Klingemann v. Breg, Inc. et al
Filing
147
ORDER Plaintiffs Motion for Partial Summary Judgment ECF No. 96 , is DENIED; Defendants Motion for Summary Judgment ECF No. 87 , is GRANTED IN PART and DENIED IN PART; Judgment in favor of Defendant shall enter on Plaintiffs breach of implied warr anty claim; and The following claims shall proceed to trial by jury: (1) negligence; (2) negligent misrepresentation; (3) fraud; (4) strict product liability; and (5) strict product liabilityfailure to warn. Plaintiff shall also be permitted to pursue exemplary damages against Defendant. by Judge William J. Martinez on 4/20/2012.(ervsl, )
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Judge William J. Martínez
Civil Action No. 1:10-cv-1797-WJM-CBS
BLAINE W. KLINGEMANN,
Plaintiff,
v.
BREG, INC.,
Defendants.
ORDER DENYING MOTIONS FOR SUMMARY JUDGMENT
In this product liability action, Plaintiff Blaine W. Klingemann brings claims
against Defendant Breg, Inc. arising out of Plaintiff’s 2003 shoulder surgery. Before the
Court are the following: (1) Defendant’s Motion for Summary Judgment (ECF No. 87)
on all claims; and (2) Plaintiff’s Motion for Partial Summary Judgment (ECF No. 96).
For the reasons set forth below, Plaintiff’s Motion is denied and Defendant’s Motion is
granted in part and denied in part.
I. LEGAL STANDARD
Summary judgment is appropriate only if there is no genuine issue of material
fact and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P.
56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Henderson v. Inter-Chem
Coal Co., Inc., 41 F.3d 567, 569 (10th Cir. 1994). Whether there is a genuine dispute
as to a material fact depends upon whether the evidence presents a sufficient
disagreement to require submission to a jury or conversely, is so one-sided that one
party must prevail as a matter of law. Anderson v. Liberty Lobby, 477 U.S. 242, 248-49
(1986); Stone v. Autoliv ASP, Inc., 210 F.3d 1132 (10th Cir. 2000); Carey v. U.S. Postal
Service, 812 F.2d 621, 623 (10th Cir. 1987).
A fact is “material” if it pertains to an element of a claim or defense; a factual
dispute is “genuine” if the evidence is so contradictory that if the matter went to trial, a
reasonable party could return a verdict for either party. Anderson, 477 U.S. at 248.
The Court must resolve factual ambiguities against the moving party, thus favoring the
right to a trial. Quaker State Mini-Lube, Inc. v. Fireman’s Fund Ins. Co., 52 F.3d 1522,
1527 (10th Cir. 1995); Houston v. Nat’l General Ins. Co., 817 F.2d 83, 85 (10th Cir.
1987).
II. FACTUAL BACKGROUND
The relevant facts are as follows:
Plaintiff Blaine Klingemann underwent arthroscopic surgery on his left shoulder on
October 10, 2003. (ECF No. 96-1.) Plaintiff’s orthopedic surgeon was Dr. John D.
Papilion, M.D. (ECF No. 96-3.) To manage Plaintiff’s post-operative pain, Dr. Papilion
placed a catheter for Defendant’s Pain Care 3000 pain pump into Plaintiff’s shoulder.
(ECF No. 96-1.) The pain pump injected an anesthetic into Plaintiff’s shoulder on a
continuous basis for the first few days following his surgery. (Id.)
Plaintiff began to notice a gradual loss of motion, pain, and inability to use his left
arm. (ECF No. 96-2.) On a follow-up visit with Dr. Papilion in November 2005, x-rays
showed significant narrowing of the glenohumeral (shoulder) joint and collapse of the joint
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space. (ECF No. 96-5.) Dr. Papilion believed that Plaintiff was suffering from a condition
known as chondrolysis and progressive degenerative osteoarthritis in the glenohumeral
joint. (Id.) Chondrolysis is the rapid loss of joint cartilage following some chemical,
mechanical, infectious, immunological, or thermal insult. (ECF No. 87 at 3.)
