Opinion
Civ. No. JFM-95-3870.
December 1999.
MEMORANDUM
Plaintiff Theresa Fitzgerald instituted this action on October 10, 1996. Pursuant to 28 U.S.C. § 1407, the case was transferred to the multidistrict litigation in the United States District Court for the Eastern District of Pennsylvania. On May 28, 1999 Judge Louis Bechtle, the MDL judge, having resolved many preliminary issues and managing the litigation through discovery, remanded the case for disposition on the merits.
Ms. Fitzgerald contends that she has suffered injuries proximately caused by a defect in a spinal implant manufactured by Smith Nephew Richards ("SNR"). SNR has filed a motion to exclude the testimony and expert report of Dr. Norman Krause and for summary judgment on the issue of causation as to all of Ms. Fitzgerald's claims. Since I find, in my role as "gatekeeper" over expert testimony, that Dr. Krause's causation testimony is unreliable, the motion will be granted.
In light of my ruling on this point, I need not reach the other issues presented by SNR's motion for summary judgment or by its motion to exclude the testimony of Dr. Harold Alexander.
I.
On January 25, 1993, Ms. Fitzgerald underwent spinal vertebrae fusion surgery. Such surgery is intended to stabilize the patient's spine, relieving her of back pain and instability. Dr. John C. Barry performed the surgery and attached the Rogozinski Spine Rod System, manufactured by SNR, to Ms. Fitzgerald's spine. Ms. Fitzgerald's alleges that she experienced bowel and bladder complications, numbness in her feet and increased back pain after the fusion surgery. She alleges that her worsening condition was proximately caused by SNR's Rogozinski spinal fixation system.Theresa Fitzgerald has suffered back problems dating back to 1970. In 1970, Ms. Fitzgerald underwent back surgery which failed to alleviate her pain. Thus, in 1971, she received fusion surgery without instrumentation. According to Ms. Fitzgerald, the fusion surgery was successful and relieved her of pain. By 1988, however, she complained of pain in her lower back.
In 1989, Ms. Fitzgerald began to suffer neck pains as a result of a fall. She was diagnosed with cervical disc disease and eventually underwent fusion surgery on her neck. Shortly after the surgery, Ms. Fitzgerald complained of discomfort in both of her legs. By 1991, she was experiencing stabbing pain in her lower back and pain and tingling in her extremities. When the pain failed to subside, Ms. Fitzgerald consulted Dr. Barry who recommended physical therapy. She alleges that the physical therapy increased her discomfort.
In August, 1991, Drs. Randy Davis and David Tolner performed fusion surgery on Ms. Fitzgerald and implanted a bone growth stimulator. After this surgery, she was still suffering stabbing pain in her lower back and in February, 1992, she underwent surgery to remove the bone growth stimulator. In November, 1992, Ms. Fitzgerald again consulted Dr. Barry who now recommended an instrumented surgery using the Rogozinski device. The fusion surgery was performed by Dr. Barry with assistance from Dr. Tolner on January 25, 1993.
Although she told Dr. Barry that she was pleased with the results of the surgery, Ms. Fitzgerald continued to suffer from a variety of ailments, including blurred vision, tremors, and bladder and bowel complications. She also continued to complain of tingling sensations in her lower extremities and that her feet were going numb. In May, 1994 Ms. Fitzgerald was diagnosed by one of her physicians with fibromyalgia — a condition of general physical malaise consisting of musculoskeletal pain and stiffness, spasms, fatigue, and severe sleep disturbances. In August 1996, Ms. Fitzgerald underwent surgery to have the Rogozinski device removed. She alleges that her condition improved upon the removal of the hardware.
II.
Summary judgment is appropriate where the evidence shows that "there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). To avoid summary judgment, the non-moving party must present evidence such that "a reasonable jury could return a verdict for the non-moving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). While the movant bears the initial burden of showing that no genuine issue of material fact exists, he need not negate every allegation made by his opponent's case. Movant's motion should be granted if a showing is made that the non-moving party has failed to establish one of the elements essential to her case. Celotex v. Catrett, 477 U.S. 317, 322 (1986).
