Defective Medical Devices

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Regulators Recall 465,000 Pacemakers After Finding Security Issues

The U.S. Food and Drug Administration (FDA) recently decided to recall 465,000 pacemakers due to security issues. Regulators feared that certain vulnerabilities with these devices would allow hackers to access and reprogram them, possibly putting patients’ lives at risk. Devices in the Recall The recall includes several devices from Abbot,…

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Investigation Finds FDA Delayed Warnings Against Power Morcellators

A new federal report has revealed that the Federal U.S. Food and Drug Administration (FDA) knew about the link between power morcellators and uterine cancer for 23 years before the administration warned the public. The Government Accountability Office (GAO) began investigating the FDA’s knowledge of power morcellators link to cancer…

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Power Morcellator Use Declines Following FDA Warning

The use of power morcellators has significantly decreased following a 2014 Food and Drug Administration (FDA) warning that the devices can cause the spread of cancerous cells throughout the abdomen. Power morcellators have been in use since the 1990s and are commonly used in minimally invasive surgeries such as hysterectomies…

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J & J Ordered to Pay $500 Million in Hip Implant Case

Earlier this month, a federal jury in Texas found Johnson & Johnson liable for $500 million in damages in a Pinnacle hip implant case in which five patients sustained injuries following the implantation of the device sold by the company’s DePuy division. The two-month trial led to a week-long deliberation,…

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J & J Is Beginning to Settle Power Morcellator Cases

Manufacturer Johnson & Johnson has begun settling claims related to its power morcellator hysterectomy device which claimants say caused them harm by spreading undetected cancer. To date, approximately 100 claims have been made against the company, of which approximately 70 cases have been settled in the past months. Settlements range…

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Hip Implant Manufacturer is Subject of Court Cases

Zimmer Holdings Inc., maker of the Durom Cup hip implant, will soon have to fend off lawsuits over the medical device when two trials begin, The National Law Journal said in a recent article. The plaintiffs Christine Brady and Gary Kline each had the device implanted and then removed later,…

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Stryker Settlement Deadline Extended; Claims Are Being Filed

In November 2014, Stryker Corporation agreed to settle thousands of claims related to its metal-on-metal hip implant devices. Now, the deadline to register a claim of injury, revision surgery or other loss has been extended to April 17, 2015. For patients who received one of Stryker’s faulty devices, this means…

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Australian Study Questions Effectiveness of DePuy Hip System

The following is an article that ran in the March 2010 Bioengineering Bulletin from the Department of Medical Engineering and Physics at the Royal Perth Hospital. Metal-on-Metal Bearings: How Effective? The increase in use of metal-on-metal (MoM) bearings over the past 5 years has been dramatic. The claimed advantages of…

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