$1.04 Billion Dollar Hip Implant Verdict
The fourth bellwether trial of J&J’s Pinnacle hip implants began before Judge Kinkeade in Texas federal court. Six Plaintiffs advocate that Johnson & Johnson and it’s subsidiary, DePuy Orthopaedics, defectively designed and manufactured the Pinnacle Ultamet metal-on-metal hip implants, failed to provide adequate safety warnings and made misleading marketing statements about the successful results of the implants.
The Plaintiffs allege that J&J didn’t warn surgeons or patients about the risks of metal on metal devices causing microscopic metal particles to be shed into their bodies, leading to serious complications and additional surgeries.Two previous trials delivered multi-million dollar verdicts for California and Texas Plaintiffs, and one defense verdict.
$1.04 billion verdict against Johnson & Johnson DePuy Pinnacle hip implant devices was delivered in Texas for six plaintiffs in a bellwether trial. The Texas jury found six plaintiffs were injured by Pinnacle hip implants metal-shedding causing injuries. The December 1, 2016 $1.04 billion award follows the $150 million verdict in a previous bellwether trial. The Court ordered ten bellwether trials to begin September 2017 as follows:
- Alicea (Cause No. 3:15-cv-03489-K).
- Barzel (Cause No. 3:16-cv-01245-K).
- Buonaiuto (Cause No. 3:14-cv-02750-K).
- Cousin (Cause No. 3:13-cv-00244-K).
- Heroth (Cause No. 3:12-cv-04647-K).
- Kirschner (Cause No. 3:16-cv-01526-K).
- Miura (Cause No. 3:13-cv-04119-K).
- Riedhammer (Cause No. 3:11-cv-02460-K).
- M. and A. Stevens (Cause No. 3:14-cv-01776-K).
- E. and Y. Stevens (Cause No. 3:14-cv-02341-K).
A Texas jury delivered a $498 million verdict against Johnson and Johnson in the second bellwether Pinnacle hip implant manufactured by DePuy Orthopaedics. The plaintiffs proved that the metal-on-metal devices caused inflammation of surrounding tissues, bone erosion and metallosis, as the hip implant components grind against each other shedding metal debris into the bloodstream. The award was later reduced by the judge to approximately $150 million. A Dallas jury found in favor of five plaintiffs and delivered a verdict that included $360 million in punitive damages.
The jury found for the plaintiffs on their failure to warn and design defect claims, holding both J&J and DePuy liable. $240 million of the punitive damages were assessed directly against J&J with DePuy assessed $120 million. $140 million in compensatory damages will be divided among the five plaintiffs based on the extent of their individual injuries. The defendants vow to appeal the verdict.
The Pinnacle Acetabular Cup System contains a cobalt-chromium “Ultamet” liner. The trial involved the consolidated claims of plaintiffs Margaret Aoki, Jay Christopher, Donald Greer, Richard Klusmann and Robert Peterson, who all underwent hip arthroplasty. U.S. District Judge Ed Kinkeade, began bellwether trials on January 8, 2016 in the Northern District of Texas, Dallas Division and the Dallas jury rendered the verdict on March 17, 2016.
$11 Million Verdict Against Wright Hip Implant Replacement
Federal Judge William Duffey reduced a Wright hip implant punitive damages award from $10 million to $1.1 million. However, the jury’s $1 million award for compensatory damages was upheld for a 73-year-old Salt Lake City ski instructor Robyn Christiansen. The trial was the first of a group deciding whether the Wright hip implant device, which is no longer on the hip implant market, was defective.Wright Conserve Hip Implant Litigation is consolidated before Judge Duffey as noted below:
$2.5 Billion Dollar Settlement for Depuy ASR Hip Implant Plaintiffs
$2.5 billion has been offered to resolve thousands of defective DePuy ASR hip implants manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. On November 19, 2013, Johnson & Johnson announced its agreement to pay at least $250,000 per qualified claimant who underwent revision or removal surgery more than 180 days after the hip original implantation. The surgery must have been before August 31, 2013. An additional benefit is that most medical insurance liens will also be assumed by the manufacturer.
The award may be adjusted depending on whether or not the patient received multiple surgeries or revisions, thrombosis, strokes, or heart attacks suffered as a result of revision surgery. Reductions in payments may occur based upon comorbid factors, such as, smoking or obesity and other conditions regarding the life of the implant and whether or not there were previous hip implants. Hip implant patients who have not had the implant revised or removed before August 31, 2013 are not eligible for this settlement.
The first MDL DePuy Orthopaedics metal-on-metal hip replacement device was delayed involving a New York woman who dislocated her hip and was forced to undergo surgery to remove her ASR XL hip implant. Approximately 8,000 cases are coordinated in the MDL before U.S. District Judge David Katz. There are a concerning number of re-revision surgeries among ASR patients resulting from injury to the tissue and muscle from metal debris, pain and suffering. This follows the $8.3 million jury verdict against Johnson and Johnson in March 2013, in Los Angeles. In its decision, the jury panel ordered Johnson & Johnson to pay the plaintiff, a retired prison guard, Loren Kransky, $338,000 to cover his medical expenses and $8 million to cover his pain and emotional suffering. Thousands of the individual cases have been consolidated into a large proceeding in a Federal District Court in Ohio and a resolution of that action provided a framework for settling the bulk of the cases and determining awards to patients.
