Lois Eskind's daughter, Eva Sloan, sued Synthes in federal court in Philadelphia on Friday, alleging wrongful death and failure to warn patients such as Eskind about problems with the bone cement. Sloan was joined in the suit by Eskind's husband, Ike, and son, Roger Lee McConnell. The suit did not specify the amount of money being sought.
Eskind died during surgery at the Texas Back Institute in Plano, but she lived in the southeastern Oklahoma town of Antlers. Eva Sloan lived nearby.
"I feel like my mother was murdered," Sloan said Monday. "I wanted to destroy them, and I didn't know any other way. I might only be a bumble bee to them, but I want them to know I'm ticked off. Well, I'm more than ticked off."
When J&J completed the acquisition of Synthes on June 14, it assumed Synthes' legal liabilities. A J&J spokeswoman said by e-mail that the company had not reviewed the suit and declined further comment.
The suit does not name Eskind's surgeon, Barton Sachs, as a defendant but refers to him as a "co-conspirator." Sachs, who now practices in Charleston, S.C., did not respond to an e-mail and telephone call to his office.
As part of the plea bargain, Synthes had to divest itself of all Norian assets. They were sold to Kensey Nash, which then was purchased by Royal DSM, a Dutch life sciences company.
Prosecutors from the U.S. Attorney's Office in Philadelphia showed that Synthes ignored aspects of the U.S. Food and Drug Administration approval and labeling process while promoting the bone cement to surgeons from 2001 through 2004 and teaching them how to use it. Patients were not informed that they were part of what former Synthes consultant Ken Lambert called "human experimentation."
Lois Eskind was the first of three to die on the operating table before Synthes stopped testing of the bone cement. Ryoichi Kikuchi and Barbara Marcelino were the others. They lived in Northern California, and their families filed a joint lawsuit against Synthes in California state court earlier in 2012.
Four Synthes executives were also charged in the criminal case and sent to prison in 2011 after pleading guilty to misdemeanors in 2009. Prison sentences have been unusual in health-care legal cases. After calling the conduct "egregious," Judge Legrome D. Davis sentenced Michael Huggins and Thomas Higgins to nine months in prison, Richard Bohner to eight months, and John Walsh to five months.
Sloan's suit was also assigned to Davis.
Synthes is the market leader in selling plates and rods to fix broken bones. But by 1999, Synthes saw that surgeons were performing high-paying back operations by injecting compounds into vertebrae, even though the FDA had not approved any compounds for that procedure. Doctors are allowed to use drugs and devices "off-label," meaning in ways not on the official FDA label.
Hoping to catch up, Synthes bought Norian Corp., which had an FDA-approved bone cement for use on arm bones and portions of the skull. Evidence in the case showed that Synthes encouraged surgeons it selected to try the procedure in back operations, all the while receiving reports and warnings that the bone cement caused blood clots. A large vein runs through vertebrae on the way to the heart and lungs. Though the deaths could not be attributed directly to the bone cement, all three patients suffered heart attacks shortly after the cement was injected.
One potential legal hurdle for Sloan's suit is the federal statute of limitations, which in such cases is usually five years. Sloan's Philadelphia lawyer, Laura Feldman of Feldman & Pinto, argued in the complaint that the statute should not apply because Synthes failed to tell Eskind's family that it was testing an unapproved device and Sloan only learned of the situation from a reporter in 2011.
"I know I didn't realize it was experimental," Sloan told The Inquirer in 2011. "I guess we assumed it was her heart. But if this could have been caused by a clot, then, well, that's kind of shocking."
Key dates regarding Synthes' bone cement
1958: Four Swiss surgeons gather in Basel, form company to help promote the use of plates and rods to fix broken bones surgically.
1974: Synthes begins U.S. operation in Chester County to sell products in the United States.
1999-2000: Within the growing population of elderly people, many suffer from osteoporosis. Surgeons were injecting bone-fixing compounds into spines to fix vertebrae, though the FDA had not approved any compounds for that procedure. Doctors are allowed to use drugs and devices "off-label," meaning in ways not on the official FDA label.
June 1999: Hoping to catch up to the trend, Synthes buys Norian Corp., which had an FDA-approved bone cement for use in arm bones and portions of the skull.
2000-2002: Synthes seeks input from surgeons about the possibility of using Norian bone cement in vertebral compression fractures, then trains selected surgeons on how to mix the compound in the operating room and inject it into vertebrae. The promotion and unapproved testing on humans is a violation of FDA laws. At the same time, Synthes was getting reports and warnings that the bone cement did not mix well with blood and caused clots.
Jan. 13, 2003: Lois Eskind of Antlers, Okla., dies on the operating table at the Texas Back Institute in the Dallas suburb of Plano. She went into cardiac arrest shortly after Dr. Bart Sachs injected the bone cement into vertebrae.
Sept. 19, 2003: Ryoichi Kikuchi dies on an operating table in Walnut Creek, Calif., under similar circumstances.
Jan. 22, 2004: Barbara Marcelino dies on an operating table in the same clinic in Walnut Creek, but with a different surgeon.
May 2004: FDA inspectors arrive at Synthes' U.S. headquarters in West Chester to investigate.
June 16, 2009: Synthes, the Norian subsidiary, and four executives are indicted by a grand jury after an investigation by the U.S. Attorney's Office in Philadelphia.
Fall, 2010: Synthes and Norian plead guilty to criminal charges and pay $23.5 million in penalties. Synthes must divest Norian as part of a corporate integrity agreement with the federal government.
April 2011: Johnson & Johnson announces agreement to buy Synthes for what turns out to be $19.7 billion.
Fall 2011: After each having pleaded guilty to one misdemeanor, Synthes executives Michael Huggins and Thomas Higgins are sentenced to nine months in prison, Richard Bohner to eight months, and John Walsh to five months.
Feb. 29, 2012: Kikuchi's and Marcelino's families sue Synthes and various executives in state court in California.
July 27, 2012: Lois Eskind's family sues Synthes in federal court in Philadelphia.
Contact David Sell at dsell@ phillynews.com or 215-854-4506. Read his blog at www.philly.com/phillypharma and on Twitter @phillypharma.