cir. 2013) (internal quotation marks omitted).
S&N has moved to exclude evidence concerning claims that were already dismissed from the litigation. The court has previously ruled that several claims in this case are preempted; it has not, by contrast, ruled that any evidence is preempted. See In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Prods. Liab. Litig., 300 F. Supp. 3d 732, 743, 745, 747-48 (D. Md. 2018). Nor will it categorically do so today.
Without knowing specifically what evidence may be introduced or what arguments may be raised at trial, the court can offer only abstract guidance at this stage: evidence relevant only to dismissed claims will not be admitted; but evidence relevant to claims that remain in the case, even if also relevant to dismissed claims, may be admissible. A ruling on this motion is reserved. If such evidence is admitted, the parties may request appropriate limiting instructions as necessary.
S&N moves to exclude evidence related to medical device reports ("MDRs"), otherwise known as adverse event reports ("AERs"). It argues these reports are not relevant to prove medical causation or comparative risk.
Under 21 C.F.R. § 803.10(c), medical device manufacturers are obligated to submit MDRs to the FDA. The FDA discloses those reports in its Manufacturer and User Facility Device Experience ("MAUDE") database, but notes that the database has limitations, "including the submission of incomplete, inaccurate, untimely, unverified, or biased data" and that establishing "a cause-and-effect relationship is especially difficult if circumstances surrounding the event havenot been verified or if the device in question has not been directly evaluated."1 The regulations provide that submission of an MDR is "not necessarily an admission that the device . . . caused or contributed to the reportable event." 21 C.F.R. § 803.16.
While MDRs may be used to establish notice or knowledge or to suggest alternative causes, see Berman v. Stryker Corp., No. 11 C 1309, 2013 WL 5348324, at *4 (N.D. Ill. Sept. 24, 2013) (collecting cases), they are generally not admissible as conclusive evidence of a product defect, see id.; In re Bard IVC Filters Prods. Liab. Litig., No. MDL 15-02641-PHX DGC, 2018 WL 495607, at *5-6 (D. Ariz. Jan. 22, 2018), or as independent evidence of causation, see McClain v. Metabolife, Int'l, Inc., 401 F.3d 1233, 1250 (11th Cir. 2005); cf. In re Mirena IUD Prods. Liab. Litig., 202 F. Supp. 3d 304, 325 (S.D.N.Y. 2016) (); Dunn v. Sandoz Pharms. Corp., 275 F. Supp. 2d 672, 682 (M.D.N.C. 2003) (); Rider v. Sandoz Pharms. Corp., 295 F.3d 1194, 1199 (11th Cir. 2002) ().2 On the other hand, a larger number of case reports with more detailed information might be a reliable source of expert opinion, see Hollander v. Sandoz Pharms. Corp., 289 F.3d 1193, 1211 (10th Cir. 2002), and AERs may show notice or provide at least limited support for an expert's causation opinion, see In re Tylenol (Acetaminophen) Mktg., Sales Practices and Prods. Liab. Litig., 181 F. Supp. 3d 278, 286-87 (E.D. Pa. 2016) (); In re TestosteroneReplacement Therapy Prods. Liab. Litig., MDL No. 2545, 2018 WL 2393161, at *3 (N.D. Ill. May 28, 2018) ().
Where it is unclear for what purpose an MDR or AER may be offered at trial, it is appropriate to "refuse[] to exclude such evidence in the motions stage of MDL litigation" because "there are simply too many factors" that might determine whether the evidence would be admissible. Eghnayem v. Bos. Sci. Corp., No. 2:13-cv-07965, 2014 WL 5465741, at *7 (S.D.W. Va. Oct. 28, 2014) (internal quotation marks omitted).
In this case, the parties have not indicated which MDRs may be proffered, nor for what purpose. Accordingly, the court will not order any blanket exclusion of MDRs at this time. If evidence of MDRs is sought to be introduced at trial, the court may admit them subject to the preceding parameters. A ruling on this motion is reserved.
S&N moves to exclude evidence concerning other litigation against it and other manufacturers and evidence concerning other individuals and their alleged injuries. It argues such evidence is irrelevant and would cause undue prejudice, confuse the jury, and result in unnecessary mini-trials.
Courts have concluded that evidence of other lawsuits, though it may be admissible to show notice or motive, often constitutes inadmissible hearsay and is likely to confuse a jury, waste time, and be prejudicial to the defendant. See Sutphin v. Ethicon, Inc., No. 2:14-cv-001379, 2020 WL 5079170, at *6 (S.D. W. Va. Aug. 27, 2020); Davenport v. Dunlop Tires N.A., Ltd., No. 1:15-cv-03752-JMC, 2018 WL 833606, at *2-3 (D.S.C. Feb. 13, 2018); In re Tylenol 181 F. Supp. 3d at 300. This is true especially when the evidence of lawsuits involves different devices ormanufacturers than the one involved in the present suit. See Tyree v. Bos. Sci. Corp., No. 2:12-cv-08633, 2014 WL 5445769, at *7 (S.D. W. Va. Oct. 22, 2014).
When a party seeks to introduce evidence of other accidents or injuries arising from the same product, the party must demonstrate that the other accidents or injuries were substantially similar to the one at issue. See Mirchandani v. Home Depot U.S.A., Inc., 470 F. Supp. 2d 579, 583 (D. Md. 2007). A court may exclude such evidence when its proponent fails to eliminate the material differences in the circumstances or nature of the alleged injury. See Bryte ex rel. Bryte v. Am. Household, Inc., 429 F.3d 469, 479 (4th Cir. 2005). This requirement is somewhat relaxed, however, when evidence of other incidents, claims, and lawsuits is offered to show notice. See Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1385-86 (4th Cir. 1995); see also Johnson v. Ford Motor Co., 988 F.2d 573, 579-80 (5th Cir. 1993) (). When evidence of prior claims or suits is offered to show notice, a court may (1) admit the evidence or (2) exclude the evidence under Rule 403 and instruct the jury that the defendant received notice. See Benedi, 66 F.3d at 1386.
A court may choose to deny as premature a motion which seeks a broad prohibition against the use of all prior incidents or lawsuits and fails to identify specific evidence that may be proffered at trial. See A.K.W. by and through Stewart v. Riddell, Inc., No. 1:09CV703-HSO-JMR, 2012 WL 13018753, at *1 (S.D. Miss. Oct. 1, 2012) ().
In this case, it is theoretically possible but practically unlikely that a proper basis can be shown to admit evidence of other lawsuits brought against other manufacturers, other lawsuits brought with respect to other devices, or even other lawsuits within this MDL. Even assumingsuch evidence could be offered under an exception to the hearsay rule, it is almost certain to be of little or no probative value and is likely to pose a risk of unfair prejudice. If evidence of earlier lawsuits is offered to show notice—a permissible purpose—an instruction may be a sufficient substitute to achieve the proper effect without the risk of unfair prejudice. This analysis is not intended to exclude evidence, such as registry data, which documents the performance of other manufacturers' products as compared to the BHR; such evidence may be directly relevant to the plaintiffs' misrepresentation claims. A ruling on this motion is reserved.
S&N argues that any evidence about subsequent remedial measures it took is barred by Federal Rule of Evidence 407 and 401. It contends that because Ms. Mosca's and Ms. Redick's injuries occurred due to implantation of the devices in 2010 and 2012, and because S&N's withdrawal of BHR components occurred later, in 2015, the act of withdrawal constitutes a subsequent remedial measure.3
Rule 407 provides that "[w]hen measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the...
To continue reading
Request your trial