As a patient, being a health advocate is important. As our world progresses so does technology and the advancement in the medical field. Companies are making products so quickly, so the product can be sold in stores. Often products have not been tested to ensure the product works correctly. This therefore leads to severe consequences. As patients and citizens we trust doctors and hospitals to care for us in a proper and safe manner. We also trust companies to produce products that are not harmful and work correctly, although more times than not this does not happen. From simple products that you receive from the convenience store to products that could save your life, need to work properly.

Jason Peters, a Philadelphia Eagles left tackle player ruptured his Achilles tendon in March 2012. He was told to use a rolling walker after his surgery on his Achilles tendon. A rolling walker enabled Peters to still be mobile without putting pressure on his Achilles tendon. There are various amounts of rolling walkers, although the one Peters was using was one that he put one knee on while pedaling with the other leg. However, Peters walker broke below the handlebar while he was using it. This failure led to Peters re injuring his Achilles Tendon during the fall which resulted in another surgery on Peters Achilles tendon. The second surgery prevented Peters from returning for the 2012 season. The Roll-A-Bout walker is suppose to hold any person up to 500 pounds. Peters was 340 pounds which does not explain why the walker broke. The malfunction of the walker has not been stated but assumed that the walker was just broken. Peters was awarded $2 million in the lawsuit against the walker company.

Something simple as a walker can cause injuries that could have been prevented. However it is hard to ensure that a walker is working properly because we just assume that things similar to this are in proper condition. However if you or someone you know used a walker, be a health advocate and make sure it assembled properly. It is essential to triple check that all the parts are assembled correctly to prevent casualties from happening.

In addition to making sure walkers are in the best condition before use, as patients it is important to make certain prescribed drugs are suitable for you. One minor mishap could cause severe complications to you or a loved one. As patients we can prevent from horrible medical malpractice, defective medical device or a defective product. It is easy to check to make sure that what you are using is right for you. It is more of a hassle and life threatening to deal with the complications from not being proactive.

If you or a loved on has been hurt in a walker accidents please call for a free consultation. No one deserves to be hurt when it is out of their control.

Please call us for a free consultation.
Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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The transvaginal mesh is surgically implanted through the vagina to help support the organs. However, as with many technological advances, this breakthrough also came with its share of disadvantages. The transvaginal mesh is associated with many complications. The most common are organ perforation and erosion. Transvaginal mesh erosion, also called mesh extrusion, occurs when the rough edges of the synthetic mesh cut through the vaginal lining and nearby organs. This can cause organ perforation, infection, bleeding, pain during intercourse and urinary problems. The Food and Drug Administration (FDA) noted that there are reports of recurrent prolapses, neuromuscular problems, vaginal scarring and emotional problems as a result of the mesh. Other complications include constipation and urinary incontinence (UI). UI is the involuntary loss of urine usually during pregnancy, after childbirth and menopause.

There have been many issues and complications associated with the FDA concerning the transvaginal mesh. A similar mesh has been used successfully for many years to remove hernias. However, the mesh was never tested by the FDA for use in vaginal repairs. The FDA’s fast-track approval system, called the 510(k), doesn’t require testing prior for a product’s release into the market as long as the product is similar to an already-approved product. In this case, the successful removal of hernias was the similar procedure and thus the mesh was approved.

In addition, after the FDA assessed the mesh further, conclusions were that the mesh does not fix the symptoms of pelvic prolapse or improve the patient’s quality of life more effectively than non-mesh repairs. The FDA also concluded that using the mesh causes more risks than a non-mesh repair would. There is no evidence that mesh used for repairs on the top or back wall of the vagina provide any added benefits compared to traditional surgeries without the mesh. The FDA also found that the mesh can shrink or contract once inside the patient causing pain and tightening. This erosion and contraction can lead to pain during intercourse. It can also cause irritation of the penis when exposed to the mesh. The drugwatch has more information concerning this issue.

American Medical System Inc., unit of Endo Health Solutions agreed to pay $54.5M to settle lawsuits of women who were in pain and left with incontinence after having transvaginal mesh surgically implanted. Officials of the company said in a securities filing that the medical device maker is paying to resolve an unidentified number of suits over the company’s vaginal-mesh devices. These devices include the Perigee, Apogee and Elevate implants.

