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granting motion for summary judgment in favor of defendants because Florida law does not recognize a negligence per se claim based on a violation of FDCA
Summary of this case from Metz v. Wyeth, LLCOpinion
Case No. 95-14293-CIV-PAINE
April 16, 1999
OMNIBUS ORDER
THIS CAUSE comes before the Court upon the following motions: (1) Defendants' Motion for Final Summary Judgment (D.E. 64); (2) "Defendants' Motion to Preclude Testimony of Harold Alexander, Ph.D., and to Strike Portions of His June 16, 1998, Report" (D.E. 70); (3) Plaintiffs' Motion to Reinstate Their Claim of "Fraud on the Food and Drug Administration" (D.E. 108); (4) Defendants' Motion to Exclude Plaintiffs' "Expert" Witnesses on Conspiracy and/or FDA Regulations (D.E. 45); (5) Defendants' Request for Oral Argument on Motion for Final Summary Judgment (D.E. 63); (6) four motions for extensions of time by Plaintiffs (D.E.s 72, 75, 77 and 96); (7) a motion for extension of time by Defendants (D.E. 102); (8) motions for leave to exceed page limitations by Plaintiffs and Defendants (D.E.s 98 and 105); and (9) two motions regarding the scheduling of various pretrial deadlines (D.E.s 21, 22).
For the reasons set forth below, partial summary judgment will be granted; the disputes regarding the various experts' testimony will be resolved only to the extent required for summary judgment purposes; rulings on the other aspects of those motions will be reserved until trial; the fraud on the Food and Drug Administration (WFDAII) claim will not be reinstated; the remaining procedural motions will be disposed of in summary fashion at the end of this Order; and the parties will be required to submit an updated scheduling report and proposed scheduling order in order to facilitate the scheduling of trial and pre-trial deadlines.
PROCEDURAL BACKGROUND
On or about October 23, 1995, Plaintiffs Nancy Stevens ("Stevens") and Mark Stevens (collectively, "the plaintiffs"), filed the instant ten-count complaint against, among others, Defendants Danek Medical, Inc., Sofamor Danek Group, Inc., Warsaw Orthopedic, and Sofamor, Inc. (collectively, "the Danek defendants"). Thereafter, this and thousands of other similar cases where consolidated by the Judicial Panel on Multidistrict Litigation and transferred to the United States District Court for the Eastern District of Pennsylvania ("MDL 1014" or the "MDL litigation") for resolution of certain issues common to all claims. The Honorable Louis C. Bechtle presided over the MDL litigation. Judge Bechtle made several preliminary rulings and then remanded the cases to the federal district courts in which they were originally filed for determinations involving application of state law. Currently, as outlined above, this Court addresses the parties' various pending motions.
As will be discussed further in Section I.A. of this Order, infra, what are considered "the facts at this stage may not turn out to be the actual facts if the case goes to trial, but these are the facts for summary judgment purposes." Cottrell v. Caldwell, 85 F.3d 1480, 1486 (11th Cir. 1996).
The instant lawsuit concerns the marketing, promotion and eventual application of the Danek defendants' TSRH Pedicle Screw Fixation System ("the TSRH System"). The TSRH System is an internal fixation device used to hold the spine in place to increase the chances of a successful solid bony fusion of the vertebrae. In the instant case, the TSRH System was implanted in the lumbar pedicles of Stevens' spine, an application not then approved by the Food and Drug Administration ("FDA"). Stevens claims that (1) her injuries were caused by the negligent design, manufacture and inspection by the Danek defendants; (2) the defendants acted negligently in failing to provide adequate warnings to physicians and patients; and (3) the TSRH System was fraudulently marketed and promoted to surgeons across the country, by advertising the system as suitable for use in pedicles (posterior portions of the spine) and opposed to the FDA approved uses in the sacrum, ilium and anterior portions of the spine.
Marketing of the TBRH System
According to the plaintiffs, the Danek defendants planned to market the TSRH System for pedicular use, even as they were representing to the FDA that the TSRH System would only be marketed for use in the sacrum, ilium and anterior portions of the spine. Indeed, the FDA's approval of "the TSRH System was conditioned on two restrictions: (1) that the device not be labeled or promoted for pedicular attachment to, or fixation of, the spine; and (2) that all labeling for the device prominently state that the device is intended for sacral-iliac attachment only and include the statement: "WARNING — THIS DEVICE HAS NOT BEEN APPROVED FOR PEDICULAR APPLICATION" (emphasis in original). The plaintiffs further assert that notwithstanding this directive, the Danek defendants failed to include the required warning in the TSRH System labels.
