Man Files $15 million Lawsuit Against NYC Citi Bike Claiming Smell Loss From Bike Crash

Image by Pharos of Wikipedia

In 2013, a man rented a bicycle from New York City's Citi Bike program. Apparently while riding this rental bike, the front wheel struck a wheelstop installed near a bicycle docking station which the man did not notice, flipping him resulting in head trauma. This head trauma resulted in permanent smell and taste loss. [link]

The wheelstop is meant to prevent cars from from backing into bike stations, but the lawsuit alleges "no cones or colored warnings to alert a bicyclist of its existence... constituted a trap for the unwary."

Regardless of the legal merits of the case, how does head trauma like this cause smell and taste loss?

The smell nerve is located right between the eyes and is analogous to the roots of a plant where the plant is the nerve next to the brain and the roots are the nerve endings that go through the skull bone (cribiform plate) and into the nose where "smell" is detected (the yellow in pic below). With significant head trauma, the brain suddenly moves and "bounces" around in the skull when struck. When this happens, the delicate smell nerve endings which are going through the bone "tear" when the brain moves relative to the bone.

With such nerve damage, smell can be permanently lost. With complete smell loss, taste can be adversely affected given so much of flavor is attributable to smell. As such, the man can technically probably still taste (salt, sweet, sour, bitter, etc), but not smell.

BTW... Did you know that the tongue taste map we all learn in school is incorrect?


Source:
Conn. man files $15 million lawsuit against NYC, Citi Bike, claiming nerve damage from bike crash. Daily News 2/27/14

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Man Sues ENT for Wrongful Tracheostomy

Image from ParaMedicine101

In December 2012, a West Virginia man suffered angioedema causing tongue swelling due to a not uncommon reaction from lisinopril. Presumably due to airway concern from the tongue swelling, an urgent tracheostomy (cutting a hole in the throat) was performed.

The patient later filed suit against the ENT who performed the tracheostomy stating that it was unnecessary as the tongue swelling was getting better. [link]

Although a tracheostomy is not always performed for tongue swelling due to angioedema, it also is not unusual to do so, mainly because the alternative outcome is airway loss and death. It is a judgement call on the physicians who are caring for a patient with angioedema whether close monitoring alone is sufficient versus performing a tracheostomy. If the tongue swelling is large enough to cause some airway obstruction, no physician or ENT would ever question the need for a tracheostomy, regardless of whether the swelling "might" be getting better or not.

If one waited until the airway became critical before performing a tracheostomy, the risk of death and complications become MUCH larger. As such, a tracheostomy is performed well before there's any chance of airway loss. (Intubation is not recommended or at times even possible as the act of trying to intubate may trigger airway loss.)

Indeed, the patient who is suing the ENT may not be alive today to sue the ENT if it weren't for the tracheostomy. Instead, it would be the family who would be suing the ENT for wrongful death for NOT doing a tracheostomy.

Check out this lawsuit where an ENT did NOT perform a tracheostomy for airway swelling resulting in death. Here's another lawsuit for similar though under more convoluted circumstances.

Source:
Clay Co. man says doctors performed unnecessary tracheostomy. West Virginia Record. 1/29/14

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Should Risk of Death Always be Part of the Surgical Consent?

Ever since reports of alleged medical negligence came up in the case of 13 years old Jahi McMath who suffered cardiac arrest and subsequent brain death after a "routine" tonsillectomy that occurred Dec 9, 2013, the question has come up whether risk of death should become part of every single surgical procedure's informed consent no matter how rare that risk might be.

It also brings up the question whether patients would want to hear every single possible conceivable risk that may occur (which could ALWAYS include some infinitesimal risk of death) with even simple surgical procedure like ear tube placement for chronic ear infections.

[Disclaimer... I am not a lawyer and this is not legal advice.]

From the physician's perspective, Duke surgeons have thought about this quandary and here were their suggestions of what is considered "reasonable" when it comes to risk of death and the consent process:

• When the risk of death is so low as to be unexpected and highly improbable, including it as part of the consent may actually be misleading (may cause a patient not to pursue a needed surgical procedure due to unreasonable concern for a remote risk of death)
• When the risk of death is felt to be “high enough” to disclose, then this adverse outcome should be discussed among the risks, and the patient must be informed.
• How high should the risk of death be before one would want to include it as part of the consent process? This risk could be any chance at all to about 0.1% risk as a reasonable threshold.

From the patient's perspective, when it at least comes to anesthesia risks with children (which also has a remote risk of death), researchers were able to provide some numbers when it comes to consent:

• 87% of parents wanted to know the risk of death as a result of anesthesia. 13% did not.
• 68% of parents knew that risk of death was "extremely rare." 19% believed that risk of death occurs "once in a while," and 13% thought there was "no chance."
• 74% of parents wanted to know "all possible risks," 24% wanted to know only "those that are likely to occur," and 2% wanted to know only about those that would "result in significant injury."
• Mothers were more likely to want to hear all possible risks, whereas fathers were more likely to want to know only about those that are likely to occur.

Although media reports stated that Jahi underwent a "routine" tonsillectomy, that was actually not true. She underwent a UPPP surgery which is much more aggressive throat surgery than tonsillectomy alone. The reported risk of death with UPPP is around 0.2%. As such, disclosure of possible low risk of death would have been not unreasonable.

The risk of death for routine tonsillectomy is somewhere between 0.003% to 0.01%.

Just for comparison, the risk of dying from driving a car for over 50 years is 1.1% and annual risk of death from smoking 10 cigarettes per day is 0.5%. [Link] Note that these "mundane" risks of driving and smoking are higher than the risk of death associated with tonsillectomy or UPPP.

In the end, there is no set policy about when risk of death should be discussed. This disclosure has been left up to individual surgeons who use their professional judgement when that risk becomes large enough to merit discussion as part of the informed consent.

What do you think?


References:
Parental knowledge and attitudes toward discussing the risk of death from anesthesia. Anesth Analg. 1993 Aug;77(2):256-60.

Surgery and the D-Word: Approaching the Topic of Death and Dying with Surgical Patients. J Palliative Care Med 2:108. doi:10.4172/2165-7386.1000108

Risk perception and communication: recent developments and implications for anaesthesia. Anaesthesia 2001;56:745-55.

Risk language and dialects. BMJ 1997;315:939-42.

Safety of Adult Tonsillectomy: A Population-Level Analysis of 5968 Patients. JAMA Otolaryngol Head Neck Surg. 2014 Jan 30. doi: 10.1001/jamaoto.2013.6215.