There are 5,000 vaginal mesh suits that do not affect the settlement of the American Medical System. All 5,000 suits are being consolidated for pre-trial proceeding before a federal judge in West Virginia. The first case is set for December 2013.

If you or a loved one had transvaginal mesh implanted and has experienced complications or pain, please consult your doctor. In addition please call us for a free consultation. It is your right to learn the best treatment possible and your legal options concerning this issue.

Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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The Form 483 is a notice that informs a company about possible violation(s) of federal regulations that are found by FDA inspectors. These are inspection observations and do not represent a final determination by the agency regarding compliance.

The FDA noted in its observations that a correction conducted by Intuitive to reduce the health risks posed by its devices was not reported in writing to the agency. According to the FDA, on October 10, 2011 Intuitive notified patients about “suggestions and recommendations for the proper use of instruments with tip coverage and for the correct generators that should be used with mono-polar instruments.” This was not reported to the San Francisco District Recall Coordinator. This notice was in response to the 134 complaints and 82 filed Medical Device Reporting, or MDRs, related to tip cover issues.

On October 13, 2011, the FDA noted that Intuitive sent another letter to da Vinci Surgical Robot clients informing them that the devices were not cleared for thyroidectomy indication. However, the company did not report this to the regulator. The agency noted that Intuitive received 13 complaints and filed five MDRs related to thyroidectomy performed with the devices.

Intuitive sent another letter to da Vinci clients on October 17, 2011 with information on the proper flushing of instruments, the proper transportation of the da Vinci between buildings and inspecting instrument cannulas. This information was also not reported to the San Francisco District Recall Coordinator.

Intuitive also did not report injuries or illnesses that occurred with the use of correctable devices. This includes the five MDRs associated with the action taken on October 13.
In addition, Intuitive did not establish procedures for design changes. They did not document the decision to add thyroidectomy indication to the da Vinci system general laparoscopy clearance. At the time there was no procedure in place to document this, but on April 2, 2012 there was a procedure.

Finally, Intuitive failed to adequately document design input requirements. The intrasurgical cleaning of surgical instruments was not part of the user needs included with the robot. However, the design of surgical instruments is commonly known to need cleaning during surgery.

With all of these observations, the San Francisco District Recall Coordinator was never notified.

These observations are essential for the use of the da Vinci Robot manufactured by Intuitive Surgical, Inc. As patients we trust our physicians to do the right thing. We also trust the companies who produce products to uphold certain standards that keep us safe. When information is not released to the FDA about an issue like this, serious complications arise. If you or a loved one had surgery performed by a da Vinci Robot and may be injured please call us for a free consultation. Justice can be sought and no innocent person deserves to be injured.

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Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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Stryker’s Rejuvenate Modular system was approved by the Food and Drug Administration (FDA) in June 2008. The ABG II system received FDA approval in November 2009. However, both of the products were submitted under FDA’s 510(k) Premarket Notification Process. The process does not test the product if it is similar to one the FDA has already approved. Thus neither product was tested and both were approved because they were similar to other “sanctioned technologies.”

Approximately 20,000 Stryker Rejuvenate and ABG II devices were implanted between 2009 and 2012. Before the recall, Stryker acknowledged that the company was aware of the problems in an Urgent Field Safety notice sent to doctors in April 2012.

Stryker suggests that surgeons consider performing a clinical examination, such as blood work and cross section imaging on all patients who received a Rejuvenate or ABG II modular-neck hip stem regardless of whether a patient is experiencing pain and/or swelling. Physicians should also perform a repeat follow-up examination, such as blood work. Cross section imaging should be considered even in the presence of normal initial findings, according to Stryker.

If you or a loved one is a patient who received Rejuvenate and ABG II modular-neck hip stems frequently asked questions for your physician are crucial in the follow up appointment. In addition Stryker is reimbursing patients for testing, treatment, revision surgery, and other costs relating to this voluntary recall, only if necessary. Questions on claims and reimbursement may assist you further. Stryker is partnering with Broadspire Services, Inc., immediately. This is a third-party claim that will help mange requests for reimbursements of costs relating to the voluntary recall.

If you or a loved one had one of these devices implanted and suffered from complications or side effects, you have the option to seek justice. You are not alone, while 20,000 other patients received the same procedure. Please feel free to give us a call for a free consultation.

