Opinion
Case No. 2:99-CV-1355
March 26, 2002
OPINION AND ORDER
This matter is before the Court for consideration of the Defendant's Motion for Summary Judgment. (Doc. #26). For the reasons that follow, the motion is granted.
I.
Plaintiff, Sharon D. Baker ["Plaintiff"], brings this action under Ohio law for injuries sustained as a result of the failure of a SynchroMed Implantable Infusion Pump [hereinafter the "SynchroMed pump"]. The pump was implanted subcutaneously to administer dosages of the anti-spasm medication, Baclofen, to Plaintiff. The Defendant in this case is Medtronic, Inc., manufacturer of the SynchroMed pump. Plaintiff claims are for alleged negligent design, testing and manufacture under R.C. §§ 2307.74 and 2307.75; inadequate warning under § 2307.76; breach of implied warranty; and nonconformance with manufacturer's representation under § 2307.77. This action was originally filed in the Court of Common Pleas for Franklin County, Ohio and was removed to this Court on the basis of diversity jurisdiction. 28 U.S.C. § 1441 and 1332.
The SynchroMed pump at issue was surgically implanted by Dr. Gary Rea, a neurosurgeon, at the Ohio State University Hospital on May 6, 1993. With the pump, Plaintiff receives doses of Baclofen to control spasms she suffers as a result of a gun-related incident which rendered her a paraplegic. Plaintiff was aware at the time of surgery that the pump was operated by a battery which had a limited life. ( Deposition of Sharon Baker, hereinafter "Plaintiff's Depo." at 16). According to Plaintiff, the pump performed satisfactorily until the battery failed on February 13, 1998.
On January 27, 1998, Plaintiff received a routine pump refill of Baclofen at the office of her physician, Dr. Samuel Colachis. The office note of Dr. Colachis' nurse, Ann Smith, states as follows:
1/27/98 Saw Sharon in clinic for routine . . . baclofen pump refill. Denies [shortness of breath] or lethargy. Did not notice any change in function [with reduction] in [infusion] rate [at time of] last appointment. Refilled [without] difficulty. No change in rate or dose. Noted low battery alarm occurring. Sue Bell / Dr. Rea notified. To schedule OR time prior to next refill time [about] 2/16. Will refill / reprogram as indicated [with] OR procedure for new pump.
Exhibit A-2 attached to Defendant's Reply.
On January 28, 1998, Plaintiff called nurse Smith and reported feeling "very tired." (Exhibit A-1, Id.). Nurse Smith called Medtronic and spoke with technical assistant, Jose Hernandez, who reported that the pump "accuracy is good for [approximately] 4 weeks." ( Id.). Nurse Smith verified that she didn't "misprogram the pump." ( Id.). On deposition, Smith testified that the term "accuracy" refers to the pump "being able to deliver the intrathecal Baclofen at the correct rate and dose for about four weeks." (Exhibit B at 83-84). Smith further testified that Medtronic assistant Jose Hernandez did not "guarantee" that the pump would work for four weeks. ( Id.).
Nurse Smith testified that she played no role in the scheduling of Plaintiff's pump replacement surgery because the neurosurgery department was responsible for all such scheduling. ( Id. at 86). Smith further testified that her contact to Dr. Rea's office to advise them that surgery needed to be scheduled occurred after Plaintiff's office visit on January 27 and before Smith's conversation with Medtronic on January 28. ( Id. at 88). Plaintiff was scheduled for surgery with Dr. Rea on February 17, 1998.
On February 13, 1998, Plaintiff called Nurse Smith. Smith's office note states:
2/13/98 1330 Sharon called. Stated her pump alarm stopped beeping last evening. Called up to Medtronic ( sic). Stated (Mike) that it is possible that her battery could have died within 2 weeks. . . .
(Exhibit A-3 attached to Defendant's Reply). Nurse Smith's note further reflects that Plaintiff had no Baclofen "on hand" that was not expired and had no way of transportation to OSU hospital because her husband was "out of town." ( Id.). Smith reported the facts to Sue Bell, Dr. McGregor and Dr. Colachis. Smith told Plaintiff that "Dr. Colachis wishes to have her call 911 and go to [the] local [emergency room] to be treated" in order to prevent baclofen withdrawal, but that Plaintiff "refused to go to the local ER" because she wanted to go to OSU. (Id.).
As a result of the pump failure, Plaintiff experienced Baclofen withdrawal which allegedly caused her to experience "significant pain and discomfort . . . which continues today." ( Plaintiff's Memorandum contra at 2).