Furthermore, the plaintiffs allege that the Danek defendants engaged in an elaborate marketing campaign to promote the use of the TSRH System as the "standard of care" for pedicular bone fusion surgery. This alleged campaign apparently included seminars at which physicians were introduced to the TSRH System. The plaintiffs further claim that these marketing efforts were among the ways in which Stevens' treating physicians learned of the TSRH System and its pedicular application.
Stevens' Use of the TSRH System
It is undisputed that Stevens' history of back problems significantly predates her use of the TSRH System. In 1976, Stevens was diagnosed with scohosis. Deposition of Nancy Stevens, pp. 71, 74. As a result of that diagnosis, Stevens underwent back surgery to place a metal rod down the length of her spine. Id. at 73-74. For the following sixteen years, Stevens apparently suffered constant but tolerable pain. Id. at 78.
Neither that surgery nor the implanted rod is a subject of this lawsuit.
On April 26, 1992, Stevens was working her regular job at the concessions stand at the Ft. Peirce jai-alai fronton when her back "gave out," causing her "excruciating" pain. Id. at 23-25. This pain continued unabated until September 1992, when she decided to undergo treatment to relieve the pain. Id. at 88, 99.
On September 3, 1992, Stevens visited Dr. Michael MacMillan, a board certified orthopedic surgeon, who was on the faculty of the University of Florida Department of Orthopedics in Gainesville, Florida. Deposition of Michael MacMillan. M.D., p. 7. During this initial visit, Stevens was diagnosed with spondylolisthesis at the L5-S1 level of her spine, spondylosis, and a non-union between the L3-L4 vertebrae. Based on this diagnosis, Dr. MacMillan recommended that Stevens undergo a surgical procedure to (1) remove the existing rod; (2) fuse her vertebrae; and (3) stabilize her spine using orthopedic bone screws from the TSRH System.Id. at 19-20.
Spondylolisthesis is a forward displacement of one vertebra over another. Dorland's Illustrated Medical Dictionary, 24th Ed.
Spondylosis is a degenerative condition of the spine. Dorland's Illustrated Medical Dictionary, 24th Ed.
A non-union is a false joint resulting from a failed fusion. Dorland's illustrated Medical Dictionary, 24th Ed.
Although Dr. MacMillan informed Stevens of the general risks of surgery, apparently he never informed her of the risks and consequences of her use of the TSRH System. Stevens Depo., pp. 96, 99. Nor was she informed that the FDA disapproved the labeling and marketing of TSRH System for pedicle implantation. Id. at 97. Indeed, MacMillan testified that he, himself, was unaware of such FDA disapproval. MacMillan Depo., p. 29.
On September 28, 1992, Dr. McMillan surgically implanted the TSRH System bone screws into Stevens' lower spine. September 28, 1992. Operative Report. In the months following the implantation surgery, Stevens' experienced some degree of relief from her back pain. Stevens Depo., pp. 104-05. However, in June 1993, approximately eight months after the implantation surgery, Stevens' pain returned. Stevens' Depo., pp. 110-11. An x-ray showed that one of the screws inserted into Stevens' S1 pedicle had fractured. July 6, 1993. Office Notes.
Thereafter, on August 23, 1993, Stevens underwent a second surgery involving the TSRH System. Request for Hospital Services and Physicians' Orders; August 23, 1993, Operative Report. During the second surgery, Dr. MacMillan replaced the broken screw and once again attempted to fuse portions to Stevens' spine. Id. In the months following this surgery, Stevens continued to suffer "sharp" back pain. Stevens' Depo., p. 121-22. In this period, she was referred to Dr. Jeffrey Fernyhough for continued care. See April 19, 1994, Letter from Dr. Fernyhough to Dr. Sullivan.
The fusion attempted with the first surgery had proven unsuccessful. Id.
Upon examining Stevens, Dr. Fernyhough found that her lumbar flexion and extension had decreased considerably since her implantation surgery.Id. Dr. Fernyhough's diagnostic studies also indicated that a lower cross link of the TSRH System was loose and that a lock nut from a cross link was missing. Id. Dr. Fernyhough further found evidence of yet another failed fusion at various levels of Stevens' spine. Id. As a result, he recommended surgery to correct these failures. Id.
