UNPUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

THERESA L. FITZGERALD; JOHN

PATRICK FITZGERALD, JR.,

Plaintiffs-Appellants,

v.

SMITH & NEPHEW, INCORPORATED,

Defendant-Appellee,

SMITH & NEPHEW PLC; BURNETT

MEDICAL COMPANY, INCORPORATED;

T. G. MEDICAL, INCORPORATED;

LARRY GROSS & ASSOCIATES,

INCORPORATED; HERRINGTON AND

ASSOCIATES, INCORPORATED;

ORTHOPEDIC SYSTEMS, INCORPORATED;

DUSTY SULLIVAN CORPORATION;

No. 00-1145

ABRAHAM ROGOZINSKI; CHAIM

ROGOZINSKI; SAM ROGOZINSKI; JAMES

WALT SIMMONS; WILLIAM WATTERS,

III; G. LEE CROSS; GARTH RUSSELL;

AMERICAN ACADEMY OF ORTHOPEDIC

SURGEONS; NORTH AMERICAN SPINE

SOCIETY; SCOLIOSIS RESEARCH

SOCIETY; COLUMBIA REGIONAL

HOSPITAL; JACKSONVILLE MEMORIAL

MEDICAL CENTER; GEORGIA BAPTIST

HOSPITAL; ST. LUKE'S EPISCOPAL

HOSPITAL; MASSACHUSETTS GENERAL

HOSPITAL; SAN ANTONIO REGIONAL

HOSPITAL, AKA HUMANA; ACROMED

CORPORATION, CHARTER NUMBER

614043; ACROMED CORPORATION;
ACROMED CORPORATION, CHARTER

NUMBER 816942; ACROMED

RESEARCH AND DEVELOPMENT

CORPORATION; ACROMED SPINE

RESEARCH FOUNDATION,

INCORPORATED; 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; DEPUY-MOTECH,

INCORPORATED; HOWMEDICA,

INCORPORATED; SCIENTIFIC SPINAL;

SYNTHES (U.S.A.); SYNTHES NORTH

AMERICA, INCORPORATED; SYNTHES,

A.G. CHUR; DANEK MEDICAL,

INCORPORATED; SOFAMOR,

INCORPORATED; SOFAMOR-DANEK

GROUP, INCORPORATED; SOFAMOR,

S.N.C.; NATIONAL MEDICAL

SPECIALTY, INCORPORATED, AKA

STUART MEDICAL SPECIALTY,

INCORPORATED; ADVANCED BIOSEARCH

ASSOCIATES; SPINAL SCIENCE

ADVANCEMENT FOUNDATION; HEALTH

INDUSTRY MANUFACTURER'S

ASSOCIATION; ORTHOPEDIC SURGICAL

MANUFACTURERS ASSOCIATION; SPINAL

IMPLANT MANUFACTURERS GROUP;

ZIMMER, INCORPORATED,

Defendants.

 2
Appeal from the United States District Court

for the District of Maryland, at Baltimore.

J. Frederick Motz, Chief District Judge.

(CA-95-3870-Y)

Argued: September 27, 2000

Decided: June 12, 2001

Before WILLIAMS, Circuit Judge,

HAMILTON, Senior Circuit Judge, and

Robert E. PAYNE, United States District Judge for the

Eastern District of Virginia, sitting by designation.

_________________________________________________________________

Affirmed by unpublished per curiam opinion.

_________________________________________________________________

COUNSEL

ARGUED: Frederick Steven Longer, LEVIN, FISHBEIN, SEDRAN ARGUED:

& BERMAN, Philadelphia, Pennsylvania, for Appellants. Terri Steinhaus Reiskin, HOGAN & HARTSON, L.L.P., Washington, D.C., for

Appellee. ON BRIEF: ON BRIEF: ON BRIEF: Arnold Levin, Scott Levensten, LEVIN,

FISHBEIN, SEDRAN & BERMAN, Philadelphia, Pennsylvania; Steven M. Pavsner, JOSEPH, GREENWALD & LAAKE, Greenbelt,

Maryland, for Appellants. James B. Irwin, Nathan T. Gisclair, Jr.,

MONTGOMERY, BARNETT, BROWN, READ, HAMMOND &

MINTZ, L.L.P., New Orleans, Louisiana, for Appellee.

