The stage was all set in Judge Crystal Mittelstaedt’s courtroom in Prince George’s County, Maryland. Seven women and five men of the jury were picked and seated. The first trial over metal-on-metal hips was about to start on January 8, 2013.
The trial over DePuy Orthopaedics, Inc.’s ASR Articular Replacement System was expected to last three weeks. Then came a surprise announcement. The three patient plaintiffs were withdrawing their lawsuit. They reportedly decided to move their complaint from state court and join in with over 10, 000 previous lawsuits filed against DePuy and other device makers in federal court.
Shades of Pedicle Screw Litigation
The sheer number of lawsuits, dollar amounts and number of patients makes this the biggest legal case in orthopedic history—even bigger than the pedicle screw litigation of the 1990s. The case is so big, a federal judge in Ohio was appointed to oversee evidence collection for all the ASR cases.
Three patients named, Moira Jackson, Kathryn Rassier and Robert O’Bryhim, sued DePuy and Chesapeake Surgical Ltd., the distributor that sold the devices to the patients’ surgeons. As the first case to go to trial, the event promised to provide a first look and preview of how the remaining 10, 000 cased in federal court might play out. Think of the Spanish Civil War as a trial run for World War II.
It was the second time in the last six months that DePuy successfully avoided having to go to trial. The first trial was scheduled to take place in a state court in Las Vegas in December. That case was reportedly settled after DePuy agreed to pay about $600, 000 to three ASR hip recipients.
Stryker, Biomet, Zimmer and Wright Medical
Before we go into DePuy’s lawsuit, we note that the company isn’t the only maker of metal-on-metal hips in the plaintiff’s bar’s crosshairs. Here is a list of the other device makers and their devices in consolidated lawsuits:
- DePuy’s Pinnacle Hip
- Stryker Corporation’s Rejuvenate Modular Hip
- Biomet, Inc.’s M2a Magnum Hip Replacement
- Zimmer Holding, Inc.’s Durom Cup
- Wright Medical Technology, Inc.’s Conserve Hip
FDA and Hip Societies
To underline the seriousness of the metal-on-metal hip problems, the FDA has required post-market studies and held an unprecedented two-day meeting of their orthopedic panel in June 2012 to advise the agency of what to do with patients currently implanted with the devices. The panel found very little reason for the devices to be implanted in future patients and recommended elevated monitoring of current patients. The meeting brought together the world’s leading hip societies, overseas registries, regulators, patients, manufacturers and experts on biology, surgery and metallurgy.
Patient Questions
Patients questioned why the agency allowed the devices to come to market in the first place without requiring clinical trials. The FDA cleared the devices through the 510(k) process, which only required manufacturers to prove their device was substantially equivalent to non-metal-on-metal devices already on the market.
It was also notable to observe the different reactions by hip societies in different countries. British surgeons quickly called for a ban on the devices while their American counterparts at the American Academy of Orthopaedic Surgeons left the question of a ban up to the FDA and focused on educating their members about the available evidence.
Question of Malice
The primary question in the Maryland case, and presumably in the federal suits, goes to “malice” and sets up the following three questions:
- What did the manufacturers of the devices know about the risks
- When did they know about them
- What did they do with the information?
The Plaintiffs, all residents of Virginia and Maryland, claim that after DePuy began selling the large diameter systems in 2005, “independent experts from around the world were warning that the design of the [hip] was flawed.” The experts warned that the hip cup was too thin and thus prone to deformation. They warned that the clearance between the cup and head was too small and in some patients could lead to jamming of components. They also warned that the treatment of the metal used for the cup and head was prone to increase wear.
The Plaintiffs cite company literature which “touted the advantages of the ASR hip, including reduced wear.” The brochure stated that the ASR hip is “based on a strong clinical history” and “reduces wear compared to traditional hip replacement.” The literature shows photographs of three individuals engaged in demanding athletic activities such as a golf swing and jogging.
“By 2005, the DePuy ASR Hip cup was shown to have a four-fold higher rate of revision than a similar cup in the Australian Joint Registry, ” stated the complaint. However, according to the lawsuit, DePuy “countered these warning with a host of arguments” and continued to “heavily promote” the hip for the next four years.
Record of Failure and Recall
From 2005 to 2009, “hundreds of complaints of failed” hips were made by orthopedic surgeons and hospitals to DePuy.
