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Articles Posted in Medical Devices

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FDA Issues Warning Letter to St. Jude Medical Regarding Defective Defibrillator Batteries

The U.S. Food and Drug Administration recently published a warning letter that it sent to St. Jude Medical, stating that the company likely downplayed the risks associated with its defibrillator batteries last fall. A defibrillator is a device that provides an electric shock to the heart in the event it…

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FDA Reports Link Between Breast Implants and Cancer

Breast implants are very common and have been used as a cosmetic modification for several decades. According to some reports, breast implants are the second-most common cosmetic operation that women seek out. The most common procedure is liposuction. In 2015 alone, more than 300,000 breast augmentation procedures were performed. There are…

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Fresnius Medical Care Wins First Bellwether Trial in MDL Proceeding Regarding GranuFlo and NaturaLyte Dialysis Drugs

Medical devices are intended to improve our ailments and make our lives easier. Although this is achieved in many cases, there are some instances where medical devices do more harm than good due to design defects or a manufacturer’s failure to provide adequate warnings about the potential side effects. Recently,…

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California Judge Approves $12.3 Million Settlement in Caldera Pelvic Mesh Lawsuit

A federal judge in California recently entered an order approving a $12.3 million settlement involving Caldera Medical’s transvaginal mesh product and associated insurance claims. According to the terms of the settlement, Caldera’s insurance company will provide $10.6 million in payments to nearly 3,000 members of the class, in addition to…

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Zimmer Biomet Initiates Recall of Comprehensive Reverse Shoulder System Device Due to Fracturing

The U.S. Food and Drug Administration (FDA) recently announced a Class I recall for the Zimmer Biomet Comprehensive Reverse Shoulder System, Model 115340 (“CRS”). A Class I recall is the highest level of recall according to the FDA’s regulations. This class of recall is used in situations in which there is…

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State Supreme Court Rules Plaintiff Can Proceed with Failure to Warn Claim Against Surgical Robot Manufacturer

Intuitive Surgical, the company who developed and markets the da Vinci surgical robot, is facing another lawsuit challenging the sufficiency of the warnings that the manufacturer provided with the device. Recently, the Washington Supreme Court ruled that a plaintiff could proceed with a product liability lawsuit on behalf of her…

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Safety of Silicone Breast Implant Challenged in Recently Filed California Lawsuit

Johnson & Johnson was named as a defendant in a recently filed product liability lawsuit involving its silicone breast implant product. The action, which was filed in state court in California, alleges that the plaintiff suffered severe injuries as a result of receiving the company’s silicone breast implants. The plaintiff’s…

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DePuy Seeks New Trial After Jury Returns $1 Billion Punitive Damages Verdict in Pinnacle Metal-on-Metal Case

Johnson & Johnson, the manufacturer of the DePuy Pinnacle hip implant device, has asked a federal judge to issue an order granting new trials after juries returned a total of $1 billion in judgments to six total plaintiffs. Each of these plaintiffs sued the medical device maker, alleging that the…

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Federal Court Allows Shareholder Lawsuit Against Medtronic Alleging Fraud Regarding Infuse Product to Go Forward

In the final days of 2016, a federal appellate court revived a lawsuit brought by a group of shareholders accusing Medtronic, a major medical device and technology company, of concealing information about the negative impacts of its bone growth protein product, Infuse, for over 10 years. According to the United States…