Incidence Of Hip & Knee Implant Failures Expected To Increase

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Defective Knee and Hip ImplantsWith more and more Americans getting hip and knee implants each year, the likelihood of more these implants failing also increases.

According to a Lawyers and Settlements report, with a continuing rise in replacement procedures and continuing problems with latest-generation devices such as metal-on-metal implants, it is fair to assume that more hip and knee implants are likely to fail.

Dramatic Increase in Replacement Surgeries

The Sandusky Register of Ohio reports that more than two out of every 100 people in the United States More

Generic Versions of Heart Drug Recalled for Serious Side Effects

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generic heart drug recallTwo large Indian manufacturers of generic heart drugs have announced recalls over the last two months totaling more than 100,000 bottles because of serious reported side effects.

According to an article in The New York Times, the recalls are the latest in the string of recent problems involving generic drugs made by Indian manufacturers such as Wockhardt and Dr. Reddy’s Laboratories.

The drug is a beta blocker that treats More

FDA Warns about Defective Philips Defibrillators that May Fail in Emergency

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The U.S. Food and Drug Administration (FDA) has issued a fresh warning to consumers about some models of HeartStart automated external defibrillators (AED) may not work during a cardiac emergency. According to a CBS news report, about 700,000 of the medical devices, manufactured by Philips Medical Systems, had been recalled in 2012, but people may still have the faulty models in their possession. The FDA is urging consumers to inspect and monitor the capabilities of these AEDs and also know how to use them during an emergency, particularly when there are no other available options.

The Philips AEDs first got FDA approval in 2004. The AEDs that are being recalled were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. These devices were recalled in 2012 because an internal electrical component was malfunctioning, causing the machine not to give a shock.

Why an AED is Life Saving

The federal safety agency is also advising that you keep the recalled HeartStart AEDs in service until you obtain a replacement from Philips or another AED manufacturer. The AED’s function is to analyze heart rhythm and deliver an electric shock, which can restart the heartbeat of those who go into cardiac arrest. In 2013 alone, about 359,400 people will have an out-of-hospital cardiac arrest, the American Heart Association estimates. If you still own one of these devices, contact Philips Healthcare for a replacement AED unit. In North America, call 1-800-263-3342 for more information.

Defective Medical Devices

When an AED fails to work as it is supposed to, it may become difficult or impossible to resuscitate someone whose heart has stopped functioning. Anyone who has been affected by a defective medical device can file a product liability claim against the manufacturer of the defective product. In cases where a person has died, his or her family can file a wrongful death claim against the product manufacturer. Victims or families of deceased victims would be well advised to contact an experienced product liability lawyer who will ensure that the negligent manufacturers are held liable. The best product defect law firms will always offer a free consultation and comprehensive case evaluation to injured victims and their families.

FDA Issues Warning on Medtronic Devices

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Federal health officials have issued a defective product recall for about 15,000 Medtronic guide wires used in heart procedures. According to a USA Today news report, the recall was issued after Medtronic received four serious complaints. Officials say that the defects are severe enough to cause injury or death. The guide wires involved in this recall are inserted through an artery and are used to guide other devices into place, such as stents to hold open blocked arteries.

Potential for Serious Injury or Death

In one complaint involving this device, a patient went into cardiac arrest but was resuscitated. The recall notice warned hospitals and distributors worldwide that the coating on the guide wires could break off, which could increase the possibility of blocking a blood vessel. The coating on the wires is meant to make them slide through the blood vessels more easily. The FDA has classified this as a Class I recall, a category reserved for defective products with the potential to cause serious injury or death.

Medtronic, which is based in Minneapolis, said the recall affected certain lots of the products manufactured since April. The company said it has taken steps to prevent new shipment of the wires and has notified regulators globally. Any problems with the defective medical devices can be reported by calling 1-877-526-7890 or to the FDA’s web site at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

Defective Medical Devices

Flaws in medical devices may occur due to manufacturing defects, defective design or defective marketing. If you have been injured or have suffered a loss as the result of a defective medical device, a number of parties may be held liable. The manufacturing company, a testing lab, a medical sales representative, medical clinic or doctor, may all be potentially liable parties in a product liability lawsuit involving a faulty medical device.

If you have been injured as a result of using a faulty medical device, an experienced product liability attorney can help you prove that the device was faulty and caused your injuries. All product manufacturers have a legal obligation to consumers to manufacturer products that are safe and of good quality. When they fail to do so, they can and should be held accountable. Injured victims in such cases can seek compensation for damages such as medical expenses, lost wages, hospitalization, pain and suffering and emotional distress.