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Lawsuit for Botched Laser Vocal Cord Surgery

In February 2012, an ENT surgeon removed vocal cord polyps using a laser while the patient was asleep with a Medtronic Laser-Shield II endotracheal tube. Unfortunately, the laser perforated the endotracheal tube, ignited the 100% oxygen being used at the time resulting in catastrophic burns to the patient. [link]

Subsequent lawsuit resulted in favor of the patient who received an award totaling $30 million on 12/5/13.

What Happened?

Even though an endotracheal tube meant for use with laser procedures was utilized, if this specially designed tube sustains enough damage from the laser, it will either perforate or heat to a high enough temperature to ignite. Furthermore, 100% oxygen was administered by the anesthesiologist which just added gasoline to the flame.

Ideally, in such laser procedures, meticulous surgical technique is still required and care taken to avoid damaging the endotracheal tube, even if a "laser-safe" tube is used. The "weak" part of any laser-safe tube is the cuff that is inflated to make a tight seal between the trachea and the tube itself. As such, the cuff material is necessarily thin. Saline-soaked pledgets placed immediately above the cuff helps protect the cuff as well as use of a tube with two cuffs (in case one fails). Also, room air should have been administered to the patient in the event the tube fails in order to minimize oxygen in the area... and the patient placed temporarily on apnea whenever the laser is turned on.

The risk of fire among other reasons are why many ENT surgeons (myself included), have stopped using lasers for procedures done in the mouth and airway.

With vocal cord procedures, I still utilize cold steel techniques which has a zero risk of airway fire.

Sources:
Botched surgery will cost hospital. The Wenatchee World. 12/6/13.

Medtronic slips $18M verdict in surgical fire case. MassDevice. 12/10/13

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Tracheostomy Fire During Surgery Burning Patient

Image from Wikipedia

In early 2012, a surgeon was performing a trach (breathing hole in the neck) when the oxygen used during the procedure caught fire severely burning the patient. Apparently, the surgeon used an electrocautery device which most likely emitted a spark igniting the oxygen being given to the patient leading to the fire. [link]

What happened?

Tracheostomy procedures are performed typically in very sick patients who have been intubated for a prolonged period of time. Often, such patients require higher concentrations of oxygen than normal in order to maintain oxygen levels in the body.

Problem in this scenario is that higher concentrations of oxygen also mean a higher risk of accidental fire when using instruments that help stop bleeding like an electrocautery device.

During a tracheostomy, an opening is created in the windpipe (watch video below). This allows oxygen that is being given to the patient to leak out into the surgical field. If electrocautery is used in this oxygen rich environment, any spark from an electrocautery device can lead to ignition and a flash fire.

Typically, in order to minimize this risk of fire, the surgeon should avoid using any electrical instruments in the surgical field that may create a spark after entering into the airway. Cutting into the airway would allow oxygen to escape into the surgical field. That usually means meticulous surgical technique and controlling all bleeding BEFORE cutting into the airway. If possible, reducing the oxygen given to the patient as much as possible is also beneficial.

Nitrous oxide should be avoided as an anesthetic agent as it is also ignitable like oxygen.

If electocautery use is unavoidable after the airway is surgically entered, the endotracheal tube cuff should re-inflated and advanced past the tracheostomy incision. Vacuum suction should be applied to evacuate as much oxygen from the surgical field and if possible, a period of apnea while cautery is applied.


Source:
Revealed: The chief of surgery who set patient on fire when his electronic scalpel caused 'EXPLOSION' Mail Online. 5/6/12

References:
Airway fire during tracheostomy: prevention strategies for surgeons and anesthetists. Ann R Coll Surg Engl. 2001 November; 83(6): 376–380.

Fatal inhalation injury caused by airway fire during tracheostomy. Acta Anaesthesiol Scand. 2007 Apr;51(4):509-13.

Tracheostomal fire during an elective tracheostomy. Chang Gung Med J. 2005 Mar;28(3):186-90.

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Don't Like a Research Paper? Sue the Journal and Authors...

What is a lawyer to do if medical research produces results that make it more difficult to win lawsuits? Why you sue the medical journal and the researchers who authored it.

And you ask the medical journal to retract it.

And than you ask for a court order forbidding the report to be entered as evidence in future litigation.

Sound like a joke?

Wish it was, except it happened... is happening...

A Boston lawyer has sued the American Journal of Obstetrics and Gynecology for a case report published in 2008 regarding an infant delivery in which a brachial plexus injury was sustained via natural forces of labor without any excessive traction provided by the physician.

More info can be found on the lawsuit here which was initially dismissed by a trial court, but is on appeal to the First Circuit.

Given I'm an ENT, I can't necessarily state whether this published medical report has merit or not, but typically if a study is without merit, one criticizes it by publishing additional research studies to either support or refute it.

If lawyers now start influencing what can be published or not, or indirectly influence researchers whether to publish "unpopular" results for fear of lawsuits, it will have a chilling effect on the advancement of science and medical research.

Hopefully, suing medical journals and researchers will not become a popular trend.


Sources:
Publish an article that undermines lawsuits? See you in court. Overlawyered 9/18/13

Maternal forces causing injury. United Brachial Plexus Network 5/16/11

Permanent brachial plexus injury following vaginal delivery without physician traction or shoulder dystocia. American Journal of Obstetrics & Gynecology. Volume 198, Issue 3 , Pages e7-e8, March 2008

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Lawsuit Alleges Transcranial Magnetic Stimulation Paralyzed Patient's Face

University of Iowa Hospitals and Clinics is being sued by a patient who underwent an experimental transcranial magnetic stimulation (TMS) therapy which allegedly caused a facial paralysis which was than negligently treated. The trial is scheduled for Oct 13, 2013. [link]

Briefly, the patient in 2008 underwent experimental TMS to treat constipation and incontinence. TMS is a noninvasive method to cause depolarization or hyperpolarization in the neurons of the brain using pulses of electromagnetic induction through the scalp. Researchers were hoping to learn more about the nerve connections between the brain and the rectum and how biofeedback training may affect them.

Unfortunately, the patient contended that the treatment gave her a severe headache and by the next day, a facial paralysis. She went to the emergency room and was given an anti-viral antibiotic to take, but no steroids.

Her facial paralysis worsened and she ultimately underwent facial nerve decompression surgery 12 days later which helped with her taste loss, but not her facial paralysis.

The lawsuit contends that:
1) The patient was not informed of the risks of TMS as it relates to facial paralysis
2) Steroids should have been prescribed and the patient immediately referred for nerve decompression surgery

Does TMS carry a risk of facial paralysis?

I honestly do not know much about TMS, but I can certainly state that I've never heard of TMS causing or carrying a risk of facial paralysis. In fact, TMS is used to evaluate facial paralysis by being able to assess the integrity of the facial nerve as well as predict its potential for regeneration after injury [link].

Hypothetically, could TMS cause cranial nerve injury and swelling leading to facial paralysis??? I suppose so, but will defer to people more knowledgeable than I to answer this question.

