Maxwell v. Howmedica Osteonics Corp. et alMaxwell v. Howmedica Osteonics Corp. et al
DECISION and ORDER
Currently before the Court in this products liability action, filed by Beverly Maxwell (“Plaintiff’) against Howmedica Osteonics Corp. (“Defendant”), is Defendant’s motion for summary judgment. (Dkt. No. 28.) For the reasons set forth below, Defendant’s motion is granted in its entirety, and Plaintiffs Complaint is dismissed.
I. RELEVANT BACKGROUND
A.Plaintiffs Complaint
On March 27, 2008, Plaintiff filed her Complaint in this action. (Dkt. No. 7.) Liberally construed, Plaintiffs Complaint, brought under theories of negligence and strict products liability, asserts against Defendant claims of design defect and failure to warn, arising from the injuries she sustained during a total knee replacement surgery on June 15, 2004. (Dkt. No. 2.) More specifically, Plaintiff alleges that she sustained personal injuries as a result of (1) Defendant’s defective design of a total knee-replacement system known as the Duracon Total Knee System (“Duracon System”), which it manufactured, and (2) Defendant’s failure to provide adequate warning labels regarding the Duracon System’s metallic components in its prosthetic knee, in particular, the prosthetic knee’s “high percentage of nickel,” which created a foreseeable danger, and caused her to suffer an allergic reaction. (Id.) Familiarity with the remaining factual allegations supporting Plaintiffs claims in her Complaint is assumed in this Decision and Order, which is intended primarily for review by the parties.
B. Deadline for Service of Expert Disclosures
On April 18, 2008, United States Magistrate Judge David E. Peebles issued a Uniform Pretrial Scheduling Order in this action. (Dkt. No. 14.) That Order required, among other things, Plaintiff to serve expert disclosures by June 1, 2009. (Id. at 2.) On May 28, 2009, upon the request of the parties, Magistrate Judge Peebles reluctantly issued an Amended Scheduling Order, noting that there would be “NO FURTHER EXTENSIONS OF THE DEADLINES UNDER ANY CIRCUMSTANCES.” (Text Amended Scheduling Order filed May 28, 2009.) That Amended Order required, among other things, Plaintiffs expert disclosures to be served by July 15, 2009, and Defendant’s expert disclosures to be served by September 14, 2009. (Id.) 1
C. Undisputed Material Facts
The following material facts are asserted and established (through the citation to admissible record evidence) by Defendant in its Local Rule 7.1 Statement, and either expressly admitted by Plaintiff or unsuccessfully controverted by her in her Local Rule 7.1 Response. (Compare Dkt. No. 28, Attach. 3 [Def.’s Rule 7.1 Statement] with Dkt. No. 33 [Plf.’s Rule 7.1 Response].) 2
On June 15, 2004, Plaintiff underwent a total knee replacement procedure at Oswe
The Duracon System is an FDA-regulated medical device that can only be sold to licensed health care providers and must be prescribed for use by a licensed surgeon based upon his or her education, training and experience, and based upon his or her own medical judgment and assessment of the patient’s specific needs. All potential risks associated with use of the Duracon System were provided by Defendant to Dr. Mahon as the learned intermediary. The package inserts for the Duracon System components distributed with the components themselves contained specific information regarding the metallic composition of the components. The package inserts for the Duracon System warned specifically of the potential for material sensitivity and reactions to the metallic components.
In accordance with expert disclosure deadlines, Plaintiff disclosed one expert, Dr. Michael Clarke, an orthopedic surgeon who performed Plaintiffs “revision” surgery on August 8, 2005. Dr. Clarke opines that “Plaintiff suffered from an exacerbation of a probable true nickel allergy arising out of insertion of the [Duracon System] ...” and that, during the revision surgery, the Duracon System had to be removed and replaced with a Smith & Nephew Genesis II Oxinium femur (“the Genesis II”) which “is almost nickel free.” (Dkt. No. 32, Attach. 1 [Affid. of Dr. Clarke].)
Familiarity with the remaining undisputed material facts of this action, as set forth in the parties’ Local Rule 7.1 Statement and Local Rule 7.1 Response, is assumed in this Decision and Order, which is intended primarily for review by the parties. (Id.)
D. Defendant’s Motion for Summary Judgment
On August 6, 2009, Defendant filed a motion for summary judgment in this action. (Dkt. No. 28.) Generally, in support of its motion, Defendant asserts the following two arguments: (1) Plaintiffs entire Complaint should be dismissed because she has failed to introduce expert witness testimony demonstrating either a design defect or the existence of inadequate warnings, and such testimony is required to establish such claims; and (2) Plaintiffs failure-to-warn claim should be dismissed because Defendant warned physicians and the medical community of the specific risk at issue in this action. (Dkt. No. 28, Attach. 1, at 5-11 [Def.’s Mem. of Law].)
