Drug & Device News

FDA Warns of Serious Adverse Event Potential with Use of Psoriasis Drug Raptiva

The U.S. Food and Drug Administration issued a public health advisory Feb. 19 about a connection between use of the psoriasis drug Raptiva and the development of progressive multifocal leukoencephalopathy (PML), a rare brain infection. PML usually occurs in people with severely weakened immune systems. Raptiva, which patients take via a once-per-week injection, controls psoriasis outbreaks by suppressing T-cells in the immune system.

The FDA's announcement noted that, as of Feb. 19, there had been three confirmed fatal cases of PML in Raptiva users, as well as one other possible case in a patient who had not died. All of the affected Raptiva users had been taking the drug for more than three years, but none of them were taking any other medications that suppress the immune system.

The agency is advising health-care providers to carefully monitor patients who are currently, or were previously, on Raptiva. They should watch for signs of PML, including unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. However, there is no known method for preventing or treating PML, which, the FDA notes, leads to irreversible decline in neurologic function and death. This being the case, the agency notes, health-care providers and their patients may want to consider alternative treatments for psoriasis. To view the FDA's release, go to: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01958.html.

Doctor Pleads Guilty to Overcharging Insurers for Medications Not Given

A doctor who operated AIDS treatment centers in California ' Valley View Internal Medicine Group and Ocean View Internal Medicine Group ' has pleaded guilty to giving patients smaller doses of the medications they were supposed to have been receiving. Dr. George Steven Kooshian admitted to two counts of health-care fraud and two counts of making a false statement. The charges stemmed from several types of alleged actions, including the doctor giving patients less medication than prescribed yet billing for the full doses; billing patients' insurance companies for medications that had been discontinued for those patients; and billing as though patients had received their medications from medical personnel in the office setting, when in fact they had self-administered them at home. Although the government alleged that losses to health insurance providers might have been higher than $600,000, the doctor admitted only to losses of at least $350,000.

Documents Indicate Withholding of Adverse Information From Patients/Caregivers

The New York Times reports that documents, released by the plaintiffs in a case against drug maker AstraZeneca concerning its psychiatric drug Seroquel, suggest the company tried to minimize the effects of unfavorable test results on public perception of the drug. Wilson, The New York Times, 2/28/09. For example, in a 1997 e-mail allegedly sent by an official at the drug manufacturer to a doctor then working for the company, the official praised the doctor for downplaying unfavorable test results for Seroquel. The plaintiffs claim in their lawsuit that they were not adequately warned that the drug could cause weight gain and diabetes.

Doctor Arrested for Dispensing Painkillers Without Patient Examinations

A Duarte, CA, doctor was arrested without incident at his offices Feb. 10 for allegedly selling prescription narcotics without examining patients. Dr. Daniel J. Healy came to the attention of the Drug Enforcement Administration (DEA) after an informant told authorities that he was dispensing drugs to people for cash, with no examination or only a cursory examination. The informant alleged these “patients” could obtain any amount of the drugs they wanted, which they could then use or sell for a profit. According to the U.S. Attorney's Office, Dr. Healy purchased more than 1 million hydrocodone tablets in 2008 ' more than any other single health-care provider in the country. A release issued by the U.S. Attorney's Office notes that, in an affidavit accompanying the complaint, a DEA agent estimated the doctor's profit on the drugs ordered in 2008 to have been nearly $700,000.

Boxed Warnings Now Required for Metoclopramide-
Containing Drugs

The FDA has ordered manufacturers of metoclopramide, which is used to treat gastrointestinal disorders, to add a boxed warning to their labels. Those warnings concern the risk that users could develop tardive dyskinesia, a disorder involving involuntary movements. These “ticks” could include repetitive grimacing, sticking out of the tongue, lip smacking and other involuntary motions. The FDA notes that the risk of developing tardive dyskinesia with use of metoclopramide increases when patients are on the medication for long periods of time, or when they take large doses of it. In an FDA release, Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said, “The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.” The FDA's public notice of the boxed warning requirement can be found at: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html.

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 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 FDA approval of drug warning labels did not immunize drug manufacturers from suit for failure to give adequate warnings (see articles on pages 1, 7 and 11), 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.”

The first step 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).

“As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety,” said Chairman Waxman in a release announcing the introduction of the new legislation. “The Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products.”

