Articles Posted in Defective Medical Device

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The Stryker Rejuvenate hip implant is a defective medical device that suffers from similar flaws as the DePuy hip replacement product. Elements of this implant contain metal-on-metal qualities that may lead to very serious complications. Many adverse reactions to the product have been reported, internal and external product testing has confirmed the potential dangers of this product, and there are currently lawsuits filed against the manufacturer.

The friction of its metal parts can lead to, according to Stryker, “…a potential for fretting and corrosion at the modular neck junction which may lead to adverse local tissue reactions.” Such reactions include unbearable pain, swelling, and the development of metallosis. Metallosis is the buildup of metal debris in the body caused by the grinding of metal parts. Effects of metallosis include dislocation, bone deterioration, and metal toxicity. These products suffer from a very high early failure rate as well, working directly against their original marketing as a more long-lasting product for younger patients. Often patients implanted with defective devices must consequently undergo extremely costly and painful revision surgeries to correct the trouble.

Additionally, after reports of trouble with Stryker hip implants began to mount, the FDA launched an investigation into one of its manufacturing facilities. The disappointing findings included inadequate quality control measures and even the presence of the Staphylococcus bacteria. In 2007, the FDA warned Stryker to rectify these problems immediately or face very detrimental consequences. These deficiencies are independent of the serious structural problems that plague the two recalled implants.

Reuters reports that Stryker recommends clinical follow-up for all patients affected by the July 2012 recall of Rejuvenate and ABG II modular hip stems. Such clinical follow-up should include blood and imaging tests even if the patient is not experiencing pain, swelling or other symptoms that might suggest hip implant failure. Stryker contends that they have received reports of patients with no or mild symptoms who still found high levels of metal ions in their bloodstream and evidence of local tissue reactions.

Stryker stated that the hip implant recall could ultimately cost between $190 million and $390 million in order to cover patient testing and treatment, new surgeries, lawsuits and insurance payments.

If you have suffered from complications associated with the Stryker Rejuvenate product, don’t hesitate to contact a lawyer and find out what justice you may be entitled to for your physical, mental, or financial distress.

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New records have come to light in the face of impending trials regarding Johnson & Johnson’s metal-on-metal hip replacements. The company recalled their ASR (Articular Surface Replacement) implants in August of 2010. Over 31,000 patients have received these implants worldwide. There are now over 10,000 lawsuits against the manufacturer citing premature failure and metal poisoning, among other complications. Most of these lawsuits are consolidated in California and Ohio, and the trial proceedings in the California Superior Court are expected to begin today.

Newly disclosed court records show that in 2011, Johnson & Johnson conducted an internal analysis of the device, not long after the troubled hip implant was recalled. According to the New York Times, the analysis estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it. While Johnson & Johnson never released the results of this investigation, the company downplayed the result of a British study with similar findings.

According to Bloomberg, J&J defends their actions by stating that they were attempting to look out for patient interests by conducting an internal review, but that their analysis was based on too small of a sample to be generalized, unlike other published data on the matter. However, regardless of intent, this new information may prove very important in the upcoming trials on this defective medical device; many lawyers representing hip replacement patients have rejected Johnson & Johnson’s offers to settle outside of court.

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“The Food and Drug Administration said Monday it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology,” reported CBS News last week.

A nonprofit group named Medical Device Innovation Consortium (MDIC) was formed to improve the approval process of medical devices. This process is currently slow, complex and sometimes doesn’t even require clinical trials. This organization’s mission aims to speed up, simplify and ensure the quality of medical device testing. Minnesota-based LifeScience Alley founded this new consortium.

Since most medical device companies are small businesses, their budgets and staff don’t allow for extensive research and testing. This new agency, the MDIC, will procure high quality information and research from the government, industry and academia.

The new group reported that 17% of Americans currently are living with an implanted medical device of some sort. That is too high of a percentage to take testing these implanted devices lightly.

