United States District Court, D. Minnesota
In re BAIR HUGGER FORCED AIR WARMING DEVICES PRODUCTS LIABILITY LITIGATION This Document Relates to All Actions
N. ERICKSEN United States District Judge
matter is before the Court pursuant to the District of
Minnesota’s Local Rule 72.2(a)(3), which provides for
review of objections to a magistrate judge’s order on
nondispositive matters. Plaintiffs in this multidistrict
litigation (“MDL”) filed a Motion to Overrule
VitaHEAT Medical LLC’s Relevancy Objection to Subpoena
[Dkt. No. 218], seeking a ruling on the relevancy of
discovery they seek from third party VitaHEAT Medical LLC
(“VitaHEAT”). MDL Defendants and VitaHEAT jointly
opposed the motion. See Dkt. No. 236. After holding
a hearing, the Honorable Franklin L. Noel, United States
Magistrate Judge, denied the motion. Dkt. No. 249
(“Order”). Plaintiffs timely objected. The Court
must modify or set aside any objected-to part of the Order
that is clearly erroneous or is contrary to law. 28 U.S.C.
§ 636(b)(1)(A); Fed. R. Civ. P. 72(a); D. Minn. L.R.
72.2(a)(3). Having reviewed the record, the Court affirms.
subpoenaed VitaHEAT for the production of documents relating
to VitaHEAT’s product the “UB3 patient-warming
system,” a medical device that uses conductive heat to
warm patients (“UB3”). See Pls.’
Mem. 1, Dkt. No. 220; Sacchet Decl. Ex. N, Dkt. No. 221-14
(subpoena). VitaHEAT objected to the subpoena as overly broad
and unduly burdensome, as well as on the grounds that
Plaintiffs had not shown that the requested documents were
relevant. See Id. Ex. O, Dkt. No. 221-15 (VitaHEAT
objections). During the meet-and-confer process, Plaintiffs
represented that they had identified the “UB3, among
other conductive warming devices, as a safer alternative
design to the [Defendants’] Bair Hugger forced-air
warming system at issue in this litigation.” Conlin
Decl. ¶ 7, Dkt. No. 222. VitaHEAT objected that the UB3
is not an alternative design to the Bair Hugger because the
UB3 is a different product, not a different design of the
same product. See Id. ¶ 12.
moved for an order “ruling that Federal Rules of Civil
Procedure 26(b)(1) and 45(d)(2)(B)(i) govern VitaHEAT
Medical, LLC’s relevancy objection to the
subpoena” and “determining that VitaHEAT Medical,
LLC’s relevancy objection has no basis in fact or
law.” Dkt. No. 218. They argued that their discovery
requests sought documents relevant to their allegations that
an “economically and technologically feasible and safer
alternative design existed for the Bair Hugger, including but
not limited to airflow-free warming technologies . . .
.” Plfs.’ Mem. 9; Am. Master Compl. ¶ 95,
Dkt. No. 97. Other references to alternative designs in the
pleadings are more general. See, e.g., Am. Master
Compl. ¶¶ 10 (“safer alternative
designs”), 52 & 61 (same), 114 (“other
alternative devices”), 128 (“safer alternative
warming devices”). In support of their argument,
Plaintiffs relied on multiple documents that they submitted
with their brief, including: an internal email by a 3M
Company executive which they contend supports their theory;
materials on VitaHEAT’s former website; a VitaHEAT
press release; a § 510(k) summary that VitaHEAT
submitted to the Food and Drug Administration
(“FDA”) for authorization to market the UB3; and
what appears to be a study comparing the effectiveness of
forced-air warming devices and conductive heating devices for
patient warming. See Id. at 11-14. Plaintiffs
acknowledged that the Bair Hugger and the UB3 use different
“type[s] of heating technology.” Id. at
14 n. 50. They argued, however, that forced-air warming
devices and conductive heating devices are simply alternative
versions of the same product, a patient-warming device, as
alleged in their Amended Master Complaint.
