SIRVA – The Vaccine Injury

For Latasha George, a nurse in Louisiana, getting a flu shot was nothing extraordinary or a matter of concern.  However, what followed was something that she had not bargained for.  Latasha ended up with SIRVA, a shoulder injury resulting from incorrect vaccine administration.  To compensate for her injury, the National Vaccine Injury Compensation Program awarded her more than $1 million.  Patients with injuries caused due to vaccination are barred from filing suits in state or federal courts.  In order to hear their claims, the government has set up the U.S. Court of Federal Claims Office of Special Masters.  Shoulder problems related to vaccination have been recently added to the list of injuries eligible to receive damages.  The special court has increased accepting the number of claims for this injury and it is now being added to the no-fault system.

What causes SIRVA?

Shoulder pain is a common side effect of being administered a vaccine like a tetanus or flu shot, in the arm.  However, sometimes the pain persists even after a prolonged period and can be accompanied by limited range of motion or other shoulder related injuries.  In its most severe form, this injury is known as Shoulder Injury Related to Vaccine Administration (SIRVA).

SIRVA is a result of injury to the musculoskeletal structure of the shoulder – i.e. tendons, bursa, ligaments etc, which is caused due to incorrect administration of the vaccine.  The most common cases of SIRVA occur in patients receiving a flu shot in the deltoid muscle of the arm.  It is important to remember that the injury is not caused by the vaccine itself, but by the incorrect administration of the injection.  Symptoms of SIRVA start showing in a few days and continues for weeks after receiving the shot.

What are the symptoms of SIRVA?

The most common symptom of SIRVA is severe shoulder pain.  While most people suffering from SIRVA complain of intense and persistent shoulder pain and limited mobility of the shoulder, there are other injuries that can also take place.  These include shoulder bursitis, shoulder tendonitis and adhesive capsulitis.

How is SIRVA treated?

Most cases of SIRVA can be treated with pain medication and physical therapy which helps in alleviating inflammation and improving the mobility of the shoulder.  However, in cases where patients continue to experience pain and/or other symptoms of SIRVA, it may be necessary to operate and repair the damage to the ligaments and tendons.

SIRVA in the news

Any medical treatment or intervention can result in injury – minor or major.  However, that does not mean that medical treatment should be stopped.  There are state and federal courts that take cognizance and allow claims against medical malpractice or injuries.  Similarly, just because vaccines or their administration can result in injuries, it should not dissuade vaccine manufacturers from production or patients from receiving them.  Keeping this in mind, claims against vaccine manufacturers cannot be filed in state or federal courts, but are heard by the U.S. Court of Federal Claims Office of Special Masters, which has no jury.

In order to shield vaccine manufacturers from liability, a trust, The National Vaccine Injury Compensation Program, was set up in 1988.  Funded by charging a small surcharge on vaccines, the fund has paid around $3.2 billion since 1988, to patients for a range of injuries related to vaccinations.  Some of these include arthritis, polio, Guillain Barre Syndrome, encephalitis and even death.  The fund also pays for attorney fees for claimants – within a reasonable amount, of course; to ensure that patients do not have to pay their attorneys out of the awarded amount.

More than $18 million has been awarded to 112 SIRVA patients since 2011; with more than half that amount disbursed in the last year.  An increased awareness of SIRVA and the growing number of immunizations have contributed to this rise in claims and awards.


References

  1. Brandon C. Taylor, M., & David Hinke, M. (2014). Shoulder Injury Related to Vaccine Administration (SIRVA). Retrieved February 25, 2016, from http://www.medscape.com: http://www.medscape.com/viewarticle/837089_2
  2. DUGAN, I. J. (2015, August 24). Vaccine Injury Payouts Rise. Retrieved February 25, 2016, from The Wall Street Journal: http://www.wsj.com/articles/vaccine-injury-payouts-rise-1440430702
  3. Matthew G. Barnes, M. C. (2016). A “Needling” Problem: Shoulder Injury Related to Vaccine Administration. Retrieved February 25, 2016, from http://www.jabfm.org: http://www.jabfm.org/content/25/6/919.full

 

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What Physicians Need to Know about Defenses to Malpractice

Practicing physicians are always vulnerable to malpractice litigation.  The threat of litigation, unfortunately, leads to defensive practice, which in turn adds billions to the cost of healthcare.  Defensive practice is also unsafe for patients.  This fear of litigation affects the daily practice of physicians and also the quality of life outside the clinic.

What constitutes Malpractice?

In order to be held liable for a malpractice suit, there are four elements that need to be proved:

  1. The physician had a duty.
  2. The physician breached that duty.
  3. The patient was harmed.
  4. The harm was caused due to the physician’s breach of duty.

The physician cannot be held liable if all the four conditions are not met.  However, there are certain cases where even if the four conditions are met, the physician cannot be held liable for malpractice.

