Product News and Recalls

FDA Taking Legal Action after Hospital-Acquired Infections in Texas

hospital-acquired infection in texas spurs FDA actionThe FDA is taking legal action against a compounding pharmacy after 17 hospital patients acquired infections from contaminated injectable drugs.

In August 2013, Specialty Compounding, LLC, issued a nationwide voluntary recall of all lots of its unexpired sterile products. The recall came after 17 cases of hospital-acquired infection were linked to injectable drug products supplied by the company. Patients were reported to have developed bacterial bloodstream infections after receiving infusions of calcium gluconate that had been contaminated with bacteria.

Upon reviewing the company’s facilities in August and September 2013, the FDA found that some of Specialty Compounding’s injectable drugs were contaminated with bacteria. The agency further discovered that the company had not been appropriately cleaning its equipment and rooms, nor had it performed adequate testing of its injectable drugs in its laboratories.

Now the FDA has taken out a consent decree against the Texas-based company. This means that Specialty Compounding must stop manufacturing or holding sterile drugs until FDA inspectors have determined the company meets the legally required standards of manufacturing quality. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, claims the “consent decree reflects the FDA’s commitment to taking enforcement action against companies that fail to produce sterile drugs in compliance with the law.”

Hospital-acquired infections are by no means a rare occurrence in U.S. health care facilities. In 2011 the federal Centers for Disease Control and Prevention estimated that 1 in every 25 hospitalized patients acquires an infection, and roughly 722,000 hospital-acquired infections result in or contribute to 75,000 deaths each year.

Hospital-acquired infections can be caused by a variety of factors. Bacteria and viruses may be transmitted when hospital staff do not properly wash their hands or sterilize their instruments. Infections can also be caused by misdiagnoses and procedural accidents resulting from negligence or poor training. In cases like the one discussed here, manufacturers of medical devices may be at fault. Recently, contaminated duodenoscopes — a type of instrument used to diagnose and treat cancer and gallstones — were found to be responsible for at least six hospital-acquired infections in two LA hospitals. Two of the six patients eventually died from their infections.

The attorneys at Lopez McHugh are dedicated to protecting the health and rights of hospital patients. If you believe you or a loved one acquired an infection due to hospital mismanagement or a contaminated medical device, contact our team of lawyers for a free consultation. You may be eligible for compensation through a medical malpractice or product liability lawsuit.