It has been the practice of most patients to hold surgeons responsible for any manufacturing
defect in an implant that was carried out and accountable for deficiency of services
and sue them for medical negligence.
My implant broke; the surgeons are responsible for this; their service is deficient;
this is tantamount to medical negligence—say most patients. This is not true and has
no scientific evidence. We come across such instances many times in our practice.
According to scientific literature, only 2 to 3% of implant failures are because of
compromise and quality.[1] Therefore, before commenting on the poor/low quality of implants used in orthopaedic
surgery, we need to understand the complexity involved.
Most implants in orthopaedic surgery and its allied specialties have U.S. Food and
Drug Administration (USFDA) approval. The CE European certificate for orthopaedic
instruments equally holds good efficacy and performance. In countries where these
facilities are unavailable, the local administration has the safety and performance-based
check for orthopaedic devices and issues a license for some time. So, instruments
of inferior quality cannot be supplied or applied for patient use.
Universally, the raw material and the manufacturing device for orthopaedic implants,
such as plates, screws, interlocking nails, rods, arthroscopic screws, spine instruments,
and others, remain the same. Therefore, implants that come out of the factory must
be in good shape and that will be subjected to a performance test. The implants used
for new fracture types, fractures with specific requirements (osteoporosis, metabolic
bone disease, metastatic cancers, genetic disorders, etc.), and fractures of unique
anatomical locations are tested for more excellent performance and compared with predicate
devices. Countries have specifications for testing metallic bone plates, interlocking
rods, Kirschner's wires, spinal instruments, arthroscopic screws, and other specialty
instruments. The United States evaluates and issues licenses for materials with titanium-6
Aluminium-4 Vanadium, unalloyed titanium, 18 chromium-14 Nickel-2.5 Molybdenum stainless
steel bar, wires, and Cobalt-28-Chromium-6 Molybdenum alloys.[2]
[3] India issues licenses for 316L stainless steel and 316 LVM titanium grade 5 for
all orthopaedic surgeries, hand surgeries, spinal surgery, and other subspecialty
implants. All these implants do not emit radiation; follow ergonomic principles, construction,
and environmental properties; and do not explode during usage. The device and manufacturing
process of the implants are designed to eliminate or reduce the risk of infection
in the patient. The manufacturers also protect against the mechanical and thermal
risks of the implants. Certain standard and accreditation bodies (ISO, ITC, MEDDEV
ASTM) regulate the essential safety requirements of the implants.
The USFDA, CE, and other agencies strictly analyze plate and screw characteristics
with their engineering drawings, including the safety and performance pathway. There
are standard specifications and test methods for metallic bone plates and screws.
It follows the worst-case rationale. For each anatomical location, the test is performed
on a plate design, interlocking nails, spinal instruments, and other that represents
the worst case for bending strength, bending structural stiffness performance, rehabilitation
activities, and postoperative loading. A similar test is performed for the screws
(screw holes that will have the highest and lowest stress under loading).
There are standard bone screws and washer guidance. All mechanical testing is performed
on the final and finished versions of the plates, screws, spinal instruments, arthroscopic
screws, and interlocking nails/rods. The worst-case bone screw size compatible with
the worst-case bone plate for each anatomical location is checked. The torsional strength
and driving torque testing of the screw are performed. Interestingly, the FDA does
not consider individual screw pullout strength testing because multiple screws are
used with the plating, which minimizes en bloc plate pullout.
The USFDA, CE, and other agencies use static four-point bending tests to assess the
bone plate's mechanical strength. The criteria are based on aggregated data available
from the worst-case plate evaluation. The acceptance criteria include minimum bending
strength (N-m) and minimum bending structural stiffness (N-m2) for all anatomical locations of the bone plate. The humerus has 11.6 and 4.39; elbow
(distal humerus and ulna) 6.7 and 0.89; hand, wrist, and forearm 1.6 and 0.18; femur
and proximal tibia 26.3 and 8.66; distal tibia 11.9 and 3.49; fibula 2.3 and 0.17;
foot 1.2 and 0.13; and clavicle has 11.9 and 1.69. For the test to be successful,
the implants must meet the acceptance criteria, or the average of all implants must
meet or exceed the above, and the standard deviation should be 10% or less of the
calculated averages. Therefore, plate, screw, and orthopaedic implants manufactured
from identical raw materials using similar manufacturing processes without any changes
in geometry are competent and mechanically strong with good performance.
A hypothetical question arises from the common man: Can the plate break? Yes, the
plate can break if we apply a force exceeding the minimum bending strength (N-m) and
minimum bending structural stiffness of the implant of specific anatomical areas.
This does not mean inferior quality, but it is the inherited and accepted mechanical
strength of the plates, screws, and other implants for their application on the bones.
