COMMENTARY

Let Patients See Visit Notes?; also, Medical Device Risks

Wayne J. Guglielmo, MA

Disclosures

January 13, 2012

In This Article

Let Patients See Visit Notes? Doctors Have Mixed Reactions

When it comes to sharing visit notes with patients, primary care physicians are far less uniformly enthusiastic than their patients are. This is the conclusion of a study published in the December 20, 2011, issue of Annals of Internal Medicine.[1]

Researchers conducted surveys of primary care practices in 3 states -- Massachusetts, Pennsylvania, and Washington -- to gauge expectations of a voluntary program that would give patients electronic access to their doctors' visit notes. Those surveyed included 114 participating primary care physicians (PCPs) (doctors whose patients would actually view their office notes), 140 nonparticipating PCPs, and more than 90,000 adult patients.

Of the 110 participating PCPs who completed the survey, as many as 8 in 10 across the 3 sites "thought open visit notes were a good idea." Patients who responded to the survey (42%) were even more enthusiastic, embracing the idea of open access almost universally.

Nonparticipating PCPs, however, saw things differently: Of the 63 doctor respondents, only 16%-33% (10-20) liked the idea. These physicians were also significantly less likely than either patients or their participating colleagues to see the potential benefits of open visit notes, including improved communication and patient education.

On the contrary, "most nonparticipating PCPs (88% to 92%) expected that open visit notes would result in greater worry among patients." Their participating colleagues were less pessimistic on this score; only somewhat more than one half voiced the same concerns. But even participating doctors were worrywarts compared with their patients, of whom only 12%-16% concurred with physicians' pessimistic prognostications about increased patient worry.

The one area involving open access about which neither participating nor nonparticipating PCPs expressed much concern was "increased risk from lawsuits." Zero to 1 in 3 PCP respondents saw this as a potential risk.

According to the study, "patient enthusiasm extended across age, education, and health status, and 22% anticipated sharing notes with others, including other doctors."

Are Doctors Liable If They Don't Know That a Product Was Updated?

Do changes in medical device information pose a liability risk for physicians? This is one of the questions at issue in a lawsuit against a Kentucky surgeon by the manufacturer of a pain pump, according to a December 19, 2011, story on amednews.com.

The manufacturer, I-Flow, claims in its suit that the physician, Dr. Bruce Holladay, an orthopaedic surgeon at St. Elizabeth Medical Center, Edgewood, caused injury to his patient because he failed to read "the product's latest instructions, which included a warning about using the pump with certain anesthetics."[2] Dr. Holladay says in turn that he was not made aware of the new warning or of the fact that the US Food and Drug Administration (FDA) had not approved the pump "for the way it which he used it."

The case stems from a 2007 reconstructive shoulder surgery that Dr. Holladay performed on patient Lucas Frietsch. Court documents indicate that during the surgery, the doctor implanted a pain pump in the patient's shoulder in order to inject anesthetic medication directly into his shoulder joint. After surgery, Frietsch returned to Dr. Holladay "complaining of shoulder pain" and "was diagnosed with chondrolysis, a condition resulting in the loss or near loss of shoulder cartilage. The condition can be caused by the continuous administration of certain anesthetics into the shoulder joint by a pain pump."

Doctor Gets Sued by the Device Company

Initially, the Frietsch family named both the device manufacturer and Dr. Holladay in its complaint. But after a change of attorneys, the family dropped Dr. Holladay from its complaint, noting that I-Flow and not the surgeon was responsible for the plaintiff's injury.

I-Flow then filed a claim against Dr. Holladay. The device maker named him as a third-party plaintiff, arguing that he had failed to follow the pain pump's updated directions.

The case is ongoing in Kenton Circuit Court, Kentucky.

Among the other questions raised by the case is the extent to which doctors can -- and should -- rely on manufacturers' sales representatives to explain updated directions.

Not everyone thinks such reliance is a good idea. Doctors themselves should remain current and not depend on sales representatives for the latest warnings, Washington, DC-based medical liability defense attorney Alfred F. Belcuore told amednews.com. "Operating within the standard of care means keeping current with the literature," Belcuore says. "If the manufacturer or the FDA puts out notifications or warnings, it is probably not going to be a good defense to say [the doctor] never saw it."

Other observers concur. "It's in companies' financial interest to promote their products off-label, but when a lawsuit occurs, a company can then hide behind the label and leave the physician out there hanging in the wind," says Dr. Adriane Fugh-Berman, of the Department of Family Medicine at Georgetown University School of Medicine."

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