Defective Medical Devices

The New York Times reports the U.S. Food and Drug Administration (FDA) has received a huge number of complaints in recent months about failed metal-on-metal hip implants. Looking at the FDA data based on adverse events, the newspaper found more than 5,000 reports since January, which is more than the prior four years combined.

Who is having problems? The Times reports many have had the all-metal hip removed or have experienced a device failure after a few years instead of the 15 years they are supposed to last. All of this is leading up to what could be the biggest implant problem since a Medtronic heart led was recalled in 2007 following nearly 8,000 complaints.

The complaints come from the tiny bits of metal – cobalt and chromium – that appear to shed from the metal-on-metal wearing and can cause crippling injury and tissue damage. All metal hip implants, until recently, accounted for about one-third of all of the 250,000 hip implants in the U.S. performed every year, with about a half million patients in all who have received the metal replacement hip. Manufacturers of these medical devices include Johnson & Johnson, maker of the A.S.R. or Articular Surface Replacement, which accounted for about three-quarters of the complaints into the FDA found by the Times. J & J recalled the A.S.R. last year.

Many of these medical devices are sold to consumers and implanted without undergoing the rigorous premarket testing that drugs must undergo and they were sold with no process to do follow-up monitoring on implanted patients. Patients may know they have to have repeat surgery if they are in pain, though pain is not a consistent indicator that the metallic debris is causing damage.

In the meanwhile, manufacturers have been told by the FDA to study why the devices are failing. Not surprisingly, the market for metal hips has declined to about five percent of the market. Other manufacturers include DePuy (Johnson & Johnson) and Zimmer Holdings makers of A.S.R. and the Durom Cup.

If you have been injured or have suffered serious adverse effects due to a hip implant, talking with a hip replacement recall injury lawyer in Florida can help you understand what legal options are available to you, based upon your specific circumstances.

Sources: http://www.nytimes.com/2011/08/23/business/complaints-soar-on-hip-implants-as-dangers-are-studied.html?_r=2&pagewanted=1&ref=health and http://www.nytimes.com/2010/03/04/health/04metalhip.html

It may not be comforting news that an Institute of Medicine (IOM) panel issued Friday, July 29, in saying that the approval process for thousands of medical devices each year is “fatally flawed” and needs to be replaced. The U.S. Food and Drug Administration (FDA) had asked the IOM to look at the 510(k) approval process, which allows manufacturers to bypass any scientific scrutiny of a new medical device as long as it is “substantially similar” to one already on the market, reports Reuters.

Manufacturers love this option and about 4,000 applications are filed every year with about 3,000 being approved. That means that a medical device, such as a hip implant placed in your body, likely has not undergone any premarket review for safety. That is the shocking revelation to thousands of patients every year who find their device, whether a defibrillator, an artificial hip, or a piece of surgical mesh, has failed and it never received a premarket approval for safety.

The IOM report says “What we are recommending is that the 510 (k) is fatally flawed in terms of not evaluating safety and effectiveness of a device.” The FDA quickly defended itself saying in a statement that the fast-track process should not be eliminated, “but we are open to additional proposals and approaches for continued improvement of our device review programs,” according to Dr. Jeffrey Shuren who directs the Center for Devices and Radiological Health which oversees medical devices.

For its part, the major medical device manufacturers argue that 510(k) is needed because it brings much needed technologies to patients. A group representing industry, Advanced Medical Technology Association or AdvaMed, said Congress should not consider the report’s conclusions. That is no wonder considering that the 510(k) delivers billions in profits to the major manufacturers such as Johnson & Johnson, Boston Scientific, Medtronic Inc, and Abbott Laboratories.

Unfortunately, we often find after a device is placed in a patient that it needed to undergo premarket clinical trials because problems that would have shown up premarket surface instead by injuring the implanted patient. Sometimes the product must be recalled, but the patient is still injured, some permanently or fatally. Consider J&J’s DePuy artificial hips which were recalled last year after some 93,000 patients received the implant. External defibrillators found in public places such as airports have also been recalled recently after thousands of reports of malfunctions of the defective product.

