Sanchez et al v. Boston Scientific Corporation
Filing
134
MEMORANDUM OPINION AND ORDER (Motions for Summary Judgment on Substantive Claims and Punitive Damages) granting in part and denying in part 60 MOTION by Boston Scientific Corporation for Summary Judgment Against Plaintiffs Rosanne Sanchez and Rod S anchez; granting in part and denying in part 62 MOTION by Rod Sanchez, Roseanne Sanchez for Partial Summary Judgment; denying 64 MOTION by Boston Scientific Corporation for Partial Summary Judgment on Plaintiffs' Punitive Damages Claim. Directing the Clerk to post a copy of this published opinion on the court's website, www.wvsd.uscourts.gov. Signed by Judge Joseph R. Goodwin on 8/18/2014. (cc: attys; any unrepresented party) (skh)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
ROSEANNE SANCHEZ, et al.,
Plaintiffs,
v.
CIVIL ACTION NO. 2:12-cv-05762
BOSTON SCIENTIFIC CORPORATION,
Defendant.
MEMORANDUM OPINION AND ORDER
(Motions for Summary Judgment on Substantive Claims and Punitive Damages)
Pending before the court is Boston Scientific Corporation’s Motion for Summary
Judgment [Docket 60], the Plaintiffs’ Motion for Summary Judgment [Docket 62], and Boston
Scientific Corporation’s Motion for Partial Summary Judgment on Plaintiffs’ Punitive Damages
Claim [Docket 64]. For the reasons stated below, Boston Scientific Corporation’s Motion for
Summary Judgment [Docket 60] is GRANTED in part and DENIED in part, the Plaintiffs’
Motion for Summary Judgment [Docket 62] is GRANTED in part and DENIED in part, and
Boston Scientific Corporation’s Motion for Partial Summary Judgment on Plaintiffs’ Punitive
Damages Claim [Docket 64] is DENIED.
I. Background
This case is one of more than 60,000 assigned to me by the Judicial Panel on Multidistrict
Litigation. These cases involve the use of transvaginal surgical mesh to treat pelvic organ prolapse
and stress urinary incontinence. In this particular case, plaintiff Roseanne Sanchez was implanted
with two products manufactured by defendant Boston Scientific Corporation (“BSC”): the
Pinnacle Pelvic Floor Repair Kit (the “Pinnacle”) to treat pelvic organ prolapse and the Advantage
Transvaginal Mid-Urethral Sling System (the “Advantage”) to treat stress urinary incontinence.
The plaintiffs allege that as a result of implantation with these products Ms. Sanchez experienced
several complications, including vaginal discharge, painful intercourse, bleeding, pelvic pain, and
cramping. (See Pls.’ Mem. in Supp. of Pls.’ Mot. for Partial Summ. J. [Docket 63], at 1). The
plaintiffs currently advance the following claims: negligence, strict liability (defective design,
manufacturing defect, and failure to warn), loss of consortium, breach of express and implied
warranties, fraudulent concealment, and punitive damages. (See Short Form Compl. [Docket 1] ¶
13).
The parties have filed several motions for summary judgment. I have already denied BSC’s
motion for summary judgment on the statute of limitations. See Sanchez v. Boston Scientific Corp.,
No. 2:12-cv-05762, 2014 WL 202787 (S.D. W. Va. Jan. 17, 2014). Currently before me are
motions by BSC for summary judgment on all claims, and the plaintiffs’ motions for summary
judgment on express preemption, implied preemption, and the learned intermediary doctrine.
II. Legal Standard
To obtain summary judgment, the moving party must show that there is no genuine issue as
to any material fact and that the moving party is entitled to judgment as a matter of law. Fed. R.
Civ. P. 56(a). In considering a motion for summary judgment, the court will not “weigh the
evidence and determine the truth of the matter.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
249 (1986). Instead, the court will draw any permissible inference from the underlying facts in the
light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574, 587-88 (1986).
2
Although the court will view all underlying facts and inferences in the light most favorable
to the nonmoving party, the nonmoving party nonetheless must offer some “concrete evidence
from which a reasonable juror could return a verdict in his [or her] favor.” Anderson, 477 U.S. at
256. Summary judgment is appropriate when the nonmoving party has the burden of proof on an
essential element of his or her case and does not make, after adequate time for discovery, a
showing sufficient to establish that element. Celotex Corp. v. Catrett, 477 U.S. 317, 322-23
(1986). The nonmoving party must satisfy this burden of proof by offering more than a mere
“scintilla of evidence” in support of his or her position. Anderson, 477 U.S. at 252. Likewise,
conclusory allegations or unsupported speculation, without more, are insufficient to preclude the
granting of a summary judgment motion. See Felty v. Graves-Humphreys Co., 818 F.2d 1126,
1128 (4th Cir. 1987); Ross v. Commc’ns Satellite Corp., 759 F.2d 355, 365 (4th Cir. 1985),
abrogated on other grounds, Price Waterhouse v. Hopkins, 490 U.S. 228 (1989).
III. Choice of Law
While this case was filed directly into this multidistrict litigation, I have already decided
that California choice-of-law rules apply here. See Sanchez, 2014 WL 202787, at *4. The parties
agree that California law applies to the substantive claims in this case. Therefore, I will apply
California law to the plaintiffs’ substantive claims. The parties disagree, however, whether to
apply California law or Massachusetts law to the punitive damages claim. As I explain below,
California law also applies to the punitive damages claim.
IV. Analysis
A. Failure to Warn
The plaintiffs allege that BSC failed to warn about particular risks associated with the
Pinnacle and Advantage devices. BSC moves for summary judgment, contending that the
3
plaintiffs have failed to adduce any evidence that inadequate or absent warnings caused their
injuries. In a separate motion, the plaintiffs move for summary judgment by arguing that the
learned intermediary doctrine is inapplicable in this case. I will address each motion separately,
beginning with the plaintiffs’ contention that the learned intermediary doctrine is inapplicable.