Plaintiff claims that Medtronic made an "express representation that [the pump] would continue to function for 30 days after the low battery alarm sounded. Instead, the device only worked for 15 days." ( Id. at 1). Plaintiff's theory is that if this information had been given to Nurse Smith "on January 27, 1998, Dr. Rea's surgery would have been scheduled two weeks earlier which would have prevented the pump's failure and the Plaintiff's baclofen withdrawal." ( Id. at 2).
The Court notes that Plaintiff fails to point any evidence to support the chronology of events in this case. The Defendant has, however, supplied the Court with the relevant record which contradicts Plaintiff's unsupported version of the events.
Defendant Medtronic points out, however, that Nurse Smith did not call Medtronic until January 28, 1998, one day after the surgery had been scheduled by Dr. Rea. Medtronic further points out that the statements of pump accuracy made by Medtronic technicians on January 28 and February 13, 1998 are consistent with statistical information which the Food and Drug Administration ["FDA"] approved with respect to the approximate time for the remainder of pump function after the low battery alarm sounds.
David Mueller, the Regulatory Affairs Manager for the Neurostimulation Business of the Medtronic Neurological and Spinal Division, provides testimony on this issue. Mueller points out that the Technical Manual, which has been approved by the FDA, and which was provided to Dr. Rea, states:
Extensive in vitro testing has been performed to establish the battery longevity of the SynchroMed Infusion System. The results of this testing indicate that the pump longevity is limited as a function of drug delivery rate. The expected pump service life relative to drug delivery rate is shown in Figure 8. The expected time from the pump's Low Battery Alarm to pump stoppage, relative to the pump's drug delivery rate, is shown in Figure 9.
(Exhibit T attached to Defendant's Motion).
The manual containing the foregoing statistical information is sent to the physician each time a SynchroMed pump is implanted. ( Mueller Declaration at ¶ 4 attached as Exhibit C to Defendant's Reply). Dr. Rea has performed seventeen implant surgeries, and thus, would have received seventeen copies of the FDA approved manual. ( Id. at ¶¶ 6-7). Mueller avers that by studying the manual, a physician would know that "not all users whose device performance is being plotted will fall within the average expected life graph. Approximately 33% will fall outside the graph. Medical professionals know that [plus or minus] one standard deviation means that approximately 60% of the devices fall within the average expected life graph." ( Id. at ¶ 18).
Mueller further avers that in plotting Plaintiff's daily dosage of baclofen, which was 0.7906 ml, "the Average Expected Life curve is approximately 59 days. The Standard Error Expected Life curve yields a potential life range for all pumps within the [plus or minus] 1 standard deviation of approximately 30 to 80 days." ( Id. at ¶ 14). Thus, according to Mueller, Medtronic's representation on January 28, 1998 that the pump would continue to function for approximately four weeks is consistent with the statistical range. ( Id. at ¶ 15).
II.
The procedure for considering whether summary judgment is appropriate, is found in Fed.R.Civ.P. 56(c); this section provides:
The judgment sought shall be rendered forthwith if the pleadings, depositions, answers to interrogatories and admissions on file, together with the affidavits, if any, 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.
The evidence must be viewed in the light most favorable to the nonmoving party. Adickes v. Kress Co., 398 U.S. 144, 158-59 (1970). Summary judgment will not lie if the dispute about a material fact is genuine; "that is, if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Summary judgment is appropriate however, if the opposing party fails to make a showing sufficient to establish the existence of an element essential to that party's case and on which that party will bear the burden of proof at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); see also, Matsushita Electronic Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574 (1986).
The United States Court of Appeals for the Sixth Circuit has recognized that Liberty Lobby, Celotex, and Matsushita have effected "a decided change in summary judgment practice," ushering in a "new era" in summary judgments. Street v. J.C. Bradford Co., 886 F.2d 1472, 1476 (6th Cir. 1989). The court in Street identifies a number of important principles in new era summary judgment practice. For example, complex cases and cases involving state of mind issues are not necessarily inappropriate for summary judgment. Id. at 1479.
In addition, in responding to a summary judgment motion, the nonmoving party "cannot rely on the hope that the trier of fact will disbelieve the movant's denial of a disputed fact, but must `present affirmative evidence in order to defeat a properly supported motion for summary judgment.'" Id. (quoting Liberty Lobby, 477 U.S. at 257). The nonmoving party must adduce more than a mere scintilla of evidence in order to overcome the summary judgment motion. Id. It is not sufficient for the nonmoving party to merely "`show that there is some metaphysical doubt as to the material facts.'" Id. (quoting Matsushita, 475 U.S. at 586). Moreover, "[t]he trial court no longer has the duty to search the entire record to establish that it is bereft of a genuine issue of material fact." Id. That is, the nonmoving party has an affirmative duty to direct the Court's attention to those specific portions of the record upon which it seeks to rely to create a genuine issue of material fact.
