Wednesday, October 27, 2010

$11.5 Million Awarded to Woman Who Lost Unborn Baby Due to Negligence

$11.5 million has been awarded to Sabine Miller, 30, who lost her unborn baby and her small intestine due to negligence by staff at Edward Hospital in Naperville. Miller had been taken to the hospital on the night of Nov. 30, 2004, with abdominal pains. She was 14 weeks pregnant at the time and admitted to the postpartum unit, where nurses failed to monitor her deteriorating condition and that of her unborn baby, attorney Robert Strelecky said. When Miller was 4 years old she had suffered a twisted intestine and had told medical personnel of this prior condition.

Several hours had gone by and Miller had lost consciousness before medical personnel moved her to the intensive care unit. By then, her small intestine was beyond saving and her baby was dead, Strelecky said. Miller had a small intestine transplant months later at Northwestern Memorial Hospital but is expected to face severe medical challenges for the rest of her life, including a number of risk factors if she were to try to get pregnant again, her attorney said.

Tuesday, October 26, 2010

$750 Million to be Paid by Drug Maker for Defective Drugs

$750 million has been agreed to be paid by GlaxoSmithKline, one of the world’s largest pharmaceutical makers, to settle a Justice Department lawsuit accusing the company of selling adulterated and improperly made drugs, federal officials say. This settlement is the result of a long-running federal investigation of the company’s former drug manufacturing plant in Cidra, Puerto Rico. “The government claimed that the plant churned out medications that were mislabeled, mixed up in the wrong packaging, and even defective – made either too weak or too strong. The allegations included such popular prescription drugs as Paxil and Avandia.” "We regret that we operated the Cidra facility in a manner that was inconsistent with current Good Manufacturing Practice (cGMP) requirements and with GSK's commitment to manufacturing quality," PD Villarreal, GSK's senior vice president and head of global litigation said in a statement Tuesday. "GSK worked hard to resolve fully the manufacturing issues at the Cidra facility prior to its closure in 2009 and we are committed to continuous improvement in our manufacturing processes." The Justice Department's original lawsuit claimed that the plant mixed different strengths of some pills together, such as both 30 mg and 10 mg tablets in the same bottle. The government also claimed that some drugs were contaminated with micro-organisms, including an ointment used to treat skin infections in small children and an injectable drug for treating nausea in patients undergoing chemotherapy.

Tuesday, October 19, 2010

Meridia Weight Loss Drug Recall

The FDA has asked Abbott Laboratories to issue a recall of the weight loss drug Meridia and to stop marketing the product in the United States due to results of a study indicating an increased risk of heart attack and stroke in Meridia users. In November 2009, the finding of a study known as SCOUT (Sibutramine Cardiovascular Outcomes Trial) prompted a Meridia recall in Europe and a FDA safety review in the United States. The study showed a 16% increase in the risk of heart attack, stroke, death and the need for resuscitation upon cardiac arrest in patients taking Meridia compared with those receiving placebo. The study also only showed a 2.5% difference in body weight between the two groups. After examining the drug’s risk-to-benefit ratio, the FDA asked Abbot Laboratories to issue a voluntary Meridia recall.