In an adverse event form later filed with the FDA, according to press release by the law firm handling the case, Guidant admitted that the defibrillator short-circuited and that the failure directly contributed to Mr Gohde's death.
"Guidant has an ethical responsibility and duty to its patients and their physicians for ensuring the safety of their implantable heart defibrillators," said Tara Sutton, Mr Gohde's attorney, of the law firm, Robins, Kaplan, Miller & Ciresi LLP.
"Mr. Gohde's death could have and should have been prevented, and this complaint serves as a notice that such conduct is not acceptable," Ms Sutton stated.
"They admitted to hiding a life-threatening defect in these defibrillators for three years," the press release said, "while continuing to sell them."
Another lawsuit suit filed in March 2006, involves Donald Whitting, of Norwalk, Conn, who received a 1298 Insignia pacemaker in September 2004, and died just two days later. Whitting's pacemaker model was recalled a year later in September 2005. This lawsuit also alleges Guidant should have informed patients about the dangers posed by the devices after hearing about the risks as far back as 2003.
According to the latest reports, "Guidant is facing approximately 60 state and federal class actions and about 145 individual lawsuits, many of which have been consolidated in a multidistrict proceeding, and has been informed of another 2500 individual claims that have not yet been filed," says Attorney Victoria Davis, a partner in the product liability group of Alston + Bird LLP in Atlanta, in the May/June issue of Medical Device Link.
"These lawsuits characteristically set forth claims for punitive damages for alleged willful, wanton, or deliberate acts," she explains.
Ms Davis also discussed the numerous regulatory investigations. "Fines could theoretically be imposed by multiple state and federal regulatory entities if violations are found," she says.
"On top of these financial concerns," she notes, "you have to take into account the costs of managing the public relations and investor relations regarding the recall, the lawsuits, and the regulatory investigations, and these costs can be significant as well."
Legal experts say punitive damages are bound to be a major concern for Guidant as well, because depending on the region of the country where a case originates; many punitive damage awards are not covered by insurance.
According to attorney, Brooks Magratten, of Vetter & White, in Providence, RI, in the January/February issue of MX, whether insurance coverage is allowed for punitive damages varies from state to state and many of the most populated states like California, Florida, Illinois, New Jersey, New York, and Pennsylvania, prohibit insurance coverage for punitive damages.
In those states, Mr Magratten says, no insurance carrier is permitted to reimburse a company for any punitive damages under the theory that punitive damages are intended to punish the wrongdoer and insurance thwarts the sting of the punishment.
Another issue of debate that will likely arise, experts say, involves the federal defense of preemption. Guidant will argue, they predict, that state law claims are preempted by federal law since the devices were subject to the FDA's premarket approval process.
But experts say they have serious doubts about the success of a preemption defense in this case. "If reports that Guidant knowingly distributed defibrillators that had known defects and deliberately did not disclose this to physicians are true, it does not seem like the Guidant experience is the poster child for seeking to extend preemption protections," says Genese Kay Dopson, special counsel at Sedgwick, Detert, Moran & Arnold LLP, in the May/June 2006 issue of MX.
On June 6, 2006, Texas Judge Jake Hunter, unsealed more documents containing information about Guidant's recalled defibrillators, saying he did not trust the company's claims that they contain trade secrets and an appeals court denied Guidant's challenge of the ruling