McCarthy v. Danek Medical, Inc.

• Decision Date: 05 January 1999
• Docket Number: No. CIV.A. 95-1667.,CIV.A. 95-1667.
• Citation: 65 F.Supp.2d 410
• Parties: Carliss A. McCARTHY, Sr. and Bonnie Jean McCarthy Individually and on Behalf of Their Three Minor Children v. DANEK MEDICAL, INC., Sofamor Snc, and Sofamor Danek Group, Inc.
• Court: U.S. District Court — Eastern District of Louisiana

Page 410

65 F.Supp.2d 410

Carliss A. McCARTHY, Sr. and Bonnie Jean McCarthy Individually and on Behalf of Their Three Minor Children v. DANEK MEDICAL, INC., Sofamor Snc, and Sofamor Danek Group, Inc.

No. CIV.A. 95-1667.

United States District Court, E.D. Louisiana.

January 5, 1999.

David B. Allen, Stephen M. LaRussa & Associates, Houma, LA, Daniel E. Becnel, Jr., Law Offices of Daniel E. Becnel, Jr., Reserve, LA, for plaintiffs.

William Kearney Christovich, Kevin Richard Tully, Terry Christovich Gay, Christovich & Kearney, LLP, New Orleans, LA, Anthony Vale, Pepper Hamilton, LLP, Philadelphia, PA, for defendants.

ORDER AND REASONS

LEMELLE, District Judge.

This matter is before the Court for consideration of defendant Danek Medical, Inc.'s motion for summary judgment. This matter involves the plaintiffs' products liability and consortium claims which have been remanded from MDL 1014 in the United States District Court for the District of Pennsylvania. Plaintiffs' claims arise out the attachment of the Compact Cotrel-Dubousset System ("CCD System") into the pedicles of the plaintiff's lumbar spine. The procedure at issue was performed on June 15, 1994, by Dr. Thomas Whitecloud of the Tulane University Medical Center in New Orleans, Louisiana. The purpose of the implant is to provide biochemical stability, so that a solid fusion would develop from the bone graft laid down by Dr. Whitecloud. The CCD System consists of screws, hooks, rods, and other components that allow the surgeon to fashion customized constructs for each patient.

The Louisiana Products Liability Act ("LPLA") imposes liability against a manufacturer of a defective product when that product causes damage. La.Rev.Stat. ann. § 9:2800.51 et seq. The LPLA "establishes the exclusive theories of liability for manufacturers for damages caused by their products." La.Rev.Stat. ann. § 9:2800.52; Brown v. R.J. Reynolds Tobacco Co., 52 F.3d 524, 526 (5th Cir.1995); Lewis v. Intermedics Intraocular, Inc., 56 F.3d 703, 706 (5th Cir.1995). Under the LPLA, § 2800.54(B) sets forth the four exclusive theories of recovery:

B. A product is unreasonably dangerous if and only if:

(1) The product is unreasonably dangerous in construction or composition as provided in R.S. 9:2800.55;

(2) The product is unreasonably dangerous in design as provided in R.S. 9:2800.56;

(3) The product is unreasonably dangerous because an adequate warning about the product has not been provided as provided in R.S. 9:2800.57; or

(4) The product is unreasonably dangerous because it does not conform to an express warranty of the manufacturer about the product as provided in R.S. 9:2800.58.

Plaintiff has alleged in this case that the CCD System, particularly the use of the screw component in the pedicle, is unreasonably dangerous in design under § 9:2800.56 and because of inadequate warning under § 9:2800.57.¹

Under the LPLA, a product is unreasonably dangerous in design if at the time the product left the manufacturer's control 1) there existed an alternative design for the product that was capable of preventing the claimant's damage, and 2) the likelihood that the product's design would cause the claimant's damage and the gravity of that damage outweighed the burden on the manufacturer of adopting the alternative design and the adverse effect, if any, of the alternative design on the utility of the product. La.Rev.Stat. ann. § 9:2800.56. The LPLA also provides that "an adequate warning about a product shall be considered in evaluating the likelihood of damage when the manufacturer has used reasonable care to provide the adequate warning to users and handlers of the product." Id.

To avoid a summary judgment on the claim of defective design, the plaintiff must present competent evidence that would enable a trier of fact to conclude the two factors listed above. Morgan v. Gaylord Container Corp., 30 F.3d 586, 590 (5th Cir.1994); McKey v. General Motors Corp., 691 So.2d 164, 170 (La.Ct.App.1997). Plaintiff in this instance has presented no expert evidence to support a claim that an alternative design exists or to identify an alternative design. Failure to do so leaves no issue of fact. Marks v. R.J. Reynolds Tobacco Co., 965 F.Supp. 857, 859-60 (W.D.La.1997); See also, Tauzier v. Dodge, No. 97-2444, 1998 WL 227170, slip op. at *5 (E.D.La. May 5, 1998).

