Orthopedic Equipment Co. v. Eutsler

Decision Date14 March 1960
Docket NumberNo. 8002.,8002.
Citation276 F.2d 455
PartiesORTHOPEDIC EQUIPMENT CO., Incorporated, Appellant, v. Dennis EUTSLER, Appellee.
CourtU.S. Court of Appeals — Fourth Circuit


James H. Simmonds, Arlington, Va. (Howard M. Murphy, Arlington, Va., on brief), for appellant.

David G. Bress, Washington, D. C., and Hardy C. Dillard, Charlottesville, Va. (John T. Camblos, Charlottesville, Va., Leonard Braman, Newmyer & Bress, Washington, D. C. and Michie, Taylor, Camblos & Deets, Charlottesville, Va., on brief), for appellee.

Before SOBELOFF, Chief Judge, and SOPER and BOREMAN, Circuit Judges.

SOBELOFF, Chief Judge.

A manufacturer of surgical instruments and equipment, an Indiana corporation known as Orthopedic Equipment Company, Inc., is accused in this diversity action of misbranding a surgical nail which became stuck in the plaintiff's leg in the course of an operation. From a judgment for $75,000 in favor of Dennis Eutsler, the plaintiff, a resident of Virginia, the defendant appeals.

The circumstances out of which the action arises are as follows. On March 30, 1956, the twenty-one year old plaintiff was helping his father take down a tree on a farm near Orange, Virginia. He was injured by the tree falling upon him. At the University of Virginia Hospital, it was found that he had sustained a fracture of the leg and other injuries. In the judgment of the surgeons, the treatment indicated for the fracture was an operation known as intramedullary nailing by use of a Kuntscher Cloverleaf Intramedullary Nail.1 This involves the insertion of a long metal rod or nail into the medullary canal (containing the marrow) of the femur (or thigh bone), in order to stabilize the broken fragments. The advantage sought by this method is an early union and weight-bearing without the necessity of a plaster cast.

A team of orthopedists, experienced in this technique, operated on April 3, 1956. Having prepared the canal by use of a 9mm.2 medullary reamer or drill, the surgeons began to insert into the medullary canal a Kuntscher Cloverleaf intramedullary nail manufactured by the defendant. These Kuntscher nails usually have imprinted upon them two figures signifying their dimensions, e. g., 9 × 40, 10 × 42, but the imprint or label does not explain the meaning of these figures. It is agreed by the parties that the larger figure is understood to represent the length of the nail in centimeters. According to the plaintiff's expert witnesses, the interpretation placed upon the smaller figure by orthopedists is that the nail will fit into a hole having a width or diameter corresponding in millimeters to the figure on the nail. This follows from the necessity that the nail shall fit tightly into the canal previously prepared by a reamer of corresponding diameter. These witnesses also testified that after the canal is reamed, the nail is selected on the basis of the measurement on its "label," or imprint, conforming to the measurement of the reamer used. Furthermore, plaintiff's experts testified, orthopedic surgeons invariably rely upon the figures imprinted on the nail, when there are figures imprinted, without making independent measurements. Thus, according to the surgeons, they relied in this instance too on the accuracy of the marking, "OEC 9 × 40," in selecting the nail.

As the nail was driven down the canal of the upper fragment of the thigh bone, the surgeons at first met normal resistance. When it penetrated further, however, greater resistance was encountered. Nevertheless, the doctors did not regard this as unusual, since they knew that they had used a 9mm. reamer and the nail was marked to indicate 9mm.; they concluded that it must merely have met some slight obstruction which, as in past operations, would be passed or overcome without difficulty. Accordingly, as was customary in such cases, two or three slightly heavier blows were then struck.

Because the nail would progress no further even after these heavier blows, the surgeons decided to remove it. However, when persistent efforts to dislodge the nail proved unavailing, the portion of the nail protruding below the canal of the upper fragment was cut off, the wound closed, and a plaster cast applied in the hope that in a few weeks the bone would atrophy sufficiently to loosen the nail and permit its withdrawal.

About a month later, on May 4, the surgeons again tried to extract the nail, but were unsuccessful. Thereupon, one of the doctors designed a new instrument, and by its use removal of the nail was finally accomplished in a third operation on June 5. Measurements of cross-sections of the nail, as testified to by a machinist, varied from a minimum of 9.27mm. to a maximum of 10.12mm.