_________________________________________________________________

Unpublished opinions are not binding precedent in this circuit. See

Local Rule 36(c).

_________________________________________________________________

 3
OPINION

PER CURIAM:

This is an appeal from an order of the district court granting summary judgment in favor of Smith & Nephew, Incorporated ("S&N"),

the manufacturer of an allegedly defective medical device referred to

as the Rogozinski Spinal Rod System ("Rogozinski System") which

was implanted in Theresa Fitzgerald in 1993 and explanted in 1996.

The district court granted summary judgment because, after it precluded, as unreliable, the testimony of Mrs. Fitzgerald's only expert

witness on the subject of causation, there was no evidence on which

a jury reasonably could find that the medical device had caused Mrs.

Fitzgerald's injury. We affirm.1

I.

Mrs. Fitzgerald has a long history of back problems dating back to

1970 when, at the age of 19, she was diagnosed with defects in the

configuration of her lumbar spine. The medical history is documented

in the record and is not disputed. To assess the district court's decision, it is necessary to appreciate the medical background against

which the district court precluded the expert testimony as unreliable.

In December 1970, Mrs. Fitzgerald had the first of six lumbar spine

surgeries, an interlaminal exploration and foraminotony at the L4

level of her spine. J.A. 1420. However, that surgery did not relieve

her symptoms (generalized back pain, which radiated into both legs).

Id. Therefore, a second surgery ensued in July 1971, another

foraminotony, accompanied by an attempted fusion at the L4-L5 and

L5-S1 levels of the spine. J.A. 213, 1420-21. According to Mrs. Fitzgerald, the second surgery was successful and her back pain subsided.

By 1988, however, Mrs. Fitzgerald began to again experience low

back pain, accompanied by bladder problems, constipation and numb-

_________________________________________________________________

1 Mr. Fitzgerald's claim is for loss of consortium and depends on the 1 

same causation evidence as that offered by Mrs. Fitzgerald to support her

claims. For the sake of simplicity, we will refer hereafter only to Mrs.

Fitzgerald.

 4
ness in both legs. J.A. 1422. A CAT scan revealed developmental

abnormalities and degenerative changes at the L4-L5 and L5-S1

levels of Mrs. Fitzgerald's spine. Mrs. Fitzgerald fell in 1989 and she

began thereafter to suffer neck pains. J.A. 1364. In January 1990,

Mrs. Fitzgerald reported pain and tingling in her arms and, later in the

month, she reported numbness and pain over the entire left side of her

body. J.A. 1423, 1426. A CT scan revealed that Mrs. Fitzgerald's

brain was normal, but it also disclosed disc difficulties. J.A. 1427.

Later, Mrs. Fitzgerald was diagnosed with cervical disc disease and,

in October 1990, underwent fusion surgery on her neck. J.A. 1430-35.

About five weeks later, she began to complain of frequent urination

and again reported discomfort in both legs. J.A. 1436-38.

Subsequently, in February 1991, Mrs. Fitzgerald continued to

report bladder problems as well as tingling in her legs. J.A. 1444-45.

Additionally, she continued to complain of lower back pain for which

no objective cause was uncovered, notwithstanding extensive testing.

In May 1991, Dr. Tolner, Mrs. Fitzgerald's treating physician, cataloged her reports of leg and back pain for the three preceding years,

observed that those reports were unsupported by objective neurological findings and confessed still to be "quite at a loss to explain this

patient's symptoms." J.A. 1448. Hence, Dr. Tolner referred Mrs. Fitzgerald to Dr. Randy Davis, an orthopedic surgeon.

Shortly thereafter, but also in May 1991, Dr. Davis examined Mrs.

Fitzgerald, reviewed her medical history, and reached the conclusion

that Mrs. Fitzgerald likely had a nonunion of the spine at L4-L5 or

a pseudarthrosis there. J.A. 1449. Dr. Davis recommended rehabilitation therapy and advised Mrs. Fitzgerald that, if the rehabilitation

therapy was unsuccessful, she might consider surgery to explore the

fusion that had been accomplished in 1991, a surgical procedure to

which Dr. Davis ascribed a 40% chance of improving Mrs. Fitzgerald's situation and a 10% chance of making it worse. J.A. 1449-50.