On July 18, 1994, Stevens underwent explantation of the original TSRH System; implantation of a new TSRH System; and refusion of her L5-S1 vertebrae. July 18, 1994, Operative Report. Although Stevens' pain improved for a few months after this surgery, ultimately, it returned "with great force." Stevens Depo., p. 136.
Over at least three successive visits, Dr. Fernyhough found that one of the S1 screws had broached the outer cortex of Stevens' pedicle (February 9, 1995. Office Notes), and that Stevens' pain was probably hardware related. See July 17, 1996, Office Notes; June 7, 1996, Office Notes. Upon making such diagnosis, Dr. Fernyhough recommended another surgery to explant the TSRH System. Id.
On August 7, 1996, Stevens underwent a fourth surgery, to explant the TSRH System. In his surgery notes, Dr. Fernyhough observed that the fusion attempted in Steven's third surgery had occurred at all levels.July 17, 1996, Operative Report. Thereafter, Dr. Fernyhough reevaluated these observations and noted that fusion had, in fact, not been successful at all levels. May 20, 1997, Letter from Dr. Fernvhough to Dr. Sullivan. Stevens asserts that she continues to suffer severe back and leg pain. Stevens Depo., pp. 59-60, 140, 142, 145. Her husband and coplaintiff, Mark Stevens, asserts that before undergoing the four TSRH System surgeries Stevens "could sit . . . and have her children on her lap. She could pick them up and give them a hug. She could walk across the room without being bent over. She could walk for a little bit . . . Without being uncomfortable and having to sit down to take a break because she is in so much pain." August 22, 1997, Deposition of Mark Stevens, p. 25.
DISCUSSION
I. Motion for Summary Judgment
"In their response to the motion for summary judgment, the plaintiffs concede that summary judgment is appropriate with respect to Count II (Civil Conspiracy), Count III (Concert of Action), and Count IX (Breach of Warranty). Therefore, as to these counts, the motion for summary judgment will be granted without further discussion.
A. Standard of Review
In deciding a summary judgment motion, a court must apply the standard stated in Fed.R.Civ.P. 56(c):
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 applying this standard, the Eleventh Circuit has stated that:
The party seeking summary judgment bears the exacting burden of demonstrating that there is no genuine dispute as to any material fact in the case. In assessing whether the movant has met this burden, the courts should view the evidence and all factual inferences therefrom in the light most favorable to the party opposing the motion. All reasonable doubts about the facts should be resolved in favor of the non-movant.Clemons v. Dougherty County, Ga., 684 F.2d 1365, 1368-69 (11th Cir. 1982) (citations omitted); see also Tisdale v. United States, 62 F.3d 1367, 1370 (11th Cir. 1995). Moreover, "the party opposing the motion for summary judgment bears the burden of responding only after the moving party has met its burden of coming forward with proof of the absence of any genuine issues of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986).
The United States Supreme Court has provided significant additional guidance as to the evidentiary standard which trial courts should apply in ruling on a motion for summary judgment:
[The summary judgment] standard mirrors the standard for a directed verdict under Federal Rule of Civil Procedure 50(a), which is that the trial judge must direct a verdict if, under the governing law, there can be but one reasonable conclusion as to the verdict. Brady v. Southern R. Co., 320 U.S. 476, 479-480 (1943).Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250 (1986). The Court inAnderson further stated that "[t]he mere existence of a scintilla of evidence in support of the position will be insufficient; there must be evidence on which the jury could reasonably find for the [non-movant]."Id. at 252.
B. Fraudulent Marketing/promotion — Count IV
The Danek defendants seek summary judgment as to this count on two grounds. First, they assert that Florida does not recognize a claim for fraudulent marketing. Second, they argue that, even if the cause of action were recognized, it must fail because Stevens failed to demonstrate that she relied upon a misrepresentation.
1. The Claim is Recognized Under Florida Lair
Florida law provides a private cause of action for fraudulent advertising and marketing. Fla. Stat. §§ 817.40(5), 817.41(1). Moreover, at least one Florida court has held that a plaintiff need not specify that the claim arises under these statutes when pleading it. Vance v. Indian River Hammock Runt Riding Club, Ltd., 403 So.2d 1367, 1369 (Fla. 4th DCA 1981). Therefore, as to the Danek defendants' first argument, the motion for summary judgment will be denied. Accordingly, the Court will now address the Danek Defendants' second issue.