1. Learned Intermediary Doctrine
The plaintiffs argue that the learned intermediary doctrine “does not apply when a plaintiff
alleges that a manufacturer failed to adequately warn a plaintiff’s doctor of a device’s risks.” (See
Pls.’ Mem. of Law in Supp. of Pls.’ Mot. for Partial Summ. J. [Docket 63], at 7). They contend that
the learned intermediary doctrine is inapplicable where it is alleged that product warnings were
inadequate. (See id. at 8). The plaintiffs are incorrect, but they are not at fault. In my opinion,
several courts applying California law have recently confused this issue.
In order to establish a claim for failure to warn, whether in strict liability or in negligence, a
plaintiff must prove that the defendant’s warnings were inadequate, and that the inadequate
warnings were a substantial factor in causing the plaintiff’s harm. See Anderson v. Owens-Corning
Fiberglas Corp., 810 P.2d 549, 558 (Cal. 1991) (stating that both negligence and strict liability
require showing that warnings were inadequate); Rosa v. City of Seaside, 675 F. Supp. 2d 1006,
1011 (N.D. Cal. 2009) (listing elements of negligence and strict liability failure-to-warn claims). It
is the plaintiff’s burden to demonstrate that he or she would have acted differently if provided with
adequate warnings. See, e.g., Ramirez v. Plough, Inc., 863 P.2d 167, 177 (Cal. 1993) (holding that
plaintiff failed to produce evidence of causation in failure-to-warn claim where plaintiff could not
read English-language warning).
The learned intermediary rule is part and parcel of a failure-to-warn analysis in California.
Under the learned intermediary rule, manufacturers of prescription drugs and medical devices
4
satisfy their duty to warn if they provide adequate warnings to prescribing physicians, rather than
patients. See Carlin v. Superior Court, 920 P.2d 1347, 1354 (Cal. 1996) (“[I]n the case of
prescription drugs, the duty to warn runs to the physician, not to the patient.”); Brown v. Superior
Court, 751 P.2d 470, 477 n.9 (Cal. 1988) (“It is well established that a manufacturer fulfills its duty
to warn if it provides adequate warning to the physician.”). A pharmaceutical manufacturer is not
required to warn anybody other than prescribing physicians about the dangerous propensities of
their prescription drugs and medical devices. Period.
In order to satisfy the element of causation under the learned intermediary doctrine, a
plaintiff must demonstrate that the prescribing physician would have acted differently had he or
she received adequate warnings. See Motus v. Pfizer Inc., 196 F. Supp. 2d 984, 995 (C.D. Cal.
2001) (“Pfizer may prevail in its motion for summary judgment if Ms. Motus has failed to adduce
evidence that Dr. Trostler would have acted differently had Pfizer provided an adequate
warning[.]”); Georges v. Novartis Pharm. Corp., 988 F. Supp. 2d 1152, 1157-58 (C.D. Cal. 2013)
(holding that plaintiff was required to prove that her injuries “resulted from Defendant’s
inadequate warnings” and upholding jury verdict for plaintiff where treating physician “testified
that he changed his treatment practices once he was aware of the [product] risk”); Plummer v.
Lederle Labs., Div. of Am. Cyanamid Co., 819 F.2d 349, 358 (2d Cir. 1987) (applying California
law) (noting that plaintiff had failed to prove proximate causation where he “failed to prove that a
proper warning would have altered the doctor’s conduct”); Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d
299, 308-09 (Ct. App. 2008) (denying summary judgment where plaintiff produced evidence that
prescribing doctor “probably read” manufacturer’s warnings, creating dispute of fact whether the
warnings were “a substantial factor” in his prescribing decision).
5
The plaintiffs assert that the learned intermediary rule “does not apply” to their claims
because they allege that BSC failed to adequately warn Dr. Kerri Wiltchik, the prescribing
physician. (Pls.’ Mem. of Law in Supp. of Pls.’ Mot. for Partial Summ. J. [Docket 63], at 7). The
plaintiffs cite several cases in support of this proposition. See, e.g., Hatherley v. Pfizer, Inc., No.
CIV. 2:13-00719 WBS, 2013 WL 3354458, at *4 (E.D. Cal. July 3, 2013) (stating that the learned
intermediary doctrine “appears to be inapplicable” where plaintiffs alleged that warnings were
inadequate); Hill v. Novartis Pharm. Corp., 944 F. Supp. 2d 943, 954 (E.D. Cal. 2013) (stating that
if plaintiff proffered evidence of inadequate warnings, plaintiff could argue that prescription drug
manufacturer had a duty to warn individuals other than her prescribing physician); In re Avandia
Mktg., Sales Practices & Prods. Liab. Litig., 624 F. Supp. 2d 396, 419 (E.D. Pa. 2009) (applying
California law) (“the learned intermediary defense simply does not apply where a plaintiff alleges
that the manufacturer failed to adequately warn doctors of the danger of the drug”) (internal
quotation omitted); In re Fosamax Prods. Liab. Litig., No. 1:06-MD-1789, 2008 WL 2940560, at
*7 (S.D.N.Y. July 29, 2008) (holding that the learned intermediary doctrine did not “operate to
preclude recovery” where plaintiff alleged warnings were inadequate); Stewart v. Union Carbide
Corp., 117 Cal. Rptr. 3d 791, 797-98 (Ct. App. 2010) (learned intermediary doctrine, “where it
applies at all, applies only if a manufacturer provided adequate warnings to the intermediary”).
To the extent that these cases suggest that the learned intermediary doctrine has no effect
where plaintiffs allege that warnings are inadequate, I respectfully believe that these cases are
incorrect. The learned intermediary rule merely holds that the “the prescribing doctor . . . in reality
stands in the shoes of ‘the ordinary consumer’” to receive a manufacturer’s warnings. Carmichael
v. Reitz, 95 Cal. Rptr. 381, 401 (Ct. App. 1971). There are several policies behind the rule:
(1) The doctor is intended to be an intervening party in the full sense of the word.
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Medical ethics as well as medical practice dictate independent judgment,
unaffected by the manufacturer's control, on the part of the doctor. (2) Were the
patient to be given the complete and highly technical information on the adverse
possibility associated with the use of the drug, he would have no way to evaluate it,
and in his limited understanding he might actually object to the use of the drug,
thereby jeopardizing his life. (3) It would be virtually impossible for a
manufacturer to comply with the duty of direct warning, as there is no sure way to
reach the patient.