On September 11, 2009, after receiving an extension by the Court, Plaintiff filed an opposition to Defendant’s motion.
(See
Text Order filed 9/2/09; Dkt. No. 32.) In her opposition, Plaintiff addresses only Defendant’s first argument (i.e., its argument regarding Plaintiffs failure to adduce expert testimony), neglecting to ad
On September 18, 2009, Defendant filed a reply in further support of its motion for summary judgment. (Dkt. No. 36.) Generally, in its reply, Defendant (1) rejects Plaintiffs three arguments regarding her failure to adduce expert testimony, and (2) argues that Plaintiff has failed to address Defendant’s argument regarding its having provided warnings to physicians and the medical community. (Id. at 2-7.)
II. LEGAL STANDARD GOVERNING MOTIONS FOR SUMMARY JUDGMENT
In their motion papers, the parties demonstrated an accurate understanding of the general standard governing motions for summary judgment. As a result, and for the sake of brevity, the Court will not recite the well-known general legal standard governing motions for summary judgment in this Decision and Order, but will direct the reader to the Court’s decision in
Pitts v. Onondaga County Sheriff’s Dep’t,
04-CV-0828,
The Court will add only one point. Implied in the burden-shifting legal standard described in Pitts v. Onondaga County Sheriffs Dep’t is the fact that, where a nonmoving party willfully fails to adequately respond to a properly filed motion for summary judgment, a district court has no duty to perform an independent review of the record to find proof of a factual dispute. 3
For this reason, this Court has often enforced Local Rule 7.1(a)(3) by deeming
A. Defendant’s Duty to Plaintiff
As a threshold matter, a manufacturer must owe a duty to an individual injured by the manufacturer’s product before the manufacturer can potentially incur liability for the injured party’s injuries.
See McCarthy v. Olin Corp.,
Manufacturers of a product have a duty to market safe products.
Dalton v. Stedman Machine Co.,
05-CV-0452,
B. Strict Products Liability Based Upon Design Defect 8
A plaintiff seeking to impose liability for a design defect must demonstrate the following: (1) the product, as designed, posed a substantial likelihood of harm; (2) it was feasible to design the product in a safer manner; and (3) the defective design was a substantial factor in causing plaintiffs injury.
Cuntan v. Hitachi Koki USA, Ltd.,
06-CV-3898,
It is not enough, however, to demonstrate that a product is dangerous.
Cuntan,
‘an inquiry into such factors as [the following]: (1) the product’s utility to the public as a whole; (2) its utility to the individual user; (3) the likelihood that the product will cause injury; (4) the availability of safer design; (5) the possibility of designing and manufacturing the product so that it is safer but remains functional and reasonably priced; (6) the degree of awareness of the product’s potential danger that can reasonably be attributed to the injured user; and (7) the manufacturer’s ability to spread the costs of any safety-related design changes.’
Id.
(quoting
Clarke v. LR Sys.,
Finally, a plaintiff must show that the defective design was the proximate cause of her injury.
Galletta,
1. Whether the Design Was Unreasonably Dangerous
a. Feasibility of Alternative Design
Generally, under New York law, a plaintiff seeking to establish a design defect is required to provide expert testimony as to the feasibility and efficacy of alternative designs.
Cuntan,
Here, “after research and investigation,” Dr. Clarke concluded that an alternative design has been put into use by makers of similar equipment. (Dkt. No. 32, Attach. 1.) Indeed, Dr. Clarke replaced the Duracon System with the Genesis II during Plaintiffs revision surgery, which occurred approximately fourteen months after the original surgery. Therefore, the Court will assume that an alternative design existed during the time in question, i.e., on June 15, 2004. 10
However, it is not enough to demonstrate simply that an alternative design existed during the time in question.
See Cuntan,
b. Substantial Likelihood of Harm
Similarly, Plaintiff does not provide evidence that the product in question, as designed, was “unreasonably dangerous.”
See Cuntan,
By making this argument, Plaintiff implicitly concedes that Dr. Clarke is not being offered as an expert on the issue of whether there was anything “wrong” with Defendant’s product.
See Galletta,
This argument is without merit. Nickel’s toxicity in knee replacement systems is not within the understanding of the ordinary juror, who is a layperson.
