Medical device maker Synthes, Inc., based in West Chester, PA, entered into a settlement agreement with the New Jersey Attorney General (AG) to resolve allegations the company failed to disclose financial conflicts-of-interest among doctors who conducted clinical testing on its products, according to the AG.
As part of the settlement agreement, Synthes will:
- Prohibit compensation of clinical investigators tied to the outcome of the clinical trial
- Pay clinical investigators fair market value compensation for their clinical trial and consulting work
- Collect information on financial interests from clinical investigators
- Record all financial interests related to clinical investigators in a financial interest information database
- Disclose all financial interests of all clinical investigators on the company’s Web site
- Provide complete disclosure of financial interests to the FDA
- Disclose all financial interests directly to healthcare facilities serving as clinical trial sites
- Train employees on financial interest and disclosure
Government investigators are examining allegations that Biomet improperly sold, promoted, and billed for its bone growth stimulation devices, the company disclosed in an April 14 SEC filing.
Federal authorities in West Virginia are investigating sales and marketing practices for Biomet’s subsidiary EBI, which makes electric stimulators for post-surgery patients. The U.S. Attorney in Massachusetts is also investigating possible improper conduct in the sale and leasing of the electrical-stimulation devices.
St. Jude Medical received an FDA warning letter citing manufacturing problems mainly related to the Safire ablation catheter, the company disclosed in an SEC filing.
Physicians use ablation catheters to carefully burn heart tissue to disengage electrical signals that cause atrial fibrillation.
The FDA raised concerns about the facility after inspections conducted between December 8 and December 19, 2008, according to the filing. St. Jude detailed proposed corrective actions in a written response to the FDA.
The company believes it can resolve the problems cited in the letter and does not expect customer orders to be affected.
Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the Department of Justice.
As a territory manager for an unnamed medical device manufacturer based in Hopkinton, MA, Doyle promoted the devices designed to promote bone growth for unapproved uses, the DOJ said. Doyle promoted a combination of the devices with bone void filler, and in furtherance of that promotion provided mixing instructions to surgeons, medical technicians and others.
Doyle is the third former medical device employee to plead guilty to misbranding a medical device. Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device in February. In November 2008, Darnell Martin pleaded guilty to similar charge.
The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound stimulation product EXOGEN from 1995 and onward, the company announced.
EXOGEN is FDA approved for specific fresh fractures and long bone non-unions and was first marketed in 1998.
Smith & Nephew said it plans to comply fully with the request and believes its competitors have received similar subpoenas.
Quest Diagnostics and its subsidiary, Nichols Institute Diagnostics (NID) will pay $302 million to resolve civil and criminal allegations NID sold misbranded diagnostic tests, according to a Department of Justice (DOJ) release.
The criminal allegations focused on NID’s Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Immunoassay, a test that was used to measure parathyroid hormone (PTH) levels in patients. In May 2000 and at various other times, the Advantage Intact PTH Assay provided elevated results, according to the DOJ. NID allegedly knew the test was not providing consistent and accurate results, as claimed in its marketing.
NID pleaded guilty to felony misbranding and will pay a criminal fine of $40 million. Quest entered into a deferred prosecution agreement.
In the civil case, the DOJ claimed NID allegedly manufactured, marketed, and sold test kits, despite knowing that between May 1, 2000, and April 30, 2006, some of these kits produced inaccurate and unreliable results. Some laboratories submitted false claims for reimbursement as a result, according to the DOJ.
Quest and NID will pay $262 million plus interest to resolve False Claims Act allegations relating five assays manufactured by NID that allegedly provided inaccurate results. Quest also agreed to pay state Medicaid programs approximately $6.2 million to resolve similar civil claims and entered into a corporate integrity agreement with the OIG.
Arrow International recalled 45,211 units of volume connectors for its 30-, 40- and 50-cc intra-aortic balloon pump catheters manufactured from January 2008 through January 2009 because of faulty connection tubes.
