02/27/2012    Allen Jacobs, DPM

The Technological Imperative: A Warning

The most recent issue of "case closed", produced
by PICA for the education of insured
podiatrists, featured a case in which a Pegasus
graft was utilized in the 1st MPJ. It was noted
by the reviewing defense experts that this
particular graft is not approved for, nor is
there literature to support, utilization in the
1st MPJ. The complications which occurred in the
surgery performed may or may not have been
related to the unapproved use of the Pegasus,
but the use of this material in an unapproved
manner contributed, shall we say, to the
vulnerability of the defendent in this case. The
case settled for over $350,000

I have just completed the review of yet another
case of less than adequate outcome following the
use of a Pegasus graft in the 1st MPJ, with
complications from that surgery resulting in
litigation.

I have evaluated several negligence actions
related to orthobiologics, particularly
following use in the 1st MPJ and as augmentation
in Achilles tendon surgery.

Although representatives of the companies making
various products for surgery might encourage you
to utilize new devices, and hired podiatric
surgeon/"consultants" encourage the non-FDA use
of various implants, please use appropriate
judgement. A white paper, a lecture by a hired
gun, or the "experience of a rep" watching "
others do it with great successs", will not be
of much help when you are sued for complications
following the non-FDA use of implant materials.

It is my opinion that the companies making such
products need to be held accountable for
encouraging and "handing over" these products
for unapproved use. Furthermore, it is time to
stop speakers at our meetings from allowing
speakers who encourage unapproved use of implant
materials, fixation devices, and so forth.

It is you who will be sued, NOT the speaker or
the company rep that encouraged you to use these
materials.

What is the opinion of the PM News readers?

Allen Jacobs, DPM, St. Louis, MO,
allenthepod@sbcglobal.net

Other messages in this thread:

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03/07/2012    Michael M. Rosenblatt, DPM

RE: The Technological Imperative: A Warning (Allen Jacobs, DPM)

When I was in podiatry school, one of our
professors, Dr. Vinocur, an allergist teaching
us pharmacology, was known for his common-sense
approach to many issues. He advised us against
using new drugs or drugs that had not been
thoroughly tested, especially those that were
not commonly used in our area of practice.

His sage advice: “Let others shoulder the risk
of new drugs and medical technologies. You have
enough to worry about.” The “others” he was
referring to might be university-based medical
school-backed programs that have their own built-
in legal protections and attorneys on retainer.
He further advised us to use only medications
that we had an opportunity to become expert on,
with knowledge of interactions, allergies, and
spectrum of application.

This would also seem to apply to surgical
implants. Fortunately there are many surgical
implants in podiatry that are commonly used and
have a long history. As an example, the Swanson
hemi-surgical implant has been in use since
1967. I’m not saying one type fits all, but if
you are sued because of a sub-optimal result,
the implant you used will not be on plaintiff’s
attorneys table. Instead, your experts will
introduce hundreds of articles and studies on
your behalf. That might be enough to sink the
suit before it starts.

Introduction of surgical joint implants will
always be a risky technical issue in itself. But
using tried and true devices will expose your
patient to very long historical use. That is
what I would choose for my own feet.

Michael M. Rosenblatt, DPM, San Jose, CA,
Rosey1@prodigy.net