See Lusch v. Matrixx Initiatives, Inc.,
05-CV-0292,
Furthermore, even if the Court were to take judicial notice of the fact that, in certain quantities, nickel can be toxic to humans in general, the Court would be unable, under the circumstances, to take judicial notice of how little nickel can be toxic to humans (either to the average humans, or to humans with sensitivity to nickel). In reaching this conclusion, the Court relies on the case of
Patrick v. Sharon Steel Corp.,
in which the Northern District of West Virginia refused to take judicial notice of the “dangerous properties” of a list of twenty-one chemical compounds (including benzopyrene, antracene, sodium phenolate, or ammonium sulfate), because those chemical properties are “certainly not generally known within the territorial district of this, or any other[,] Court.”
Patrick v. Sharon Steel Corp.,
The Court ... notes that of the twenty-one compounds listed by Plaintiffs several are quite common and not generally considered to be dangerous. These include copper, lead, nickel and carbon dioxide. While the Court does not doubt that under certain conditions these compounds could be dangerous, it is incumbent upon the Plaintiffs to prove the existence of those ‘certain conditions’ or exposure levels. These matters should be decided by a jury after full development of the evidence at trial, not by a Court on a motion for judicial notice.
Patrick,
Here, Plaintiff has provided no evidence of the incidence and/or level of sensitivity to nickel in the general population. Similarly, Plaintiff has provided no evidence of the industry standard for acceptable levels of nickel in knee-replacement devices. Finally, Plaintiff has provided no evidence of the point at which the utility of using nickel in knee replacement devices outweighs the risk. 13
2. Whether the Defective Design Proximately Caused Plaintiffs Injuries
Because the Court has concluded that, based on the record evidence, no rational factfinder could conclude that the Duracon System was defectively designed, the Court need not, and does not, decide the issue of proximate cause. The Court will only note that the bulk of Dr. Clarke’s testimony pertained to this issue. (Dkt. No. 32, Attach.l.)
C. Defendant’s Duty to Warn 14
As an initial matter, the Court notes that, as explained above in Part I.C. of this Decision and Order, Plaintiff failed to respond to Defendant’s argument regarding Plaintiffs duty-to-warn claim, despite having been granted an extension of time in which to do so. As a result, Defendant’s burden with regard to this portion of its motion is lightened such that, in order to succeed on this portion, it need only show its entitlement to the relief requested in this portion, which has appropriately been characterized as a “modest” burden. 15 For the reasons stated by Defendant in its motion papers, the Court finds that Defendant has met this lightened burden. (See generally Dkt. No. 58.) In any event, the Court finds that Defendant’s argument would survive even the heightened scrutiny appropriate on a contested motion.
The Duracon System is not available to the general public, but rather, is available only by prescription. (Dkt. No. 28, Attach 3.) Therefore, pursuant to 21 C.F.R. § 801.109, warning information was disseminated to Plaintiffs physician, rather than Plaintiff directly. 21 C.F.R. § 801.109. “Warnings are furnished to the medical community as the ‘informed intermediary’ between the manufacturer and the patient.”
Fane,
The sufficiency of a manufacturer’s warning for a prescription device is generally a question of fact for the jury.
Id.
(citing
Wolfgruber,
Here, the package inserts accompanying the Duracon System adequately warned Plaintiffs surgeon, Dr. Mahon, of the risks associated with the metallic components of the Duracon System. The package inserts for the Duracon System knee replacement provided, in pertinent part:
ATTENTION OPERATION SURGEON
In using total knee joint implants, the surgeon should be aware of the following: ...
B. In selecting patients for total joint replacements, the following factors can be of extreme importance to the eventual success of the procedure:
4) Foreign body sensitivity: Where material sensitivity is suspected, appropriate tests should be made pri- or to material selection or implantation ....
ADVERSE EFFECTS
2) Although rare, metal sensitivity reactions in patients following joint replacement have been reported. Implantation of foreign material in tissues can result in cellular reactions that may include lymphocytes, macrophages and fibroblasts....
10) Allergic reactions to the materials utilized in the implant, although uncommon, can occur....
(Dkt. No. 28, Attch. 10, at 7, 11-12, 19-20, 24, 31, 35-36.) Moreover, the package inserts distributed with the Duracon System contained specific information regarding the metallic composition of the components of the device:
The metallic components (the femoral component, tibial and patellar baseplates, sintered beads, wedges and spacers) are manufactured from cast cobalt-chromium-molybdenum alloy (Vitallium Alloy) conforming to ASTM standard F75. The screws and stem extenders are manufactured from wrought cobalt-molybdenum alloy (Vitallium Alloy) conforming to ASTM standard F1537. The polyethylene components are manufactured from ultra-high-molecular weight polyethylene (UHMWPE) conforming to ASTM standard F648.
