Opinion
Case No.: 1:04 CV 2338.
May 5, 2006
ORDER
Now pending before the court is Defendants' Medtronic, Inc. and Medtronic, USA, Inc.'s (together, "Medtronic" or "Defendants") Motion for Summary Judgment (ECF No. 32). For the reasons stated below, the motion is granted in part. The court withholds ruling on the remainder.
I. FACTS AND PROCEDURAL HISTORY A. Procedural History
Plaintiffs Joe Grant and Magdalena Grant (together, "Plaintiffs" or the "Grants") filed the above-captioned case on October 22, 2004, in the Cuyahoga County Court of Common Pleas. Defendants removed the case to this court on the basis of diversity jurisdiction. Plaintiffs allege product liability claims against Medtronic for manufacturing a defective cardiac pacemaker. The cardiac pacemaker in question, Model KSR401, serial number PEU104501H, was originally implanted in Joe Grant on November 24, 1998, and removed and replaced with a substitute on October 28, 2002. According to the complaint, the original pacemaker was defective and caused multiple blackouts, permanent loss of partial balance, partial loss of hearing, permanent heart damage, and other related problems.
Plaintiffs' complaint asserted claims of: (1) defective manufacture, pursuant to O.R.C. § 2307.74; (2) defective design, pursuant to O.R.C. § 2307.75; (3) failure to provide adequate warning or instruction, pursuant to O.R.C. § 2307.76; (4) failure to conform to a representation made by Medtronic, pursuant to O.R.C. § 2307.77; (5) negligence; and (6) loss of consortium.
The pacemaker in question is and has been in Plaintiffs' control since the beginning of this litigation. In mid-2005, a dispute arose when the Grants refused to permit Defendants to test the pacemaker. In response, Defendants filed a motion for a protective order, as well as a motion to permit testing of the device. (ECF Nos. 15, 16.) Shortly thereafter, counsel for Plaintiffs filed a motion to withdraw, citing "continuously escalating disagreements" with the Grants as to how to proceed in the case. (ECF No. 19.) The court granted counsel's motion on September 20, 2005, and agreed to hold the pending motions in abeyance for at least forty-five days to enable Plaintiffs to obtain new counsel. (ECF No. 22.)
Plaintiffs did not obtain new counsel, and on December 13, 2005, the court granted both pending motions. (ECF No. 29.) The court subsequently held a January 23, 2006 teleconference, to discuss testing with the parties. (ECF No. 30.) At this conference, Plaintiffs indicated that they did not trust the Defendants to test the device, and wished to test the device themselves, although they did not have the technical data necessary to do so. Defendants also agreed at that time to permit Plaintiffs to test the device. The court thus ordered Defendants to disclose any technical data necessary for Plaintiffs to test the pacemaker, and indicated that Plaintiffs would have thirty days from the receipt of such data to test the device, with the Defendants present. ( Id.)
The court notes that Plaintiffs Joe and Magdalena Grant have indicated that they are unprepared to participate in the case, except through their son, Frank Grant, because of health and other issues. The court has permitted Frank Grant to speak on behalf of his parents, and has repeatedly warned Joe, Magdalena, and Frank Grant as to the importance of obtaining legal counsel.
Plaintiffs indicated in their reply to Defendants' summary judgment motion that they had not received "a Parts List and the Heart Rate Drop Response Test Procedure" necessary in order to test the device. (ECF No. 34.) In a May 4, 2006 teleconference, Defendants represented to the court that Medtronic did not produce or use a "Heart Rate Drop Response Test Procedure," and that they believed the device could be tested without a parts list. Nonetheless, the court ordered Defendants to produce the parts list to Plaintiffs, and instructed Defendants to file an affidavit regarding the "Heart Rate Drop Response Test Procedure" or lack thereof. While noting that discovery was over, the court granted Plaintiffs two weeks from the receipt of the parts list to complete any testing of the device, and reiterated the requirement that Plaintiffs clear the testing date with Defendants and permit Defendants to be present.
B. KSR401 Pacemaker and FDA Approval Process
On January 30, 1998, Medtronic obtained FDA approval for the KSR401 pursuant to the Medical Device Amendments ("MDA") to the Federal Food, Drug and Cosmetic Act. 21 U.S.C. §§ 321, et seq. (Tim Samsel Aff. ¶ 9, ECF No. 32, Att. 2.) Under the MDA, a Class III medical device, such as the KSR401 requires pre-market approval ("PMA"). The PMA application included:
a summary of safety and effectiveness, including indications for use and adverse effects; a detailed description of the device, its function components and properties, and principles of operation; a manufacturing section describing the physical plant, manufacturing equipment, manufacturing processes and quality control procedures, sterilization procedures and finished device inspection procedures; a technical section including the results of clinical testing and non-clinical laboratory tests and software validation, and copies of proposed product literature and labeling.
