Scrutiny of defibrillator defects grows.

Since the FDA announced recalls for 11 models of implantable defibrillators made by Guidant Corp. in July 2005, nearly 400 cases have been filed against the company, and the FDA and the Department of Justice have launched investigations. Now, additional recalls and unsealed documents point to more problems.

The defibrillators, which are implanted in the patient's chest, are intended to shock an abnormal heartbeat back to a normal rhythm, but defects cause them to issue shocks when they are not needed or prevent them from working when they are needed.

Lawsuits have asserted that Guidant knew certain defibrillators were defective and fixed the problem in later versions--but continued to sell the older models still on shelves. (See Allison Torres Burtka, Implanted Defibrillators Linked to Patient Deaths and Injuries, TRIAL, Oct. 2005, at 14.) New York Attorney General Eliot Spitzer filed suit against the company in November, saying it concealed information about flaws.

On June 23, Boston Scientific Corp. (which acquired Guidant) notified doctors and patients that it was recalling seven types of pacemakers and defibrillators from hospitals and sales inventory because a defective electrical component may cause malfunctions. The company said five malfunctions have been reported out of the approximately 27,200 such devices implanted in patients.

Meanwhile, documents obtained in a Texas lawsuit and made public in June suggest that Guidant considered disclosing some defects earlier but opted not to. Judge Jack Hunter released nearly 400 pages of documents that had been designated confidential and that plaintiffs had sought to unseal. (Motal v. Guidant, No. 05-3377-C (Tex., Nueces County Dist. Ct. June 5, 2006).) The case is set for trial on September 18.

The New York Times, which also filed motions to disclose the documents, reported that those released include a letter and memo that Guidant had drafted but never sent and an internal FDA memo that "indicates that agency officials believed that Guidant was playing down the risks posed by the devices." (Barry Meier, Papers Show Guidant Considered Warning Doctors of Hazards, N.Y. Times, June 7, 2006.)

In the fall of 2004, the company drafted a memo for sales representatives explaining why it was asking them to return unsold inventory of two types of defibrillators, according to the Times report. Then, in January 2005, it drafted a "dear doctor" letter saying that these models had an electrical flaw and that it had taken back all the devices not yet implanted in patients--but it had sold most of its inventory by then, the report says. Guidant never sent the memo or the letter.

"This clearly demonstrates what we've been saying all along--that Guidant has been playing fast and loose with people's lives," said Paul Pennock, a New York City lawyer and member of a plaintiff steering committee for a multidistrict litigation against Guidant. (In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., No. MDL-1708 (J.RM.L transferred to D. Minn. Nov. 7, 2005).)

Pennock estimated that 11,000 people had defective defibrillators implanted after Guidant knew about the defects and before the recalls. He said the documents represent a "basis of knowledge that goes backward and forward, so they should be admissible in all cases," regardless of when the device was implanted in the patient. The documents also apply to cases involving defective models other than those mentioned, because they reveal the company's misconduct, he added.

Teresa Toriseva, cochair of ATLA's Heart Devices Litigation Group, agreed. "This is critical for punitive damages," she said. "Guidant will be hard-pressed to now say their motives were pure."

Pennock said the documents will make cases against Guidant easier to try, and they may make the company more likely to settle. "They're out of their minds if they don't quickly come to terms with what they've done," he said.

In December 2005, the FDA announced that 67 clinical failures, including 7 deaths, had been reported worldwide involving three models that were part of the July recall.

Some patients and doctors have chosen to remove implanted devices; others have left them in to avoid risky surgery. Patients seeking replacements have criticized Guidant for providing only a new device and $2,500. Critics say that amount is a fraction of what the procedure costs, and Medicare and private insurers are picking up the rest of the tab.

If Guidant had told patients and doctors about the problems earlier, Toriseva said, "a great number of patients could have avoided the ordeal."

Guidant announced in March that it had received a report from an independent panel it convened to review its Cardiac Rhythm Management unit's practices.

"The panel has presented Guidant with a blueprint for improvement and enhancement of our postmarket evaluation of product reliability and communications procedures regarding the performance and safety of our devices," said James Cornelius, Guidant's chairman and CEO, in a press release.

"We intend to implement the recommendations to further benefit patients and physicians," he said. One of the panel's recommendations was to establish an external committee of experts.

In April, the New York Times reported that the FDA planned to strengthen its oversight of heart devices by expanding an existing advisory panel. (Barry Meier, F.D.A. Plans to Intensify Oversight of Heart Devices, N.Y. Times, Apr. 7, 2006.)

The Heart Rhythm Society, a group of cardiac physicians and related professionals, released comprehensive guidelines for the surveillance, analysis, and performance reporting of pacemakers and defibrillators in April. The society called for better systems to identify malfunctions and notify physicians and patients about them, and for both manufacturers and the FDA to establish independent expert committees.

Guidant's June 23 letter to doctors said, "Consistent with Heart Rhythm Society and independent panel recommendations for timely, transparent, and responsible actions, Guidant is taking this product retrieval action before our investigation is complete and prior to finalizing patient care recommendations."