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COURT FINDS SUFFICIENT EVIDENCE TO ALLOW CLAIM THAT MANUFACTURER ILLEGALLY
PROMOTED OFF-LABEL USE OF MEDICAL DEVICE
Claim Rejected on
Basis That Physician
Made Independent Decision to Use Device
A federal district court in New York has concluded that a patient produced
sufficient evidence pursue his claim that a manufacturer illegally promoted a
medical device for an off-label use by funding grants, seminars and a doctor's
manual which encouraged use of the device for a purpose which had not been
approved by the FDA. Nevertheless, the court granted summary judgment in favor
of the manufacturer on the basis that the physician who treated the patient
decided to use the device based on his independent knowledge and experience.
Plaintiff underwent spinal fusion surgery to alleviate severe back pain. During
the surgery, the operating physician implanted orthopedic bone screws in the
pedicles of plaintiff's spine to aid in the fusion process. Plaintiff
subsequently suffered complications which he attributed to breakage of one of
the bone screws. Plaintiff filed an action against the manufacturer of the bone
screws, alleging that the screws were defectively designed and were not suitable
for spinal surgery, a purpose for which they had not been approved by the FDA.
(The bone screws had been approved by the FDA for other types of medical
treatment.) The suit further alleged that the manufacturer had promoted this
unapproved use of the bone screws by funding seminars, research grants and the
publication of a doctor's manual that had the effect of inducing the medical
profession to use the screws in spinal surgery. This promotional activity by the
manufacturer was alleged to have constituted negligence per se because
the Federal Drug & Cosmetic Act (FDCA) and the Medical Device Amendments (MDA)
to that Act prohibit the marketing of a medical device for a use which has not
been approved by the FDA. The manufacturer filed a motion for summary judgment.
The court concluded that plaintiff had presented sufficient evidence of illegal
promotional activity to avoid summary adjudication on that issue. The court
determined that although this evidence was "tenuous," plaintiff had
adequately supported his allegation that the manufacturer "subtly
brainwashed" the medical profession - through a discreet promotional
campaign - to adopt an off-label use of the bone screws as the prevailing
medical standard of care. The court explained that it was possible that
physicians who perform spinal surgery had been influenced by colleagues with
financial ties to the manufacturer, and that the manufacturer had thereby
promoted an unapproved use of the bone screws without having its name directly
associated with the promotion.
The court proceeded, however, to find that plaintiff had failed to present
sufficient evidence of causation on his illegal promotion claim because the
surgeon who operated on him was a highly qualified, experienced doctor who could
not have based his decision to use the bone screws on the manufacturer's alleged
promotional campaign. In so finding, the court reasoned that a jury could not
reasonably conclude that the physician was unaware of developments in his field
and had simply relied upon the manufacturer's promotional campaign in deciding
to use the bone screws. The court therefore rendered summary judgment on the
illegal promotion claim.
The court also rendered summary judgment on plaintiff's design defect and
failure-to-warn claims, finding (a) that the lack of FDA approval for use
of the bone screws in spinal fusion surgery did not render the device defective;
and (b) that although the manufacturer did not expressly warn doctors that the
bone screws had not been approved for use in spinal surgery, the manufacturer
did advise doctors of the uses which the device had been approved.
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