( Id. at ¶ 10.)
According to Medtronic's records, the KSR401, as well as its ventricular lead, passed all quality control inspections and were free from manufacturing defects at the time they were released for sale, and complied with the FDA approved design, manufacturing, and labeling processes. (Michael Ebert Aff. ¶ 7, ECF No. 32, Att. 3.)
II. LAW AND ANALYSIS A. Summary Judgment Standard
Federal Rule of Civil Procedure 56(c) governs summary judgment motions and 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 a judgment as a matter of law. . . .
In reviewing summary judgment motions, this court must view the evidence in a light most favorable to the non-moving party to determine whether a genuine issue of material fact exists. Adickes v. S.H. Kress Co., 398 U.S. 144 (1970); White v. Turfway Park Racing Ass'n, Inc., 909 F.2d 941, 943-44 (6th Cir. 1990). A fact is "material" only if its resolution will affect the outcome of the lawsuit. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Determination of whether a factual issue is "genuine" requires consideration of the applicable evidentiary standards. Thus, in most civil cases the court must decide "whether reasonable jurors could find by a preponderance of the evidence that the [non-moving party] is entitled to a verdict." Id. at 252.
Summary judgment is appropriate whenever the non-moving 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, 477 U.S. at 322. Moreover, "the trial court no longer has a duty to search the entire record to establish that it is bereft of a genuine issue of material fact." Street v. J.C. Bradford Co., 886 F.2d 1472, 1479-80 (6th Cir. 1989) (citing Frito-Lay, Inc. v. Willoughby, 863 F.2d 1029, 1034 (D.C. Cir. 1988)). The non-moving party is under an affirmative duty to point out specific facts in the record as it has been established which create a genuine issue of material fact. Fulson v. City of Columbus, 801 F. Supp. 1, 4 (S.D. Ohio 1992). The non-movant must show more than a scintilla of evidence to overcome summary judgment; it is not enough for the non-moving party to show that there is some metaphysical doubt as to material facts. Id.
B. Federal Preemption
Defendants argue that with the exception of the defective manufacture claim, each of Plaintiffs' state law tort claims are preempted by the federal law regulating medical devices, such as Joe Grant's pacemaker. The MDA contains the following express preemption clause: No 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). Defendants point to numerous Supreme Court and Sixth Circuit cases in which courts have used the above-preemption clause, in light of the Supremacy Clause, to dismiss state law product liability lawsuits as preempted by federal law. See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000). Not all state law claims are preempted; only if liability on a state law tort claim interferes with the requirements of the MDA is a state law claim preempted. The Sixth Circuit has identified a three-part test to determine whether state law claims are preempted: "whether (1) the FDA has established specific counterpart regulations or other specific federal requirements; that are (2) applicable to a particular device; and thus (3) make state regulations different from, or in addition to, the specific FDA requirements." Kemp, 231 F.3d at 224-25.
1. Specific Federal Requirements, Applicable to a Particular Device
The first two preemption issues are whether the FDA has established device-specific federal requirements, applicable to Medtronic pacemaker model Model KSR401, through the PMA process. Without specific federal requirements which apply to the KSR401, there are no federal laws for Ohio's tort laws to interfere with, and thus no preemption. Nearly every court to address this issue, including each Sixth Circuit panel reaching the question, have concluded that the extensive PMA process does establish device-specific federal requirements. Kemp, 231 F.3d at 227-28; Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005); Martin v. Telectronics Pacing Sys., 105 F.3d 1090 (6th Cir. 1997) (holding that related Investigation Device Exemption process also establishes specific federal requirements); Mitchell v. Collagen Corp., 126 F.3d 902, 913 (7th Cir. 1997); Brooks v. Howmedica, Inc., 273 F.3d 785, 795-96 (8th Cir. 2001); Horn v. Thoratec Corp., 376 F.3d 163, 169 (3d Cir. 2004); Martin v. Medtronic, Inc., 254 F.3d 573, 584 (5th Cir. 2001); Dunlap v. Medtronic, Inc., 47 F.Supp.2d 888 (N.D. Ohio 1999). But see Lohr, 518 U.S. at 501 (finding no preemption when the non-exacting substantial equivalence test was used, but suggesting that a more rigorous and detailed approval process would be sufficient to establish specific federal requirements); Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999) (finding PMA process insufficient to establish specific federal requirements and preemption).
In this case, the KSR401 went through the rigorous PMA process, as outlined in 21 U.S.C. § 360e(d)(2) and 21 C.F.R. § 801.109(b)(2). This process established specific federal requirements for the design, manufacturing, labeling, and advertising of the KSR401. Medtronic was not free to modify any of these elements without working through the FDA to amend its PMA. The process meets the first two prongs of the preemption test.
