News: A man with three broken ribs was admitted into a local hospital. It was determined the man did not need surgery but should have his pain managed before being discharged a few days later. The doctor treated his pain with two catheter devices that instill numbing medication onto the three ribs.This doctor also had a financial interest in the company that produced the catheters, which he failed to disclose to the man. One of the catheters fell out of place the first time the devices were inserted. The second time the devices were inserted, one of the catheters perforated the man’s chest wall and damaged his internal organs. This damage caused the man to undergo numerous surgeries and spend 49 nights in healthcare facilities to recover. The man filed a lawsuit against the doctor and hospital, and he alleged that he never was informed the doctor had an interest in the company making the product the doctor was recommending or that oral pain medication could have sufficiently managed his pain. The doctor admitted to not informing the man of the oral pain medication being sufficient to manage his pain, but he maintained the patient need not have been informed of the doctor’s financial interest in the catheter company. The jury found the doctor negligently failed to inform the man of the doctor’s financial interest in the catheter company and the other available pain medication available to treat the man’s pain. The jury found the doctor 65% liable and the hospital 35% liable for the $5.5 million verdict.
Background: In 2009, an elderly man fell from a ladder and broke three ribs.He was admitted into a hospital where surgery was determined to be unnecessary. Rather, the plan was to have the man’s pain managed for a few days before he would be released. He then was given oral pain medication, but it was causing pains in his chest. A doctor evaluated the man and determined the man’s pain should be managed by a catheter device that is inserted over the ribs allowing pain medication to drain onto the injured ribs. The doctor explained the medical risks associated with the catheter, but the doctor did not inform the man that other oral medication also would treat his pain or that the doctor had a small interest in the company that produced the catheter. The interest the doctor had was that he was part of the “speaker’s bureau” and was paid to give presentations on the catheters. The man agreed to use the catheters, and two of them were inserted over the man’s injured ribs. The next day, one of the catheters had moved out of place and needed to be reinserted. While reinserting the catheter, and unbeknownst to the doctor, the catheter perforated the man’s chest wall. Two days after the reinsertion, it became apparent the man was sustaining damage to his internal organs.
The man underwent multiple operations to remove the catheters and repair his internal organs. The hospital stay that was supposed to last a few days resulted in the man spending 49 days in healthcare facilities to address the complications. The man sued the doctor for failing to obtain informed consent, which would have required explanation of the alternative pain medication and disclosure of the doctor’s interest in the catheter company. The man also sued the hospital for the management and conduct of its staff.
The doctor admitted to not explaining that a specific type of oral medication was an alternative treatment and to not disclosing his interest in the catheter company, but he maintained that the disclosure of his interest was not necessary. The doctor specifically asserted that if doctors have to disclose their financial interests to patients, then doctors won’t know how much personal financial information they are to disclose to avoid liability. However, according to court documents, this argument failed because the procedure the doctor recommended, the insertion of the catheters, directly related to the doctor’s arrangement with the catheter company and is something reasonable patients would deem “relevant” in their medical decision. The jury agreed with the man and awarded him $5.5 million in damages, for which the doctor was 65% liable and the hospital was 35% liable.
What this means to you: This case shows the value and necessity of knowing and following informed consent requirements.
The basic requirements of informed consent consist of the patient being reasonably informed of the nature of the procedure and the risks and alternatives to the procedure. With respect to risk and alternatives, a patient is entitled to the relevant information a reasonable person should know to make a prudent decision. Such information can include knowledge of the physician’s experience with a procedure, whether the hospital is understaffed the day of the procedure, or other relevant factors a reasonable person would want to know to make an informed decision. Informed consent comes from the right of self-determination, which is the notion that all patients have the right to make their own decisions on matters such as healthcare. This notion is one with which mostly every juror would agree.
In this case, the failure to obtain informed consent occurred when the doctor failed to explain the “alternatives and risks” of using the catheter devices. The “alternative” that was not adequately explained was the option of other oral medication for treating the man’s pain. The “risks” the doctor failed to explain was his own financial interest in the catheter company. Interestingly, the doctor did inform the man of all the medical risks involved with use of the catheters, including damage to the internal organs. However, it was determined that the financial interest of being paid to speak on the particular product’s behalf is so directly connected with the course of action the doctor prescribed for the patient that the information was certainly relevant and required disclosure.
Physicians often are asked by companies to endorse their products, prescribe their medications, or use their equipment. There are many guidelines, rules, and laws involving physician ownership of or participation in outside entities that limit or restrict this activity depending on what it is, where it is being used, and the community standard of practice
A physician should become familiar with these requirements applicable in his or her jurisdiction before proceeding. The withholding of this relevant information deprived the patient of his ability to make his own decision because the physician has a personal interest in the suggested course of treatment. As such, and as a means of sheltering themselves from liability, physicians should consider what could be “relevant” to the patient making an informed decision, even if the information is not specific to medicine, and then disclose that information to their patients.
More generally, in addition to a physician’s personal interest adding to the difficulties of obtaining informed consent, a physician’s personal interest also can implicate Stark Law and Anti-Kickback Statutes. These federal statutes generally prohibit remuneration or compensation for referrals that involve products or services in which the physician has an interest, and they focus specifically on products and services covered by Medicare or Medicaid. There are exceptions to these referral limitations, and such referrals may be permitted in the following situations:
• when the referral is for in-office ancillary services;
• the physician’s ownership is limited to publicly traded securities or office space rental;
• the physician is a bona fide employee.
Another act often prohibited by these statutes is the waiving of co-payments for Medicare or Medicaid patients when the proceeds are to be paid to an entity in which the physician has an interest. While it might be permissible to waive the co-payments of patients believed to be in need of it, the systematic waiving of fees of Medicare or Medicaid patients might become impermissible when there is a personal interest in the product or facility at issue. A physician having a financial interest in medical companies or entities can raise complex issues with potentially severe consequences. When a financial relationship between a physician and a healthcare facility or a specific product exists, consider obtaining advice from qualified counsel.
- Delaware Superior Court, Case Number N11C-06-092 (Nov. 14, 2012).