Opinion
Case No.: CV04-704 WJR (MCx).
December 17, 2004
MORRIS POLICH PURDY LLP, Janet M. Richardson, CARDIAC PACEMAKERS, INC., Attorneys for Defendant.
ORDER ON MOTION FOR SUMMARY JUDGMENT
TO ALL PARTIES AND TO THE ATTORNEYS OF RECORD:
The Motion of Defendant Cardiac Pacemakers, Inc. (CPI) for Summary Judgment was heard December 13, 2004 at 10:00 a.m. Plaintiff Mary Clement appeared pro se. Janet M. Richardson and Jeffrey Kruse appeared on behalf of defendant Cardiac Pacemakers, Inc. ("CPI").
After consideration of all papers filed in support of and in opposition to the Motion, and after hearing oral argument, the Court orders as follows.
The tentative ruling, a copy of which is attached, is adopted as the Court's Order and is incorporated into this Order by reference. The Motion was granted in part and denied in part.
The Court holds that claims relating to design, manufacture, labeling and warnings, whether grounded in strict liability or in negligence, are preempted by federal regulation of medical devices, as set for the in Medical Device Amendments to the Food, Drug and Cosmetic Act, 21 U.S.C. § 360k. The Motion is therefore granted as to those claims.
The Court further holds that the intentional tort cause of action in the Complaint is not preempted, and the Motion is denied as to that cause of action. The Court also rules that plaintiff will be permitted to pursue a claim for negligence in failing to follow FDA regulations applicable to the devices.
IT IS SO ORDERED.
UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA TENTATIVE RULING
Case Number: CV 04-0704 WJR (Mcx) Docket Number: ____ Title: Mary Clement v. Kaiser Foundation Health Plan, et. al. Date: December 13, 2004Nature of Motion: Defendant Cardiac Pacemakers, Inc.'s Motion for Summary Judgment
HON. WILLIAM J. REA, JUDGE Marva Dillard, Deputy Clerk TENTATIVE RULING
The Court is inclined to GRANT, in part, and DENY, in part, Defendant Cardiac Pacemakers, Inc.'s Motion for Summary Judgment.
DISCUSSION
I. Legal Standard
Under Rule 56 of the Federal Rules of Civil Procedure, a summary judgment motion should be granted 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." Fed.R.Civ.P. 56(c).
A fact is material if, under the substantive law governing the case, it "might affect the outcome of the suit." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). Further, there is a "genuine" issue over such material fact "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Id. Factual disputes that are irrelevant or unnecessary under the relevant substantive law will not be considered. Id.
The burden of establishing that there is no genuine issue of material fact lies with the moving party. Mutual Fund Investors v. Putnam Management Co., 553 F.2d 620, 624 (9th Cir. 1977);Doff v. Brunswick Corp., 372 F.2d 801, 805 (9th Cir. 1966). To "defeat" such a burden, and survive a summary judgment motion, the responding party need only present evidence from which a jury might return a verdict in its favor. See, e.g., Anderson, 477 U.S. at 255.
More specifically, the "issue of material fact required by Rule 56(c) to be present to entitle a party to proceed to trial is not required to be resolved conclusively in favor of the party asserting its existence; rather, all that is required is that sufficient evidence supporting the claimed factual dispute be shown to require a jury or judge to resolve the parties' differing versions of the truth at trial." Id. at 248-49. But the mere existence of a scintilla of evidence in support of the non-moving party's position will be insufficient as there must be evidence on which the jury could reasonably find for the respondent. Id. at 252.
Because summary judgment is based on an inquiry of the facts, and their status as being material and undisputed, a summary judgment motion is appropriate "after adequate time for discovery . . . against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which the party will bear the burden of proof at trial." Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986).
Finally, the Court notes that "at the summary judgment stage the judge's function is not himself to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial." Anderson, 477 U.S. at 249. In that regard, "[t]he evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor."Id. at 255 (citing Adickes v. S.H. Kress Co., 398 U.S. 144, 158-59 (1970)).