Louisiana law does not allow a fact finder to presume an unreasonably dangerous design solely from the fact that injury occurred. Ashley v. GMC, 666 So.2d 1320, 1322 (La.App.1996). Without expert or technical evidence to support the contention that the design was defective or to establish an alternative design, plaintiff has failed to create an issue of fact to be left to a jury. Marks, 965 F.Supp. at 860; Hebert v. Miles Pharmaceuticals, No. 92-4290, 1994 WL 10184 (E.D.La. Jan.13, 1994); White v. Mossy Oldsmobile, Inc., 606 So.2d 33, 35 (La.App.1992).

In the instant case, plaintiffs' experts have not offered or contended that alternative designs existed to the CCD System at the time of surgery. Rather, plaintiffs and their experts have confused the existence of alternative methods with alternative designs. In Theriot v. Danek Medical, Inc., C.A. 94-2646"F" (E.D.La. Dec. 5, 1997), the trial court granted summary judgment in favor of Danek et al under the LPLA. The Court held that the plaintiff's evidence, like Mr. McCarthy's, did not prove the existence of an alternative design. Rather, plaintiffs' evidence only established "surgical alternatives to the pedicle screws." Theriot, at p. 7 (Dec. 5, 1997). In recognizing that the only remedies available are those under the LPLA, the Theriot Court also held that Louisiana does not recognize any claim for a manufacturer's violation of the Food and Drug Administration's regulations. The Court also specifically rejected the plaintiffs' claims based on fraudulent misrepresentation and conspiracy citing Jefferson v. Lead Industries Ass'n, 930 F.Supp. 241, 245 (E.D.La.1996), aff'd, 106 F.3d 1245 (5th Cir.1997).

In a second opinion entered January 26, 1998, the Theriot court denied the plaintiffs' motion for reconsideration recognizing that the "new evidence" plaintiffs presented were two articles which addressed alternative procedures, not designs, to pedicle screws. In a third opinion entered August 4, 1998, the Court denied plaintiffs' second motion for relief from final judgment. In that motion, plaintiffs sought reconsideration based on more "new evidence" discovered in MDL 1014 related to other spinal systems. Judge Feldman found that the design "alternatives" in those systems were discoverable prior to the first motion and therefore denied the motion for reconsideration. He also reasoned that plaintiffs had not argued that other pedicle screw systems were better designed than the CCD System. Instead, as here, Theriot condemned all pedicle screw designs and argued that the only safer alternative was another procedure.

This Court can not find any supportable difference in the medical and legal conclusions which must be reached in this case. Mr. McCarthy has presented expert evidence which identifies numerous alternative methods, or surgical alternatives, which can be used to attempt fusion. As noted by counsel, alternative methods were included in the CCD System package itself, i.e. wires, hooks, and sacral screws. Plaintiffs misread defendant's reply memorandum as an admission that alternative "designs" existed. That is not so.

Defendant has argued that, if plaintiffs' arguments that hooks and wires, etc. are in fact "alternative designs" then there is no disputed fact that the alternative was available at the time of plaintiff's surgery and in fact being manufactured by Sofamor Danek at the time of plaintiff's surgery. Therefore, defendant contends, it was the surgeon, and the plaintiff, who chose the off-label pedicle screw method and not a "defect" in the design of the CCD System or its components which led to plaintiffs' claims.

The generalities urged against the pedicle screw procedures offered by plaintiffs' expert, Dr. Alexander, have been rejected time and again by various courts which found him unqualified to offer an opinion or rejected his conclusions finding that they did not prove a design defect. See e.g. In re Orthopedic Bone Screw Prod. Liab. Lit., 1997 WL 39583 (E.D.Pa. Jan.23, 1997); Theriot, Dec. 5, 1997 op. at p. 8, n. 3; Talley v. Danek Medical, 7 F.Supp.2d 725, 732 (E.D.Va.1998).

In addition, § 9:2800.56 also provides that if the manufacturer used reasonable efforts to provide adequate warnings to users and handlers, that is to be considered in determining the likelihood of damage to plaintiff. In this case, the summary judgment evidence reflects that the warnings were adequate for the reasons to follow.

With respect to the failure to warn, plaintiff must establish a connection between the manufacturer's omission and the damage suffered. Delery v. Prudential Ins. Co., 643 So.2d 807, 814 (La.Ct.App.), writ denied, 648 So.2d 393 (La.1994). The LPLA in part defines an adequate warning to be one that "would lead an ordinary reasonable user" to contemplate danger in using or handling the product. § 9:2800.53(9).²

Under Louisiana law generally, a manufacturer of medical drugs and devices has no duty to warn the consumer directly of any risks or contraindications associated with its product. Mikell v. Hoffman-LaRoche, Inc., 649 So.2d 75, 80 (La.App. 1994). The Mikell court also described how this obligation is met:

The obligation to the...