Many of the orthopedic surgeons in the Dallas/Fort Worth area used the Stryker Rejuvenate and ABG II neck stems. Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.

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The da Vinci robot has also surprised Wall Street in “growing sales but also concerns.” The da Vinci Surgical Robot is manufactured and marketed by Intuitive Surgical, Inc. of Sunnyvale, California. Sales of the robot are growing, starting with 40 machines in 2000 and increasing to 2,500 in 2012 and 450,000 surgeries. Hospitals all around the country have this machine and surgeons perform countless surgeries using the robot. It has been marketed as a way to increase their revenue and gain market share. Hospitals and physicians around the country, regardless the cost of $1 million dollars to make and use, have not been deterred and continue to use this product to perform surgeries. Intuitive Surgical Inc. pays for doctors to have a two-day tutorial on the product and ensure doctors are performing the best surgeries possible. Some hospitals continue their own training on the product while other hospitals allow their surgeons to perform surgeries after just two days of training. Many lawsuits have resulted from inexperienced and uneducated physicians using the robot.

Always ensure your surgeon is experienced and well trained. This is one way to prevent from malpractice and complications for you or a loved one.

The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database is the best source for medical adverse events. Since 2000, the database shows reports of at least 85 deaths and 245 da Vinci-related injuries.

These injuries could result from numerous incidents but one da Vinci lawsuit has resulted from surgical tips (scissors) of the arms that were not insulated. According CNBC, “micro-cracks” in some models of Intuitive Surgical’s monopolar curved scissors can cause leaks that “may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause thermal injury”. The article goes on to say that “these micro-cracks may not be visible to the user.” Because of these cracks, an electric current jumps from the tip of the arm to healthy internal organs and tissue. It is a spark that is burning the organs and leading to severe injuries and even death.

Da Vinci Surgical Robot injuries include surgical burns to arteries or organs, peritonitis (painful and tender inflammation of the lining of the abdomen), sepsis, excessive bleeding, burning of nearby organs including the intestines, punctured blood vessels, organs or arteries, burns and/or tears of the intestines, bowel injuries, punctured or cut ureters, vaginal cuff dehiscence (reopening of the incision made to remove the uterus and cervix during a hysterectomy), additional surgical procedures following robot surgery, swelling of the belly, no appetite, a fever, and wrongful death.

Some critics say Intuitive Surgical Inc. is ignoring the defect of the tip of the arms and care more about profits from the product.

The da Vinci Robot is a groundbreaking invention. It has created better surgeries for surgeons and greater results for patients. However, a defective tip on the product is harming innocent patients, which could lead to serious injuries and even death. Every patient deserves justice. Technology and the advancement of our world should not lead to something worse. This machine was designed to help and improve surgeries, not create more complications.

If you or a loved one has experienced a situation similar to this please give us a call. No one deserves poor medical treatment. We accept all cases regarding defective or unsafe medical device.

Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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Medtronic allegedly promoted and encouraged its use in other types of spinal surgeries including thoracic fusion, cervical fusion, posterior lumbar fusion and multilevel fusion. The “off-label” use that physicians were implementing was not approved by the FDA. The use of the INFUSE Bone Graft generated more than $3 billion in sales for Medtronic. When an “off-label” is used by physicians, they must relay all of the risks and complications that may come with the “off-label” product prior to the surgery. Once the patient gives consent they may risk their life in order to use the “off label” product. Some physicians who were using the INFUSE Bone Graft in ways that were not approved by the FDA, received payments from Medtronic to use the Bone Graft. These physicians did not notify their patients of the risks that come with using “off-label.”

The use of this Bone Graft incorrectly can lead to swelling of the airways resulting in difficulty breathing, swallowing or speaking, respiratory depression, nerve damage, male sterility, formation of inflammatory cysts, unwanted bone growth, and even death. These symptoms occur two to fourteen days after surgery.
Situations like this one or very similar can result in unfortunate situations that no one should encounter. If you have received an INFUSE Bone Graft or know of someone who has they could have symptoms similar to the ones above. Do not let a situation like this be ignored. Please call for a free consultation to ensure that you or a loved one is getting the best health care service possible. The misuse of a medical device can be extremely risky.

