Driggers v. Sofamor, S.N.C.

• Court: U.S. District Court — Middle District of North Carolina
• Writing for the Court: Tilley
• Citation: Driggers v. Sofamor, S.N.C., 44 F.Supp.2d 760 (M.D. N.C. 1998)
• Decision Date: 31 December 1998
• Docket Number: No. 4:95CV00750.,4:95CV00750.
• Parties: Alexander DRIGGERS, and wife, Margie Ann Driggers, Plaintiffs, v. SOFAMOR, S.N.C., F/K/A Sofamor, S.A.; Sofamor, Inc.; and Sofamor Danek Group, Inc., Defendants.

44 F.Supp.2d 760

Alexander DRIGGERS, and wife, Margie Ann Driggers, Plaintiffs, v. SOFAMOR, S.N.C., F/K/A Sofamor, S.A.; Sofamor, Inc.; and Sofamor Danek Group, Inc., Defendants.

No. 4:95CV00750.

United States District Court, M.D. North Carolina.

December 31, 1998.

Notice of Appeal Filed January 29, 1999.

William F. Horsley, Greensboro, NC, John J. Cummings, III, New Orleans, LA, Darryl J. Tschirn, La Jolla, CA, for plaintiff.

James Donald Cowan, Jr., Greensboro, NC, Stephen S. Phillips, Philadelphia, PA, for defendant.

MEMORANDUM OPINION

TILLEY, District Judge.

Plaintiffs Alexander and Margie Ann Driggers ("Driggers") filed a Complaint against the Defendants Sofamor, S.N.C., f/k/a Sofamor, S.A.; Sofamor, Inc.; and Sofamor Danek Group, Inc. ("Sofamor") asserting claims for (1) fraudulent marketing; (2) negligent misrepresentation; (3) strict liability; (4) negligence; (5) negligence per se; (6) breach of implied warranty; and (7) loss of consortium. Jurisdiction is vested in this Court pursuant to 28 U.S.C. § 1332. Because most of the claims are barred by the statute of limitations and because Driggers has failed to produce evidence of causation, Sofamor's Motion for Summary Judgment [Doc. # 33] as to all claims is GRANTED. As no claims remain, this case will be DISMISSED. Defendants' Motion to Exclude Testimony of Dr. William J. Mitchell [Doc. # 58] and Motion to Preclude or Limit Evidence [Doc. # 56] are DENIED AS MOOT.

I.

A moving party is entitled to summary judgment "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 genuine issue of material fact exists "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, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). In considering a motion for summary judgment, the court is required to view the facts and draw reasonable inferences in the light most favorable to the nonmoving party. Id. at 255, 106 S.Ct. 2505. The party seeking summary judgment has the initial burden to show absence of evidence to support the nonmoving party's case. Celotex Corp. v. Catrett, 477 U.S. 317, 325, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). If successful, the burden shifts and the opposing party must demonstrate that a triable issue of fact exists; he may not rest upon mere allegations or denials. Anderson, 477 U.S. at 248, 106 S.Ct. 2505.

The facts presented in the light most favorable towards Driggers are as follows. On November 7, 1970, Driggers fell at his workplace, which resulted in pain and back and leg injuries. (Driggers Dep. at 29; Mitchell Report at 1, Ex. 13, Pl.'s Opp'n Defs.' Mot. Summ. J. [Doc. # 45].) Over the next eleven years, Driggers underwent five surgical procedures including a posterior lumbar fusion in 1971; the removal of lumbar osteophytes in 1973; a sensory rhizotomy in 1976; a posterolateral lumbar fusion in 1980; and an anterior lumbar fusion at L5-S1 in 1981. (Mitchell Report at 2; Mitchell Dep. at 27-30; Beaver Dep. at 15; Urbaniak Dep. at 32-36.) In July 1985, Driggers was in an automobile accident and his physician, Dr. James Urbaniak, concluded that this accident caused a pseudoarthrosis, or a nonunion of the lumbar bone mass, from L5 to S1. (Urbaniak Dep. at 44; Mitchell Dep. at 31-32.)

On November 24, 1986, Dr. Urbaniak performed surgery on Driggers and attached the Cotrel-Dubousset System ("CD system") designed by Sofamor to L5 to S1 of Driggers' spine. (Urbaniak Dep. at 26, 50.) Dr. Urbaniak did not inform Driggers that the device had been implanted in his spine until the day after his surgery. (Driggers Dep. at 62-63; Urbaniak Dep. at 68.) Furthermore, Dr. Urbaniak did not warn Driggers of the risks associated with the CD system, nor did he tell Driggers that the device had not been approved by the FDA for pedicle use. (Id.)

According to Dr. William Mitchell, an orthopedic surgeon and plaintiffs' expert, "the purpose of using instrumentation in the lumbar area for fusion surgery" is "to stop motion so that fusion can occur" (Mitchell Dep. at 33), which in this case was accomplished. (Urbaniak Dep. at 54-55; Beaver Dep. at 31, 36, 39-40).

