Defective Medical Devices

The injuries to patients from defective all-metal artificial hips are beginning to be understood in terms of dollars and cents. The New York Times reports the most widespread medical device failure in decades involves metal hips that have a high failure rate and leave patients thousands of dollars in debt and will cost Medicare, taxpayers, and insurers billions in the coming years. The Times reports on one patient who is typical of the injured – a 55-year-old from Illinois, who had a metal-on-metal artificial hip that failed. Infection set in. His bills exceed $400,000 – all for a metal-on-metal hip that was supposed to last 15 years or longer but instead had to be removed and replaced.

The defective medical device injures patients when the metal wearing on metal creates debris that gets into the body, damaging tissue and sometimes crippling patients.

So far, about 5,000 lawsuits have been filed against Johnson & Johnson’s DePuy division and Zimmer Holdings. Zimmer has settled hundreds of patient claims over its metal implants while at the same time insisting they are safe. DePuy recalled the defective medical product known as the A.S.R. (Articular Surface Replacement) hip last year and its Pinnacle artificial hip is the subject of about 560 defective product lawsuits.

Medicare and insurance are paying the cost of the product failures and repeated surgeries. Both expect to be paid back when the cases are done.

A defective product case involves a failure during the manufacturing process or in a defective design of a product. Whether it is a medical device, a consumer product, or an automobile, if a patient or user is harmed, an experienced product liability law firm can file an action to recover the lost wages, medical expenses, and pain and suffering experienced by the user. Call the Florida hip replacement failure lawyers at Farah & Farah for a complimentary assessment of your case at (800) 533-3555.

Source: http://www.sacbee.com/2011/12/28/4148435/suits-mount-costs-soar-for-failed.html; http://www.nytimes.com/2011/12/28/business/the-high-cost-of-failing-artificial-hips.html?pagewanted=all

The consumer group Public Citizen frequently calls for the recall of dangerous drugs or medical devices. Now a former FDA director is joining them.

Larry Kessler used to work for the U.S. Food and Drug Administration (FDA) as director of the Center for Devices and Radiological Health (CDRH), a section of the FDA that oversees medical devices. He is joining Public Citizen in asking that the Stryker Wingspan brain stent be withdrawn from the market because of a concern that it may lead to death in users. Kessler has joined a product recall petition filed by Public Citizen on December 21, asking the FDA to also revoke Stryker’s 510(k) clearance, a way that medical devices are fast-tracked onto the market without clinical studies.

Device manufacturers like the 510 (k) because it costs them less money in research and a reduced application fee, however, many devices have later been found to be defective after they are marketed without studies for safety and efficacy. Kessler said that the stents add no benefit to patients but have an enormous downside in an elevated risk of strokes and death.

Mass Device reports the Wingspan system was cleared by the FDA in 2005 under a humanitarian device exemption (HDE). Stents serve to open up narrowed arteries that deliver blood to the brain. Since then, studies have shown that the risks of injury outweigh the benefits. Public Citizen’s research shows that blood thinners and lifestyle changes reduce the risk of stroke and death better than receiving medication and the Wingspan stent. A New England Journal of Medicine study reported the death rate from stroke rose 12.2 percent in the group of patients without stents and 20 percent for the patients receiving the stent medical device. In addition, Public Citizen recently called for a recall of synthetic surgical mesh for transvaginal placement.

Product Liability

If a person is injured or killed by a medical device or any defective product marketed to the public, that individual or his survivors may be able to file a product liability action against the manufacturer who knew or should have known that injuries were likely to occur. Farah & Farah has a team of Jacksonville defective medical device attorneys who can offer you guidance in this area. Remember, you may have a limited time period within which to file a case so call us at (800) 533-3555 and we can start the conversation.

Sources: http://www.massdevice.com/news/former-cdrh-director-joins-public-citizen-demanding-recall-strykers-brain-stent; http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3489

The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall concerning a defibrillator lead that can lead to death from a defective heart rhythm. The device is made by St. Jude Medical and the FDA notified health care providers of the most serious recall of the Riata and Riata ST Silicone Endocardial Defibrillation Leads. The problem is that the silicone that insulates the covering is defective and may cause the leads to come out of the insulation. This is when a lead has the potential to misfire. The implantable cardioverter defibrillator, or ICD, is connected to the patient’s tissue through the leads whose job it is to monitor the heart rhythm. In the case of an irregular heart rate, the defibrillator, if connected properly, will deliver a jolt to encourage a regular heart rate.

The particular defibrillator leads listed in the Recall Notice says they were distributed from June 2001 to December 31, 2010, so the recall could affect thousands of patients.

St. Jude has notified physicians by certified mail of the failure rate, which the FDA does not include in this Safety Notification. As far as patients who are living with the implanted leads which could be faulty, the FDA reminds doctors that they must manage patients with this particular implant and that the doctor can report any adverse events to the FDA’s MedWatch program, which may give patients with a potentially defective implanted lead little peace of mind.

A Class 1 recall is conducted when the defective device has the potential to cause serious harm or death to a patient.

