New Drug Could Become Standard of Care To Stop Bleeding

On Behalf of | Mar 21, 2012 | Medical Malpractice

Emergency room doctors often need to act quickly, and the failure to do so can result in a medical malpractice claim. The role of an Emergency room doctor is often to stabilize the patient so that a specialist may then assume the care of the patient. When dealing with trauma patients, the first order of concern is often to stop the bleeding.

As reported in The New York Times, tranexamic acid has been saving lives of Americans in battlefields by slowing the bleeding of even gravely wounded soldiers

A 2010 study by Dr. Ian Roberts(audio) reported on the benefits of tranexamic acid. Following the study The World Health Organization added tranexamic acid to its essential drugs list last year, and British ambulances now carry it. The fact that it is carried on ambulances is important because a new analysis of the 2010 CRASH-2 study shows that tranexamic acid should be given as early as possible to bleeding trauma patients; if treatment is not given until three hours or later after injury, it is less effective and could even be harmful.

Incredibly enough, because this effective drug is so inexpensive, it has not yet been adopted in all emergency rooms. Because there is so little profit in it, the companies that make it do not champion it. Despite the fact that this drug could save thousands of lives of car accident, shooting, and stabbing victims.

Many companies in India and China make tranexamic acid. Pfizer, which makes an injectable form for hemophiliacs (and donated thousands of doses to the Crash-2 trial), declined to give sales figures or even discuss administering it to trauma patients because the Food and Drug Administration has not approved that use. A company spokeswoman declined to say whether Pfizer had applied for approval. (Doctors may prescribe approved drugs for “off-label” uses, but drugmakers cannot endorse off-label uses without F.D.A. permission.)

This drug is very similar to another break through drug known as tPA, which has the opposite effect in that it is a clot buster. Like tranexamic acid, it to needs to be given within three hours of the onset of stroke symptoms. If given after three hours, the results can be fatal. tPA is the standard of care for patients who present to the emergency room within 3 hours of stroke onset and meet other criteria. The failure to administer tPA can lead to a
claim for medical malpractice. Hopefully, tranexamic acid will become the standard of care for trauma patients, and the failure to administer tranexamic acid will be medical negligence.

Negligence of a physician as defined by Florida Jury Instructions:

Negligence is the failure to use reasonable care. Reasonable care on the part of a physician is that level of care, skill and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by similar and reasonably careful physician. Negligence on the part of a physician is doing something that a reasonably careful physician would not do under like circumstances or failing to do something that a reasonably careful physician would do under like circumstances.

The key is that the treatment or procedure is recognized as acceptable and appropriate.

Mark Kaire has been practicing law in Miami for nearly 30 years. He is dedicated to helping the injured people of Miami receive compensation. Mr. Kaire has been blogging on Miami’s legal issues for many years.