Drug & Device News

Employees Plead Guilty to Charges Company Misbranded Medical Devices

Two employees of AM2PAT Inc., which manufactured pre-filled syringes containing heparin and saline, have pleaded guilty to various charges stemming from the shipment of the company's products, which were misbranded as “sterile.” The company did not, in fact, test the syringes for sterility. Once they were shipped, the company then falsified device history reports to make it appear that sterility testing had been accomplished on the syringes prior to shipment. According to the U.S. Attorney's release announcing the guilty pleas, as a result of the scheme “between 200 and 300 medical patients around the country developed bacterial infections after having been injected with syringes from AM2PAT, Inc. Some of these infections resulted in serious illness such as spinal meningitis and permanent brain damages, while other infections led to death.”

Just days prior to the acceptance of these guilty pleas, a Federal Grand Jury sitting in the Eastern District of North Carolina indicted AM2PAT and its former president, Dushyant Patel, on similar charges.

Legislation Introduced to Reverse Supreme Court's Device Ruling

Following publication of the March 4 U.S. Supreme Court's decision in Wyeth v. Levine, which held that U.S. Food and Drug Administration (FDA) approval of drug warning labels did not immunize drug manufacturers from suit for failure to give adequate warnings, Henry A. Waxman (D-CA) said, “I am pleased that the Supreme Court has recognized the important right of patients to seek redress in court if harmed by a drug ' this is a critical check that helps ensure the safety of pharmaceuticals. I hope that the Congress will now move to level the playing field and act swiftly to enact legislation to reverse the Court's earlier decision regarding medical devices and restore the ability of patients injured by medical devices to have their day in court.”

One of the first steps in that direction was taken March 9, when Rep. Waxman, Chairman of the Energy and Commerce Committee, along with Congressman Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, introduced legislation to do just that: to reverse the Supreme Court's ruling in Riegel v. Medtronic. That case held that state-law-based failure-to-warn claims against medical device manufacturers are generally pre-empted by a clause within the Medical Device Amendments of 1976 (MDA).

New FDA Chief Named

On March 14, President Obama announced his nominee for FDA Commissioner, Dr. Margaret (Peggy) Hamburg. He also said he would appoint Dr. Joshua (Josh) Sharfstein to be the agency's Deputy Commissioner. Dr. Hamburg was most recently Vice President for the Biological Program at the Nuclear Threat Initiative. Prior to that, she was the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Dr. Sharfstein's most recent position was as Commissioner of Health for the City of Baltimore.

Congressman Bart Stupak (D-MI), Chairman of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations, who has been vocally critical of the FDA's recent performance, hailed the choices. In a statement, Stupak said, “I am pleased President Obama has gone outside the agency to fill the FDA's top two leadership positions, as I urged him to do back in December. There are thousands of dedicated employees at the FDA who are unfortunately trapped in system plagued by low morale, antiquated systems, inadequate funding and management more interested in protecting the companies they regulate than the American people. In just the past year the deaths and illnesses we have seen linked to contaminated food and drugs are a direct result of the FDA not doing its job ' . With Margaret Hamburg and Josh Sharfstein, President Obama has named two leaders whose records speak for themselves in standing up for the public's health.”

Medtronic Defibrillator Leads Linked to Deaths

The New York Times reports that Medtronic, the heart device maker, has disclosed that its now-recalled Sprint Fidelis defibrillator leads may be linked to 13 deaths, including four that occurred when the devices were removed from patients. Meier, The New York Times, 3/14/09. Medtronic recalled the Sprint Fidelis leads in 2007, following the deaths of several patients who were implanted with heart defibrillators.

Soon after the recall was issued, plaintiffs nationwide filed suits against the company, claiming damages for fraud, negligence and product liability, among other things. In February of last year, the Judicial Panel on Multidistrict Litigation consolidated 27 of those suits, sending them to the U.S. District Court for the District of Minnesota. Since then, they have been joined by hundreds of similar suits.

External Heart Defibrillator Recall Issued

Welch Allyn Protocol Inc., of Beaverton, OR, has sent Class I recall notification letters to distributors and customers concerning the Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED. These devices, which analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock where necessary, are used by emergency medical personnel and others to treat adults in cardiac arrest. The defibrillators in the affected lots (manufactured from Oct. 3, 2002 through Jan.25, 2007) may deliver too little energy, or may shut down completely during attempted usage, possibly leading to death. To view the recall notice, go to: http://www.fda.gov/cdrh/recalls/recall-121508.html.

Medical Marijuana Dispensers Can Breathe More Easily

At a press conference March 18, U.S. Attorney General Eric Holder indicated that his office would shift away from the Bush administration's policy of going after medical marijuana growers and dispensaries that are in compliance with state laws permitting the distribution of marijuana for medicinal purposes. Although some states' laws allow distribution of marijuana for this limited purpose, federal law still prohibits marijuana use, production and distribution under almost all circumstances. The new policy will target marijuana dispensers who attempt to use the medical marijuana legal exceptions to shield distribution of marijuana for non-medicinal purposes.

