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Hip implants shed metal into body, patients alleged

Amount:

$502,043,868

Type:

Verdict-Plaintiff

State:

Texas

Venue:

Federal

Court:

United States District Court, Northern District, Dallas

Injury Type(s):

hip; other-necrosis

Case Type:

Fraud; Products Liability – Design Defect, Failure to Warn, Medical Devices, Marketing Defect

Case Name:

Donald Greer v. DePuy Orthopaedics, Inc., and Johnson & Johnson Services, Inc., Johnson & Johnson and Thomas P. Schmalzreid, M.D.,
No. 3:12-cv-01672-K

Date:

March 17, 2016

Parties

Plaintiff(s):

Donald Greer (Male, 68 Years), 

Margaret Aoki (Female, 61 Years), 

Pete Peterson (Male, 66 Years), 

Karen Peterson (Female), 

Susan Klusmann (Female), 

Jay Christopher (Male, 44 Years), 

Richard Klusmann (Male, 57 Years), 

Jacqueline Christopher (Female)

Plaintiff Attorney(s):

Richard J. Arsenault;
Neblett, Beard & Arsenault;
Alexandria,
LA,
for
Donald Greer, Margaret Aoki, Pete Peterson, Jay Christopher, Richard Klusmann ■ Ernest H. Cannon;
Ernest Cannon & Associates;
Stephenville,
TX,
for
Donald Greer, Margaret Aoki, Pete Peterson, Jay Christopher, Richard Klusmann ■ Mark Lanier;
Lanier Law Firm;
Houston,
TX,
for
Donald Greer, Margaret Aoki, Pete Peterson, Jay Christopher, Richard Klusmann ■ Jayne Conroy;
Simmons Hanly Conroy;
New York,
NY,
for
Donald Greer, Margaret Aoki, Pete Peterson, Karen Peterson, Susan Klusmann, Jay Christopher, Richard Klusmann, Jacqueline Christopher

Plaintiff Expert(s):

Al Burstein; Ph.D.; Biomechanical; Reno,
NV called by:
Richard J. Arsenault, Ernest H. Cannon, Mark Lanier ■ Pat Campbell; Ph.D.; Engineering; Los Angeles,
CA called by:
Richard J. Arsenault, Ernest H. Cannon, Mark Lanier ■ Matt Morrey; M.D.; Orthopedic Surgery; San Antonio,
TX called by:
Richard J. Arsenault, Ernest H. Cannon, Mark Lanier ■ Tony Nargol; FRCS; Orthopedic Surgery; called by:
Richard J. Arsenault, Ernest H. Cannon, Mark Lanier ■ Bernard Morrey; M.D.; Orthopedic Surgery; San Antonio,
TX called by:
Richard J. Arsenault, Ernest H. Cannon, Mark Lanier ■ Richard Kearns; M.D.; Orthopedic Surgery; Houston,
TX called by:
Richard J. Arsenault, Ernest H. Cannon, Mark Lanier ■ Nicholas Athanasou; M.D., Ph.D.; Pathology; called by:
Richard J. Arsenault, Ernest H. Cannon, Mark Lanier ■ Minette (Meme) Drumwright; Marketing; Austin,
TX called by:
Richard J. Arsenault, Ernest H. Cannon, Mark Lanier

Defendant(s):

Johnson & Johnson, 

DePuy Orthopaedics Inc., 

Thomas P. Schmalzreid, M.D., 

Johnson & Johnson Services Inc.

Defense Attorney(s):

Michael V. Powell;
Locke Lord LLP;
Dallas,
TX,
for
Johnson & Johnson, DePuy Orthopaedics Inc. ■ Richard E. Sarver;
Barrasso, Usdin, Kupperman, Freeman & Sarver, L.L.C.;
New Orleans,
LA,
for
Johnson & Johnson, DePuy Orthopaedics Inc. ■ Steven W. Quattlebaum;
Quattlebaum, Grooms, Tull & Burrow;
Little Rock,
AR,
for
Johnson & Johnson, DePuy Orthopaedics Inc.

