U.S. Department of Justice reaches agreement with maker of heart devices on illegal kickbacks

The U.S. Department of Justice announced last month yet another agreement with a health-care company concerning alleged fraud. The settlement of $16 million with St. Jude Medical, a multi-billion dollar company in St. Paul, Minn. that makes medical devices, is small compared with some previous settlements. And the company said that it didn't admit liability or wrongdoing by settling allegations of illegal kickbacks to doctors for using the company's heart defibrillators and pacemakers.

Still, I'm concerned, for several reasons.

First, the way those kickbacks were allegedly offered—through post-market studies and a product registry—undermines mechanisms established by the Food and Drug Administration to ensure patient safety. Post-market studies may be required by the FDA to assess the safety of devices after initial approval. And registries—databases that are designed so doctors can record information about good and bad patient experiences with the devices—are often promoted by industry groups as efficient ways to evaluate their safety and effectiveness. But don't you think a cardiologist might be less likely to report problems with a device if he or she were paid up to $2,000 a patient to use it, as the Justice Department alleged happened with St. Jude Medical?

The Justice Department apparently has the same worry. In a statement, it said,  "When companies pay kickbacks to healthcare providers in order to pad their bottom line, it taints the information patients rely on to make informed choices about their health."

Second, there's reason to worry that St. Jude Medical's case is only the tip of the iceberg. An article in the January 5, 2011 issue of the Journal of the American Medical Association suggested that nearly a quarter of defibrillators implanted in patients in the U.S. from January 1, 2006 to June 30, 2009 might not have been done for reasons consistent with evidence-based guidelines. And the Heart Rhythm Society, the professional organization for specialists in cardiac arrhythmia issued a press release on January 21 stating that it "has agreed to assist in an advisory role" with an ongoing DOJ investigation.

The Heart Rhythm Society says that it will make no further comments because the investigation is still ongoing. But the organization's code of ethics, listed on it's website, does say this: "Patient welfare must be paramount in the practice of medicine and under no circumstances shall a member of the Society place his or her self-interest above the welfare of the patient".
 
Finally, this case means a lot to me because, as a child growing up, I often prayed to St. Jude, the patron saint of desperate causes. So when it comes to health care, I hold folks who use St. Jude in their name to a particularly high standard. Usually, as in the case of St. Jude Children's Research Hospital in Memphis, Tenn., they live up to those high expectations. But in the case of St. Jude Medical, I'm not so sure.

I think St. Jude Medical, the Department of Justice and the FDA still need to provide us with more information. Like the names of any of the physicians who have received DOJ alleged kickbacks and all the St. Jude executives who knew of the activity. And since patients who received these devices probably didn't know of the possible relationship between their physician and St. Jude Medical, I think they should now have the option of working with an independent cardiologist to take whatever medical action they feel is needed—at St. Jude Medical's expense.

I know it's asking a lot. But I am praying to St. Jude, the patron saint of desperate causes. My hope is that he can at least figure out a way to remove his name from this mess. Certainly he has done nothing to deserve this kind of attention.

— John Santa M.D., M.P.H., director of the Consumer Reports Health Ratings Center