MEDICO-LEGAL CHALLENGES IN ORTHOPAEDIC SURGERY©

By Dr. Lalit Kapoor 

We are all aware of the rapidly changing scenario of medical practice in this country. Doctors are no longer surrounded by an aura of infallibility and the expectations of the public have risen sharply in an era of hi-tech medicine. Sub-optimal or adverse outcome of treatment is not accepted easily and often automatically equated to negligence/ deficiency in service. As a result, there is an exponential rise in medical litigation, especially in the wake of the Consumer Protection Act.

Undoubtedly, certain medical specialties are more prone to risks of malpractice litigation and are considered high-risk. For example, in India Obstetrics is the branch of Medicine at highest risk of malpractice litigations. Orthopedic surgery is lower down in the list though still in the high-risk group. (see chart below)

Hence it is prudent for Orthopedic surgeons to be cognizant of the vulnerable risk factors.

WHAT ARE THE SPECIAL RISK FACTORS IN ORTHOPEDICS?

COMMON MALPRACTICE ALLEGATIONS IN ORTHOPEDICS

Negligent/Incompetent treatment of Fractures---resulting in surgical site infection, non-union, malunion, implant failure, deformity.

Complications following hip and knee replacement

Intra-operative adverse events such as vascular or neurological injuries

Missed diagnosis e.g. missed fracture, missed malignancy

Post-operative complications such as DVT, Pulmonary embolism, etc.

Per-op anesthesia / surgical mishaps

Dr. K.T. Dholakia

Some years ago, I had done a study of medico-legal cases which had occurred in an eight-year period  and analyzed the incidence and nature of the cases, with special reference to orthopedic practice. 

I had presented it in the 41st Western India Regional Orthopaedic Conference (WIROC) , having been invited to deliver the DR K.T.Dholakia Lecture


Admittedly,  it is  not  a recent study, and because of the tortuous judicial  system in this country, and loss of follow-up in some cases, the final outcome in all the cases may not be known to us. However, the results of the study do give an overall picture of the nature of litigation one could get involved in and possibly alert us to  a message or two for a litigation-free practice!

I would like to share the findings of this informal study.

In the US, the average percentage of Orthopedic litigation is stated to be  20 % as per  a number of their studies.

I believe, in the contemporary Indian scenario a ballpark  figure for Orthopedic surgery in our country  would be around 15 %.  

No.1 Cause of Malpractice Litigation in Orthopaedics

Surgical site infection, non-union of fractures, malunion, and implant failure are the leading causes of malpractice claims. Practicing evidence-based medicine and adhering to established guidelines and protocols formulated by peer groups is one way of preventing allegations of negligence. Every unsuccessful surgery does not add up to negligence. One can easily defend oneself by remembering the following definition of Negligence namely: A deviation from the standard of care which results in damage to the patient. Hence to absolve yourself of the charge of negligent treatment, all you have to do is to be able to demonstrate that the treatment you gave or the procedure you carried out was what any reasonably competent practitioner would have done in similar circumstances. Merely because the end result was unfavorable does not establish negligence.


As far as the mode or choice of treatment is concerned it is at the discretion of the surgeon. For example, fixing a fracture by nailing or plating has to be the decision of the surgeon, though it is a good idea to explain the pros and cons of each option to the patient before the surgery.

In a case of comminuted fracture of tibia and fibula following RTA, internal fixation with interlocking tibial nail was done. This was followed by non-union. At another hospital External fixator applied, plate fixation and grafting was done, The patient alleged that it was wrong to have done nailing which had caused infection and non-union. A complaint was filed in the Consumer forum for damages. However, the case was dismissed and the surgeon was exonerated. The following excerpt from the judgment, will provide solace to my orthopedic colleagues and assure them that the mere fact that some complication arose, is not evidence of culpability of the surgeon.

Does failure to deliver results amount to deficiency? With respect to the service of a professional, the answer to this question is a definite NO.A professional is expected to do what a reasonable practitioner would do under similar circumstances and he is not expected to guarantee results. Hence in the instant case, we do not feel the non-union of the fracture amounts to deficiency of service on the part of the doctor “ 

Another quote from a judgment in another similar case:

“Any professional does not assure his client of the result. A lawyer does not tell that his client shall win in all cases. A physician cannot assure the patient recovery to the extent of 100 %”

It can be noted from the above figures that lower limb fractures are more prone to complications than upper limb injuries. This is in sync with studies all over the world.  