III.
Defendant Medtronic moves for summary judgment on the basis that Plaintiff's product liability claims under Ohio law are preempted by the Medical Device Amendments ["MDA"] to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321, et seq., which require that Medtronic obtain "premarket approval" from the FDA prior to marketing the SynchroMed pump at issue. Plaintiff argues that even if MDA preemption applies, there is an exception in this case because Medtronic's representations concerning battery longevity allegedly amount to "off label representations" and because the pump is a "misbranded product." Thus, Plaintiff argues that her state law tort claims should proceed as to the 30 day representation. The Defendant disagrees. Before considering the merits of the parties' arguments, the Court will outline the preemption standard and its applicability to the SynchroMed pump.
The MDA was enacted in 1976 as a means of allowing the FDA to regulate medical devices. Under the MDA, medical devices are classified into three categories, with the most strict regulations applying to Class III medical devices. The SynchroMed pump in this case is a Class III medical device. In order to market such a device, the manufacturer must submit its product to the FDA for premarket approval or qualify for one of two exceptions to the regulatory review. Defendant in this case obtained premarket approval of the SynchroMed pump.
Premarket approval entails rigorous and close scrutiny of the device by the FDA. See 21 U.S.C. § 360e(c). Manufacturers must provide samples of the device, an outline of device components, a description of the manufacturing process, copies of the proposed labels, as well as various other information with regard to safety and effectiveness. See 21 C.F.R. § 814.20 (b). The FDA then reviews the submissions before either approving or disapproving the device. Id. at §§ 812.1-.150.
In this case, the Defendant submitted detailed information to the FDA on the design, construction, manufacturing and labeling of the SynchroMed pump. Defendant also submitted the results of clinical study on the safety and effectiveness of the device. ( Mueller Affidavit at ¶¶ 35-36). The FDA ultimately granted premarket approval for the SynchroMed pump on November 6, 1990 and Medtronic began marketing the device. ( Id. at ¶¶ 40-43).
The requirement of premarket approval, including the studies of safety and effectiveness of Class III medical devices, can make such approval a federal "requirement" with preemptive effect under the MDA. Kemp v. Medtronic, Inc., 231 F.3d 216, 228 (6th Cir. 2000). With regard to preemption, the MDA provides:
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement —
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.21 U.S.C. § 360k(a).
In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the United States Supreme Court
considered whether, under this provision, state law tort claims are preempted by the MDA. The device at issue in that case, a pacemaker, had not undergone the FDA premarket approval process. In a five to four decision, the Supreme Court concluded that the plaintiff's state law claims were not preempted under the MDA. Justice Stevens' plurality opinion was joined by Justices Kennedy, Souter and Ginsburg. Justice Breyer concurred in part and in the judgment, joining five of seven parts of Justice Stevens' opinion, which parts form the opinion of the Court in Lohr.
In this opinion, the Court concluded that both "[t]he ambiguity in the statute — and the congressional grant of authority to the agency on the matter contained within it — provide a `sound basis' for giving substantial weight to the agency's view of the statute." Id. at 496. In determining what common law duties constitute preempted "requirements" the Court explained:
[I]t is impossible to ignore [the Act's] overarching concern that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest. . . . The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations.Id. at 499.
A majority of the Court held that state law tort claims do impose "requirements" under the MDA and are therefore preempted when certain criteria are satisfied. First, the state requirement must be "with respect to" a medical device and must be "different from, or in addition to" federal requirements. Id. at 500. Second, the state requirement must relate to "the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device." Id. Finally, state regulations of "general applicability" are not preempted except when they have "the effect of establishing a substantive requirement of a specific device." Id. In Lohr, the Court concluded that because the device was never reviewed for safety and efficacy, there was no federal "requirement" and, consequently, plaintiff's state law claims for defective design could proceed.
In this case, Plaintiff contends that premarket approval process does not amount to a federal "requirement" for purposes of preemption. Plaintiff's argument is similar to that recently considered, and rejected, by the Sixth Circuit in Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000). In Kemp, the Court held that premarket approval by the FDA "constitutes approval of the product's design, testing, intended use, manufacturing methods, performance standards and labeling" and constitutes a specific requirement under the MDA. Id. at 226-27, citing Martin v. Telectronics Pacing Systems, Inc., 105 F.3d 1090, 1097 (6th Cir. 1997). Thus, Plaintiff's assertion that premarket approval of the SynchroMed pump does not constitute a federal requirement is contrary to controlling Sixth Circuit caselaw.