magistrate judge found that the Bair Hugger forced-air
warming device and a patient warming device that uses
conductive heating, like VitaHEAT’s UB3 device, use
“fundamentally different types of technology” and
are “substantially different products.” Order, at
2. Therefore, the magistrate judge found, Plaintiffs are not
entitled to the discovery they seek from VitaHEAT because it
is not relevant. Id.
objections do not convince the Court that the Order contains
any clear error or mistake of law. It was Plaintiffs’
burden to establish a “threshold showing of
relevance.” Hofer v. Mack Trucks, Inc., 981
F.2d 377, 380 (8th Cir. 1992). “While the standard of
relevance in the context of discovery is broader than in the
context of admissibility . . ., this often intoned legal
tenet should not be misapplied so as to allow fishing
expeditions in discovery.” Id.
initial matter, the Court questions the propriety of
Plaintiffs’ request for a standalone relevancy
determination. A motion to compel discovery, in contrast,
would involve weighing relevancy against burden and other
proportionality factors. See Fed. R. Civ. P.
26(b)(1). “The court’s responsibility, using all
the information provided by the parties, is to consider these
and all the other factors in reaching a case-specific
determination of the appropriate scope of discovery.”
Advisory Comm. Notes to 2015 Amendment of Fed. R. Civ. P. 26.
Plaintiffs now complain that the magistrate judge prematurely
ruled that conductive heating devices are not an alternative
design to the Bair Hugger forced-air warming device, but they
teed up that ruling by filing the motion styled as it was.
first object that the Order contains erroneous factual
findings. The Court concludes that Plaintiffs have not
demonstrated any clear factual error based on the record
before the magistrate judge. The magistrate judge relied on
the declaration of Albert Van Duren, a 3M Company manager
with responsibilities in its patient warming business, to
find that the Bair Hugger forced-air warming system and the
UB3 conductive heating device used different types of
technology. Order at 2. Plaintiffs admitted this fact in
their briefing before the magistrate judge. Pls.’ Mem.
14 n. 50 (stating that “[t]he only difference between
the Bair Hugger and the UB3 is the type of heating
technology”). The magistrate judge also cited
Plaintiffs’ overarching theory that the technology
inherent to the Bair Hugger-that is, forced-air, convective
heating- is more dangerous than the technology in conductive
heating devices, which do not use convective heating. Order,
at 3. Indeed, the whole thrust of Plaintiffs’
allegations is that the Bair Hugger’s air-blowing
technology is what causes infections. See, e.g., Am.
Master Compl. ¶¶ 3-8. Plaintiffs reinforce this
point by referring to the Bair Hugger as a “forced air
warming device.” See, e.g., id.
¶¶ 1, 40; Conlin Decl. ¶ 7. Based on this
record, it was not clear error to conclude that a forced-air
warming device is a different product using different
technology than a conductive heating device.
arguments as to factual error largely rely on facts not
before the magistrate judge. In their objection, Plaintiffs
submitted a copy of a § 510(k) summary that appears to
have been filed by Augustine Biomedical & Design, LLC to
receive FDA approval to market the Hot Dog Patient Warming
System, another conductive heating device. See Dkt.
No. 281-1. Plaintiffs assert that the UB3 was found to be
substantially equivalent to the Hot Dog, and that the Hot Dog
was found to be substantially equivalent to the Bair Hugger,
and that these findings demonstrate the relevance of
Plaintiffs’ discovery requests. See
Pls.’ Obj. 5-6, Dkt. No. 279. The Court will not
consider new evidence that was not submitted to the
magistrate judge for consideration. See Roberts v.
Apfel, 222 F.3d 466, 470 (8th Cir. 2000); Peerless
Indem. Ins. Co. v. Sushi Ave., Inc., No. 15-CV-4112
(ADM/LIB), 2017 WL 631547, at *4 (D. Minn. Feb. 15, 2017).