The timing is certainly suspicious in this case with paralysis occurring within 24 hours of TMS.

But if it can, it certainly is worth a published case report.

Even more importantly, patients who are currently undergoing TMS to evaluate their facial paralysis now need to be warned of the risk that the TMS test itself may make their facial paralysis even worse!!!

What about steroids?

Although some may consider medical management of facial paralysis still controversial, I personally feel that steroids SHOULD have been immediately prescribed without any anti-virals.

The current preponderance of evidence is that anti-virals make absolutely no difference in the treatment of facial paralysis... even when the facial paralysis is due to a virus [link].  I personally do not prescribe anti-virals for patients with facial paralysis regardless of etiology.

What about steroids? Moderate quality evidence show that steroids were significantly more likely than anti-virals to produce complete recovery [link #1; link #2]. I always prescribe steroids to treat facial paralysis.

What about facial nerve decompression surgery?

Now surgical decompression of the facial nerve can be considered controversial. Decompression entails removing part of the skull, moving the brain to one side slightly, and removing all bone covering the facial nerve.

The theory being that if the facial nerve is swollen as it courses through the skull from the brain to the face, strangulation followed by nerve death occurs. To use an analogy, if a finger starts to swell from trauma, a ring being worn may prevent blood flow and eventually cause strangulation of the finger. Treatment to reestablish finger blood flow is to cut the ring off. Facial nerve decompression is akin to cutting a ring off to save a swollen finger.

Typically, surgical decompression of the facial nerve is pursued when facial paralysis occurs in the context of physical head trauma (ie, car accident). In the absence of preceding physical trauma, it would be the rare surgeon who would recommend surgical facial nerve decompression.

Obviously, the main question related to this lawsuit is whether nerve swelling occurred due to the TMS therapy necessitating surgical decompression. Presumably, an MRI scan was performed showing a highly inflamed and swollen facial nerve as well as significant nerve degeneration on ENoG testing. Supporting evidence (not mentioned in media reports) would be if profound hearing loss also occurred. Why? Because the facial nerve and hearing nerve both go through the same boney canal.

Malpractice?

TMS is not known to cause facial paralysis. As such, in a normal situation, this particular risk would not be expected to be included in the consent (as it has not been previously described). However, given this therapy was provided in the context of an experimental research protocol, the consent process is much more rigorous with much higher standards. With such higher standards, should risks never before seen be also included in the consent, especially if TMS has been performed many times for other purposes??? I don't know...

Certainly, my feeling as an ENT specialist is that steroids should have been given and not an anti-viral medication. Whether ENT specialist standards should apply to emergency room staff is harder to say.

Without more information, negligence as it pertains to delayed surgical facial nerve decompression is also hard to say.

Ultimately, we shall see what the court decides.


Source:
Lawsuit alleges Iowa doctors left patient's face paralyzed. Associated Press 8/13/13

References:
Transcranial magnetic therapy. Wikipedia

Electrical and transcranial magnetic stimulation of the facial nerve: diagnostic relevance in acute isolated facial nerve palsy. Eur Neurol. 2012;68(5):304-9. doi: 10.1159/000341624.

Antiviral therapy for Ramsay Hunt syndrome (herpes zoster oticus with facial palsy) in adults. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006851. doi: 10.1002/14651858.CD006851.pub2.

Antiviral treatment for Bell's palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2009 Oct 7;(4):CD001869. doi: 10.1002/14651858.CD001869.pub4.

Do either corticosteroids or antiviral agents reduce the risk of long-term facial paresis in patients with new-onset Bell's palsy? J Emerg Med. 2010 May;38(4):518-23. doi: 10.1016/j.jemermed.2009.08.016. Epub 2009 Oct 21.

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Malpractice Lawsuit for Nerve Damage Sustained After Neck Cyst Excision

Earlier this month, a malpractice lawsuit resulted in a $4 million dollar award to the patient plaintiff who suffered permanent nerve damage after a family practice physician excised a cyst from the neck. [link]

Briefly, the patient visited the family physician in July 2009 for a lump in his left neck. The family physician recommended that the mass be surgically excised which was subsequently performed by the same family physician (not a surgeon) in the office. After the procedure, the patient experienced a weakened left arm and shoulder and had difficulty picking things up with that arm or moving the arm more than 90 degrees. Subsequent evaluation by an orthopedic surgeon and neurosurgeon determined that the spinal accessary nerve was cut at the time of the neck mass excision.

So what probably happened?

The spinal accessory nerve (also known as cranial nerve XI), is a major nerve that comes off the spinal cord and supplies motor function to the shoulder and arm (red arrow below pointing to the nerve which is yellow).

Image Modified from Wikipedia

I suspect that in this case, the mass was located in the same area denoted by the red arrow above. Now assuming that media and court documents were correct that it was truly a cyst that was excised, the cyst must have laid right below the skin, but on top of the nerve.

Careless excision of the cyst would have resulted in this nerve being cut especially during dissection on the mass's deepest aspect, especially if the physician did not hug the mass during dissection. Using an analogy, good surgical technique is like peeling an orange without puncturing the yummy orange underneath. Poor surgical technique would be peeling the rind and taking bits of the edible orange as well... or leaving some nasty rind on the fleshy orange itself.

Often, novice surgeons take large cuts around a mass with the tip of the scissor or scalpel extending beyond visualization. Also, thick layers of tissues are cut rather than thin transparent amounts. Furthermore, when a mass is grasped and pulled, anatomic structures like a nerve can get pulled out of its usual location along with the mass which can lead to unintentional damage. 

As such, experienced surgeons know when to cut big (no important structures are around) and when to cut in tiny microscopic degrees (important nerves and blood vessels are around).

The neck has a large number of important blood vessels and nerves in a highly compacted area making surgery in this part of the body potentially fraught with peril. However, there are certain "safe" areas where no significant important nerves or blood vessels are found. Such a "safe" zone from a nerve perspective is right under the chin extending down over the voicebox. Of course, there are other important structures located in this area that could get damaged even if nerves aren't a concern.

Source:
Montco jury awards Hatboro man $4M for nerve damage. Phillyburbs 8/27/13

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Facial Plastic Surgery Leading to Clones? Scandal? Divorce? Lawsuits?

Earlier this year, pictures of the 20 finalists for Miss Korea 2013 went viral due to the clone-like appearance of the women. Such clone-like appearance is due to suspected plastic surgery undergone by many if not all of the contestants towards the idealized "Korean plastic face look." Fueling plastic surgery in Korea is the acceptance and popularization of plastic surgery encouraged by celebrity worship culture. Check it out:

Image Taken from MailOnline

Of course, it could be all the makeup and photoshopping that made these contestants all look alike. The reality is a bit more disappointing as shown in pre-makeup pictures published in KoreaBang.