To rectify this condition, Plaintiff underwent a second surgery on his shoulder in
January 2006. (ECF No. 96-11.) A third surgery was performed in August 2006. (ECF No.
96-8.)
During this procedure, Dr. Papilion noted that Plaintiff’s humeral head was
“completely devoid of any cartilage circumferentially.” (Id.) Plaintiff’s shoulder condition
significantly impairs his ability to lead a normal life and it is anticipated that Plaintiff will
need additional shoulder surgeries in the future. (ECF No. 96-4 at 19.)
Defendant Breg first sought approval from the Food and Drug Administration
(“FDA”) to market a pain pump in 1998. (ECF No. 96-11.) Breg sought approval for
updated versions of its pain pumps in subsequent years. (ECF Nos. 96-16 & 96-17.) Each
of these devices was approved for use in general surgery; none was approved for use in
orthopedic surgery or in the intra-articular1 space. (ECF Nos. 96-16; 96-17; 96-19.)
However, Breg marketed its pain pumps, including the Pain Care 3000 used following
Plaintiff’s surgery, to orthopedic surgeons. (ECF No. 96-56.)
Plaintiff alleges that Defendant’s Pain Care 3000 pain pump inserted directly into
the intra-articular space following his October 2003 surgery caused his chondrolysis.
Plaintiff brings this action to recover damages for his injuries.
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“Intra-articular” means “[w]ithin the cavity of a joint”. Stedmans Medical Dictionary
(27th ed. 2000).
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III. ANALYSIS
Plaintiff’s Amended Complaint brings the following causes of action: (1)
negligence; (2) negligent misrepresentation; (3) fraud; (4) strict product liability; (5) strict
product liability—failure to warn; and (6) breach of implied warranty. (ECF No. 73.)
Plaintiff seeks compensatory and punitive damages, as well as other relief. (Id.)
Defendant moves for summary judgment on all claims and on Plaintiff’s request for
punitive damages. Plaintiff moves for summary judgment on his strict liability and
breach of implied warranty claims.
The Court will address each in turn below.
A.
Breach of Implied Warranty
Defendant moves for summary judgment on Plaintiff’s breach of implied warranty
claim and argues that it is barred by a three year statute of limitations. (ECF No. 87 at
20-21.) Plaintiff does not dispute the fact that a three year statute of limitations applies
or that his claim was filed more than three years after his injury. Instead, Plaintiff
argues that his limitations period should be equitably tolled so that his action is timely.
(ECF No. 107 at 31-32.) Because whether a limitations period should be equitably
tolled is a question of law, this issue is appropriate for summary disposition by the
Court. Hall v. U.S. Dep’t of Labor, 198 F.3d 257 (10th Cir. 1999).
Equitable tolling is a extraordinary remedy that is to be used sparingly by the
courts. Montoya v. Chao, 296 F.3d 952, 957 (10th Cir. 2002). The Supreme Court has
held that equitable tolling may be appropriate “where the claimant has actively pursued
his judicial remedies by filing a defective pleading during the statutory period, or where
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the complainant has been induced or tricked by his adversary’s misconduct into
allowing the filing deadline to pass.” Irwin v. Dep’t of Veterans Affairs, 498 U.S. 89, 96
(1990).
Plaintiff contends that Defendant intentionally withheld information from him and,
therefore, his limitations period should be tolled. However, the accrual of a breach of
warranty cause of action does not depend on the injured party’s knowledge. In
Colorado, a breach of warranty claim accrues at the time delivery is made, “regardless
of the aggrieved party’s lack of knowledge of the breach.” Colo. Rev. Stat. § 4-2725(2). Because the Colorado legislature explicitly stated that the three year limitations
period begins to run regardless of whether the injured party is aware of the breach, the
Court is not compelled to toll Plaintiff’s limitations period simply because Defendant
withheld information from Plaintiff.
Moreover, Plaintiff has presented no evidence that Defendant intentionally
misled him into allowing the limitations period to run. Plaintiff’s allegations of fraud and
deceit by Defendant are generalized as to the public at large; there is no allegation that
Defendant intentionally and actively induced or tricked Plaintiff in any manner. See
Wallace v. Kato, 549 U.S. 384, 396 (2007). The lack of alleged wrongdoing directed
specifically at Plaintiff weighs against finding that equitable tolling applies here.
