Cooper v. Smith & Nephew
| Decision Date | 09 May 2001 |
| Docket Number | INCORPORATED,No. 00-2556,DEPUY-MOTEC,SOFAMOR-DANEK,00-2556 |
| Citation | 259 F.3d 194 |
| Parties | (4th Cir. 2001) WILLIAM COOPER, Plaintiff-Appellant, v. SMITH & NEPHEW, INCORPORATED, Defendant-Appellee, and SMITH & NEPHEW RICHARDS, INCORPORATED; ABRAHAM ROGOZINSKI; CHAIM ROGOZINSKI; JAMES WALT SIMMONS; AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS; NORTH AMERICAN SPINE SOCIETY; SCOLIOSIS RESEARCH SOCIETY; ACROMED CORPORATION, CHARTER NUMBER 614043; ACROMED CORPORATION,CHARTER NUMBER 816942; ACROMED INCORPORATED, CHARTER NUMBER 811415; ACROMED INCORPORATED, CHARTER NUMBER 816943; ACROMED HOLDING CORPORATION, CHARTER NUMBER 811416; ACE MEDICAL COMPANY; ADVANCED SPINE FIXATION SYSTEMS, INCORPORATED; CROSS MEDICAL PRODUCTS;; SYNTHES; SYNTHES, INCORPORATED; SYNTHES NORTH AMERICA, INCORPORATED; SYNTHES A.G. CHUR; DANEK MEDICAL, INCORPORATED; SOFAMOR, INCORPORATED;GROUP, INCORPORATED; SOFAMOR, S.N.C.; YOUNGWOOD MEDICAL SPECIALTIES, INCORPORATED, formerly known as Stuart Medical Specialty, Incorporated, formerly known as National Medical Specialty, Incorporated; ZIMMER, INCORPORATED, Defendants. Argued: |
| Court | U.S. Court of Appeals — Fourth Circuit |
Appeal from the United States District Court for the District of Maryland, at Baltimore. J. Frederick Motz, Chief District Judge.
[Copyrighted Material Omitted] COUNSEL ARGUED: Frederick Steven Longer, LEVIN, FISHBEIN, SEDRAN & BERMAN, Philadelphia, Pennsylvania, for Appellant. Terri Steinhaus Reiskin, HOGAN & HARTSON, L.L.P., Washington, D.C., for Appellee. ON BRIEF: Arnold Levin, Scott Levensten, LEVIN, FISHBEIN, SEDRAN & BERMAN, Philadelphia, Pennsylvania; Steven M. Pavsner, JOSEPH, GREENWALD & LAAKE, Greenbelt, Maryland, for Appellant. James B. Irwin, David O'Quinn, IRWIN, FRITCHIE, URQUHART & MOORE, L.L.C., New Orleans, Louisiana, for Appellee.
Before WILKINSON, Chief Judge, NIEMEYER, Circuit Judge, and Arthur L. ALARCON, Senior Circuit Judge of the United States Court of Appeals for the Ninth Circuit, sitting by designation.
Affirmed by published opinion. Chief Judge Wilkinson wrote the opinion, in which Judge Niemeyer and Senior Judge Alarcon joined.
This case is one of several thousand involving the promotion, sale, and use of pedicle screw fixation devices to treat spinal injuries. Appellant William Cooper brought this lawsuit against Smith & Nephew, Inc., claiming that its defective device was responsible for his failed back surgeries and the accompanying deleterious side effects. The district court dismissed Cooper's claims after determining that Cooper had no admissible medical evidence indicating that Smith & Nephew's device was the proximate cause of his injuries. Because the district court did not abuse its discretion in excluding the testimony of Cooper's expert on medical causation, we affirm the judgment.
Appellee Smith & Nephew, Inc., ("S&N"), manufactures the Rogozinski Spinal Rod System. The Rogozinski System is a medical device consisting of connectors, rods, bone screws, and hooks. Orthopedic surgeons use the Rogozinski System to aid them in performing spinal fusion surgeries. This type of surgery stabilizes the spine by fusing two or more vertebrae together into a single bone. The Rogozinski System is used to promote a successful fusion between vertebrae by providing stability for the spine.
Since June 25, 1990, the FDA has cleared the Rogozinski System for sale for some spinal applications. Prior to the initiation of this lawsuit, the Rogozinski System had not been approved for pedicle fixation. The pedicles are two pieces of bone on each side of the spinal vertebrae. Pedicle fixation is the process by which bone screws are inserted through the pedicles in order to provide increased spinal stability, thereby promoting fusion.
Once the FDA has cleared a device for introduction into the stream of commerce, physicians may use the device in any manner they determine to be best for the patient, regardless of whether the FDA has approved the device for this usage. This practice by physicians is known as "off-label" usage. See Buckman Co. v. Plaintiffs' Legal Comm., 121 S. Ct. 1012, 1018 (2001). Although the FDA had not approved the Rogozinski System for pedicle fixation prior to 1998, many physicians engaged in the off-label usage of the Rogozinski System for this purpose. Indeed in 1998, the FDA adjusted its assessment of devices capable of lumbar pedicle screw fixation, stating that "FDA believes that there is reasonable assurance that pedicle screw spinal systems are safe and effective for certain intended uses." See 63 Fed. Reg. 40,025, 40,035-36 (July 27, 1998).