The statutes were enacted as parts of the same act and are intended to be read together. Major v. State, 180 So.2d 335 (Fla. 1965).
2. Reliance upon a Misrepresentation
In order to recover for fraud, Florida law requires Stevens to prove, among other things, that she reasonably relied on a misrepresentation by the Danek defendants. See Kramer v. Unitas, 831 F.2d 994, 998 (11th Cir. 1987). The Danek defendants assert that they are entitled to summary judgment on this issue because Stevens is unable to show that her decisions to undergo surgery were influenced by representations made by any Danek defendant. The defendants are correct in that it is undisputed that Stevens testified that she never (1) spoke to a representative of one of the Danek defendants, or (2) read or even saw anything from the Danek defendants. Stevens Depo., pp. 132-33. Never-the-less, the defendants' argument fails because in Florida, generally, a patient can maintain an action in fraud against a manufacturer when that manufacture makes a misrepresentation to her physician. Albertson v. Richardson-Merrell, Inc., 441 So.2d 1146 (Fla. 4th DCA 1983).
In the instant case, based on the express limitations on the FDA's approval of the TSRH System and the Danek defendants' apparent promotion of that System for an unapproved use as the "standard of care," a reasonable jury could find that the defendants' alleged failure to disclose the express limitations on FDA approval was a misrepresentation by omission. Therefore, Stevens has met her burden of raising a triable issue of fact as to alleged false representations made to and relied upon by Drs. MacMillan and Fernyhough. Accordingly, as to Count IV, the motion for summary judgment must be denied.
With regard to the issue of reliance, the Danek defendants assert that the two physicians' advice to Stevens regarding the implantation of the TSRH System based on their medical knowledge and experience rather than the result of their attendance at a seminar or group of seminars. However, in the MDL proceedings, Judge Bechtle had occasion to consider the relevance of such assertions. Judge Bechtle ruled that "[t]he fact that a surgeon attended a seminar, learned techniques for pedicle screw fixation at the seminar and later performed pedicle screw fixation utilizing those techniques is a basis upon which a jury could find that a particular implanting surgeon relied upon information provided at or through those seminars in making the determination to implant bone screws in the pedicles of the patient's spine." In re: Orthopedic Bone Screw Products Liability Litigation, MDL Docket No. 1014 (E.D. Pa. Aug. 13, 1998) (PTO No. 1543). This Court agrees with Judge Bechtle's assessment. Accordingly, the issue of reliance upon alleged misrepresentations is one that must be resolved by a jury.
C. Negligent Misrepresentation Under Restatement (Second) of Torts § 402B — Count V
Although the plaintiffs acknowledge that no Florida court has ever adopted Restatement (Second) of Torts § 402B, they never-the-less, urge this Court to apply it in this case. The Court declines to do so.
Under Erie R.R. Co. v. Tompkins, 304 U.S. 64 (1938), a federal court sitting in diversity must apply the substantive law of the forum state.Id. at 78. The Supreme Court has further held that in a diversity case, a federal district court is "not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits." Day Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975).
In accordance with these principles, this Court will not permit the plaintiffs to assign liability on a theory never before recognized under Florida law. Therefore, as to Count V, the motion for summary judgment will be granted.
D. Products Liability Claims — Counts VI, VII and VIII
1. Count VII — Liability Per Se
In Count VII, the plaintiffs attempt to assert a cause of action for liability per se based on the Danek defendants' alleged violation of the Food Drug and Cosmetics Act ("FDCA"), 21 U.S.C. § 301. Private claims asserting FDCA violations are expressly prohibited by the FDCA itself. 21 U.S.C. § 337 (a); Medtronic, Inc. v. Lohr, 518 U.S. 470, 487 (1996) ("[T]here is no explicit private cause of action against manufacturers contained in the [Medical Device Amendments to the FDCAJ, and no suggestion that the Act created an implied right of action."). Moreover, Florida courts have refused to recognize a private right of action for negligence per se based on an alleged violation of a federal statute that does not provide for a private right of action. See Jupiter Inlet Corp. v. Brocard, 546 So.2d 1, 2-3 (Fla. 4th DCA 1998) (OSHA does not provide a basis for a private right of action and violations do not constitute negligence per se).