In sum, the Court does not find that the facts of this case are so extraordinary as
to merit the exceptional relief of equitable tolling. Accordingly, the Court finds that
Plaintiff’s claim for breach of implied warranty is time-barred. Plaintiff’s Motion for
Summary Judgment is denied and Defendant’s Motion for Summary Judgment is
granted as to the breach of implied warranty claim.
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B.
Negligence and Strict Liability
Defendant moves for summary judgment on Plaintiff’s negligence and strict
liability claims arguing that chondrolysis was not a foreseeable injury at the time of
Plaintiff’s surgery in 2003. (ECF No. 87 at10.) What Defendant knew or could have
known about the possibility of the injury that Plaintiff suffered is key to both Plaintiff’s
negligence and strict product liability claims. With respect to negligence, the Colorado
Supreme Court has held: “When a manufacturer or seller knows or should know of
unreasonable dangers associated with the use of its product . . ., it has a duty to warn
of these dangers; and a breach of this duty constitutes negligence.” Palmer v. A.H.
Robins Co., Inc., 684 P.2d 187, 198 (Colo. 1984). For a product liability claim, “the
focus of the inquiry is whether the defendant failed to warn of particular risks that were
known or knowable in light of the generally recognized and prevailing scientific and
technical knowledge available at the time of manufacture and distribution.” Fibreboard
Corp. v. Fenton, 845 P.2d 1168, 1175 (Colo. 1993). Thus, to defeat Defendant’s
summary judgment motion, Plaintiff must show a genuine dispute of fact as to whether
Defendant knew or should have known that there was a risk of chondrolysis if its pain
pump was inserted directly into the intra-articular space at the time of Plaintiff’s October
2003 surgery.
Defendant contends that the risk of chondrolysis as a result of the use of its pain
pump was not known or knowable in light of the scientific literature published in 2003.
(ECF No. 87 at 11-12.) The Court disagrees. While the medical literature may not
have explicitly linked the particular condition of chondrolysis to pain pumps until 2006 or
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2007, publications dating back to at least 1985 linked direct application of anesthetics
and other fluids to deterioration of cartilage. (ECF No. 107-6 at 2-3.) Upon
consideration of the medical literature, a reasonable juror could find that Defendant
knew or should have known that there was a risk of injury to the cartilage if a pain pump
was inserted directly into the joint space. (Id.; ECF No. 107-2 at 51-52.)
Additionally, Defendant breached its duty as a manufacturer of medical
equipment if it did not exercise reasonable care in marketing, selling, and labeling its
product. See Mile High Concrete v. Matz, 842 P.2d 198, 202 (Colo. 1992). Defendant
is held to the standard of care of a reasonably prudent medical device manufacturer
under the same or similar circumstances. See Palmer v. A.H. Robbins, Co., Inc., 684
P.2d 187, 210 (Colo. 1984). Plaintiff has presented evidence showing that Defendant
was repeatedly informed by the FDA that it would approve Defendant’s pain pump only
for use in general surgery. (ECF Nos. 107-7 at 30-71; 107-11 at 67-68; 107-16; 10733.) The FDA made Defendant remove all references to orthopedic surgery or use of
the pain pump in the intra-articular space on its applications for at least three different
medical devices. (Id.) Despite the lack of approval, Defendant routinely marketed its
devices to orthopedic surgeons and recommended that its pain pumps be used intraarticularly. (ECF Nos. 107-36 at 8, 11.) The Court finds that this evidence creates a
genuine dispute of fact as to whether Defendant breached its duty in the manner in
which it marketed and promoted its pain pumps.
In its Motion, Defendant relies heavily on Pavelko v. Breg, No. 1:09-cv-1461PAB-KMT, 2011 WL 782664 (D. Colo. Feb. 28, 2011), in which United States District
Judge Philip A. Brimmer granted Breg’s Motion for Summary Judgment. The Court
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notes that it is not bound by the decision in Pavelko. See B.T. ex rel. G.T. v. Santa Fe
Public Sch., 506 F.Supp.2d 718, 727 (D.N.M. 2007) (principle of stare decisis does not
apply to decisions of other district court judges). However, such authority can
oftentimes be persuasive. Id.