At about the same time, Mrs. Fitzgerald consulted Dr. Barry who also

recommended physical therapy. J.A. 1451-52.

Mrs. Fitzgerald, however, reported that physical therapy made her

worse. J.A. 1455. She complained that she could not walk without

pain and determined to proceed with surgery. After consulting again

with Dr. Davis, who emphasized that he was pessimistic about the

 5
benefit of surgery, Mrs. Fitzgerald elected to proceed with the surgical alternative and, on August 1, 1991, Drs. Davis and Tolner performed Mrs. Fitzgerald's next surgery, this time a revision lumbar

laminectomy with extended foraminotomies and an L4-L5 fusion.

J.A. 1455, 1456-57. They also implanted a bone growth stimulator to

assist the process of fusion. J.A. 1456-57. Mrs. Fitzgerald initially

reported significant improvement, and she was discharged from neurological care in December 1991. J.A. 1458. However, in February

1992, she had surgery to remove the bone growth stimulator.

A month later, in March 1992, Mrs. Fitzgerald again complained

that the back pain had returned and that it significantly limited her

activities. J.A. 1459. Dr. Davis expressed the opinion that she might

have pseudarthrosis, but advised against further surgery because it

would involve the use of plates and screws to stabilize her spine. J.A.

1460. Mrs. Fitzgerald returned to Dr. Davis in September 1992,

reporting that she could no longer live with her severe and debilitating

pain and that she wanted once again to consider surgical options. J.A.

1461. In November 1992, Mrs. Fitzgerald told Dr. Barry that she

wanted to have surgery but that she did not want to return to Dr.

Davis because she had "lost repore [sic] with him." J.A. 1462.

Dr. Barry informed Mrs. Fitzgerald, as had Dr. Davis sometime

before, that further relief would require implanting the Rogozinski

System. Dr. Barry's records reflect that he informed Mrs. Fitzgerald

that there was "significant risk of damage to nerve roots from placement of pedicle screws possibly requiring the need to go back and

remove the screws." J.A. 1462. Dr. Barry also recorded that Mrs. Fitzgerald "understands that even with the instrumentation there was no

guarantee that the fusion would take and that the instrumentation

itself would not hold up without a solid fusion." Id.2 Mrs. Fitzgerald's 2

next surgery, implantation of the Rogozinski System, was performed

on January 21, 1993 to fuse the spine at the L4-L5 level. J.A. 1417-

19.

_________________________________________________________________

2 Dr. Tolner corroborated this information, although Mrs. Fitzgerald 2 

now contends that neither doctor warned her of the experimental nature

of the Rogozinski System. J.A. 1464.

 6
Immediately after that surgery, Mrs. Fitzgerald reported improvement; and, on a follow-up visit in May 1993, she had no back or leg

pain, and she reportedly was "very pleased" with the result of the surgery. J.A. 1469. That circumstance did not last long, and, by July

1993, Mrs. Fitzgerald complained of "some bizarre symptoms in her

arms and legs" as well as headaches, weakness, short term memory

loss, and difficulty judging distances. J.A. 1469-70.

Dr. Barry examined Mrs. Fitzgerald in September 1993 and

observed, through x-rays, that there was a solid fusion at L4-L5 "with

no change in the excellent position of the fixation hardware." J.A.

1472. Like Mrs. Fitzgerald's family doctor, Dr. Barry thought that

perhaps her difficulties were psychiatric or psychological in origin

and suggested exploring that alternative for treatment. Id.

In May 1994, another doctor diagnosed Mrs. Fitzgerald with fibromyalgia, J.A. 1476, a form of nonarticular rheumatism which is said

to cause pain or stiffness in the lower back, neck, shoulders, arms,

hands, knees, thighs, legs and feet. J.A. 1476. Later in 1994, Dr. Hennessy, a neurosurgeon, suggested that the Rogozinski System could

be related to Mrs. Fitzgerald's recurring back pain and asked whether

she wanted to remove it. J.A. 1474. Although Mrs. Fitzgerald refused

to proceed with that course in 1994, she did have the Rogozinksi System removed on August 8, 1996 after she had learned about pending

multidistrict litigation involving the use of bone screws. J.A. 1479-80,

85. Dr. James Murphy performed the explant of the Rogozinski System and confirmed that, at the time, there was a solid fusion of L4-L5.

