Lawyers circle as St. Jude struggles with regulators

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St. Jude Medical ($STJ) is already facing scores of suits over its now-recalled Riata leads, but new concerns over the next-generation Durata devices have piqued the interest of attorneys on the hunt.

TorkLaw, which already represents Riata patients in 15 states, is looking to expand its base of clients who suffered injury from the eroding leads, and, in light of the FDA's January warning letter over St. Jude's Durata-making plant, the firm sees fresh opportunity with the newer devices.

"The FDA makes it very clear that their month-long inspection resulted in pinpointing the systematic failure of St. Jude Medical to follow approved manufacturing processes, proper monitoring, analysis, quality control and testing," Senior Partner Reza Torkzadeh said in a statement. "That is not acceptable."

Last quarter, St. Jude reported $27 million in charges related to litigation for its implants business, and that number could move north in 2013 as the company faces a shareholder suit, accusing management of withholding information about the FDA's concerns with St. Jude's manufacturing. Back in October, CEO Dan Starks disclosed that the company had been chided by the agency but failed to mention that Durata was at issue.

Since then, St. Jude has faced mounting rumors that Durata would get yanked off the market like its predecessor, which have been amplified by a recent study sponsored by Medtronic ($MDT) finding that Durata's proprietary polymer insulation--the change that sets it apart from Riata--could break up in the body within 6 years.

But the company is still looking ahead to a sunny 2013, projecting net income growth of up to 35%, and Starks has dismissed the talk of a Durata recall, touting third-party data that pegs the device's 5-year survival rate at 98.7%.

- read the firm's announcement

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