|MEDTRONIC IN THE NEWS
SEMPER FIDELIS – CONSUMER PROTECTION FOR PATIENTS WITH IMPLANTED MEDICAL DEVICES
By William H. Maisel, M.D., M.P.H.
When the Food and Drug Administration (FDA) approved the Medtronic Sprint Fidelis implantable cardioverter–defibrillator (ICD) lead in 2004 on the basis of bench testing but no human clinical data, there was no public outcry. … During the ensuing 3 years, 90% of Medtronic ICDs were implanted with this lead (see diagram). But in October 2007, after 38 months on the U.S. market and 268,000 implantations worldwide, the Fidelis was voluntarily recalled by Medtronic because of its propensity to fracture. (pdf format 50.3Kb)
Source: New England Journal of Medicine
Volume 358:985-987. Number 10.
www.nejm.org
Published online March 6, 2008
MEDTRONIC RECALLS DEFECTIVE HEART LEADS
Wires Connected to Heart May Break
BY Cindy L. Nations
October 15, 2007
Medtronic announced today that it will no longer make Sprint Fidelis defibrillator leads because they may be prone to fracture. Leads are electronic wires used with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds). ICDs and CRT-Ds are devices that are implanted into the chest of a cardiac patient to monitor the heart rate and prevent cardiac arrest. The device delivers an electrical shock when needed to restore a normal heart rhythm. The leads connect the device directly to the heart.
268,000 people worldwide have these defective leads implanted. So far, less than 1% of these leads have actually broken. But the FDA states, "We don't know if this rate of adverse events will remain constant or increase over the life of these leads." It would be logical to expect that the wires are more likely to break the longer they are in use. If a lead breaks, the defibrillator may not function properly, i.e., it may deliver a shock when not needed or may not deliver a shock when it is needed. This can be life-threatening. The FDA has not released data as to the number of resulting injuries or deaths, if any, resulting from these defective leads. See the FDA Statement and the FDA Questions and Answers.
Source: Law Offices of Howard L. Nations
A National Pharmaceutical Litigation Firm
www.howardnations.com
October 15, 2007
F.D.A. Plans to Intensify Oversight of Heart Devices
By BARRY MEIER
The Food and Drug Administration plans to strengthen how it monitors critical heart devices like defibrillators by appointing outside medical experts to help it review the safety of units already on the market, a top agency official says.
The move would be the first time the F.D.A. would have outside experts regularly advising it about the safety of medical devices being sold ...
Both the agency's action and the medical group's report, which will be released in a few weeks, follow a controversy last year over decisions by the Guidant Corporation not to publicize life-threatening defects in some of its defibrillators. The episode also highlighted gaps in the F.D.A.'s oversight of such products, as well as a lack of uniform standards in the industry governing how and when device flaws are disclosed. [more...]
Source: The New York Times
www.nytimes.com
April 7, 2006
Medtronic Continued Selling Flawed Defibrillators (Update1)
Reporter: Avram Goldstein for Bloomberg
Feb. 16 (Bloomberg) -- Medtronic Inc. continued selling flawed cardiac defibrillators for two years after learning that some of them may suddenly quit working, according to company documents filed in a California lawsuit.
After Medtronic last year recalled the devices, 19,000 people had to have surgery for a replacement, said Medtronic spokesman Rob Clark. At least one of them died from post- surgical complications, according to the man's widow. Defibrillator patients are vulnerable to potentially fatal heartbeat irregularities, which the $20,000 devices detect and correct using electrical shocks.
``Medtronic has been taking products they know are not quite right and putting them into people rather than take the loss,'' said Hunter Shkolnik, a New York lawyer, who said in a Feb. 13 interview that he represents more than 200 people whose Medtronic devices were recalled. ``If you know there's a problem with a component, you don't put it out and sell it to people.''
Medtronic, the leader in the $10 billion-a-year market for heart rhythm devices, told 87,000 patients in February 2005 that the defibrillators implanted in their chests might fail. According to company documents filed in federal court in San Jose, California, the Minneapolis-based company had discovered the flaw in January 2003 and started producing a redesigned product one year later.
Shares of Medtronic fell 13 cents, or 0.3 percent, to 47.92 euros ($56.89) in Germany after closing at $57.14 yesterday in New York Stock Exchange composite trading. They're little changed this year.
The company's recalled Marquis, Maximo and Protect defibrillators haven't been linked to failures that led to deaths or serious injuries, according to Medtronic spokesman Clark. He declined to comment on any individual cases.
Conference Today
Medtronic attorneys and lawyers in scores of suits over the matter will meet today in a Minneapolis federal court on pretrial preparations. Another federal judge in St. Paul, Minnesota, next month will hold a similar meeting in advance of trials in at least 60 lawsuits filed against competitor Guidant Corp., whose defibrillators were linked to at least seven deaths and led to the recall last year of 109,000 devices.
St. Jude Medical Inc., the third-largest maker of the devices, last year said 39,000 defibrillator patients needed software upgrades to correct defects and later said 26,000 other people had units that might fail because of exposure to cosmic rays. The U.S. Food and Drug Administration said last September that the number of defibrillator failures is rising.
``There is not enough FDA safety oversight,'' said Shkolnik, who is on a steering committee of trial lawyers suing Medtronic. ``It seems as though the FDA is being led by the companies instead of the companies being led by the FDA.''
