Chicago Injury Law Blog

"Boston Scientific Corp. said it agreed to settle all pending federal lawsuits against the company alleging harm from faulty defibrillators and pacemakers for $195 million, well below the sum the company had estimated as its likely liability.

The company acquired liability for the suits through its 2006 acquisition of Guidant Corp., which was forced to recall more than 100,000 cardiac-assist devices in 2005. One of its defibrillator models occasionally failed to deliver lifesaving shocks to the heart when needed.

Several attorneys representing plaintiffs declined to comment, saying they were subject to a judge's order not to speak.

Guidant already has settled some cases brought on behalf of patients who died. The vast majority of pending cases -- about 1,850, covering more than 5,000 individuals -- were brought by patients who had their devices removed because of the Guidant recalls, complaining that the company waited too long before informing them and doctors of the flaw."

For Full article, http://online.wsj.com/article_email/SB118436796413866300-lMyQjAxMDE3ODE0NTMxNjU3Wj.html

"Medtronic has voluntarily suspended shipments of its emergency-response external defibrillators made by its subsidiary, Physio-Control Inc, at its Redmond, WA facility. Physio-Control makes external defibrillators and other emergency-response products. Medtronic opted to suspend delivery of products after "quality system issues" were identified, a press release notes."

Read more here.

The Medtronic heart device multidistrict litigation court on Nov. 28 denied the defendant’s motion to find that any of the claims involving implantable cardiodefibrillators (ICD) are preempted.
This is a victory for all plaintiffs with drug and medical device claims.  The drug and medical device industry is on a well funded mission to preempt all state consumer protection laws with more favorable federal laws.

"Millions of chest pain and heart attack sufferers thought they were getting a phenomenal medical advance when tiny coils that ooze medicine were placed in their arteries to keep them from squeezing shut again.

These gizmos, called drug-coated stents, worked so much better than plain old metal ones that 6 million people worldwide received them in the few years they have been available. It was a modern record for any medical device.

Now their long-term safety is in question."

"Millions of Americans could be walking around with tiny time bombs in their hearts. The concern centers on devices called drug-eluting stents. Doctors implant them in the hearts of about a million Americans a year to treat coronary artery disease. They generate some $5 billion a year in sales for the two companies that make them. But they may be doing more harm than good.
Next month a panel of experts will try to advise the Food and Drug Administration on what to do about it. But many top doctors and scientists admit they are in uncharted waters with a frightening problem that was largely unanticipated. By one estimate the devices already kill 2,000 Americans a year — and no one knows what the long-term danger will be."

Read the full story at MSNBC.com

The pending litigation involving defective heart devices made by Guidant recently revealed that Guidant actually drafted a letter to doctors in 2005 warning them of potential problems with certain devices.  The problem?  It was never sent. 
Company documents reveal that the January 2005 letter included notice of Guidant's intention to pull back devices that had not been already implanted.  The "Dear Doctor" letter is a mode of informing doctors of changes in drug labeling, warnings, and new benefits, used by all drug companies and medical device manufaturerers.  Unfortunately for the consumers who continued to receive the defective devices, Guidant made a concious decision not to send the letter, putting additional lives at risk.

On June 26, 2006, Boston Scientific, which acquired Guidant in April, 2006, announced the recall of a new subset of pacemakers, cardiac resynchronization pacemakers and implantable cardioverter defibrillators from its sales force and hospital inventories. The new subset includes INSIGNIA and NEXUS pacemakers, CONTAK RENEWAL TR/TR2 cardiac resynchronization pacemakers, and VENTAK PRIZM 2, VITALITY, and VITALITY 2 implantable cardioverter defibrillators. According to Guidant's June 23, 2006, Dear Doctor Letter titled, "Urgent Medical Device Safety Information and Corrective Action." a problem with a supplier's low voltage capacitor was "not performing to the company's expectations." Some capacitors from specific lots may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion.

