Deadly Superbug Bacteria - "CRE"

The Seattle Times reported that dozens of patients of patients at Virginia Mason Medical Center were infected with the "Superbug" bacteria carbapenem-resistant Enterobacteriaceae (CRE) between 2012 and 2014. The article reported that the infections occurred when endoscopes contaminated with bacteria were used on other patients. That is, a scope used in one patient was then used in another patient without being adequately cleaned beforehand, thus transferring a disease from patient to another. Most of the patients in question underwent a procedure "known as ERCP, or endoscopic retrograde cholangiopancreatography, which diagnoses and treats bile-duct and pancreatic problems. The VMMC came under fire when patients learned that the hospital officials did not disclose the nature of the illness at the time of the infection.

The manufacturers of the particular scopes used (called duodenscopes) have also come under scrutiny because the scopes themselves may have been defectively designed by allowing these bacteria to transfer from one patient to another, even if the the clean procedures were followed. In March, CNN reported that some of the endoscopes involved in one CRE Superbug death case were not cleared by the FDA prior to use. One large manufacturer, Olympus America, reported began "selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market..." Families of those who were injured or dies as a result of the defective endoscopy scopes have filed lawsuits against the manufacturers. VMMC has joined a lawsuit against the scope manufacturer Olympus, alleging that the endoscope was defective.

According to the Centers for Disease Control and Prevention, "healthy people usually do not get CRE infections - they usually happen to patients in hospitals, nursing homes, and other healthcare settings." The frightening thing about these Superbugs is that "some CRE bacteria have become resistant to most available antibiotics. Infections with these germs are very difficult to treat, and can be deadly - one report cites they can contribute to death in up to 50% of patients who become infected." After all the attention to the Superbug, the White House has developed a Superbug action plan that addresses CRE, and the CDC has issued a new duodenscope protocol for healthcare facilities to use to reduce the spread of the Superbug.

Toyota Recalls 1.4 Million and Honda Adds 1.39 Million Cars to Recall Due to Faulty Air bags

According to the Associated Press, " Toyota is adding nearly 1.4 million cars, trucks and SUV's to a growing recall for air bags that can explode with too much force." The previous recall has been expanded based on further concerns that the air bags, made by Takata Corp. of Japan are defective. This recall will add the "2003 to 2007 Corolla and Matrix, 2005 and 2006 Tundra pickup, 2005 to 2007 Sequoia SUV and the 2003 to 2007 Lexus SC430 convertible," the AP reports. Takata last month gave in to pressure from the NHTSA "and declared many of its products defective, agreeing to double the number of air bag inflators being recalled," according to AP, and making it "the largest auto recall in US history." According to the USA Today, as part of the NHTSA's expanded recall of faulty Takata air bags, Honda "said it will recall another 1.39 million cars to replace the same component" as Toyota. Since the initial announcement, 11 affected car manufacturers "have been trying to figure out which of their models need to be included," the article reports.

Defective Product Update: Thousands of defective St. Jude Riata leads still remain implanted in US

St. Jude Medical Inc. sent a letter to physicians warning of problems with Riata and Riata ST leads, which connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms, on November 28, 2011. The FDA later classified the letter as a Class I Recall, the most serious type of recall – for products or devices that may cause serious adverse health consequences or death. St. Jude had already stopped selling these leads in late 2010, after more than 227,000 had been distributed worldwide. The FDA reported that, as of 2011, approximately 79,000 Riata leads remained implanted in patients in the US. The FDA, concerned that the Riata and Riata ST leads that show insulation abnormalities on imaging may be at greater risk of future electrical failure, recommends that physicians image Riata and Riata SST implanted  leads to assess for externalization or other visible insulation abnormalities.

New York Times  reported in its March 27, 2012, issue that at least 22 deaths were caused by the defective wires. Another eight patients died during procedures to remove the wires. Dr. Robert Hauser, author of the study, said the number of deaths was small compared with the number of patients who had these models of wires. However, “because it may be catastrophic, we need to be paying more attention to what are the electrical signs that might help us identify patients who are at risk,” he said.

Defibrillator Lead Lawsuits: St. Jude’s Motion to Dismiss Denied

As reported by Cardiovascular Business, California Federal Judge James V. Selna earlier this year denied St. Jude’s motion to dismiss five cases in which manufacturing defects that caused their Riata leads to fail were alleged. According to the judge, plaintiffs had met their burden of showing a plausible association between the injuries alleged and the allegedly defective St. Jude leads. He also found that the claims were not preempted by federal law. Preemption is a legal concept that a number of medical device makers have used in liability lawsuits that have been filed over devices that have received FDA approval.

Riata and Riata ST ICD leads are prone to high-voltage failures, which appear to be caused by insulation defects that lead to short circuits between high-voltage components. A phenomenon known as “externalized conductors” occurs when conductor cables wear through the silicone insulation from inside out, ending up outside the lead’s body. According to the American College of Cardiology research, inappropriate shocks were common and high voltage cable insulation abrasion also occurred. JACC concluded that Riata leads may have more widespread damage than can be detected by fluoroscopic exam.

Testosterone lawsuits: Additional Warning from the FDA

The FDA is adding a general warning to testosterone products due to the risk of blood clots. Blood clots can form in the veins and cause a pulmonary embolism, a potentially life-threatening event that occurs when the clot travels to the lungs. The new warning is not related to the FDA’s ongoing evaluation of possible links between testosterone therapy and risk of a heart attack, stroke and death in those taking testosterone products.

If you or someone you know has suffered adverse effects from testosterone therapy, we welcome your inquiry. The Product Liability attorneys here at SGB would be happy to provide a prompt and confidential evaluation of your case.