On January 28, 1990, appellant William Cooper slipped on a patch of ice, resulting in lower back and leg pain. An MRI performed on Cooper in March 1990 revealed herniated disks between lumbar vertebrae positions 3 and 4 ("L3-L4"), 4 and 5 ("L4-L5"), and lumbar position 5 ("L5") and sacral region 1 ("S1"). The MRI also revealed a compression of the L4 nerve root sheath. Cooper subsequently underwent two procedures in order to alleviate his pain. The hospital records from these surgeries revealed that Cooper had smoked one pack of cigarettes per day for 25 years.
Following his second surgery, Cooper experienced worsening pain in his lower back and legs. After further diagnosis, an orthopedic surgeon, James Murphy, M.D., determined that there was instability in Cooper's lumbar spine. On June 19, 1991, Dr. Murphy performed spinal fusion surgery on Cooper, inserting the Rogozinski System between the L3-L4, L4-L5, and L5-S1 vertebrae. The goal of the surgery was to obtain a fusion at all three levels of vertebrae.
Following this surgery, Cooper continued to experience back and leg pain. By May 1992, Dr. Murphy believed that there likely was a nonunion at all three levels of vertebrae. Subsequent X rays revealed that the right S1 pedicle screw appeared to have loosened. During this time, Dr. Murphy continued to urge Cooper to stop smoking.
On October 15, 1992, a second fusion surgery on Cooper revealed that fusion had indeed occurred at L3-L4 and L4-L5. Dr. Murphy removed the pedicle screws from these levels. The surgery also revealed, however, that there was a nonunion at the L5-S1 level. Dr. Murphy attempted to refuse L5-S1, using the same bone screws, but attaching new rods and cross-links. After this surgery, Cooper continued to experience pain. An X ray taken on June 15, 1993, revealed that a screw had cracked on the left side of S1. In addition, a fusion failed to occur at L5-S1 following the second surgery. In preparation for yet another surgery, Dr. Murphy wrote in Cooper's medical records: "I think the most important function if we are going to reoperate on [Cooper] is that he stop smoking because that is going to really have a great deal of effect on the success or failure of the procedure."
In February 1995, Dr. Murphy performed a final surgery on Cooper, in which he attempted to fuse L5-S1. Dr. Murphy also removed the broken screw at left S1, and inserted new Rogozinski screws and rods at L4 and S1. Although Cooper suffered some complications, the surgery resulted in a fusion at L5-S1.
On August 12, 1997, Cooper filed a nine-count complaint against S&N and several other defendants. Cooper asserted claims for fraud, civil conspiracy, concert of action, fraudulent marketing and promotion, negligent misrepresentation, strict liability in tort, liability per se, negligence, and breach of implied warranty of merchantability. Pursuant to 28 U.S.C. S 1407, the suit initially was transferred to the multidistrict litigation in the United States District Court for the Eastern District of Pennsylvania. While in the multidistrict litigation, Cooper's conspiracy claims were dismissed. See In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781 (3d Cir. 1999). On August 11, 1999, the case was transferred back to the district court, with only the claims against S&N remaining.
In the present litigation, Cooper retained William Mitchell, M.D., and Harold Alexander, Ph.D., to present expert testimony that the Rogozinski System was the proximate cause of Cooper's injuries. Dr. Alexander is an expert in the field of biomedical engineering. He is not a medical doctor. For this reason, Dr. Alexander was found unqualified in the multidistrict litigation to opine as to causation in any individual plaintiff or to testify outside the area of orthopedic bioengineering. See In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1014, 1997 WL 39583 (E.D. Pa. Jan 23, 1997).
Cooper retained Dr. Mitchell to serve as his medical expert on specific causation. Dr. Mitchell has been a practicing orthopedic surgeon for approximately 38 years, and regularly examines spinal patients. Dr. Mitchell has performed numerous spinal fusion surgeries throughout his career. While Dr. Mitchell has been trained in the use of spinal implants, he has never implanted them in his patients. It was Dr. Mitchell's opinion that the Rogozinski System was incapable of bearing the stress to which it was subjected in Cooper's body. Dr. Mitchell claimed that, as a result of this defect, the left S1 pedicle screw fractured. This in turn caused the non-union at L5-S1. Dr. Mitchell's ultimate conclusion was that all of Cooper's injuries were the result of the Rogozinski System's failure to provide spinal stability.
On November 20, 2000, the district court granted S&N's motion to exclude all of Dr. Mitchell's testimony on medical causation. The court assumed that Dr. Mitchell was qualified as an expert under Fed. R. Evid. 702. Nonetheless, the court agreed with the numerous other district courts that had excluded Dr. Mitchell's testimony as unreliable in similar bonescrew lawsuits. Because all of Cooper's claims required expert medical testimony that the Rogozinski System was the proximate cause of his injuries, and because Dr. Alexander...
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