So what does this mean for consumers? It means that with this new nonprofit in place, we may have easier access to more efficiently and thoroughly tested medical devices. This would save the pain of dealing with faulty transvaginal mesh procedures or complications with metal-on-metal hip replacements. This could save medical device consumers thousands of dollars in lawsuits and years of suffering and pain.

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Boston Scientific, a worldwide developer, manufacturer and marketer of medical devices, stated that it is facing more than 2,500 product liability lawsuits over transvaginal surgical mesh implants. The liability lawsuits are due to “defective design and manufacturing, a failure to warn, breach of warranty, fraud, loss of consortium and violations of state consumer protection laws.”

Boston Scientific was contacted by Kamala Harris, the California Attorney General, warning them that multiple attorneys general offices plan to initiate a civil investigation on the sale of synthetic transvaginal mesh. The company released this information in its quarterly regulatory filins with the Securities and Exchange Commission (SEC) on Nov. 6. The company, based in Massachusetts, will face these lawsuits in the coming months in various state and district courts.

There is an estimated 29% adverse events rate with synthetic mesh operations. Lawsuits against six various vaginal mesh manufacturers have reached 10,000 cases and are growing. According to court records in Georgia, West Virginia and New Jersey, and that number is expected to double. The pain that women endure caused by mesh erosion, organ perforation, mesh and vaginal shrinkage and other “adverse events” should be ended.

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hipski.jpg For the past two years, claim after claim has been filed against Johnson & Johnson subsidiary DePuy for their questionable ASR metal-on-metal hip replacements. As the two year anniversary of the manufacturer’s voluntary product recall is upon us, the window of opportunity to file your claim may be closing. It’s time to take action.

In August 2010, DePuy issued a voluntary recall of its ASR hip replacement system “after receiving new, then-unpublished data from a joint replacement registry in the UK.” More hip replacement patients than previously expected or reported to DePuy had to undergo a revision surgery. This process is painful, unfair and frustrating.

At Borchardt Law Firm, we strongly encourage those who have been affected by faulty medical devices to speak up, learn your rights, and file your claim. The time is now! Nobody should have to walk wounded daily, especially when it’s not their fault. If you or a loved one received a DePuy hip implant between 2005 and 2010 and are experiencing pain or adverse effects, don’t fight this alone. Give us a call; it may not be too late for you to receive the justice and wellness you deserve.

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A recent survey shows that specialists have decreased their use of travsvaginal mesh (TVM) for the surgical treatment of pelvic organ prolapse (POP).

In July 2011, the U.S. Food and Drug Administration issued a warning that TVM products put patients at a higher risk of developing adverse effects from the procedure. The FDA continued to say that “…serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”

Earlier this month the American Urogynecologic Society held its 33rd Annual Scientific Meeting in Chicago. At the event, a team headed up by Catherine Matthews, MD, from the Univeristy of North Carolina Chapel Hill presented the results of a November 2011 survey for surgeons. This survey’s purpose was to determine whether practitioners were heeding the TVM warning issued by the FDA just months before.

The survey revealed that almost one-fourth of the 281 specialists surveyed were observing the FDA warning by decreasing the use of vaginal mesh to correct POP cases.

Because of the potentially dangerous effects of TVM procedures, at Borchardt Law Firm, LLP we see the results of this survey as extremely positive. Thousands of women are currently suffering pain because of complications with this all too often faulty procedure. It’s exciting to see tangible results of doctors moving away from mesh solutions.

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Screen shot 2012-09-26 at 10.36.44 AM.png New data show that metal-on-metal hip implants are not linked to an increased risk of cancer within the seven years after the procedure.

Although these typically harmful medical devices have caused a multitude of other health defects, the U.K. National Joint Registry (NJR) stated earlier this month in their annual report that it cannot link the hip replacement surgery with cancer in the short term.

While this is good news for hip replacement patients and the medical community, the NJR also said, “We must, however, point out that many cancers have prolonged latency after initial exposure to carcinogens and thus long-term follow up is needed to provide a definitive answer.”