In Murthy v. N. Sinha Corp., 644 So.2d 983, 985 (Fla. 1994), the Florida Supreme Court held that a court should look to the legislative intent of a statute to determine whether a claim for negligence per se should lie. Because the statute in Murthy displayed "no evidence in the language or the legislative history of a legislative intent to create a private remedy," the Florida Supreme Court affirmed the dismissal of the plaintiff's negligence per se claim. Id. at 986-87. Murthy is the authoritative Florida statement of negligence per se and, therefore, because the FDCA expressly precludes a private right of action, the motion for summary judgement will be granted as to Count VII.
2. Counts VI (Strict Liability) and VIII (Negligence)
The motion for summary judgment raises similar issues with respect to these two counts. Specifically, the Danek defendants contend that they are entitled to summary judgment as to both of these counts because the plaintiffs have not proffered competent evidence of (1) a defect in the TSRH System or (2) that such an alleged defect caused the injuries of which Stevens complains. Therefore, in the interests of clarity and brevity, the Court will address Counts VI and VIII simultaneously.
a. Defect
The plaintiffs assert that the Danek System has three types of defects: (1) defective design; (2) defective manufacture and inspection; and (3) a failure to provide adequate warnings. The Danek defendants contend that they are entitled to summary judgment as to each of these claims because the plaintiffs failed to offer competent evidence of any such defects.
The Danek Defendants further assert that, as to the alleged failure to warn, they are also insulated from liability because of the "learned intermediary" doctrine. However, when, as alleged here, a manufacturer withholds negative information about Its product and a physician relies on the manufacturer's literature in forming an opinion about the product's risks, then the manufacturer must meet a heightened evidentiary standard in order to show that the physician was "an intermediary sufficiently informed to interrupt the causal link of liability between the manufacturer and the plaintiff." Zanzuri v. G.D. Scarle Co., 748 F. Supp. 1511, 1518 (S.D. Fla. 1990).
In the instant case, the plaintiffs make sufficient allegations that the Danek defendants misled the medical community, including Stevens' physicians, regarding the risks associated with the TSRH System. Therefore, there is a jury question on the issue of whether or not the Danek defendants should be insulated from liability on the basis of the "learned intermediary" doctrine. See also the discussion contained in foot note 7, supra.
Upon an extensive review of the record and the law, the Court finds that the plaintiffs have adduced sufficient evidence to preclude summary judgment on the issue of alleged defects in the TSRH System. Through the testimony of various experts, the plaintiffs have adduced evidence to the effect that the TSRH System "Contains design defects," that the system was "not adequately tested," that "no tests supported the use and efficacy of pedicle screw fixation systems," and that tests found the opposite to be true — that the system "provided absolutely no benefit to patients." The plaintiffs have also raised triable issues with regard to the adequacy of the warnings on the TSRH System. Therefore, as to this issue, the motion for summary judgment must be denied. Accordingly, the Court now turns to the issue of causation.
The plaintiffs have submitted expert testimony on the issue of defects from Drs. Kimmel, Welford and Alexander. The Danek "defendants have filed motions to preclude at least some testimony from these experts as well as that of Frank Sloan, Ph.D. and David Helfry, Esq. To the extent that the motions seek to exclude these experts for being disclosed in an untimely fashion, the motions are denied. As to the other issues raised in the motions, the Court reserves judgment until the time of trial.
b. Causation
The Danek defendants assert that the plaintiffs have failed to offer competent evidence that the alleged defects in the TSRH System caused the injuries of which Stevens complains. The Court disagrees.
According to the plaintiffs' causation expert, Dr. Jack Moshein, the TSRH System "has create a lot of problems for (Stevens]. Mostly back pain and the irritation of her right S1 nerve root, it would appear from the broken screw." August 21, 1998 Deposition of Jack Moshein, M.D., pp. 44-45. "That necessitated another operation." Moshein Depo., p. 43. Indeed, even Stevens' implanting physicians, Drs. MacMillan and Fernyhough, acknowledged the TSRH System's malfunction and Stevens' ensuing pain. See MacMillan Depo., pp. 98-99; July 19, 1993, Letter from Dr. MacMillan; August 18, 1993, Office Note; July 18, 1994, Operative Report. Accordingly, the Court finds that the plaintiffs have raised a material question of fact as to the issue of causation. Therefore, the motion for summary judgment must be denied as to Counts VI and VIII.
