DePuy Hit With $1 Billion Jury Verdict

Last week, a Texas federal jury found Johnson & Johnson’s DePuy Orthopaedics Inc., unit liable for more than $1.04 billion in a six-plaintiff bellwether trial targeting metal-shedding artificial hips that are part of its Pinnacle line.

This MDL bellwether trial involved the DePuy Pinnacle implant, not to be confused with the recalled DePuy ASR implant. The Pinnacle implant was designed with a metal, rather than a safer ceramic or polyethylene, socket. The metal-on-metal design causes the socket to rub against the ball head, which can lead to corrosion and can cause bone and surrounding tissue to erode over time. All of the Plaintiffs in the trial had to undergo revision surgeries to replace the implants and repair the damage. Jurors heard testimony that Johnson & Johnson and DePuy aggressively marketed the implants and employed tactics that included paying kickbacks to surgeons for using the device although they were aware of safer alternatives.

The verdict includes more than $30 million in actual damages for the six plaintiffs and more than $1 billion in punitive damages assessed against Johnson & Johnson and DePuy.

This is the not the first loss for J&J and DePuy over the Pinnacle. In March 2016, a Dallas jury awarded more than $500 million to five individuals who suffered similar physical and medical complications caused by the controversial Pinnacle hip implant. DePuy did win the first bellwether trial.

The case is IN RE: DePuy Orthopaedics Inc., Pinnacle Hip Implant Products Liability Litigation, MDL 3:11-md-0244

Another bellwether trial, which will involve 10 patients, has been scheduled by U.S. District Judge Ed Kinkeade in Dallas for September, 2017.

First Pinnacle Bellwether Trail To Start Today

Jury selection is set to begin today in the first bellwether case in the DePuy Pinnacle MDL. It is among more than 6,000 cases currently pending in the MDL. The cases have been consolidated before U.S. District Judge Ed Kinkeade in Dallas. Judge Kinkeade will preside over the trial.

Depuy is a subsidiary of Johnson & Johnson (“J&J”). The plaintiffs allege metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. 

J&J had heavily touted the metal-on-metal implants, first sold in the U.S. in 2005, as a design that would last 20 years and offer greater range of motion. However, J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval.

The Pinnacle line of hips wasn’t covered by J&J’s $2.5 billion settlement of claims that its ASR hip devices shed chromium and cobalt debris from the metal-on-metal which caused tissue death and increased metal ions in the blood. Other complications from the ASR hip devices included dislocations, pain, and required surgical removal.

It is estimated the trial will last up to six weeks.

Biomet Settles Metal-On-Metal MDL

It was reported last week that Warsaw, Indiana-based Biomet Inc. agreed to pay at least $56 million to settle claims in the Indiana MDL over defective metal-on-metal hip implants. Thousands of plaintiffs have filed suit in the MDL and this agreement would affectively resolve their claims. The cases were consolidated in October 2012.

The agreement stipulates that each plaintiff who received a Biomet M2a-38 or M2a-Magnum hip implant that later had to be revised will receive a base payment of $200,000, though the variations of each patient’s payment are numerous, dependent on an array of court-approved conditions.

The agreement may mirror the DePuy ASR settlement where deductions from base payments are incurred if the claimant smoked, had the device in for a certain amount of years, and is of a certain age. The base settlement can increase for multiple surgeries, complications from revisions, and other factors. The Biomet product was not recalled like the ASR, even though they are both metal-on-metal models.

Biomet’s settlement deal is in a sense bifurcated. The corporation will put $50 million into an escrow account to fund payments to plaintiffs who claim they were damaged by the hip implants. In the second prong, a common benefit settlement agreement, Biomet will pay $6 million to the plaintiffs’ attorneys.

The deadline to file a claim in order to be considered for participation in the settlement is April 15, 2014.

The MDL is In re: Biomet M2A Magnum Hip Implant Products Liability Litigation, case number 3:12-md-02391, in the U.S. District Court for the Northern District of Indiana.

ASR Total Hip Replacement: A Painful Fail?