Vital aspects determine a deficiency in the doctor's service and are termed medical
negligence. Some of the essential conditions to be fulfilled here is (1) a duty of
care, (2) breach of the duty, and (3) consequential damage arising there. It is the
duty of an orthopaedic surgeon to use an appropriate implant obtained from a manufacturer
during an operative fracture treatment and provide standard medical care. Standard
care is the standard of an ordinary skilled man exercising and professing that special
skill. A man need not possess the highest expert skills: it is a well-established
law that it is sufficient if he exercises the ordinary skill of an ordinary competent
man exercising that particular art. In the case of a medical professional, negligence
means failure to act in accordance with the standards of a reasonably competent medical
professional at the time. There may be one or more perfectly proper standards, and
if he or she conforms to one of these proper standards, then it is not negligence.[4] Also, an orthopaedic surgeon must follow up with the patient and should not neglect
those who underwent an operation. Additionally, the consequent damage from the medical
or surgical treatment must be taken care of.
Also, the manufacturer supplies an implant with the required approvals and licenses
for use in the patient. The orthopaedic surgeon did not participate in the implant
research, designing, collecting raw materials, manufacturing, and the final finished
product of the implant. They are at the user's end, like the patient who receives
them. Therefore, a treating doctor or orthopaedic surgeon cannot be held medically
negligent if an implant breaks or fails. The Tortious liability is to be directly
imposed on the product manufacturer. Nevertheless, the implants that fall or break
must be sent for metallurgy analysis and another mechanical stress test to prove incompetency
or poor quality.
The challenge in fracture fixation surgery is the development of designs and materials
that transmit the physiological stress across the implant to the bone interfaces and
bone-to-bone fracture interfaces. There are specific characteristics of an ideal fracture
fixation. The implant must maintain alignment at the fracture site within variable
tolerance and depending on the fracture location. The fracture fixation should allow
early mobilization, and the physiological forces must be transmitted across the fracture
interfaces within limits. As the manufacturers noted implant failures in the past,
there have been various modifications and advancements in the combination of raw materials
to foresee the significant breaks in the implants. The failure often occurs at the
nail–plate junction, and the break occurs at the nail or plate portion of the implant.[5]
Additionally, the screws fail and cut out of the implant. One known reason for implant
failures is the loading forces concentrating over a small area of the implant without
being transmitted across the fracture interfaces. Also, cutout of the implant, especially
in an osteoporotic femoral head, is well known. Because of these complications, implant
manufacturers have developed various sliding devices. Instead of using more robust
materials for the implants, the manufacturers design implants with relatively elastic
titanium alloy that addresses implant failure and yields promising results.
The common man's question is why the doctors cannot use a rigid plate and screws or
interlocking nails? Researchers have found that fractures occur after removal of rigid
plates in osteoporotic long-bone fractures.[5]
[6] This is because of a mechanically weak bone healing. Therefore, using titanium alloy
or graphite-methacrylate composite plates results in less stress shielding and augments
efficient bone healing. However, orthopaedic surgeons must balance rigid (stress shielding)
and flexible (less stress shielding) implant fixations. The selection purely lies
at the surgeon's discretion based on the standard medical care given to the local
community, population, or country. Smoking, alcohol abuse, increased body mass index
(BMI; > 30 kg/m2), age, and inadequate or premature weight-bearing ambulation are risk factors for
implant break or failure in orthopaedic fracture fixation surgeries.[7]
[8]
Interestingly, certain countries like India encourage self-dependence and reliance
with the motto “Make in India, Made in India” (
https://www.makeinindia.com/about). This is a welcome move wherein the country encourages manufacturers to produce
orthopaedic implants in their country with research and development analysis, standard
raw materials, mechanical testing, and manufacturing devices. Therefore, it is always
the country's pride to make orthopaedic implants in the country to serve humanity.
But these nationally produced implants are not inferior in quality because they follow
all the strict guidelines, protocols, and stringent license regulations and use universal
raw materials and manufacturing devices. The make-in-India initiative has transformed
India into a global design and manufacturing hub, which is a timely response to meet
the critical demand–supply chain. Soon, various sectors opened-up for manufacturing
orthopaedic implants, defense equipment, railway equipment, single band retails, etc.
This increased the credibility of the country, with visible energy, momentum, and
optimism among investors to make the country one of the world's most powerful economies.
Therefore, orthopaedic surgeons using nationally produced implants efficiently contribute
to the country's prosperity and are not considered to use inferior quality derailing
the country's national building initiatives.
It is rational and essential to perform the metallurgy test and biomechanical strength
analysis for all broken implants to prove their inferior quality. Without this test,
it would be anecdotal to comment on the broken implant quality.
Ratio Decidendi
The complainant's allegations appear to be without substance and are not substantiated
by any medical evidence or expert. Additionally, the doctor is a well-known orthopaedic
surgeon, and the surgery involving internal fixation by plating screws is the standard
surgical procedure for a patient with such a fracture. Moreover, it is medically well
accepted that even after successful surgery, the union of the bones (3%) may get delayed,
as in this case. Still, the respondent/doctor cannot be held responsible because the
postoperative X-rays confirmed that the plate and screws were properly fixed.