Defendant Expert(s):

Cato Laurencin;
Orthopedics;
Farmington,
CT called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum ■ Aaron Waxman;
Pulmonology;
Boston,
MA called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum ■ Brian Haas;
Orthopedic Surgery;
Denver,
CO called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum ■ Roger Emerson;
Orthopedic Surgery;
Dallas,
TX called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum ■ Scott Nelson;
Pathology;
Los Angeles,
CA called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum ■ Donald Belsito;
Allergy/Asthma/Immunology;
New York,
NY called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum ■ Edward Boyer;
Medical Toxicology;
Boston,
MA called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum ■ Matthew Heinrich;
Orthopedic Surgery;
Austin,
TX called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum ■ Timothy Ulatowski;
FDA Regulatory Affairs;
Washington,
DC called by:
Michael V. Powell, Richard E. Sarver, Steven W. Quattlebaum

Facts:

Between 2004 and 2010, plaintiff Richard Klusmann, 57, a hospital chief executive officer; plaintiff Jay Christopher, 44, an electrician; plaintiff Donald Greer, 68, a retired physician; plaintiff Margaret Aoki, 61, an editor; and plaintiff Pete Peterson, 66, a rancher and retired Navy SEAL, each underwent hip arthroplasty, or replacement of a hip joint, with a Pinnacle prosthetic hip implant manufactured by DePuy Orthopaedics Inc., a wholly owned subsidiary of Johnson & Johnson. Each of the patients underwent revision surgery within three to seven years. The original implant in each case had a metal, cobalt-chromium liner, called the UltraMet liner, which was intended to help the implant last longer than others on the market. DePuy and Johnson & Johnson sold the Pinnacle implant with UltaMet liner from 2002 to 2013. All the plaintiffs were Texas residents. The surgeon who implanted Greer’s original implant was Dr. Thomas P. Schmalzreid. The plaintiffs sued DePuy, Johnson & Johnson and Johnson & Johnson Services Inc. on theories of strict products liability, alleging that the companies sold a product that was defectively designed and marketed. They also claimed the Johnson & Johnson entities were liable on theories of aiding and abetting DePuy, negligent undertaking, and commercial bribery. The plaintiffs, in addition, alleged gross negligence and fraud. Greer also sued Schmalzreid, but the doctor was nonsuited or dismissed long before trial. Johnson & Johnson Services Inc. was not submitted to the jury. Each of the plaintiff patients had filed suit separately. In May 2011, a multidistrict litigation that included these cases was formed under the name In Re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation. The multidistrict litigation currently includes about 8,000 cases, most of which involve the Pinnacle implant with UltaMet liner. The plaintiffs contended that the implant was defectively designed because the metal liner rubbed against the metal femoral-head component and thereby shed metal debris into the bloodstream and surrounding tissue, resulting in severe complications. The lawsuit argued that DePuy and Johnson & Johnson started selling the implant without having tested it on humans. They tested it using machines and determined how much metal wore off, the plaintiffs alleged, but never investigated the effect that this metal debris would have on a human being. According to the plaintiffs’ biomechanical engineering expert, at the time that the plaintiffs received the metal-lined implants, an implant with a highly cross-linked polyethylene liner was available and was a safer alternative design. DePuy, the expert said, represented the metal-lined implant as achieving minimal wear, due to full fluid film lubrication, a representation that he said was neither true nor based on adequate testing. The plaintiffs had four orthopedic experts who testified that, at the time they received their metal-lined implants, highly cross-linked polyethylene was available and was a safer alternative design. One of these experts said that there was no reason for the defendants to believe that the Ultamet metal-lined implant would be any better than the first generation of metal-lined implants, which were used in the 1960s and 1970s and were inadequate. The plaintiffs’ orthopedic expert, Dr. Tony Nargol, testified that he had alerted DePuy very early on about failures that he and others were seeing in patients with the company’s metal-lined implants, and that DePuy not only failed to heed, but actively resisted, his warnings. Although the Pinnacle implant with UltaMet liner was never recalled, DePuy’s other metal-lined hip implant product, which is called the ASR, was recalled, in 2010. The plaintiffs said the ASR recall prompted DePuy and Johnson & Johnson to redouble their marketing of the defective Pinnacle implant with UltaMet liner, in order to make up for lost sales of the ASR. The plaintiffs further alleged that DePuy and Johnson & Johnson assured surgeons that the Pinnacle implant with UltaMet liner was safe; that DePuy and Johnson & Johnson failed to warn of the risk of complications from unsafe levels of cobalt and chromium in the bloodstream; and that they kept reports of adverse events artificially low by training their sales force not to report revision surgeries as adverse events. Even so, out of about 150,000 Pinnacle implants with UltaMet liner that were sold, the Food and Drug Administration received more than 1,300 adverse event complaints, plaintiffs’ counsel said. The plaintiffs’ marketing expert opined that the defendants failed to be truthful in their marketing of the design attributes of the metal-lined implant. He said physicians do pay attention to marketing, especially when it is disseminated through sources that appear to have scientific legitimacy, such as scientific literature and physician peers. The plaintiffs also alleged that DePuy, in an act of commercial bribery, retained and paid one of Klusmann’s and Aoki’s treating physicians as an expert at some point during litigation, with the understanding that it would influence his conduct in relation to the patients. According to plaintiffs’ counsel, defense counsel demanded that Klusmann and Aoki have no contact with their doctor after the defense retained him. Plaintiffs’ counsel argued that commercial bribery flowed from the inappropriate interference with the doctor-patient relationship by defense paying Heinrich as an expert, and then telling the patients not to speak with him. The defense denied that the product or its marketing was defective in any way and said its performance was excellent. Defense orthopedic expert Dr. Cato Laurencin opined that the marketing efforts of medical-device companies do not affect orthopedists’ treatment decisions. The defense expert on Food and Drug Administration regulatory matters opined that the defendants acted reasonably and that they complied with the FDA regulations that were in effect at the time of the device’s launch and thereafter. According to the defense, DePuy and Johnson & Johnson stopped selling this implant because lawyers ran advertisements saying that the product was defective, which in turn made surgeons and patients unwilling to trust it.

