› $4.85 Billion settlement in drug case
Rep. Joe Barton of Texas wants the Food and Drug Administration (FDA) to turn over databases stemming from last year’s tainted heparin scandal that killed more than 80 Americans and injured hundreds more, according to NASDAQ.com. At a public hearing last week, Barton raised concerns that the agency doesn’t know for sure what caused the contamination.
The Food and Drug Administrating (FDA) is accusing two Chinese pharmaceutical manufacturing companies of lying to federal regulators about their role in shipping batches of contaminated heparin into the United States between 2007 and 2008, according to Easy Bourse.
Dusty Martin blamed himself after almost losing his 8-year-old son Michael to a bacterial infection. The boy is a hemophiliac who needs regular injections of medicine to reduce the risk of bleeding to death from a slight cut. Martin uses pre-filled syringes of saline and heparin to flush out the port in his son’s chest before administering his medication. But early last year, shortly after receiving his drugs, Michael began shaking. His temperature shot up to 106 and Martin rushed him to the hospital where he underwent emergency surgery.
A class action lawsuit has been filed against Baxter claiming the drug maker substituted an ingredient in its blood thinner heparin with a cheaper, more dangerous one in order to reap more profits, according to the Madison-St. Clair The Record. Twenty-eight people are named in the lawsuit, most of whom are spouses of individuals who died after receiving injections of the tainted heparin. The lawsuit was filed in St. Clair County Court in Illinois.
In an effort to ship heparin- and saline-filled syringes faster, workers at a facility in North Carolina failed to check sterility and then falsified manufacturing dates to make it appear those safeguards were followed, according to an Associated Press report. Those syringes, as it turned out, were tainted with a bacteria known as Serratia marcescens and may have lead to five deaths and hundreds of infections in those who received them.
Pharmaceutical giant Baxter International faces yet another lawsuit, this time for playing a role in the distribution of a contaminated saline syringe that was used on a woman who afterward suffered serious medical problems that may have led to her death a year later, according to the Hays Daily News.
The insurance companies for Scientific Protein Laboratories’ parent company, American Capital Ltd., are suing to nullify the policies with the laboratory, according to The Daily Record. The Wisconsin-based company entered a joint venture with Baxter International Inc. to produce heparin in China. Last year, heparin produced at that plant was found to have been contaminated with oversulfated chondroitin sulfate (OSCS), a heparin-mimicking material that can cause life-threatening allergic reactions. The contaminated heparin killed more than 80 people in the U.S. and sickened hundreds more before several batches of the blood thinner were recalled.
The FDA announced today that it will launch a voluntary two-year pilot program to help promote the safety of drugs and active drug ingredients made outside the U.S. As part of the Secure Supply Chain program, the FDA will select 100 volunteers to maintain control over drug products beginning with when they are produced until it enters the U.S.
Actor Dennis Quaid and his wife Kimberly now have closure in their year-long heparin overdose lawsuit against Cedars-Siani Medical Center, according to OK! and Entertainment Tonight. The entertainment media reported that a Los Angeles judge has signed off on the $750,000 settlement the couple reached with Cedars-Siani last month. According to the settlement, the hospital did not admit wrongdoing in the potentially fatal overdose of heparin that was accidentally administered to the couple’s newborn children Zoe Grace and Thomas Boone Quaid. The settle also allows for the couple to pursue claims for their children in the future. The California Department of Public Heath fined Cedars-Siani $25,000 for the error.
A class action lawsuit has been filed against Baxter Healthcare Corp., claiming the company began substituting ingredients in its anti-coagulant heparin with a dangerous counterfeit to “reap greater profits as a result of utilizing cheap component parts,” according to The Madison St. Clair (Illinois) The Record.