Id. at 400-01. For these reasons, California holds that in the case of prescription drugs and medical
devices, “the duty to warn runs to the physician, not to the patient.” Carlin, 920 P.2d at 1354.
It does not withstand scrutiny to say that the learned intermediary doctrine suddenly
becomes inapplicable when a plaintiff alleges that warnings are inadequate. If the learned
intermediary doctrine became inapplicable when a plaintiff alleged that warnings were inadequate,
the doctrine would never operate in California. Plaintiffs could simply plead around the doctrine
by alleging inadequate warnings—which they must necessarily do to state a claim for failure to
warn. Every time a plaintiff brings a claim for failure to warn, he or she must allege that warnings
were inadequate. Cases involving prescription pharmaceuticals are no different: a plaintiff must
allege that the product’s warnings were inadequate.
Even where a plaintiff proves that warnings were inadequate, the learned intermediary
doctrine still applies. A plaintiff must prove that inadequate warnings altered the prescribing
physician’s decision to prescribe. Anything to the contrary would violate the California Supreme
Court’s clear holding that “the duty to warn runs to the physician, not to the patient.” Carlin, 920
P.2d at 1354.
California courts, apart from the ones cited above, consistently apply the learned
intermediary rule even when a plaintiff alleges and proves that warnings were inadequate. See,
e.g., Stanley v. Novartis Pharm. Corp., --- F. Supp. 2d ---, No. CV 11-03191-JGB, 2014 WL
7
1316217, at *11 (C.D. Cal. Apr. 2, 2014); Motus v. Pfizer Inc., 196 F. Supp. 2d 984, 991, 995-98
(C.D. Cal. 2001), aff’d, 358 F.3d 659 (9th Cir. 2004); Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299,
307-08 (Ct. App. 2008); Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr. 2d 252, 263 (Ct. App.
1999); Plenger v. Alza Corp., 13 Cal. Rptr. 2d 811, 819 (Ct. App. 1992).
For instance, in Conte, the plaintiff contended that Wyeth’s information provided for the
Physician’s Desk Reference was inadequate. See 85 Cal. Rptr. 3d at 307. The court applied the
learned intermediary rule and held that “Wyeth’s duty to warn of risks associated with its
[product’s] usage runs to the physician, not the patient.” Id. at 308 n.5. The court then found a
genuine dispute of fact as to whether the prescribing physician read and relied on the Physician’s
Desk Reference in prescribing the drug. Id. at 308-09. If the law were as the plaintiffs here argue,
the Conte court should have ignored the learned intermediary rule altogether and held that Wyeth’s
duty to warn ran to the plaintiff directly. But the court correctly recognized that the duty to warn in
that case ran to the physician, not the patient.
Similarly, in Motus, the parties and the court assumed for the purposes of argument that
Pfizer’s warnings were inadequate. See 196 F. Supp. 2d at 991 (“Pfizer tacitly concedes for
purposes of this summary judgment motion that its warning about the risk of suicide was
inadequate.”). Again, the court applied the learned intermediary rule. See id. 990-991. The court
found that the plaintiff “failed to adduce evidence that Dr. Trostler [the prescribing physician]
would have acted differently had Pfizer provided an adequate warning about the risk of suicide
associated with the ingestion of Zoloft.” Id. at 995. The Ninth Circuit affirmed and again applied
the learned intermediary rule. See Motus v. Pfizer Inc., 358 F.3d 659, 661 (9th Cir. 2004). The
Ninth Circuit held that “[b]ecause the doctor testified that he did not read the warning label that
accompanied Zoloft or rely on information provided by Pfizer’s detail men before prescribing the
8
drug to Mr. Motus, the adequacy of Pfizer’s warnings is irrelevant to the disposition of this case.”
Id.
Thus, the plaintiffs’ assertion that the learned intermediary rule “does not apply” in this
case is without merit. In a failure-to-warn claim, the manufacturer of a prescription drug or
medical device owes a duty to the plaintiff to warn the prescribing physician about the potential
dangers associated with a product. The plaintiffs in this case must prove at trial that BSC’s
warnings were inadequate and that the inadequate warnings affected the prescribing physician’s
decision. If they do not, the learned intermediary rule will preclude recovery on their
failure-to-warn claim. The plaintiffs’ motion for summary judgment on the learned intermediary
doctrine is DENIED.
2. Causation
Having determined that the learned intermediary rule applies in this case, I now move to
BSC’s arguments that the plaintiffs have failed to present evidence that inadequate warnings
caused their injuries. BSC contends that there is no evidence that Ms. Sanchez’s treating physician,
Dr. Wiltchik, read or relied on BSC’s product warnings. I disagree.
BSC’s argument extends to both the strict liability failure-to-warn claim and the negligent
failure-to-warn claim. As I have explained, for both the negligence and strict liability claims, the
plaintiffs must prove that BSC’s warnings were inadequate, and that the inadequate warnings were
a substantial factor in causing the plaintiffs’ harm. The plaintiffs must prove that Dr. Wiltchik
would have acted differently had she received adequate warnings. See Latiolais v. Merck & Co.,
Inc., 302 F. App’x 756, 757 (9th Cir. 2008) (affirming summary judgment for defendant where
deposition testimony of prescribing physician indicated that drug warnings “did not play a role in
his decision to prescribe” the drug); Motus v. Pfizer, Inc., 196 F. Supp. 2d 984, 995 (C.D. Cal.
9
2001). Summary judgment is inappropriate where there is evidence that “stronger warnings
would . . . have altered the conduct of the prescribing physician.” Motus v. Pfizer, Inc., 358 F.3d
659, 661 (9th Cir. 2004).
Despite BSC’s contentions, there is at least a dispute of fact whether Dr. Wiltchik read each
product’s Directions for Use (“DFU”). Although Dr. Wiltchik could not pinpoint exactly when she
read the DFUs, she clearly testified that she had read them at some point:
Q.
Do you remember the first time you saw a directions for use with the
Pinnacle?
A.
No.
Q.
And do you remember the first time you would have seen directions for use
for the Advantage Fit?