Injury:

The plaintiffs claimed that the product caused painful complications, including inflammation and death of tissue and bone near the implant, as well as metallosis, or toxic concentrations of metal in the bloodstream. Klusmann’s tissue damage was more extensive than that of the other plaintiffs. All five plaintiffs underwent replacement of the implant, and several of them claimed that the pain continued. They each claimed additional surgery might be necessary, followed by use of a wheelchair or crutches for some time. At a minimum, they claimed, they would need physical therapy, eventually. The plaintiffs’ pathology expert opined that Aoki, Greer, Klusmann and Peterson sustained extensive tissue necrosis and that all the plaintiffs experienced adverse reactions to Cobalt-Chromium "wear particles," or particles worn from the metal implant components. For past medical bills, Klusmann sought $144,000; Christopher sought $41,000; Greer sought $26,000; Aoki sought $41,762; and Peterson sought $25,995. For future medical bills, they sought the same amounts as for past medical bills. They sought unspecified damages for past and future physical pain and mental anguish, disfigurement and physical impairment, as well as punitive damages. The wives of Christopher, Klusmann and Peterson were also plaintiffs and sought unspecified damages for past and future loss of household services and loss of consortium. According to the defense’s pathology expert, and defense orthopedic expert Dr. Roger Emerson, who examined the plaintiffs, the implants failed for reasons other than the implants themselves. According to these experts, Greer’s implant failed because he had sarcoidosis (an inflammatory disease), and the defense’s pulmonologist and immunologist agreed. Christopher’s implant failed because of hemarthrosis (bleeding into a joint), the pathologist and orthopedist said. Aoki’s implant failed because of joint-tissue laxity, which led to excessive wear. Peterson’s failed because of a recurrence of an osteolytic cyst. Finally, the pathologist and orthopedist opined, Klussman’s failed because he was hypersensitive or allergic to metal. The defense’s toxicology expert opined that exposure to cobalt/chromium at the level that the plaintiffs experienced is not toxic. The defense retained an engineering expert to testify about implant wear, and she said that Klusmann’s, Greer’s, Christopher’s, and Peterson’s implant wear was too low to be the cause of their revisions. Aoki had a high degree of wear, but it was due to her joint tissue laxity and not the implant, the expert said.

