Lois Eskind died on Jan. 13, 2003 when she went into cardiac arrest moments after bone cement made by Synthes and its then-subsidiary Norian was injected into Eskind's spine by Dr. Bart Sachs at the Texas Back Institute in the Dallas suburb of Plano.
Eskind's family filed a wrongful death and negligence suit against Synthes and Norian in federal court in Philadelphia on Friday, while alleging Sachs was a co-conspirator.
Eva Sloan is Eskind's daughter and Sloan is the lead plaintiff, but was joined by her brother and Eskind's husband, Ike.
Synthes, which was founded in Switzerland and had a U.S. headquarters in West Chester, is now part of Johnson & Johnson.
Synthes, Norian and four company executives pleaded guilty to criminal charges stemming from a 2009 indictment brought by the U.S. Attorney's Office in Philadelphia. As part of settlement with the government, Synthes had to sell all Norian assets to Kensey Nash, which has since become part of Dutch life sciences company, Royal DSM.
Federal prosecutors showed 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 to use it in surgeries.
Three patients died on the operating table in the unapproved and illegal clinical trials in 2003 and 2004.
Lois Eskind was the first of the three. Ryoichi Kikuchi and Barbara Marcelino were the second and third people to die. They lived in Northern California and their families filed a joint lawsuit against the company and named executives in California state court earlier in 2012.
The legal case was unusual because four executives went to prison, which is rare in health-care fraud cases.
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, according to court records.
One potential hurdle for Eskind's family is the federal statute of limitations in such cases is usually five years.
Eva Sloan's Philadelphia attorney Laura Feldman of Feldman and Pinto argued in the complaint that the statue should not apply because Synthes' failed to tell Eskind's family that it was testing an unapproved device and Eva Sloan only learned of situation from a reporter in 2011.
A link to that Philadelphia Inquirer story from 2011 is here.