Knoth v. Smith, 98-4063WM

• Decision Date: 16 September 1999
• Docket Number: No. 98-4063WM,98-4063WM
• Citation: 195 F.3d 355
• Parties: (8th Cir. 1999) Keith A. Knoth, Appellant, v. Smith & Nephew Richards, a/k/a Smith & Nephew North America, Appellee. Submitted:
• Court: U.S. Court of Appeals — Eighth Circuit

Page 355

195 F.3d 355 (8th Cir. 1999)

Keith A. Knoth, Appellant, v. Smith & Nephew Richards, a/k/a Smith & Nephew North America, Appellee.

No. 98-4063WM

United States Court of Appeals FOR THE EIGHTH CIRCUIT

Submitted: September 16, 1999

Filed: October 28, 1999

On Appeal from the United States District Court for the Western District of Missouri.

Before RICHARD S. ARNOLD, FLOYD R. GIBSON, and LOKEN, Circuit Judges.

RICHARD S. ARNOLD, Circuit Judge.

The plaintiff, Keith Knoth, appeals from the judgment in this products-liability case after the jury returned a verdict in favor of the defendant, Smith & Nephew Richards. The defendant is a manufacturer of surgical and orthopedic devices. The plaintiff argues ten points of error by the District Court.¹ Many of these arguments relate to his contention that the defendant violated the Medical Devices Amendments (MDA) to the Food, Drug, and Cosmetics Act, 21 U.S.C. 360, and that such a violation was either negligence per se, evidence of negligence, or relevant to a strict-liability claim. We affirm.

I.

In September of 1993, the plaintiff, a muscular 215-pound man, fractured the area above his left knee in an auto accident. Dr. William Gondring treated plaintiff's fracture with an 11mm intramedullary supracondylar (IMSC) nail that was manufactured by the defendant. "Intramedullary" means placed into the center of a bone, the place where marrow is made. "Supracondylar" means above the condyles, a portion of the knee. The model of IMSC nails in issue had less than a 1% failure rate and evolved from other types of intramedullary nails also manufactured by the defendant. The IMSC nail was to serve as an internal splint to hold the broken pieces of bone together while the bone healed. Dr. Gondring reamed the inner canal of the bone to 13.5mm, and he wrapped stainless steel wires around the bone to stabilize the fracture. Dr. Gondring did not bone graft the affected area. He had plaintiff wear a knee immobilizer.

The plaintiff underwent physical therapy. Dr. Gondring ordered heavy exercising of the leg on November of 1993, and by December 2, 1993, he had plaintiff progress to 25% weightbearing. In January of 1994, plaintiff was fully weightbearing on his leg. Plaintiff was advised to reduce his weightbearing, because the leg was not healed. Dr. Gondring continued plaintiff at 50% weightbearing for two weeks and then 75% for two weeks. On January 23, 1994, the plaintiff sat down in a chair, and the IMSC nail broke. Dr. Gondring performed another surgery and replaced the 11mm nail with a 13mm nail. The plaintiff sued defendant for product defect and negligence.

The District Court's original scheduling order provided that amendments to the pleadings should be filed by March 1, 1996. Well after that date, plaintiff discovered that defendant had made no filings with the Food and Drug Administration before marketing the IMSC device. After discovering this, the plaintiff, on September 9, 1996 (18 months after the original complaint was filed), moved to modify the scheduling order so that he could amend his complaint to include a statutory issue. The plaintiff wanted to show that the defendant's failure to make FDA filings, or seek approval under the MDA prior to marketing the device, constituted negligence per se. The District Court denied the plaintiff's motion, citing its original scheduling order. The original scheduling not only fixed the closing date for pleadings, but also stated that the time provided was generous, no extensions should be expected, and all pretrial discovery should be completed on or before September 1, 1996. App. 75.

On June 30, 1997, the plaintiff filed a Motion to Reconsider Leave to Amend, which stated in part:

The proposed amendments previously submitted contained claims for relief specifically due to violations of the MDA amendments to the FDA Act and negligence per se claims which are omitted from the attached proposed First Amended Petition, which seeks to specify claims of "failure to warn" and seeks submission of punitive damages . . .. Wherefore, plaintiffs respectfully pray leave to amend their cause against defendant to add a claim for failure to warn and/or to add a claim for punitive damages.

Appellee App. 1. The Court denied the plaintiff's motion for reconsideration on December 30, 1997. However, on February 24, 1998, the Court, on its own motion, allowed the plaintiff to amend to add his claims for failure to warn and punitive damages.

After a 9-day trial, the jury returned a verdict in favor of the defendant. This appeal followed.

II.

The plaintiffs' first argument is that Instruction No. 11 was an incorrect statement of the law. This instruction stated:

The manufacturer of an Intramedullary Supracondylar Nail is not a guarantor that nobody will get hurt in using the article. What the manufacturer is required to do is to make a product which is free from defective and unreasonably dangerous conditions.

App. 131. Plaintiff argues that the Medical Devices Amendments, 21 U.S.C. 360, required the product to be "safe and effective," and that Instruction No. 11 was erroneous because it failed to refer to this statutory standard. As the case went to the jury, however, there was no claim for...