If you have been injured by a medical device, or believe the device you received is the source of your pain and further injury, the Florida medical equipment error attorneys at Farah & Farah can help you understand the process and your options under product liability law.

Sources: http://health.usnews.com/health-news/managing-your-healthcare/policy/articles/2011/07/29/report-urges-new-review-system-for-medical-devices and http://www.reuters.com/article/2011/07/29/us-medical-device-regime-idUSTRE76S4D720110729

The article in The Chicago Tribune almost reads like a horror story, especially if you have been implanted with an artificial heart valve called the annuloplasty ring. This is often recommended for patients even though the rings were put into a classification with sutures and hearing aids and no longer have to undergo any premarket approval before being implanted in a patient’s body.

But the new rings have more deaths associated with their use than any other device in their class, according to the article. The paper went through Food and Drug Administration (FDA) adverse events records to find out whether patient safety is being compromised. It turns out Advanced Medical Technology Association, or AdvaMed, which represents medical device companies, petitioned the FDA in 1997 to have the device downgraded with virtually no premarket scrutiny by claiming the valves were “substantially equivalent” to a medical device already on the market. That way the manufacturer, Edwards Lifesciences, did not have to fund years of premarket clearance and testing. The heart valve joins other implantable devices such as defibrillators and surgical mesh that are cleared through the regulatory agency with a wink and a nod.

When the annuloplasty rings were put in a new class, dozens of new models were introduced, which also did not have to undergo clinical trials. Ironically, Edwards Lifescience didn’t submit the rings for FDA clearance, yet the company did apply for a patent and claimed that there were at least 40 different ways the rings were different from rings already on the market. Substantially equivalent and different all at the same time?

The Institute of Medicine is looking into the tail wagging the dog federal review process for some medical devices that clearly put a manufacturer in charge and the FDA is expected to rewrite some of its rules. In the meantime, if you or a loved one have been injured by a defective medical device or other product, an experienced Florida defective medical device lawyer can begin the process of determining if the device underwent any critical review by the agency, or just received a rubber stamp of approval.

DePuy Orthopaedics made the ASR Hip Replacement implants and introduced them in the market in 2005 with promises the device would relieve the pain and suffering of patients with degenerated hips. But seven Rochester, New York area residents are suing DePuy and its parent company, Johnson & Johnson, alleging the defective medical device products were not tested before being put on the market, reports The Rochester Democrat and Chronicle. Of those suing, several had to undergo complicated and expensive replacement surgery.

The lawsuit was filed on Wednesday, March 2, in U.S. District Court alleging the companies were negligent in failing to test the medical device. In August 2010, DePuy recalled approximately 93,000 defective hip implants admitting that 13 percent would have to be replaced. The metal-on-metal hip implant caused hip failure, a loosening of the medical device, an inflammatory reaction, and unexplained pain. At that time, 90,000 patients had received the implant and the Food and Drug Administration (FDA) had received hundreds of complaints about complications.

Meanwhile, another lawsuit representing about 30 other patients is expected to be filed.

If you receive a medical device that has a design flaw that makes the device inoperable or defective, you may have a product liability action against the manufacturer, designer and/or distributor. Under Florida product liability law, the manufacturer or responsible party can be held accountable for the injuries that are caused to consumers of the product.

Farah & Farah’s experienced Florida product liability lawyers have helped hundreds of victims of defective products recover compensation to cover the injuries they have suffered. Call us around Florida and South Georgia at 1-800-533-3555 so we can begin looking at your case.

You may see them in airports and other public places. Automated external defibrillators (AEDs) are used on the nearly 300,000 Americans who suffer a cardiac arrest in public every year. Some people are saved, but the Food and Drug Administration (FDA) says many of these devices are malfunctioning and are defective products, according to an article in Consumer Affairs.

According to an FDA advisory panel, there have been at least 68 recalls and reports of more than 28,000 defibrillators failing at a time when they were needed to save a life. While the malfunction reports are mounting, the defibrillator industry says less regulation is needed, not more. Public Citizen’s Dr. Michael Carome, testified before the FDA panel and said that 17 recalls for 100,000 AEDs were Class 1, the most serious recall that can cause serious injury and death.