FDA Safety Communications
In January 17, 2013, the FDA published a safety communication stating that studies show in metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can be released from other parts of the implant where two implant components connect causing tiny metal particles to wear off of the device around the implant, which may damage bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an “adverse local tissue reaction (ALTR)” or an “adverse reaction to metal debris (ARMD).” Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery. Some of the metal ions released will enter the bloodstream known as metallosis, and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body. Lawsuits have been filed involving the following manufacturers:
- Depuy Pinnacle Hip Replacement System
- Depuy ASR
- Depuy ASR Hip Resurfacing System
- Stryker Rejuvenate
- Stryker ABG II modular neck hip stems
- Smith & Nephew’s R3 Acetabular System
- Biomet’s M2a-Magnum, M2a Magnum Tri-Spike, M2a-38, M2a-Taper, M2a-Ringloc
- Wright Metal-on-Metal Conserve Total Hip System
- Wright Metal-on-Metal Conserve Plus Total Resurfacing Hip System
- Wright Lineage Acetabular Cup System
- Wright Dynasty Acetabular Cup System
Patients suffering complications may be entitled to compensation for:
- Medical Bills – including doctor’s visits, medical tests, pain and other medications, hospitalization, x-rays, blood testing, revision surgery, new hip replacement
- Pain and Suffering – physical suffering, mental and emotional suffering, other personal limitations
- Loss of Consortium – damages to relationship with spouse
- Punitive Damages – awards to discourage similar conduct
- Other Damages – including caregiving services, lost income
Signs and Symptoms of Complications
There may be adverse events after surgery, regardless of the type of hip system implanted including:
- ALTR, adverse local tissue reaction
- ARMD, adverse reaction to metal debris
- Hip dislocation, when the ball of the thighbone (femur) slips out of its socket in the hip bone (pelvis)
- Bone fracture
- Joint infection
- Local nerve damage with numbness/weakness
- Device loosening or breakage
- Difference in leg lengths
- Bone loss (osteolysis)
Patients with hip implants should be aware of potential symptoms that may occur after 3 or more months after surgery that may indicate that their device is not functioning properly. Symptoms may include:
- Pain in the groin, hip or leg
- Swelling at or near the hip joint
- A limp or change in walking ability
- Noise (popping
- grinding, clicking or squeaking) from the hip joint
DePuy Hip Implant Recalls
DePuy ASR XL Acetabular System and DePuy ASR Hip Resurfacing System
On August 24, 2010, 93,000 defective hip implants were recalled by the manufacturer, Depuy Orthopedics, a subsidiary of Johnson and Johnson. Patients with the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System implanted since July 2003 may be entitled to compensation. At least 13% have required surgical revision or removal within five years of receiving the implants and thousands more may be required.
Defective Design and Failure to Warn
The Plaintiffs advocate that DePuy Orthopedics defectively designed the ASR hip implant systems. Specialists believe that the acetabular cup may be the problem since it is shallower than other proven hip implants. Tiny metal shavings and debris may damage the surrounding tissue causing painful complications and impeding the chances of a successful revision surgery. According to the DePuy Recall Packet, the defects also include component loosening and misalignment, dislocation of the elements, infection, fracture of the bone, metal sensitivity, and pain.
The Plaintiffs believe that DePuy failed to adequately test the product before placing it on the market and they failed to issue immediate warnings once they became aware of the serious problems. DePuy received complaints for at least two years and recalled these hip implants in Australia in December 2009.
Depuy ASR Hip Implant Litigation – MDL No. 2197
The DePuy ASR Hip implant cases have been centralized in Multidistrict Litigation (MDL) No. 2197 in the U.S. District Court for the Northern District of Ohio with the Honorable Judge David Katz presiding. These actions share factual issues as to whether DePuy’s ASR XL Acetabular Hip System was defectively designed and/or manufactured, and whether DePuy failed to provide adequate warnings concerning the device, which DePuy recalled along with another ASR device, the ASR Hip Resurfacing System in August 2010. All claimants have individual lawsuits which are filed in this federal court to centralize and streamline the litigation process.
DePuy Pinnacle Hip Litigation – MDL No. 3:11-MO-02244
The DePuy Pinnacle Hip Implant cases are centralized in Multidistrict Litigation (MDL) No. 3:11-MO-02244 in the Northern District of Texas with the Honorable Judge Ed Kinkeade presiding. James Stanton has been appointed Special Master. Other DePuy cases are filed in New Jersey, California and Illinois.
Stryker Rejuvenate and ABG II Hip Implants Recalled
In June 2012, Stryker Corporation recalled hip implants, Rejuvenate Modular and ABG II modular-neck hip stems, due to fretting and/or corrosion in the implant which may lead to an adverse local tissue reaction, as well as possible pain and/or swelling, in or around the hip. Plaintiffs allege that there are defects and failures of the Stryker Rejuvenate and ABG II artificial hip implants.
