Why Doctors Can Prescribe Arena's Belviq For Off Label Uses Without Worrying About Legal Liability

| About: Arena Pharmaceuticals, (ARNA)

For those just learning about the drug, Belviq is an FDA-approved weight loss aid developed by Arena Pharmaceuticals (NASDAQ:ARNA). Its intended benefit to patients is to reduce the user's appetite, thus leading the user to consume less calories and ultimately lose weight.

One issue that will have great importance to Arena and the success of Belviq is whether doctors are legally permitted to prescribe Belviq for off label uses (uses intended for conditions other than weight loss). The answer to this question should have much bearing on the amount of Belviq prescriptions that will be written, at least in the short term.

As a Plaintiff's attorney, I often see the public throwing around words such as "liability," "negligence," and "causation" in ways that sometimes make my colleagues and I chuckle but often make us extremely concerned. Daily I get phone calls from potential clients, many of whom tell me stories about how their doctors have mistreated them, misdiagnosed them, or even caused them emotional trauma because the doctor looked at them funny.

In this article, I will explain why many doctors will prescribe Belviq for off-label uses without fear of facing liability and why doctors will never face liability for not prescribing Belviq to obese patients unless some very incredible and unprecedented things happen with Belviq and the medical community in the coming years.

To help the reader understand how I came to the conclusions above, I will give the reader a short and non-exhaustive background on the subjects of legal liability and legal negligence. Both the words "liability" and "negligence" are legal terms of art that mean something much different than their lay, dictionary meanings. This is crucial to understanding the duties medical providers are held to under the law.

Liability is a legal conclusion that carries with it legal effect. Liability can only be established when certain elements of negligence are met. As stated above, legal negligence is much different than its common usage in the lay community. Legal negligence is what one needs to show in order to prove that a defendant is liable to the plaintiff.

Negligence as used in typical conversation is defined as:

the quality, fact, or result of being negligent; neglect: negligence in discharging one's responsibilities.

Legal Negligence is a term of art and a legal conclusion. It requires: 1) A duty; 2) A breach of that duty; 3) Causation (both "but for" and "proximate cause); 4) Damages.

Whether one has a duty is a question of law. The fact finder (jury or judge) has no power to decide that someone has a duty when there is no legal duty.

What the duty is depends on the subject matter. The general standard of care (duty) is typically "reasonable care under the circumstances."

However, there are more specific duties for other subject areas. For example, in my state, children are held to a "reasonable child of the same age under the circumstances" unless they are "engaging in a typically adult activity." Statutes can also sometimes serve as a legal standard of care (known as "negligence per se") and if someone violates specific statutes they are legally negligent.

What we are concerned with regarding Belviq prescriptions is medical malpractice. Generally, the standard of care for a physician is controlled by statute. This is because state legislatures became afraid of the slew of torts cases in the 70's and 80's and as a result many states enacted "Tort Reform" laws. Typically, these state legislatures made it much more difficult to bring suit against doctors by implementing certain requirements, such as in Idaho where a Plaintiff must pass through an "objective" board of "judges" by proving the doctor's care fell below the applicable standard as well as sometimes service hurdles such as having to fill out certain forms and submit them to committees before serving a doctor, sometimes forcing Plaintiff's to wait more than 90 days before serving the doctor, thus making the statute of limitations even more pressing than usual.

One big hit legislators leveled against plaintiffs in medical malpractice cases was the statutorily mandated "duty" that doctors were to meet. Doctors are not held to the general standard of negligence (reasonable care under the circumstances) and the Plaintiff must prove a vastly higher level of medical negligence to prevail on a claim. The most common standard of care doctors must meet in most states can be summarized as follows:

A doctor does not face liability unless "[t]he plaintiff proves by a preponderance of the evidence that the defendant medical provider failed to exercise that degree of skill, care, and learning possessed at that time by other medical providers in the same profession in the same community, and that as a proximate result of such failure the plaintiff suffered damages."

This is extraordinarily difficult to prove. The following example should help to explain why:

If a surgeon cuts a major artery during heart surgery and the doctor was clearly negligent (legal negligence where the general standard of care would have been easily breached), he is not liable unless his conduct fell below the applicable standard of care which is "the same care other medical providers in the same profession in the same community would use." If, because there are always risks in surgery, it is not wildly uncommon for doctors to slip up and cut arteries, then the standard of care has not been breached. This is a huge hurdle to overcome for many reasons, some of which include the following:

1) You need expert medical testimony to a) establish what the standard of care is for similar medical professionals in the same community and b) state convincingly to the judge or jury that the doctor's actions fell below that standard.

2) The only real way to establish a) above is to actually find a doctor in that community to testify against his/her colleagues. Good luck. You can get an outsider to go interview doctors in the community to ask about the standard of care but it is a very tough sell.

3) The burden on the plaintiff is enormous. Instead of a "reasonableness standard" you have this "falls below the typical standard of care" standard.


Unless a doctor finds herself in an extremely conservative, uninformed, lightly populated community (and community can be as large as half a state in some circumstances), it is highly unlikely that prescribing a medication (Belviq) for off label usage could ever meet the Plaintiff's enormous burden to show that the doctor's decision to do so actually fell below the applicable standard of care. There would have to be overwhelming negative sentiment in the applicable medical community for such a burden to ever get met.

I will provide some real life examples from my time as a med mal attorney to demonstrate just how high this burden can be.

Medical Malpractice-YES

A client goes in for surgery on his left ankle and the doctor accidentally cuts open the right ankle in the operating room, causing nerve damage in the healthy foot.

Medical Malpractice-NO

A known drug addict continues to abuse percocet to the point she almost kills herself overdosing years before. She has pneumonia and goes to see her doctor. The doctor gives her more percocet without checking her lungs even though the patient tells her doctor that she has a cough. All doctors know or should know that taking too many pain killing narcotics can cause a person to aspirate. The patient takes her typical whole bottle of pills in two days and dies due to pneumonia complicated and worsened by the extreme consumption of percocet. What the doctor did was "negligent" but it was not "legal negligence" because there are no medical experts willing to testify that the doctor's actions were far enough below the typical standard of care in the community to hold the doctor legally liable.

Can a doctor be held liable for NOT prescribing Belviq to a clearly diabetic and or obese patient?

This could never happen now and, barring some drastic change in perception and acceptance of Belviq to treat obese and diabetic patients, never will.

For this theory to ever pan out, Belviq would have to become as crucial to treating critical illnesses as, say, giving epinephrine to a patient that just stepped into a bee hive and is severely allergic to bee stings. Or, say, failing to give a patient antibiotics when they come into the office with a nasty infection.

It is extremely difficult in the world of torts to hold somebody liable for failing to take action. The medical profession, because the public relies on doctors and other providers for their very lives, is an exception. However, courts and legislatures have adamantly refused to extend this exception to the point that doctors merely deciding not to give someone with depression anti-depressants or an obese person weight loss medication could subject them to legal liability.

Disclosure: I am long ARNA. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: I am a plaintiff's attorney with extensive experience in medical malpractice