In a related story, a new study finds there were more cardiac arrests that were treatable with shock in public places than at home.

The law holds the makers, sellers, distributors, and designers of medical devices responsible for dangerous products. If you have been injured by a device that you suspect was defective, you may be able to recover for your injuries under product liability and/or negligence law. The Florida product liability lawyers at Farah and Farah have experience handling these cases and can analyze the facts to determine how the product was defective and who, along the chain, may be responsible for your injuries.

A new report published by The British Medical Journal (BMJ) says that lax procedures are allowing defective medical devices to enter the marketplace to harm patients with very little follow up and oversight by federal regulators after their initial approval, reports news outlet Bloomberg.com.

As an example, the authors point to a medical device that prevents seizures in epilepsy patients. The Vagus Nerve Stimulator (VNS) made by Cyberonics is implanted under the skin and sends electrical impulses to stimulate the vagus nerve. With about 60,000 patients implanted with the device, authors Shannon Brownlee and Jeanne Lenzer say there have been 900 deaths reported to the Food and Drug Administration (FDA) among patients using the device. But whether their deaths are linked to the device remains a mystery because the FDA did not investigate the cause of the deaths.

The FDA misses problematic devices, say the authors, because device makers are not required to report problems to the FDA database. Additionally, many post-approval studies are not conducted to establish the safety of a medical device pre-approval. Some devices are only approved for marketing and a pre-market approval is not even required by the FDA. Then there are those devices that are approved even though the FDA’s own scientists raise objections about its safety indicating the FDA has its ear to the requests of the companies it regulates.

An accompanying article that runs in the BMJ, says that the medical device division within the FDA has been conducted in a much looser manner than the drug regulating arm of the FDA.

If you or a loved one has been harmed by a medical device, the Florida product liability attorneys at Farah & Farah can help you determine if the device has a defective design, was manufactured with a defect, or labeled incorrectly leading to patient harm, the basis for a product liability claim against the manufacturer.

There are questions arising in the medical community about the popular artificial hips as some suspect the medical devices are causing bone and severe tissue damage in some patients that can lead to surgery. Metal-on-metal implants are used in about one-third of the 250,000 hip replacements performed in the U.S. every year, according to this NY Times article. The ball-and-socket joints are made from cobalt and chromium, but recent studies show that sometimes the devices can wear, causing metal debris to be absorbed into the patient’s body.

Metal debris can begin an inflammatory reaction that can eventually lead to the death of tissue in the hip joint and bone. Not only do they have to be replaced sooner than the 15 years that hip replacements generally last, but complications can arise such as destruction of the bone. So far a limited number of studies show that one to three percent of patients may be affected by this form of defective medical device in Florida and throughout the nation, and women are more likely to have the problem than men.

Manufacturers downplay the complications of the fairly new metal-on-metal medical devices. Zimmer Holdings says its meal-on-metal system is not associated with an increased risk to the patient. But doctors at some major hospitals such as the Mayo Clinic, are removing the metal hip replacements and Mayo has reduced by 80 percent its use of the metal-on-metal implants. Adding to the complications, when the metal hips are installed slightly askew, they are less forgiving and may cause severe pain to patients.

The FDA reports that it is launching a new initiative to minimize damage from the ionizing radiation that comes from defective CT scans. Part of the campaign includes promoting personal medical imaging history cards. They will record the number of images one receives in a certain time period to minimize the cumulative number of radiation exposures. The initiative follows a series of reports from the Los Angeles Times that 260 patients were accidentally exposed to more than eight times the normal dose over a period of 18 months.

The FDA will hold public meetings March 30 and 31 to consider suggestions about further training requirements for CT scan operators. Also the groundwork must be laid for a national database to pre-determine the optimal dosage for any given procedure. The more radiation, the clearer the picture, but the manual override by operators is what has caused the overexposure problem. The use of CT scans has tripled since 1995 and many critics believe the review doesn’t go far enough. Up to one-third of the 70 million scans in the U.S. annually may be unnecessary. A 2007 study published in the New England Journal of Medicine, finds that up to 0.4% of cancers in the U.S. may be due to unnecessary scans. As it stands now, without a patient history card, it is up to the patient to remind medical technicians and their doctor of the number of scans they have received to avoid multiple, cumulative exposures.

