Staggering. It’s really the only word for it. Yesterday a Texas jury awarded six plaintiffs over one billion dollars for injuries sustained following the failure of the Depuy Pinnacle metal-on-metal artificial hip. And that comes out to more than $170,000,000.00 per plaintiff. The verdict was handed down last night following ten weeks of punishing trial.

This trial was the third “bellwether” case in the Depuy Pinnacle MDL (multidistrict litigation). The first Pinnacle bellwether trial ended in a defense verdict, which means the jury did not find negligence on the part of the defendants, Depuy Orthopaedics and Johnson & Johnson, and therefore the plaintiffs received no compensation. The second bellwether trial resulted in a huge $502 million dollar verdict for five plaintiffs, which I wrote about here. In fact, much of the speculation about this third bellwether trial was whether the plaintiffs’ team could put on the same powerful case that they did in the second bellwether trial, or whether the $500 million verdict in March was simply a bizarre outlier, one of those remarkable unicorn verdicts that come along once and never again.

Today, the $500 million dollar verdict seems modest compared to yesterday’s jury verdict. Plainly, juries are sending a huge message to Depuy and J&J that they hurt many people when they marketed and sold the Depuy Pinnacle Hip.

21 Expert Witnesses

The trial involved six consolidated cases: Andrews, Davis, Metzler, Rodriguez, Standerfer, and Weiser. Each of these plaintiffs lived in California and received the Pinnacle in hip replacement surgeries in California. Because of this California citizenship, the laws of the state of California governed the case, even though the case was being tried in federal court in Texas. Essentially, Texas was chosen as the Pinnacle MDL venue, but in each case that reaches trial, the substantive law of the state where the plaintiff resides is utilized. This is important because California, unlike many states (including Texas and North Carolina), does not have a cap on punitive damages awards.

The trial was hard fought. Opening arguments began on October 3. Along the way, both sides argued their cases aggressively, and spent many days cross-examining the opponent’s expert witnesses. I counted 21 expert witnesses who testified in this bellwether trial. One attempted defense for Depuy was that the surgeons implanted the Pinnacle hip in these plaintiffs incorrectly. Depuy and J&J also asked for a mistrial a few days ago, which Judge Kinkeade in Dallas denied.

The Jury Verdict

After closing arguments, the jury “received” case on November 30, which means it was finally time for the jurors to sit in a conference room and decide whether the plaintiffs had proven their cases, and if so, how much money they were entitled to receive. After just one day of deliberation, the jury delivered its staggering verdict. The jury award totaled $1,041,311,648.17, and included $28,311,648.17 total in personal injury (“compensatory”) damages for the six plaintiffs, and $4,000,000.00 in loss of consortium damages to the four spouses of four of the plaintiffs. Finally, the jury awarded $1,008,000,000.00 in punitive damages total for the plaintiffs, and $1,000,000.00 in punitive damages for four spouses of the plaintiffs.

The jury found that DePuy and J&J were negligent in designing the Pinnacle Ultamet artificial hip. The jury also found against the defendants on the plaintiffs’ strict liability claim (failure to warn), negligence (failure to warn), negligence (failure to recall), negligent misrepresentation, negligent misrepresentation to the plaintiffs’ physicians, intentional misrepresentation, intentional misrepresentation to the plaintiffs’ physicians, fraudulent concealment, and fraudulent concealment to the plaintiffs’ physicians.

J&J was also found by jurors to have aided and abetted with DePuy, concluding that the defendant knowingly gave “substantial assistance or encouragement” of the negligence of DePuy that ultimately caused injury to the plaintiffs under claims of negligence, failure to warn, failure to recall, negligent misrepresentation, intentional misrepresentation, and fraudulent concealment.

Plaintiffs won every claim except one. The jury found that J&J did not conspire with Depuy to commit negligence as to the design of the implant.

As I said, it was a staggering win for the plaintiffs, and by extension, the thousands of other victims still waiting in the Pinnacle MDL.

Remember that California has no statutory cap on punitive damages. In the second bellwether trial, Judge Kinkeade invoked Texas law to reduce the total jury award by $350 million, which you can read about here. But Judge Kinkeade can’t do that with this latest award, as California law does not authorize courts to invade the province of the jury. Thus, the one billion dollar verdict should stand. Again, staggering.

The Jury Award

Plaintiffs Andrews, Davis, and Metzler underwent single hip replacements, which then failed, and each were awarded over $4 million in personal injury damages, $84 million in punitive damages against Depuy, and $84 million in punitive damages against J&J. Their spouses separately received $1 million in loss of consortium damages, $125,000 in punitive damages against DePuy, and $125,000 in punitive damages against J&J.

Plaintiffs Rodriguez, Standerfer, and Weiser underwent bilateral hip replacements (when means both hips were replaced), which then failed, , and each was awarded personal injury damages ranging from $4 million to $6 million, plus $84 million in punitive damages against Depuy, and $84 million in punitive damages against J&J. Spouses received $1 million in loss of consortium damages, $125,000 in punitive damages against DePuy, and $125,000 in punitive damages against J&J.

Do You Have a Depuy Pinnacle Hip Implant?