II. Application to the Instant Case
Defendant Cardiac Pacemakers, Inc. ("CPI") moves for Summary Judgment on the basis of pre-emption. Specifically, Defendant argues that "Plaintiff's claims against Cardiac Pacemakers, Inc. are preempted by the Medical Device Amendments of 1976." See Defendant's Motion at 6. Defendant relies on two key cases:Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Papike v. Tambrands, Inc., 107 F.3d 737 (9th Cir. 1997). See id. at 17-18.
Plaintiff opposes Summary Judgment because it is "pre-mature" and discovery has just begun. See Opposition at 3, 4-5. Rule 56(f) "allows a party who has no specific material contradicting his adversary's presentation to survive a summary-judgment motion by presenting valid reasons justifying his failure of proof." Wright, Miller Kane, Federal Practice and Procedure: Civil 3d § 2740, at 398 (West 1998). A Rule 56(f) affidavit "need not contain evidentiary facts going to the merits of the case; rather it is merely a sworn statement explaining why these facts cannot yet be presented." Id. The purpose of Rule 56(f) is to allow parties to avoid the "premature grant of summary judgment" and courts have applied the rule "with a spirit of liberality." Id. at 402. Accompanying her Opposition, Plaintiff has included two declarations stating that, essentially, it would be premature for this Court to grant Summary Judgment. See Opposition, Ex. A (Declaration of Mary Clement); Ex. B (Declaration of Ted Gunderson).
The Court notes that Defendant filed her Opposition on December 1, 2004. The filing deadline for the Opposition was November 29, 2004. The Court urges both parties to file their papers in a timely manner.
"Should it appear from the affidavits of a party opposing the motion that the party cannot for reasons stated present by affidavit facts essential to justify the party's opposition, the court may refuse the application for judgment or may order a continuance to permit affidavits to be obtained or depositions to be taken or discovery to be had or may make such other order as just." Fed.R.Civ.P. 56(f).
However, as Defendant has brought a pre-emption argument, the Court may grant Summary Judgment as to those claims that are pre-empted as a matter of law. Further fact discovery will not affect the Court's decision as to that issue.
In Medtronic, the Supreme Court addressed whether the Medical Device Amendments of 1976 ("MDA") pre-empts state common law tort actions against medical device manufacturers. Id. at 474. Unfortunately, this case does not lend itself to simple analysis due to the several opinions issued by the Supreme Court.
The key statutory provision can be found at 21 U.S.C. § 360k(a):
"Except as provided in subsection (b) of this section, 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."
The threshold issue is to determine what kind of state common-law claims are being brought by Plaintiff Mary Clement. Unfortunately, this is not entirely clear to the Court at this point. The instant case was removed to federal court by the Defendant and the state court complaint does not provide any detail as to Plaintiff's claims. See Notice of Removal, Ex. A. Against Defendant CPI, Plaintiff Clement has brought "general negligence" and "intentional tort" claims as counts one and two of her Complaint. To the extent it can, the Court will attempt to outline the boundaries of what kinds of claims would be preempted by the FDA.
Plaintiff seems to have sued Guidant Corporation (Cardiac Rhythm Management) instead of CPI. As explained in Defendant's Notice of Motion papers, CPI may be a distinct entity. See Notice of Motion at 2.
On the basis of Medtronic, the Court is unable to conclude that all state common-law tort claims are pre-empted by the MDA. See Medtronic, 518 U.S. at 485 (stating that "because the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action"); id. at 508 (Breyer, J., concurring in part and concurring in the judgment) (finding no "indication that either Congress or the FDA intended the relevant FDA regulations to occupy entirely any relevant field");Committee of Dental Amalgam Manufacturers and Distributors v. Stratton, 92 F.3d 807, 811 (9th Cir. 1996) (explaining that, inMedtronic, the Supreme Court "rejected a broad construction" of § 360k).
But, a majority of the Supreme Court did hold that state common-law tort actions could be pre-empted by the MDA. In his separate opinion, Justice Breyer wrote that the MDA would "pre-empt a [state] requirement that takes the form of a standard of care or behavior imposed by a state-law tort action." Id. at 504-05 (Breyer, J., concurring in part and concurring in judgment). Similarly, in her opinion joined by Justices Rehnquist, Scalia and Thomas, Justice O'Connor wrote that "state common-law damages actions do impose `requirements' and are therefore pre-empted where such requirements would differ from those imposed by the FDCA." Id. at 509 (O'Connor, J., concurring in part and dissenting in part). What types of tort actions may be pre-empted by the MDA is the central issue in the instant motion.