2. State Regulations Different from, or in Addition to, the Federal Requirements
Justice Breyer described this issue conceptually in his concurrence in Lohr:
Imagine that, in respect to a particular hearing aid component, a federal MDA regulation requires a 2-inch wire, but a state agency regulation requires a 1-inch wire. If the federal law, embodied in the "2-inch" agency regulation, pre-empts the state "1-inch" agency regulation, why would it not similarly pre-empt a state-law tort action that premises liability upon the defendant manufacturer's failure to use a 1-inch wire (say, an award by a jury persuaded by expert testimony that the use of a more than 1-inch wire is negligent)?. . . .
Consequently, I believe that ordinarily, insofar as the MDA pre-empts a state requirement embodied in a state statute, rule, regulation, or other administrative action, it would also pre-empt a similar requirement that takes the form of a standard of care or behavior imposed by a state-law tort action.Lohr, 518 U.S. at 504-05 (J. Breyer, concurring in part and concurring in the judgment). Thus, the third prong of the preemption analysis asks whether each specific state law cause of action could impose a conflicting state regulation analogous to the one-inch wire requirement discussed in Lohr. See also Martin, 105 F.3d at 1099.
Defendants argue generally that with respect to Plaintiffs' claims for failure to provide adequate warning, defective design, negligence, and failure to conform, such claims are "premised on the notion that Medtronic should have done something different than it actually did in designing, manufacturing, or labeling the product." (Defs. Mot. for Summ. J. 18, ECF No. 32.) Thus, according to Defendants, "Medtronic was not at liberty to utilize a product of a different design, or to use different manufacturing processes or to use different labeling, warnings or instructions." ( Id.) Defendants thus argue that these state law claims are preempted. For these reasons, and the reasons stated below, the court agrees.
a. Failure to Warn
O.R.C. § 2307.76 states that a product is defective due to inadequate warning if the manufacture knew or should have known of the risk that ultimately caused the harm, and failed to provide such a warning. The sole allegation in Plaintiffs' complaint related to this claim is "[s]aid pacemaker was defective by reason of all named Defendants' failure to provide adequate warning or instruction pursuant to § 2307.76 of the Ohio Revised Code." The Sixth Circuit addressed an identical issue in Kemp and found the claim preempted:
[the complaint] could be read as asserting that the warnings found in the label and literature approved by the FDA for the Model 4004 and Model 4004M were inadequate under Ohio law. . . . [H]owever, the information submitted to and approved by the FDA in the Model 4004M PMA Supplement — including information regarding warnings and disclaimers — comprise the specific federal requirements applicable to defendant's pacemaker lead. Accordingly, to the extent that plaintiffs' claim is premised on the adequacy of the warnings reviewed and approved by the FDA, . . . the claim is . . . preempted.Kemp, 231 F.3d at 236. The same analysis applies to the instant case. Any claim that the FDA-approved warnings were inadequate is preempted.
However, the court notes that there are two additional interpretations of the complaint which require a slightly different analysis. First, if the complaint is read to allege that Defendants' warnings did not comply with the FDA-approved warnings, an action to enforce the FDA's requirements would not impose conflicting requirements, and would not be preempted. See Mitchell v. Collagen Corp., 126 F.3d 902, 914 (7th Cir. 1997) ("to the degree that these claims may be read to allege that [defendant] failed to meet the standards set forth in the PMA process, the allegations are not preempted"). However, in their brief in opposition to summary judgment, Plaintiffs did not argue this interpretation, and Plaintiffs have placed no evidence in the record to rebut the Defendants' affidavit evidence that the pacemaker "complied with the FDA-approved . . . labeling processes and requirements." (Ebert Aff. ¶ 7, ECF No. 32, Att. 3.) Accordingly, to the extent Plaintiffs assert this interpretation, summary judgment is granted against them. Second, the complaint could be read to assert that Defendants learned of additional dangers subsequent to the FDA approval, but failed to amend the warnings or labeling. See Kemp, 231 F.3d at 236-37. However, such a claim would also be preempted. Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005). Moreover, Plaintiffs have placed no evidence on the record to support this claim, let alone suggest it is the proper interpretation. Accordingly, summary judgment is granted on the failure to warn claim.