If you are a loved one has encountered a situation like this, call us for a free consultation. Borchardt Law Firm represent clients all across the country to settle cases regarding improper use of medical devices. Feel free to give us a call.

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The medical device manufacturer Intuitive Surgical, Inc. continues to run into legal trouble over their Da Vinci Surgical Robot. An increasing number of injuries connected to this device and questions over Intuitive’s training and credentialing processes have made this product the source of numerous lawsuits.

Intuitive’s surgical robot was cleared by the FDA in 2000 and claims to be a much-desired minimally invasive alternative to traditional surgery. The robot functions similar to a video game; the physician sits several feet away from the patient and uses a small screen and hand and foot pedals to control the robotic arms. According to the Los Angeles Times, use of the Da Vinci robotic surgery “…has quadrupled in the last four years, and the machine now helps with incisions and sutures in 2,000 hospitals around the world.”

Although this medical device has been touted as a great innovation superior to traditional surgery, its risks may outweigh the benefits. Common complications associated with the Da Vinci robot include extreme internal burning in areas surrounding the incision site. Additionally, Reuters reports that nerve damage has increasingly become a problem in these robotic surgeries due to the way the device requires a patient to be placed on the operating table. These “positioning injuries” occur because the patient must lie on a large ramp, with their head closest to the ground, to allow the doctor greater traction. However, sliding can easily occur and the patient can experience pulling on their nerves. Reuters reports a study in which of 334 patients who underwent Intuitive’s robotic surgery, 22 woke up with nerve injuries related to their positioning.

In addition to the danger of severe complications, Bloomberg has recently noted that some of Intuitive’s business operations may also be questionable. According to recent lawsuits, Intuitive has insufficient training regimens available to those who will operate the device. The major problem with Intuitive’s training regimen is the lack of requirement for doctors to practice under the guidance of a physician who is experienced with the surgical robot. In fact, in the attempt to sell his product, one Intuitive salesman reportedly told a hospital that five supervised surgeries is too many, that a doctor may be considered credentialed to use the robot with even less supervision. This salesman’s manager praised him for using this tactic.

According to the San Francisco Chronicle, the FDA recognizes that the alleged problems with the Da Vinci Surgical Robot have led to over 4,600 injuries and at least 80 deaths. Don’t let a defective medical device ruin your life. Profit-driven medical device manufacturers may often mislead the physicians and the public about the real risks and training requirements of their product in order to reach the highest sales margin possible. It is crucial to know the facts of a given procedure, and those facts may not always be easy to find. Borchardt Law Firm is committed to defending the rights of those who may have suffered devastating injuries from defective medical devices.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one has ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

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DePuy and Stryker are far from the only medical device manufacturers under fire for producing and promoting defective metal-on-metal hip replacement products. Biomet’s M2A-Magnum hip replacement is now the target of increasing litigation claiming the same disastrous consequences that have occurred under DePuy and Stryker systems. According to the Jere Beasley Report, Biomet marketed this product as having “set the standard for performance and design in hip systems” and as “an ultra-high performance metal-on-metal articulation.” Biomet also asserted that the M2A is superior to other hip replacement products because it is subject to lower wear, excellent stability, better range of motion, and superior joint mechanic restoration.

Metal-on-metal hip replacements may actually be much more risky than the traditional polyethylene hip replacement device. Even though metal-on-metal hip replacements are said to last much longer than their polyethylene counterparts, they are prone to an early failure rate that would likely shock most patients. In addition to the risk for early failure, the health consequences of a metal-on-metal hip replacement can be extremely dangerous. Due to the grinding of metal components, metallic debris may be released into the body and cause serious complications. The problems caused by such grinding include the destruction of surrounding tissue and bone, pseudotumors, and metal blood poisoning. Metal blood poisoning is an especially severe effect of the increase of metal ions in the blood and can even lead to death. Generally, once a hip replacement fails, the patient must undergo at least one revision surgery that can be very complex, painful, and may sustain little hope to re-establish pre-surgery quality of life. Ultimately, the proposed advantages of metal-on-metal hip replacements may be inadequate to outweigh the hazards of such extreme complications.

