Johnson & Johnson Cleared of Witness Tampering in Pinnacle Case
Walter Eisner • Mon, December 18th, 2017
Lawyers representing patients suing Johnson & Johnson’s DePuy Orthopaedics, Inc. over the company’s Pinnacle metal-on-metal hip implant, thought they might have caught the company tampering with a surgeon who was a witness in a trial completed last month in Dallas.
We reported at the time that a federal jury in Dallas ordered the company to pay $247 million to six patients who said they were injured by the Pinnacle implant.
What we didn't know at the time was that in October the federal judge hearing the case had asked federal prosecutors and the FBI to look into possible witness tampering at the trial.
We've now learned that the U.S. Justice Department reportedly closed the investigation and cleared the company.
Mark Lanier, the lead attorney for the Pinnacle plaintiffs, raised the issue of tampering during an October 16 hearing, citing a conversation that took place between a DePuy sales rep and a surgeon who was a witness in the case.
According to an article in MassDevice, the surgeon, David Stein, M.D., said in an affidavit, that he had a conversation with Glen Swajger, the sales rep, to discuss "a procedure requiring [Swajger’s] involvement.”
Stein reportedly said in the affidavit that Swajger warned him of possible “ramifications” to his medical practice “in connection with my upcoming Dallas testimony.”
“Mr. Swajger looked terrible and appeared stressed, so I asked him what was going on,” Stein reportedly said in the affidavit. “He [Swajger] said the day before (October 12, 2017), he had been contacted by the DePuy lawyers and that discussion made him anxious. He said the lawyers were ‘on him like crazy.’ They were putting ‘big-time pressure’ on him.”
Stein's affidavit continues, “He [Swajger] indicated the lawyers were ‘peppering him.’ He said the ‘business in Dallas was freaking [him] out.’ He said he had a ‘terrible’ day on Thursday as a result of this and my going to Dallas was driving him crazy. He said ‘I care about you.’”
In a court filing, DePuy attorneys Jessica Brennan and Michael Zogby denied the tampering allegations, saying that Brennan’s contact with Swajger was limited to brief phone conversations confirming his availability for a conference call to discuss the case.
“At no time during Ms. Brennan’s aforementioned calls to Mr. Swajger, or on Mr. Swajger’s call to her, did she request that Mr. Swajger do anything other than be available for a conference call with the trial team. She certainly did not tell Mr. Swajger to do anything or to communicate with Dr. Stein. She merely explained that the trial team wanted to visit with him, explained why, and worked through the timing of such call given Mr. Swajger’s busy schedule,” according to the filing.
After the company announced that the tampering investigation was closed, it provided a statement to Law360 stating, “DePuy has always known these allegations to be meritless," said Bill Mateja, the lawyer representing Brennan and Zogby.
“We’ve known all along that there was never any evidence of witness tampering on our part, and are not surprised with either the U.S. attorney’s office’s decision or the court’s prior ruling. The issue has now been put to rest here in Texas, and we’re hopeful plaintiffs’ counsel in other products liability cases who have attempted to exploit these patently false accusations against Drinker Biddle, Brennan and Zogby will cease as the assertions are baseless.”
After the latest loss by the company, the score is now 3-1 in favor of plaintiffs with over $900 million in damages.
If Johnson & Johnson decides to settle, it would not be the first time the company settled a metal-on-metal hip case. In 2013 the company reached a $2.5 billion ASR settlement with approximately 8,000 patients.
Metal-on-Metal and the FDA
The FDA cleared the 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 metal-on-metal hip implants.