A.
No.
Q.
But you have read both of those; is that right?
A.
At some point.
(Wiltchik Dep. [Docket 75-2], at 117:4-13). 1
Further, there is at least a dispute of fact whether Dr. Wiltchik relied on the DFUs
accompanying the Pinnacle device. Dr. Wiltchik testified that she would not have used the
Pinnacle device had the Pinnacle DFU characterized dyspareunia as a “warning/potential
complication” rather than as an “adverse event.” (See id. at 21:13-15; 22:10-14; 25:14-26:8). Dr.
Wiltchik also stated that the Pinnacle DFU did not warn about the rates of certain complications,
including pain, infection, erosion and exposure of the mesh, failure of the implantation procedure,
1
The plaintiffs’ attachment containing Dr. Wiltchik’s deposition is frustrating. It consists of dozens of small portions
of the deposition removed from context and chronological order. For instance, the exhibit starts with one-page
excerpts of pages 137, 117, and 21. It then jumps to a four-page exchange on pages 34-38. It then jumps to a one-page,
heavily redacted excerpt of page 43. And it goes on like this. The court was forced to manually reconstruct much of the
165-page exhibit in order to review (where possible) relevant portions of the deposition in context.
10
and recurrence of prolapse and incontinence. (See id. at 23:8-23). She then testified that she
wanted to know this information because it would affect her “risk/benefit analysis” in prescribing
the Pinnacle device. (See id. at 23:25-24:23). Accordingly, I FIND that there is a genuine dispute
of fact whether inadequate warnings on the Pinnacle DFU caused the plaintiffs’ injuries.
The result is different with respect to the Advantage device. The plaintiffs have failed to
point to evidence that Dr. Wiltchik relied on the Advantage DFU. Although the plaintiffs argue
that Dr. Wiltchik “relied on each [product’s] DFU,” (see Pls.’ Resp. in Opp. to BSC’s Mot. for
Summ. J. Against Pls. Rosanne Sanchez and Rod Sanchez [Docket 75], at 10), their briefing fails
to point to anything showing that Dr. Wiltchik specifically relied on the Advantage DFU. Further,
as far as the court can tell, none of the plaintiffs’ citations to Dr. Wiltchik’s deposition relate to Dr.
Wiltchik’s reliance on the Advantage DFU. The citations relate only to the Pinnacle DFU.
Accordingly, as it relates to the Pinnacle device, BSC’s motion for summary judgment on
the failure-to-warn claims is DENIED. As it relates to the Advantage device, BSC’s motion for
summary judgment on the failure-to-warn claims is GRANTED.
B. Design Defect
The plaintiffs also bring claims for strict liability for defective design and for negligent
design. (See Short Form Compl. [Docket 1], at 4). California does not recognize strict liability for
defective design of implantable medical devices. See Hufft v. Horowitz, 5 Cal. Rptr. 2d 377, 382
(Ct. App. 1992); see also Armstrong v. Optical Radiation Corp., 57 Cal. Rptr. 2d 763, 772 (Ct.
App. 1996) (“In the context of medical devices, design defects must be pursued under a negligence
theory.”). In light of these authorities, plaintiffs concede their strict liability defective design
claim. (See Pls.’ Resp. in Opp. to BSC’s Mot. for Summ. J. Against Pls. Rosanne Sanchez and Rod
Sanchez [Docket 75], at 1 n.1). Accordingly, BSC’s motion on the strict liability defective design
11
claim is GRANTED and this claim is DISMISSED.
Although California does not recognize strict liability for defective design, the plaintiffs
may still pursue defective design under a negligence theory. BSC’s arguments to the contrary are
unavailing and lack legal support. BSC argues that Brown v. Superior Court, 751 P.2d 470, 483
(Cal. 1988), forecloses negligence actions against medical device manufacturers. In Brown, the
California Supreme Court abolished strict liability actions against prescription drug
manufacturers. See Brown, 751 P.2d at 480. The court reasoned that prescription drugs are often
unavoidably unsafe even though they serve the public welfare by saving lives and reducing pain
and suffering. See id. at 478-480. The court noted that imposing strict liability on drug
manufacturers might cause them to be “reluctant to undertake research programs to develop some
pharmaceuticals that would prove beneficial or to distribute others that are available to be
marketed, because of the fear of large adverse monetary judgments.” Id. at 479.
The court then exempted drug manufacturers from strict liability for design defect, but
clarified that such manufacturers could still be liable under the ordinary principles of negligence.
See id. at 483 n.12 (“Our conclusion does not mean, of course, that drug manufacturers are free of
all liability for defective drugs. They are subject to liability for manufacturing defects, as well as
under general principles of negligence, and for failure to warn of known or reasonably knowable
side effects.”) (emphasis added).
Several California appellate courts have made clear that Brown did not abolish ordinary
negligence actions against drug manufacturers. See, e.g., Garrett v. Howmedica Osteonics Corp.,
153 Cal. Rptr. 3d 693, 699 (Ct. App. 2013) (“The California Supreme Court in Brown . . . held that
a manufacturer of prescription drugs cannot be strictly liable for a design defect and that the
appropriate test for determining a prescription drug manufacturer’s liability for a design defect
12
involves an application of the ordinary negligence standard.”); Armstrong, 57 Cal. Rptr. 2d at 772;
Hufft, 5 Cal. Rptr. 2d at 382 (“Brown does not exempt a drug manufacturer from . . . liability for
negligence or failure to warn of known or reasonably knowable side effects.”). Several federal
courts applying California law also agree that manufacturers of medical devices may be liable for
ordinary negligence for the design of their products. See, e.g., Dilley v. C.R. Bard, Inc., No.
2:14-cv-01795-ODW, 2014 WL 2115233, at *3-4 (C.D. Cal. May 21, 2014) (granting plaintiff
leave to amend complaint to add design defect negligence claim); Tucker v. Wright Med. Tech.,
Inc., No. 11-cv-03086-YGR, 2013 WL 1149717, at *7-10 (N.D. Cal. Mar. 19, 2013) (denying
device manufacturer’s motion for summary judgment on negligent design claim).