FDA Warns of Serious Adverse Event Potential with Use of Psoriasis Drug Raptiva

The U.S. Food and Drug Administration issued a public health advisory Feb. 19 about a connection between use of the psoriasis drug Raptiva and the development of progressive multifocal leukoencephalopathy (PML), a rare brain infection. PML usually occurs in people with severely weakened immune systems. Raptiva, which patients take via a once-per-week injection, controls psoriasis outbreaks by suppressing T-cells in the immune system.

The FDA's announcement noted that, as of Feb. 19, there had been three confirmed fatal cases of PML in Raptiva users, as well as one other possible case in a patient who had not died. All of the affected Raptiva users had been taking the drug for more than three years, but none of them were taking any other medications that suppress the immune system.

The agency is advising health-care providers to carefully monitor patients who are currently, or were previously, on Raptiva. They should watch for signs of PML, including unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. However, there is no known method for preventing or treating PML, which, the FDA notes, leads to irreversible decline in neurologic function and death. This being the case, the agency notes, health-care providers and their patients may want to consider alternative treatments for psoriasis. To view the FDA's release, go to: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01958.html.

Doctor Pleads Guilty to Overcharging Insurers for Medications Not Given

A doctor who operated AIDS treatment centers in California ' Valley View Internal Medicine Group and Ocean View Internal Medicine Group ' has pleaded guilty to giving patients smaller doses of the medications they were supposed to have been receiving. Dr. George Steven Kooshian admitted to two counts of health-care fraud and two counts of making a false statement. The charges stemmed from several types of alleged actions, including the doctor giving patients less medication than prescribed yet billing for the full doses; billing patients' insurance companies for medications that had been discontinued for those patients; and billing as though patients had received their medications from medical personnel in the office setting, when in fact they had self-administered them at home. Although the government alleged that losses to health insurance providers might have been higher than $600,000, the doctor admitted only to losses of at least $350,000.

Documents Indicate Withholding of Adverse Information From Patients/Caregivers

The New York Times reports that documents, released by the plaintiffs in a case against drug maker AstraZeneca concerning its psychiatric drug Seroquel, suggest the company tried to minimize the effects of unfavorable test results on public perception of the drug. Wilson, The New York Times, 2/28/09. For example, in a 1997 e-mail allegedly sent by an official at the drug manufacturer to a doctor then working for the company, the official praised the doctor for downplaying unfavorable test results for Seroquel. The plaintiffs claim in their lawsuit that they were not adequately warned that the drug could cause weight gain and diabetes.

Doctor Arrested for Dispensing Painkillers Without Patient Examinations

A Duarte, CA, doctor was arrested without incident at his offices Feb. 10 for allegedly selling prescription narcotics without examining patients. Dr. Daniel J. Healy came to the attention of the Drug Enforcement Administration (DEA) after an informant told authorities that he was dispensing drugs to people for cash, with no examination or only a cursory examination. The informant alleged these “patients” could obtain any amount of the drugs they wanted, which they could then use or sell for a profit. According to the U.S. Attorney's Office, Dr. Healy purchased more than 1 million hydrocodone tablets in 2008 ' more than any other single health-care provider in the country. A release issued by the U.S. Attorney's Office notes that, in an affidavit accompanying the complaint, a DEA agent estimated the doctor's profit on the drugs ordered in 2008 to have been nearly $700,000.

Boxed Warnings Now Required for Metoclopramide-
Containing Drugs

The FDA has ordered manufacturers of metoclopramide, which is used to treat gastrointestinal disorders, to add a boxed warning to their labels. Those warnings concern the risk that users could develop tardive dyskinesia, a disorder involving involuntary movements. These “ticks” could include repetitive grimacing, sticking out of the tongue, lip smacking and other involuntary motions. The FDA notes that the risk of developing tardive dyskinesia with use of metoclopramide increases when patients are on the medication for long periods of time, or when they take large doses of it. In an FDA release, Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said, “The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.” The FDA's public notice of the boxed warning requirement can be found at: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01963.html.

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 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 FDA approval of drug warning labels did not immunize drug manufacturers from suit for failure to give adequate warnings (see articles on pages 1, 7 and 11), 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.”

The first step 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).

“As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety,” said Chairman Waxman in a release announcing the introduction of the new legislation. “The Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products.”