Invacare, FDA: 'A lot of back and forth'

Thursday, January 5, 2012

ELYRIA, Ohio - Invacare and the U.S. Food and Drug Administration (FDA) are still trying to hammer out an agreement to address concerns with the company's corporate headquarters and wheelchair manufacturing facility here.

"The negotiations can take a couple of months," said Lara Mahoney, director of investor relations and corporate communications. "It could be sooner or later than that. There's a lot of back-and-forth that happens."

Invacare announced last month that the FDA has proposed it suspend certain operations at the facilities until the company makes changes to its operations.

While in negotiations, Invacare continues to boost its compliance efforts: Last week, it announced it has named Doug Uelmen senior vice president, quality assurance and regulatory affairs. Uelmen has successfully led remediation efforts in his previous positions with GE Healthcare and Abbott Laboratores.

Invacare also continues to manufacture products, Mahoney said.

"We're in full production," she said.

Since Invacare announced that it would work with the FDA to negotiate an agreement, called a consent decree, at least half a dozen law firms have announced investigations on behalf of shareholders. All of their releases have similar verbiage:

"(Insert name of law firm here) is investigating potential claims against the board of directors of Invacare concerning the company's failure to comply with the federal regulations in its wheelchair manufacturing business," reads one. "Our investigative concerns whether the board of directors has breached its fiduciary duties, mismanaged the company and/or wasted corporate assets at the expense of shareholders."

Such releases are "fairly typical" for publicly traded companies whose stocks suffer a dramatic decline, Mahoney said. Invacare saw its stock price drop from $20.58 to $14.70 on Dec. 8. It was $15.63 on Jan. 4.

"I have been on the phone with different investors and shareholders, and what we've been talking to them about is that we're taking the situation seriously and that we've hired outside consultants to help," she said. "We've been available to answer their questions."