Result:

The jury found that there were design and marketing defects attributable to DePuy as to all five patients; that Johnson & Johnson was in the business of selling the product and participated in its design; that, as to Aoki only, Johnson & Johnson actually knew of the defect when it supplied the product to her; that Johnson & Johnson negligently undertook a duty to provide services to DePuy that proximately caused the patients’ injuries; that Johnson & Johnson knowingly gave substantial assistance or encouragement to the tortious conduct of DePuy, and this assistance and encouragement was a substantial factor in causing the patients’ injuries; and that DePuy and Johnson & Johnson committed gross negligence and fraud as to all five patients. The jury did not find that DePuy intentionally or knowingly offered, conferred or agreed to confer a benefit on Klusmann’s and Aoki’s doctor on the agreement or understanding that the benefit would influence his conduct in relation to Klusmann’s and Aoki’s affairs. The jury awarded the plaintiffs actual and punitive damages totaling $502,043,868. The Klusmanns’ damages were $170,000,432; the Christophers’ were $75,000,600; Greer’s were $90,002,876; Aoki’s were $74,999,960; and the Petersons’ were $92,040,000. The jury awarded all of the past and future medical bills that the plaintiffs sought. For physical pain and mental anguish, the award to Klusmann was $7,084,022 past and $11,806,703 future; the award to Christopher was $2,128,893 past and $4,967,417 future; the award to Greer was $7,487,719 past and $7,487,719 future; the award to Aoki $2,237,471 past and $5,220,767 future; and the award to Peterson was $4,552,592 past and $10,622,713 future. For physical impairment, the award to Klusmann was $7,084,022 past and $11,806,703 future; the award to Christopher was $2,128,893 past and $4,967,417 future; the award to Greer was $7,487,719 past and $7,487,719 future; the award to Aoki $2,237,471 past and $5,220,767 future; and the award to Peterson was $4,552,592 past and $10,622,713 future. For disfigurement, the award to Klusmann was $4,722,681 in the past and the same in the future. For punitive damages, the award to Klusmann was $40 million as to DePuy and $80 million as to Johnson & Johnson. The award to each of the other plaintiffs was $20 million as to DePuy and $40 million as to Johnson & Johnson. For loss of household services, the award to Klusmann’s wife was $1,242,810; the award to Christopher’s wife was $373,490; and the award to Peterson’s wife was $798,700. The awards for 1oss of consortium were the same as for loss of household services. This trial was the second bellwether trial in the multidistrict litigation. The first one also involved Pinnacle implant with UltaMet liner and ended in a defense verdict in October 2014.

Trial Information:

Judge:

Ed Kinkeade

Trial Length:

10
 weeks

Trial Deliberations:

5
 days

Jury Vote:

9-0

Jury Composition:

1 male/ 8 female

Post Trial:

The defense moved for judgment as a matter of law. The plaintiffs filed a motion to set aside the cap on punitive damages as unconstitutional. If the cap applies, then it reduces Klusmann’s punitives to $1,326,000; Christopher’s to $872,000; Greer’s to $854,000; Aoki’s to $917,048; and Peterson’s to $853,980. Combining these figures with the actual damages results in a total of $146,866,935.70.

Editor’s Comment:

This report is based on information that was provided by plaintiffs’ counsel. Defense counsel did not respond to the reporter’s phone calls.