Plaintiff also contends that her state law tort claims do not amount to requirements that are "different from or in addition to" the federal requirements. Plaintiff's claims are for defect in manufacturing and design under R.C. § 2307.74 and § 2307.75; inadequate warning under § 2307.76; breach of implied warranty; and nonconformance to express representation under § 2307.77. The Court will consider each claim, in turn.
First, with respect to a claim for defect in manufacturing, Ohio law provides:
A product is defective in manufacture or construction if, when it left the control of its manufacturer, it deviated in a material way from the design specifications, formula or performance standards of the manufacturer, or from otherwise identical units manufactured to the same design specifications, formula or performance standards.
It is undisputed the that the premarket approval process for the SynchroMed pump included detailed information with respect to the manufacturing process. (See Mueller Affidavit at ¶ 35). The FDA ultimately approved the pump finding the manufacturing processes safe and effective. As the Defendant points out, such a finding constitutes a specific federal requirement that ordinarily preempts any state law manufacturing defect claim. See Martin, 105 F.3d at 1098-99. Further, no claim is made that the pump in question did not comply with the design and manufacturing standards approved by the FDA. Thus, this Court concludes that to allow Plaintiff's manufacturing defect claim to proceed would, in essence, impose a requirement different from or in addition to that already approved by the FDA. Consequently, Plaintiff's claim under § 2307.74 is preempted.
The Court reaches the same conclusion with respect to Plaintiff's claim for design defect under § 2307.75. This section provides:
A product is defective in design . . . if either of the following applies:
(1) When it left the control of its manufacturers, the foreseeable risks associated with its design or formulation . . . exceeded the benefits associated with that design . . .
(2) It is more dangerous than an ordinary consumer would expect when used in an intended or reasonably foreseeable manner.
As the Sixth Circuit held in Martin, "[t]o allow a cause of action for design defect where the FDA has specifically approved of the design of the device . . . would thwart the goals" of the MDA. Martin, 105 F.3d at 1099. In this case, the benefits and risks associated with the SynchroMed pump have already undergone rigorous analysis and scrutiny. Thus, to allow a jury to consider the benefits and risks would amount to imposing a state requirement different from or in addition to that already approved by the federal requirement. Consequently, Plaintiff's claim for design defect is preempted.
Plaintiff also presents a state law claim for inadequate warning under § 2307.76, which provides:
(1) [A product] is defective due to inadequate warning or instruction at the time of marketing if, when it left the control of its manufacturer, both of the following applied:
(a) The manufacturer knew or, in the exercise of reasonable care, should have known about a risk that is associated with the product and that allegedly caused harm for which the claimant seeks to recover compensatory damages;
(b) The manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided concerning that risk, in light of the likelihood that the product would cause harm of the type for which the claimant seeks to recover compensatory damages and in light of the likely seriousness of that harm.
In this case, in granting premarket approval for the SynchroMed pump, the FDA specifically reviewed and approved the package labeling and technical manuals, which included the warning that "potential complications associated with the use of this device may include . . . cessation of therapy due to battery depletion. . . ." (Exhibit 1 at 5 attached to Mueller Affidavit). The manual further provides that "[n]o representation is made that any one pump will last the entire lifetime of any user. Inherent uncertainties regarding the longevity of the power supply and other components make any such assurance impossible." ( Id. at 18).
As the Sixth Circuit held in Martin, "[t]o allow a state cause of action for inadequate warnings would impose different requirements or requirements in addition to those required by federal regulations." Martin, 105 F.3d at 1100. Thus, this Court concludes that since the FDA considered and approved the aforementioned warning with respect to battery life of the SynchroMed pump, Plaintiff's state law claim for failure to warn is preempted by the MDA.
Plaintiff also asserts a claim for breach of implied warranty. This common law claim imposes liability on a manufacturer for breach of an implied representation that a product is of good merchantable quality and is fit and safe for its ordinary, intended use. See Temple v. Wean United, Inc., 50 Ohio St.2d 317, 322 (1977). In Ohio, such a claim is interchangeable with one for strict product liability under § 402A of the Restatement of Torts 2d. Chemtrol Adhesives, Inc. v. Am. Mfrs. Mut. Ins. Co., 42 Ohio St.3d 40 (1989).