J.A. 1479-80.

For a brief period after explantation of the Rogozinski System

occurred, Mrs. Fitzgerald experienced relief. However, by October

1996, she again complained of "constant excruciating pain," of numbness and weakness, cervical pain, and reported that her level of activity had significantly decreased. J.A. 1414. Her complaints of cervical

pain persisted into December 1997, at which time she also reported

suffering from neck, arm and posterior iliac spine pain and twitching

and numbness in both legs. J.A. 1416. In April 1998, nearly two years

after explanation of the Rogozinski System, Mrs. Fitzgerald still complained of headaches, neck and arm pain, "chronic pain with her back

and [was] severely limited in her activities." J.A. 1415.

 7
II.

Mrs. Fitzgerald instituted this action on October 10, 1996 and, pursuant to 28 U.S.C. § 1407, it was transferred to the multidistrict litigation pending in the United States District Court for the Eastern

District of Pennsylvania. On May 28, 1999, after Judge Bechtle, the

MDL judge, had resolved a goodly number of issues, the action was

remanded for disposition on its merits.

The claims left for resolution on remand that remain the subject of

this appeal are those of strict liability in tort, negligence in the design,

manufacture, testing and marketing of the Rogozinksi System and the

alleged breach of the warranty of merchantability. 3 The Amended

Complaint alleges that the assertedly defective Rogozinski System

caused various injuries to Mrs. Fitzgerald's spine and neural system.

Mrs. Fitzgerald's brief on appeal charges that her"symptoms

increased dramatically upon the implantation of S&N's defective

device and decreased significantly upon its explantation." Appellants'

Opening Brief at 16. Dr. Norman M. Krause was designated to present Mrs. Fitzgerald's only evidence on the issue of causation.

Dr. Krause is a general orthopedic surgeon who does not specialize

in spine surgery and who is expert neither in spinal instrumentation

nor in the Rogozinski System. Although S&N asserted Dr. Krause's

lack of qualifications as a ground for precluding his testimony, the

district court found it unnecessary to confront that issue. It is undis-

_________________________________________________________________

3 The Amended Complaint asserted various claims of, and related to, 3 

fraud on the FDA. The Plaintiff argued on appeal that, in light of the "but

for" proximate causation doctrine available under Maryland law, the

mere implantation of the Rogozinski System would permit her claims of

fraud on the FDA to proceed without the need for expert testimony.

However, after oral argument in this case, the Plaintiff rightly acknowledged that the recent decision of the Supreme Court of the United States

in Buckman Co. v. Plaintiffs' Legal Committee , 531 U.S. 341, 121 S. Ct.

1012 (2001), precludes her claims of fraud on, and related to, the FDA.

In Buckman, the Supreme Court held that a state law action based on

fraud on the FDA is preempted by the Medical Device Amendments to

the Food, Drug and Cosmetic Act, 21 U.S.C.A. § 360e(b)(1)(A, B).

Hence, the causation argument respecting those claims is moot and we

do not further consider it.

 8
puted, however, that Dr. Krause did not examine Mrs. Fitzgerald, did

not speak with her or with her treating physicians, did not review her

deposition testimony and never reviewed any x-rays of Mrs. Fitzgerald's spine. J.A. 496, 581. And, it is agreed that Dr. Krause's opinion

was reached, and his report prepared, based on a review of medical

records. J.A. 483, 486, 496. On that basis, Dr. Krause expressed an

opinion, to a reasonable degree of medical certainty, as follows:

I feel that Ms. Fitzgerald's back and leg problems were

made substantially worse by the instrumentation with the

Rogozinski frame in 1993. This, being a very bulky foreign

body, as reflected in Dr. Alexander's defect report, caused

increased tissue scarring, fibrosis, nerve root entrapment and

exacerbation of her medical condition. Based on the records

reviewed, I am able to rule out other potential causes of Ms.

Fitzgerald's pain such as disc herniation, otseomyelitis, etc.

