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Defective Medical Devices

Eisbrouch Marsh, LLC is committed to the rights of consumers who have received recalled, defective medical devices and other poorly designed, inadequately tested implants. We believe the makers of these products owe victims far more in damages than they tend to offer in the aftermath of a recall. As more patients come forward with complaints, already widespread litigation continues to grow against the makers of several companies.

 

  1. Bloomberg, Stryker to Pay More Than $1 Billion for Recalled Devices, www.bloomberg.com/news.2014-11-03/stryker-to-pay-more-than-1-billion-for-recalled-devices.html 
  2. Bloomberg, J&J May Pay $250 Million to Settle 1,000 More Hip Claims, www.bloomberg.com/news/2014-103-/j-j-may-pay-250-million-to-settle-1-000-more-hip-claims.html
  3. Public Citizen, Surgical Mesh in Pelvic Repair Procedures Should Be Recalled, Public Citizen Tells FDA, http://www.citizen.org/pressroom/pressroomdirect.cfm?10=3405
  4. U.S. Food and Drug Administration, FDA warns against using laparoscopic power morcellators to treat uterine fibroids, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm424435.htm

Defective Medical Devices

Defective Medical Devices

Defective medical devices have found their way into the bodies of thousands of trusting patients forced to undergo painful revision surgery after learning their devices had failed. Plaintiffs blame not only the makers of these products, but also the FDA whose 510(k) loophole allows devices to market without testing.

Patients undergoing surgery of any kind, whether elective in nature or out of medical necessity, have little choice but to put their faith in the notion that the devices to be used during their procedures are safe and effective. Sadly, it is all too often the case that medical equipment manufacturers have placed surgical and other devices on the market that actually pose serious risks of injury and even death. While the U.S. Food and Drug Administration takes broad responsibility for ensuring the suitability of such devices for their stated uses, there are many cases in which flaws in commonly-used equipment do not make themselves known until unacceptably large numbers of patients have already been harmed.

There are also cases in which device makers neglect to inform regulatory agencies such as the FDA of known concerns relating to their products. They may also conduct fraudulent sales and marketing campaigns or engage in misleading communications to physicians and the public at large.

When the trust placed in doctors and medical device makers proves to have been misplaced and serious injury results, it is often in a patient’s best interest to contact a defective device attorney who can carefully assess the facts and help seek full and fair compensation.

Individuals harmed by defective medical devices may gain awareness of their situation in one of the following ways:

  • A journal article or a study is published tying a particular device to serious side effects. May 2014 saw the presentation and discussion at the annual meeting of the American Urological Association of two major studies linking the use of transvaginal mesh to treat pelvic organ prolapse and very serious side effects.
  • Devices are subjected to a recall once their dangers become widely known. In 2010, DePuy Orthopaedics, a subsidiary of Johnson & Johnson initiated a recall of its ASR XL Acetabular System and ASR Hip Resurfacing System following an onslaught of evidence demonstrating alarmingly high failure rates for the devices.
  • The FDA issues a warning regarding the dangerous effects of a given device. In November of 2014, the agency called for a “black box” warning on power morcellators used in uterine fibroid removal surgery and laparoscopic hysterectomies due to a link between the device and the spread of deadly cancers.

When such evidence reaches the public, patients who may have believed their difficulties were unique to them learn that they were in fact part of a larger class of individuals harmed by the negligence or fraud of a medical device manufacturer.

Once such facts come to light, patients may decide to initiate litigation as a means to secure compensation for the losses sustained because a defective device was used as part of their surgical procedure.

Multidistrict litigation for defective device cases

Because it is often the case that a defective medical device has harmed a significant number of individuals, a multidistrict litigation (MDL) may be created to consolidate similar complaints and streamline processes.

Benefits of an MDL when dealing with a defective device case include the fact that it can:

  • Establish a coordinated, common pre-trial discovery procedure meant to prevent conflicting rulings
  • Put in place a system of case management that can assist with settlement negotiation
  • Select “bellwether” cases that will be heard early on as a way to gauge jury receptiveness to witnesses, evidence and legal arguments and predict trends in the litigation

Defective device MDLs have a history of producing sizable financial settlements for plaintiffs, particularly in recent years. For instance, Stryker Corporation has agreed to pay $1.43 billion to settle claims concerning its Rejuvenate and ABG II metal-on-metal hip implants. It was also recently announced that Johnson & Johnson is contemplating paying an additional $250 million on top of the $2.5 billion it has already paid to settle claims pertaining to its DePuy ASR implants.

While it is impossible to predict the outcome of any defective medical device case, the notable settlements referenced above should give prospective plaintiffs cause for optimism. With increased attention being paid to the alleged dangers of devices including power morcellators, transvaginal mesh, intrauterine devices and other commonly used products, it is more important than ever for those who believe they have been harmed by a medical device to seek legal counsel and begin pursuing the compensation they deserve.

  1. Bloomberg, Stryker to Pay More Than $1 Billion for Recalled Devices, www.bloomberg.com/news.2014-11-03/stryker-to-pay-more-than-1-billion-for-recalled-devices.html 
  2. Bloomberg, J&J May Pay $250 Million to Settle 1,000 More Hip Claims, www.bloomberg.com/news/2014-103-/j-j-may-pay-250-million-to-settle-1-000-more-hip-claims.html
  3. Public Citizen, Surgical Mesh in Pelvic Repair Procedures Should Be Recalled, Public Citizen Tells FDA, http://www.citizen.org/pressroom/pressroomdirect.cfm?10=3405
  4. U.S. Food and Drug Administration, FDA warns against using laparoscopic power morcellators to treat uterine fibroids, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm424435.htm