On October 23, 2014, a nine-member federal jury ruled unanimously that DePuy Orthopaedics ‘ metal-on-metal (MoM) Ultamet Pinnacle artificial hip did not cause the plaintiff’s eventual re-surgeries. This was a bellwether trial and the first of more than 6, 800 civil cases that have been filed against the company. It was a really important verdict. And it took the jury just hours to reach it after a seven-week trial.
The Dallas jury’s decision came after a 58-year-old Montana woman named Kathleen Herlihy-Paoli and her lawyer, Mark Lanier, asked the court to make DePuy pay more than $1.5 million in damages to compensate Herligy-Paoli for surgeries to remove the Ultamet from her hip.
Herlihy-Paoli received her Pinnacle hip replacements in 2009. They were removed two years later. Eventually she would have five replacement surgeries on both hips to improve pain and restore function after complications and infections allegedly caused by the metal-on-metal implant. Tests prior to hip implant removal surgery showed, according to court filings, “dangerous levels of cobalt and chromium in her bloodstream”—85 times higher than normal.
For the Plaintiff – “Marketing Run Amok”
Lanier tried to convince the jury that the Pinnacle implants leached the cobalt and chromium material into his client’s bloodstream and that those toxins caused the infection that required the removal of the devices. He also tried to convince the jury that DePuy executives ignored data that showed there was a design flaw with the device and failed to warn patients and surgeons about the risks.
Lanier grilled Pamela Plouhar, the worldwide vice president of clinical research at DePuy, over what studies the company had performed on the implants.
Plouhar reportedly said there was “no human study that looked at” the health effects of metal debris for the Pinnacle hips before 2001. Lanier countered that research as early as 1974 suggested problems with the metal-on-metal devices.
DePuy had followed industry standards, said Plouhar. When asked by Lanier whether the company had done the “necessary studies” on the metal-ion issue to prove the hips were safe, she said they had.
Lanier then called the current chairman of DePuy Synthes’ Orthopedic division, Andrew Ekdahl, for questioning. Ekdahl was the president of DePuy when the products were launched.
Ekdahl said that the company had clarified the risks associated with the device in a brochure addressed to doctors in 2002, and that surgeons were aware of the possibility of metals being leached into patients’ bodies.
Other testimony offered by Lanier included:
- Internal memos (dating back to February 2001) from consulting physician Thomas Schmalzried, M.D., who made the company aware that the device would require extensive testing to see whether metal debris was getting into the bloodstream.
- Internal files from 2012 that showed DePuy officials the Pinnacle hips had a 15% five-year-failure rate.
- 2010 letters from John Irving, M.D., a Connecticut orthopedic surgeon, who said the wave of complications from metal devices is “an epidemic” and that it would be “borderline unethical” to continue to market these products.
“They [DePuy executives] didn’t tell people they were basically guinea pigs, ” and “marketing run amok, ” was responsible for thousands of injuries to patients, Lanier reportedly told jurors.
For the Defense – Surgeon Error
Richard Sarver, DePuy’s lead lawyer who also won DePuy’s first ASR hip verdict in Chicago last year, reportedly told jurors the “exaggerated” complaint about the DePuy Pinnacle’s marketing was nothing more than a “smokescreen” designed “to make you mad.”
Sarver blamed the surgeon, arguing that Herlihy-Paoli’s issues were related to the surgical positioning of the hip implants in her body, rather than inherent design flaws.
He told jurors during closing arguments that overwhelming evidence showed the implants were placed in a position that made it “impossible for them to function properly…If you place a cup in the wrong position, which is what happened here, bad things happen.”
He said the device did not fail and the plaintiff’s lawyers never identified a specific flaw that caused her injuries and that Herlihy-Paoli’s active lifestyle may have exacerbated any problems.
DePuy executives also disclosed the risks of the metal-on-metal hips to both FDA regulators and orthopedic surgeons, Sarver told jurors.
“They don’t want to know the truth because it destroys their case, ” Sarver said of Herlihy-Paoli and Lanier.
The jurors agreed with Sarver.
Lanier’s “Long War”
“It’s the first battle in a long war, ” Lanier reported said outside the courtroom after the verdict was announced.
“A defense verdict in the first bellwether case, tried by Mark Lanier, one of the nation’s premiere plaintiffs’ lawyers, does not augur well for the other 6, 000-plus Pinnacle hip cases, ” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview with Bloomberg.