In any case, a scandal of sorts occurred when before and after pictures of Miss Korea 2012 Kim Yu-Mi  surfaced. Note the complete lack of resemblance between her natural looks and her winning appearance (see pics below):

Image Taken From KoreAm

It is perhaps little wonder that with such high prevalence of plastic surgery, that it was only a matter of time before marital strife and even divorce would occur by men who have been "deceived" by a woman's "natural" beauty which was anything but.

Indeed, a Chinese man divorced and sued his wife in 2012 for being ugly... and won [link]. Apparently his wife's appearance became an issue when his daughter was born and resembled nothing like either parent (and allegedly was "incredibly ugly" to boot). After initially thinking his wife cheated on him, the wife admitted spending $100,000 on plastic surgery to become beautiful, and never disclosed this information before marrying him. The lawsuit was based on his belief that he married her under false pretenses of her being beautiful. See pics below.

Image taken from KDVR

I wonder if potential marriages in Asia are now preceded by full disclosure of any plastic surgery done along with the more usual disclosures of educational, family, and financial background.

Sources:

Chinese man sues wife for being ugly, wins $120,000. KDVR 10/26/12

Has plastic surgery made these beauty queens all look the same? Koreans complain about pageant 'clones'.  MailOnline 4/25/13

Miss Korea’s Plastic Surgery Scandal After Photos Surface. KoreAm 7/20/12

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ENT Sued for Wrongful Death from Airway Closure

Media reported on a malpractice case whereby in October 2010, a woman presented to the emergency room at Ochsner Medical Center (Louisiana) with symptoms of sore throat, neck pain, and painful swallowing.

A CT neck performed at that time revealed "swelling in her neck and a narrowing at the top of the throat" [link]. Patient was given a strong pain medication to help with her discomfort (presumably a narcotic), admitted into the hospital, and ENT consulted for further evaluation and management. Unfortunately, the patient's airway completely closed early the next morning resulting in a massive brain injury due to oxygen deprivation with eventual withdrawal of life support four days later.

Lawsuit against the hospital and ENT among others pending.

What could have happened?

Based on the limited information provided, it seems that the airway swelling noted on the CT scan could have been due to a large peritonsillar abscess, throat tumor, or epiglottitis.

A peritonsillar abscess is basically a tonsillitis gone real bad with pus collecting under the tonsil causing it to swell. This condition could have been treated quickly with an incision and drainage.

Epiglottitis is when the "throat flap" becomes infected resulting in massive swelling which can lead to airway closure. Typical management would include IV antibiotics, IV steroids, and close observation. If airway truly becomes critical, an awake tracheostomy should be pursued. However, medical management is most always tried first if airway is still patent (albeit narrowed).

Throat tumor (ie, cancer) is pretty much a large growth in the throat causing airway narrowing. Treatment is an emergent awake tracheostomy followed by biopsies to determine what type of cancer is present so that treatment can be pursued as quickly as possible.

It is unclear from media reports exactly what was causing the airway narrowing and whether ENT had even seen the patient until the airway closed off. Also unclear was whether the ENT was made aware just how critical the airway was.

A tragedy...

Source:
Daughter of woman who died from brain damage after airway swollen shut sues hospital. The Louisiana Record 4/15/13

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Scam Tracheostomy in Hospital Leading to Arrests

Image from Wikipedia

A Chicago hospital owner and a few doctors were arrested in a horrific scandal involving deliberately over-sedating patients thereby ensuring a patient will not be able to come off the breathing machine leading to the excuse needed to perform a tracheostomy [link]. All done in the name for greater profits.

This scandal is particularly notable given it has come right at the heels of a New York Times story which reported that hospitals often profit from surgical errors, though in this criminal case, it was deliberate rather than unintentional errors.

Tracheostomy is typically performed whenever a patient is on a breathing machine for a prolonged period of time and there is a low likelihood of recovery.

However, prior to tracheostomy consideration, sedation is turned off so that the patient is allowed to wake up and try to breath on their own. If able to breath on their own with machine assistance, the breathing tube may be removed thereby avoiding a tracheostomy.

However, according to the lawsuit, the hospital and physician colluded to over-sedate patients thereby ensuring the patient is "ventilator-dependent" for which a tracheostomy is (erroneously) "justified".

Furthermore, patients who have undergone tracheostomy were intentionally made to stay in the hospital longer than required ("28 days") in order to earn as much money as possible in insurance reimbursements for the hospital.  [link: paragraphs 123-142]

According to media reports, this scam has so far involved 28 patients... 5 who ultimately died within 2 weeks. The most recent unnecessary tracheostomy was performed on March 1, 2013.

Because of the trach and subsequent prolonged hospitalizations, the hospital received up to $160,000 for each patient from Medicare and Medicaid.

There's more... there was a massive kickback scheme whereby the hospital paid doctors to refer cases to the hospital (clear violation of Stark Laws), doctors ordered unnecessary ER visits, and fraudulently referred patients to nursing homes and ambulance services which the hospital had a relationship with.

This awful scam was brought to light by hospital workers (administrators, physicians, and nurses) who secretly worked with the FBI and other federal investigators.

Sources:
Feds raid Sacred Heart Hospital, arrest owner and doctors. Chicago Sun-Times 4/16/13.

United States of America Criminal Case Record. 4/15/13

Hospitals Profit From Surgical Errors, Study Finds. New York Times 4/16/13

Relationship Between Occurrence of Surgical Complications and Hospital Finances. JAMA. 2013;309(15):1599-1606. doi:10.1001/jama.2013.2773.

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17 Year Old Girl Dies After Tonsillectomy

Patients sometimes focus too much on the intricacies and risks of the surgery itself and not realize that subsequent care AFTER surgery may be just as important and risk-laden.

Media reported yesterday about the tragic death of a 17 year old girl after tonsillectomy.

Apparently in March 2012, the Pennsylvania teenager underwent a routine tonsillectomy without any problems. While in recovery after surgery (PACU), she was given fentanyl, a powerful narcotic to help with pain, but also has a known side effect of slowing the breathing down.

"Over the next 25 minutes, her respiratory condition rapidly worsened and went unnoticed by nurses, who failed to perform required assessments and were not warned by the equipment monitoring Mariah's vital signs because it was not set properly and was muted. Sadly, as a result of these oversights and others, Mariah sustained significant brain damage due to oxygen deprivation and died 15 days later." [link]

It is also implied that in order to give the patient privacy, curtains were drawn such that her distress was also not visually seen by nurses.

Clearly, multiple lapses occurred leading to this tragic death.

Those alarms are there for a reason!!! Why mute them? Patients (and even staff) do complain of the annoying beeps and noises such machines make and out of exasperation, they can be muted due to the many false-alarms, but as this case illustrates, those very alarms could have saved her life.

