James E. Looper, Jr.
Providers and administrators understand clinical mistakes have the potential to lead to negative financial consequences. What is sometimes overlooked, however, is that medical malpractice isn’t the only way providers, practices and facilities open themselves up to liability. From seemingly harmless publicity to living in an electronic age, there are often unforeseen pitfalls that can trip up the unwary. (See related story below.)
James E. Looper, Jr., partner, and Bryant C. Witt, of counsel, with Hall Booth Smith & Slover PC (HBSS) offered insight into several areas where hospitals, practices and physicians could potentially find themselves in legal hot water. Both Nashville-based attorneys work in the healthcare arena of HBSS, which has eight regional offices in Georgia, Tennessee and South Carolina and one international office in the Republic of Georgia (part of the former Soviet Union).
Prior to law school, Looper attended graduate school in pharmacology and medical school. As a result, he has focused his practice both on the business side of healthcare and on the defense of healthcare professionals in medical malpractice suits. Witt — in addition to having substantial trial experience defending healthcare entities in professional liability and business litigation matters — is recognized for his expertise in unwinding the complex regulatory issues that are part of today’s healthcare environment.
Garnering Disapproval Even After FDA Approval
For the most part, FDA approval affords providers some measure of protection when prescribing a medication or using a medical device in a reasonable manner even if that drug or device is later found to be harmful in certain patient populations. Looper was quick to say that any such protection doesn’t mean physicians, practices, hospitals or other facilities might not be named in a lawsuit, only that they often are eventually able to extricate themselves.
For drug manufacturers, the learned intermediary doctrine shifts the focus to the prescriber … the idea being that no manufacturer could be expected to contact every patient to talk about potential side effects. Instead, if the drug company explains side effects and appropriate usage to the prescriber (the learned intermediary), then the manufacturer or distributor has taken the necessary steps to warn and protect the general public. For prescribers, protection generally comes from the research that led to FDA approval. “Once there is a strong body of literature behind you, the risk (of being named in a lawsuit) becomes less,” explained Witt.
That said, Looper and Witt noted there are times when FDA approval might not hold up. Looper said this is particularly true when there is ‘smoking gun’ evidence that a provider or facility knew about additional dangers but continued prescribing or using a device anyway. Famously, the Fen-Phen debacle showed several providers and interested parties were aware of the potential for heart damage long before it became common knowledge … an assertion that could be proven through a chain of emails.
Even with the recent hue and cry over defective hip implants, surgeons who have performed hip replacement surgery with one of the recalled devices are probably in the clear. In most cases, the reasonableness standard comes into play.
As Witt explained, “The question becomes would a reasonable physician under similar circumstances use that device in the same way that this particular doctor did?” If the answer is yes, then a physician could argue the usage was both reasonable and medically competent. “For the manufacturer, it’s a pure product liability issue,” he continued.
Today, however, surgeons using one of the defective hip implants might find their odds of being sued has significantly increased. “It’s when there’s the potential of knowledge. If a doctor put in a (recalled) DuPuy hip implant today, there could be some liability,” Looper said, adding wryly that physicians could reasonably be expected to know there are problems at this point since billboards advertising lawsuits are up all around town.
Off label use is another area where FDA approval could fall short as a protective shield. “Anytime you do something off label and a negative consequence occurs, that certainly would give an attorney on the other side more ammunition against you,” Looper stated. However, he added, many of the successful treatment protocols we have today started with the off label use of drugs. Happily, he continued, most physicians are not deterred by the potential threat of litigation when they believe research indicates an off label use is truly beneficial for their patients and holds the promise of better outcomes.
Watch What You Say in Cyberspace
Websites are commonplace for practices and hospitals today. In fact, providers without an Internet presence risk facing the ire of a wired society that wants quick access to information and the convenience of online tools.
“Websites are still the scary new frontier even though we’re neck deep in them,” Looper pointed out. Continuing, he warned, “Think about what you are saying. If you say you can see breast cancer the size of a pinhead on a mammogram, then by goodness you better be able to do it. Otherwise, you’re going to be living with that for every deposition and every trial after that.”
Witt added, “If you’re a physician who is unfortunate enough to be sued and your practice has a website, the first thing the plaintiff’s attorney is going to do is come with a stack of papers that’s a printout of every representation that’s on your website. They are going to force you to defend those comments in terms of that particular case.”
Looper added that it’s also very important to be careful in how you solicit patients and tout your abilities. Rather than claiming expertise by citing an exact number of diagnoses or treatments of a particular condition, Looper suggested establishing competence in the area by outlining credentials including board certification, educational background, and published studies and articles. “If you stay out of the hyperbole and the puffery, you should stay out of trouble.”
Witt concurred, noting, “It’s best to stick with qualifications and experience and stay away from promising a particular outcome because that’s a source of liability for you. Medicine is a science, but it’s also an art. Take 100 patients — 90 might go according to form, but 10 will react in a way you don’t expect.”
