• 22
  • December
    2011

In our last post, we began discussing a lawsuit recently filed by a medical device manufacturer against Kentucky surgeon.

While the suit is still ongoing in Kenton Circuit Court in Kentucky, it does bring up interesting questions regarding expectations of doctors. In particular, the suit raises the question of whether doctors should be held responsible for seeking out information concerning changes to medication instructions or whether medical device manufacturers should announce updates to physicians.

Defense attorneys tend to say that doctors are responsible for staying current with respect to drug and medical device information, and that they should not depend on sales reps for the most current warnings. Others, supporting this position, say there are ways for doctors to keep current, whether by receiving email updates from the FDA or by forming electronic information networks between medical professionals.

According to a study in the November 2009 issue of Pharmacoepidemiology and Drug Safety, many doctors are not aware which drugs uses are off-label and/or lack scientific evidence. Out of the 457 primary care physicians and psychiatrists who were presented with 14 drug-indication pairs, 41 percent said at least one pair of drugs was FDA-approved when it was in fact not approved.

These types of cases are apparently going on nationwide, and according to experts, will likely introduce tension between doctors and manufacturers. Depending on how these suits end up going, doctors may find themselves with a heightened duty to research the way they are prescribing and using medical devices and medications.

Source: amednews.com, "Changes in medical device information pose lawsuit risks for doctors," Alicia Gallegos, December 19, 2011.