West Chester Company Penalized for Unlawful Clinical Trials
The Philadelphia Daily News reported in a story that Synthes, Inc., a medical-device manufacturer in West Chester (as well as one of its subsidiaries and four company executives), was charged by a federal grand jury for allegedly scheming to conduct clinical trials using a bone cement on spinal fractures without the approval of the FDA.
Synthes Inc. specializes in trauma products and devices to treat damaged bone. According to the article, from May 2002 into fall 2004, a subsidiary, Norian Corp. conspired with Synthes and four Synthes executives to conduct unauthorized clinical trials of a bone cement called Norian SRS and Norian XR in surgeries to treat vertebral-compression fractures of the spine.
The article stated that the surgeries were performed despite a warning on the FDA-cleared label for Norian XR against this use. Before the marketing program began, the company knew that the bone cement reacted chemically with human blood in a test tube to cause blood clots. Despite knowing this, the company proceeded to market the defective product Norian XR for vertebral-compression fractures, and didn’t stop until three patients died on the operating table.
The patients were dependents of people serving in the U.S. military and died of hypotension, or a rapid drop in blood pressure.In January 2004, Norian and Synthes did not recall Norian XR from the market after the third patient died. Instead, they tried to cover up the details of the patient deaths by lying to FDA regulators during an official inspection in May and June 2004.
Norian was charged with 52 felony counts, including conspiracy, making false statements, and shipping adulterated and misbranded Norian XR with intent to defraud. Synthes was charged with 45 misdemeanor counts of shipping adulterated and misbranded Norian XR. Four Synthes executives were each charged with one misdemeanor count of shipping adulterated and misbranded Norian XR.
The families of these patients who died because of these clinical trials would be well advised to contact a wrongful death attorney. When needless death occurs due to negligence of another party, wrongful death lawsuits can be filed. In these lawsuits, the decedent’s heirs sue the negligent party or parties for damages related to the loss of life and their own pain and suffering. It is recommended that families who think their family member’s death was wrongful first contact a wrongful death attorney for a case assessment. If the case is valid, the attorney can help investigate the claim, gather evidence, represent them in court, and collect the compensation they deserve.
The attorneys at Cherry, Fieger, Marciano, understand the devastating impact a Pennsylvania wrongful death can have on a family. They can help you find justice and compensation for your loved one’s death. Your case consultation with one of the experienced Philadelphia wrongful death attorneys is free of charge and completely confidential.