III.
Ms. Fitzgerald has filed several claims against SNR, including ones for fraud on the market, fraudulent marketing and promotion, negligent misrepresentation, strict liability in tort, liability per se, negligence, and breach of implied warranty of merchantability, In order to withstand SNR's motion for summary judgment as to all of these claims, she must present evidence that tends to show that the Rogozinski device was the proximate cause of her injuries. See, e.g., Doe v. Miles Labs., Inc., 675 F. Supp. 1466, 1475 (D.Md. 1987) (holding that under any products liability theory, a plaintiff is required to prove "a causal relation between the defect and the injury"); Lubore v. APM Assoc., Inc., 674 A.2d 547, 555 (Md. Ct. Sp. App. 1996) (noting that the tort of fraud or deceit requires proof of causation).
To meet her evidentiary burden for causation, Ms. Fitzgerald must rely upon expert testimony. Meda v. Brown, 569 A.2d 202, 207, 318 Md. 418 (Md. 1988). To be admissible under Rule 702 of the Federal Rules of Evidence, expert testimony must "assist the trier of fact to understand the evidence or to determine a fact in issue" and must be provided by a witness considered expert due to his or her "knowledge, skill, experience, training, or education." Fed.R.Evid. 702. In practice, FRE 702 requires a trial court to act in a "gatekeeping" capacity to protect against the admission of unreliable or irrelevant expert testimony. See Daubert v. Merrill Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Before admitting expert testimony regarding causation, the court must be convinced that such testimony is derived from "scientific knowledge" instead of speculation unsupported by the factual record. United States v. Dorsey, 45 F.3d 809, 813 (4th Cir.), cert denied, 515 U.S. 1168, 115 S.Ct. 2631 (1995).
Ms. Fitzgerald argues that her burden of proof varies from claim to claim, i.e., that what she must establish for her negligence claims is not the same as what she must establish for her strict liability claim. Assuming that to be true, my exclusion of Dr. Krause's testimony is fatal to all of her claims since evidence of medical causation is necessary as a bare minimum on any claim.
Here, in proffering evidence for causation, Ms. Fitzgerald has indicated that she will rely upon the expert testimony of Dr. Norman M. Krause. SNR has filed a motion to exclude the testimony of Dr. Krause on the grounds that he is unqualified and that his opinions and testimony are unreliable. In response, Ms. Fitzgerald alludes to a "liberality associated with admitting expert testimony" and claims that Dr. Krause is in fact qualified and would present reliable and relevant testimony.
SNR also argues that Dr. Krause's testimony does not "fit" the facts of the case and assist the trier of fact. See, e.g., Westberry v. Gislaved Gummi AB, 178 F.3d 257, 260-61 (4th Cir. 1999). This argument is based upon Dr. Krause's reliance on the findings of Dr. Harold Alexander. Dr. Alexander — Ms. Fitzgerald's other expert — has identified the "bulkiness" of the Rogozinski device as its design flaw. According to SNR, Dr. Alexander has related this defect only to the failure of the device to effect a proper fusion. Since it is undisputed that Ms. Fitzgerald's 1993 surgery did result in a fusion, SNR contends that Ms. Fitzgerald's attempt to prove medical causation through Dr. Krause is unavailing. I need not decide this question since I find that Dr. Krause's opinions should be excluded because of their unreliability.
Ms. Fitzgerald alleges that, after the implantation of the Rogozinski system, she experienced heightened pain and complications in her right leg and foot, urinary urgency, and bowel incontinence. She seeks to admit the testimony and opinions of Dr. Krause to prove that these health problems emanated from her spine and were proximately caused by defects in the device. Ms. Fitzgerald correctly contends that I "need not be persuaded by plaintiff's expert proposed causation testimony in order to find that it is admissible." Pl.'s Response at 6-7. I must be persuaded, however, that the causation testimony is based upon some objective, scientific methodology and is not of a "wholly conclusory" nature. MM Medical Supplies v. Pleasant Valley Hospital, 981 F.2d 160, 165 (4th Cir. 1992).