The Court has carefully reviewed Pavelko and finds it distinguishable because
the record in this case is significantly more developed. For example, in Pavelko, Judge
Brimmer found “that the risk of pain pumps to cartilage was not foreseeable to
defendant at the time of plaintiff’s surgery” in part because “plaintiff has provided no
expert testimony explaining the significance” of the medical literature. Id. at *1, 6. In
this case, Plaintiff has presented evidence from an expert who has reviewed the
medical literature and opined that it “would and should have provided part of the basis
for a reasonably prudent pain pump manufacturer to test for and warn of adverse
effects of regional anesthetics on the cartilage.” (ECF No. 107-6 at 2.)
With respect to the FDA approval process, in Pavelko, the plaintiff failed to
present any admissible evidence showing that Breg’s pain pump was not approved for
intra-articular use or that Breg had been advised by the FDA that it was not approving
its pain pump for intra-articular use due to the lack of safety data. 2011 WL 782664, at
*7. Here, Plaintiff has provided a plethora of evidence regarding Breg’s approval
process with the FDA, including both a deposition of Irene Naveau, the FDA reviewer
who oversaw the approval process, and an expert opinion that Breg’s marketing and
promotion of the device for intra-articular use after being denied approval by the FDA
was unreasonable and violated a number of federal regulations. (ECF Nos. 96-9 & 96-
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12.) Given the significant differences in the record between this case and Pavelko, the
Court has little difficulty reaching a different conclusion.
Ultimately, whether a manufacturer of a product acted reasonably in the manner
in which it designed, manufactured, marketed, or promoted its device is generally a
question of fact that must be decided by the jury. Hesse v. McClintic, 176 P.3d 759,
765 (Colo. 2008). Many courts looking at the same or substantially similar evidence,
including one judge in this District, have held that whether the risk of injury to cartilage
from the intra-articular use of a pain pump was foreseeable issue at the time of the
plaintiff’s surgery is an issue that should be resolved by the jury. See, e.g., Hackett v.
Breg Inc., No. 1:10-cv-1437-RBJ-KMT, 2011 WL 4550186 (D. Colo. Oct. 3, 2011);
Staub v. Breg, Inc., 2012 WL 1078335, *9 (D. Ariz. March 30, 2012); Creech v. Stryker
Corp., 2012 WL 33360, *6 (D. Utah Jan. 6, 2012); Kildow v. Breg, 796 F.Supp.2d 1295,
1300 (D. Or. 2011).
For all of the reasons discussed above, the Court finds that Plaintiff has
presented evidence showing a genuine dispute of fact as to whether Defendant knew or
should have known about the risk of harm at issue here at the time of Plaintiff’s surgery.
Because there is evidence from which a reasonable juror could find in favor of Plaintiff
on his negligence and strict product liability claims, Defendant’s Motion for Summary
Judgment is denied as to these claims. However, the Court finds that a reasonable
juror could view the same evidence and find in favor of Defendant. Therefore, Plaintiff’s
Motion for Summary Judgment on these claims is also denied.
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C.
Fraud and Misrepresentation
Defendant moves for summary judgment on Plaintiff’s fraud and
misrepresentation claims. An essential element of both Plaintiff’s fraud and negligent
misrepresentation claims is that Plaintiff or his physician reasonably relied on false
information provided by Defendant. See Mehaffy, Rider, Windholz & Wilson v. Central
Bank Denver, N.A., 892 P.2d 230, 236 (Colo. 1995). Concealment of a material fact
also constitutes a tort. Ackmann v. Merchants Mortgage & Trust Corp., 645 P.2d 7, 13
(Colo. 1982).
