FDA Issues Warning Letter to St. Jude Medical Inc Regarding Surgical Ablation Devices
The FDA recently issued a warning letter to St. Jude Medical Inc regarding its Epicor surgical ablation device. Systems like Epicor are approved for ablation, or the burning of tissue to seal a wound to stop bleeding. It was alleged that St. Jude was promoting the Epicor system to treat a condition known as atrial fibrillation, or abnormal heart rhythm, which had not been approved by the regulatory agency.
Doctors are permitted to use these medical devices in any way they see fit, but manufacturers are legally barred from promoting these products for uses that are not approved. The FDA has not approved atrial fibrillation as a usage of the device.
Other medical device manufacturers, such as Medtronic, Boston Scientific and AtriCure have had trouble with federal regulators in the past over inappropriate marketing of surgical ablation devices. AtriCure previously agreed to pay $3.8 million to resolve allegations it had inappropriately marketed surgical ablation devices.
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Healthcare Professionals Warned that ASR, a Hip Replacement Device, has High Early Rate of Failure
The New York Times recently reported that DePuy Orthopaedics, a unit of Johnson & Johnson, has warned doctors that an artificial hip implant known as the ASR has a high early failure rate in some patients. The warning comes after more than two years of reports of implant failures in patients after only a few years post-surgery. Typically, artificial hips are projected to last 15 years. As a result of these failures, patients required costly and painful replacement surgeries.
Orthopedic experts urged DePuy to stop sales of the ASR earlier. Some believed that the implant had a defect making implantation difficult. Dr Stephen Graves, the director of an implant database in Australia, has said that data showed some time ago that the ASR was failing early at a much higher rate than comparable devices. In December 2009, DePuy voluntarily withdrew the ASR from the Australian market. DePuy also announced in late 2009 that it would phase out sales across the world by the end of 2010.
The ASR is part of a category of devices known as metal-on-metal implants. These types of devices have been increasingly under evaluation because they create a lot of metallic debris over time. This debris can lead to severe inflammatory responses, damaging patient muscles and other soft tissues, and requiring patients to have further surgery to replace the device soon after surgery. Since early 2008, the FDA has received over 300 complaints regarding the ASR from patients.
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Label Changes Mandated for Pain Pumps Due to Dangers of Permanent Cartilage Damage
A recent report from the Wall Street Journal stated that the FDA is seeking to change labels on pain pumps that deliver pain medication to patients after surgery. Pain pumps are small plastic tubes that deliver and regulate pain medication, usually for a couple of days. The proposed label changes come in the wake of many reports of irreversible cartilage damage from patients who had the medication delivered to their joints, primarily after shoulder surgery. Doctors say that after a procedure like shoulder surgery, the pain pumps can provide too much medication to the tissue, resulting in severe and permanent damage.
From 2006 to 2008, the FDA states that it has received 35 reports of severe cartilage damage from these pumps. Manufacturers of the pumps include I-Flow Corp., Stryker Corp, and Moog Inc., and the FDA has given them 30 days to update the warning labels to account for potential cartilage damage. The pain pumps in question have been approved by the FDA for use after abdominal and certain other surgeries, but not after joint procedures like shoulder surgery.
Hundreds of cases have already been filed against these companies due to the severe cartilage damage many patients have experienced. If you or a loved one has used a pain pump and sustained cartilage damage, contact the personal injury attorneys at the Pintas Law firm immediately. We can provide you with a free no-obligation consultation and explain your legal rights to you.
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Heartstart Defibrillator Recall
Heartstart Fr2+ Automated External Defibrillators were voluntarily recalled by its Dutch manufacturer Philips on October 3, 2009. Philips recalled worldwideabout 5,400 of the defibrillators due to the possibility of a memory chip failure. This defect may render the device inoperable. The recall includes models manufactured between May 2007 and January 2008.
Heartstart Defibrillators and Cardiac Arrest
Heartstart Fr2+ Automated External Defibrillators are used by trained responders and response teams to treat sudden cardiac arrest. The defibrillators can apply electrical therapy to stop irregular heart rhythm and coax the heart into re-establishing regular rhythm.
Fire departments, emergency medical service people, hospitals, and other groups across the world have purchased these devices. If a faulty defibrillator were used to treat sudden cardiac arrest, the result could be fatal. Left untreated, patients who have gone into cardiac arrest could die in as few as four minutes.
Contact the Injury Attorneys at the Pintas Law Firm
If you or someone you know has died or suffered severe injury due to cardiac arrest and you suspect a faulty defibrillator may be to blame, contact the Pintas firm immediately. Our experienced team of personal injury attorneys can provide you with a free consultation and explain your rights.
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Urgent Recall of Portex Pediatric Tracheal Tubes!
Portex Pediatric Tracheal Tubes were urgently recalled by the U.S Food & Drug Administration and their manufacturer Smiths Medical on September 11, 2009. These tubes, sizes 2.0, 3.0 and 3.5mm, are used in tracheotomies for children, or during surgery in which a tracheal tube is inserted into a child’s windpipe to aid with breathing and removal of secretions.
The recall of Portex Pediatric Tracheal Tubes by the FDA stated that a number of the tubes were manufactured with internal diameters smaller than indicated on the label. This error may cause difficulty clearing secretions from the device or the airway, which may lead to a partial or complete airway obstruction. The product defect may also increase airway resistance and make breathing more difficult. Due to these complications, the FDA recall states, “there is a reasonable probability of serious injury and/or death”.
If your child or someone you know has suffered an airway obstruction injury or death that may be associated with usage of these Portex tracheal tubes, please contact the Pintas Law Firm immediately. Our experienced personal injury attorneys will be able to evaluate your claim. Our Chicago law firm can provide you with a free consultation and an explanation of your legal rights.
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Pending Lawsuits for Faulty Defibrillators
"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
Posted In Medical Device Litigation
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Medtronic Defibrillator Shipment Suspended Due to Quality Issues
Read more here. Posted In Medical Device Litigation
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No Preemption For Medtronic Heart Device, MDL Court Says
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. Posted In Medical Device Litigation
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FDA Questions Safety of Widely Used Heart Stents
"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."
Read the full article at Forbes.com. Posted In Medical Device LitigationComments / Questions (0) | Permalink
Risk of Death From Defective Heart Stents
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 Posted In Medical Device Litigation
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Guidant Never Mailed Warning Letters to Doctors
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. Posted In Medical Device Litigation
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More Recalls of Guidant Defibrillators
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Failure Rate of Guidant Defibrillators Doubled
"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.
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Medtronic Accused of Millions in Kickback to Doctors
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.
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Guidant Knew of Defibrillator Problems Long Before Recall
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.
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Documents Indicate Guidant Covered Up Defibrillator Problems
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.
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Guidant Settles First Civil Suit
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.
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Class Action Filed Against Medtronic's Defibrillators
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.
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FDA and Guidant Failed to Timely Report Faulty Heart Devices
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.
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