The Life Sciences Report // Spring 2010

Summary of Recent Kickback and Bribery Settlements with Medical Device
and Pharmaceutical Companies

No.

Case Name

Date

Institution

Payment/Bribe

Settlement

Medtronic, Inc.

12/12/11

Medical Device Company

The company used physician payments related to post-market studies and device registries as kickbacks to induce doctors to implant the company’s pacemakers and defibrillators. In each case, the company paid participating physicians a fee ranging from approximately $1,000 to $2,000 per patient.

$23.5 million

Serono Laboratories Inc., EMD Serono Inc., Merck Serono S.A., and Ares Trading S.A.

5/4/11

Pharmaceutical Company

The companies paid healthcare providers kickbacks in the form of hundreds of speaker training meetings and programs, as well as payments for attending consultant, marketing, and advisory board meetings, all at upscale resorts and locations. The payments were to induce the providers to promote or prescribe Rebif, a recombinant interferon injectable that is used to treat relapsing forms of multiple sclerosis.

$44.3 million

Cardinal Health, Inc.

4/21/11

Pharmaceutical Company

The company paid $440,000 to a pharmacy consultant in exchange for an agreement that he purchase prescription drugs from the company for his pharmacies. 

$8 million

Johnson & Johnson

4/8/11

Pharmaceutical Company

The company’s subsidiaries, employees, and agents made improper payments to publicly employed healthcare providers in Greece, Poland, and Romania to induce the purchase of medical devices and pharmaceuticals manufactured by its subsidiaries. The company also paid kickbacks on behalf of its subsidiary to the former government of Iraq under the U.N. Oil-for-Food Program to secure contracts to provide humanitarian supplies. 

$70 million and Deferred Prosecution Agreement (DPA) requiring federal monitor for 3 years

St. Jude Medical Inc.

1/20/11

Medical Device Company

The company used post-market studies and a registry to pay kickbacks to induce physicians to implant its pacemakers and defibrillators. Each participating physician received a fee of up to $2,000 per patient.

$16 million

Exactech, Inc.

12/8/10

Medical Device Company

From 2002 to 2008, the company used consulting agreements with physicians as vehicles for kickbacks to induce physicians to purchase the company's products. These arrangements included fee-for-service contracts, fixed-fee contracts, and product development contracts.

$3 million, 5-year CIA, IRO required, and DPA requiring federal monitor for 12 months

Kos Pharmaceuticals

12/7/10

Pharmaceutical Company

Kos offered and paid doctors, other medical professionals, physician groups, and managed care organizations illegal kickbacks in the form of money, free travel, grants, honoraria, and other valuable goods and services in violation of the Anti-Kickback Statute to get them to prescribe or recommend Niaspan and Advicor.

$41 million and DPA

Ameritox Ltd.

11/16/10

Medical Device Company

From 2003 to 2006, the company made cash payments to physician clients to induce referrals and offered lab testing services at no cost to the lab’s physician clients to induce referrals from 2003 to 2010.

$16.3 million, 5-year CIA, and IRO required

ELA Medical

11/1/10

Medical Device Company

From 2004 to 2007, the company paid doctors $2,500 - $4,000 per patient enrolled in a study, although the patients were unaware of their participation. The company also provided kickbacks in the form of gifts, meals/entertainment, tickets to sporting events, travel to conferences, travel to Costa Rica, fishing and boating trips, cash payments to a physician-owned foundation, and travel expenses for spouses.

$9.2 million, 5-year CIA, and IRO required

10 

Wright Medical

9/30/10

Medical Device Company

From 2002 to 2007, Wright Medical used consulting agreements to induce surgeons to purchase and use the company's artificial hip and knee reconstruction and replacement products. The arrangements included fee-for-service contracts, fixed-fee contracts, and product development contracts. The government alleged that the remuneration paid under these arrangements was improper.

$7.9 million, 5-year CIA, IRO required, and federal monitor for 12 months pursuant to DPA with DOJ

11 

Novartis Pharmaceuticals Corp.

9/30/10

Pharmaceutical Company

In addition to illegally promoting a drug for uses that were not medically accepted, the company paid kickbacks to healthcare professionals to induce them to prescribe Trileptal and five other drugs, Diovan, Zelnorm, Sandostatin, Exforge, and Tekturna.

$422.5 million, 5-year CIA, and IRO required

12

Forest Laboratories

9/1/10

Pharmaceutical Company

The civil complaint alleges that Forest used illegal kickbacks to induce physicians and others to prescribe Celexa and Lexapro. Kickbacks allegedly included cash payments disguised as grants or consulting fees, expensive meals, and lavish entertainment.

$313 million, 5-year CIA, IRO required, and plea of guilty with DOJ

13 

General Electric

7/27/10

Medical Device Company

The company's subsidiaries paid kickbacks to the Iraq Ministry of Health in the form of after-service fees and in-kind payments. In return, the company's subsidiaries obtained contracts for the supply of disposable electrodes, transducers, fetal monitors, and other injectable agents used for MRI and X-rays. 

$23.4 million

14 

United Shockwave Services, United Urology Centers, and United Prostate Centers

7/8/10

Medical Device Company

The OIG alleged that United and certain physician-investors (PIs) used their ability to control patient referrals to obtain contract business from various hospitals. United threatened to refer patients to competing hospitals if the hospital did not agree to a contract with United, and promised additional referrals to hospitals that did contract with United. The relationships between United's PIs and the hospitals raised Stark concerns regarding the financial relationships between United's PIs and the hospitals to which they made referrals. Also, United sold more shares to physicians who produced referrals or other business for the company. United had processes for having physicians divest if they did not use United's services sufficiently and offered huge returns on investment with virtually no business risk.