Once a patient is identified with respiratory distress, narcan could have been given that would have reversed fentanyl's sedating (as well as pain-killing) effects. At worst, the patient could have been re-intubated.

This case also highlights that in certain situations, patient safety trumps patient privacy.

In PACU (a common open room where patients go after surgery), there is absolutely no patient privacy. Everyone can see everything. That way, if there's any problems, nurses can immediately see if a patient is in distress. That's also one reason among others why family is not allowed in the PACU (due to lack of privacy for other patients).

Abington Surgical Center where the surgery was performed has imposed a series of policy changes to ensure another death like this may never happen again. According to media, these policy changes include:

• each patient who has received IV narcotics (which is pretty much all patients who have surgery) in the PACU must be assigned one-on-one nurse care
• patient monitoring equipment may no longer be muted
• curtains restricting the view of the patient can no longer be drawn
• there must be a dedicated charge nurse to oversee nurse staffing and patient flow in the unit.

Except for the first point, I agree with all these policy changes which really shouldn't be a policy change per se... It should have been always there.

However, the one-on-one nursing care certainly can't hurt, but is probably unnecessary and potentially a waste of nursing resources. I should point out that IV narcotics are given ALL THE TIME in the hospital whether in PACU, the hospital floor, ER, and ICU, but one-on-one nursing care is not usually present in any of these locations. Rather, the intensity of nursing care should depend on the acuity of the surgery as well as the medical needs of the patient. A blanket policy change that applies indiscriminately is needlessly wasteful.


Source:
17-Year-Old Girl's Tragic Death After Routine Tonsillectomy Leads to Post-Operative Care Changes. SacBee.com 2/5/13

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ENT Uses Laser Resulting in Patient Death

In 2010, an ENT used a Sharplan laser with an Omniguide Sidefire Adapter to address a superficial lip hemangioma.

The tip of the laser probe was inserted through a small incision made to one side of the hemangioma and activated. Seconds later, the lip and surrounding tissues immediately swelled up indicating trapped gas. A second incision was made in an attempt to release the buildup of gas (analagous to popping a balloon to release air). A short time later, the patient's vital signs dropped and in spite of life-saving measures, was pronounced dead within 2 hours.

The official autopsy report declared death due to "arterial embolism." [link]

What happened?

In the operation of the Sharplan laser, there are two channels present in the laser probe. One channel carries the laser and the other channel carries compressed helium gas that flows over the probe tip to cool it down (a laser is essentially a very focused beam of light and is quite hot... just like direct sunlight which is unfocused).

The helium gas pressure flow can be varied between 50-70 psi (pounds per square inch). Just for a frame of reference, car tires are pressurized to about 35 psi.

What essentially happened at the time of the procedure was helium gas built up within the lip under too high a pressure. Some of this helium gas (as a bubble) entered the blood stream where it blocked blood flow to vital organs like the brain and/or heart resulting in death

To prevent this complication, when using a Sharplan laser, the manufacturer specifically states to keep the probe perpendicular and at least 5mm away from contact with soft tissues. The probe should be completely away from any blood vessels.

I did want to add that Sharplan lasers are no longer made. In fact, it is also appears that the company that makes this laser no longer exists.

Take home message?

A surgeon should be the master of the tools he uses. Not understanding the operation of a tool can lead to unintentional, but disastrous mistakes.

Secondary message?

Lasers are dangerous, even if used properly.

There's a reason why many ENT's (including myself) have voluntarily elected to no longer use lasers at all for any purpose. Lasers introduce additional risk to a procedure that can be performed in alternative and safer ways with just as good an outcome.

It's not just arterial embolism that can occur. Lasers can also cause life-threatening hemorrhage from blood vessel damage (death of a 5 years old child), airway fire (laser can ignite oxygen), blindness (laser can reflect off metal surfaces and bounce into somebody's eye), etc.

Smart Laser, Dumb Surgeon

If lasers must be used, depending on the procedure, there are two different "styles" of laser that can be utilized. For simplicity's sake, I'll describe these two laser types as:

1) Smart Laser, Dumb Surgeon
2) Dumb Laser, Smart Surgeon

For style #1, the "smart laser, dumb surgeon," the laser is used much like the flash of a camera. You just have to aim the laser in the general vicinity of whatever it is the surgeon wishes to address, typically a vascular lesion like a hemangioma. When the laser is activated (typically a KTP or PDL laser), the laser selectively attacks the lesion without damaging the surrounding tissue. The surgeon is "dumb" in that all he has to do is crudely aim the laser in the general vicinity and the "smart" laser will do the rest. Watch a video of this type of laser in action here.

For style #2, the "dumb laser, smart surgeon," the laser (typically a CO2 laser) is used more like a handgun. It needs to be precisely aimed, precisely activated, precisely used. If the surgeon makes a mistake in aim, activation, or use, unintentional damage (and even death) may occur. The surgeon has to be "smart" in that he needs to precisely guide the "dumb" laser which will destroy anything in its path.


Source:
California Health and Human Services Department of Health Report. Report completed 12/3/10. Received by Licensing & Certification Office 6/15/12.

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Julie Andrews and Her "Botched Throat Surgery"

It has already been well-publicized that the former singing sensation Julie Andrews underwent some type of throat surgery in 1997 after which she never regained her phenomenal 4-octave voice thus relegating her to more conventional roles of being an actress without the singing. This "botched throat surgery" per Julie Andrews lead to a lawsuit that was ultimately settled.

It is unknown precisely what type of (presumed) vocal cord pathology was present as well as what type of surgical approach was used to try and fix it. In a recent interview, she stated:

"The operation that I had left me without a voice and without a certain piece of my vocal chords"

However, given her aggressive and active singing career prior to surgery, she probably had vocal cord nodules, a benign growth that occurs due to vocal overuse, a situation not uncommon with professional singers.

Vocal cord nodules are most always due to excessive voice use leading to "callous" formation on the vocal cord lining, much like shoveling dirt will eventually lead to callous formation on the hands.

Traditional standard of care management of vocal cord nodules is voice therapy and avoidance of any activities leading to voice abuse (screaming, yelling, etc). However, resolution of nodules with such behavior focused treatment takes months. However, although it takes a while for the nodules to resolve with this treatment method, they typically do not come back.

For patients who are more "impatient" for results (not unusual with professional singers whose livelihoods depend on singing), there are more aggressive ways to address vocal cord nodules with possible resolution within weeks. However, the caveat is if the underlying voice behavior that led to nodule formation in first place is not addressed, the vocal cord nodule WILL recur after initial resolution/improvement. Furthermore, as with any more invasive treatments to obtain a "quick fix", scar formation may occur leading to permanent voice changes, usually for the worse which obviously happened with Julie Andrews.