In one recent West Virginia lawsuit, the plaintiff has argued that Biomet was aware of the risks and failure rates of their product without releasing this information to the public. The West Virginia Record reports that at the time of the plaintiff’s original surgery in 2008, there had already been more than 100 reports of adverse events associated with the M2a Magnum filed with the FDA. It is thus argued that Biomet knew that the product was defective. If Biomet was aware of their product’s severe risks and continued to promote the product as safe, effective, and superior to other hip replacement systems, Biomet could certainly be found guilty of misrepresentation.

Don’t let yourself become a victim of metal-on-metal hip replacement complications. When information is withheld from surgeons, doctors, and patients, it can be difficult to be sure that the procedure you undergo poses no serious health risks. If you believe that you have been misled by the Biomet M2A system, or another defective hip replacement device, it is important to know your rights.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one has ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

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According to the New York Times, a jury in New Jersey has recently awarded a plaintiff over 3 million dollars in compensation for her pain and suffering after being implanted with Johnson & Johnson’s Gynecare Prolift transvaginal mesh device. Shortly after surgery, the plaintiff became plagued with constant pain, trouble sitting, and painful intercourse resulting from the mesh eroding through her organ walls. She then underwent 18 revision surgeries, all of which failed to effectively remove the mesh and restore her previous quality of life. The San Francisco Chronicle reports that Johnson & Johnson may face additional charges up to $16.75 million in punitive damages. The manufacturer was charged with failing to warn the plaintiff’s surgeon of potential risks and for fraudulently misrepresenting the product.

Transvaginal mesh is a surgically implanted device designed to help with problems of organ prolapse (or “falling out”) and bladder incontinence. This mesh is a synthetic material which acts as a reinforcing sling around the intended organs. The mesh sling is not an entirely new concept – it has been used with some success in surgeries in other areas of the body. However, this procedure has proven especially problematic in the female pelvic region due to the increased number of organs involved, the very small area, and possibility of erosion from movement.
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. A patient may suffer for years after their original surgery from debilitating pain and discomfort. The Houston Chronicle notes that hundreds of thousands of women have had transvaginal mesh devices implanted.

Johnson & Johnson currently faces an estimated 4,000 transvaginal mesh lawsuits, according to Drugwatch. However, Johnson & Johnson is not the only manufacturer facing defective medical device charges for their transvaginal mesh products. Last August, a California jury awarded a plaintiff $5.5 million in a case against medical device producer C.R. Bard.

What’s the take-home message? Even though the New Jersey plaintiff who was awarded 3 million dollars was a nurse, had her surgeon’s confidence, and read a company brochure on the procedure, she still fell victim to a defective medical device. Don’t suffer for years as a result of transvaginal mesh. If you believe you have been adversely affected by this product, contact a lawyer and find out what compensation you may be entitled to.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one has ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

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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.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one has ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

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The 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.
Even with the proof of the dangers of mesh products, drug manufacturers continued to manufacture and market the harmful devices. How could this happen? An FDA loophole. The 510(k) process speeds up the marketing of “low to moderate risk” medical devices. In this process, no clinical trails are necessary to prove the safety of a product if it is substantially similar to those already on the market.

Even after thousands of hurting patients speaking out about surgery complications and lawsuits, drug manufacturer, Ethicon, continued to promote their faulty products nine months after the FDA ordered a halt on sales. Now the company is defending more than 1,400 transvaginal mesh implant lawsuits in both federal and state courts.

The court order issued by Judge Higbee last month shows that the struggle between secretive drug manufacturers and wrongfully harmed patients is far from over. Have you been relying on assurances from drug companies? It should be the responsibility of the medical community and the FDA to ensure the safety of U.S. consumers of medical devices. Don’t take drug manufacturers at face value. If you have been wrongfully affected by a transvaginal mesh procedure, you may have a case.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

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Although the recall on Johnson & Johnson’s metal-on-metal DePuy hip replacement was in August of 2010, the problems are far from over. Johnson & Johnson created the Pinnacle hip replacement as a second generation of DePuy, and it has already begun suffering similar results to its predecessor. According to Fox News, it is estimated that over 10% of Pinnacle hip replacements will fail within the next 2-3 years. At Borchardt Law Firm, we have seen many cases protesting the hazards of DePuy’s metal-on-metal hip replacement surgery, and it seems that litigation over this defective medical device still has a long road ahead.