Stryker issued an “Urgent Safety Alert”
This follows Stryker’s “Urgent Safety Alert” issued in April 2012 to surgeons regarding the two hip replacement systems. The alert listed “excessive metal debris and/or ion generation” as one of the safety risks to patients. According to Stryker’s Safety Alert, the following problems can result:
- Metallosis (release of metal ions into the tissue and blood stream):
- Necrosis (premature tissue death);
- Osteolysis (bone dissolution);
- inflammatory tissue damage,
- loosening of the implant,
- painful and complicated revision surgeries,
- painful and complex removal surgeries.
Lawsuits charge that the Rejuvenate and ABG II devices are defective because the modular neck is prone to fretting, degradation, and fracture. Injured Plaintiffs allege that Stryker knew or should have known that the Rejuvenate and AGB II hip systems were not safe for patients, yet continued to market and sell the products.
Stryker’s Neck and Stem components
Stryker marketed the Rejuvenate and ABG II systems as the next generation and latest evolution in hip replacements. Typically, artificial hip implants contain a one-piece neck and stem and a cup. Stryker’s Rejuvenate and ABG II systems included multiple neck and stem components at the surgeon’s choice. The ABG II system contained eight right stems, eight left stems, ten modular necks purported to give greater stability and minimal bone stress. The Rejuvenate hip, with six stems and sixteen necks, was marketed to active, younger patients as longer-lasting devices that offered a better range of motion.
Stryker began selling the Rejuvenate hip system in 2009 and the ABG II hip system in 2010. Stryker conducted little to no clinical testing on the safety and effectiveness of either set of devices in hip replacement patients before placing the Rejuvenate and ABG II hip systems on the market.
Chromium, Cobalt and Titanium metals
Physicians and health regulators exposed the dangers to patients from the release of tiny metallic particles by, and the widespread failures of, all-metal (also called metal-on-metal) hip implants. There is no metal ball that rubs against a metal socket, therefore, Stryker’s Rejuvenate and ABG II modular-neck hip stem systems are not actually called metal-on-metal devices. However, the Stryker Rejuvenate and ABG II necks are made of chromium and cobalt, the stems are coated with titanium, they contain a metal-on-metal junction and it is possible to release metallic debris into nearby tissue and the blood stream.
Consolidation of the Litigation
SMF & MODULAR REDAPT recalled November 2016
R3 Acetabular System recalled June 12, 2012.
Complications with the R3 Acetabular System
Complications and problems relating to the metal liner of the R3 Acetabular System may be the result of its Metal-on-Metal design. The metal liner is made of cobalt and chromium. Cobalt-chromium implants have been linked to metallosis, which is also known as metal poisoning. After the recall, the Smith & Nephew sent out “hazard alert” letters to doctors who had implanted the metal liners, claiming that the recall was a “precautionary step.” Smith & Nephew claimed it was unable to identify one single reason for the device failure, but there were reports of “infection, dislocation, metal sensitivity, loosening/lysis and fracture.” The letter further instructed doctors to follow up with their patients that had received the liner.
Whether you experienced injury or are concerned about future injuries, if you have received a hip replacement implant, whether or not it is subject to a recall and regardless if your case has been rejected by another law firm, please contact us for a free medical legal consultation at 1-800-814-4540.
Although device manufacturers may offer compensation as part of a recall, it may limit compensation to certain medical treatments and revisions and will not offer potential losses like lost wages and pain and suffering, future medical and hospital bills. According to some claimants, some hip implant manufacturers offered a small fraction of revision costs, burdening the injured patients to pay the rest of the bill and provide no compensation for other damages.
To protect your rights, consider a free medical legal consultation with an experienced lawyer before signing documents or accepting any compensation. Recall notices from product manufacturers may be an opportunity to have patients sign waivers, releases or accept a finite amount of compensation. Doing either of these things may prevent you from filing a lawsuit later, therefore, it is best to talk to a lawyer first. Bear in mind that injuries may be permanent and require future care, medical and hospital bills.
A lawsuit may offer a better opportunity to receive compensation for the costs of future care and medical monitoring in the event your product fails, loss of wages, pain and suffering, disability, loss of consortium and other damages. Be careful about talking to a recall helpline as implant manufacturers sometimes use patient call centers to obtain information to limit legal claims. Before speaking to a device maker or recall call center representative, bear in mind that you may not have yet had testing to diagnose the extent of your injuries. Consider a free medical legal consultation first to avoid stating anything that could limit your legal rights.
Bear in mind that your physician or surgeon may turn over evidence in your case, including the failed implant to the product manufacturers, rather than preserving the evidence for the patient. As your lawyers, we will have the faulty device preserved for you to protect your legal rights. During recalls, implant manufacturers often provide information about revision surgery and other treatment, however, their recommendations may not be the best treatment for you. Consider getting a second opinion before committing to a particular treatment plan.
Statute of Limitations
There are statutes of limitations in every state that may limit the time you may file a claim, so call us toll free now at 1-800-814-4540 or fill out the contact form to preserve your legal rights.