Accordingly, I FIND that medical device manufacturers may be liable for design defects
under the ordinary principles of negligence. BSC’s motion for summary judgment on the
plaintiffs’ negligence claim is DENIED.
C. Loss of Consortium
BSC contends that it is entitled to summary judgment on Mr. Sanchez’s loss of consortium
claim. BSC’s only argument is that loss of consortium is a derivative claim that cannot survive
without Ms. Sanchez’s personal injury claims. See Vanhooser v. Superior Court, 142 Cal. Rptr. 3d
230, 233 (Ct. App. 2012) (“A cause of action for loss of consortium is, by its nature, dependent on
the existence of a cause of action for tortious injury to a spouse.”) (quotation omitted). As noted,
the plaintiffs’ claims for failure to warn about the Pinnacle device survive summary judgment, as
well as the plaintiffs’ negligent design claim. Therefore, Mr. Sanchez’s loss of consortium claim is
not improper, and BSC’s motion on this issue is DENIED.
D. Punitive Damages
BSC additionally moves for summary judgment on the plaintiffs’ punitive damages claim.
13
BSC argues that Massachusetts law applies to the punitive damages claim and bars recovery of
punitive damages in this case. BSC alternatively argues that under California law, the plaintiffs
have failed to present sufficient evidence in support of their punitive damages claim. The plaintiffs
assert that California punitive damages law should apply because California has the greatest
interest in seeing its law applied to injuries occurring within its borders. For the reasons that
follow, I hold that California law applies to the punitive damages claim and that the plaintiffs have
proffered sufficient evidence to sustain their punitive damages claim at this stage.
California’s choice-of-law rules apply to this case. Sanchez v. Boston Scientific Corp., No.
2:12-cv-05762, 2014 WL 202787, at *4 (S.D. W. Va. Jan. 17, 2014). Therefore, I use California’s
choice-of-law rules to determine which state’s law to apply to the punitive damages claim.
California courts apply a three-step governmental interest approach to resolve choice-of-law
disputes. See Kearney v. Salomon Smith Barney, Inc., 137 P.3d 914, 922 (Cal. 2006); Hurtado v.
Superior Court, 522 P.2d 666, 669 (Cal. 1974). Under the first step, the court should determine
whether the laws of each potential jurisdiction actually differ. Kearney, 137 P.3d at 922. Second,
where the laws of each jurisdiction differ, the court must determine whether a “true” conflict exists
by determining whether each state has an interest in applying its law in this case. Id. Finally, if a
true conflict exists, the court will determine “which state’s interest would be more impaired if its
policy were subordinated to the policy of the other state” and apply that state’s law. Id. (quoting
Bernhard v. Harrah’s Club, 546 P.2d 719, 723 (Cal. 1976)). California law will presumptively
apply unless there are compelling reasons to do otherwise. Browne v. McDonnell Douglas Corp.,
504 F. Supp. 514, 517 (N.D. Cal. 1980) (citing Kasel v. Remington Arms Co., 101 Cal. Rptr. 314,
327 (Ct. App. 1972)).
The parties agree that the first step—whether the laws of California and Massachusetts
14
actually differ—is satisfied. California permits awards of punitive damages where a plaintiff
proves by “clear and convincing evidence” that the defendant is “guilty” of “oppression, fraud, or
malice[.]” Cal. Civ. Code § 3294(a); see also Boeken v. Philip Morris Inc., 26 Cal. Rptr. 3d 638,
675 (Ct. App. 2005). Massachusetts, however, prohibits awards of punitive damages “unless
expressly authorized by statute.” Flesner v. Technical Commc’ns Corp., 575 N.E.2d 1107, 1112
(Mass. 1991). The parties agree that Massachusetts law does not permit recovery of punitive
damages in this case. I therefore FIND that the punitive damages laws of California and
Massachusetts differ.
Having determined that the punitive damages laws of California and Massachusetts
actually differ, I now move to the second step. Under the second step, I must determine whether
both states have an interest in having their respective laws applied in this case. In other words, I
must decide whether “only one of the states has an interest in having its law applied.” Wash. Mut.
Bank, FA v. Superior Court, 15 P.3d 1071, 1081 (Cal. 2001). If only one state has an interest in
having its law applied here, I will apply the law of that state. See id. (“[T]he trial court may
properly find California law applicable without proceeding to the third step in the analysis if the
foreign law proponent fails to identify any actual conflict or to establish the other state’s interest in
having its own law applied.”). BSC must therefore demonstrate that Massachusetts has a
legitimate interest in having its law applied to the punitive damages claim in this case. As I explain
below, I find that Massachusetts does not.
California has a clear interest in applying its punitive damages law. California’s punitive
damages law serves the important purposes of punishing and deterring harmful conduct. See Cal.
Civ. Code § 3294(a) (punitive damages recoverable “for the sake of example and by way of
punishing the defendant”); Simon v. San Paolo U.S. Holding Co., 113 P.3d 63, 80 (Cal. 2005)
15
(state has interest in “punishing [defendant’s conduct] and deterring its repetition”); Stonewall
Surplus Lines Ins. Co. v. Johnson Controls, Inc., 17 Cal. Rptr. 2d 713, 720 (Ct. App. 1993)
(“California’s paramount interest is in protecting its residents by deterring tortfeasors.”).
According to the California Supreme Court, punitive damages “are not intended to compensate the
injured party, but rather to punish the tortfeasor whose wrongful action was intentional or
malicious, and to deter him and others from similar extreme conduct.” Ferguson v. Lieff,
Cabraser, Heimann & Bernstein, 69 P.3d 965, 970 (Cal. 2003) (internal quotation omitted).
“Perhaps nowhere is this clearer than in the punitive damages jurisprudence established by
California courts in products liability actions.” Hill v. Novartis Pharm. Corp., No.
1:06-cv-00939-AWI, 2012 WL 967577, at *3 (E.D. Cal. Mar. 21, 2012) (citing Johnson v. Ford
Motor Co., 113 P.3d 82 (Cal. 2005); Bullock v. Philip Morris USA, Inc., 131 Cal. Rptr. 3d 382,
399-406 (Ct. App. 2011)).
