The pressure from the FDA is long coming. In 1990, Congress ordered the more rigorous testing of medical devices before they became available for use, however the FDA never finished implementing the law, getting caught up in a federal loophole that allowed products that are “substantially equivalent” to combinations of other products marketed before 1976 to be sold. Thus, hundreds of new “Class C” devices were approved and made available for use. Class C is the FDA’s most risky category.

Products that currently fall in the Class C category include external heart defibrillators from Medtronic Inc., Royal Phillips Electronics NV and Zoll Medical Corp; dialysis catheters from Covidien Ltd.; hip joints from Zimmer Holdings Inc.; spinal screws from Medtronic and Johnson & Johnson; and a heart pump from Abiomed Inc.

The FDA’s recent action on the measure is spurred by the Government Accountability Office, which criticized the delay last January. The FDA will issue the regulations to the makers of the high-risk medical devices and based on the data, the agency will determine whether to reclassify devices to a less risky category or require the manufacturers to undergo further, more rigorous pre-market testing.

SOURCE: Sprint Fidelis Lead Recall › FDA to crack down on medical device manufacturers

Medtronic defended the Minnesota judge on Friday, saying that “this is clearly an effort to remove a well respected judge following rulings the plaintiffs’ lawyers do not like.”

Richard H. Kyle, Jr., works for a Minneapolis based law firm with offices in the Midwest, China, and Mexico. Kyle’s bio on the firm’s website states that he is “a shareholder in [the firm's] White Collar & Regulatory Defense, Health Care Fraud & Compliance and Litigation Groups.”

The website also says that Kyle “is one of the top 40 criminal defense lawyers in Minnesota by the Minnesota Journal of Law and Politics.” Medtronic says that Kyle is not a part of its legal defense and has never represented the company.

Medtronic is the world’s largest medical device manufacturer. Its Sprint Fidelis defibrillators were removed from the market in 2007 because of faulty wires that shocked patients unnecessarily. The defibrillators are blamed for numerous injuries and deaths.

According to the Associated Press, Judge Kyle is “not aware of any formal attempt to remove him from the case.” He also said that that he felt no need to disclose his son’s relationship with the law firm because his son practices criminal law and “would not work with a company like Medtronic.”

Judge Kyle claims that he threw out the lawsuits against Medtronic because the company’s faulty devices had been deemed safe and effective by the Food and Drug Administration. The doctrine of pre-emption, a legal premise that took shape during the Bush administration, allows federal laws to trump state laws. Therefore, since the federal government said that the Sprint Fidelis defibrillators were safe, people harmed by them cannot turn to state law and thus have little or no legal recourse.

Which begs the question: if judges, politicians, and FDA regulators are all attached to big corporations, can the FDA’s stamp of approval on medical devices and drugs ever be trusted to protect the American people?

SOURCE: Sprint Fidelis Lead Recall › Judge tosses medtronic lawsuits, doesn’t disclose son’s ties

And change is apparently what the FDA needs the most. On Thursday, the Government Accountability Office (GAO) said that from 2003 to 2007, the FDA cleared 228 medical devices for the market without a complete evaluation of their safety and effectiveness. Some of the devices were intended for sensitive and risky uses, such as pacemakers and heart valves, and a few have since been recalled because of malfunction or other problems.

“It all adds up to less-than-rigorous rigorous device review, and it’s placing tens of thousands of Americans at risk,” said Peter Lurie, deputy director of Public Citizen’s health research group, in a report by the Associated Press.

The GAO report (link to PDF of report) did not evaluate the number of people, if any, who were harmed by the hastily approved devices. Instead it focused on the approval process for medical devices, calling into question why FDA scientists are routinely pressured to approve of medical machinery against their professional judgment.

A factor that may be contributing to the FDA’s problem is the quickening pace of technology development. Manufacturers of high-tech medical devices have made giant strides in the past decade, and so the number of devices trying to enter the market has grown. The number of upgraded products up for review has also increased. As technology began to outpace the FDA’s approval process, which was established as a three-tier system in 1976, the Federal government pressured the FDA to speed things up.

With drug companies and medical device manufacturers seeking refuge in legal preemption, the current FDA approval system can be a formula for disaster for the American public. Last year, the U.S. Supreme Court ruled that federal (FDA) approval of medical devices could displace many laws on the state level. In other words, someone who has been harmed by an FDA-approved medical device may have little legal recourse in state courts.

SOURCE: Sprint Fidelis Lead Recall › FDA says approval of medical devices was rushed

It was reported yesterday in the Wall Street Journal that the global medical device manufacturer acknowledged the federal investigations as part of a filing with the SEC (Securities and Exchange Commission).On October 15, 2007, a nationwide Medtronic recall was issued for all models of the Sprint Fidelis defibrillator lead. Defects in the lead could cause the thin electrical wire to fracture or break, resulting in electrical shock or device failure.

A lot of controversy has surrounded the approval of this device by the FDA, since no specific testing was required before it was introduced in 2004. In addition, many have expressed concerns about the timing of the defibrillator lead recall, as the Company delayed removal of the device from the market for many months, allowing thousands of people to receive the lead which was known to be dangerous and defective.

Medtronics indicates that the Senate Finance Committee has requested information regarding the defibrillator lead recall as well as information about alleged payments made to doctors by the company. Shortly after the recall, the company was also the subject of a letter from the U.S. Congressional Committee on Oversight and Government Reform, which was sent to the commissioner of the FDA inquiring about the Sprint Fidelis lead’s approval process and when the FDA first learned about the risk that the leads could fracture.

A separate Medtronic investigation has been initiated by the Justice Department, through the U.S. attorney’s office for the Eastern District of Pennsylvania. The U.S. attorney requested that the company provide information about payments made to doctors outside of the United States. The alleged payments could be in violation off the U.S. Foreign Corrupt Practices Act, which is designed to prevent companies from bribing foreign government officials.

Any defibrillators implanted since 2004 could have the Sprint Fidelis lead. To determine if you, a friend or family member may be impacted by the recall, contact your doctor for medical advice and contact our office for a free legal consultation.

December 6th, 2007 by Austin Kirk with Permalink

SOURCE: Sprint Fidelis Lead Recall › Medtronic investigations initiated by federal government