(Id. at 8, 20, 32.)
Indeed, Plaintiff acknowledges in her own Statement of Material Facts that “potential risks, warnings, indications and contraindications, and potential adverse events are provided to the physician as a learned intermediary [and] [tjhrough the learned intermediary the patient should be advised of the risks, benefits, indications, contraindications and potential adverse events in connection with the use of the device.” (Dkt. No. 33 at 2.) More importantly, Plaintiff concedes that “[t]he package inserts for the [Duracon System] components distributed with the components themselves contained specific information regarding the metallic composition of the components.” (Id. [emphasis added].) Therefore, Plaintiffs argument that Defendant did not make her aware of the risks and warnings regarding use of the device and its metallic components is unfounded as it contradicts her own Statement of Material Facts. (Id.)
In any event, it seems that Plaintiff has abandoned this claim. Indeed, Plaintiff does not even mention her failure to warn claim in the “Legal Argument” section of her opposition papers, but merely makes a conclusory statement in the “Relevant Factual Background” section that “[a]t no
Defendant provided an adequate warning to Dr. Mahon of the very risk which Plaintiff now complains of.
16
As the learned intermediary, it was Dr. Mahon who was required to communicate these warnings to Plaintiff. Therefore, Plaintiff has failed to demonstrate a
prima facie
claim of product defect based on a failure to warn.
See Fane,
ACCORDINGLY it is
ORDERED that Defendant’s motion for summary judgment (Dkt. No. 28) is GRANTED; and it is further
ORDERED that all of Plaintiffs claims asserted in her Complaint (Dkt. No. 7), are DISMISSED.
Notes
. Although Plaintiff timely disclosed one expert, Dr. Michael Clarke (an orthopedic surgeon who performed Plaintiff's “revision” surgery on August 8, 2005), Plaintiff failed to disclose any experts on the issues of the design, manufacture or metallic composition of the subject medical device, or on the adequacy of the product warnings.
. Plaintiff's 7.1 Statement is identical to Defendant’s 7.1 Statement, except for Defen
.
See In re Agent Orange Prod. Liab. Litig.,
.
See, e.g., Murray v. Weissman,
05-CV-1186,
.
See, e.g., Beers v. GMC,
97-CV-0482,
.
Hernandez v. Nash,
00-CV-1564,
.
See
N.D.N.Y. L.R. 7.1(b)(3) ("Where a properly filed motion is unopposed and the Court determines that the moving party has met its burden to demonstrate entitlement to the relief requested therein, the non-moving party's failure to file or serve any papers as this Rule requires shall be deemed as consent to the granting or denial of the motion, as the case may be, unless good cause is shown.”);
Ru
. Plaintiff asserts her design defect claim under theories of strict liability and negligence. Essentially, Plaintiff must make out the same
prima facie
case under both theories.
See Galletta v. Valmet, Inc.,
04-CV-0313,
.
See also Rypkema v. Time Mfg. Co.,
. The Court makes this assumption with some hesitation. Although this fact is not in the record (and is thus not considered by the Court in reaching its decision), the Court notes that the Genesis II, which is manufactured using Smith & Nephew’s exclusive nickel-free Oxinium technology, did not enter the market until February of 2003, and was apparently not widely used in the industry in June of 2004, having been subjected to a recall in September 2003.
.
Cf. Guarascio,
.
See United Nat’l Ins. v. Motiva Enter., LLC,
04-CV-2924,
. The Court notes that the fact that Dr. Clarke replaced Defendant's product with a product containing less nickel than was contained in the Duracon System does not establish that the replacement product’s alternative design is a more reasonable alternative than is the Duracon System’s design.
See Guarascio,
. As with product defect claims
(see, supra,
Part III.B. of this Decision and Order), duty to warn claims for negligence and strict liability are one in the same.
Tompkins v. R.J. Reynolds Tobacco Co.,
. See, supra, note 6 of this Decision and Order.
. There is a dispute between the parties as to whether Plaintiff advised Dr. Mahon prior to surgery of her past reactions to "cheap jewelry.” (Dkt. No. 32 at 6 n. 2 [Def.'s Reply Mem. of Law].) This dispute is not material to Defendant’s motion because it was Dr. Ma-hon’s duty to inquire about such allergies once he was provided with a clear warning of the risks associated with the Duracon System.