Vascular Device Forum

Medical Malpractice Vascular Surgery/Intervention-Current Status

Today, I received an email from a colleague lamenting how disappointing it is that there has been no support for malpractice reform in the current discussion on healthcare reform. A recent article in the liberal New York Times source summarized the situation by suggesting that malpractice is responsible for 3% of overall healthcae costs (relatively minimal). However my impression is that the study underestimated the significant impact that impending medical liability has on increasing costs of providing care in terms of a constant cycle of unneccessary test and labs for defensive purposes. To the point that young doctors are now trained in the art of practicing defensible medicine. I posted previously on medical malpractice in vascular surgery and vascular disease treatment and it was well received. Issues like limb ischemia, gangrene and amputation are common topics with significant medical legal liability.

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To be certain, there are egregious cases of medical negligence that virtually indefensible, however from what I have seen, the vast majority of malpractice cases are frivolous and even if they dont make it to trial, they cause a great deal of anguish, increased costs and loss of professional integrity. For this reason, Im always available to participate in defending a vascular practitioner vigorously as a vascular expert.

I actually think that far more systems errors occur that result in patient injury than direct physician mediated injuries. And the data would suggest that most of these medical errors dont result in medical malpractice litigation

My colleague sent me a couple links for agencies that advertise for vascular surgery, cardiology, cardiac surgery medical malpractice cases. Its always interesting to see what the process is and to hear plaintiffs describe the potential errors in management during the review of a medical malpractice case. For example read a list of vascular surgery medical malpractice cases and awards here

Also read about some sample cases here These cases are quite fascinating

Here at the VascularDeviceForum.com we spend a lot of time talking about the safe use of technology for the treatment of vascular disease and the ultimate benefit of our patients. But lets not forget that its a tough world out there for the vascular practitioner

Malpractice issues in vascular device use

endovascular repair, is the physician expected to

relate complications of a specific device, or just

those of endovascular repair in general?

Ms. Rode:

If the specific risks associated with a particular

device are recognized in the medical literature and

acknowledged to have significant incidence rate, then the

patient should be informed. For instance, if there is a procedure

in which two devices may be used, and the

devices carry different risks, the patient needs to be

informed of the risks associated with both devices and

consent to it (eg, in hip-replacement cases or other cases

in which the choice of two devices is determined intraoperatively,

the patient needs to know that device selection

will take place during the procedure, and—if the risk

associated with each device differs—the risks associated

with each device).

Ms. Rode:

However, you should be prepared for the

added sex appeal of the “investigatory/guinea pig” spin

that the plaintiff’s counsel will use to inflate the

verdict/settlement value of a case involving off-label

products. Insurance carriers take that factor very seriously

in evaluating cases involving off-label devices, institutional

review board protocol, etc.

Given the different types of endografts used in

Instructions for Use (IFU). I always notify the

patients and family of this and note that the

patient may be at increased risk of short- and

long-term adverse events as a result of this. If

adverse events do occur, what is my liability?

I received very positive feedback on a previous post discussing basic medical malpractice considerations. So I thought it might be helpful to discuss some examples of medical malpractice considerations specific to vascular devices. This goes without saying, but consult an attorney in your state as laws very from state to state and this should not be perceived as legal advice.

Are we obligated to tell patients that some

peripheral stenting is not approved by the FDA

even though it is done very commonly?

Requirements regarding the disclosure of

off-label uses likely vary by state. In Pennsylvania, a physician

is under no obligation to advise a patient of the FDA

status of a medical device (eg, Southard v. Temple Univ.

Hosp., 781 A.2d 101 [Pa. 2001]). The law in your state

may vary and on this important topic, and you should

consult with local counsel.

I use many products off-label and outside of the

This will usually fall under the “standard of

care” discussion. If what you do falls under the accepted

“standard of care,” it should not expose the surgeon to

increased liability.

source

Medical Malpractice focused on Free Standing Dialysis Access Maintenance Space

This topic is a little bit off course from what we generally talk about on VascularDeviceForum.com-ie upbeat optimism of new technology, creative energies and competition of the vascular device space. However, I know that once in a while, it's important to pull our heads out of the clouds and return to discuss the realities of day-to-day medical practice. Certainly one of those realities is the potential for medical malpractice lawsuit at any time.

 

Although, medical malpractice was on the front lines of healthcare issues and at critical proportions in many states, it seems that some efforts have been moderately successfull at stopping the hemorrhage (pardon the symbolism, but it is vasculardeviceforum.com after all).  The max exodus of physicians from certain hot beds like PA has equilibrated to some degree.

 

Today, I received a comment from an anonymous individual describing himself as an attorney specializing in medical malpractice. He seemed to suggest that the new wave of malpractice will focus on medical devices, suggesting that medical device misuse and malfunction offer the potential to tag the physician, hospital and deep pocketed medical device manufacturer. Additional, a single event of malfunction uncovered usually suggests that other events have occurred  but just have not been recognized or announced

 

Additionally, he suggested that the free standing facilities like vascular access maintenance centers are being closely observed for several reasons. These are dialysis access maintenance facilities usually managed by a company like Davita, Fresenius, Lifeline or American Access. Sometimes they are set up as an extension of practice or an Ambulatory Surgical Center (ASC).  Because the model is developing, oversite by various agencies is sometimes lacking and quality controls that are in place in hospital settings are sometimes lacking, Reporting of adverse events, best medical practices and actions to rectify issues may not be as stringent

 

Lastly, combined with the for-profit model, absence of economies of scale and close attention to expenses-medical practice may be altered in these circumstances.

 

While his comments seem quite plausible, I always like to believe that all healthcare practioners focus on patient interest. I then remembered a question that I received from a conference participant at a dialysis access maintenance talk. The question was from an access company administrator. He wanted to know why he had one facility that used two different balloon sizes on a particular dialysis access maintenance procedure while another facility routinely used one for the same procedure. The answer was quickly apparrent that once facility was using and inappropriately large balloon to "cut costs".

In all likelihood, if carefully done, it would have no consequences-but clearly it was not "standard medical practice". But it may be what happens when every piece of equipment used impacts the users bottom line

 

I would like to hear comments and questions about this provocative idea.

Medical Malpractice in Vascular Surgery-The Changing Dynamics

Although it's a topic no one really wants to talk about, medical malpractice remains an important discussion for medical providers.  The crisis of medical litigation which prompted mass exodus of physicians from crisis regions like Pennsylvania, West Virginia and Florida still exists. For a vascular surgeon practicing in greater Philadelphia Pennsylvania, an experienced surgeon with no cases, who has been practicing for over 5 years can expect to pay a malpractice premium of $60-80,000 There appears to be some plateauing of the number of annual suits in many states. However as anyone who has been through the unsettling process of a plaintiff's claim of negligence; a single experience into this dark realm of our profession is sufficient motivation to learn more about avoiding the situation

Endovascular Today recently dedicated a supplement issue to this topic. It's a must read for any cardiologist, interventional radiologist or vasculcar surgeon performing endovascular and catheter based interventions. Several highlights of the supplement include A Primer on Malpractice Litigation, Expert testimony, How to prepare and a round table discussion which uses an actual case study format.

Particularly interesting is the round table discussion that describes some of the issues of standard of care that are evolving in this fluid environment of evolving technology and skill level. For example, off label use of devices, use of hybrid devices for EVAR and others. Does a poor outcome, indicate malpractice. Noncompliant long term follow up after EVAR. Expert witness variance from state to state

I encourage everyone to consider reading this brief overview that provides a timely resource on Medical Malpractice Litigation