Plaintiffs were on notice of the argument that conductive
heating devices and forced-air warming devices were different
products, see Pls.’ Mem. 7, 14 n.50; Conlin
Decl. ¶ 12, and they could have presented this evidence
to the magistrate judge. There is no error in not considering
a document that Plaintiffs failed to submit for
consideration. Similarly, Plaintiffs argue that testimony
that was elicited in a deposition after the
magistrate judge already ruled demonstrates that the Bair
Hugger and the UB3 do not use different types of technology.
See Pls.’ Obj. 7 (citing to Dkt. No. 268).
Even if the Court were to consider this new evidence, it
would not find clear error because the testimony, read in
full, does not say what Plaintiffs want it to say.
also argue that the magistrate judge erred as a matter of law
because the question of whether conductive heating devices
are reasonable alternative designs should be reserved for
summary judgment or trial. They cite no controlling case law
on this point. They discuss several cases in which the court
declined to decide the
See Pls.’ Obj. 8-9. But those decisions
involved different procedural postures. For example, Sec.
Nat’l Bank of Sioux City v. Abbott Labs., No.
11-cv-4017-DEO, 2012 WL 327863, *1 (N.D. Iowa Feb. 1, 2012),
and Burks v. Abbott Labs., No. 08-cv-3414 (JRT/JSM),
2010 WL 1576779, at *1 (D. Minn. Apr. 20, 2010), are
unremarkable because in each case, the court was deciding a
motion to dismiss and was thus unable to look beyond the
pleadings. Here, Plaintiffs themselves asked the magistrate
judge to consider numerous documents outside the pleadings.
addition, Plaintiffs argue that the magistrate judge erred as
a matter of law in determining that a different product
cannot be a safer alternative for purposes of design defect
liability. Again, they do not cite any controlling authority
that makes the magistrate judge’s conclusion contrary
to law. Plaintiffs quote part of a comment in the Restatement
(Third) of Torts that “[f]urthermore, other products
already available on the market may serve the same or very
similar function at lower risk and at comparable cost,”
and that “[s]uch products may serve as reasonable
alternatives to the product in question.” Restatement
(Third) of Torts § 2 cmt. f (Am. Law Inst. 1998). These
remarks, however, relate to an inapposite hypothetical
discussion about expert testimony for an obvious design
alternative to removable hard buttons on a toy, and thus do
not appear pertinent. Other comments in the Restatement
appear to support the magistrate judge’s ruling. The
Restatement indicates that it is appropriate for a court to
characterize what the product at issue is, which necessarily
affects a determination of what a reasonable alternative
design to that product is. See Id. cmt. e; cf.
Hofer, 981 F.2d at 381 (conducting a
“fact[-]specific determination of the extent of the
similarities or dissimilarities” between an allegedly
defective product and an older model about which plaintiff
sought discovery, “inquir[ing] about the basis for the
discovery request,” and affirming denial of the
discovery request where the product models were
“sufficiently dissimilar in
design”).Moreover, Defendants and VitaHEAT point to
a case in which the district court granted a motion to
dismiss because it determined that the plaintiff’s
proposed alternative was a different product, not an
alternative design. Massa v. Genentech, Inc., Civ.
No. H-11-70, 2012 WL 956192, at *7 (S.D. Tex. Mar. 19, 2012);
see also Simon v. Smith & Nephew, Inc., 990
F.Supp.2d 395, 405 (S.D.N.Y. 2013) (“[A]n allegation
that [defendant] could have manufactured a different product
altogether, or that others have done so, does not itself make
out a plausible claim of a design defect.”).
Court cannot say that the magistrate judge erred as a matter
of law by deciding that discovery into the conductive heating
device UB3 is not relevant, particularly when Plaintiffs
sought a ruling on that very question in connection with
their discovery requests.
on the files, records, and proceedings herein, and for the