In contrast, Massachusetts has no legitimate interest in applying its prohibition on punitive
damages to injuries occurring outside of Massachusetts. BSC contends that Massachusetts has an
interest in protecting its citizens from excessive financial liability. BSC is a Delaware Corporation
with its principle place of business in Massachusetts. (BSC’s Mem. of Law in Supp. of Mot. for
Partial Summ. J. on Pls.’ Punitive Damages Claim [Docket 65], at 4). BSC asserts that the
decisionmaking and conduct for which the plaintiffs seek punitive damages, including designing,
marketing, and distributing the devices, all occurred in Massachusetts. (See id.).
First, BSC is incorrect that the conduct at issue here—the wrongs giving rise to the
plaintiffs’ claim for punitive damages—occurred in Massachusetts. California considers the
“place of the wrong to be the state where the last event necessary to make the actor liable
occurred.” Mazza v. Am. Honda Motor Co., 666 F.3d 581, 593-94 (9th Cir. 2012) (internal
16
quotation marks omitted). The last event necessary to make BSC liable is Ms. Sanchez’s
implantation surgery, which occurred in California. Therefore, for our purposes, BSC’s wrongful
conduct occurred in California.
Second, BSC points to no Massachusetts legal authority supporting its proposition that
Massachusetts has an interest in protecting its citizens from excessive liability, let alone liability
for wrongs occurring outside of Massachusetts. Likewise, I am unable to locate any Massachusetts
cases articulating the state’s interest in prohibiting punitive damages at common law. Each case
simply restates the Massachusetts rule without providing an explanation of the policy behind it.
See, e.g., Pine v. Rust, 535 N.E.2d 1247, 1249 (Mass. 1989) (“Punitive damages are not favored in
Massachusetts, and we have long followed the principle that, absent statutory authorization,
punitive damages may not be awarded.”); Santana v. Registrars of Voters of Worcester, 502
N.E.2d 132, 135 (Mass. 1986) (“Punitive or exemplary damages are not allowed in Massachusetts
except under statutory authority.”); Int’l Fid. Ins. Co. v. Wilson, 443 N.E.2d 1308, 1317 n.20
(Mass. 1983) (“Under Massachusetts law, punitive damages may be awarded only by statute.”);
Boott Mills v. Boston & M.R.R., 106 N.E. 680, 683 (Mass. 1914) (“In this commonwealth there is
no such thing known to the common law as the recovery of punitive damages in addition to
compensatory damages.”); Ellis v. Brockton Pub. Co., 84 N.E. 1018, 1020 (Mass. 1908) (“In this
commonwealth the damages recoverable in actions of tort have always included only
compensation for those injuries, which flow from the wrong as a natural result.”); Burt v.
Advertiser Newspaper Co., 28 N.E. 1, 5 (Mass. 1891) (“Vindictive or punitive damages are never
allowed in this state.”).
Even assuming Massachusetts’s punitive damages prohibition is based on a policy of
shielding its residents from excessive liability, Massachusetts has no legitimate interest in
17
enforcing this policy outside of its borders. Two recent California cases are instructive on this
point. In the first case, Scott v. Ford Motor Co., 169 Cal. Rptr. 3d 823, 835-36 (Ct. App. 2014), the
court found that California law applied to a punitive damages claim because Michigan had no
legitimate interest applying its laws to injuries occurring outside of Michigan. Ford argued that
Michigan law should apply to the punitive damages claim because the conduct underlying the
plaintiff’s failure-to-warn claim allegedly occurred at Ford’s Michigan headquarters. See id. at
834. Ford asserted that Michigan had an interest in regulating “the legal consequences of conduct”
that occurred within its borders and that Michigan’s ban on punitive damages represented “a
declaration that corporate conduct occurring in Michigan should not be subject to punitive
damages[.]” Id. at 836. The court disagreed and found that Michigan had no legitimate interest in
imposing its punitive damages policy on other states. The court wrote that
Ford effectively argues it should be found to carry a nationwide shield from
punitive damage liability because the state in which it maintains its headquarters
has decided punitive damages are poor public policy. We cannot agree, any more
than we expect a Michigan court would yield to a plaintiff’s plea to impose punitive
damages on a California-based corporation because its home state has made the
opposite policy judgment.
Id. at 834.
The court then wrote that even if Michigan had intended to protect resident businesses
from punitive damages outside of the state, Michigan “would have no legitimate interest in
imposing that intent in California.” Id. at 835. A foreign state such as Michigan “has no interest in
shielding its resident corporations from punitive damages when those corporations chose to do
business in states permitting the imposition of such damages.” Id. at 835-36.
The second case demonstrating that Massachusetts has no legitimate interest in applying its
punitive damages rule here is Sullivan v. Oracle Corp., 254 P.3d 237 (Cal. 2011). In that case, the
18
California Supreme Court held that Arizona and Colorado had no legitimate interest in applying
their wage laws to work performed by their residents in California. The plaintiffs were residents of
Arizona and Colorado and were employed by Oracle, a California corporation. See id. at 239.
Their jobs required them to travel to work in several states, including California. Id. They argued
that they were required to be paid overtime in accordance with California laws for work performed
in California. Id. Oracle contended that the laws of the employees’ home states controlled. See id.
at 244.
To determine which state’s law to apply, the court conducted the governmental interest
choice-of-law analysis. On the second step of the governmental interest analysis, the court
determined that neither Colorado nor Arizona had a legitimate interest in shielding Oracle from the
requirements of California wage laws for work performed in California. See id. at 246. The court
rejected Oracle’s argument that Arizona and Colorado “have an interest in shielding their own
businesses from more costly and burdensome regulatory environments in other states.” Id. The
court explained:
We do not doubt the premise that a state can properly choose to create a
business-friendly environment within its own boundaries. The federal system
contemplates that individual states may adopt distinct policies to protect their own
residents and generally may apply those policies to businesses that choose to
conduct business within that state. However, every state enjoys the same power in
this respect. Therefore, it follows from this basic characteristic of our federal
system that, at least as a general matter, a company that conducts business in
numerous states ordinarily is required to make itself aware of and comply with the
law of a state in which it chooses to do business.