This provision provides:
(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
Section 402A of the Restatement of Torts 2d.
As with Plaintiff's claims for defective design and manufacture, this Court concludes that allowing a claim for breach of implied warranty to proceed would impose requirements different from or in addition to those already approved by the FDA under the rigorous premarket approval process for the SynchroMed pump. Consequently, Plaintiff's breach of implied warranty claim is preempted.
Finally, the Court considers Plaintiff's claim for alleged nonconformance to an express representation under § 2307.77. This statute provides:
A product is defective if it did not conform, when it left the control of its manufacturer, to a representation made by that manufacturer. A product may be defective because it did not conform to a representation even though its manufacturer did not act fraudulently, recklessly, or negligently in making the representation.
As the Defendant points out, the FDA requires manufacturers to include proposed medical device labeling and warnings as to safety and effectiveness as part of the premarket approval process. See 21 C.F.R. § 801.109, 860.7(d)(1), (e)(1). As the Martin court observed, express representations are subject to comprehensive FDA regulation. Martin, 105 F.3d at 1100. In light of the FDA approved warnings with respect to the battery life of the SynchroMed pump, any claim premised on state law would impose requirements different from or in addition to those already approved by the FDA.
Plaintiff concedes that she "does not allege that the FDA-approved product literature was inadequate in that it failed to warn Plaintiff of the possibility that the SMP pump could cease to function due to complete battery depletion. . . ." ( Memorandum contra at 5).
Nonetheless, Plaintiff argues that the representations made by Medtronic technicians on January 28 and February 13, 1998 that the battery life would continue for 30 days constitute "off label representations" that have not been regulated by the FDA and which therefore fall outside the scope of preemption. Plaintiff alleges that the FDA "did not address the issue of the time frame in which the pump would need to be replaced after the alarm sounds to prevent the pump from ceasing to function," but Medtronic employees did address the issue orally. ( Memorandum contra at 6). Plaintiff argues that the representation of thirty days was false because the battery lasted only fifteen days.
Defendant Medtronic argues that the thirty day representation does not amount to an "off label representation" because the representation was not in conflict nor did it vary from the FDA approved warnings. As the Defendant points out, the FDA approved literature delivered with the SynchroMed pump provides statistical values for a physician to utilize in estimating the life of the pump in the presence of a low battery alarm. The literature provides that 66% of users would fall within the standard error life expectancy curve, which amounts to a period of 30 to 80 days of pump effectiveness, and 33% would fall outside that range. (Exhibit C attached to Reply Memorandum). Dr. Rea was aware of these statistics. Moreover, the representations made by Medtronic technicians as to the 30 day life expectancy were consistent with the statistical literature approved by the FDA. In addition, the undisputed evidence of record reveals that Plaintiff's pump replacement surgery was scheduled by Dr. Rea's office, before the representations by Medtronic technicians were made. Thus, the schedule was not made in reliance on the representations by Medtronic technicians. In view of the consistency of the representations made as well as the chronology of events, the Court concludes that the thirty day life expectancy representation is not an "off label" representation. Plaintiff's claim is therefore preempted.
The Court notes that in her memorandum contra, Plaintiff also argues that, even if the FDA approved the thirty day time frame for battery life, then the SynchroMed pump is a misbranded product, for purposes of 21 C.F.R. § 808.1(d)(6), because it failed to conform to approved labeling. The Court notes that this claim was never pleaded in the complaint. In any event, the evidence of record does not support such a theory.
The MDA defines "misbranding" as labeling that is "false or misleading in any particular." 21 U.S.C. § 352 (a). As stated above, the statistical evidence provided to Plaintiff's physician, and approved by the FDA, provides that 66% of patients will fall within the range of 30-80 days of pump life expectancy in the presence of a low battery alarm; 33%, however, will fall outside this range. Further, there are specific warnings of the effect that pump failure will cause patients to suffer. In view of these approved statistical studies and warnings, and Dr. Rea's knowledge of the same, the Court finds that the warnings and labels with respect to pump life are not false or misleading as to any particular. Further, allowing Plaintiff's misbranded product claim to proceed on the basis that some other life expectancy should have been provided would create a requirement different from or in addition to those already approved by the FDA. Thus, any claim Plaintiff presents for misbranding is without merit.
In sum, the Court concludes that the entirety of Plaintiff's state law product liability claims are preempted by the MDA. The Defendant is entitled to summary judgment.
IV.
In light of the foregoing, the Defendant's Motion for Summary Judgment ( Doc. #26) is GRANTED. This action is hereby DISMISSED.