The agency does inspect device maker factories regularly, said FDA spokesman Susan Bro in an interview yesterday.
``The safe use of these important devices requires the involvement of many, including the companies,'' Bro said. ``Safety oversight is something that is always undergoing important improvements and is best carried out when all cooperate in a timely and prudent manner.''
`Madder Than Hell'
Andrew Groh, 82, a retired mechanical engineer, died in August of complications after a surgeon replaced his recalled Medtronic Marquis defibrillator, said June Groh, his wife of 59 years, in an interview from her Cupertino, California, home this month. Before he died, Groh expressed anger about his declining health.
``He said he was madder than hell about this,'' she said. ``He felt that Medtronic ought to pay for this one way or the other. He definitely felt that this was all brought on by the surgery. If not for the recall, he would be alive today.''
Medtronic ``would not have a comment on something like that,'' said spokesman Clark. ``We're not aware of the details.''
Brian Devine, a San Francisco lawyer who represents Groh, said he expects to file suit on her behalf in the next few months. He represents about 100 other families with complaints against Medtronic, he said in an interview this month.
`People Did Suffer'
``Medtronic continues to report that they've had no deaths or even injuries,'' Devine said. ``Apparently they don't consider undergoing the replacement surgery to even be an injury.'' The company should ``at least face up to the fact that these people did suffer,'' he said.
Based on Medtronic's estimate of a 2 percent to 5 percent post-implantation infection rate, 380 to 950 patients may have developed infections after replacement of their devices. Spokesman Clark said Medtronic doesn't keep track of deaths, disabilities or extra medical costs resulting from such complications.
Jim Strasko, an unemployed 45-year-old father of six from Fremont, Iowa, was uninsured and disabled when Medtronic sent him a letter recommending he consult with his doctor on replacing his Marquis defibrillator.
Patient's Bankruptcy
``It's like playing Russian roulette,'' Strasko said in a Jan. 31 interview. ``There is no way of knowing for sure'' whether an implanted defibrillator may be defective. Medtronic put the failure rate at one in 10,000 units.
Strasko said his doctor urged him to have replacement surgery because his defibrillator was less than a year old and the unknown risks would last for at least five more years. Strasko was born with a heart defect that now leaves him at higher risk of sudden cardiac death.
The cost of the defibrillator replacement at a Des Moines hospital and post-operative complications reached $100,000, none of which he could pay. Indebtedness drove him to the ``humiliation'' of bankruptcy and problems in his new marriage, Strasko said.
``When someone has a defective product, they need to quit selling them instead of continuing to put them into people,'' Strasko said. His only income is a $1,600 monthly disability check, and he is suing Medtronic, he said.
Medtronic's Case
More than 2,000 patients so far have filed lawsuits against Medtronic, and dozens of plaintiffs' lawyers across the U.S. are pursuing additional claims, lawyers said. It isn't clear how many deaths are being attributed to the recall in lawsuits or how many plaintiffs suffered only minor pain and inconvenience.
To Medtronic officials, the advisory about the 87,000 defibrillators was a ``field action.'' Only later did the FDA classify it as a recall. Recalled medical devices don't necessarily have to be removed like defective car parts because the government and manufacturers leave that decision to doctors and patients.
Medtronic found a ``potential'' for battery-draining short circuits in its defibrillators during special high-stress testing in January 2003, according to spokesman Clark. The first unit with battery failure was returned in April 2003 and a second one was reported in June or July 2003, he said. A total of nine devices with battery failure were reported by February 2005, he said.
Medtronic applied to the FDA for approval of a different battery design that October and got approval to start production of an upgraded model in December 2003, Clark said.
`Manageable Situation'
``The incidence was so low that just through increased monitoring and diligence and notification, it was a manageable situation,'' Clark said in a Feb. 2 interview.
The company offered each patient who opted to switch defibrillators a free replacement and reimbursement of as much as $2,500 for expenses. Medical insurance providers and the government's Medicare health program were to cover the rest. Patients who elected to keep their defibrillators were offered as much as $1,000 for medical costs.
Clark said most replacements are outpatient procedures that take less than an hour. In May the company estimated the entire recall would cost $35 million.
Of 16,000 Marquis defibrillators returned to Medtronic, none were found by lab analysis to have the battery failure problem that the company identified, Clark said.
``66,000 of those devices remain in patients today because doctors made the decision to keep them in the patient,'' Clark said yesterday.
The California case in which Medtronic submitted documents on when the company became aware of defibrillator flaws is Randall v. Medtronic, No. C-05-3707-JW, U.S. District Court for the North District of California (San Jose Division).
Feb. 16, 2006
Bloomberg
Medtronic Press Release Announcing Expanded Recall of Lifepak 500 Automated External Defibribillators
April 22, 2005
http://www.fda.gov/oc/po/firmrecalls/lifepak04_25.html
Medtronic Press Release Announcing Recall of Lifepak 500 Automated External Defibrillators (AEDs)
February 25, 2005
http://www.fda.gov/oc/po/firmrecalls/lifepak02_05.html
Press Release from Medtronic
February 11, 2005
http://www.fda.gov/oc/po/firmrecalls/medtronic02_05.html
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