Could drug rep relationship get your ED sued?
Gifts and perks may inflame a jury
Consider this scenario: During a malpractice trial involving a patient's adverse outcome in your ED, the jury learns that you've been in the habit of accepting expensive dinners and vacations from drug companies.
This fact may have nothing to do with the patient's care, but if the jury is allowed to hear it, it can still make you appear less trustworthy and help the plaintiff to make his/her case.
"Anytime something of value is exchanged, whether it's lunch, cash, or a trip to Cancun, you get into the question of conflicts of interest and fraud and abuse," says Robert W. Markette, Jr., a health care attorney with Gilliland & Markette in Indianapolis, IN. "And appearances can be as bad as anything else."
Unless a medication was inappropriately given that can be linked directly to a patient's adverse outcome, it's unlikely that a lawsuit would be filed purely on the basis of an ED doctor's accepting gifts from drug companies. "I think it's a pretty weak prosecution unless it's flagrant. You may not be able to make a case out of that alone, but you can certainly use it to inflame a jury," says Frank Peacock, MD, vice chief of emergency medicine at The Cleveland (OH) Clinic Foundation.
In most jurisdictions, however, the fact that an ED doctor accepted gifts from a drug company would not be allowed to be introduced as evidence simply to inflame the jury during a malpractice trial. "If you show that somebody is a bad person, the jury is more likely to think they have committed a bad act," says Markette. "But as a society, we frown upon trying the person for what they are instead of what they have done."
However, if the plaintiff's theory was that the doctor's judgment was influenced by gifts from the pharmaceutical company, anything received from the company might become relevant but the evidence would be offered simply to show the gifts were received. "The plaintiff would need to have other evidence to show the effect of the gift for example, data showing the doctor's prescribing trends," says Markette.
If the plaintiffs do not have the evidence to support that kind of claim, they might try to find another way to make the gifts relevant. For example, if the plaintiff is arguing that the doctor routinely breached compliance, the information could be relevant if the ED physician didn't follow the hospital's policy on drug representatives to the letter.
"They could find a way to offer it as evidence to prove some other point, knowing that when they get that fact in front of the jury, that they will do exactly what the judge will tell them not to do," says Markette. "The jury may think of the doctor as 'bad' simply for doing what is common in the industry, and be more likely to find against the doctor."
If your hospital doesn't have a policy on accepting gifts from pharmaceutical companies, your ED should develop one, advises Markette. "If you develop your own compliance guidelines in advance and apply them consistently to all pharmaceutical reps, it is much easier to argue that one manufacturer was not favored over another," he says.
Still, there may appear to be a conflict of interest that will be hard for a jury to ignore. "Patients need to be treated for their individual situations, not because the doctor got a free trip," says Peacock. "You can taint somebody by asking if they got $50,000 from the company. There is no doubt in my mind that if you were involved in a lawsuit, that would come up."
Concerns are growing
There is a growing focus on pharmaceutical companies and their marketing practices, which could trickle down into ED malpractice litigation.
"This is an issue that more and more people are looking at," says Markette. "'How come pharmaceutical companies give away all these freebies and gifts?' is a question being asked by legislatures and states. Until now, they have basically gotten a free pass."
Recently, five states (Minnesota, Vermont, California, Maine, and West Virginia) and the District of Columbia passed laws mandating disclosure of payments made to physicians by pharmaceutical companies, and in Vermont and Minnesota, payment disclosures are publicly available. Other states are likely to follow suit, says Markette, due to concerns that the perks being offered can color the medical judgment of physicians.
Even if a given drug is medically appropriate, if you are steering all of your patients to a particular drug because you are getting a benefit from it, this can raise the question of fraud and abuse. "Any arrangement where a physician is receiving remuneration from a pharmaceutical company can implicate several federal laws and state laws," says Markette.
Penalties can range from being convicted of a felony and going to prison to steep civil monetary penalties, and exclusion from participation in Medicare or Medicaid.
For example, if a pharmaceutical company has a rewards programs for high volume prescribers, there may be a medical reason for giving the drug in a particular circumstance, but the appearance is that all of your patients are getting the same treatment. "You might be prescribing the same drug in every case when others would also be appropriate," says Markette. "Maybe there are clinical reasons for it, but maybe you are looking to hit a certain volume."
There is value to meeting with drug reps, as they provide information and free samples that patients can benefit from, says Markette. The question is, how much is too much?
"When you really are looking at the benefit to yourself, that's when you will get into trouble," says Markette. "Maybe you see free dinners as a perk, but if the perception is you are out there fishing for them, it might cause people to question your true motivation."