Big-name manufacturers that have faced lawsuits include DePuy Orthopaedics and Stryker Corporation. Manufacturers such as these must be held responsible for the adverse effects of their products that suffering patients must endure. Metal-on-metal hip implants have extremely high failure rates. Although they are expected to last an average of 15 years, an estimated 80% of DePuy implants fail just 8 years after surgery.

Problems after surgery range from pain, swelling, limited mobility, trouble walking, and dislocation, to a very serious disease called metallosis. The grinding that occurs between parts of the hip replacement can release metal debris into the body and bloodstream, causing the blood levels of chromium and cobalt to become dangerously high. This metal poisoning in the blood can cause cardiovascular, neurological, thyroid and renal issues in the body as well as destroying muscle, tissue, and bone.

Many variations of these metal-on-metal replacements were FDA cleared by the 510(k) program, which acts as a fast track for getting innovations in medicine on the market. Although this process makes cutting-edge products readily available to patients in need, it has also proven to be dangerous. Because manufacturers don’t necessarily have to guarantee their safety or effectiveness as they would in a typical FDA clearance, corners are cut and consumers are put in potential harm.

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laydown PM.pngThe legal controversy surrounding transvaginal mesh procedures is nothing new. The complications with surgeries, warnings from the U.S. Food and Drug Administration, abounding lawsuits, and unhappy patients seem to be ever-present in the media. However, something that may have been flying under consumers’ radars is that some drug manufacturers are under scrutiny for deliberately withholding vital information from consumers.

On Aug. 8, 2012, New Jersey judge, the Honorable Carol E. Higbee, issued an Order for drug manufacturer Ethicon to release all of their communications with the U.S. Food and Drug Administration (FDA). Ethicon is a subsidiary of healthcare superpower Johnson & Johnson. Higbee has presided over all transvaginal mesh (TVM) lawsuits filed in New Jersey state court. Although FDA warnings for TVM cases have been in effect since 2008, after thousands of cases Judge Higbee continues to crack down on these companies to hold a high standard of transparency.

The mesh treatment was originally known as the magic cure for urinary issues and bladder, bowl and uterine prolapse. Over time, procedure complications can cause mesh erosion, contraction, migration and exposure, as well as the formation of scar tissue.

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A verdict has finally been reached in the first transvaginal mesh lawsuit to go to trial. C.R. Bard, a medical device company, has been ordered to pay a significant amount in damages for the horrific complications it caused one patient after being implanted with an Avaulta device. This woman suffered incapacitating complications as her implant began to cut into surrounding tissues and organs, leaving her with many painful corrective surgeries. After years of legal battle, her family may have finally found justice. The jury deemed that Bard was 60% liable for the damages caused by the product, and the operating doctor 40% responsible for faulty implementation of the device. However, the doctor will not be forced to pay in the settlement.

Surgeries involving transvaginal mesh have proven the risk for disastrous consequences. Some side effects include organ perforation, extreme pain, infection, bleeding, urinary problems, mesh contraction and mesh erosion through the vagina. After such complications ensue, multiple surgeries are often required to remove the device and reconstruct any damage it caused. These complications may leave a patient in severe and chronic pain for long periods of time. A patient may suffer for years after their original surgery from debilitating pain and discomfort.

According to the Legal Examiner, “On July 13th, 2011, the FDA released an updated safety concern that stated ‘serious complications associated with surgical mesh for transvaginal repair of POP are not rare'” It was ultimately decided that transvaginal mesh products are high risk and are not more effective than more traditional, non-mesh procedures. Across the United States, there are thousands of transvaginal mesh lawsuits being filed, against many different manufacturers. The Sacramento Bee states that over 47,000 women have received an Avaulta implant, and that there are currently over 650 lawsuits against Bard pending. Johnson & Johnson, another notable medical device manufacturer faces over 1,400 transvaginal mesh lawsuits.

What does all this mean? If you have suffered serious side effects due to a transvaginal mesh implant, you could be eligible to receive justice and compensation for your troubles. At least one jury has decided in favor of the victims of such defective medical devices. Don’t hesitate to contact a lawyer and find out what potential your case may hold.

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