The Depuy Pinnacle Hip was originally designed to replace your natural bone “ball-and-socket” with artificial ball-and-socket parts. The Pinnacle was supposed to provide more range of motion and to be more useful to an active group of patients undergoing hip replacement surgery. The Pinnacle system was supposed to give surgeons different options in the materials to be used for the hip replacement: metal-on-metal, or ceramic-on-metal, or other combinations. One of the major complaints against the Pinnacle is that the metal components grind and release metal particles into the body and blood of the patient, often leading to extremely high metals levels.

The Pinnacle Hip was first sold in 2000. Depuy stopped manufacturing and selling the device in 2013. But it can take years for serious trouble to occur with a failed Pinnacle hip, which means many people are still out there with failing devices that don’t yet know the device is failing. Quick example: you receive the Pinnacle hip in surgery in late 2012 or early 2013, prior to the device being taken out of the marketplace. Your hip feels OK in the first few years, but in 2016 you begin to feel a new discomfort. The pain gets worse over time. Then after a routine blood test, your doctor tells you that your metals levels are 12 parts per billion, which is very high and not healthy. Turns out you are developing metallosis from the metal particles leaching into your body. Your doctor recommends revision surgery in January 2017. In that case, you should qualify for participation in the Depuy Pinnacle MDL.

Like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through a process known as “510(k).” This process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 of its intent to market a device (like an artificial hip) and to explain the device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States, which it did for the Depuy ASR and Pinnacle, and which I believe is a significant reason for all the injuries and suffering related to failed medical devices.

In any event, yesterday’s jury verdict will send shock waves through medical device industry. Stay tuned here for more information.

But let’s back up.

What is Risperdal?

Risperdal is an anti-psychotic drug that was approved for limited use in 1993 to manage the symptoms of schizophrenia. According to multiple sources, in the years that followed Johnson & Johnson pressed the FDA for approval to treat other conditions, such as bipolar disorder and autism, and to permit use in children. Risperdal was soon prescribed for adults and children to treat attention deficit hyperactivity disorder, anxiety and depression. Treating these conditions using Risperdal is considered an “off label” use, which is the use of a drug in a manner unapproved by the FDA. Off-label use could involve using a drug to treat a condition which is not authorized by the FDA, or prescribing the drug to an unapproved age group. Shockingly, Risperdal has had horrific side effects in children. Among other symptoms, Risperdal can cause the growth of female breasts in male children, a condition known as gynecomastia. I have written about Risperdal often in this blog. You can check out those articles here.

The Case of Andrew Yount

Andrew Yount is a boy from Tennessee who was prescribed Risperdal in 2003 to treat attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder. At the time the FDA had not approved the drug for use in treating behavior disorders in children. Andrew was just five years old when he began taking the drug. A year after taking Risperdal, Andrew grew female breasts.

Andrew Yount is now in his late teens. He has had to deal with this embarrassing disfigurement for most of his life.

At trial, the lawyers for Andrew and the Yount family argued that Janssen Pharmaceuticals and its parent company Johnson & Johnson were aware of the risks of children growing female breasts but worked to downplay the risk involved. Despite the data showing a connection between use of Risperdal and the growth of female breasts in vulnerable boys, Janssen and Johnson & Johnson kept pushing the prescription to doctors and parents and children.

What the Jury Saw

The jury reviewed the evidence and concluded that Janssen and Johnson & Johnson failed to warn the Yount family about the risks of taking Risperdal. The jury also seems to have concluded that the defendant companies intentionally buried or falsified scientific evidence showing a link between Risperdal and gynecomastia. If this is true (and evidence supports the view), then it represents hideous behavior from the companies. The jury in the Yount case clearly saw this horrific corporate behavior and awarded Andrew Yount a huge monetary award. But just as likely, the jury got angry and awarded this money as a signal to Johnson & Johnson that this kind of corporate greed will be severely punished. The hope is that jury verdicts like this one will discourage Johnson & Johnson and all pharmaceutical companies to recommit to developing and testing and marketing safe and effective drugs.

Naturally, Janssen and J&J have stated they will appeal the verdict.

Other Risperdal Cases

I wrote about the Austin Pledger trial from last fall, which resulted in a $2.5 million verdict and which you can read about here. Other Risperdal trials have yielded jury awards ranging from $500,000.00 to $1.75 million. One jury trial ended in a defense verdict for Janssen and Johnson & Johnson, though I would not put much stock in that outcome, as plainly the plaintiffs are winning many more of these cases than they are losing. After this latest huge loss in the Yount case, Johnson & Johnson would be wise to consider settling many of the more than 1,500 cases still in the pipeline. Another Risperdal case goes to trial in Philadelphia later this month. I’ll let you know how it turns out.

The Takeaway

For much of my life I have mainly believed that pharmaceutical companies develop and market drugs with the overarching goal to improve and extend the lives of patients. But this is not always the case. Sometimes a company can become blinded by greed. Companies may then push an untested drug onto the market, or even sell a drug it knows to be unsafe. So be skeptical. Do some research. Ask your doctor many questions about the latest drug she wants to prescribe for you or your child. Get a second or a third opinion. You can never eliminate all risk, but you can at least learn how a product reached the market, whether it was adequately tested, and even whether lawsuits have been filed against the drug maker.

The case is titled A. Y. v. Janssen Pharmaceuticals, Pennsylvania Court of Common Pleas (No. 130402094)

Photographs for illustrative purposes only.