Product liability: Medtronic announces warning of drug pump issues

February 15, 2013 (Press-News.org) Product liability: Medtronic announces warning of drug pump issues

Article provided by Tracey Law Firm
Visit us at http://www.traceylawfirm.com

Near the close of last year, Medtronic announced a warning that some of its drug infusion pumps may fail to properly deliver medicines, contributing to a return of symptoms and possibly death. In December, the medical device manufacturer sent a notice to doctors that motors may stall on the SynchroMed II and Synchro Med EL pumps. The notice repeats a previous warning that the pumps are more likely to fail if used with unapproved drugs. The devices remain on the market.

FDA echoes Medtronic's warning

The Food and Drug Administration echoed the warning and reiterated that only approved drugs should be used with the pumps and patients should be closely monitored for the return of symptoms. The pumps are nearly three-times as likely to stall when used with unapproved drugs. According to Bloomberg News, Medtronic is not aware of any deaths related to the pump. The medical device maker is investigating the risk of motor gear corrosion, which is thought to be the primary cause of the pump stalling. Despite the issue, Medtronic has stated the SynchroMed pump continues to demonstrate reliability at or above expected levels. The risk of corrosion was first identified in October 2007 and since mid-summer 2012 there have been 567 complaints regarding the problem.

Product liability and medical devices

A person who suffers an injury from a medical product may be able to pursue a product liability claim. A product liability claim can arise from injuries caused by defective or dangerous medical appliances, equipment, organ transplants, surgical implants and prosthetic devices, among other medical equipment. A central part of a product liability claim concerning medical products is whether the manufacturer of the device failed to warn about the potential dangers of the product. Frequently, medical device manufacturers can fulfill their duty to warn by providing warnings to doctors or other medical professionals prescribing and using the products. Having been warned, the duty then passes to professionals who are supposed to inform patients. Thus to reduce the risk of liability, companies like Medtronic often try to issue warnings when a potential problem with one of their products exists. Through the regulation of medical devices, the FDA also plays a role in actually warning consumers about potentially problematic products and the establishment of liability.

The FDA has established standards and practices that manufacturers must follow. Evidence of a company's compliance with the FDA may help show that a defendant company was not negligent, and evidence that shows the company failed to comply may support an injured, plaintiff's claim that the product was defective. The FDA also issues labeling requirements for medical products, but a company's compliance with the agency's labeling requirements does not necessarily relieve the company from any failure to warn.

Because of overlapping duties to warn, there is a fine line between a products liability case involving a defective medical device and a medical malpractice action. The help of an experienced personal injury attorney who specializes in medical device cases is crucial to presenting the best legal theory for your recovery. Product liability cases are often complex and frequently require the assistance of experts. Moreover, each state, including Texas, has limitations on when a patient injured by a defective medical product may bring suit. Therefore, it's important if you've been injured by a medical device to contact a personal injury attorney who can put your best case forward.