After a costly $3 billion dollar recall on the DePuy product, Johnson & Johnson could still pay $5 billion dollars to cover revision surgeries for affected patients. There are 1600 lawsuits filed with the U.S. District Court for Northern Texas alone. The statistics on DePuy failure rates continue to look very grim. It is currently believed that DePuy will see a 49% failure rate after just 6 years, a number that is four times what DePuy cited when it decided to recall the product. Additionally, this failure rate is expected to rise to 80% at 8 years after surgery.

The complications of a metal-on-metal hip replacement can be extremely severe. 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.

In light of the current situation, the FDA has recently stated that they see no reason to continue the usage of metal-on-metal products in hip replacement surgeries. Many doctors have begun to refuse using them altogether, because the extreme risk of exposure to dangerous substances can render any proposed benefits negligible. Ultimately, it has been proven that the DePuy hip replacement and other metal-on-metal systems can be very unsafe and potentially life-threatening to patients, warranting deep concern over the continuing presence of such products on the market and concern that manufacturers and physicians take responsibility for exposing patients to danger.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
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801 Cherry St #1005
Fort Worth, Texas 76102

Transvaginal mesh is a surgically implanted device designed to help with problems of organ prolapse (or “falling out”) and bladder incontinence. This mesh is a synthetic material which acts as a reinforcing sling around the intended organs. Such mesh has been used with some success in other surgeries, but has proven especially problematic in the female pelvic region due to the increased number of organs involved, the very small area, and possibility of erosion from movement. According to the American Association for Justice, in 2010, approximately 300,000 transvaginal mesh devices were implanted in American women.

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. A patient may suffer for years after their original surgery from debilitating pain and discomfort.

If transvaginal mesh is such a problem, why is it on the market? The answer lies in the FDA’s 501(k) approval process. If a device is considered low to moderate risk or if it can prove it is sufficiently similar to another device that has already gained approval, then there are very few requirements necessary to begin marketing and selling a product. Most transvaginal mesh devices have been approved in this manner, meaning they did not have to prove rigorous clinical testing to the FDA before they began selling the devices. In fact, very few studies have even been conducted that aim to assess the safety of transvaginal mesh. However, those studies that have been conducted provide conclusive evidence that transvaginal mesh is neither safer nor more beneficial than traditional methods of surgery. Transvaginal mesh devices were approved because they are similar to the forms of mesh used in other surgeries without consideration of the fact that they are intended to be used in a totally different procedure. The FDA has since recognized the extreme risks involved and issued a statement recognizing that serious complications are not rare in these procedures.

Many lawsuits have already been filed against transvaginal mesh manufacturers. Most patients are horrified to find that the procedures they have undergone with the assumption that they are safe have, in fact, been approved without sufficient attention to safety. Widespread concern and litigation has prompted Johnson & Johnson to remove their transvaginal mesh device from the market. However, there are other manufacturers producing these devices. Every patient deserves assurance that their intended surgery is safe and effective. It should be the responsibility of the medical community and the FDA to ensure the safety of U.S. consumers of medical devices.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102

Off-label usage of the Infuse Bone Graft has been linked with many serious complications. It has been known to cause difficulty breathing, swallowing or speaking, airway compression, respiratory depression, nerve damage, unwanted bone growth, and even death. Despite the FDA’s warning of the potential dangers of off-label Infuse procedures, usage of this system has not waned. It is alleged that Medtronic actually encouraged doctors to pursue the Infuse Bone Graft for cervical spine surgeries, a purpose for which Infuse has not received approval. Medtronic subsequently received a 3 billion dollar payday as a result of this questionable tactic. The Wall Street Journal also alleges that Medtronic paid a physician to falsify a study that produced positive results from Infuse’s off-label use in the cervical area.

