1The Hon. Dean Whipple, United States District Judge for the Western District

of Missouri.

United States Court of Appeals

FOR THE EIGHTH CIRCUIT

_____________

No. 98-4063WM

_____________

Keith A. Knoth, *

*

Appellant, *

* On Appeal from the United

v. * States District Court

* for the Western District

* of Missouri.

Smith & Nephew Richards, *

a/k/a Smith & Nephew North *

America, *

*

Appellee. *

___________

Submitted: September 16, 1999

Filed: October 28, 1999 

___________

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
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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 strictliability 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.

 
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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.
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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 violation of the federal statute as such. Plaintiff

appears to concede, as a general matter, that the instruction was correct under the law

of Missouri. Moreover, we do not see that inclusion of the "safe and effective"

language would have materially changed the instruction. Plaintiff agrees that the first

sentence of the instruction, to the effect that a manufacturer is not a guarantor that no

one will get hurt, was correct. We do not believe that the Medical Devices

Amendments change this standard. Even if, as plaintiff argues, defendant was in

violation of the federal statute for failing to make proper filings with the FDA, this

circumstance, in and of itself, has nothing to do with the safety and effectiveness of the

device as such. On the whole, we are not persuaded that there was any error in the

instruction, or that, if there was error, it affected plaintiff's substantial rights. The main

issue argued to the jury in this case appears to have been defendant's contention that

the plaintiff's difficulties were the physician's fault, and if, as seems likely, the jury
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accepted this theory, any error in the instruction would have been harmless in any

event.

Plaintiff also argues that the District Court erred in denying his motion to amend

his complaint to add claims under the Medical Devices Amendments and implementing

regulations, 21 C.F.R. Pts. 801, 807, and 820. Plaintiff argues that the defendant had

not registered the IMSC device with the FDA, that it was therefore marketing the

device unlawfully, which was proof of defendant's negligence per se. We find no abuse

of discretion in the District Court's action. The motion to amend the pleadings was

made after the deadline for amendments in the original scheduling order. It is well

within the authority of the district courts to set such deadlines, and, within broad limits,

it is up to those courts, not us, to determine when exceptions to these deadlines are

appropriate. Here, plaintiff suggests that the lateness of his motion for leave to amend

was due to discovery delays on the part of defendant. It was evidently the view of the

District Court that any such delays were not a sufficient ground for allowing the late

amendment. We are not persuaded that this decision was incorrect. In addition,

plaintiff appears later to have abandoned his MDA theory, because, in his motion to

reconsider the denial of the motion for leave to amend, the MDA and negligence per

se claims were omitted from the pleading he sought leave to file. Significantly, the

District Court did allow amendment of the complaint to assert claims for failure to warn

and for punitive damages. Finally, any amendment to assert a claim under the MDA

would probably have been futile, because the violation of the MDA that plaintiff sought

to establish, a failure to make certain filings, was not relevant to the substantive quality

of the devices. In sum, we are not persuaded that the District Court abused its

discretion by not allowing the full scope of amendment to the complaint desired by

plaintiff.

The plaintiff urges a number of other points, including the following: that the

District Court erred in refusing to allow evidence of FDA statutes and regulations; that

expert testimony on the relationship of the MDA to medical-industry standards was
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incorrectly excluded; that the defendant was incorrectly allowed to offer an expert

witness even though some of the opinions he presented had not been disclosed in a

timely fashion; that it was error to require the plaintiff to pay a portion of the expenses

of defense counsel in attending a deposition of plaintiff's expert; that the Court should

have allowed plaintiff's request for expenses owing to defense counsel's late arrival at

the deposition; and that the time for final arguments was unduly restricted. We have

considered these and other points made by plaintiff. They all relate to evidentiary and

discovery rulings which rest within the sound discretion of the District Court. We see

no abuse of discretion.

Accordingly, the judgment is affirmed.

A true copy.

Attest:

CLERK, U.S. COURT OF APPEALS, EIGHTH CIRCUIT.