Emody v. Medtronic, Inc., CIV.A.02-AR-0111-S.
| Decision Date | 07 January 2003 |
| Docket Number | No. CIV.A.02-AR-0111-S.,CIV.A.02-AR-0111-S. |
| Citation | 238 F.Supp.2d 1291 |
| Parties | Immogene EMODY, Plaintiff, v. MEDTRONIC, INC., et al., Defendants. |
| Court | U.S. District Court — Northern District of Alabama |
Before the court is a motion for summary judgment filed by defendants, Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively "MSD").1 Immogene Emody ("Emody") filed this action under Alabama Extended Liability Manufacturer's Doctrine (AEMLD). MSD's motion is due to be granted.
Emody first saw a Dr. Stan Faulkner on October 4, 1996, for chronic back pain despite four prior back operations. Emody suffered from "spinal stenosis" and "degenerative scoliosis." Dr. Faulkner, an orthopedic surgeon, recommended "posterior lumbar interbody fusion" across five levels of Emody's spine. Before Emody's surgery, Dr. Faulkner knew of the risks of instrumented spinal fusion surgery, including the possibility that the instrumentation may break, cause additional pain, or result in the need for additional surgery. With experience in over 1,000 prior spinal fusion surgeries, Dr. Faulkner had made independent assessments of how the TSRH system performed. Dr. Faulkner testified that he did not obtain his information about the risks and benefits of the TSRH instrumentation from MSD. The source of his knowledge came from medical books, journals, newsletters, meetings, and peer discussions. He did not rely on information from MSD. He did not even read the package insert provided by MSD.
The TSRH Spinal System is a multi-component medical device consisting of rods, cross-links, hooks, and screws. For each patient the surgeon selects the size and configuration of the component parts. The package insert provided by MSD with the TSRH instrumentation discusses the need for a second operation to remove the instrumentation. Concerning marring breakage, renewed pain, and falls, the insert states that potential adverse events include but is not limited to: breakage of any or all of the components, development of pain, and device component fracture. The insert recommends that the patient be warned to avoid falls. The insert also states that the system is intended only to provide stabilization during the development of a solid fusion and should be removed after the development of a solid fusion. The insert notes that additional surgery may be necessary to correct some of these anticipated adverse reactions.
On November 13, 1996, Dr. Faulkner performed the spinal fusion with MSD's titanium TSRH instrumentation. Spinal instrumentation serves as "an internal support and a brace." Dr. Faulkner testified that the device holds the spine together in the position it needs to be in while it is fusing. Dr. Faulkner uses spinal instrumentation in 98% of the spinal fusion surgeries he performs. From the various TSRH components, Dr. Faulkner constructed a custom made implant for Emody. Dr. Faulkner's assistant explained to Emody the potential complications of the surgery. Emody contends that she was told the rods would last forever in her back and not need to be taken out. Dr. Faulkner admits that Emody was told that the plan was to leave the rods in place forever but that Dr. Faulkner does remove the instrumentation in about 20% of his patients and that Emody was told that the instrumentation may get loose or break or cause pain and may have to be removed later.
After surgery, Emody saw Dr. Faulkner for several routine follow-up visits until August 20, 1997. On August 20, 1997, although the fusion was progressing well, Emody's spine was not totally fused. Dr. Faulkner scheduled Emody for another appointment in a year. Emody did not keep that appointment and did not see Dr. Faulkner at all for the next three years. Whether this constituted contributory negligence as a matter of law is a matter of legitimate dispute. On October 11, 2000, Emody returned to Dr. Faulkner complaining of increased back pain. X-ray's showed a non-displaced broken rod on the right side and a solid appearing spinal fusion. Dr. Faulkner had never seen before a broken rod with a solid fusion. It was his opinion that the rod broke before the spine was totally fused due to trauma. Emody admitted that she had fallen down three to four times since her surgery in 1996.
Dr. Faulkner gave Emody the option of leaving the rod in or having it surgically removed. It was his opinion that the pain was caused by the hardware and not because of the fracture of the rod. Dr. Faulkner testified that in 20% of his patients he removes the rod for that specific reason. On January 9, 2001 Emody opted to have the rod removed. Emody claims that she has suffered immensely from physical pain and mental pain because the broken TSRH titanium rods were removed.
Emody stated that her medical experts are: (1) Dr. Faulkner, with his deposition serving as an expert report, (2) a psychiatrist, Dr. Margaret Sellers-Bok, M.D., ("Dr.Sellers-Bok") and (3) Raymond Thompson, Ph.D. ("Dr.Thompson"), a professional engineer. Dr. Faulkner testified that the TSRH rod did not have any defects in either its design or manufacture. Dr. Faulkner also opined that no defect caused the rod to break and that no defect caused any injury to Emody.
Dr. Sellers-Bok is a psychiatrist who has been treating Emody for depression, anxiety, and psychotic symptoms since June of 1999. Dr. Sellers-Bok's notes do not mention Emody being in pain of any sort until October of 1999 and do not mention her back until July of 2001. Dr. Sellers-Bok's notes seem to indicate that one source of Emody's depression was her hypothyroidism. Dr. Sellers-Bok's records do not contain any medical causation opinions concerning the rod.
Dr. Thompson subjected the removed rod to objective metallurgical testing for composition, hardness, and microstructure. Dr. Thompson's test indicate that the rod met ASTM (American Society for Testing and Materials) standards for chemistry, for hardness, and for microstructure. Based on subjective visual inspection, it is his opinion that the rod was "substandard in respect to surface finish leading to multiple cracking, failure, and reduced service life." However, his report does not reveal the standard against which he declared the rod to be substandard. He described seeing several scratches and impressions. When he examined the rod it had been out of MSD's hands for about six years. Dr. Faulkner also testified that before implantation he cut and shaped the rod to match Emody's anatomy. The rod then spent four years in Emody's body. When it first broke is anybody's guess. After the break was discovered, the rod and other components were removed by a process that broke the heads off of several the screws. Dr. Thompson never states that any of the alleged defects was the medical cause of injury, and as a non-physician he would hardly have expressed such an opinion even if he had formed it.
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