Employees Plead Guilty to Charges Company Misbranded Medical Devices

Two employees of AM2PAT Inc., which manufactured pre-filled syringes containing heparin and saline, have pleaded guilty to various charges stemming from the shipment of the company's products, which were misbranded as “sterile.” The company did not, in fact, test the syringes for sterility. Once they were shipped, the company then falsified device history reports to make it appear that sterility testing had been accomplished on the syringes prior to shipment. According to the U.S. Attorney's release announcing the guilty pleas, as a result of the scheme “between 200 and 300 medical patients around the country developed bacterial infections after having been injected with syringes from AM2PAT, Inc. Some of these infections resulted in serious illness such as spinal meningitis and permanent brain damages, while other infections led to death.”

Just days prior to the acceptance of these guilty pleas, a Federal Grand Jury sitting in the Eastern District of North Carolina indicted AM2PAT and its former president, Dushyant Patel, on similar charges.

Legislation Introduced to Reverse Supreme Court's Device Ruling

Following publication of the March 4 U.S. Supreme Court's decision in Wyeth v. Levine, which held that U.S. Food and Drug Administration (FDA) approval of drug warning labels did not immunize drug manufacturers from suit for failure to give adequate warnings, Henry A. Waxman (D-CA) said, “I am pleased that the Supreme Court has recognized the important right of patients to seek redress in court if harmed by a drug ' this is a critical check that helps ensure the safety of pharmaceuticals. I hope that the Congress will now move to level the playing field and act swiftly to enact legislation to reverse the Court's earlier decision regarding medical devices and restore the ability of patients injured by medical devices to have their day in court.”

One of the first steps in that direction was taken March 9, when Rep. Waxman, Chairman of the Energy and Commerce Committee, along with Congressman Frank Pallone, Jr. (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, introduced legislation to do just that: to reverse the Supreme Court's ruling in Riegel v. Medtronic. That case held that state-law-based failure-to-warn claims against medical device manufacturers are generally pre-empted by a clause within the Medical Device Amendments of 1976 (MDA).

New FDA Chief Named

On March 14, President Obama announced his nominee for FDA Commissioner, Dr. Margaret (Peggy) Hamburg. He also said he would appoint Dr. Joshua (Josh) Sharfstein to be the agency's Deputy Commissioner. Dr. Hamburg was most recently Vice President for the Biological Program at the Nuclear Threat Initiative. Prior to that, she was the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Dr. Sharfstein's most recent position was as Commissioner of Health for the City of Baltimore.

Congressman Bart Stupak (D-MI), Chairman of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations, who has been vocally critical of the FDA's recent performance, hailed the choices. In a statement, Stupak said, “I am pleased President Obama has gone outside the agency to fill the FDA's top two leadership positions, as I urged him to do back in December. There are thousands of dedicated employees at the FDA who are unfortunately trapped in system plagued by low morale, antiquated systems, inadequate funding and management more interested in protecting the companies they regulate than the American people. In just the past year the deaths and illnesses we have seen linked to contaminated food and drugs are a direct result of the FDA not doing its job ' . With Margaret Hamburg and Josh Sharfstein, President Obama has named two leaders whose records speak for themselves in standing up for the public's health.”

Medtronic Defibrillator Leads Linked to Deaths

The New York Times reports that Medtronic, the heart device maker, has disclosed that its now-recalled Sprint Fidelis defibrillator leads may be linked to 13 deaths, including four that occurred when the devices were removed from patients. Meier, The New York Times, 3/14/09. Medtronic recalled the Sprint Fidelis leads in 2007, following the deaths of several patients who were implanted with heart defibrillators.

Soon after the recall was issued, plaintiffs nationwide filed suits against the company, claiming damages for fraud, negligence and product liability, among other things. In February of last year, the Judicial Panel on Multidistrict Litigation consolidated 27 of those suits, sending them to the U.S. District Court for the District of Minnesota. Since then, they have been joined by hundreds of similar suits.

External Heart Defibrillator Recall Issued

Welch Allyn Protocol Inc., of Beaverton, OR, has sent Class I recall notification letters to distributors and customers concerning the Welch Allyn AED 10 Automatic External Defibrillator (AED) and MRL JumpStart AED. These devices, which analyze an unconscious patient's heart rhythm and automatically deliver an electrical shock where necessary, are used by emergency medical personnel and others to treat adults in cardiac arrest. The defibrillators in the affected lots (manufactured from Oct. 3, 2002 through Jan.25, 2007) may deliver too little energy, or may shut down completely during attempted usage, possibly leading to death. To view the recall notice, go to: http://www.fda.gov/cdrh/recalls/recall-121508.html.

Medical Marijuana Dispensers Can Breathe More Easily

At a press conference March 18, U.S. Attorney General Eric Holder indicated that his office would shift away from the Bush administration's policy of going after medical marijuana growers and dispensaries that are in compliance with state laws permitting the distribution of marijuana for medicinal purposes. Although some states' laws allow distribution of marijuana for this limited purpose, federal law still prohibits marijuana use, production and distribution under almost all circumstances. The new policy will target marijuana dispensers who attempt to use the medical marijuana legal exceptions to shield distribution of marijuana for non-medicinal purposes.