For that reason, Looper also said it’s risky to offer opinions via blog or email unless a physician is intimately aware of the surrounding conditions. “If I was a doctor, there’s no way I would let people who aren’t my patients email me and then answer questions.” Similarly, he continued, “I’m always amazed the call-in radio shows survive. Man, that just seems like a bad idea.”
When Good Publicity Goes Bad
It isn’t just the Internet that can trip up providers. Looper recalled a case involving emergency room physicians when he was practicing in Georgia. Representing a local hospital, the facility wound up having to stay in the lawsuit much longer than necessary because of a few words in an advertisement.
Looper was arguing that the physicians being sued were not the agents of the hospital. Unfortunately, the judge pulled back the blinds and pointed to a nearby billboard, which proudly proclaimed ‘Hospital X’s ER doctors are the best in the state!’ By proudly laying claim to the physician group, the hospital made it much more difficult to disassociate itself from the contracted group.
Ultimately, Looper said, a little forethought and common sense goes a long way in crafting the correct message.
Nowhere to Hide
Witt noted that in the era of healthcare reform, quality and transparency have become key issues. While most hospitals are keenly aware that Medicare will no longer pay for a number of adverse events including hospital-acquired infections, patients are still admitted without the proper documentation of co-morbidities present upon arrival.
Not only does failure to properly document these ‘never events’ cost a hospital money, it potentially increases the facility’s liability if sued since CMS publishes the number of adverse events at each facility on their website.
“That’s a very powerful tool for the plaintiffs and a highly increased area of liability for the facility,” Witt warned. “If I was a plaintiff’s attorney and I had a patient who got an infection after surgery, I’d be sure to go to the website to see how many times this hospital has had a similar problem in the past.”
Witt noted the passage of healthcare reform has come with a range of side effects. “One of the unintended outcomes has been some areas of increased liability and exposure to providers,” he said. “For example,” he continued, “as you go from paper to electronic records, now all of a sudden you have to deal with the issue of metadata … that’s the little electronic signature or tag along that is created anytime you create or edit a document. Not that it’s necessarily a good thing or a bad thing … but just that now these records have a lot more data than a paper record ever had.”
When a physician is asked if he altered the record and says ‘no,’ that can easily be corroborated or disproven because an attorney can verify any word that is added or deleted and know when and by whom. “It doesn’t have to be anything nefarious,” Witt was quick to add. “Your resident put in the wrong word in a report, and you fixed it and probably didn’t even remember doing it.” Still, he noted, by claiming that you didn’t alter the record and then having a plaintiff’s attorney show you did, it could cast doubt about your overall veracity.
Not Guilty … But at What Cost
No matter how meticulous the provider, practice or acute care facility … no matter how stellar the reputation … there’s a pretty good chance you will be sued at some point.
In fact, a 2010 report by the American Medical Association found that by late career, 61 percent of physicians had been sued. Drawing on data from nearly 6,000 physicians across the United States, the study also found male doctors are twice as likely as their female colleagues to be sued during their career, and physicians in a solo or single specialty practice were more likely to be sued than those in a multispecialty practice.
“If you’re a provider, and you’re doing hip implants or prescribing medication, you certainly have to be prepared for the late night lawyers advertising on TV,” James Looper, partner with Hall Booth Smith & Slover PC, noted ruefully.
He added, “I tell physicians that very seldom is there such a thing as a ‘frivolous’ medical malpractice case because an attorney had to consult with a doctor to bring the case, and the only way it can get to trial is if they have an expert willing to testify.”
As part of reform laws passed in Tennessee over the past three years, Looper said, “A plaintiff’s attorney does have to file a certificate of good faith that they have conferred with an expert in the field; and after conferring with that expert, there is reasonable likelihood of a deviation from the standard of care.”
Even if exonerated, physicians and facilities undertake significant costs in terms of time and money to fight lawsuits. Looper did note that defendants who win a medical malpractice suit or receive a motion for summary judgment have the option to try to reclaim discretionary costs for fighting the suit, which would include items such as putting on their own expert witness and deposition transcripts. However, it does not include reimbursement for attorneys’ fees and is completely at the discretion of the trial judge whether or not to require reimbursement from the plaintiff.
“With the new medical malpractice statutes, I can demand the plaintiff’s attorney provide the basis for their certificate of good faith,” Looper continued of other options to reclaim some of the costs to mount a defense. “If I can determine that basis was really not in good faith, the statute says they are obligated to pay my attorneys’ fees,” he continued.
Still, it is very rare a physician or facility recoups the hard costs of answering a lawsuit, and there are still no provisions to help offset the very real costs associated with the time it takes to fight a case.
According to 2008 statistics from the Physician Insurers Association of America, only about 5 percent of cases ever make it to the courtroom at which point defendants won 90 percent of the time. The trade association data showed the cost to defend a suit that is ultimately dropped, dismissed or withdrawn averages just over $22,000 and defending a case that goes to trial averages more than $100,000.