Spine surgery is sometimes the cause of malpractice claims by patients. Operative morbidity or leading to paraplegia, bladder, and bowel dysfunction. In one case, per operative, accidental injury to the common iliac occurred whilst doing a laminectomy and the patient died of hemorrhagic shock.

Post-op Pulmonary embolism leading to mortality occurred in 3 cases. It is necessary to establish the fact that all measures were taken for DVT /PE prophylaxis.

πŸ”°2 cases of High Tibial Osteotomy were found in the study. In one case, post-op infection was the cause of the patient allegations and in the other case non-correction of the deformity was cited as the cause of ‘deficiency in service


πŸ”°Soon after an Epidural injection of xylocaine and steroid, a patient collapsed and could not be revived. An axillary block for operating a fracture humerus ended up tragically with a mortality

πŸ”°Failed Tendo Achilles repair in one case caused a patient to file a complaint before a Consumer court. There have been similar cases (though not in this study) of failed Hallux Valgus surgery

πŸ”°Vascular complications following tight plaster leading to gangrene and amputation were also seen in this study. Criminal complaints and compensation demands had to be dealt with



CASE OF FRACTURE OF IMPLANT

A patient underwent surgery for a fractured neck femur wherein a hip prosthesis was put. About 8 months later the patient had a fall at home.  X-ray hip revealed a fracture of the implant! The patient was re-operated at another hospital whereupon he filed a complaint in the Consumer Forum demanding compensation. The demand for damages was directed towards the Orthopedic surgeon and the hospital where the earlier surgery had been done.

The surgeon and hospital wanted to know how they could be held responsible for fracture of the implant, but still the two were the only defendants in the case.

In what can be considered good news for doctors, the new CPA Act 2019 which was notified in 2020 now has a specific provision, called PRODUCT LIABILITY. It has been defined thus:

“Product liability “is the responsibility of a product manufacturer or product seller of any product to compensate for any harm caused to a consumer by such defective product manufactured or sold” (Clause 34 in the CPA 19 Act)

Under this provision the orthopedic surgeon in the above case could have deflected liability for the loss to the patient to the Implant manufacturer--- citing a defect in the product.

However, invariably, the complainant will still make the surgeon a defendant. but a good defense is available. A number of surgeons in India are still grappling with the cases filed against Johnson and Johnson for the faulty hip implants supplied by them worldwide. It was alleged that metal ions were leaking into tissues and causing reactions. A class-action suit was filed in the USA.

The introduction of Product Liability in the new CPA 2019 is welcome as it can shift the liability to the right quarters.







PREVENTIVE ASPECTS 

πŸ“ŒDiligent record-keeping and documentation of clinical notes, investigations carried out,per-operative and post-operative records, discharge card with instructions, etc should be maintained scrupulously. Well-documented records are your best defense against charges of negligence. It is a dictum in law that justice in Law must not only be done but should also be seen to be done. Taking a cue from this I am enunciating my very own dictum: Competent, diligent treatment should not only be given to a patient but should also appear to be so! Only good records can establish this.

πŸ“ŒValid, informed consent for the proposed surgery, preferably Operation –specific and in a language the patient understands is not only mandated by law but also ethically correct. Please refer to my blog on informed consent 


πŸ“ŒJudicious selection of patients is important. As they say, discretion is the better part of valor! Hence select cases which are well within your expertise and training. It goes a long way in preventing any malpractice issues.


πŸ“Œ Effective communication with patients and relatives is good insurance against future discord. Communication failure results in breakdown of the Doctor-patient relationship and proves costly in the event of any subsequent medico-legal issues.


πŸ“Œ Criticizing colleagues and the treatment given by them to a patient is the surest way of provoking a patient to initiate legal proceedings. It is also the commonest cause of medical litigation. I have several examples, too numerous to be listed here. This bad-mouthing of colleagues has a special name for it. In the USA they call it JOUSTING. More about it in a future communication. Please avoid it.


I will conclude with my favorite one-liner: THE BEST WAY TO AVOID MEDICO-LEGAL PROBLEMS IS TO PREVENT THEM!



Please scroll down and post your comments in the comments section.

ABOUT THE AUTHOR

Dr. Lalit Kapoor is a general surgeon practicing in Mumbai. He is the founder of the Medico-Legal cell, Association of Medical Onsulatnts& is a medico-legal expert assisting affected members with medico-legal problems for over four decades.