b. Design Defect
For similar reasons, the court finds Plaintiffs' design defect claim conflicts with federal law and is thus preempted. Under Ohio law, a product's design is defective if "the foreseeable risks associated with its design or formulation . . . exceeded the benefits associated with that design or formulation . . ." O.R.C. § 2307.75. In Martin, the Sixth Circuit held that this statute was preempted by FDA approval:
Thus, because under the federal requirement the FDA has determined that the benefits of the device outweigh the risks and, under the state requirement, a jury in a state court action could conclude that the risks outweigh the benefits, the state requirement is different from the federal requirement . . . the state statute is the kind of requirement that would impede the implementation and enforcement of specific federal requirements. To allow a cause of action for design defect where the FDA has specifically approved of the design of the device for investigational purposes would thwart the goals of safety and innovation.Martin, 105 F.3d at 1099. In Enlow v. St. Jude Medical, Inc., 171 F. Supp. 2d 684, 689 (W.D. Ky. 2001), the court found a Kentucky state law design defect claim preempted by the FDA requirement as established in the PMA approval process for a heart valve. Similarly, in the instant case, Medtronic's device went through the rigorous PMA process, and its design was specifically accepted by the FDA. Any state law finding of defective design would necessarily conflict with the FDA approval and be preempted.
c. Negligence
Plaintiffs' negligence claim also conflicts with federal law and is likewise preempted. In Mitchell, the Seventh Circuit found identical claims preempted:
The [plaintiffs'] negligence claims must be considered preempted to the extent that they allege that [defendant] was negligent despite its adherence to the standards required by the FDA in its PMA for this specific product. A state court judgment premised on a determination that such a specific allegation is true would necessarily conflict with the determination of the FDA that its requirements rendered the product safe and effective. n6
N6 To the extent that the [plaintiffs'] complaint may be read as alleging that [defendant] was negligent in its adherence to the standards of the FDA in the PMA, the negligence claim would not be preempted. It would, however, be subject to dismissal on the merits because the [plaintiffs] failed to meet their burden on summary judgment.Mitchell, 126 F.3d at 914; see also Enlow, 171 F. Supp. 2d at 691. There is nothing in the complaint, nor is there evidence in the record, to suggest that the Defendants were negligent in failing to adhere to the FDA standards, as determined by the PMA process. Therefore, the court finds that Plaintiffs' negligence claim conflicts with federal law, and is preempted.
d. Failure to Conform
The court finds this claim also conflicts with the federal requirements. Under O.R.C. § 2307.77, 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.
The Sixth Circuit had occasion to address FDA preemption of this statute in Martin, and found it completely preempted by FDA regulations. 105 F.3d at 1100. Accordingly, since the PMA process specifically regulates the pacemaker literature, labeling, and design for the pacemaker in question, the court finds that these FDA regulations preempt a failure to conform claim. The court notes that to the extent the complaint may be read to suggest Defendants made representations outside of those authorized by the FDA, Plaintiffs have put no evidence on the record to support such a claim. Accordingly, summary judgment is granted as to this claim.
C. Defect in Manufacturing
The sole argument Plaintiffs raise in opposition to the above analysis is that the FDA "does not get involved in manufacturing consistency" and cannot determine whether Medtronic sold "any pacemaker that does not perform the same way as the one pacemaker that was submitted to the Food and Drug Administration during the approval process." (Pls. Opp. Br., ECF No. 34.) Defendants concede this point, and admit in their brief that if Plaintiffs can demonstrate that the device, as manufactured, deviated from the FDA-approved specifications, such a claim would not be preempted. Defendants argue, however, that Plaintiffs have offered no such proof. Although discovery has concluded, the court will permit Plaintiffs a brief additional time to test the device and put evidence on the record in support of this claim. The court will withhold ruling on Defendants' motion for summary judgment on the defect in manufacturing claim until June 16, 2006. If, at that time, Plaintiffs have not put forth additional evidence to support their claim, the court will rule on Defendants' motion.
D. Loss of Consortium
Plaintiffs' final claim is for loss of consortium resulting from the allegations in the other claims. While Ohio law recognizes claims for loss of consortium, it does so only on a derivative basis: "[a] cause of action based upon a loss of consortium is a derivative action. That means that the derivative action is dependent on the existence of a primary cause of action and can be maintained only so long as the primary action continues." Messmore v. Monarch Mach. Tool Co., 463 N.E. 2d 108 (Ohio App. 1983). To the extent the court has dismissed all claims except the manufacturing defect claim, summary judgment is granted on the loss of consortium claim to the same extent. However, her loss of consortium claim, which derives from the manufacturing defect claim, remains, since the court is withhold ruling on the manufacturing defect claim at this time.
III. CONCLUSION
For the reasons stated below, Defendants' Motion for Summary Judgment (ECF No. 32) is granted in part, and the court withholds ruling on the manufacturing defect and loss of consortium claims. Defendants shall produce a parts list for the device for Plaintiffs within ten days of the date of this Order. Plaintiffs are permitted two weeks from that date to test the device, provided that at least ten days prior to doing so, Plaintiffs notify Defendants as to who will perform the testing, and where and when the testing will take place. Defendants shall have the right to be present at any such testing. If no additional evidence is placed on the record, the court will rule on the remaining claims on or after June 16, 2006.
IT IS SO ORDERED.