Id. (quotations and citations omitted). The court then held that California law applied to the
plaintiffs’ wage claims.
The reasoning in Sullivan and Scott is equally applicable here. Massachusetts undeniably
has an interest in crafting economic policies that benefit its residents and encourage corporations
19
to relocate there. This interest extends to shielding corporations from liability for harms occurring
in Massachusetts. But in this case, Massachusetts has no legitimate interest in shielding BSC from
punitive damages liability for injuries occurring in California.
BSC additionally argues that applying Massachusetts law would provide a “uniform rule
so that those who market their product outside of Massachusetts might know what risks they are
subject to when they make and sell their products.” (BSC’s Mem. of Law in Supp. of Mot. for
Partial Summ. J. on Pls.’ Punitive Damages Claim [Docket 65], at 12). BSC asserts that this
uniformity interest is especially important because this case is one of many thousands in
multidistrict litigation. (See id.). BSC fails to demonstrate how Massachusetts’s interests are
advanced by simplifying the legal issues in multidistrict litigation. In any event, as I explained
above, this same argument was dispatched in Scott. See Scott, 169 Cal. Rptr. 3d at 834 (“[S]tates
have the prerogative to establish a uniform rule applicable to all enterprises that elect to do
business there, but they have no legitimate interest in imposing that policy decision on the courts
of a sister state.”). Further, there already exists a uniform rule. Companies that conduct business in
different states are generally required to comply with the laws of those states. See Sullivan, 254
P.3d at 346.
For these reasons, I FIND that no true conflict exists between the punitive damages law of
California and Massachusetts. Therefore, I need not conduct the final step of the governmental
interest analysis, and I will apply California law to the punitive damages claim in this case.
Having found that California law applies to this claim, I now examine whether the
plaintiffs have proffered sufficient evidence to survive summary judgment. I find that they have.
Punitive damages are available in tort claims “where it is proven by clear and convincing evidence
that the defendant has been guilty of oppression, fraud, or malice[.]” Cal. Civ. Code § 3294(a).
20
Because there are no allegations of fraud in this case, my analysis will focus on whether there is
evidence of malice or oppression. Malice is statutorily defined as “conduct which is intended by
the defendant to cause injury to the plaintiff or despicable conduct which is carried on by the
defendant with a willful and conscious disregard of the rights or safety of others.” Id. § 3294(c)(1).
Malice does not require intent to harm. Pfeifer v. John Crane, Inc., 164 Cal. Rptr. 3d 112, 135 (Ct.
App. 2013). Rather, malice can be shown by conscious disregard for the safety of another “where
the defendant is aware of the probable dangerous consequences of his or her conduct and he or she
willfully fails to avoid such consequences.” Id. Oppression means “despicable conduct that
subjects a person to cruel and unjust hardship in conscious disregard of that person’s rights.” Cal.
Civ. Code § 3294(c)(2).
Here, the plaintiffs argue that BSC was aware that the polypropylene used to construct the
Pinnacle device was not intended to be implanted in the human body. The plaintiffs point to a
material data safety sheet (“MSDS”) issued by BSC’s supplier of polypropylene that warned BSC
not to implant the material into the human body. The Pinnacle device is constructed using a
polypropylene resin supplied by Chevron Phillips Chemical Company, LP. Chevron Phillips
authored the MSDS that accompanied the resin. The MSDS included the following warning:
MEDICAL APPLICATION CAUTION: Do not use this Chevron Phillips
Chemical Company LP material in medical applications involving permanent
implantation in the human body or permanent contact with internal body fluids or
tissues.
(MSDS [Docket 77-3], at 38 2). Despite this warning, BSC used Chevron Phillips polypropylene in
its Pinnacle devices.
Additionally, the plaintiffs argue that BSC knew it needed to conduct long-term safety
studies of the polypropylene material in the Pinnacle device. The plaintiffs point to the written
2
Pagination here is the court-stamped page number at the top of the exhibit pages.
21
agreement between BSC and its polypropylene supplier. The agreement cautioned BSC to make
its own determination of the safety and suitability of the polypropylene material in BSC’s
products. The agreement stated:
BOSTON SCIENTIFIC IS ADVISED AND CAUTIONED TO MAKE ITS OWN
DETERMINATION AND ASSESSMENT OF THE SAFETY AND
SUITABILITY OF THE . . . POLYPROPYLENE PRODUCT FOR USE BY,
FOR OR ON BEHALF OF BOSTON SCIENTIFIC. IT IS THE ULTIMATE
RESPONSIBILITY OF BOSTON SCIENTIFIC TO ENSURE THAT
THE . . . POLYPROPYLENE PRODUCT IS SUITED TO BOSTON
SCIENTIFIC’S SPECIFIC APPLICATION.
(Agreement [Docket 77-9], at 3-4 3).
Despite the MSDS warning and the admonition from BSC’s polypropylene supplier to
conduct its own tests, there is evidence that BSC conducted no clinical studies on the safety or
efficacy of the Pinnacle device. (See Berry Dep. [Docket 77-5], at 69:19-23 (“There were no
clinical studies.”)). An internal BSC document indicated that “[n]o pre-clinical studies have been
conducted and there are no future studies planned.” (See Pinnacle Clinical Risk/Benefit Analysis
[Docket 77-6], at 10).
In light of this evidence, I FIND that there is a genuine dispute of material fact whether
BSC’s actions with respect to the Pinnacle device were malicious under California Civil Code §
3294. A reasonable jury could find that by ignoring a warning on the MSDS and failing to conduct
clinical testing, BSC’s actions were “despicable conduct” with willful and conscious disregard of
the safety of consumers. Cal. Civ. Code § 3294(c). Accordingly, BSC’s motion for summary
judgment on the issue of punitive damages is DENIED with respect to the Pinnacle device.
The plaintiffs failed to proffer arguments or evidence on the issue of punitive damages in
relation to the Advantage device. Therefore, BSC’s motion for summary judgment on the issue of
3
Pagination here is the court-stamped page number at the top of the exhibit pages.
22
punitive damages is GRANTED with respect to the Advantage device.
