Medical Malpractice Exposure: Off-Label Use of Medications and Medical Devices

On August 20, Judge John Keller of the 22nd Judicial District ruled that St. Tammany Parish Hospital must give ivermectin to a 64-year old patient critically ill with COVID-19 at the request of family members.

Due to a large number of questions and concerns, LHA Trust Funds reached out to the hospital and its defense counsel to learn where things stand at present.

St. Tammany Court Case

In the St. Tammany case, the hospital received the court’s order at approximately 4:30 p.m. on a Friday. No medical provider on the hospital’s staff would agree to comply with the order.

The family alleged that one of the patient’s relatives is a healthcare provider willing to administer the medication and allegedly had done so before the patient’s admittance to the hospital. However, this family member was not a credentialed member of the hospital’s staff. The patient passed away the following afternoon.

A January 2022 hearing is scheduled on a procedural issue - St. Tammany Parish Hospital’s position that the court’s order was improper and should be declared null and void.

Future concerns brought forth by the ruling include:

• Is the “off label” use of Ivermectin in the treatment of COVID proper?
• Can a court mandate that a healthcare provider administers a medication against their medical judgment?

Neither issue is set to be heard as of this date.

Prescribing Off-Label Medications

Prescribing medications for off-label use is not an uncommon practice.

Clinicians are afforded substantial deference in prescribing medications for off-label use. Physicians should use evidence-based studies or guidelines to determine if off-label use of medication is beneficial in treating a specific illness. Medications can have a variety of side effects, some potentially significant enough to worsen an individual’s health rather than improve it. A physician should balance a patient’s individual needs and characteristics with available scientific evidence when deciding whether to prescribe a drug for off-label use.

Many rationales support the increased use of both off-label medications and medical devices. Medical advances can outpace the regulatory approval route, which can often be expensive and time-consuming. There is often limited availability of data for rare conditions as well as for patient groups who are excluded from clinical trials such as children, pregnant women, and the elderly. Patients faced with terminal conditions often seek out off-label medications once all of the FDA- approved options have been exhausted.

However, off-label drug use has begun to fuel some medical malpractice cases. While physicians are given great freedom of judgment, the regulations about physicians and pharmaceutical manufacturers regarding any off-label use are complex.

In 2012, Washington D.C. attorney Alfred Belcoure wrote a feature article for the PIAA (now MPL) Quarterly Magazine entitled “For Off-Label Medicine, Knowledge is Power”. He listed five important guidelines:

1. It must be a course of treatment corroborated by others – the “off-label” use must have received favorable attention in the medical community.
2. The law where the physician practices determines how broad the standard’s reach may be.
3. The standard of care should tolerate “respectable” minority views to accommodate medical advancement.
4. The physician has a duty to educate themselves on pertinent information about the “off-label” application; especially warnings and contra-indications.
5. Special attention must be given to eliciting - and documenting - the patient’s informed consent.

Physicians should consider expanding their informed consent process to incorporate any off-label use of medications. These processes could be modified to include a discussion of the risks, benefits, and uncertainties of the proposed off-label treatment. Educate the patient about the medication or product, the proposed off-label use — including the evidence to support or decline the use of the proposed treatment and how they would expect the patient to benefit from it.

There should be very meticulous documentation in the patient’s chart of the clinical assessment and reasons for recommending or not recommending the off-label treatment. It could be viewed as potentially neglectful if a physician fails to inform their patients that the drug has not been approved for the intended purpose.

Consent forms could include some of these key points:

• Off-label use is the use of the drug or device in a way that differs from that described on the FDA-approved drug label so all the possible side effects and complications are not known.
• The use may involve a different route, dose, or condition and may change the risk profile of the drug.
• The details of the treatment have been fully explained and the patient’s understanding was verified.
• No guarantees about the results of the medication or device were given.
• The patient is not required to take the medication or use the device.

Our Conclusion

In summary, “off-label” use is not wrong or illegal. The U.S. Supreme Court in the case of Buckman County v Plaintiffs’ Legal Committee (2001) noted:

“ ‘Off-label’ usage of medical devices is an accepted and necessary corollary of the FDA’s mission to regulate in this area without interfering with the practice of medicine. The FDA is charged with the difficult task of regulating the marketing and distribution of medical devices (and medications) without intruding upon decisions statutorily committed to the discretion of health care professionals.”

Let’s hope that our courts extend the same deference and respect to a health care professional’s discretion NOT to accede to a patient’s request or demand for what the provider believes is an unreasonable “off-label” medication use.

About The Authors

Senior Claims Consultant and Process Improvement Analyst began her career in claims in 1997. Her experience includes handling multi-line claims in the areas of general liability, professional liability, automobile liability, commercial and personal property, excess and umbrella policies. Her experience comes as a former Manager and Litigation Specialist. Highly involved in education and training of both internal and external customers her entire career. Ms. Lamb attended both Evangel University in Springfield, Missouri, and Loyola University in New Orleans.

Mike Walsh is an AIC and CPCU-credentialed professional with more than three decades of experience in insurance claims, primarily in medical malpractice. As Liability Claims Manager for LHA Trust Funds, Mr. Walsh heads a team of senior claims consultants who investigate and assist in the resolution of claims. Mr. Walsh also works closely with hospital administrators, risk managers, safety officers, and clinical staff to help them identify and address potential liability issues.