Showing all posts written by Andrew Ng
Reuters recently reported that a California state court jury (in the case of Perry et al v. Luu et al, Superior Court of the State of California, Kern County, No. 5-1500-CV-279123) awarded $5.7 Million to plaintiff Coleen Perry for injuries allegedly related to Ethicon Inc.’s TVT Abbrevo product. Ethicon is a subsidiary of Johnson & Johnson.
The Reuters article stated that Abbrevo is one of Ethicon’s transvaginal mesh products that is currently the subject of thousands of lawsuits. According to Reuters, Abbrevo was cleared in 2010 by the U.S. Food and Drug Administration (FDA) to treat stress urinary incontinence.
According to Bloomberg, the plaintiff alleged that the Abbrevo device that was implanted inside of her began to erode in her body, causing pain and requiring her to have another surgery to remove part of the device. The jury found that Abbrevo was defectively designed and that officials of J&J’s Ethicon unit failed to properly warn doctors and consumers about the device’s risks. As a result, the jury awarded the plaintiff $700,000 in compensatory damages and $5 million in punitive damages.
Med Device Online reports that Ethicon has issued the following statement, and plans to appeal the verdict:
The evidence showed the TVT Abbrevo midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research development and marketing of the product.
St. Paul, MN-based EnteroMedics Inc. recently announced that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system. The system is indicated for treatment of obese adults having a Body Mass Index (BMI) of at least 40 to 45 (units of Kilogram per Meter squared), or a BMI of at least 35 to 39.9 with a related health condition such as high blood pressure or high cholesterol levels, and who have already tried to lose weight in a supervised weight management program within the past five years. A news release by the FDA further noted that the Maestro System is the first obesity treatment device to be approved by the FDA since 2007.
According to the Wall Street Journal, the Maestro system disrupts signals between the stomach and brain by blocking electrical signals in the abdominal vagus nerve through the use of high-frequency electrical pulses. The FDA reported that the Maestro System was evaluated in a 233-patient clinical study where the experimental group lost about 8.5% more of its excess weight than the control group in a 12 month period. The FDA further reported that about half (52.5%) of patients in the experimental group lost at least 20% of their excess weight, and 38.3% of the experimental group lost at least 25%. According to NBCnews, as part of the approval process, EnteroMedics must conduct a five year post approval study following at least 100 patients to collect additional safety and effectiveness data.
According to its website:
EnteroMedics® is committed to the delivery of safe, effective and sustainable therapies that address the growing global health crises associated with the increased prevalence of obesity and metabolic diseases, including diabetes and hypertension. EnteroMedics is rapidly advancing its novel technology, VBLOC® vagal blocking therapy delivered via the Maestro® Rechargeable System, to broadly benefit patients, health care providers and stakeholders around the world.
The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical devices. The same charges were also brought against VSI. According to its website, Minneapolis MN-based VSI makes medical devices for diagnostic and interventional vascular procedures.
According to the United States Department of Justice, the indictment alleges that VSI and Root ran an off-label promotion scheme to market VSI’s Vari-Lase product for the ablation of perforator veins, which connect superficial veins to deep veins. According to its 510(K) summary, the FDA cleared the Vari-Lase for treatment of superficial veins. As the Department of Justice notes, the FDA did not approve the Vari-Lase for treating perforator veins due to higher risks associated with perforator veins’ contact with deep veins. Yet, as stated by the indictment, VSI and Root continued to promote and sell Vari-Lase for treating perforator veins even after failing to obtain FDA approval.
The Department of Justice reports that VSI and Root continued off-label promotion of the Vari-Lase even after a whistleblower complained to Root in 2009 and the government told VSI about its investigation in 2011, and VSI and Root continued to deceive the FDA by using code words and misleading investigators. The Star Tribune states that Vari-Lase was eventually voluntarily pulled from the market in July 2014 when VSI agreed to pay $520,000 to resolve civil allegations related to the same alleged off-label promotion.
Following the indictment, VSI issued a press release stating that “[t]he indictment is the profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation.” The case is now pending in the U.S. District Court for the Western District of Texas.