Driggers indicated that he suffered from severe pain immediately after the surgery in 1986. (Driggers Dep. at 62). As early as 1987 or 1988, Driggers suspected that the CD system was causing some or all of his pain. (Id. at 62-66, 71.) In 1989, Dr. Robert Beaver took x-rays of Driggers' back and informed him that something in the hardware had broken. (Id. at 65). In December 1989, Driggers consulted with Dr. Beaver about "whether or not some of the persistent pain that he was having in his lower back was related to the internal fixation device ... and he questioned whether or not there was a potential necessity for removing the plate and screws from the lumbar spine." (Beaver Dep. at 28.)

In the spring of 1990, Driggers was in another automobile accident. (Driggers Dep. at 73.) In a letter to Dr. Beaver dated May 13, 1991, Driggers stated that "due to the wreck, it has caused an increase in my problems with more pain in my lower back." (Beaver Dep. at 63.) However, in his deposition, Driggers stated that the accident caused pain in his shoulder and upper back, but not in his lower back or legs. (Driggers Dep. at 73.)

A July 1, 1992 medical report prepared by Dr. Brian Howard, a radiologist, indicated that the "[l]ocking screw of the right L5 pedicle system is disrupted and has migrated proximally. This suggests possible unlocking of the right proximal system although I do not see evidence for pedicle screw disruption." (Driggers Med. Records, Ex. 12, Pls.' Opp'n Defs.' Mot. Summ. J. [Doc. # 45]; Mitchell Report at 3). In 1997, Dr. Matthew Ohl, an orthopedic surgeon, advised Driggers that the screw that migrated in his back should be explanted. (Driggers Dep. at 70-73.) After reviewing Driggers' medical records, Driggers' expert witness, Dr. Mitchell, also concluded that the screw should be explanted to prevent further migration. (Mitchell Report at 3.) Dr. Mitchell stated in his report that:

It is my professional opinion, with a reasonable degree of medical certainty, that the instrumentation performed its role as a spinal stabilizer and a solid fusion at the L5-S1 level was achieved after the final operation on November 23, 1986. However, the unit did show a complication in its system design, which indicated that it is incapable of bearing and withstanding the loads, stresses and strains to which it is subjected in the human body. As a result, the discogram of July, 1992, indicated that the locking screw on the right at the L5 pedicle was disrupted and migrated proximally, suggesting an unlocking of the entire proximal system. Unfortunately, no further x-rays appear to have been taken of this particular phenomena and as a result, it is impossible to tell at this time, whether the metal has migrated further or whether it is remaining in position. Clearly, if it does migrate and even the presence of some migration at that time in 1992, suggests it should be removed so it does not migrate into a critical area.

(Mitchell Report at 3.) There is no evidence that Driggers ever had the screw removed.

On October 23, 1995, Driggers and his former wife, Margie Ann, filed their original complaint. Plaintiffs filed an amended complaint on October 29, 1996 [Doc. # 21]. This case has been remanded back to this Court from MDL Number 1014 proceedings before Judge Louis Bechtle in Philadelphia. All necessary discovery on liability in this case has concluded, including expert discovery. See In re Orthopedic Bonescrew Prods. Liability Litig., MDL No. 1014, 1997 WL 688805, slip op. at 3-4 (E.D.Pa. Oct. 21, 1997) (PTO No. 1120); id. slip op. at 2, 1997 WL 857174 (E.D.Pa. Dec.15, 1997) (PTO No. 1201).

II.

Driggers' first cause of action for fraudulent marketing and promotion alleges that Sofamor's representations to surgeons and patients that the CD system was safe and effective was misleading in that Sofamor failed to disclose that the FDA had refused to clear the CD system for use in the pedicles; that there was no valid scientific evidence demonstrating its safety and efficacy; that pedicle screw fixation was to be done only in accordance with the Investigational Device Exemption provisions of the Food Drug and Cosmetic Act; or that the surgeon-promoters had a significant financial relationship with Sofamor.

This cause of action for fraud is barred by the three-year statute of limitations set forth in N.C.Gen.Stat. § 1-52(9), which states that "the cause of action shall not be deemed to have accrued until the discovery by the aggrieved party of the facts constituting the fraud or mistake." The limitations period begins to run when the plaintiff discovered or should have discovered, in the exercise of reasonable care, the facts constituting the fraud. See Hiatt v. Burlington Indus., Inc., 55 N.C.App. 523, 526, 286 S.E.2d 566, 568, disc. rev. denied, 305 N.C. 395, 290 S.E.2d 365 (1982). If the evidence is not conclusive or is conflicting, the question of when the plaintiff should have discovered the facts constituting the fraud is one for the jury. Id. "Failure of plaintiff, however, to exercise due diligence in discovering fraud can be determined as a matter of law where it is clear that there was both capacity and opportunity to discover the fraud." Id.

Here, the evidence is clear that Driggers had the capacity and opportunity to discover the fraud, at the latest, in December 1989. Driggers indicated that he suffered from severe pain immediately after the surgery in 1986 (Driggers Dep. at 62) and suspected as early as 1987 or 1988 that the CD system was causing his pain. (Id. at 65-66). In 1989, Dr. Beaver took...