IV.
Dr. Krause is a general orthopedic surgeon with twenty years' experience. He performs, on average, six to seven surgeries a week. His surgeries often involve placing pins or plates in bone to hold broken pieces of bone together when fractures have occurred. As part of his almost daily routine, he also "listen[s] to patients and examine[s] them and look[s] at films and render[s] an opinion regarding the cause of their back and leg pain." Accordingly, he considers himself "an expert on non-surgical treatment of spine disease." In rendering his opinions he necessarily is familiar with the effects of implementation of metallic hardware.
Dr. Krause is not, however, a spine surgeon. He has never seen a Rogozinski device and does not consider himself an expert in spinal instrumentation. For these reasons SNR asserts that he is unqualified to render an opinion concerning the genesis of Ms. Fitzgerald's pain. SNR cites in support of its position a series of cases in which trial judges have analyzed the qualifications of proffered medical experts and concluded that general expertise is not sufficient to qualify a physician to testify on a matter that requires particularized knowledge, training, education, or experience. See, e.g., Sutera v. Perrier Group of America, Inc., 986 F. Supp. 655, 667 (D. Mass. 1997); Waiting v. Boston Edison Co., 891 F. Supp. 12, 24 (D. Mass. 1995).
SNR's contention may be meritorious. I need not, however, decide the issue of Dr. Krause's qualifications since I find, assuming he is qualified to express an opinion, that his testimony is unreliable. His opinions are not based on "the methods and procedures of science [but] rather . . . on subjective belief or unsupported speculation." Sutera, 985 F. Supp. at 660.
In reaching his conclusions Dr. Krause purportedly performed a differential diagnosis. Differential diagnosis is a "standard scientific technique of identifying the cause of a medical problem by eliminating the likely cause until the most probable one is isolated." Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th Cir. 1999). In and of itself differential diagnosis certainly is a "method and procedure of science." However, in order for conclusions drawn from a differential diagnosis to be admissible, the diagnosis must be conducted with "intellectual vigor." Kumho Tire Co. v. Carmichael, 119 S.Ct. 1167, 1176 (1999). Its underlying integrity requires professional thoroughness, and it must at least "take serious account of other potential causes."Westberry 178 F.3d at 265. Dr. Krause's diagnosis does not hold up under these standards.
Where a plaintiff has a complicated and troubled medical history, any reliable causation testimony based on temporal relationship must be based upon complete and accurate facts. See Heller v. Shaw Industries, Inc., 167 F.3d 146 (3d. Cir. 1999) (excluding expert testimony based on temporal relationship due to expert's disregard of critical facts). Here, Dr. Krause's conclusions are based upon only a portion of Ms. Fitzgerald's partial medical history. He has not reviewed Ms. Fitzgerald's medical records prior to 1991 (or, at least, only a portion of them) despite Ms. Fitzgerald's history of back and other health problems beginning in 1970. Nor has he reviewed any of her medical records subsequent to the 1996 explantation procedure. Moreover, Dr. Krause never examined Ms. Fitzgerald. On deposition he testified that such an examination was not critical to his differential diagnosis since, although "ideally it would be nice to see every patient before and after their surgery, . . . many times I have to rely on records to render opinions. It's an acceptable way of doing things." Krause dep. at 149-50. Earlier in his deposition, however, when being questioned about his qualifications, Dr. Krause testified that the opinion of a physician must be "based on the chronology of the symptoms and the patient's presentation and the patient's credibility and things of that nature." Krause dep. at 49. This clinical judgment requires personal contact between a physician and patient. See Westberry, 178 F.3d at 262 ("a reliable differential diagnosis typically, though not invariably, is performed after `physical examination, the taking of medical histories, and the review of clinical tests, including laboratory tests'" (quoting Kannankeril v. Terminix Int'l, Inc., 128 F.3d 802, 807 (3d Cir. 1997)). There was no such contact in this case. Indeed, Dr. Krause did not even bother to read Ms. Fitzgerald's deposition although it had been taken by the time he conducted his review.