One recent lawsuit involves a woman who still suffers disabling complications after an Infuse spinal surgery in 2006, according to The Courier-Journal. The extensive nerve damage incurred during the procedure has left her barely able to walk or sit up, and simple tasks such as tying shoes and shaving legs are impossible without assistance. It is argued that this surgery was an off-label usage of Infuse carried out without the patient’s consent. This lawsuit is only one of multiple similar suits citing debilitating results of an Infuse Bone Graft. Such extreme side effects should be cause for much stricter enforcement of the Infuse Bone Graft’s usage in only approved procedures. No one should be the victim of a practice that has intentionally hidden the truth from those it affects. Moreover, medical device companies must be held to a higher standard of transparency and legitimate concern for patient outcomes, instead of profit margins.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective and deceptive medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102

Though this system was once touted as a great achievement of modern innovation, its problems may outweigh the technological benefits. For instance, the da Vinci robot uses very powerful electrical energy in order to cauterize the desired tissue, effectively “burning” away the tissue that a surgeon would cut for an incision or remove if infected. This electrical current is concentrated at the tip of the robotic arm. However, it has been found that, due to repeated use, insulation on the robotic arm may degrade over time, allowing electricity to flow into unintended surrounding tissue. This defect can cause serious burns and life-threatening complications.

Three lawsuits have already been filed citing the da Vinci system’s defects. All three suits stem from hysterectomy surgeries, in which two serious injuries and one death have been directly linked to the da Vinci robot. Two women continue to suffer from internal burns on surrounding organs that were meant to be untouched. Both have been forced to undergo extensive, expensive and ineffective corrective surgery to fix these mistakes. One woman died following surgery because the da Vinci robot inadvertently burned a pelvic artery; she hemorrhaged internally and died within two weeks.

The lawsuits also claim that Intuitive Surgical practiced questionable marketing and business techniques in order to sell its da Vinci robots. The company reportedly suppressed complaints and the actual rate of complications and errors in its marketing campaign. It is also argued that Intuitive Surgical employed intimidation tactics in order to persuade hospitals into purchasing the equipment, causing hospitals to fear the loss of business if they did not buy the robots. The company has been accused of fraud for misrepresentation of facts and competition risks.

The Intuitive Surgical case has highlighted the problem of medical communities choosing profit over patient safety. Medical device companies like Intuitive Surgical can be more concerned with keeping products like the da Vinci robots in service than considering any potential health risks. The FDA and organized medicine must take greater steps to protect the public from defective medical devices.

At Borchardt Law Firm, we wish for no family to ever experience tragedies due to the defects of medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102

Due to the design of the ASR, the metal material was a leading factor in the failure. Adverse Event Reports disclosed to the Food and Drug Administration (FDA) that the DePuy ASR hip system is associated with “loosening, pseudotumour and metallosis” / (sic) metalosis.” Metallosis occurs when the DePuy ASR metal ball rubs against the metal cup which releases metal shavings of cobalt and chromium into the tissue and circulatory system. This causes tissue necrosis and osteolysis, killing or severely damaging body cells and tissue.

Four months after the recall an article written in the New York Times discussing the issues with DePuy hip replacements stated, “failures in new implants are much more likely rather than failures with new drugs because unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients. That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the ASR, that process unfolded with devastating results. ‘You are basically testing these devices in an uncontrolled way on a large number of people,” said Dr. Sidney M. Wolfe, the director of the Public Citizen’s Health Research Group and a longtime F.D.A. critic.’” That August DePuy issued a recall for more than 90,000 of the DePuy ASR metal hip implants. Read more about the recall in The New York Times.

Now, concerns have developed about all metal-on-metal hip implant procedures causing surgeons and doctors to rethink implants. DePuy Orthopaedics still offers one other type of metal-on-metal hip implant, the Pinnacle. The Pinnacle has a slightly different design, using a cup and a liner, whereas the ASR only uses the metal cup. Patients and surgeons are able to choose a metal-on-metal, metal-on-ceramic, or a metal-on-polyurethane line to be inserted inside the metal outer cup for the Pinnacle. However, studies have shown the metal-on-metal option for the Pinnacle has proven to cause very similar problems as the ASR model, mainly concerning the release of metal shavings of cobalt and chromium into the tissue and circulatory system.

In May 2011, nearly 60 DePuy hip lawsuits were incorporated in multidistrict litigation (MDL), all citing problems with the Pinnacle procedure. As of today, DePuy claims their Pinnacle device is safe, and any problems that have been accounted for are from surgeon error, though the Pinnacle is the subject of these recent lawsuits and were recently concentrated in the Northern District of Texas.

If you think you have a DePuy ASR or Pinnacle hip system, contact Borchardt Law Firm, LLP. We can immediately assist you and discuss your legal options.

Burnett Building
801 Cherry St #1005
Fort Worth, Texas 76102
Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
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