A General Electric Co. unit must pay $5 million to an Ohio man who developed a skin disorder tied to the company’s Omniscan contrast agent used in medical tests, a jury ruled in the first verdict over the dye.
Jurors in federal court in Cleveland today found GE Healthcare Inc. liable for Paul Decker’s injuries from the Omniscan dye he received during 2005 tests on his heart, Christopher Tisi, one of Decker’s lawyers, said in a telephone interview. The dye caused an ailment that leads to a hardening of the skin and makes it difficult to move limbs, Tisi said.
“We alleged at trial that GE officials were aware Omniscan could cause this debilitating condition and didn’t properly warn patients and doctors,” Tisi said.
Decker’s case was the first over the Omniscan agent to go to trial, the lawyer said. GE, Bayer AG and Tyco International Ltd., which all made dyes for medical testing that have been found to cause medical problems, have settled about 90 percent of the cases over the products, Tisi said.
GE Healthcare plans to appeal, according to an e-mailed statement. Jurors found the company didn’t provide proper warnings about Omniscan’s health risks, while ruling in the company’s favor on whether the agent was defectively designed.
“We are disappointed in the jury’s decision,” Aleisia Gibson, a spokeswoman for GE Healthcare, said in the statement. “We are pleased, however, that the jury found that Omniscan is not defective.”
Lawyers for Decker and other plaintiffs contend dye makers included the chemical gadolinium in their products. Researchers have found that the substance can cause ailments such as nephrogenic systemic fibrosis (NSF), the disease Decker developed after receiving the Omniscan agent.
The U.S. Food and Drug Administration ordered in May 2007 that U.S. makers of products containing gadolinium include a black-box warning on labels about the dyes’ risks. Such a warning is the agency’s strictest caution.
GE officials contend the FDA approved Omniscan as safe and effective and haven’t demanded that company take it off the market. The argued the contrast agent has been safely used for more than 17 years.
“When used according to its FDA-approved labeling, the benefits of Omniscan far exceed the risks,” Gibson said in the statement.
At one time, GE and other contrast makers faced about 1,000 suits over their products in federal courts around the U.S., Michelle Parfitt, one of Decker’s lawyers, said in a telephone interview today. The cases were consolidated before U.S. District Judge Dan A. Polster in Cleveland for pre-trial information exchanges. “There are only a handful of cases left” after a round of settlements, Parfitt added.
The 61-year-old Decker, a retired production worker for Cooper Tire & Rubber Co. who lives near Toledo, Ohio, said he developed NSF after receiving one dose of Omniscan during a heart test. The disease left him “immobile and dependent on 24-hour care,” his lawyers said in an e-mailed statement after the verdict was announced.
Decker’s attorneys alleged GE officials knew patients with a history of kidney ailments were at a higher risk for developing NSF from Gadolinium-based contrast agents.
After hearing 17 days of evidence and arguments, jurors found GE officials “knew or should have known about a risk to patients with impaired renal function” posed by Omniscan, according to court filings. The company “failed to provide reasonable and adequate” warnings about those risks, the filings said.
The case Decker v. GE Healthcare Inc., 12-gd-50004, U.S. District Court, Northern District of Ohio (Cleveland).