Joseph Saunders, a personal injury lawyer representing other metal-on-metal plaintiffs wrote on October 24 that juries are different in each case and it is impossible to predict how they might rule. “In this case the jury heard a vigorous defense from [DePuy’s] lawyers differing from the defenses used earlier in the ASR cases. They argued aggressively that design flaws in the Pinnacle did not cause the plaintiff’s injuries; rather surgeon error was to blame for her ailments.”
“The defense in this case also argued more forcefully that the Pinnacle had been ‘thoroughly tested’ and ‘closely monitored’ for design defects and the company properly marketed the devices.”
Saunders said the jury in this bellwether case seemed to react to the defense’s argument that surgeon error was the cause of Herlihy-Paoli’s injuries. “Arguing that the incompetence of orthopedic surgeons is to blame in over 6, 200 cases will be a difficult strategy to maintain.”
Aside from the Pinnacle and ASR, metallosis and premature failure have exposed other manufactures of metal-on-metal hip joints. Biomet, Zimmer, Stryker, Smith & Nephew, and Wright Medical, are facing suits over metal-on-metal implants.
Metal-on-Metal and the FDA
The FDA cleared the metal Pinnacle hips for sale in the U.S. through the 510(k) process and the company began selling the product in 2005.
On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement systems to conduct postmarket surveillance study of the devices. Five manufacturers were marketing metal-on-metal hip implants in the U.S. and all five had approved postmarket surveillance study plans. Data from these studies provided patients and healthcare providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
The FDA then undertook an unprecedented national and international effort to gather all available information, including the clinical information discussed during a June 2012 Orthopedic and Rehabilitation Devices Advisory Panel Meeting, about currently marketed MoM hip implants.
The agency sought expert scientific and clinical opinion on the benefits and risks of MoM hip implants and asked specifically for the following information:
- Failure rates and modes
- Metal ion testing
- Imaging methods
- Local and systemic complications
- Patient risk factors
- Considerations for follow-up after surgery
Panel members discussed the follow-up of symptomatic and asymptomatic patients with metal-on-metal total hip replacement systems and resurfacing hip systems, the most appropriate patient populations that may be considered candidates for metal-on-metal hip implants, and important labeling considerations.
The FDA undertook the following actions following the meeting:
- Issued a Safety Communication to provide updated safety information and recommendations to patients and health care providers.
- Issued a proposed order on January 17, 2013 requiring manufacturers of MoM total hip replacement systems to submit premarket approval (PMA) applications. MoM total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the agency premarket authority over medical devices. As “pre-amendment devices, ” they were designated as Class III (higher risk) devices but were regulated under the 510(k) premarket notification program.
DePuy Stops Sales
The company stopped selling the metal-on-metal version of the hip in August 2013 after the FDA published its January 2013 safety communication. In that communication the agency warned that metal-on-metal hips were more likely to fail earlier than those made of other materials. The agency went on to say that it would require device makers to submit new versions of the artificial hips for pre-market approval.
Market Pressure
DePuy’s management said that they reached the decision to discontinue metal-on-metal hips not because of safety issues, but because of low clinician use of the devices, the availability of other options that meet the clinical needs of patients, and proposed changes in FDA regulation of the entire class of metal-on-metal products, which included the Pinnacle implants.
Clinician use of ceramic-on-metal and metal-on-metal bearings, said the company, is extremely low and not expected to increase. In the U.S. and Europe in 2012, according to the company, metal-on-metal bearings comprised less than 2% of the bearings implanted. This represents a 90% decline in industry sales since 2007. Consistent with this overall market trend, the DePuy metal-on-metal brands represented less than 1% of DePuy bearings sold in these markets.
Physician use of ceramic-on-ceramic (CoC) bearings, according to the company, is widespread in Europe where, in 2012, CoC represented over one in five bearings used. The company also believes that CoC bearings also have considerable growth potential in the U.S. where new options are coming to market.
Lanier Will be Back
As attorney Saunders said, it will be tough to use the surgeon incompetence defense for the remaining 6, 000+ cases and Lanier is relentless.
Lanier persuaded a federal jury in Louisiana last year to order Takeda Pharmaceutical Co. and Eli Lilly & Co. to pay a combined $9 billion in punitive damages over their handling of the Actos diabetes drug.
He also won the first Vioxx verdict against Merck & Co. in 2005, persuading a state court jury in Texas to award $253 million to the family of a marathoner who had a fatal heart attack after taking the recalled painkiller.
So, it is almost certain that Lanier will be back—if for no other reason than the precedent set by the earlier $2.5 billion ASR settlement with DePuy—a company with very deep pockets.