Women Say Permanent Contraceptive Device is Causing Excruciating Pain

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A Ventura County mom says a permanent contraceptive device called Essure has caused her and thousands of other women excruciating pain. According to a news report on CBS Los Angeles, Tanya Lovis says she was walking around hunched over holding on to her stomach for three weeks out of the month and that “the pain was just too much to bear.” For 10 months, doctors could not figure out what was wrong with Lovis. When she started researching her condition online, Lovis says she found 1,800 women on Facebook who had also opted for Essure and were experiencing similar symptoms. More

New Concerns about the Safety of Robotic Surgeries

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A new study in The Journal for Healthcare Quality states that injuries and fatalities caused by the da Vinci robotic surgery system are being grossly underreported. According to an article in The New York Times, the equipment is being made by Intuitive Surgical Inc. based in Sunnyvale, California. More than a million procedures have been performed with it. Between January 2000 and August 2012, thousands of mishaps were reported to the U.S. Food and Drug Administration (FDA).

Among those were 71 reports of deaths and 174 injuries. Combining news reports and court records, researchers at Johns Hopkins were able to find examples of botched operations using the da Vinci system that were not reported to the FDA. The study concluded that adverse events associated with the da Vinci system were “vastly underreported.”

Prevalence of Robotic Surgery

The New York Times cites the example of Erin Izumi, a woman in her 30s from Tacoma, Washington, who underwent robotically-assisted surgery to treat endometriosis. Ten days after an 11-hour surgery she was rushed to the emergency room where doctors discovered that her colon and rectum had been torn during the operation. While what is reported to the FDA only represents the “tip of the iceberg,” many hospitals nationwide are aggressively marketing the benefits of robotic surgery without really telling consumers the high risk involved. Intuitive officials say they have been diligent about reporting adverse events.

Robotic surgery has grown dramatically in the five years between 2007 and 2011 – with a 400 percent increase. About 1,400 da Vinci systems, which cost $1.5 million to $2.5 million, have been purchased by hospitals nationwide. The Johns Hopkins study looks at documents detailing aggressive tactics used to market the equipment and raises questions about the quality of training provided to surgeons in addition to pressure put on doctors and hospitals to use it.

Protecting Victims’ Rights

In my opinion, this is an extremely disturbing report because not only are these devices causing injury and harm, but they are being aggressively marketed to consumers and to surgeons and hospitals. In addition, doctors are not receiving the training to use this equipment. If you or a loved one has been injured as a result of a botched robotic surgery, please contact an experienced California product liability lawyer to obtain more information regarding your legal rights.

Are Vaginal Mesh Implants the Cure or the Problem?

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A recent article in the Houston Chronicle asks an important question: Do transvaginal mesh implants worsen the condition of women who suffer from pelvic organ prolapse instead of providing a cure? The Chronicle reports that 3.3 million women in the United States suffer from pelvic organ prolapse and stress urinary incontinence and 350,000 of those patients undergo surgery to rid themselves of pelvic pressure and lower back pain caused by those conditions.

However, what many women are finding out is that the cure for the problems associated with pelvic organ prolapse seems worse than the condition itself. This is true particularly if the surgery involves a transvaginal mesh implant. These implants are made of nonabsorbent material and are intended to provide better support for the pelvic area compared to stitching or grafts.

However, women who expected a cure did not get it. The mesh implants caused significant problems including erosion leading to chronic pain, painful intercourse and even nerve injuries. The mesh, in many women, was popping out through the vaginal walls cutting through the surrounding tissue and causing excruciating pain.

Understanding the Risks of Surgery

In 2008, the U.S. Food and Drug Administration (FDA) alerted consumers about vaginal mesh implants and the complications involved. In 2011, the alert was updated stating that complications were more common than initially thought. Doctors are now telling women that mesh implant surgery for prolapse is often not the only or best option. Prolapse is not life threatening, but a quality-of-life issue. Women who are seeking treatment should look into all options. They should equip themselves with the most information so they can make a decision regarding their course of treatment.

Liability Issues

Women who are experiencing the serious side effects of vaginal mesh implants have filed thousands of lawsuits. One woman who was recently awarded $3.3 million in compensatory damages and $7.8 million in punitive damages testified during the jury trial that the Ethicon mesh was marketed to her as safe and effective.

Anyone who has suffered the adverse effects of these vaginal mesh implants would be well advised to contact an experienced product liability attorney who is currently handling these cases. Please remember that you have legal rights and the right to file a claim seeking damages for your significant monetary and other losses.

First Legal Trial Against Ethicon Sets Stage For Subsequent Legal Actions

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Johnson & Johnson and its subsidiary, Ethicon, are facing their first legal trial in a consolidated proceeding in Atlantic County in New Jersey. The proceeding is one of the 1,800 lawsuits that Johnson & Johnson and Ethicon currently face due to the failure to disclose some of the dangerous risks in the label of its transvaginal mesh product, Prolift.

Prolift was introduced to the market in 2005 after it received the approval of the U.S. Food and Drug Administration through the fast-track approval system. The transvaginal mesh was claimed to be similar to Gynecare so that it could bypass the additional testing required for the approval to market the drug.

However, it was not until March 2012 that the FDA released a communication confirming that the Prolift was initially marketed without any clearance or approval, that tests should have been done to determine its readiness for the market, and that it had been illegally marketed to the consumers, risking their health and well-being.