Source Articles: http://abcnews.go.com/Health/CancerPreventionAndTreatment/fda-radiation-safety-standards-popular-rays/story?id=9795804

http://www.kaiserhealthnews.org/Daily-Reports/2010/February/10/FDA-and-medical-radiation.aspx

One of the big cries in health care reform is the need to have our medical information transferred to an electronic data base. The theory is that is patient records are accessible immediately and there will be fewer mix-ups in an emergency and during routine medical treatment. The government is so convinced this is a good idea that it plans to spend up to $27 billion on electronic medical records systems, also called health information technology, or HIT. Every American is supposed to have an electronic medical trail by 2014. But there are problems. Over the last two years, six patients have reportedly died and several were injured when the system malfunctioned. Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health testified at a government hearing on February 18 that there have been malfunctions of the system. HIT has mixed up patients, put test results in the wrong file, and lost medical information.

Other examples include a “locking up” of data in an operating room, and a failure to display a patient’s allergies due to software errors. The system is largely unregulated and the FDA may suggest some sort of framework of federal oversight which could include requiring the system makers to register with the government and submit reports on safety issues, errors and problems that surface. The systems could even face a pre-market review by the agency before they are launched. Sen. Charles Grassley says there needs to be a national system for reporting errors and product failures. Some manufacturers are resistant to additional scrutiny arguing regulation will not necessarily make electronic medical records safer, while others favor the stepped up scrutiny. Device makers also testified suggesting a patient safety organization be created to collect reports of problems in electronic health systems. Hospitals are interested too in finding out the most they can about safety flaws before they jump forward into the electronics age. After all, patient lives are at stake.

Guidant LLC, a medical device manufacturer, was charged on February 25, with a criminal violation of the Federal Food, Drug and Cosmetic Act in relation to the safety of its implantable defibrillators. Guidant LLC, owned by Boston Scientific Corporation, formerly did business as Guidant Corporation. The Justice Department is expecting a formal guilty plea from the company as part of an agreement and the company has previously announced it would pay nearly a nearly $300 million fine.

Guidant Offenses
What did the company do wrong? Guidant is accused of concealing information from the FDA regarding the failures of some of its lifesaving devices, specifically the implantable cardioverter defibrillators or ICDs short-circuited, specifically three models, the Ventak Prizm 2 DR (Model 1861) and the Contak Renewable (Models H135 and H155). Beginning in 2003, Guidant reportedly became aware that the Ventak tended to arch, rendering the lifesaving device inoperative and unable to deliver life-saving shocks to patients with abnormal heart rhythms. The devices are supposed to constantly monitor the electrical activity of a heart and when it gets out of rhythm, the ICDs is supposed to deliver an electrical shock to the heart to return it to a normal heartbeat. Without that, the patient can die within minutes. In response, Guidant says it changed the design of the Prizm 2 in November 2002 but the Justice Department says the Guidant lied to the FDA when it said the design change did not affect device when in fact it was made to correct the flaw. Guidant had similar problems with the Renewal 1 and 2 devices that resulted in a patient death in July 2004. Under law, Guidant was supposed to alert the FDA, but it failed to do so. The government says that Guidant undermines the FDA’s role to protect the public from dangerous medical devices.

Guidant wants to remind the public that paying a fine is not an admission of guilt.

Assistant Attorney General Tony West, who heads the Justice Department’s Civil Division said, “Our message is clear: We will vigorously prosecute individuals and organizations who put profit over public health and safety by violating the law.”

“The community has the right to expect that companies that violate federal law by submitting false or misleading information to the FDA will be held accountable, particularly when that information relates to lifesaving devices, such as defibrillators,” said Frank J. Magill, Acting U.S. Attorney for the District of Minnesota on this case. “I want to thank the prosecutors and investigators responsible for this challenging investigation that resulted in these charges being filed. For that, we all can be very thankful.”

Source Article: http://www.prnewswire.com/news-releases/medical-device-manufacturer-guidant-charged-in-failure-to-report-defibrillator-safety-problems-to-fda-85372982.html