Due to the nail's impaction, incurable osteomyelitis or bone infection resulted. The plaintiff has permanently lost the use of his leg, and its ultimate amputation is expected.

This action was brought against defendant for alleged "negligent manufacture, labelling and launching on the market of said nail * * *," plaintiff presumably at first intending to charge ordinary common law negligence only. Later, however, it was stipulated by counsel that, without formal amendment, the complaint should also be regarded as alleging a violation of the Federal Food, Drug, and Cosmetic Act. In this appeal, the defendant assigns five grounds of error, which we shall now discuss.

The Federal Food, Drug, and Cosmetic Act

Defendant contends, for two reasons, that the District Judge erred in basing his charge to the jury on the Federal Food, Drug, and Cosmetic Act, 21 U.S. C.A. §§ 301-392.3 It asserts first, that the evidence of misbranding is insufficient, and second, that in any event, the Act does not apply to surgical instruments.

It will be seen that "misbranding" is defined in section 352 of the Act as labeling that is false or misleading in any particular. Defendant argues that the evidence was insufficient to raise a jury question of a "misbranding" violation under the Act since its labeling was neither false nor misleading. The doctors who performed the operation testified that in accordance with the prevailing interpretation of the profession they understood that the cross-sectional dimension, imprinted on the nail, meant that it could be inserted into a hole made with a reamer bearing a diameter measurement corresponding to the number appearing on the nail. Defendant's brief insists, however, that this "understanding" does not relate to the measurement or dimension of the nail at all, but to the reamer. Such a reference, the argument goes, leads to numerous uncertainties: reamers are not always used in these nailing operations; the reamer used may be made by a company other than the manufacturer of the nail, as was the case here; the reamer itself may be measured inexactly.4 Thus, defendant asserts, the doctors' understanding was incorrect and unsupportable.

We think that the evidence was sufficient to raise a jury question of misbranding. Notwithstanding the defendant's expert testimony to the contrary, the testimony of plaintiff's experts as to the understanding of the medical profession of the number 9 on the nail certainly presented an issue for the jury as to the "true" meaning of the number.

Furthermore, the defendant points out that its catalogue was available in the hospital, but the surgeons performing the operation admittedly had not read it. However, what the defendant claims the catalogue would show, namely that the figure on the nail refers to its "width," does not seem to aid the defendant's argument. Even if, as defendant argues, the number did refer to the "width" of the nail, and assuming for the sake of the argument that "width" is different from diameter, it is undisputed that the nail was actually more than 9mm. wide. Properly, it was left to the jury to judge the weight of the testimony offered by the plaintiff and the answering explanations advanced by the defendant, and the jury was clearly warranted in concluding that the labeling was false or misleading.

Defendant insists that, in any event, the Federal Food, Drug, and Cosmetic Act does not apply to surgical nails marketed for use only by skilled surgeons. With this we are compelled to disagree. The definition of "devices" embraced by the Act5 is clearly of sufficient breadth and scope to include a surgical nail, which frequently remains in the patient for many months and is designed to and does affect both the "structure and function of the body".6

It is urged by defendant that the regulations issued pursuant to section 352(f) of the Act nevertheless exempt manufacturers from the obligation to give directions for the use of surgical instruments since such devices are designed for use by a skilled profession.7 This specific exemption of surgical instruments from section 352(f), however, does not relieve the defendant from compliance with other provisions of the Act, including the remainder of section 352, and seems to us rather to indicate a contrary intention. In short, while the Act imposed no obligation upon defendant to label its nail, once it undertook to do so the Act required it to avoid misbranding.8

The dicta quoted in defendant's brief to the effect that the Act was designed primarily to protect the public, especially consumers,9 do not support the inference that defendant seeks to draw, namely that surgical instruments are not meant to be covered by the Act since they are not ordinarily sold to members of the public. On the contrary, these expressions are more consistent with the inclusion of such instruments within the scope of the Act, for the patient as a member of the public is the ultimate consumer. As the District Judge said, in overruling defendant's motion for summary judgment,

"* * * I think it is immaterial that the nail was not sold to, or purchased by the plaintiff, and I think it is incorrect to say that the nail was

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