The plaintiffs also proffer the opinions of Dr. Alexander in support of their causation arguments. However, Judge Bechtle addressed Dr. Alexander's qualifications as an expert in Order No. 725 in the MDL litigation, and ruled that Dr. Alexander was qualified to testify only with regard to "the field of orthopedic bioengineering (biomechanics, biomaterials, biomedical engineering, and design and analysis of device research)." In re: Orthopedic Bone Screw Products Liability Litigation, MDL Docket No. 1014 (E.D. Pa. Jan. 21, 1997) (PTO No. 725). Therefore, in accordance with that ruling, this Court declines to rely on Dr. Alexander's opinions regarding causation.
E. Loss of Consortium — Count X
The Danek defendants' only grounds for summary judgment on this claim is that all of the other claims have failed. However, this Court declined to enter summary judgment on at least one of the plaintiffs' other claims. Therefore, summary judgment cannot be entered on those grounds. Accordingly, the motion will be denied as to Count X.
It is undisputed that Count X, for loss of consortium, is a derivative claim. See Gates v. Foley, 247 So.2d 40, 45 (Fla. 1971).
II Motion to Reinstate Count I — Fraud on the FDA
The plaintiffs seek to reinstate a fraud on the FDA claim that alleges, in essence, that the Danek defendants submitted fraudulent information to the FDA that enabled them to obtain clearance for marketing of the TSRH System for use in the sacrum, ilium and anterior portions of the spine. In the MDL litigation, Judge Bechtle dismissed this claim as preempted by the FDCA. See PTO Nos. 12 and 84.
This dismissal was not appealed. However, Judge Bechtle's dismissal of a similar claim against Buckman Company, another defendant, (PTO No. 900) was appealed to and reversed by the Third Circuit Court of Appeals. See In re: Bone Screw Products Liability Litigation, 159 F.3d 817 (3rd Cir. 1998) ("Buckman"). In Buckman, the Third Circuit held that the FDCA did not preempt states from allowing claims of fraud on the FDA. Id. at 823-26.
Currently, the plaintiffs assert that in light of Buckman, the Court must reinstate their fraud on the FDA claim. The Court declines to do so because Buckman is not the law of the case and is contrary to binding Eleventh Circuit precedent.
A. Law of the Case
The plaintiffs assert that Buckman is binding on this Court as the law of the case. In support of this argument they cite to many cases that provide that in MDL cases, such as this one, rulings by the appellate court embracing the transferee district constitute controlling authority with respect to each case that has been transferred or consolidated for coordinated pretrial proceedings pursuant to 28 U.S.C. § 1407. See In re: TMJ Implants Products Liability Litigation, 97 F.3d 1050, 1055 (8th Cir. 1996); In re: Food Lion, Inc. Fair Labor Standards Act "Effective Scheduling" Litigation, 73 F.3d 528, 532-33 (4th Cir. 1996); FMC Corp. v. Goluster Enginerring Co., 830 F.2d 770, 771-7 (7th Cir. 1987). However, those cases may be distinguished from the instant case for two reasons. First, unlike those cases, this case involves a decision made following remand. Once remand has taken place, any MDL jurisdiction that might have supported law of the case no longer exists. See In re: Upjohn Co. Antibiotic "Cleocin" Products Liability Litigation, 508 F. Supp. 1020, 1021 (E.D. Mich. 1981); Manual for Complex Litigation 3d § 31.133, at 255 (1995).
Second, and more fundamentally, the Danek defendants were not parties to the Buckman appeal. Law of the case does not apply to non-parties who have not had their day in court. 4A Wright Miller, Federal Practice Procedure, § 4478, at 832 (Supp. 1998); see In re: DG Acquisition Corp., 151 F.3d 75, 86 (2nd Cir. 1998) ("[w]here there has been no review even though appeal has been taken, it is equivalent to the party not having had an opportunity to appeal, and prevents the challenged decision from becoming law of the case").
The Danek defendants appeared only as amicus curiae in Buckman. See 159 F.3d at 821 n. 3. "[T]he filing of an amicus brief has never been enough to bind a non-party to the result of a proceeding." Munoz v. County of Imperial, 667 F.2d 811, 816 (9th Cir. 1982). Therefore, Buckman is not law of the case.