According to the suit, independent studies began to show numerous problems with the DePuy ASR Hip, including failure of the cup to achieve proper fixation due to the lack of bony ingrowth into the back of the cup, significant metal debris in patients with the hips, the formation of pseudotumors and hip fractures.
In 2009, DePuy said the company was phasing out sales of the hip due to decreased sales. In early 2010, DePuy sent letters to orthopedic surgeons warning of high failure rates.
On August 24, 2010, DePuy announced the company was recalling the hip in the U.S., noting in the Recall Notice that reasons for high rates included “component loosening, component malalignment, infection, and fracture of the bone, dislocation, metal sensitivity and pain.”
Each Plaintiff claims the hip failed to achieve proper fixation due to lack of bony ingrowth into the rear of the cup and generated excessive metal debris.
Punitive Damages Sought
The conduct of DePuy, according to the Plaintiffs, “was so wanton as to be characterized by actual malice (i.e. specific knowledge of the defects in the [hip] and a deliberate disregard of the foreseeable harm to Plaintiffs resulting from such defects), ” warranting the imposition of punitive damages.
As a result of DePuy’s alleged “negligence, ” the hip was “unfit for its intended use, the product failed, and a diagnosis of the failure was unnecessarily delayed.” For that, the Plaintiffs each wanted $5 million plus costs.
Under Strict Liability claims and Breach of Implied and Express Warranty, each Plaintiff demanded another $5 million for each claim. These claims are based on the allegation that product failed while being used for its intended purpose.
Alleged Failure to Disclose
The Plaintiffs also accuse the company of “Misrepresentation.”
They allege that DePuy failed to disclose information they had about the device at the time of purchase by Plaintiffs, thus inducing Plaintiffs and their orthopedic surgeons to purchase the product, including but not limited to the following information:
- Independent experts from around the world were warning that the design of the DePuy ASR Hip was flawed;
- Orthopedic experts were warning that the DePuy ASR Hip cup was too thin, and prone to deformation;
- The clearance between the DePuy ASR Hip cup and head was too small and patients could experience jamming of the components;
- The treatment of the metal used for the DePuy ASR Hip cup was prone to increased wear and caused excessive metal debris; and
- By 2005 the DePuy ASR Hip was shown in Australia to have a four-fold higher rate of revision than similar cups of competitors.
For “Misrepresentation” the Plaintiffs demanded $5 million in compensatory damages and another $10 million in punitive damages.
Finally, the Plaintiffs allege that DePuy’s conduct constituted actual malice and demand judgment in the amount of $50 million dollars.
Pre-Trial Arguments
In pretrial statements filed with the court, Plaintiffs argue that there was no specific clinical history of the device because it was cleared through the 510(k) program. In addition, they accuse DePuy of continuing with “heavy promotions” and sales of the device in the U.S. while failing to tell orthopedic surgeons either about the warnings DePuy had received concerning the ASR’s defective design, or about its high failure rates reported in 2005 by the Australian Joint Registry.”
For its part, DePuy stated in pre-trial statements that every year 400, 000 natural hips fail so severely that people decide on hip replacement. Of those, 1% results in some kind of problem in the first year and a revision surgery is needed. Ever year thereafter, another 1% is expected to need revision.
DePuy Denies Cover-Up
DePuy denies the ASR is defective. The device was state-of-the-art and all known risks were disclosed to the surgeons. “As Defendants will establish at trial, factors unique to each of the Plaintiffs precipitated the failures of their arthroplasties, ” noted DePuy’s statement.
DePuy planned to call a number of expert witnesses, including: Thomas Bauer, (Orthopaedic Pathology); Edward Boyer, (Medical Toxicology); Stephen Cook, (Biomedical Engineering and Biomaterials Science); John Cuckler, (Orthopaedic Surgery); Avram Edidin, (Biomedical Engineering); Michael Mont, (Orthopaedic Surgery); and Timothy Ulatowski, (Regulatory).
The Next Trial
The federal trial is scheduled to start on May 6, 2013, with a second trial set for July 8, 2013. The first trial in the DePuy Pinnacle litigation is scheduled for September 2014.
For now we’ve seen the strategy of Plaintiffs—allege and then offer up evidence that the device makers kept metal-on-metal hips on the market after they knew there were problems. The Defendants will counter that the hips were state of the art and all risks were fully disclosed. Who will win? Odds, we think, favor the lawyers.