He is also the author of the book, Better Safe Than Sorry- Medico-Legal: Do's & Don'ts

drlalitprabha@gmail.com

© Dr. Lalit Kapoor 







Comments

  1. Superb sir. Really enjoy reading your blogs. Something new to learn each and every time πŸ‘

    ReplyDelete
  2. Dear Dr.Kapoor Sir,
    We get Very apt and useful guidance in case of any problems.
    I was present in the audiance,when you delivered,K.T.Dholakia Lecture.
    Was thoroughly impressed.
    The way you guide taking in to consideration ,the minutest details if the case is unmatched.

    Most of the lawyers also can't match that.

    πŸ‘πŸ‘πŸ‘πŸ™

    ReplyDelete
  3. Dear Dr.Kapoor Sir,
    We get Very apt and useful guidance in case of any problems.
    I was present in the audiance,when you delivered,K.T.Dholakia Lecture.
    Was thoroughly impressed.
    The way you guide taking in to consideration ,the minutest details if the case is unmatched.

    Most of the lawyers also can't match that.

    πŸ‘πŸ‘πŸ‘πŸ™

    Rajesh Gandhi

    ReplyDelete
  4. Sir there is no match for you.
    You are the finest person. Who helps out of the way to everyone in need. Your knowledge is tremendous.

    ReplyDelete
  5. Dear Dr Lalit Kapoor
    I am very happy to read your blog and articles written for our doctor colleagues. These articles will surely help doctors in their prevention of medico legal complaints. I congratulate you sir for sharing your knowledge to our practicing doctors. You have been helping selflessly all doctors who have been in trouble in their practice. Please continue to write your experiences and knowledge on this blog. You can publish E books for all our colleagues. Appreciate your great contributions in this medico legal matters.

    ReplyDelete
  6. Dear Sir,

    It was nice to read you. Thanks for all the contributions made by you in this department.

    ReplyDelete
  7. Nice and practical suggestions. Should be followed by all doctors.

    ReplyDelete
  8. Practical advice very well articulated. Interesting and informative read

    ReplyDelete
  9. There is no surgery without complications. When it comes to complications, it would be useful for every surgeon to develop a deep insight into his work by asking the following:
    1. Is there a risk of life changing complication ( Paralysis, incontinence, erectile dysfunction, blindness, aphasia to name a few)
    2. Is there a risk of a complication which is an economical burden ( post operative renal failure necessitating hemodialysis for a few weeks, prolonged ICU care )
    3. Is there a risk of a complication which may call for change of profession ( a diamond setter whose dominant wrist gets frozen )
    4. Can there be a nagging complication which takes the patient on a medical shopping spree ( Non healing wounds, fistulae )

    During counseling, these should be introduced with gentleness and handled without creating panic.

    Spine surgeons have the best consent forms which are comprehensive. However, the probable risks in a given case should be discussed with honesty and empathy. These merit highlighting.

    If the case takes a turn for the worse, the primary care provider should proactively seek second opinion to validate what is done is in accordance with current practices.

    The consultant should give undivided attention to a complication ( This is the best prophylaxis against disgruntlement)

    Documentation should be done thoughtfully in real time as patient's bystanders can steal your data with the help of your subordinates who may part with it innocently.

    Make sure that all involved in the care are qualified and registered practitioners. This applies to nurses too. If there is a legal contest, then these may assume importance and go against the defendant.

    Do not hurt the ego of the patient or patient's bystanders. This does not mean that we should adopt a soft submissive stand. Communication should be ASSERTIVE.

    Whenever the patient and bystanders are convinced that the clinician is doing everything possible ( perception), the risk of litigation is low. Jousting by our own brethren is a curse on the profession. It can never be eradicated but by introspection and self discipline.

    Scope for perceived negligence should be minimised at all costs. The train of events should have enough evidence by way of documentation to prove that the clinician has been diligent.

    Dr G G Laxman Prabhu
    Urologist
    Mangalore


    ReplyDelete
  10. Very well articulated Dr Laxman . Specific procedure specific consent and discussion which should be documented always go a long way in addressing allegations , if any later .
    Thank you for re in forcing what I have said .

    ReplyDelete
  11. Very useful info Sir. Your blogs and your advice whenever needed are always very reassuring.

    ReplyDelete
  12. Please keep writing these blogs, sir. They will guide and help those who are caught in difficult situations.
    Your previous articles can also become a part of this blog. Your wealth of medicolegal knowledge and experience needs to be shared widely. And internet is the medium which will do that job effectively.
    This piece is an another gem you've penned.
    More strength to your pen and your writings.

    ReplyDelete
  13. Very informative and excellent.

    ReplyDelete
  14. Very informative sir and an eye opener

    ReplyDelete

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