E. Preemption Defenses
The plaintiffs contend that their state law claims are not barred by federal preemption and
that they are entitled to summary judgment as to BSC’s federal preemption affirmative defenses.
BSC asserts two preemption-based affirmative defenses: express preemption and implied
preemption by the Federal Food, Drug, and Cosmetic Act (“FDCA”). I have repeatedly addressed
preemption issues throughout this multidistrict litigation, and I have consistently found that federal
preemption does not apply. See, e.g., Huskey v. Ethicon, Inc., No. 2:12-cv-05201, 2014 WL
3362287, at *8-14 (S.D. W. Va. July 8, 2014); Edwards v. Ethicon, Inc., No. 2:12-cv-09972, 2014
WL 3361920, at *3-9 (S.D. W. Va. July 8, 2014); Lewis v. Johnson & Johnson, No.
2:12-cv-04301, 2014 WL 152374, at *6-10 (S.D. W. Va. Jan. 15, 2014); In re C. R. Bard, Inc., No.
2:10-cv-01224, 2013 WL 2431975, at *11 (S.D. W. Va. June 4, 2013). Here, too, preemption is not
available to BSC.
The United States Supreme Court has foreclosed the possibility of an express preemption
defense in this case. The Medical Device Amendments (“MDA”) to the FDCA contain an express
preemption provision. The provision provides that, with respect to medical devices, state law may
not impose any requirement “which is different from, or in addition to” the requirements of the
FDCA, or any requirement “which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device under [the FDCA].” 21 U.S.C. §
360k(a).
The FDCA’s preemption provision does not apply to product liability claims regarding
medical devices that underwent 510(k) clearance rather than the premarket approval process.
Medtronic, Inc. v. Lohr, 518 U.S. 470, 501-02. In Lohr, the Court found that because the 510(k)
23
requirements did not relate to the safety or efficacy of the device, they did not preempt state tort
claims. Id. As the Court noted,
The generality of [the 510(k)] requirements make this quite unlike a case in which
the Federal Government has weighed the competing interests relevant to the
particular requirement in question, reached an unambiguous conclusion about how
those competing considerations should be resolved in a particular case or set of
cases, and implemented that conclusion via a specific mandate on manufacturers or
producers. Rather, the federal requirements reflect important but entirely generic
concerns about device regulation generally, not the sort of concerns regarding a
specific device or field of device regulation that the statute or regulations were
designed to protect from potentially contradictory state requirements.
Id. at 501. Because of this, the Court reasoned, the FDCA’s express preemption provision does not
apply to products that received clearance through the 510(k) process. Therefore, BSC’s express
preemption defense must fail.
BSC’s affirmative defense of implied preemption also must fail. The FDCA impliedly
preempts private claims that seek to enforce FDCA provisions against a manufacturer. See 21
U.S.C. § 337(a) (“[A]ll such proceedings for the enforcement, or to restrain violations, of this
chapter shall be by and in the name of the United States.”); Buckman Co. v. Plaintiffs’ Legal
Comm., 531 U.S. 341, 349 n.4 (2001) (“The FDCA leaves no doubt that it is the Federal
Government rather than private litigants who are authorized to file suit for noncompliance with the
medical device provisions[.]”). Thus, plaintiffs may not bring claims based on “a mere violation”
of the FDCA. In re Medtronic, Inc., Implantable Defibrillators Litig., 465 F. Supp. 2d 886, 900 (D.
Minn. 2006).
The plaintiffs here admit that they do not assert any claim that BSC violated the FDCA or
committed fraud on the FDA. (See Pls.’ Mem. of Law in Supp. of Pls.’ Mot. for Partial Summ. J.
[Docket 63], at 7). Nonetheless, BSC contends that the plaintiffs will introduce evidence that BSC
failed to comply with the FDCA by (1) knowingly mislabeling its products and (2) failing to report
24
adverse product events to the FDA. BSC thus argues it is entitled to assert the implied preemption
defense. BSC’s fears are unfounded. As I have repeatedly ruled in relation to this multidistrict
litigation, and as I now hold in this case, no party will be permitted to introduce evidence relating
to the FDA or the 510(k) clearance process. See, e.g., Lewis v. Johnson & Johnson, No.
2:12-cv-04301, 2014 WL 152374, at *4-6 (S.D. W. Va. Jan. 15, 2014); In re C. R. Bard, Inc.,
Pelvic Repair Sys. Prods. Liab. Litig., MDL 2187, 2013 WL 3282926, at *2 (S.D. W. Va. June 27,
2013). As I stated in Lewis,
Evidence regarding the 510(k) process poses a substantial risk of misleading the
jury and confusing the issues. That a device has been given clearance through the
FDA’s 510(k) process is not relevant to state tort law. Admission of any evidence
regarding the 510(k) process runs the risk of misleading the jury to believe that
FDA 510(k) clearance might be dispositive of the plaintiffs’ state law claims. The
prejudicial value of evidence regarding the 510(k) process far outweighs its
probative value.
Lewis, 2014 WL 152374, at *4-6. Accordingly, the plaintiffs’ motion for summary judgment on
BSC’s preemption defenses is GRANTED.
F. Conceded Claims
The plaintiffs concede their claims for manufacturing defect in strict liability, breach of
express and implied warranties, and fraudulent concealment. (See Pls.’ Resp. in Opp. to BSC’s
Mot. for Summ. J. Against Pls. Rosanne Sanchez and Rod Sanchez [Docket 75], at 1 n.1).
Accordingly, BSC’s motion for summary judgment on these claims is GRANTED and these
claims are DISMISSED.
V. Conclusion
For the reasons explained above, Boston Scientific Corporation’s Motion for Summary
Judgment [Docket 60] is GRANTED in part and DENIED in part, the Plaintiffs’ Motion for
Summary Judgment [Docket 62] is GRANTED in part and DENIED in part, and Boston
25
Scientific Corporation’s Motion for Partial Summary Judgment on Plaintiffs’ Punitive Damages
Claim [Docket 64] is DENIED.
The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party. The court further DIRECTS the Clerk to post a copy of this published
opinion on the court’s website, www.wvsd.uscourts.gov.
ENTER:
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August 18, 2014
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