What are some of these more invasive treatments beyond voice therapy? To reiterate, these procedures also have a high risk of recurrence if underlying abusive voice behavior that led to the nodule formation in first place is not first addressed.

• Surgical excision can be performed, but can lead to permanent scar formation during the healing process that can lead to persistent irreversible hoarseness.

• Botox injection can also be pursued which causes a "partial" vocal cord paralysis preventing the repetitive trauma in the region of the vocal cord nodule.

• Steroid injection to the vocal cord nodule(s) can possibly resolve or reduce the nodule resulting in improved vocal quality within weeks. Such local injection technique has mainly been performed in the treatment of spasmodic dysphonia (botox injection), vocal cord granulomas, and vocal cord paralysis. Watch a video how a "local injection" to the vocal cord can be performed (video shows injection of vocal cord granuloma rather than nodule, but overall approach is identical).

Read more about vocal cord nodules here.

Source:
Julie Andrews' Voice Isn't Coming Back, But She's Not Staying Silent. Huffington Post 12/5/12

PUBLIC LIVES; Julie Andrews Sues Throat Surgeon. NYT 12/15/99

Julie Andrews Settles Lawsuit Against Doctors. ABC News 9/7/12

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57 Maggots Removed from Woman's Ear

92 years old woman with Alzheimer's was found to have 57 maggots in her ear sparking a lawsuit. Read more from media reports.

Beyond the gross factor and questions regarding how this was allowed to happen, this story does bring up some interesting teaching points and the medicinal properties of "maggot therapy".

Media reported the patient suffered from earwax build-up and had "an enlarged ear canal from surgery performed decades earlier."

This  surgery was most likely a canal-wall-down tympanomastoidectomy often performed for a benign ear tumor called cholesteatoma or a severe chronic draining ear. This surgery essentially removes all the bone from behind the ear (mastoid) and ear canal back wall. Depending on how aggressive the surgery, the eardrum and middle ear bones (malleus, stapes, and incus) may also be removed.

With such surgery, the ear canal now 2-3 times larger than before, is prone to developing earwax impaction and requires surgical debridement or removal every 4-6 months for the rest of the patient's life.

If surgical debridement is not performed regularly in such patients, infection may set in.

With such infection, ear drops can be used as described in the story, but such treatment is bound to fail until ear canal debridement of all earwax is first performed.

What I suspect is that this poor patient did not get her ear cleaned out regularly resulting in infected earwax. A fly noting the foul cesspool located in a dark, humid environment of this enlarged ear canal probably thought this the perfect place to lay eggs and allow a maggot infestation to occur.

Gross, horrid, and astounding I know...

However, medicinal maggot therapy is actually used in hospitals... Why?

Because maggots are apparently WAY better than a surgeon in certain situations at removing dead infected tissue with or without antibiotics.

It is entirely possible that given time, the maggots might have cleaned and removed the infection that was probably present in this patient's ear. However, unlike medical-grade maggots which are "sterilized" prior to use, "natural"maggots probably harbor other microbes that could cause a secondary infection.

Such medicinal maggots can be purchased for wound control with a prescription. Monarch Labs is the exclusive USA supplier of medicinal maggots which the FDA considers a "medical device."

Here is a video produced by National Geographic on maggot therapy.

Source:
92-year-old has 57 maggots removed from ear, family sues nursing home. CBS News 11/30/12

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Is Patient Abandonment in the Operating Room Ever Justified?

I ask this question mainly because there WAS an ENT who WAS sued for NOT abandoning his patient in the operating room [link]. No way to verify, but additional details can be found in this facebook post.

Imagine this hypothetical scenario (as details from original case are not available)...

You are an ENT surgeon in a rural community hospital performing a fairly difficult but elective sinus surgery on a 12 years old child with cystic fibrosis with extensive pan-sinus nasal polypoid disease. Given the extensive nasal polypoid disease, a fair amount of bleeding is occurring which was not unanticipated.

Suddenly, you get a phone call from the emergency room regarding a patient with progressive difficulty breathing suspected to have epiglottitis.

What do you do if you are the only ENT in the hospital?

Do you "abandon" the 12 years old child in the operating room, still bleeding, still under general anesthesia and attend to the ER patient who himself might die without an emergency tracheostomy? Doing an evaluation to determine how critical the ER patient may take anywhere from 15 - 60 minutes including the tracheostomy itself. Keep in mind that 99% of the time, a tracheostomy is NOT necessary.

And, if a tracheostomy WAS needed, you are now performing two different surgeries in two different rooms simultaneously which must break some rule somewhere... perhaps JCAHO?

Or, would you finish the surgical case first, and than proceed to see the ER patient?

What if you are the only ENT available in the region let alone the hospital? No fellow ENT colleagues to call upon for help. General surgery is "unavailable" or not comfortable with performing tracheostomies especially given ENT performs all tracheostomies in the hospital?

Patient abandonment is defined as:

• Failing to transfer a patient to an appropriate level of care
• Failing to respond to calls from a hospital regarding a patient
• Refusing to care for a patient after arranging the patient's admission
• Failing to treat a patient until new coverage is arranged

Proving patient abandonment includes:

• Your doctor had a duty to treat you - a duty was created when the physician-patient relationship was established
• You had a reasonable expectation that your doctor would treat you
• Your doctor failed to treat you although he or she was obligated to do so
• You suffered injury as a result

Well, according to one lawsuit, it seems that the ENT was required to abandon his patient in the operating room and attend to the ER patient. The lawsuit stemmed from the fact that the ENT did not abandon his patient in the operating room and the ER patient did die as a result of not being attended to quickly and competent emergency tracheostomy performed. Of course, the settled lawsuit also blamed the hospital, general surgery, and anesthesiology.

However, abandoning a patient on the operating room table is also tantamount to medical malpractice according to the very definition of patient abandonment.

And, I would not be surprised if the patient on the operating room table would have sued the ENT if he DID leave the operating room in the middle of surgery to attend to another patient for a long period of time (and even starting another operation without ever finishing the abandoned patient's surgery first).

What to do?

I have no answer...

Doing an emergency tracheostomy is HARD, even for someone who has performed hundreds of elective tracheostomies. I know... I've done perhaps a half-dozen emergency trachs in my career so far. In this particular lawsuit, I found it incredible that a hospitalist (not a surgeon) was the one who finally attempted the emergency tracheostomy (albeit unsuccessfully).

Do you consider the patient you are CURRENTLY caring for has a higher priority than a patient you have never met, even if possible life-threatening illness is involved? (Keep in mind that when called for an airway problem, that 99% of the time, an emergency tracheostomy is not needed.)

OR, do you prioritize the patient you have never met given the possible life-and-death circumstances involved, even if 99% of the time, no surgical airway is required.