"Medical device maker Guidant (GDT) said Monday that the failure rate from a faulty hermetic seal in some of its recalled pacemakers has increased from summer projections. The company, based in Indianapolis, told doctors that 145 cases have been reported of 16,000 pacemakers that remain implanted in patients' chests, raising the failure rate from July's range of 0.17 to 0.51 to a new range of 0.31 to 0.88%. Guidant also acknowledged another batch of 54,000 pacemakers might have a similar problem, after a manufacturing mix-up included faulty components with those that worked correctly. Of that group, about 19,300 pacemakers remain implanted."

Read the full article in USA Today here.

Based in Minneapolis, Medtronic is one of the largest medical device makers in the country, with around $10 billion in annual sales. Like other large companies in the industry, Medtronic continues to have problems with some of their products--and failing to tell doctors and patients about the problems. With the recent recall of two of their defibrillators, and questions about safety regarding some of their pacemaker devices, Medtronic has put potentially thousands of patients at risk.

Recent news also indicates that Medtronic paid surgeons exorbitant consultant fees to use and promote its devices. According to a whistle-blower suit filed two years ago in federal court, the company has spent tens of millions of dollars on consultant contract and other types of payments to prominent surgeons, including $400,000.00 per year to a Wisconsin surgeon for eight days of work.

Guidant knew of serious problems with particular defibrillators that would short circuit and fail to perform its function as early as February 2002, yet the company continued to sell the defective defibrillators. Guidant also continued to keep information about the defective devices from doctors and the public. After nearly ten months, Guidant modified the design and made additional changes to the device to eliminate the defects in November 2002.
It was not until May of 2005, on the eve of the publication of a New York Times article outing the company and the deadly defects, that Guidant finally admitted to the defects.
Thanks to the diligence of two Texas trial attorneys and the New York Times, documents that provide handwritten evidence of Guidant's decision to sell off the remaining defective defibrillators were discovered in January, 2006.

Six months before the Guidant Corporation publicly disclosed short circuits in its heart devices, a debate may have been going on within the company over whether to alert doctors about such failures, internal company documents released yesterday suggest.

The documents appear to indicate that some Guidant executives recommended in January 2005 that the company find a way to tell doctors about the failures posed by a device known as the Contak Renewal, an advanced heart defibrillator. The records, which were disclosed yesterday as part of a court proceeding in Texas, include handwritten notes said to have been composed by a top Guidant executive.

Guidant started receiving a small but growing number of reports of short circuits in Contak Renewals in late 2004, more than two years after it discovered a similar problem in another defibrillator, the Prizm 2 DR.

Read the complete article from the NY Times here.

Guidant, the second-largest maker of defibrillators, agreed to settle a lawsuit over the death of a 21-year-old man who used a company-made heart device that failed, said a lawyer representing the man's family. The agreement with the family of Joshua Oukrop, who died in Utah on March 14, 2005, may be the first civil settlement related to Guidant's recall of 109,000 heart defibrillators. 'The only thing I'm at liberty to say is the case is resolved,' said Matt Curtis, the Oukrop family's lawyer. 'It was within the past two weeks,' said Curtis, a lawyer at Sommers Schwartz PC in Southfield, Michigan.

Read the full story here.

A $500 million dollar class action lawsuit was filed this month against Medtronic on behalf of those implanted with the device. The issue lies with the defibrillator's battery, which may rapidly deplete or short circuit thereby causing the device to fail should its recipient suffer a life threatening arrythmia. The defective devices include Medtronic's implantable cardiac defibrillators ("ICDs") and cardiac resynchronization therapy defibrillators made between April 2001 and December 2003.

More information is found here.

A recent article in the NY Times reported that the FDA new of the issues with Guidant heart devices for months before the warning release and recall in June. Guidant submitted it annual report to the the FDA in February, in which it disclosed that its Ventak Prizm 2 DR was short-circuiting at a rate of about once per month.
Guidant new of the heart device's flaw for years, but did not tell physicians about the problems until May of this year.
The FDA treats all annual reports as confidential and may not review the report until 90 days after receipt or longer.

Find a timeline of Guidant's deadly inaction here.