DePuy Pinnacle $502 Million Appeal Dragging On

Dallas, TXWhen pharmaceutical and medical device giant Johnson & Johnson lost the second DePuy Pinnacle defective hip bellwether lawsuit and was ordered to pay $502 million in damages, attorneys for the defendant opined at the time that an appeal would be launched with dispatch.

However, last month The Fifth Circuit ruled that DePuy, the J&J subsidiary responsible for the allegedly defective metal-on-metal artificial hips, will not succeed in its quest for an expedited appeal. It should be noted that Johnson & Johnson won the first Pinnacle bellwether trial that involved a single plaintiff. The latter trial involved a collective of plaintiffs, with the jury finding in their favor upon the conclusion of a trial that proved complex and voluminous in nature.

The plaintiffs in the second bellwether trial argued that such complexity suggested that a speedy appeal, sought by the defendant, was not warranted.

The DePuy Pinnacle is among more recent generations of artificial joints moving beyond traditional materials to include metal in the various components. Many of these advances were brought to market quickly through a 510(k) Clearance through the US Food and Drug Administration (FDA), a loophole that allows device updates to be brought into the market sooner provided the basic design is similar to that which is already on the market and performing well.

Basic designs of artificial hips did not change beyond the choice of materials, with metal replacing porcelain, amongst other material swaps.

However, metal-on-metal hips such as the Pinnacle have proven to be problematic. Minute metal particles have been found to shear from the joint and become embedded into surrounding tissue, weakening muscle and bone and allegedly contributing to the early failure of the joint through a condition known as metallosis. Metallurgic toxicity is another problem, where metal ions are absorbed into the bloodstream, causing the potential for a grievous health complication reversible only by total removal of the problematic joint through painful and complex revision surgery.

Metal was assumed to be more robust and longer-lasting; helping to support what is increasingly an active lifestyle in older Americans. And yet for many, this has not proven to be the case. What’s more, the choice of metals used in metal-on-metal hips, identified as cobalt, chromium and titanium has been questioned. For example, it has been reported that device makers typically do not use titanium as a surface coating for bearings as titanium is known to corrode over time.

Cobalt and chromium, comprising the surface areas of many artificial hip implants, have been linked in studies to cellular toxicity, cancer, allergic reactions and tissue inflammation.

In patients with metal sensitivity, metallosis stemming from metal-on-metal implants can lead to metal poisoning.

This past March Bloomberg News (03/17/16) reported that a federal jury in Texas awarded $142 million in actual damages and $360 million in punitive damages to a group of five patients whose DePuy hips failed early, and had to be replaced.

Revision surgery can often be more complex than the initial installation of an artificial hip, with increased risk of complication - not to mention additional time away from work or a busy lifestyle for a patient having barely recovered and rehabilitated from the first procedure. Expected to last upwards of 15 years and beyond with normal use, the DePuy Pinnacle hips were found to fail, in some patients, within a matter of months.

The $502 million DePuy verdict from the second bellwether trial - and the attempt at an appeal by the defendant - is being watched closely. There are a handful of additional bellwether trials in the pipeline, helping to set the stage for the 8,000 or so lawsuits that have been filed to date by angry plaintiffs miffed over their experiences with the DePuy Pinnacle artificial hips.

The Pinnacle cases have been consolidated before US District Judge Ed Kinkeade in Dallas for pretrial proceedings. (In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 11-md-02244, US District Court, Northern District of Texas at Dallas) The most recent bellwether trial - which went against DePuy for $502 million - was actually a collective of five similar cases, combined into one trial.

Plaintiffs assert that DePuy knew about the problems, but kept marketing the Pinnacle hips anyway. Some 170,000 Pinnacle hips were implanted since 2000, the year they first appeared on the market.