The balloons are part of the Intra-Aortic Pump System (IAPS) designed to increase blood flow to the heart. In a small number of patients, the IAPS did not recognize one of the connectors. As a result, the IAPS may pump an incorrect volume of blood, potentially leading to fatal injury.
Arrow instructed users to return the recalled products and provided directions to continue using the product with specific instructions
The FDA classified the recall as a Class I recall, the most serious type of recall, in which there is a reasonable probability that use of these products will cause serious injury or death.
A new Johns Hopkins Medicine (JHM) policy prohibits physicians, scientists, students, and staff members from accepting gifts and meals from medical device companies beginning July 1, according to a Johns Hopkins release.
The Johns Hopkins Medicine Policy on Interaction with Industry also prohibits consulting arrangements that require no real work. Medical device manufacturer representatives may only meet with Johns Hopkins staff members in non-patient areas and then only at the invitation of a staff member.
Device or other industry representatives can be present during patient care interactions only if all of the following conditions are met:
- The purpose of the representative’s visit is to provide in-service training or assistance to JHM staff members on devices or equipment
- A formal written agreement between the appropriate Johns Hopkins entity and the representative’s employer specifies the terms and conditions of the representative’s presence
- The representative is appropriately credentialed
- The patient (or his or her family) has been notified in writing that industry representatives may be present in the procedure area
Among other things, the new policy also:
- Requires disclosure of the industry sponsor whenever a company supports non-credit educational courses
- Bans industry funding for Hopkins’ department meetings, retreats or social events
- Limits when Hopkins employees may speak at, or on behalf of, industry-sponsored programs
- Reiterates an existing ban on ghost-writing
Stanford University School of Medicine will reveal which of the 1,200 physicians and faculty affiliated with the medical school receive money from medical device manufacturers, the school announced.
The university plans to post medical- and research-related consulting activities of $5,000 or more per year on its Web site annually. The school expects to include the information in physician and faculty profiles by the end of the year. Physicians and faculty members already disclose the information to the university.
In addition, Stanford plans to list any companies the researcher or physician:
- Has the right to receive royalties from for inventions or discoveries
- Holds equity in as a result of activities as a founder, inventor, or consultant
- Serves as a director for or holds other fiduciary offices Stanford has taken other steps to limit potential undue influence by medical device manufacturers
In 2006, Stanford banned industry representatives from patient care areas. Last year, the university decided to stop accepting industry funding for specific programs in continuing medical education.
Massachusetts became the first state to require medical device manufacturers to report payments to physicians. The Massachusetts disclosure regulation was approved last year and goes into effect July 1.
Senator Charles Grassley (R-IA) introduced the Physician Payment Sunshine Act of 2009, which would require medical device and pharmaceutical companies to disclose payments to healthcare professionals nationally.
The Department of Justice (DOJ) dropped criminal conspiracy charges against Zimmer, Depuy Orthopaedics, Biomet, and Smith & Nephew after 18-month deferred prosecution agreements (DPA) against the companies expired March 31.
The companies entered into the DPAs September 27, 2007. After a two-year investigation, the government alleged the companies provided financial incentives—including consulting agreements, lavish trips, and other perks—to induce physicians to use one company’s artificial hip and knee reconstruction and replacement products instead of those manufactured by another company.
A fifth company, Stryker, cooperated in the criminal investigation and was not the subject of a criminal complaint or DPA. It did enter into a non-prosecution agreement in which it was subject to the same reform requirements as the other companies. Stryker, too, has satisfactorily completed terms of its agreement, according to the DOJ.
The DOJ and Office of Inspector General (OIG) concluded it was not appropriate or fair to exclude one or more of the companies and thus give non-excluded companies a competitive advantage, which risked harm to consumers and patients. As a result, the DOJ and OIG negotiated with all four companies at the same time and provided for equal treatment.
Zimmer, Depuy, Biomet, and Smith & Nephew entered into civil settlements with the DOJ and OIG and paid a total of $311 million to settle government claims under the Anti-kickback Statute and the civil federal False Claims Act. They also entered into five-year corporate integrity agreements with the OIG.