DePuy Pinnacle Bellwethers Progress


Fourth Bellwether Trial Next

DePuy Orthopaedics Pinnacle hip replacement lawsuits are being heard in Texas. The DePuy Pinnacle hip replacement lawsuits are progressing to the fourth bellwether trial involving the allegedly defective DePuy Pinnacle hip replacement system. DePuy Orthopaedics is a unit of Johnson & Johnson.

In May 2011, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized pretrial proceedings in the cases before Judge Kinkeade in the in the U.S. District Court for the Northern District of Texas, as part of a multidistrict litigation (MDL). To date, the Texas federal court has more than 9,000 hip implant lawsuits, pending that involve the DePuy Orthopaedics Pinnacle Hip Replacement system. The system uses the metal Ultamet liner.

The upcoming bellwether trial is scheduled to begin on September 18, 2017 and will involve product liability and personal injury claims that have been filed on behalf of seven patients who were implanted with the Pinnacle hips. The plaintiffs are from New Jersey and New York.

The hip plaintiffs all similarly allege that the all-metal design of the Pinnacle system and Ultamet liner cause the implant to release toxic cobalt and chromium metal ions. These ions accumulate in the hip joint and enter the blood stream. This leads to severe adverse local tissue reactions and premature hip implant failure that necessitates revision surgery to explant, or remove, the allegedly defective device, re-implanting the patient with a different device.

In August 2010, DePuy Orthopaedics announced a massive worldwide hip replacement recall for its ASR line of metal implants following global reports of metallosis (metal poisoning) and premature hip failure. In 2013, Johnson & Johnson agreed to pay at least $2.5 billion to settle more than 9,000 lawsuits over DePuy ASR hip replacements. As with other allegedly problematic metal-on-metal hip devices, this medical device also featured a metal-on-metal design that has been described as a “substantial equivalent” to DePuy’s Pinnacle hip.

Since the premature failure and metal toxicity rates are similar between the ASR and the metal-on-metal Pinnacle, many now question why DePuy Orthopaedics has not taken similar action concerning the Pinnacle/Ultamet liner combination.

The second bellwether trial, which was heard in 2016, involved five plaintiffs who were awarded a total of $500 million. The jury award was reduced to $151 million to comply with Texas law governing punitive damages. In the third bellwether trial in 2017 the six Pinnacle patients were awarded more than $1 billion. That judgment was later reduced to $543 million. The fourth bellwether trial involving the DePuy Pinnacle hip replacement lawsuit is scheduled to be heard in Texas federal court.

Bellwether trials are the first one or few cases tried in a group litigation, such as a multidistrict litigation (MDL). The outcome of bellwethers is used to predict the remaining litigation. MDLs bring together lawsuits with similar allegations in one court before one judge. This consolidation helps make the legal process more efficient as it eliminates duplicate discovery. Plaintiffs similarly allege that the DePuy Pinnacle hip implant is defective and that Johnson & Johnson and DePuy Orthopaedics either knew or should have known about the risks associated with its metal hip implants.

The nationwide attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal hip implant lawsuit.

DePuy Orthopaedics Background

In 2013, the U.S. Food & Drug Administration (FDA) issued a warning that metal-on-metal hips were associated with increased rates of early failure when compared to hips with different configurations. The Agency also initiated a safety review of metal-on-metal hip replacements in 2011. Approximately two years later, the FDA confirmed that exposure to the metal ions released from the devices might lead to adverse local tissue reaction in the area around the joint, and might enter the bloodstream, causing additional symptoms or illnesses elsewhere in the body. All-metal hip patients were advised to speak with their doctors if they experienced any issues with their implants, while physicians were urged to consider metal ion blood testing and imaging for symptomatic patients.

In May 2011, DePuy Orthopaedics announced that it would phase out metal-on-metal hip implants, including the device named in the Pinnacle hip lawsuits. According to The New York Times, the company cited slowing sales, as well as the FDA’s intention to impose stricter regulations on all-metal hip implants, as factors in its decision.

Approximately 500,000 Americans have undergone hip replacement surgery, potentially having been implanted with a metal-on-metal hip device, including DePuy hip implant devices such as the Pinnacle and the ASR.

The shedding of small metallic particles from the metal alloys used in metal-on-metal hip devices, including the metal-on-metal DePuy Pinnacle, are believed to lead to inflammation and infection of surrounding tissue, absorption into the bloodstream, swelling, the development of fluid pockets, and other health issues that progressively lead to hip loosening, hip replacement failure, toxic metallosis, and the need for revision surgery.

Revision surgery involves removing and replacing the allegedly defective device. This type of explantation surgery is more painful, costly, risky, and complex than the original implantation surgery. Revision surgery is also tied with longer recovery times and hospital stays as well as intense and longer physical therapy. In some cases, insurers do not cover revision surgeries.

When metal-on-metal implants were introduced to the market, they were believed to extend the life of traditional hip implants, expanding the market to a growing population base that is younger and more active and comprised of individuals who are looking for a stronger, longer lasting implant.

Metal-on-metal implants were permitted to enter the market with minimal testing through the FDA’s 510(k) clearance protocol. Due to the loophole, DePuy was “able to market the Pinnacle Device with virtually no clinical … trials or FDA review of the implant for safety and effectiveness,” one complaint alleges. Allegations also include that, had the Pinnacle system undergone clinical trials, the manufacturer would have been aware of the “high percentage of patients developing metallosis, biologic toxicity, and an early and high failure rate due to the release of metal particles … implantation of the Pinnacle Device results in nearly immediate systemic release of high levels of toxic metal cobalt-chromium ions into every hip implant patient’s tissue and blood stream,” according to a complaint. Under this loophole, device makers are only required to file paperwork and pay a fee to federal regulators.

Filing Defective Medical Device Lawsuit

If you or someone you know suffered injuries related to the use of defective medical device or device component, including DePuy Pinnacle metal-on-metal hip replacement and other hip devices, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).