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DePuy Synthes Elbow Replacement Lawsuits

Attorneys expect a wave of lawsuits following DePuy Synthes’ decision to pull tens of thousands of its elbow implants off the market. Dozens of reports have claimed the DePuy Synthes Radial Head Prosthesis system loosened or dislocated, requiring surgery to repair it.

Complications related to a DePuy Synthes elbow replacement?

If you were injured as a result of an elbow replacement, you may be eligible for compensation.

Depuy Synthes Elbow Lawsuit Facts
  1. Plaintiff Injuries Device loosening, osteolysis, poor joint mechanics, post-operative bone fractures, soft tissue damage, revision surgery
  2. Defendants DePuy Synthes (a Johnson & Johnson subsidiary)
  3. Litigation Status Active – case reviews currently underway
  4. Off Market DePuy Synthes pulled its Radial Head Prosthesis System elbow implants off the market in 2016
  5. Reports The FDA received 40 reports of the DePuy Synthes elbow replacement loosening
  6. Filing Lawsuits Thousands of patients may file lawsuits over complications over their faulty elbow replacements
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Lawyers have already been hearing from patients who were injured when their DePuy Synthes elbow implants failed prematurely. The U.S. Food and Drug Administration had received dozens of reports of serious problems with the device before the company decided to take it off the market in December 2016.

By then, the elbow replacements had already been implanted in thousands of patients.

Status of DePuy Synthes Elbow Replacement Lawsuits

Lawsuits over DePuy elbow replacements are still in the early stages. No major trials have taken place and no verdicts or settlements have been announced so far.

Recall Fact
50,311 DePuy Synthes Elbow Replacement Implants Were Recalled in 2016

However, DePuy Synthes’ market withdrawal of its Radial Head Prosthesis System implants could be an indication of lawsuits to come. Such large recalls often indicate a large number of lawsuits could result as people suffer complications from a faulty or defective device.

People who received a DePuy Synthes Radial Head Prosthesis System and who have suffered these complications have started talking to lawyers about seeking compensation for their injuries.

What Elbow Implant Patients May Claim

Lawsuits over the DePuy Synthes elbow replacement will likely involve those complications that led DePuy to pull the devices off the market in the first place. DePuy elbow lawsuits may claim: Loosening, Dislocation, and Revision Surgery.

Between 2014 and the time of the recall in December 2016, the FDA had received more than 40 reports of the DePuy Synthes Radial Head Prosthesis System loosening. Repairing the complication required further surgery.

Patients who suffered injuries after receiving a Depuy Synthes Radial Head Prosthesis System may be entitled to compensation for:
Medical Expenses
This includes doctor visits before and after the revision surgery, X-rays or other digital imaging to detect loosening, as well as physical therapy and treating any unexpected complications resulting from the revision surgery.
Pain and suffering
Implant failures can produce intense or constant pain. Complications from surgeries to repair the elbow can also result in painful or prolonged infections and other complications requiring hospitalization or more surgeries.
Lost earnings
Loosening may affect some people’s ability to do their job or force them to take time off for surgery to replace the faulty device. While some people may be able to use their elbow a few weeks after revision surgery, full recovery can take a year and those patients are limited in how much they may be able to lift. For people with physically demanding jobs, this can result in a loss of earnings during their recovery and may require them to change jobs. Patients should take into account the loss of both current and future earnings.

Accusations DePuy Synthes May Face in Elbow Lawsuits

Lawsuits filed over defective or faulty medical devices usually fall under products liability law. To file a lawsuit, people have to show that the device had a defect and the company didn’t do enough to protect people who received it.

Depuy Synthes lawsuits may include typical claims in a medical device case such as:
  • The company designed and manufactured a defective elbow replacement
  • DePuy knew or should have known the implant was defective
  • The manufacturer failed to warn patients and doctors of the risk the elbow implant posed

Previous Settlements and Verdicts Against DePuy

There have been no major verdicts or settlements yet involving the DePuy Synthes Radial Head Prosthesis System elbow replacement. But because so many of the devices were removed from the market, attorneys expect there could be a large number of lawsuits filed over the device.

Lawsuits over elbow implants have been fairly rare overall. Most joint-implant lawsuits have involved hips or knees. Verdicts and settlements in other DePuy joint replacement lawsuits have totaled nearly $6 billion in recent years.

Timeline of Recent Depuy Joint Implant verdicts and settlements
  • March 2013
    Jury awarded $8.3 million to a plaintiff for injuries involving a DePuy ASR hip implant
  • August 2013
    Johnson & Johnson settled three DePuy ASR hip lawsuits for $200,000 each
  • November 2013
    Johnson & Johnson settled 8,000 DePuy ASR hip lawsuits for a total of $4 billion
  • March 2015
    Johnson & Johnson settled 1,800 DePuy ASR hip lawsuits for $420 million
  • February 2016
    Jury awarded five plaintiffs $502 million for injuries involving DePuy Pinnacle hip implants
  • December 2016
    Jury awarded six plaintiffs $1 billion for DePuy Pinnacle hip injuries

More than 18,000 people filed lawsuits over the two models of DePuy hips involved in these recent lawsuits.

Class Action Lawsuits over DePuy Synthes Elbow

There are currently no class-action lawsuits over the DePuy Radial Head Prosthesis System. Class actions are generally impractical for medical device lawsuits. Instead, individual lawsuits are sometimes combined in a multidistrict litigation (MDL). Both class actions and MDLs allow people to pool resources and move their cases more quickly through the legal process, but there are some important differences.