$7,359,500, 5-year CIA, and IRO required

15 

St. Jude Medical, Inc.

6/4/10

Medical Device Company

The company, a heart-device manufacturer, paid kickbacks that included alleged rebates that were retroactive and based on a hospital’s previous purchases of the company’s heart-device equipment, as well as rebates for purchases of heart-device equipment sold by the company’s competitors to induce purchases of similar equipment from the company in the future.

$3,898,300

16 

Cochlear Americas

6/3/10

Medical Device Company

The company paid various forms of illegal remuneration to physicians who prescribed the use of their manufactured implant system for Medicare and Medicaid patients.

$880,000 and stay of DOJ proceedings

17 

Garden State Imaging (GSI)

2/8/10

Medical Device Company

The company entered into a verbal agreement with two owners of a medical center. Under the terms of the verbal agreement, the company agreed to provide mobile diagnostic imaging and related services to the recipient’s patients and to split 50 percent of the net proceeds that were generated.

$83,000

18 

ArtriCure, Inc.

2/2/10

Medical Device Company

The company paid clinic-physicians between $10,000 and $24,000 for consulting work. The clinic-physicians also were granted stock options and received royalties for devices that they helped the company to develop.

$3.76 million, 5-year CIA, and IRO required

19 

Cardiac Monitoring Services, LLC

2/1/10

Medical Device Company

Not available

$2.2 million, 5-year CIA, and IRO required

20 

St. Jude Medical, Inc.

1/20/10

Medical Device Company

The company paid kickbacks of up to $2,000 per patient to help market its products, including through the use of fake research studies on the company’s devices.

$16 million

21 

Boston Scientific Corporation

12/23/09

Medical Device Company

An entity acquired by the company used post-market surveys to pay physicians $1,000 and $1,500 for each study to induce them to purchase its products.

$22 million, 5-year CIA, and IRO required

22 

Bayer Healthcare

11/28/08

Medical Device Company

The company allegedly paid Liberty Medical Supply Inc., one of the largest direct-to-patient diabetic suppliers, approximately $2.5 million to convert its patients to the company’s supplies. The alleged kickbacks were based on the number of patients that Liberty successfully converted to the company’s supplies and were disguised as payments for advertising. In addition, the company allegedly paid kickbacks of approximately $375,000 to 10 other diabetic suppliers to convert patients to Bayer supplies.

$97.5 million, 5-year CIA, and IRO required

23

AGA Medical Corporation

6/3/08

Medical Device Company

The company, a high-ranking officer, and other company employees agreed to make corrupt payments to doctors in China who were employed by government-owned hospitals and caused those payments to be made through the company’s local Chinese distributor. In exchange for these payments, the Chinese doctors directed the government-owned hospitals to purchase the company’s products rather than those of its competitors. In addition, the company sought patents on several of its products from the People’s Republic of China State Intellectual Property Office. As a part of this effort, the company and a high-ranking officer agreed to make payments through their local Chinese distributor to Chinese government officials employed by the State Intellectual Property Office to have the patents approved.

$2 million and DPA

24 

Merck & Company

2/7/08

Pharmaceutical Company

The company had approximately 15 different programs used by its sales representatives to induce physicians to use its many products. These programs primarily consisted of excess payments to physicians that were disguised as fees paid for “training,” “consultation,” or “market research.” The government alleged that these fees were illegal kickbacks intended to induce the purchase of the company’s products.

$650 million, 5-year CIA, and IRO required

25

Akzo Nobel N.V.

12/21/07

Pharmaceutical Company

Two of the company’s subsidiaries authorized and made $279,491 in kickback payments in connection with their sales of humanitarian goods to Iraq under the U.N. Oil-for-Food Program. The kickbacks were characterized as “after-sales service fees,” but no bona fide services were performed. The kickbacks were paid by third parties to Iraqi-controlled accounts in Lebanon and Jordan.

$2.9 million

26

Zimmer, Inc.

9/27/07

Medical Device Company

The company entered into financial arrangements with orthopedic surgeons, including fee-for-service contracts, fixed-fee contracts, and product development contracts.

$169.5 million, 5-year CIA, IRO, and retention of federal monitor pursuant to DPA

27

CIA Biomet, Inc. & Biomet Orthopedics, Inc.

9/27/07

Medical Device Company

The company entered into consulting agreements with orthopedic surgeons to use joint reconstruction and replacement products.

$27 million, 5-year CIA, IRO required, and retention of federal monitor pursuant to DPA

28 

DePuy Orthopedics, Inc.

9/1/07

Medical Device Company

The company paid orthopedic surgeons to be consultants and to use their products exclusively. Hospitals and patients, however, were not informed of the arrangement.

$84.7 million, 5-year CIA, and IRO required

29 

Smith & Nephew, Inc.

9/1/07

Medical Device Company

The company and three others paid tens or hundreds of thousands of dollars to individual surgeons and provided them with trips and other perks. The physicians did little or no work for the financial inducements, merely agreeing to exclusively use the paying company's products.

$28.9 million, 5-year CIA, IRO required, and retention of federal monitor pursuant to DPA

30

Advanced Neuromodulation Systems, Inc. (ANS)

7/2/07

Medical Device Company

The company paid physicians $5,000 for every five new patients tested with its product. The company also provided physicians with tickets to sporting events, free trips and dinners, grants, and other gifts.

$2.95 million, 3-year CIA, and IRO required

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