This opinion is substantiated by the fact that her symptoms

got markedly worse, including increasing leg pain, right foot

drop and bowel and bladder problems directly after the 1993

surgery. The fact that Ms. Fitzgerald felt significantly better

and was able to resume many of her activities of daily living

starting immediately after the removal of this hardware further substantiates this assertion. The fact that, at the time of

the 1996 surgery, Dr. Murphy found that several of the

screws were loose and his diagnosis was retain painful hardware [sic] further substantiates this opinion.

J.A. 646. The district court concluded that "[i]n reaching his conclusions, Dr. Krause purportedly performed a differential diagnosis"

which, citing Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262

(4th Cir. 1999), the district court correctly identified as "a `standard

scientific technique of identifying the cause of a medical problem by

eliminating the likely cause[s] until the most probable one is isolated.'" J.A. 1369. The district court also observed that:

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

[sic]." Kumho Tire Co. v. Carmichael , 119 S. Ct. 1167, 1176

 9
(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.

Id.

The district court further correctly observed that"[w]here 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,"4 and concluded that Dr. Krause's opinions were based upon "only a portion of Ms. Fitzgerald's partial medical history." Id. That was because Dr. Krause failed to review most,

if not all, of Ms. Fitzgerald's medical records before 1991, notwithstanding that Mrs. Fitzgerald had complained of similar back problems since 1970. As a further ground, the district court rightly found

that Dr. Krause had not considered Mrs. Fitzgerald's medical records

after 1996, notwithstanding that the same kind of symptoms she had

expressed for years before implantation had returned after the explantation of the Rogozinksi System in 1996. The district court held that

those deficiencies rendered Dr. Krause's opinion scientifically unreliable considering that Dr. Krause had not examined Mrs. Fitzgerald,

had not talked with her or her treating physicians about her pre-1991

or post-1996 back pain and related symptoms, and had not read her

deposition in which she had discussed those matters. J.A. 1370. In the

district court's opinion, the approach taken by Dr. Krause "prevented

him from becoming knowledgeable about material facts that were

essential to his differential diagnosis" (the reported bladder problems

and excruciating pain before the 1993 implantation and the presence

of the same kind of "constant, excruciating pain" after the 1996

explant procedure). Thereupon, the district court held that application

of the differential diagnosis method by Dr. Krause was unreliable on

the facts of record respecting Mrs. Fitzgerald's long and complicated

medical history of back pain, which, in essentially the same form, pre-

_________________________________________________________________

4 Id. (citing Heller v. Shaw Industries, Inc., 167 F.3d 146 (3d Cir.

1999)).

 10
dated and post-dated implantation, and the subsequent explantation,

of the Rogozinski System. J.A. 1370-71.5 

III.

We review the decision precluding Dr. Krause's opinion testimony

for abuse of discretion. See General Electric Co. v. Joiner, 522 U.S.

136 (1997). Where, as here, the plaintiff's claim is based on the worsening of pain and other symptoms which have been manifest for years

before the allegedly causative event and which continue after that

event in largely the same form, where the record discloses a lengthy

and complex medical history, and where the expert's opinion is made

without reference to significant parts of the plaintiff's medical history

both before and after the event that is alleged to have caused aggravation of a pre-existing injury, we cannot say that the district court

abused its discretion in foreclosing, as unreliable, an opinion which

assertedly employed an otherwise standard method and procedure of

medical science. There being no other evidence of causation, the district court did not err in granting summary judgment on all of the

plaintiff's claims because, on each claim, the plaintiff relied only on

the opinion of Dr. Krause to establish causation. Therefore, on this

record and for the reasons stated by the district court in Fitzgerald v.

Smith & Nephew Richards, Inc., Civil No. JFM-95-3870 (D. Md.

Dec. 30, 1999), we affirm the decisions to exclude the testimony of

Dr. Krause and to grant summary judgment on the issue of causation.

The judgment of the district court is

AFFIRMED.

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5 The district court considered Dr. Krause's methodology to have been 5 

unreliable for the additional reason that he "failed to rule out what could

have been another cause of Ms. Fitzgerald's condition -- her prior four

foraminotomies." J.A. 1371. That failure was particularly problematic, in

the view of the district court, considering that Dr. Krause testified at

deposition that "Ms. Fitzgerald's tingling, numbness, and pain in the legs

could be the result of scarring from multiple foraminotomies." Id. (citing

Krause dep. at 125-26).

 11