What would YOU do? What should you do? Feel free to comment below!

The way I see it, the ENT would have been sued no matter what decision was made. It would have been a lose-lose and lose proposition.

By deciding to stay with his current patient, the ENT was sued by the ER patient's family. If the ENT left his current patient on the operating room table, the ENT would have been sued for abandonment. If the ENT did abandon the current patient and the ER patient still died in spite of an emergency tracheostomy, the ENT would probably be sued for wrongful death by the ER patient's family AND the patient he abandoned on the operating room table.

Source:

Hospital settles wrongful death lawsuit. Curry Coastal Pilot 10/31/12

ADDENDUM 12/5/12:
Information obtained from an anonymous source reported that the ENT who was sued ultimately had charges dismissed with prejudice. It was maintained from the beginning that the ENT's obligation was to the patient on the table and that there was no doctor-patient relationship with the deceased.

I also find it interesting that the hospital where the lawsuit occurred, now does not even have ENT coverage at all. I guess that's what happens when a lawsuit occurs when there's only solo specialist coverage. I'm predicting that this hospital will have a very difficult time to recruit another ENT to work there given this case even though the ENT was ultimately found blameless.

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ENT Surgeon Sues Spine Surgeon for Wrong Sided Surgery

Wrong sided surgery is extremely rare occurring anywhere from 0.09 to 4.5 per 10,000 surgeries performed.

It is almost unheard of when the patient is a surgeon as well.

On Nov 13, 2012, media reported that an ENT surgeon (plaintiff) sued his spine surgeon (defendant) over wrong-sided surgery.

The ENT surgeon had spine surgery in 2011 for low back pain which was allegedly due to pinched nerves. The treatment called for laminectomy surgery on the right side which entails bone removal to prevent the nerves from being pinched further thereby alleviating pain.

However, the ENT surgeon claims wrong-sided surgery in that left back surgery was performed rather than the right side. The spine surgeon claims he performed a left-sided approach to the right side.

Here's a video news report which includes radiological images that does appear to show bone removal on only the left side (rather than the correct right side).



Although it may seem like an open and shut case of malpractice for wrong-sided surgery, as in most cases of medicine, it is not that straightforward.

Given I'm not a spine surgeon, I asked my good colleague Dr. Jeffrey Wise who is a spine surgeon with Blueridge Orthopedic and Spine Center to comment further in this particular case.

After review of available publicized information, Dr. Wise felt that there were several possible explanations of what may be going on:

1. It was truly wrong-sided surgery that the spine surgeon is trying to cover up.
2. The correct surgery WAS done utilizing an opposite side technique.
3. It may be lack of informed consent on the part of the spine surgeon (the approach was not explained clearly to the patient).
4. The ENT surgeon may have misinterpreted the informed consent and not understood the procedure.
5. The correct procedure was done and the ENT surgeon did not have the result he was hoping for or he may have wanted to be disabled for secondary gain.

Some facts...  It is possible to do right-sided back surgery via a left-sided approach as illustrated in the textbook diagram shown in the video with the tubular retractors.

In fact, it is indeed easier to decompress the lateral recess and exiting nerve root of the spine from the opposite side via the open approach. The surgery can also be done via a minimally invasive approach (as in this case), but it is not considered standard approach of most spine surgeons who would usually use the tubular system and go on the same right side for a unilateral decompression.

On another note, the decision on the necessity for spine surgery is interesting because in the pre- and post-axial MRI pictures shown in the video, while there is clearly a spine defect on the left, the pre-op picture does not show any pathology that suggests surgery was even needed. Perhaps there are more images that do show the nerve compression better, but they are certainly not shown in this article.

From a legal standpoint, it would be possible to prove or disprove that wrong-sided surgery was done if there is clearly bone removal visualized from the right side (presuming spinal stenosis was the diagnosis for which surgery was performed) or a disc herniation was no longer visible (if a disc herniation was the problem). This scenario would favor the neurosurgeon.

However, if the bone on the right side (or disc herniation) was still present, that would favor the ENT surgeon.

Unfortunately, based on the limited publicized images shown, it is impossible to clearly tell from the images shown or information provided in the article. Again, the images shown do not show a surgically justifiable lesion to begin with and only show bone removal from the left spine.

- Dr. Jeffrey Wise

Source:
INVESTIGATION: Surgeon v. Surgeon in wrong-side surgery case KFOR.com 11/13/12

References:
Avoiding wrong site surgery: a systematic review. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S28-36.

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Problem with Medical Protocols (and Lawsuits Because of Them)

Over the past decade working in hospitals, I've seen the proliferation of "established procedures and protocols" for literally everything under the sun...

• Chest Pain Protocol
• Discharge Protocol
• Pneumonia Protocol
• Stroke Protocol
etc, etc, etc

Protocols are essentially standing orders that are supposed to be implemented whenever a given medical situation occurs. It is supposed to follow best evidence-based practices and make it easy for healthcare personnel know what to do without thinking to hard (akin to a checklist a pilot performs before flying to ensure they did not forget something).

The problem with protocols are that it can be made so detailed as to become worthlessly bloated. To use an analogy, take the protocol, "Going Shopping Protocol."

Protocol A (Simple):
1) Make grocery list
2) Drive to supermarket
3) Pickup and purchase items on grocery list
4) Come back home

Protocol B (Detailed):
1) Pickup #2 pencil
2) Sharpen pencil to appropriate point using pencil sharpener model 15-231
3) Test pencil to ensure proper writing ability
4) Obtain 3x4 inch index card
5) Write shopping item #1 on index card using pencil (from steps #1-3)
etc, etc, etc

Now when dealing with something as complex as medicine, protocols can be a godsend or hopeless depending on how it is written and who uses it.

And, that's where protocols become problematic.

Make a protocol too detailed, and it becomes bloated to the point of being useless, especially when dealing with time-sensitive medical problems.

Take for example something as simple as "Chest Pain Protocol." Orders for EKG, aspirin, IV fluids, sublingual nitroglycerin, and morphine seem obvious (assumption being heart attack), but what if we are dealing with a 10 years old child who got punched in the stomach by a bully? What about a stabbing into the chest?

Does that mean there needs to be multiple branch-points explicitly addressed in the protocol to handle every single possible scenario of chest pain under the sun at any age for every possible scenario?

Clearly, the answer is "NO"!

So protocols are made with several assumptions:

1)  A general level of medical competence of healthcare professionals
2 ) Healthcare professionals are already familiar with a given protocol and knows when to appropriately activate it
3) Protocols are deliberately made to be not too specific as it is understood that there is variability in the care of patients. Protocols can not and should not be applied cookie cutter to every patient as there are nuances that the protocol leaves to the judgement of the doctor.

