Six plaintiffs had been implanted with the DePuy Pinnacle metal-on-metal device
Texas Jury Awards More Than $1 Billion in Six-Plaintiff Consolidated DePuy Pinnacle Case. A trial heard in the federal district court in Dallas, Texas that was brought against Johnson & Johnson and DePuy Orthopaedics just found for the six plaintiffs for over $1 billion. All six plaintiffs had been implanted with the DePuy Pinnacle metal-on-metal device. DePuy Orthopaedics is a unit of Johnson & Johnson.
Individuals who underwent hip implantation surgery with the metal-on-metal DePuy Orthopaedics Pinnacle hip device likely believed the device would enable them to return to a life with increased mobility and flexibility. The device was also likely touted as being longer lasting. Sadly, this has not been the case for many patients as the device often fails prematurely, necessitating painful, complex, and expensive revision surgeries to remove and replace the implanted device.
This verdict is the second entered against the device makers in a total of three bellwether trials brought forward in the federal multidistrict litigation (MDL), Harris Martin reported. The first bellwether involved just one plaintiff and ended with a defense win. The second bellwether trial involved the consolidation of five plaintiffs from Texas. Their award was ultimately $150 million. The original award of $502 million was capped in compliance with Texas laws on punitive damage award amounts, according to Law360. The six plaintiffs in this bellwether are from California; therefore, the jury award is not subject to the cap. The next bellwether is scheduled to begin in September 2017 and is expected to include 10 plaintiffs from New York.
Bellwether trials are the initial cases that are brought to trial in large litigations, such as the DePuy Pinnacle MDL. Bellwethers enable the parties to better understand how juries may react to evidence and legal arguments that are presented and that would likely be presented if the remaining similar cases reached trial. Bellwethers are also helpful when considering trends and rapid settlement negotiations. An MDL is organized when numerous lawsuits with similar allegations are combined in one court before one judge. Consolidating similar lawsuits reduces duplicate discovery and other potential redundancies and makes complex litigation more efficient.
The claims in these bellwether cases are similar and are also similar to those in other cases in the DePuy Pinnacle MDL. Key allegations involve the friction that occurs between the Pinnacle’s metal socket and metal ball head and released metal particles that enter the bloodstream and area tissue. This metal ion release may lead to serious, life-long injuries. Allegations also included that J&J knew the Pinnacle device posed increased risks when compared to other available devices. Despite this, DePuy allegedly strongly drove sales and paid illegal kickbacks to surgeons to an effort to promote Pinnacle hip replacement device sales.
DePuy and J&J were both found liable for: Negligent and defective design, negligent failure to warn, strict liability failure to warn, failure to recall, negligent misrepresentation, intentional misrepresentation, and fraudulent concealment. In addition, J&J was found liable for aiding and abetting DePuy in the seven causes of action and the jury found J&J liable for conspiracy on the other six claims. The jury also found DePuy and J&J liable for punitive damages given that DePuy and J&J acted with malice or fraud.
If you or someone you know has had surgery involving the DePuy Pinnacle, our Metal-on-Metal attorneys would like to hear from you. Parker Waichman LLP offers free case evaluations for anyone who has questions about their legal rights.
Metal-on-Metal Hips Cleared Through Rapid Regulatory Route
Metal-on-metal hip implants are made of all-metal surfaces and, when these devices were released, they were marketed as being a more durable and longer-lasting option for younger, active individuals. Now, the metal devices have been at the center of a controversy over how the devices were approved.
Not every medical device is clinically tested for safety prior to release. The 510(k) approval route has been met with controversy and contention given the number of devices that are now the subject of personal injury lawsuits, including metal-on-metal hip devices. Many believe that had the devices undergone traditional testing, many injuries would have been avoided. Many metal-on-metal hips were approved via the 510(k) route and many lawsuits allege that the metal-on-metal hips were never clinically tested prior to approval.
The 510(k) is a regulatory clearing method utilized in the United States in which a device is quickly released to market. The 510(k) enables device makers to receive FDA clearance without having to undergo clinical testing if the manufacturers prove their devices are “substantially equivalent” to a previously approved device. Under the 510(k), device makers only need to file paperwork with the U.S. Food and Drug Administration (FDA) and pay a fee.
Federal regulators sought to modify the 510(k) in August 2015 by requiring device makers to utilize a more stringent process when seeking approval to release metal-on-metal hip devices. Following this move, Johnson & Johnson ceased sales of its metal-on-metal version of the Pinnacle device.
Metal-on-Metal Hip Device Injuries
The FDA has indicated that metal ions may cause significant complications when the metal parts of the hip device rub against one another and release cobalt and chromium ions into the patient’s bloodstream and the tissue surrounding the implant. The implant may also likely experience early failure, which leads to a variety of adverse reactions and the need for expensive, painful, and complex revision surgery to remove and replace the device. Alleged injuries include:
- Difficulty ambulating, rising, standing, and balancing
- Dislocation, fracture
- Elevated blood cobalt and chromium ion levels
- Fluid collection, pseudotumors
- Hip replacement failure
- Loosening of the implant
- Loss of mobility
- Metallosis (metal poisoning)
- Necrosis (tissue death) or soft tissue damage
- Osteolysis, damage to the bone cells
- Pain that is often severe and spreads to the groin and/or back
- Popping sounds and other noise emanating from the joint
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