Assumption of Risk

Mrs. Schneider was diagnosed with a breast lump, and was asked to get it surgically removed.  However, she decided to undergo treatment under Dr. Revici, using non-traditional, non-invasive and non-toxic methods.  She subsequently developed breast cancer that spread and required bilateral mastectomy.  Mrs. Schneider sued Dr. Revici for medical malpractice, but the consent forms that were signed by her, stated that she was aware of the risks involved in refusing conventional treatment and agreeing to Dr. Revici’s method of treatment.  The court ruled in favor of Dr. Revici, stating the expressed assumption of risk as a valid defense.

Assumption of risk lies in the adage ‘volenti non fit injuria’– to a willing person, no injury is done.  Under this, the plaintiff’s implied or expressed agreement absolves the defendant from responsibility.  It is very important to communicate the risks involved to the patient and obtain their consent to the line of treatment.  Physicians can reduce the chance of litigation if the patient is aware of the risks, benefits and alternatives before the procedure and then decide to “assume the risk”.

Good Samaritan

Ms. McCain impaled her leg on a rebar at a construction site.  Dr. Baston responded to her call for help and after cleaning the wound, asked her to seek medical care immediately.  However, Ms. McCain waited for a week before going to a clinic and by then she required surgical management for the infected wound.  Dr. Baston was sued by Ms. McCain for poor treatment.  The court did not find Dr. Baston liable for damages, as he had acted as a Good Samaritan.

The Good Samaritan law is made to protect physicians who respond to an emergency situation.  Under this law, a physician responding to an emergency is protected from being held liable for injuries or damages that occur during the emergency.  There are, however, certain caveats in the use of the Good Samaritan law.  It requires the following conditions to be met:

  1. The incident is an emergency.
  2. The act of rendering care is voluntary.
  3. The patient accepts the care received.
  4. The care is provided in good faith, intended to help.
  5. The care provider receives no remuneration for the care provided.
  6. The care provided cannot be grossly negligent.

The Good Samaritan defense was extended to in-hospital settings also, after the McKenna v. Cedars of Lebanon Hospital case.  However, the Good Samaritan defense for in-hospital settings varies from state to state.

Contributory Negligence

Despite being informed by Dr. Hull to delay scalp reduction, Mr. Smith, who underwent hair implants over several years, signed the consent forms and underwent surgery.  Unhappy with the scarring on his head, Mr. Smith sued Dr. Hull for malpractice.  The court ruled in favor of Dr. Hull as according to them, Mr. Smith knowingly underwent the surgery at his own peril, which amounted to contributory negligence.

According to the concept of contributory negligence, a person is responsible for their own action or inaction, which, if contributes to the negligence, then the person should not be awarded damages.  Contributory negligence may be used as a defense when a patient demands procedures or treatments against the physician’s advice.

Comparative fault

Dr. Azzara found Mrs. Ostrowski’s toenail producing draining, red in color and painful to touch.  In the course of her treatment, Dr. Azzara removed he toe nail to facilitate drainage.  However, Mrs. Ostrowski, who was a hypertensive diabetic, had poor weight, diet and health management habit, did not heal and her toe became a non-healing pre-gangrenous wound.  She sued Dr. Azzara and a vascular surgeon testified that removal of the toe nail was unnecessary.  Dr. Azzara, in his defense, was able to prove that Mrs. Ostrowski’s smoking and poor health management contributed to the outcome.  The court found her to be 51% at fault and Dr. Azzara at 49%.  The jury ruled in favor of Dr. Azzara and no damages were awarded.

Comparative fault is similar to comparative negligence, except, that in the case of comparative fault; a patient might be awarded some damages, depending on the percentage of contribution by the patient and the physician to the outcome of the treatment.

What physicians need to know?

Clinical defenses as stated above have been and can be used in malpractice cases, even if the four elements of duty are present.  Physicians need to know about these defenses to optimize and reduce the risk of liability if confronted with a potential malpractice suit, rather than practice defensive medical procedures or treatments.


References

  1. Bowen Berry, J. (2001, January 14). The physician’s guide to medical malpractice. Retrieved January 21, 2016, from http://www.ncbi.nlm.nih.gov: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1291321/
  2. Defenses to Medical Malpractice. (2016). Retrieved January 21, 2016, from http://www.injury.findlaw.com: http://injury.findlaw.com/medical-malpractice/defenses-to-medical-malpractice-patients-negligence.html
  3. Michael Jason Hudson, M., & Gregory P. Moore, M. J. (2011). Defenses to Malpractice. Retrieved January 21, 2016, from http://www.medscape.com: http://www.medscape.com/viewarticle/755818
  4. Sandy Sanbar, M. P. (2006). Medical Malpractice Defenses. In MedMal Survival Handbook (pp. 257-267).
  5. Suszek, A. (2016). Types of Defenses in a Medical Malpractice Case. Retrieved January 21, 2016, from http://www.alllaw.com: http://www.alllaw.com/articles/nolo/medical-malpractice/defense-2.html