The State Commission also cited the judgment of the Hon'ble Supreme Court in Jacob
Mathew vs. State of Punjab & Anr. (2005) 6 SCC 1, wherein principles of medical negligence
have been spelled out, as also in Achutarao Haribhau Khodwa vs. State of Maharashtra
(1996) 2 SCC 634, wherein the Hon'ble Apex Court had noted that the skill of medical
practitioners differs from doctor to doctor. The very nature of the profession is
such that there may be more than one course of treatment that may be advisable for
treating a patient, and negligence cannot be attributed to a doctor so long as he
or her is performing his or her duty to the best of his or her ability and with due
care and caution.
The orthopaedic surgeon had, after due consideration, including proper diagnosis and
using his best professional judgment conducted a conservative surgery that involved
fitting the screws and plating, which in the majority of cases results in union of
the bone joints. Since it did not occur as is known to happen following such surgeries,
in this case, another operation for grafting, which is the recommended surgery in
cases of nonunion, was recommended. Keeping in view these facts and respectfully following
the judgments of the Hon'ble Supreme Court cited to the State Commission, the honorable
courts agreed with the State Commission that there was no medical negligence on the
part of orthopaedic surgeons in this case.
In the realm of diagnosis and treatment, there is scope for genuine differences of
opinion. One professional doctor is clearly not negligent merely because his or her
conclusion differs from that of another professional doctor. The true test for establishing
negligence in diagnosis or treatment on the part of a doctor is whether he or she
has been proved to be guilty of such failure as no doctor of ordinary skill would
be guilty if acting with ordinary care. There can be a difference in opinion as regards
the approach to diagnosis and treatment. But the difference of opinion is not negligence.
If two accepted schools of thought exist and a doctor has adopted anyone's method,
he or she is not liable.
“The practitioner must bring to his task a reasonable degree of skill and knowledge
and must exercise a reasonable degree of care. Neither the very highest nor a very
low degree of care and competence, judged in the light of the particular circumstances
of each case, is what the law requires, and a person is not liable in negligence because
someone else of greater skill and knowledge would have prescribed different treatment
or operated in a different way; nor is he guilty of negligence if he has acted in
accordance with a practice accepted as proper by a responsible body of medical men
skilled in that particular art, even though a body of adverse opinion also existed
among medical men.
A mere deviation from normal professional practice is not necessarily evidence of
negligence. Let it also be noted that a mere accident is not evidence of negligence.
So also, an error of judgment on the part of a professional is not negligence per
se. Higher the acuteness in emergency and higher the complication, more are the chances
of error of judgment. At times, the professional is confronted with making a choice
between the devil and the deep sea and he has to choose the lesser evil. The medical
professional is often called upon to adopt a procedure which involves higher element
of risk, but which he honestly believes as providing greater chances of success for
the patient rather than a procedure involving lesser risk but higher chances of failure.
Which course is more appropriate to follow, would depend on the facts and circumstances
of a given case. The usual practice prevalent nowadays is to obtain the consent of
the patient or of the person in charge of the patient if the patient is not competent
to give consent before adopting a given procedure. So long as it can be found that
the procedure which was in fact adopted was one which was acceptable to medical science
as on that date, the medical practitioner cannot be held negligent merely because
he chose to follow one procedure and not another and the result was a failure.
There is a marked tendency to look for a human actor to blame for an untoward event,
a tendency which is closely linked with the desire to punish. Things have gone wrong
and, therefore, somebody must be found to answer for it. To draw a distinction between
the blameworthy and the blameless, the notion of mens rea has to be elaborately understood.
An empirical study would reveal that the background to a mishap is frequently far
more complex than may generally be assumed. It can be demonstrated that actual blame
for the outcome has to be attributed with great caution. For a medical accident or
failure, the responsibility may lie with the medical practitioner and equally it may
not. The inadequacies of the system, the specific circumstances of the case, the nature
of human psychology itself and sheer chance may have combined to produce a result
in which the doctor's contribution is either relatively or completely blameless. Human
body and its working is nothing less than a highly complex machine. Coupled with the
complexities of medical science, the scope for misimpressions, misgivings and misplaced
allegations against the operator i.e. the doctor, cannot be ruled out. One may have
notions of best or ideal practice which are different from the reality of how medical
practice is carried on or how in real life the doctor functions. The factors of pressing
need and limited resources cannot be ruled out from consideration. Dealing with a
case of medical negligence needs a deeper understanding of the practical side of medicine.”[10]
To conclude, orthopaedic surgeons do their best in all their fracture fixations. Care
and standard line of management are their golden braces. If consequential damage occurs
or known complications arise, surgeons intervene efficiently. Orthopaedic surgeons
cannot be held responsible for implant failure or breaking of implants and cannot
be held liable for medical negligence.
