DePuy Hips--Kickbacks, Deferred Prosecution and the role of Surgeons

In 2007, DePuy avoided criminal prosecution over financial inducements paid to surgeons to use their hip and knee products by signing a Deferred Prosecution Agreement and paying civil settlements to the Departments of Justice and Health and Human Services of $84.7 million.


The Department of Justice alleged that Depuy routinely violated the anti-kickback statute by paying physicians to exclusively use their products. In announcing the settlement, United States Attorney Christopher J. Christie stated "prior to our investigation, many orthopedic surgeons in this country made decisions predicated on how much money they could make--choosing which device to implant by going to the highest bidder."

The government alleged that these agreements were in place between 2002-2006, which happens to be when many of the now recalled DePuy ASR hips were implanted. Government officials also stated that surgeons failed to disclose the payments to the hospitals where the surgeries were performed, and more importantly, to the patients the devices were installed.

As the DePuy litigation proceeds, both DePuy and some surgeons are going to have some difficult questions to answer.
Patients who return to the physicians who installed the recalled devices need to be aware these relationships exist, inquire of their physician as to whether or not they engaged in such kickback agreements and never let their physician influence them to sign releases allowing DePuy to obtain their medical records.

DEPUY: COMMONLY ASKED QUESTIONS

I have reviewed perhaps 100 potential claims for individuals who received recall letters from their physicians indicating they had received a Depuy recalled hip.
Typical questions include:
QUESTION: SHOULD I RETURN TO MY PHYSICIAN WHO CONTACTED ME?

ANSWER: PERHAPS. IN MY EXPERIENCE, MOST DOCTORS HAVE BEEN VERY SUPPORTIVE OF THEIR PATIENTS. THEY ARE ORDERING XRAYS, MRIs, BLOOD TESTS, AND BONE DENSITY TESTS. THESE TESTS ARE IMPORTANT.


I HAVE RECEIVED SEVERAL REPORTS OF A PHYSICIAN IN NORTHWEST ALABAMA HAS ONLY ORDERED XRAYS, TOLD ALL OF THE PATIENTS THAT THEY WERE FINE, AND OPENLY STATED THAT THEIR PAIN ONSET OCCURRED WHEN THEY RECEIVED THE RECALL LETTER. THE WIFE OF ONE OF MY CLIENT'S REPORTEDLY QUIPPED TO THE DOCTOR THAT HE OBVIOUSLY HAD NOT LOOKED AT HER HUSBAND'S CHART IN IN THE TWO YEARS SINCE HIS SURGERY AND CERTAINLY HAD NOT LIVED WITH HIM OR HE WOULD KNOW OTHERWISE.

IF THIS IS YOUR PHYSICIAN, YOU PROBABLY KNOW IT. I WOULD NOT RETURN AND WOULD FIND A SURGEON WHO DOES HIP REVISION SURGERY TO EVALUATE YOUR HIP.

QUESTION: SHOULD I SIGN THE DOCUMENTS MY DOCTOR GAVE ME?

ANSWER: ABSOLUTELY NOT!!!!! THERE ARE DIFFERENT VERSIONS OF THIS DOCUMENT, BUT THEY ALLOW DEPUY TO OBTAIN YOUR MEDICAL RECORDS AND IN SOME CASES, OBTAIN YOUR DEFECTIVE DEVICE IF IT IS REMOVED. YOUR INFORMATION WILL ALSO BE PROVIDED TO DEPUY'S ADJUSTERS HANDLING THE CLAIMS.

QUESTION: DO I HAVE TO GO BACK TO MY DOCTOR FOR THIS TO BE COVERED?
ANSWER: NO: IN FACT, A CLASS ACTION HAS BEEN FILED AGAINST DEPUY CLAIMING THEY ARE MISLEADING CONSUMERS. IN THAT COMPLAINT, THEY ALLEGE:

"In our opinion, DePuy's 'offer' may deceive potential claimants into believing that the company has actually agreed to advance or reimburse their costs for medical monitoring or revision surgery. In fact, no specific offer to pay medical costs has been made and no specific plan for reimbursement has been announced. Moreover, DePuy has stated that before reimbursement of expenses will be provided, it will review the patient's medical records to determine if the patient meets DePuy's criteria for payment. According to DePuy, the medical records must confirm that the revision is related to the ASR recall and 'not some other type of cause, such as a traumatic fall.' Blaming the device failure on a fall, or another cause, such as physician error, patient misuse, pre-existing condition or underlying diseases is a standard litigation defense in these types of cases. Thus a patient who releases medical records to DePuy may do nothing but provide DePuy with a jump start on litigation defenses."


OPTING FOR FREE CARE FROM DEPUY MAY COST YOU IN THE FUTURE---IN PREVIOUS MEDICAL IMPLANT LITIGATION I HANDLED, PATIENTS WERE OFFERED FREE MEDICAL CARE. WHAT THEY WERE NOT TOLD WAS THAT THE MANUFACTURER PAID THE DOCTORS THE BILL RATE AS OPPOSED TO THE INSURANCE, MEDICARE OR MEDICAID REIMBURSEMENT RATE ,WHICH IS MUCH LOWER. WHEN IT CAME TIME TO SETTLE THEIR CLAIMS, THE MANUFACTURER DEMANDED CREDIT FROM THE SETTLEMENT FOR WHAT THEY PAID, WHICH WAS 3 OR 4 TIMES WHAT THE INSURANCE CARRIER WOULD HAVE PAID. THIS IS A NICE CARROT USED TO KEEP THE PHYSICIANS HAPPY AND IN THE BOAT.

QUESTION: WHAT ELSE DO I NEED TO KNOW?

ANSWER: FIRST, THERE IS OFTEN A VERY CLOSE RELATIONSHIP BETWEEN THE MAKERS OF DEVICES AND THE PHYSICIAN WHO INSTALL THEM. TRIPS, SEMINARS, CATERED LUNCHES ARE NOT UNCOMMON. OFTEN THE PHYSICIAN AND THEIR ORTHOPEDIC REPS, AS THEY ARE CALLED, HAVE CLOSE PERSONAL RELATIONSHIPS. THERE IS NO DOUBT DEPUY WILL SEEK TO EXPLOIT THIS RELATIONSHIP, IF IT CAN BE EXPLOITED, TO OBTAIN RELEASES AND MEDICAL RECORDS (TO PREPARE THEIR DEFENSE THAT THE FAILURE IS UNRELATED).
ON THE OTHER HAND, MANY PHYSICIAN ARE PATIENT ADVOCATES AND SOME HAVE EVEN ADVISED CLIENTS TO SEEK LEGAL REPRESENTATION.

CHRIS HELLUMS recently served as lead counsel in the Total Body Formula Multi District Litigation and is representing clients from across the country with Depuy claims.
For a free case evaluation, he can be reached at Chrish@PittmanDutton.com or toll free at 1-866.515-8880