Product Liability and Medical Devices

A responsible drug or medical device manufacturer should understand their product fully before it is put into the marketplace, including any defect in the manufacturing and design, including materials used, or in a failure to adequately warn users of the product. When a company fails to do so and patients are injured, that company needs to be held accountable. Product liability litigation may ultimately be the reason a dangerous device is removed from the market.

The defective medical device lawyers in Jacksonville of Farah & Farah will offer a complimentary consultation to anyone harmed by a drug or medical device that was defective. Call us at 1(800) 533-3555 to get started.

Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284390.htm?source=govdelivery; http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm284360.htm

Hundreds of lawsuits have been filed against defective surgical mesh used to treat pelvic organ prolapse and incontinence in women. C.R. Bard is one major manufacturer and a Georgia law firm has filed to consolidate lawsuits from Florida, Georgia, and Indiana into multidistrict litigation in West Virginia. The request is for the 29 product liability lawsuits to join the hundreds filed and consolidated last October in Charleston, West Virginia.

Manufacturer C.R. Bard is the named defendant along with its subsidiary, Covidien.

The allegedly defective devices that injured women include the Pelvicol, PelviSoft, Pelvitex, Uretex, Align, or PelviLace products. The cases already pending in West Virginia include other Bard mesh products, including the Avaulta Biosynthetic, Avaulta Plus, and Avaulta Solo, as well as non-Avaulta products. (MDL 2187)

The product liability action alleges the surgical mesh is defective in its design and manufacturers failed to provide appropriate warnings of the risks associated with its use. In July, the U.S. Food and Drug Administration (FDA) issued a notification that it had received thousands of reports of adverse events or injuries associated with mesh from nine different manufacturers. Complications include erosion, infection, pain, bleeding, and repeated surgeries to have the mesh removed.

Product Liability – Transvaginal Mesh Complications

A Florida product liability lawsuit can be filed when any product is defective in its design, its manufacture, or its instructions which results in injury. Those named can include the manufacturer, the designer, and anyone in the distribution line.

More than 75,000 women a year are implanted with this defective product which never went through an approval process within the FDA for safety. Instead, it was approved for sale through an exchange of paperwork.

The Florida transvaginal mesh lawyers at Farah & Farah are talking to women injured by surgical mesh from all manufacturers which remains on the market for now. Please have a conversation with us at the first sign of pain and complications. A statute of limitations may exist on your case so a complimentary consultation as soon as possible is recommended. Call 1-800-533-3555 and we’ll be happy to set up a meeting.

Source: http://www.wvsd.uscourts.gov/MDL/Avaulta/index.html; http://www.aboutlawsuits.com/bard-pelvic-mesh-lawsuits-in-avaulta-mdl-21215/

Synthetic surgical mesh is implanted into about 300,000 women every year for the treatment of pelvic organ prolapse and incontinence. On Thursday, August 25, advocacy group Public Citizen announced it had submitted a petition to the U.S. Food and Drug Administration (FDA) calling for a ban on synthetic mesh used for pelvic surgeries. The consumer group says the risks outweigh the benefits with mesh eroding in the body, migrating, piercing organs, hardening, and causing pain, immobility, and further complications. Public Citizen was joined by two co-petitioners, Dr. L. Lewis Wall, a Professor of Obstetrics & Gynecology from Washington University in St. Louis, and Dr. Daniel Elliott, in the Urology Department at Mayo College of Medicine in Rochester, Minnesota.

POP stands for pelvic organ prolapse where the pelvic organs descend into the vagina largely due to the weakness in the connective tissue of the pelvic floor and the muscles around the pelvic organs. Surgery can be done transvaginally (through the vagina) or abdominally or laproscopically. Public Citizen calls for a ban in the marketing of all synthetic non-absorbable mesh, specifically those used in transvaginal repair of POP and orders the manufacturers to recall them. In the future any synthetic mesh should be classified as the most high-risk or Class III and be subjected to stringent post-market approval involving clinical studies, the group says, instead of being merely cleared for marketing as is currently allowed under the 510K process of the FDA.

The petition follows a July 13 FDA safety announcement saying that complications are “not rare” and have resulted in thousands of complications. From 2008 to 2010, the FDA received almost 3,000 reports of complications associated with surgical mesh used for POP and SUI repair including pain, mesh erosion, exposed mesh through the vagina and infection.

The Florida surgical mesh injury lawyers at Farah & Farah have been hearing from many men and women who are in pain and suffering as a result of a synthetic material that may not be compatible with the human body. Call us at 1-800-533-3555 so we can discuss your injuries to determine whether you have a viable claim.

Sources: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm, http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3405, http://www.citizen.org/documents/Petition_to_Ban_Surgical_Mesh_for_Transvaginal_Repair_of_Pelvic_Organ_Prolapse.pdf, http://www.citizen.org/documents/wall_statement_on_POP_mesh_petition.pdf and http://www.citizen.org/documents/1963-Elliott_statement_in_support_of_HRG_petition.pdf

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.