B. Binding Eleventh Circuit Precedent
The Eleventh Circuit Court of Appeals recently stated that allegations attacking the submissions upon which federal administrative decisions are made as "fraudulent" are preempted because those claims inherently conflict with whatever agency action they seek to invalidate. See Lewis v. Brunswick Corp., 107 F.3d 1494 (11th Cir. 1997), cert. dismissed, 118 S.Ct. 1793 (1998). In Lewis, the court held that "fundamental systemic reasons" barred a claim that the defendant had fraudulently misled the Coast Guard about the safety of boat propeller guards:
Regulatory fraud claims of this nature are impliedly preempted for fundamental, systemic reasons. Permitting such claims would allow juries to second-guess federal agency regulators through the guise of punishing those whose actions are deemed to have interfered with the "proper functioning of the regulatory process. If that were permitted, federal regulatory decisions that Congress intended to be dispositive would merely be the first round of decision making, with later more important rounds to be played out in the various state courts. Virtually any federal agency decision that stood in the way of a lawsuit could be challenged indirectly by a claim that the industry involved had misrepresented the relevant data or had otherwise managed to skew the regulatory result. . . . Congress could not have intended for the process it so carefully put in place to be so easily and thoroughly undermined.Lewis, 107 F.3d at 1505 (footnote omitted).
The Concerns expressed in Lewis are the same as those raised by the instant fraud on the FDA claim. Moreover, Lewis is not the only Eleventh Circuit authority on point. In Papas v. Upjohn Co., 985 F.2d 516 (11th Cir. 1993), the Eleventh Circuit held that allegations of fraud committed against the Environmental Protection Agency were preempted. Papas, 985 F.2d at 518-19. Other courts of appeals that have considered whether agency-fraud claims are preempted agree with Lewis and Papas, including the Fifth Circuit, which examined the issue in the connection with this Bone Screw litigation. In Reeves v. AcroMed Corp., 44 F.3d 300 (5th Cir.), cert. denied, 515 U.S. 1104 (1995), the court recognized fraud on the FDA as a "collateral attack on the FDA's original determination" that was preempted because such claims would permit "states to impose conflicting requirements on medical device manufacturers." Reeves, 44 F.3d at 307 (citation omitted). Accord Mitchell v. Collagen Corp., 126 F.3d 902, 914 (7th Cir.) (fraud on the FDA claim preempted), cert. denied, 118 S.Ct. 1300 (1998). Therefore, under binding Eleventh Circuit law, the plaintiffs' claim of fraud on the FDA is preempted. Accordingly, the plaintiffs' motion to reinstate their claim of fraud on the FDA will be denied.
CONCLUSION
In light of the foregoing, it is hereby
ORDERED AND ADJUDGED as follows:
1. Defendants' Motion for Final Summary Judgment (D.E. 64) is GRANTED IN PANT. The motion is granted to the extent that SUMMARY JUDGMENT IS ENTERED in favor of the defendants as to Counts II, III, V, VII and IX. The motion is denied in all other respects.
2. Defendants' Request for Oral Argument on Motion for Final Summary Judgment (D.E. 63) is DENIED as moot;
3. Defendants' Motion to Preclude Testimony of Harold Alexander, Ph.D., and to Strike Portions of His June 16, 1998, Report (D.E. 70) is GRANTED IN PANT, in accordance with footnote 10, supra, resolution of the remaining portions of that motion is deferred until trial;
4. Plaintiffs' Motion to Reinstate Their Claim of "Fraud on the Food and Drug Administration" (D.E. 108) is DENIED;
5. Defendants' Motion to Exclude Plaintiffs' "Expert" Witnesses on Conspiracy and/or FDA Regulations (D.E. 45) is deferred until trial.
6. The Plaintiffs' four motions for extensions of time (D.E.s 72, 75, 77 and 96) are GRANTED nunc pro tunc;
7. The Defendants' motion for extension of time (D.E. 102) is GRANTED nunc pro tunc;
8. The Parties' motions for leave to exceed page limitations (D.E.s 98 and 105) are GRANTED;
9. Plaintiff's Motion for Expedited Discovery Track (D.E. 21) is DENIED as moot;
10. The Parties' Joint Motion for Agreed Scheduling Order (D.E. 22) is DENIED as moot; and
11. Within twenty (20) days of the date of this Order the parties SHALL file an updated scheduling report and proposed scheduling order.