Class Action Lawsuits
  • Lawsuit must go through “class certification” where a court rules whether the case qualifies as a class action
  • Can be filed in state or federal court
  • Several people must have suffered the same injuries from the same cause
  • Individual awards must be so small they would not be worth pursuing an individual court case
  • All parties receive a proportionate share of any award or settlement
Multidistrict Litigation (MDL)
  • A federal panel determines if several lawsuits can be combined in a single multidistrict litigation
  • Limited to federal courts
  • Several people must have suffered similar injuries from the same cause
  • Awards or settlements can be quite large, hundreds of thousands of dollars in some cases
  • Awards and settlements can be tailored to each individual’s injuries

Some state courts also have their own versions of MDLs, allowing several lawsuits filed in those courts to be combined into a single action.

Elbow Implant Bypassed Strict FDA Review

The FDA’s 510(k) process allows a company to market certain medical devices if they can simply show that the product is “substantially similar” in safety and effectiveness to other devices already on the market.

501(k) Program
The process sometimes draws criticism because it allows companies to skip much of the FDA’s more formal protocols and begin selling devices sooner.

The DePuy Synthes Radial Head Prosthesis System was approved through the 510(k) process in June 2011. DePuy and Synthes merged that year, but Synthes had developed the elbow implant and shepherded it through the FDA approval process.

Synthes had presented the device as substantially similar to two other elbow implants already on the market. The surface of the device, critical for attaching to the bone and potentially important in the device loosening, was compared in Synthes’ application to 10 other existing medical devices.

Please seek the advice of a medical professional before making health care decisions.

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14 Cited Research Articles

  1. DePuy Synthes. (2011, April 27). Johnson & Johnson and Synthes Announce Definitive Merger Agreement – DePuy. Retrieved from: https://www.depuysynthes.com/about/news-press/qs/johnson--johnson-and-synthes-announce-definitive-merger-agreement---depuy
  2. Rabin, S.L. (1997). Indications for Radial Heat Replacement Following Elbow Trauma. Retrieved from http://www.medscape.com/viewarticle/719214
  3. Fowler, J.R., Henry, S.E., Xu, P. and Goitz, R.J. (2016, April 5). Outcomes Following Radial Head Arthroplasty. Retrieved from https://www.healio.com/orthopedics/journals/ortho/2016-5-39-3/%7B3d0de9f8-574b-4984-81a4-d7d300a8e92a%7D/outcomes-following-radial-head-arthroplasty
  4. O’Driscoll, S.W. and Herald, J.A. (2012, January). Forearm Pain Associated with Loose Radial Head Prostheses. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21856175
  5. National Institutes for Health. (2017, July 5). Elbow Replacement. Retrieved from https://medlineplus.gov/ency/article/007258.htm
  6. U.S. District Court, Dallas Division of the Northern District of Texas. (2012, August 14). In Re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation Case Management Order No. 8 [Schedule of Pretrial Matters]. Retrieved from http://www.txnd.uscourts.gov/sites/default/files/documents/3-11-md-2244_190.pdf
  7. U.S. District Court, Dallas Division of the Northern District of Texas. (2013, September 30). In Re: DePuy Orthopaedics, Inc. Pinnacle Hip Implants Products Liability Litigation Agreed Order Staying Cases Pending Bellwether Trials. Retrieved from http://www.txnd.uscourts.gov/sites/default/files/documents/2244-348.pdf
  8. U.S. District Court, Northern District of Ohio. (2012, July 26). In Re; DePuy Orthopaedics, Inc. ASR Hip Implant Products Case Management Order No. 14. Retrieved from http://www.pacer.gov
  9. Meier, B. (2013, March 8). J.&J. Loses First Case Over Faulty Hip Implant. Retrieved from http://www.nytimes.com/2013/03/09/business/johnson-johnson-must-pay-in-first-hip-implant-case.html
  10. Possley, M., Voreacos, D. & Pettersson, E. (2013, March 8). J&J Must Pay $8.3 Million Over Defective Hip, Jury Says. Retrieved from https://www.bloomberg.com/news/articles/2013-03-08/j-j-must-pay-8-3-million-in-suit-over-defective-hip-jury-says
  11. Harris, A. & Voreacos, D. (2013, March 12). J&J Faces Second Trial over Recalled Hip after Loss. Bloomberg. Retrieved from http://www.bloomberg.com/news/articles/2013-03-11/j-j-faces-second-trial-over-recalled-hip-after-losing-first-case
  12. Meier, B. (2013, November 12). Johnson & Johnson Said to Agree to $4 Billion Settlement over Hip Implants. Retrieved from http://www.nytimes.com/2013/11/13/business/johnson-and-johnson-said-to-agree-to-4-billion-settlement-over-hip-implants.html
  13. Meier, B. (2013, November 19). Johnson & Johnson in Deal to Settle Hip Implant Lawsuits. Retrieved from http://www.nytimes.com/2013/11/20/business/johnson-johnson-to-offer-2-5-billion-hip-device-settlement.html
  14. Johnson & Johnson. (2016, March). Annual Report 2015. Retrieved from http://files.shareholder.com/downloads/JNJ/1709744668x0x881109/474857DD-8E67-43B1-BB38-0A9712D93545/2015_annual_report_.pdf
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