Carol Adams v. Synthes Spine Company, Lp

298 F.3d 1114, 2002 Cal. Daily Op. Serv. 7163, 2002 Daily Journal DAR 8999, 2002 U.S. App. LEXIS 15903, 2002 WL 1808321
CourtCourt of Appeals for the Ninth Circuit
DecidedAugust 8, 2002
Docket00-35094
StatusPublished
Cited by24 cases

This text of 298 F.3d 1114 (Carol Adams v. Synthes Spine Company, Lp) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Carol Adams v. Synthes Spine Company, Lp, 298 F.3d 1114, 2002 Cal. Daily Op. Serv. 7163, 2002 Daily Journal DAR 8999, 2002 U.S. App. LEXIS 15903, 2002 WL 1808321 (9th Cir. 2002).

Opinions

Dissent by Judge FERGUSON.

OPINION

KLEINFELD, Circuit Judge.

This is a products liability case involving no questions of federal law, just a question of state law.2

Facts

Carol Adams had persistent severe back and neck pain, radiating down into her fingers. The pain was caused by spurring on her vertebrae and deterioration of the disks in her neck. It did not respond to steroids, traction, or other conservative treatment, so she elected to have surgery to remove the spurs and the bad disks. Her neurosurgeon removed three disks and parts of three vertebrae. To maintain the stability of the spine, he removed a piece of bone from her hip and inserted it in the gap in her neck vertebrae. This is a standard way to do the cervical fusion operation he was performing.

The neck has to be held still during the three months or so until the piece of hip bone fuses with the neck bones to form a solid and stable substitute for the removed pieces of vertebrae. This used to be done, in an operation of this magnitude, by requiring the patient to wear a halo for four months. Holes would be drilled into the skull of the patient in order to screw the halo to the skull, and the halo would be held in place by a kind of vest. Obviously, this was hard for the patient to bear.

In 1991, Synthes Spine came out with a device to avoid the halo. Instead of drilling holes in the patient’s head and requiring the patient to wear the affixed halo, the surgeon would screw a metal plate to the bones of the spine during the surgery. This would hold the bones in place while they fused. Ms. Adams’ doctor, Leslie Bornfleth, M.D., testified that while patients were routinely advised that they [1116]*1116could have the halo instead, none wanted it once they could opt for the Synthes Spine plate. Ms. Adams made that election.

The operation went fine. The bones in Ms. Adams’ neck properly fused. But three years later, in 1998, Ms. Adams had neck pain and difficulty swallowing, and consulted Allan J. Drapkin, M.D. (Dr. Bornfleth had by then retired from practice). Dr. Drapkin’s x-rays showed that the plate had broken and one of the screws had come partly out. The fusion was solid, and the plate was no longer necessary to hold her spine together, so Dr. Drapkin recommended surgery to “remove the plate, and particularly remove that screw” in order to relieve “mechanical compression on the esophagus.” He performed the removal surgery, and it succeeded without complication.

A person can’t buy one of these Synthes Spine plates at the drugstore. They are sold only to physicians. Dr. Bornfleth, a neurosurgeon- who installed quite a few, did not even have them in his office. They were kept at the hospital. This was a medical device, fairly new when Dr. Born-fleth installed it in 1995 (four years after its introduction), and was sold to and used by physicians such as Dr. Bornfleth.

The directions that come with the device say to remove it once the bones have fused. In the “Precautions” section of the “SUGGESTIONS CONCERNING ORTHOPAEDIC METALLIC INTERNAL FIXATION DEVICES,” the instructions say that these implants can break. So. “[w]hile the surgeon must make the final decision,” the instructions recommend that the implants be removed once the bones, have fused:

Removal after fracture healing. Metallic implants can loosen, fracture, corrode, migrate, .cause pain, or stress shield bone even after a fracture has healed, particularly in young, active patients. While the surgeon must make the final decision on implant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished. Implant removal should be followed by adequate postoperative management to avoid refracture.

Despite this manufacturer’s recommendation, a lot of surgeons don’t remove the implants. Dr. Bornfleth went to meetings where surgeons discussed how to use the implants, and the consensus was “there is no reason to take the plates out because if the fusion is solid and the plate is there, it’s going to cause no problem.” As Dr. Drapkin, who removed the broken plate, testified, the risk of a plate breaking is “very small,” so ordinarily “there is no reason to expose the patient to a risk of a second surgery on a routine basis” to remove it. Dr. Drapkin said he would still use a Synthes Spine plate if he were performing this sort of surgery, even after Ms. Adams’ plate broke. She was the unfortunate person for whom the “very small” risk materialized, necessitating removal.

Ms. Adams sued Synthes Spine for selling a defective product: Her damages were for the pain in her throat after the plate broke, the anxiety of the several days between Dr. Drapkin’s telling her it was broken and performing the surgery to remove it, and associated pain and suffering and medical expenses. The district court granted summary judgment against Ms. Adams, and she appeals on the theory that the product was defectively designed because it could break.

Analysis

We review summary judgment de novo, to determine whether, viewing the evidence in the light most favorable to the nonmoving party, there are any genuine [1117]*1117issues of material fact.3 Having so reviewed the case, we have concluded that the district judge’s carefully analyzed decision was correct, and we affirm.

The theory of the plaintiffs case, as briefed on appeal, is that the plate didn’t conform to the reasonable expectations of the consumer, Dr. Bornfleth, because it broke, and he wasn’t adequately warned that it could break.

The applicable Washington statute on products liability says that in determining whether a product is “reasonably safe,” the trier of fact “shall consider whether the product was unsafe to an extent beyond that which would be contemplated by the ordinary consumer.”4 Under Washington law, the “consumer” of a prescription-only medical device such as this is the physician, not the patient in whom it is installed,5 a critical point which plaintiff concedes.

The Washington Supreme Court held in Terhune v. AH. Robins Co.6 that the manufacturer of the Daikon Shield was not strictly liable to a woman whose uterus was perforated by one, because medical products “available only on prescription or through the services of a physician”7 are, in Washington, treated as falling under comment k of the Restatement (Second) of Torts § 402A.8 As the Restatement puts it, some products are “incapable of being made safe” but, because of their benefit, are not “unreasonably dangerous,” such as “many ... drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician.”9 Where “proper warning is given,” the seller “is not to be held to strict liability for unfortunate consequences attending their use.”10

Washington applies this rule not only to such medical products as' vaccines for deadly diseases, but, as the Daikon Shield case illustrates, much more broadly, to medical products where the physician acts as a “learned intermediary between the manufacturer or seller and the patient.”11 In

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Bluebook (online)
298 F.3d 1114, 2002 Cal. Daily Op. Serv. 7163, 2002 Daily Journal DAR 8999, 2002 U.S. App. LEXIS 15903, 2002 WL 1808321, Counsel Stack Legal Research, https://law.counselstack.com/opinion/carol-adams-v-synthes-spine-company-lp-ca9-2002.