Medtronic Warned by FDA on Pain Pump and Insulin Pump

Medtronic Inc. received a warning letter on June 1, 2009 from the FDA regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. The FDA citesMedtronic for taking too long to recall the SynchroMed Pumps. The letter also said that a 2008 inspection at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing.

SynchroMed II pumps,implantable devices used to deliver medicine to the spine, have been recalled on several occasions including in May 2008. The Pumps were recalled in 2008 because some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the FDA letter said. The letter went on to say, “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner. It took almost two years from when the missing propellant was initially identified to conduct a recall.”

The FDA letter also noted that Medtronic failed to notify the agency within 30 days of at least two reports of potentially serious patient issues with MiniMed Paradigm Insulin Pumps, and for failing to have a person qualified to make a medical judgment determine if reported problems had anything to do with a patient’s death or serious injury. Training records showed that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.

The company has 15 working days from the date it received the warning letter to respond to the FDA. The FDA letter warned Medtronic that failure to promptly correct violations could result in regulatory action being initiated without further notice.

FDA Medical Device Approval System Broken

At the subcommittee's hearing on the Medical Device Safety Act of 2009, Rep. Frank Pallone Jr. (D-NJ), chairman of the health subcommittee of the House Energy and Commerce Committee said that "there is evidence that the Food and Drug Administration (FDA) approval system for medical devices is 'broken' and a comprehensive review of the major issues and potential problems is needed" according to CQ HealthBeat. During the same hearing, Marcia Crosse, the Goverment Accountability Office's director of Healthcare, said "that the GAO has repeatedly pointed to shortcomings in the medical device approval process that continue today." Pallone called for the standards, procedures and rules for certain approving certain devices need to be adjusted to meet modern needs in getting the devices to those in need with confidence in their safety.

Hearing on Medical Device Safety Act of 2009

On June 18, 2009, the Health Subcommittee of the House Energy and Commerce Committee will have a hearing on the Medical Device Safety Act of 2009 (H.R. 1346). The Act, if passed, would reverse the United States Supreme Court's decision in Riegel v. Medtronic handed down last year. As a result of that case, injured patients are barred from suing medical device makers for injuries caused by faulty devices. The hearing tomorrow is titled, "Medical Devices: Are Current Regulations Doing Enough For Patients?"

This hearing is a follow-up to the May 12, 2009 hearing on the Act. The June 18, 2009 hearing is coming on the heels of reports from the Wall Street Journal that new FDA Commissioner Margaret Hamburg says she is working toward earlier safety warnings to doctors as well as resolving some of the issues with the agency's medical device division.

Dr. Hamburg announced that she will look at the “division’s decision-making and” a fast-track “approval process for devices called 510(k),” said the Journal. Some devices, said scientists with the agency, have received 510(k) approval, but called for additional safety and efficacy information, explained the Journal.

The passing of the Medical Device Safety Act of 2009 would clear the way for the thousands of individuals seriously injured by recalled Medtronic Sprint Fidelis Leads to pursue their claims against the manufacturer. Given that these devices were approved during a self-titled "dysfunctional" period of the FDA, allowing injured paitents recourse in a court of law only seems fair.

Medical Device Maker and Executives Indicted

On June 16, 2009, Synthes, Inc., and four of its executives were indicted on federal charges that they improperly promoted a bone filler for purposes not approved by the FDA. The indictment sends a strong message to similar companies. Usually Federal Prosecuters seek fines through civil lawsuits rather than bringing criminal charges.

Synthes and Norian Corporation are accused of encouraging the use of its bone filler, Norian XR, in unauthorized human trials. Norian XR was used in spinal procedures including verteplasty and kyphoplasty. Verteplasty and Kyphoplasty are procedures wherein a cementlike material is injected into a spinal fracture. Three people died during these human trials, though a direct link to Norian XR in these deaths had not been made yet.

Norian XR was approved by the FDA in 2002 for general bone repair. However, the company was warned against promoting the bone filler for spinal surgeries. The warning was based on information linking use of the bone filler in spinal procedures to the development of large bloodclots.

Norian faces potential fines of $28 million and Synthes faces fines of $8million. If convicted, the the executives could serve up to one year in prsion. The individuals charged in the indictment are Michael B. Huggins, president of Synthes Spinal Division; Thomas E. Higgins, Senior Vice President for Global Strategy; Richard E. Bohner, Vice President for Operations; and John J. Walsh, a Regulatory Affairs Executive.