Defendant first argues that there is no evidence that Defendant made any
representation to Plaintiff or his physician. (ECF No. 87 at 17.) Defendant’s argument
does not comport with the evidence. Dr. Papilion, Plaintiff’s surgeon, testified that he
got the idea for placing the catheter for the pain pump directly into the joint space from
conversations that he had with Breg’s representatives. (ECF No. 107-9 at 55.) Papilion
also testified that the manner in which he used the device was “consistent with the way
the Breg representatives taught or marketed the device.” (Id. at 66.) Finally, Papilion
testified that he reviewed literature that he was provided with Breg’s pain pump and that
literature informed him that the catheter should be placed in the joint space. (Id. at 40.)
Defendant also argues that, to the extent Plaintiff has shown that it made
representations to Dr. Papilion, Plaintiff has not shown that such representations were
false. (ECF No. 87 at 19.) Defendant points out the that pain pump was approved for
general surgical use and, therefore, promotion of the pump for intra-articular use was
not false. (Id.) While a reasonable juror could agree with Defendant, the Court finds
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that a reasonable juror could also disagree. Defendant knew that the FDA repeatedly
required it to remove any reference to orthopedic surgery from its indications for use.
(ECF No. 96-12.) There is evidence that Breg’s representatives did not inform Dr.
Papilion that intra-articular use of the device—which Breg actively promoted—was not
approved by the FDA. (ECF No. 107-9.)
Moreover, the Court has already found that there is a genuine dispute as to
Defendant’s knowledge of the risk of harm to the cartilage if the pain pump was inserted
into the intra-articular space. The truth or falsity of Defendant’s representations to Dr.
Papilion is inextricably linked with the jury’s finding on Defendant’s knowledge.
Therefore, whether Defendant made false representations to Dr. Papilion should
likewise be decided by the jury.
In sum, the Court finds that Plaintiff has presented sufficient evidence to show a
genuine dispute of fact as to the essential elements of his fraud and misrepresentation
claims. Accordingly, Defendant’s Motion for Summary Judgment is denied with respect
to these claims.
D.
Punitive Damages
Defendant moves for summary judgment on Plaintiff’s claim that he is entitled to
punitive damages. (ECF No. 87.) Colorado permits a plaintiff to recover punitive or
exemplary damages in any case in which the jury finds that the defendant’s acts
constitute “fraud, malice, or willful and wanton conduct.” Colo. Rev. Stat. § 13-21-102.
“‘Willful and wanton conduct’ means conduct purposefully committed which the actor
must have realized as dangerous, done heedlessly and recklessly, without regard to
consequences, or of the rights and safety of others, particularly the plaintiff.” Id. §
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13-21-102(1)(b). "Where the defendant is conscious of his conduct and the existing
conditions and knew or should have known that injury would result, the statutory
requirements of section 13-21-102 are met." Coors v. Sec. Life of Denver Ins. Co., 112
P.3d 59, 66 (Colo. 2005); see also Qwest Services Corp. v. Blood, 252 P.3d 1071
(Colo. 2011) (restating and reaffirming this standard).
As discussed above, the Court has found that there is a genuine dispute of fact
as to whether Defendant knew or should have known of the risk of injury if its pain
pump was used intra-articularly. The standard for exemplary damages in Colorado also
involves whether Defendant knew or should have known of the risk of injury. The
similarity in these standards suggests that, because the Court has found a genuine
dispute of fact as to Defendant’s knowledge, there is likewise a dispute of fact as to
whether exemplary damages are appropriate in this case. Accordingly, Defendant’s
Motion for Summary Judgment is denied as to Plaintiff’s claim for punitive damages.
IV. CONCLUSION
For the reasons set forth above, the Court ORDERS as follows:
1.
Plaintiff’s Motion for Partial Summary Judgment (ECF No. 96) is DENIED;
2.
Defendant’s Motion for Summary Judgment (ECF No. 87) is GRANTED IN PART
and DENIED IN PART;
3.
Judgment in favor of Defendant shall enter on Plaintiff’s breach of implied
warranty claim; and
4.
The following claims shall proceed to trial by jury: (1) negligence; (2) negligent
misrepresentation; (3) fraud; (4) strict product liability; and (5) strict product
liability—failure to warn. Plaintiff shall also be permitted to pursue exemplary
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damages against Defendant.
Dated this 20th day of April, 2012.
BY THE COURT:
William J. Martínez
United States District Judge
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