Unfortunately, by making protocols to generalized, it does open up the possibility of lawsuits.

Take an ongoing case in Georgia where the medical director of an emergency room is being sued for professional negligence in the death of a woman from a heart attack... because of a chest pain protocol he wrote. Note that this medical director NEVER provided any direct medical care, did not have an established patient-physician relationship, and was not even in the hospital when the woman came into the ER. [link]

So is the solution to avoid having any protocols in place to avoid lawsuits? Sorry... NOT having a protocol in place can also be subject to a lawsuit. In 2000, a hospital was sued for either failing to follow established anesthesia procedures or protocols or failing to have any established procedures or protocols in place. [link]

So what to do?

Well, getting sued is a risk that is inherent to the medical field, especially whenever there is a bad outcome.

As such, the default action taken by physicians and hospital administrators are to minimize or spread the risk. How?

• Have as many different physicians write-up a given protocol that is signed off by everybody (spreading the risk)
• Avoid positions of responsibility (default scapegoat for lawsuits)
• Involve many physicians in the care of a patient (spreading or transferring the risk)
• Have protocols, but do not depend on them (clinical judgement trumps protocol).
• Have MANY documented training sessions on how protocols are to be used and discuss weaknesses and strengths of them

References:
UPSON COUNTY HOSP., INC. v. HEAD 540 S.E.2d 626 (2000) 246 Ga. App. 386 UPSON COUNTY HOSPITAL, INC. v. HEAD. No. A00A1601. Court of Appeals of Georgia. October 13, 2000.

Gaulden v. Green, No. A12A1872 (Ga. Ct. App. Oct. 30, 2012)

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Deaths Associated with Codeine Usage in Young Kids

For decades, surgeons have provided young children with prescriptions for pain control after tonsillectomy and/or adenoidectomy surgery, most commonly tylenol with codeine (otherwise known as tylenol #3). Millions upon millions of such prescriptions have been filled and taken without any problems, but there is now a growing concern that such narcotics may be causing more harm than good in a small percentage of kids and perhaps an even greater percentage where it absolutely does nothing. Furthermore, it has now become the subject of an FDA investigation.

Why the sudden concern?

There has been a small but increasing number of children who have suffered anoxic brain damage and even fatalities due to respiratory suppression associated with codeine use. This association was not figured out until recently as such unfortunate incidences were initially felt to be due to medication overdosage, poor care, and/or surgical error.

But now, it is felt that such adverse events were probably due to the administration of codeine itself.

What's going on?

All of the children who died following codeine administration had extra copies of the liver enzyme CYP2D6 which metabolizes codeine to its more potent form morphine [study]. Referred to as ultra-rapid metabolizers, these children metabolize codeine so rapidly to morphine that it leads to respiratory depression or arrest. Substituting codeine for hydrocodone, oxycodone, or other opioids is also unsafe as such narcotics are also metabolized by CYP2D6 and cause even more problems because the CYP2D6 metabolites of hydrocodone and oxycodone are even more potent than morphine. (Of course, on the flip side, there are patients who have minimal CYP2D6 functionality which leads to minimal if any pain relief with codeine.)

Although rare, there has been an increasing number of case reports describing children who have died after receiving codeine for post-operative pain, particularly after tonsillectomy. The most recent report published in 2012 documented the cases of three children who died after receiving standard treatment with tylenol with codeine after tonsillectomy between 2010 and 2011. However, these are only the known documented cases.

Given how rare, changing prescribing patterns may not be warranted... BUT...

What about the possibility that there may be numerous other cases which are not documented or close-calls? As we all know, for every documented case, there's probably numerous other undocumented cases.

To investigate this possibility, a close proxy would be to look at malpractice lawsuits after tonsillectomy. This report did just that looking closely at lawsuits stemming from tonsillectomy complications between 1984 and 2010 and found that the incidence of codeine-related deaths was much higher than the researchers expected. They found that 18 percent of death claims and 5 percent of injury claims resulted from the use of opioids, largely codeine. Indeed, after bleeding, opioid usage was the second most common cause of death in patients after tonsillectomy.

Additionally, death and anoxic brain injury claims associated with narcotic usage were associated with the greatest indemnity with a median payment of more than $900,000 per case.

Though likely impossible to do retrospectively, it would have been interesting to see whether all these children in these lawsuits had multiple CYP2D6 copies or not.

Alternatives to Narcotics

First, there is the question whether tylenol with codeine even helps with pain. Apparently not according to one study. In fact, children who took tylenol alone resumed a normal diet more quickly than kids who received codeine.

In fact, tylenol with codeine is associated with adverse side effects (nausea, dizziness, vomiting, etc) in up to 79% of children who take it [link].

Ibuprofen may also be given for pain control. Though ibuprofen theoretically can increase risk of bleeding due to its anti-platelet activity, numerous studies have not found this to be true.

Given codeine helps minimally with pain and tylenol alone seems to provide adequate pain control, why even given narcotics, especially given the small but significant risk of death associated with this drug?

Pain Control Protocol

Based on all these findings, we feel that narcotics for pain control after tonsillectomy for kids under 7 years of age is not recommended.

Rather, the following protocol is what we will now be implementing:

Tylenol and Ibuprofen over-the-counter as needed to help with pain control. The dosing is weight-based and exact dosing for a given child can be found on the bottle. These medications can be given alternating between Tylenol and ibuprofen every 3-4 hours (Tylenol first, followed by ibuprofen 3-4 hours later, followed by Tylenol 3-4 hours after that, etc). A prescription for a single dose of steroids is also provided which is meant as a one-time dose that can be given anytime 3 days after surgery if the child suddenly seems to have significantly more pain that is not controlled with Tylenol and ibuprofen. Pain in this scenario is often due to inflamed tissues that can be quickly minimized with steroids.

Source:
FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. FDA 8/15/12

Post-Operative Pain in Children Undergoing Tonsillectomy. ENT Today. Sept 2012.

FDA Investigates Codeine Safety After Children’s Deaths. ABC News. 8/15/12

References:
More codeine fatalities after tonsillectomy in North American children. Pediatrics. 2012 May;129(5):e1343-7. Epub 2012 Apr 9.

Preventing opioid-related deaths in children undergoing surgery. Pain Med. 2012 Jul;13(7):982-3; author reply 984. doi: 10.1111/j.1526-4637.2012.01419.x. Epub 2012 Jun 13.

Complications and legal outcomes of tonsillectomy malpractice claims. Laryngoscope. 2012 Jan;122(1):71-4. doi: 10.1002/lary.22438. Epub 2011 Nov 10.

Acetaminophen versus acetaminophen with codeine after pediatric tonsillectomy. Laryngoscope. 2000 Nov;110(11):1824-7.

Non-steroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003591.

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