Opinion
No. 97-CV-363-K.
September 30, 1999.
Terry W. West, J. David Cawthon, Bradley C. West, West Law Firm, Shawnee, OK, for the plaintiff.
Richard Mark Eldridge, Thomas E. Steichen, Rhodes, Hieronymus, Jones, Tucker Gable, Tulsa, OK, James B. Irwin, Sally I. Gaden, Kim E. Moore, Brian P. Quirk, Montgomery, Barnett, Brown, Read, Hammond Mintz, LLP, New Orleans, LA, for the defendant.
ORDER
Before the Court is the motion of the defendant for summary judgment against plaintiff Thomas Measles ("Measles"). Measles brings this action because back surgery was performed on him in 1993 utilizing components from the Rogozinski Spinal Rod System, manufactured by defendant. Measles contends that he has suffered adverse health consequences since the insertion of the Rogozinski System. In his response to the present motion, Measles withdraws his manufacturing and design defect claims and his breach of warranty claims (Response at 4 n. 1). He now asserts the following claims: (1) negligence because defendant unreasonably promoted a medical device that had not been scientifically proven safe and effective and which is dangerous to the implantee; (2) negligence per se in violating Food and Drug Administration ("FDA") requirements regarding the promotion and marketing of the medical device;. (3) fraud in engaging in deceptive conduct with the intention that a person in the position of the plaintiff be the recipient of the results of such conduct.
The Court construes the factual record and the reasonable inferences therefrom in the light most favorable to the party opposing summary judgment. See Byers v. City of Albuquerque, 150 F.3d 1271, 1274 (10th Cir. 1998). Summary judgment is appropriate if the record shows "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." Rule 56(c) F.R.Cv.P. An issue of material fact is genuine only if a party presents facts sufficient to show that a reasonable jury could find in favor of the nonmovant. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
Defendant argues that it is entitled to summary judgment as to Measles' negligence claim because he has offered no medical testimony to support a claim that the implanted device failed or in some way failed to perform as intended by his surgeon. Plaintiff's medical causation expert, Dr. Lance Yarus, did not examine Measles. Yarus' report consists of stating that he had examined some of Measles' medical records, including his records at St. Francis Hospital during the surgical stay. The report closes with the unadorned conclusions that (1) it is Yarus' opinion "to a reasonable degree of medical certainty that the pain and discomfort that Mr. Measles has experienced is directly causally related to the implantation of metallic devices for lumbar spine diagnosis as indicated in the record" and (2) it is Yarus' opinion "to a high degree of medical certainty that his continuing impairment and disability persist on the basis of the implanted metallic devices utilized in the treatment of his spinal condition." (Defendant's Exhibit T). No evidence supporting these conclusions appears in the record. Dr. John Dewitt, who did perform a physical examination of Measles, concluded that "I do not find anything on his neurological physical examination that I would not expect to see in someone who has had a lumbar fusion." (Defendant's Exhibit J).
Moreover, Dr. Yams has been presented as a medical expert in other litigation of this type, and so far as this Court can determine, it has been uniformly rejected. In McCollin v. Synthes Inc., 50 F. Supp.2d 1119 (D.Utah 1999), the district court examined a record similar to the one before this Court, and concluded "[i]t is clear that Dr. Yarus's method for formulating his opinion falls far short of the requirements the Supreme Court established in [Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)]." 50 F. Supp.2d at 1127. The court went on to cite other opinions where Dr. Yarus' testimony had been held inadmissible.Id. at 1127-28. In a negligence action pursuant to Oklahoma law, "[w]hile absolute certainty is not required, mere possibility of causation is insufficient." Hardy v. Southwestern Bell Telephone Co., 910 P.2d 1024, 1027 (Okla. 1996). This Court concludes summary judgment is appropriate as to Measles' negligence claim.
A statute's violation is deemed negligence per se if the claimed injury (a) was caused by the law's violation, (b) was of the type intended to be prevented by the statute, and (c) the injured party was a member of the class meant to be protected by the statute. Lockhart v. Loosen, 943 P.2d 1074, 1078 (Okla. 1997). In the case at bar, Measles attempts to assert a claim of negligence per se based upon defendant's alleged violation of FDA regulations. Such a theory has been advanced in other litigation of this type, and has been rejected. First, the Food, Drug and Cosmetic Act ("FDCA") does not create a private right of action, 21 U.S.C. § 337(a). Second, the administrative requirement that a given device be approved by the FDA before being marketed lacks any independent substantive content and "does not impose a standard of care, the breach of which could form the basis of a negligence per se claim." Talley v. Danek Medical, Inc., 179 F.3d 154, 161 (4th Cir. 1999) (pedicle screw litigation). Finally, as in Talley, Measles has failed to present evidence that the breach of the FDA approval requirement proximately caused any failure of the device or injury. Id. This Court deems summary judgment appropriate as to the negligence per se claim as well.
Finally, Measles seeks recovery based upon defendant's alleged fraudulent misrepresentations to the FDA as to the type of device the Rogozinski System was and in promoting the device's use after having been told by the FDA that such action was a violation of regulations. As to the so-called "fraud on the FDA" claim, even assuming such a claim is theoretically valid, a plaintiff must "show that [the manufacturer's] submissions to the FDA caused [plaintiff's doctor] to choose the [device], and to show it caused him injury according to [state] tort law." McCollum, 50 F. Supp.2d at 1128. As to any improper promotion of the device, again plaintiff would be required to demonstrate reliance. Dr. Hayes, the implanting surgeon, denies any such reliance in his affidavit (Defendant's Exhibit A). Again, plaintiff's claim fails. Some motions in limine remain pending, It is unclear if defendant intends to assert these as to any other plaintiff. Also, the factual posture may have changed since the motions were filed some months ago. The Court elects to declare the motions moot. Defendant may reurge them if necessary at a later time.
It is the Order of the Court that the motion of the defendant for summary judgment (#15) against plaintiff Thomas Measles is hereby GRANTED. The motion of the defendant to exclude or limit testimony of Norman Welford (#12), the motion of the defendant to exclude or limit testimony of Lance Yarus (#16) and the motion of the defendant to exclude testimony of Harold Alexander (#19) are hereby DENIED as moot.
SO ORDERED THIS 30 DAY OF SEPTEMBER, 1999.
TERRY C. KERN, CHIEF UNITED STATES DISTRICT JUDGE