Prolift is used for the treatment of women who have pelvic organ prolapse (POP) and/or stress urinary incontinence. Pelvic organ prolapse is a condition wherein the pelvic organ drops and presses against the vaginal wall. The mesh product works by keeping the organs in place. The problem arises when the mesh product disintegrates or contracts.

Some women complain about pain especially during sexual intercourse. There are other complications that are potentially linked to the use of Prolift, which is why lawsuits have been filed alleging the lack of proper safeguards on the part of Johnson & Johnson and Ethicon to ensure patient safety.

If you want to have your Prolift case evaluated, you may contact our Prolift lawyers at our toll-free number, 1-800-992-6878.

d’Oliveira & Associates 2540 Pawtucket Ave, East Providence, RI 02914 (401) 431-1990

Federal Prosecutors Investigating Recalled Defective Hip Implants

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Federal prosecutors are probing Johnson & Johnson’s practices when it came to marketing a line of hip replacements recalled in 2010 because of the high rate of revision surgeries. According to a news report in The Associated Press, the hip replacement recalls were a part of more than 30 product recalls by the health care giant just in the last three years.

defective hip implant

The U.S. Attorney’s Office in Massachusetts and the Civil Division of the U.S. Justice Department last August sent Johnson & Johnson an “informal request” for information about its ASR hip replacements, the company reported in a regulatory filing.

The government has apparently asked for additional documents from the company and its subsidiaries, DePuy, which is one of the world’s largest manufacturers of joint replacements and other orthopedic surgical products. DePuy recalled two artificial joint systems — the ASR Hip Resurfacing System and the ASR XL Acetabular System — in August 2010 because of unexpectedly high rates of failure.

In those cases, the implants came loose or tiny pieces of metal from the defective hip implant had disintegrated into the patient’s body causing immune problems. Several studies including Johnson & Johnson’s own internal study corroborated the fact that these hip implants were susceptible to early failure.

Series of Medical Device Recalls

In 2007, the company paid $84.7 million in government fines as part of a sweeping investigation by the Justice Department into alleged kickbacks where J & J and four other top manufacturers of hip and knee replacement devices were accused of paying surgeons to get them to use their products exclusively between 2002 and 2006.

J & J’s spate of recalls has continued into recent weeks. Last week, the company issued a recall on its “Adept” brand of all-metal hip implants due to high failure rates. On February 22, it recalled its LPS Diaphyseal Sleeve, a knee replacement device, because of the possibility that patients to suffer fractures, loss of mobility, loss of limb, infection or even death.

Justice and Compensation for Victims

The results of the federal probe are still unknown. But, it would be interesting to see how Johnson & Johnson marketed its products. Did the marketing continue even after the company knew that its products were defective and were likely to fail earlier than expected? I hope that is a question federal officials ask.

Victims of these dangerous and defective devices face serious consequences including loss of mobility, loss of income and loss of livelihood. In addition, they are saddled with medical expenses such as cost of surgery, hospitalization and rehabilitation. Anyone who has been injured as a result of a hip or knee implant device would be well advised to contact an experienced product liability lawyer who will fight for their rights and ensure that justice is served.

Plaintiff in Vaginal Mesh Case Testifies that She Cannot Work, Enjoy Sex or Even Sit Down

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As a personal injury law firm that is representing many women who have been severely injured as a result of defectively designed and manufactured transvaginal mesh implants, we completely understand what Linda Gross had to endure. Gross, 47, testified in her case against Ethicon in New Jersey, the first out of thousands of vaginal mesh cases against different manufacturers that has gone to trial.

According to news report, Gross told a jury that as a result of a Prolift Gynecare vaginal mesh implant she received in 2006, she cannot work, enjoy sex with her husband or even sit down for more than 20 minutes at a time. There are days, she says, when she cannot even get out of bed. Like many of the victims we encounter, Gross has undergone several surgeries to remove the vaginal mesh to relieve her chronic pain.

Serious Side Effects

What I find interesting about her testimony is the reason she decided to get the implant. Gross said she was impressed by Prolift because of the marketing brochure put out by the company, Ethicon. The brochure claimed that the surgery was minimally invasive, specially designed and “clinically proven.” It also advertised the procedure as low-risk stating that complications are “rare.”

Well, now we know that’s not true. Even the U.S. Food and Drug Administration (FDA) has issued warnings about these products stating that they are known to have cause serious, painful complications in thousands of women. The product is support to alleviate symptoms of pelvic organ prolapse and stress urinary incontinence. But, on the contrary, it causes severe complications including mesh erosion, nerve damage, infections, pain, vaginal scarring and urinary problems.

Holding Negligent Manufacturers Liable

It is appalling that the manufacturers of these products not only failed to warn consumers about the serious complications that could arise from using these products, but marketed the mesh devices with the promise of relief and minimal symptoms. I certainly hope that these women are able to get justice and fair compensation for their losses. I also hope that these manufacturers are held accountable for their negligence and callous disregard for the health and safety of those who buy their products.

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