A. The scope of preemption by the MDA
In this portion of its Tentative Ruling, the Court relies on Section V of Justice Stevens' opinion. This portion of Justice Stevens' opinion constitutes the opinion of the Court since Justice Breyer joined all parts of Stevens' opinion except for Parts IV and VI. See id. at 508. Defendant CPI relied on slightly different portions of Medtronic in its analysis. See Defendant's Motion at 18.
In Medtronic, the Supreme Court unanimously held that the plaintiff's defective design claims were not pre-empted by the MDA because defendant's device had only proceeded through the FDCA's § 510(k) "substantial equivalency" process. See 518 U.S. at 494 (holding that the "substantial equivalence" exemption does not pre-empt defective design claims); id. at 513 (O'Connor, J., concurring in part and dissenting in part) (agreeing with the Court that plaintiff's defective design claims were not pre-empted by "substantial equivalency").
The MDA provides multiple ways in which a medical device manufacturer may obtain approval from the FDA before public use. One path is through "premarket approval" or "PMA." Id. at 477. The PMA process "is a rigorous one." Id. "Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission." Id. There are also less rigorous methods of approval. One of the exceptions to the PMA process requirement is "substantial equivalence." Id. at 477-78. If a medical device has already been approved prior to the enactment of the MDA, medical device manufacturers seeking to sell new devices "substantially equivalent" to those already approved devices submit to the less onerous "premarket notification" or § 510(k) process. Id. at 478. "The § 510(k) notification process is by no means comparable to the PMA process; in contrast to the 1,200 hours necessary to complete a PMA review, the § 510(k) review is completed in an average of only 20 hours." Id. at 478-79.
In reaching this holding, the Court stated the following:
[E]ven though the FDA may well examine § 510(k) applications for Class III devices (as it examines the entire medical device industry) with a concern for the safety and effectiveness of a device, it did not "require" Medtronics' pacemaker to take any particular form for any particular reason; the agency simply allowed the pacemaker, as a device substantially equivalent to one that existed before 1976, to be marketed without running the gauntlet of the PMA process.Id. at 493-94 (citation omitted) (emphasis added).
The MDA classifies medical devices into three categories "based on the risk that they pose to the public." Id. at 476. Class III devices are those that present the most serious potential risks. Id. at 477. Pacemakers are Class III devices.Id.
So, even though the Supreme Court did not hold defective design claims would be preempted by the MDA in Medtronic, it did so only with respect to a device that had been approved through the less rigorous § 510(k) process. However, more specific requirements imposed by more demanding procedures may insulate medical devices from such claims. See id. at 501 (finding that general federal requirements did not preempt common-law claims where the Government did not "weigh the competing interests relevant to the particular requirement in question, reach an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implement that conclusion via a specific mandate on manufacturers or producers"). Such specific requirements may result from the FDA approval process for medical devices.
The medical devices at the center of the present dispute traversed the rigorous PDP process. "The devices at issue in this case include a Pulsar Max II DR Pacemaker, Model 1280; a Flextend Atrial Lead, Model 4086; and a Selute Picotip Ventricular Lead, Model 4035." See Defendant's Motion at 6. "FDA has already determined that these devices are safe and effective through the rigorous Premarket Approval ("PMA") and Product Development Protocol ("PDP") processes set forth in the MDA." See id.; Novak Affidavit at ¶¶ 20-29, 32-37, 39-47; Exs. 5, 8, 11. As part of these submissions, Defendant provided information relating to "the design, manufacturing methods and processes, quality control procedures, design verification testing, labeling, marketing and distribution" of all the disputed medical devices. See Defendant's Motion at 8, 10, 12.