In Dr. Krause's August 13, 1999 report he indicates that the records he reviewed were "[the] records of Dr. John Barry from 1991 through 1993; office records of Dr. James Murphy from 1996; records from St. Agnes Hospital from 1996, including the operative report of Dr. James Murphy; and records from North Arundel Hospital from 1993, including the operative reports of Dr. John Barry and David Tolner." During oral argument Ms. Fitzgerald's counsel pointed out that there are some pre-1993 operative reports included among the records reviewed by Dr. Krause. Aside from the fact that Dr. Krause apparently did not recall these records when he prepared his report, those records do not reflect much of the information that Dr. Krause should have considered from other pre-1991 medical records in performing his differential diagnosis.
These procedural irregularities, perhaps more aptly described as flaws in professional practice, demonstrate that Dr. Krause did not undertake his medical review and formulate his opinions with "intellectual rigor." Moreover, they prevented him from becoming knowledgeable about material facts that were essential to his differential diagnosis. For example, if Dr. Krause had reviewed all of Ms. Fitzgerald's pre-1991 medical records, he would have learned that Ms. Fitzgerald had experienced bladder problems prior to the 1993 fusion surgery. Furthermore, if he had simply read Ms. Fitzgerald's deposition, he would have learned that before the 1993 surgery, she was unable to work, could not sit for any length of time, and could not walk without excruciating pain. Fitzgerald dep. at 103-04. Likewise, if Dr. Krause had reviewed the medical records subsequent to the 1996 explant procedure, he would have learned that, during an October 1996 evaluation with Physiotherapy Associates, Ms. Fitzgerald reported that she was in "constant, excruciating pain" since her August 1996 surgery. When confronted with this report on deposition, Dr. Krause admitted that this report was relevant to his opinion and that it "trouble[d]" him. Krause dep. at 91-92. Dr. Krause went on to discuss certain other records from 1997 that he said "[did not] change my opinion as much." However, after being stopped in his answer by Ms. Fitzgerald's counsel, he never gave any explanation whatsoever as to how he could reconcile the October 1996 report with his conclusions.
Finally, Dr. Krause's testimony is unreliable because he failed to rule out what could have been another cause of Ms. Fitzgerald's condition — her prior foraminotomies. See In re Paoli Railroad Yard PCB Litigation, 35 F.3d 713, 759 n. 27 (3d Cir. 1994) (stating "where a defendant points to a plausible alternative cause and the doctor offers no explanation for why he or she has concluded that was not the sole cause, that doctor's methodology is unreliable"). When asked on deposition whether scarring at prior foraminotomies could have caused the irritation of the spinal cord which Ms. Fitzgerald described, Dr. Krause answered "[w]ell, except that the pain went away a lot when the whole implant was removed." Krause dep. at 63. Counsel for SNR immediately followed up, however, and the following exchange occurred:
Q. Well, didn't they also do a foraminotomy when the implant was removed?
A. Yes.
Q. And couldn't that account for the reduction of the pain?
A. It can, yes.
Id. When considered in their entirety, the net effect of these questions and answers is that Dr. Krause provides no satisfactory explanation for excluding the prior foraminotomies as a cause of Ms. Fitzgerald's pain. Moreover, later in the deposition he again testified that Ms. Fitzgerald's tingling, numbness, and pain in the legs could be the result of scarring from multiple foraminotomies. See Krause dep. at 125-26.
For all of these reasons defendant's motion to exclude Dr. Krause's testimony and its motion for summary judgment on the issue of causation is granted. A separate order effecting the rulings made in the Memorandum is being entered herewith.
ORDER
For the reasons stated in the accompanying memorandum, it is, this ______ day of December 1999
ORDERED
1. Defendant's motion to strike the expert report of Norman M. Krause, M.D. and to exclude his opinion testimony and for summary judgment on the issue of causation is granted;
2. Judgment is entered in favor of defendant against plaintiff; and
3. The Clerk is directed to close the case.