Drug & Device News

Class Action Settled Decades After Infant Deaths

A settlement has been reached in a class action suit involving the deaths in the 1980s of 40 infants who were given E-Ferol, a vitamin E supplement manufactured by the now-defunct Carter-Glogau Laboratories Inc. and distributed by O'Neal, Jones & Feldman Inc. The $110 million settlement was approved by Judge Sidney Fitzwater, chief judge of the U.S. District Court for the Northern District of Texas. The FDA never approved E-Ferol, which was administered intravenously to premature babies to prevent blindness and lesser visual impairments. The plaintiffs' suit claimed that the manufacturer and distributor led hospitals to believe the supplement had indeed received federal approval, and that it caused problems such as liver and kidney failure in hundreds of babies. A 1980s investigation of E-Ferol, conducted by the Centers for Disease Control and Prevention, found that the emulsifier Polysorbate 80 was the cause of the problems.

Group Accuses FDA of Foot Dragging

The Doctor's group Physicians Committee for Responsible Medicine filed suit in July seeking to compel the FDA to tell diabetes sufferers that a change in diet may be as effective in combating their conditions as drugs. The group says a healthy diet may help many patients to avoid the need for drugs like Avandia, which carry risks of side-effects like heart attack and stroke. “People are getting sick and sometimes dying because they are taking a medicine they may not even need,” said Daniel Kinburn, general counsel of the Physicians Committee for Responsible Medicine. “A low-fat, vegan diet is clearly safer and at least as effective.” The group petitioned the FDA in 2007, asking it to advise health care providers and patients that “oral medications are not always necessary to manage diabetes.” According to the complaint filed in the U.S. District Court for the District of Columbia, the FDA violated the Administrative Procedure Act by failing to properly respond to the petition within a reasonable time, issuing only an “interim response” in which it stated it had been “unable to reach a decision” about the petition. The suit seeks an order compelling the FDA to respond fully to the petition.

Baxter Ordered to Recall Infusion Pumps

The FDA is requiring Baxter Healthcare Corp. to commence the recall of all its Colleague Volumetric Infusion Pumps. Numerous problems with the affected infusion pumps have been identified over the years, including battery failures, service data errors and unintentional powering off. The FDA has taken action against the manufacturer before, trying to get the company to improve its product's performance, but deficiencies persisted. The recall was ordered after the FDA rejected as unacceptable the plan Baxter submitted to it in April, which would have given the company several years to correct the problems. Baxter will have to provide replacements or refunds for the recalled devices, along with a guide to help customers affected by the recall to minimize disruption as they switch to other products.

Suit Seeks Judicial Oversight of Some Medication Decisions

The New Jersey Department of Human Services and the New Jersey Department of Health and Senior Services are being sued by a patient advocate group for forcibly medicating psychiatric patients. New Jersey allows patients in state hospitals to appeal medication decisions made one their behalf, but these appeals are handled within the hospital itself. Patients at private hospital facilities have no formal appeal rights. The plaintiff, Disability Rights of New Jersey, seeks a court order requiring judicial review when patients object to medication decisions made by their care providers.

Class Action Settled Decades After Infant Deaths

A settlement has been reached in a class action suit involving the deaths in the 1980s of 40 infants who were given E-Ferol, a vitamin E supplement manufactured by the now-defunct Carter-Glogau Laboratories Inc. and distributed by O'Neal, Jones & Feldman Inc. The $110 million settlement was approved by Judge Sidney Fitzwater, chief judge of the U.S. District Court for the Northern District of Texas. The FDA never approved E-Ferol, which was administered intravenously to premature babies to prevent blindness and lesser visual impairments. The plaintiffs' suit claimed that the manufacturer and distributor led hospitals to believe the supplement had indeed received federal approval, and that it caused problems such as liver and kidney failure in hundreds of babies. A 1980s investigation of E-Ferol, conducted by the Centers for Disease Control and Prevention, found that the emulsifier Polysorbate 80 was the cause of the problems.

Group Accuses FDA of Foot Dragging

The Doctor's group Physicians Committee for Responsible Medicine filed suit in July seeking to compel the FDA to tell diabetes sufferers that a change in diet may be as effective in combating their conditions as drugs. The group says a healthy diet may help many patients to avoid the need for drugs like Avandia, which carry risks of side-effects like heart attack and stroke. “People are getting sick and sometimes dying because they are taking a medicine they may not even need,” said Daniel Kinburn, general counsel of the Physicians Committee for Responsible Medicine. “A low-fat, vegan diet is clearly safer and at least as effective.” The group petitioned the FDA in 2007, asking it to advise health care providers and patients that “oral medications are not always necessary to manage diabetes.” According to the complaint filed in the U.S. District Court for the District of Columbia, the FDA violated the Administrative Procedure Act by failing to properly respond to the petition within a reasonable time, issuing only an “interim response” in which it stated it had been “unable to reach a decision” about the petition. The suit seeks an order compelling the FDA to respond fully to the petition.

Baxter Ordered to Recall Infusion Pumps

The FDA is requiring Baxter Healthcare Corp. to commence the recall of all its Colleague Volumetric Infusion Pumps. Numerous problems with the affected infusion pumps have been identified over the years, including battery failures, service data errors and unintentional powering off. The FDA has taken action against the manufacturer before, trying to get the company to improve its product's performance, but deficiencies persisted. The recall was ordered after the FDA rejected as unacceptable the plan Baxter submitted to it in April, which would have given the company several years to correct the problems. Baxter will have to provide replacements or refunds for the recalled devices, along with a guide to help customers affected by the recall to minimize disruption as they switch to other products.

Suit Seeks Judicial Oversight of Some Medication Decisions

The New Jersey Department of Human Services and the New Jersey Department of Health and Senior Services are being sued by a patient advocate group for forcibly medicating psychiatric patients. New Jersey allows patients in state hospitals to appeal medication decisions made one their behalf, but these appeals are handled within the hospital itself. Patients at private hospital facilities have no formal appeal rights. The plaintiff, Disability Rights of New Jersey, seeks a court order requiring judicial review when patients object to medication decisions made by their care providers.