In the instant case, the devices at issue underwent the "product development protocol" or "PDP" process. See Defendant's Motion at 14-16. The Court is inclined to agree that the PDP approval process is as rigorous, at least for the purposes of preemption, as the PMA process. See Ex. 14 at 2 ("A PDP that has been declared completed by the FDA is considered to have an approved PMA.").
The PMA (or PDP) process is one that requires the medical device manufacturer to take "particular forms" for "particular reasons." In addition, the PDP process forced the FDA to weigh "competing interests" and implement its conclusions "via a specific mandate" on a manufacturer. Therefore, the FDA requirements imposed via the PDP process on the disputed medical devices may preempt many types of tort claims that could be brought by Plaintiff. See Martin v. Medtronic, Inc., 254 F.3d 573, 585 (5th Cir. 2001) (holding that "a medical device manufacturer's compliance with the FDA's PMA process will preempt state law tort claims brought with respect to that approved device and relating to safety, effectiveness or other MDA requirements when the substantive requirements imposed by those claims potentially conflict with PMA approval"); Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997) (concluding that "the premarket approval process constitutes a specific federal interest as contemplated by Medtronic and that, therefore, the FDA approval served to impose strict FDA requirements"); Papike, 107 F.3d at 742 (summarizing that "preemption is triggered by and `the scope of preemption is limited to instances where there are specific FDA requirements applicable to particular device'"). But see Brooks v. Howmedica, Inc., 275 F.3d 785, 796 (8th Cir. 2001) (citingGoodlin with approval); Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1376 (11th Cir. 1999) (finding no preemption where the FDA's approval of a device "neither reveal[ed] or nor impose[d] any ascertainable substantive prerequisite for approval that could [be compared] to a purportedly conflicting state requirement").
Thus, to the extent that Plaintiff is bringing common-law tort claims that imposes a standard different from those imposed by FDA requirements, the Court is inclined to hold that those claims would be pre-empted./
However, this pre-emption extends only so far as the medical device manufacturer is actually subject to FDA requirements. If the medical device manufacturer alters its device without prior FDA approval, a tort suit challenging those modifications may not be preempted. See id. at 497 n. 16 (noting that the FDA "permits manufacturers of devices that have received PMA to make certain labeling, quality control, and manufacturing changes which would `enhance the safety of the device or the safety in the use of the device' without prior FDA approval").
The Ninth Circuit's decision in Papike supports the conclusion that the MDA would preempt some tort claims against the particular devices at issue in this case. In Papike, the Ninth Circuit held that the plaintiff's failure to warn claim was preempted by § 360k(a). 107 F.3d at 738. The Ninth Circuit so held because the key FDA regulations focused specifically on the medical device at issue in the case and provided the specific content of the required warning. Id. at 740.
B. Negligence due to a failure to follow federal requirements
While the MDA may preempt many state common-law claims against medical device manufacturers, it does not preempt tort suits that, in effect, enforce federal requirements.
In Medtronic, the Supreme Court unanimously held that claims of negligence based on a manufacturer's failure to follow federal requirements (i.e., negligence per se) are not pre-empted because they do not impose a legal standard "different from, or in addition to" federal requirements. Id. at 494-95. That is, "[t]he presence of a damages remedy does not amount to the additional or different `requirement' that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing `requirements' under federal law." Id. at 495. See id. at 513 (O'Connor, J., concurring in part and dissenting in part) (agreeing that suits based on violations of federal requirements are not preempted because these claims do "not impose a requirement that is `different from, or in addition to,' requirements under federal law" and only "give manufacturers an additional cause to comply"); see also Kemp v. Medtronic, Inc., 231 F.3d 216, 230 (6th Cir. 2000) (holding that "a claim premised on the violation of FDA requirements established for a Class III device through the PMA process is not automatically preempted").
Thus, to the extent that Plaintiff is bringing a negligence claim based on Defendant's failure to comply with existing federal requirements, Plaintiff's negligence claims are not pre-empted.
CONCLUSION
For the foregoing reasons, the Court is inclined to GRANT, in part, and DENY, in part, Defendant's Motion for Summary Judgment.
The Court does not believe that Defendant's pre-emption arguments would affect Plaintiff's intentional tort claim.Medtronic addressed various negligence and product liability theories rather than intentional torts.