Trainee Orthopedic Surgeon David Langton from Newcastle University in the UK has dedicated the last three years of his life studying metal on metal hip replacements, specifically the ASR model, in an effort to attain his PHD. He believes that there is a problem with the configuration of the metal on metal hip replacement, namely the size of the cup. This causes wear to take in the "ring of the cup". "Chromium Cobalt ions concentrate in the hip fluid" and are also released into the blood. This subsequent accumulation of metal ions is "directly related to soft tissue damage and bony damage around the joints". His study has found that hip pain and groin pain are often noted side effects from these metal on metal hip replacements.
Site: David Langton on Metal on Metal Hips
Site: David Langton on Metal on Metal Hips

Smith & Nephew Voluntary Withdrawal of Metal Hip Liner

Smith & Nephew PLC said Friday that it is pulling a metal liner used in hip replacements from the market. The London company said the device is the optional metal liner for its R3 Acetabular System hip devices. Smith & Nephew said it is "not satisfied with the clinical results" of the liner because some patients needed an additional surgery to have the liner removed. It described the move as a precaution.

The U.K.-based device and medical technology company disclosed what it termed as a "voluntary market withdrawal" of an "optional metal liner component" for its R3 Acetabular system, which serves as the "socket" portion of a hip implant. The withdrawal encompasses the optional metal liner, or cup, component. Surgeons, however, will still be able to use the system using alternative non-metal liners and the company said it did not anticipate any delays to surgery.

A small number of patients experienced problems including infections, fractures and dislocations - but there was no evidence of "metallosis", or the build-up of metallic debris in the body, a corporate spokesman said. The veracity of this statement is yet to be determined.

Smith & Nephew said about 7,700 metal liners have been implanted since the piece first became available in 2007, mostly for stemmed total hip replacements. The component launched globally in 2009. Patients who have the liner as part of their implant are being urged to talk to their surgeons if they are dealing with any unusual symptoms.

A Smith & Nephew spokesman said that U.S. and European regulators have been notified of the company's voluntary action, which was based on clinical data from multiple sources. Among them: The U.K. National Joint Registry shows a revision rate of 6.3% after four years for the part, and the Australian National Joint Replacement Registry shows a revision rate of 4.96% after two years.

The company cautioned in its statement that other R3 system liners, made of polyethylene (and ceramic outside the U.S.) aren't affected by the market withdrawal. Smith & Nephew also downplayed the impact it would face taking the component off the market, noting that the company reported $4.27 billion in revenue in 2011 and claims less than 1 percent of that revenue came from procedures involving the recalled component.

The R3 system itself has been an issue for the company in the past. In December of 2010, the FDA issued Smith & Nephew a warning letter regarding the company's Tuttlingen, Germany facility that produces the implant. The FDA said that the company had not performed adequate tests and that it failed to establish and maintain a process that would correct manufacturing problems. At the time, Smith & Nephew said it took initial action to resolve any FDA issues. (Other sites in the U.K. and U.S. also manufacture the device.)

The voluntary recall will only add to concerns about the safety of metal-on-metal hips. Metal-on-metal hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket. Smith & Nephew, through a company spokesman said the issues with its system were different to those seen with some other all-metal implants, such as the high-profile recall of the DePuy metal-on-metal ASR system.

If you or a loved one have had hip replacement surgery and have been implanted with a defective Smith & Nephew R3 Acetabular system, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with the Smith & Nephew R3 metal liner. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.

"Hip Replacements may be Leaking Metal Fragments into their Hosts"

Surgeons in the United Kingdom fear metal debris from the failed metal hip joints have possible long term damage. The metal in the joint has been shown to wear down and these "hip replacements may be leaking metal fragments". The UK health regulator, the MHRA, announced that 49,00 patients with metal on metal hip replacements will be required to have annual check ups due to medical fears. Engineer Tom Joyce of Newcastle University, in his analysis of the wearing metal joint, claims that "these metal on metal hips are failing at rates we just wouldn't expect". Professor Sir Kent Woods, who is a medicine and health product regulator in the UK, admits there were "no clinical trials"  conducted prior to administering these metal on metal hips.