To avoid this, Markette suggests:
- Limiting any one physician's interactions by having a jar out front where drug reps drop cards, and having physicians draw the cards at random.
- Designating an administrative staff person to handle all initial pharmaceutical rep contacts, and allotting each ED physician a set number of lunches to meet with the reps, who would be assigned at random.
- Scheduling lunch meetings with two or three ED physicians and an assigned pharmaceutical rep.
"An added benefit of such a system is it reduces the physician's need to field the phone calls and contacts," says Markette. "The physicians only need to appear at the appointed time for lunch."
Disclosure is key
If you do any kind of research and you have not disclosed a relationship that is perceived as a conflict of interest, your career can be derailed, warns Peacock.
This can start with your own institution saying that the Institutional Review Board will no longer approve your research, and it can go all the way to the federal level, with the Food and Drug Administration barring you from participating in research.
"If either one of those happens, your career as an academic researcher functionally ends," says Peacock.
There are many ways you can have a relationship with a drug company, says Peacock. "They can give you a pen, well that's not really much of a relationship, or they can give you to a trip to Hawaii. That's a problem because it's excessive and inappropriate," he says.
Giving talks for money or working as a consultant for drug companies is fine so long as you disclose the fact that you do so, says Peacock. "It is commonly established that accepting anything greater than $10,000 per year for work done for a drug company is considered a significant relationship," says Peacock. "If you have done that, you have to engage in conflict mitigation."
That means taking steps to make sure that the relationship is not affecting your presentations if you are giving talks for a company. For example, if you are doing research for a manufacturer of a certain drug, you shouldn't be involved in enrolling patients for that study. "If the company gave you $50,000 last year, you might want to make their product look good," explains Peacock. "The idea is to establish some boundaries."
The reality is that the pharmaceutical industry funds about 60% of the research done in the U.S., says Peacock. "If we ignore that, we lose a lot of research. So we have to have rules to do it within an ethical framework to preserve the patient-physician relationship," he says. "Patients need to feel like doctors are acting in their best interest, not the pharmaceutical company's best interest."
Peacock recommends adopting a full disclosure strategy. "I have an Excel spreadsheet and anytime I get money from anyone for anything, it goes on that spreadsheet," he says. "When somebody asks me for my disclosures, I whip out the form and say 'Here they are.' If anyone tells me I don't need to disclose $25, I do anyway."
Lunches and dinners are commonly exchanged in the business world, but they must be within reason. "If these are to be considered a business expense, then business must be performed you can't be there just for fun," says Peacock. Also, only doctors and relevant staff may attend no spouses, kids, or dates may come. Furthermore, the total value of the dinner may not exceed $100 per person.
Peacock says $10,000 per year for the total amount of work reimbursed for doing research or providing any other consultant service from any single company is the "magic number" generally set by the professional societies without having to declare a conflict. To accept more than that gives patients a valid reason to suspect you might be biased.
"I don't ever cross that number for any reason, and I think that is the best advice," says Peacock. "You have to decide: Are you a doctor working for the patient, or are you a doctor working for a company? If you are going to do projects for industry, where you may be biased to excessively support the person paying your stipend, your personal gain needs to be less than 10 grand if you want to also do research."
When giving talks for a drug company or device manufacturer, choose your words carefully. "You are allowed to do that, and you can make a pile of money doing that. But the downside is, you better be very careful about what you say," says Peacock.
For CME talks, the physician is allowed to say anything they want, as long as it is good science and they have data to support it. Some of the drugs used in the ED every day have off-label uses because there is good research that shows it works and it's in the best interest of the patient, notes Peacock.
But for a corporate-sponsored, non-CME lecture, you cannot talk about off-label use. "There is a case pending right now involving a doctor making all sorts of specious claims that were beyond the label. The way it looks to a layperson looking in, was that this guy was working with the company," says Peacock. "He could be in serious trouble with fines and prison sentences. This is punishable at the federal level."
Sources
For more information, contact:
- Robert W. Markette, Jr., Gilliland & Markette LLP, 3905 Vincennes Road, Suite 204, Indianapolis, IN 46268. Phone: (317) 704-2400. Fax: (317) 704-2410. E-mail: [email protected]
- W. Frank Peacock, MD, The Cleveland Clinic Foundation, Department of Emergency Medicine, Desk E-19, 9500 Euclid Ave., Cleveland, OH 44195. Phone: (216) 445-4546. Fax: (216) 445-4552. E-mail: [email protected]
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content