Borchardt Law Firm

Lethal Medicine Contaminated with Fungus

Borchardt Law Firm Team — Tue, 06 Aug 2013 05:00:00 GMT

(This photo was taken from CBS.com)

Last night “60 Minutes” did a segment on “Lethal medicine linked to meningitis outbreak.” The New England Compounding Center was producing a steroid that helps to relieve chronic pain in patients’ backs and joints. This steroid has lead to 50 deaths and other significant problems for 700 innocent patients. This is all due to the lack of drug safety. The steroid is contaminated with fungus, which leads to patients contracting meningitis. This meningitis can go to a patient’s bones, nerves and even brain. When the meningitis gets to the brain there is a very low percentage of patients who survive. This lethal medicine has caused many issues for those who have used it; many of these problems cannot be cured and the lives taken cannot be replaced.

The New England Compounding Center in Massachusetts got greedy and “sloppy,” said a former employee who spoke on “60 Minutes.” They were trying to produce mass amounts of drugs while reaping the significant benefits. Therefore, the drug preparation became unsterile. There was mold found in the Clean Room One at the NECC 12 times in three years. A supervisor was warned and according to the employee who was interviewed on “60 Minutes,” the supervisor just shrugged and didn’t say anything about the issue.

According to the “60 Minutes” segment, “the New England Compounding Center was what’s known as a compounding pharmacy. By law, compounding pharmacies are not allowed to manufacture pharmaceuticals for the mass market. That would require the oversight of the FDA. Instead, the states are licensing compounding pharmacies to make drugs for individuals. For example, a doctor might order a liquid form of a medication for a patient who can’t swallow a pill. Compounding pharmacies are bound by one rule: they must have a prescription for each individual patient.”

The NECC was shipping tens of thousands steroids out of the Clean Room One. It was stated that the 3,000 clients that NECC sold to were part of the fraud. The Clean Room One was shown on “60 Minutes” for the first time for the public.

There are many concerning issues for patients. One such concern is that there is no cure for those patients who are infected by the fungus. To date, no doctor has said the fungus is completely gone from an infected patient’s body. It is a constant worry and according to patients who are infected, the treatment is very rough. The other concerning issue is that as patients, we do not know what drugs are approved by the Food and Drug Administration. We simply trust the care of the producers to have safety precautions and make drugs properly. Clearly, those producers cannot always be trusted.

It is still unclear on how the drug was contaminated. What we do know is that there is no cure and the consequences are severe. When the FDA went into the NECC for a safety and cleanliness check, they found 50 samples of the medicine and they were all contaminated with fungus. The company is now in bankruptcy and has faced many trials. However, a life of a loved one cannot be replaced. If you or a loved one has experienced a situation similar to this one please give us a call. No one deserves this kind of treatment.

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.
Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
For easy access to blog updates, follow us on Twitter: @AttorneysMB

Wyeth Pharmaceuticals Agrees to Pay $490. 9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses

Borchardt Law Firm Team — Wed, 31 Jul 2013 05:00:00 GMT

Wyeth Pharmaceuticals Inc., (now owned by Pfizer) a pharmaceutical company has agreed to pay $490.9 million to resolve the unlawful marketing of the prescription drug Rapamune. The U.S. Food and Drug Administration (FDA) did not approve it as safe and effective, the Justice Department announced the other day. Rapamune is an “immunosuppressive” drug that prevents the body’s immune system from rejecting a transplanted organ for patients 13 years or older.

The Federal Food, Drug and Cosmetic Act require companies, including Wyeth, to specify the intended use of a product in the new drug application to the FDA. Once approved, a drug may not be introduced into interstate commerce for unapproved or “off-label uses until the company receives FDA approval for the new intended uses. Rapmune was approved in 1999 for the use of renal (kidney) transplant of patients. However, Wyeth trained its national sales representatives to promote the use of the drug in non-renal transplant patients. The sales representatives were also trained on how to present the materials to physicians who make these transplants. Finally, Wyeth encouraged sales members, through bonuses and financial incentives, to target all transplant patient population to increase Rapamune sales.

Wyeth Pharmaceuticals is merely concerned about the profit the drug can make and not the risks or side effects of the patients. This was a systemic, corporate effort to seek profit over safety. Companies that ignore compliance with FDA regulations will face criminal prosecution and stiff penalties.

Wyeth has pleaded guilty for misbranding violation under the FDCA. The criminal fine and forfeiture total is $233.5 million. There is also a civil settlement with the federal government and the states that is $257.4 million. Wyeth has agreed to settle its potential civil liability in connection with its off label marketing of Rapamune. The unapproved uses included non-renal transplants, conversion use (switching a patient from another immunosuppressant to Rapamune) and using Rapamune in combination with other immunosuppressive agents not listed on the label.

The side effects of the unapproved uses include:

Peripheral edema (fluid retention in the lower limbs)
Stomatitis (inflammation of the mucus of the mouth)
Rash
Mouth ulceration
Elevated lipid concentrations

At times, being a patient is difficult. We trust our doctors, and nurses to do the right thing and provide the right care. The doctors and nurses trust the manufacturing company and pharmaceutical companies to produce the right product. Dishonesty and profit exceeding patient care and safety is occurring more often then not these days. Patients have to deal with the consequences of the unapproved prescription drugs or the product malfunction that therefore leads the patients to have severe side effects. These side effects certainly range from death to a stomach bug, but neither is acceptable or rightly deserved. All patients should be treated with the best care possible. Patients need to be health advocates and make sure what is going into their body is right. It is essential to ask different doctors about drugs and products, do research and constantly read about products. It is easier to be a health advocate then have to deal with the side effects later in life.

If you or a loved one had something like this or similar happen, you can seek justice. Please call for a free consultation. It is important to protect patient safety. Drug companies must only market and promote their drugs for FDA approved uses. The consequences do not exceed the patients life.

Roll-A-Bout Walker Product Malfunction

Borchardt Law Firm Team — Thu, 18 Jul 2013 05:00:00 GMT

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.

Two Dialysis Drugs Have Been Recalled; Granuflo and Naturalyte

Borchardt Law Firm Team — Mon, 01 Jul 2013 05:00:00 GMT

GranuFlo and Naturalyte are two dialysis products recalled by the Food and Drug Administration. Fresenius Medical Care, the world’s largest provider of dialysis clinics and products, manufactures both GranuFlo and Naturalyte. The FDA has issued a Class 1 recall – the most urgent type of recall – on both products. This recall is reserved for situations that lead or could possibly lead to death. These two drugs are leading to severe complications and increasing the risk of death.

GranuFlo and Naturalyte are dialysate acid concentrates. These products are used during dialysis, which is the process of mechanically removing toxins from the blood of patients with kidney failure. During dialysis, bicarbonate is administered to neutralize the acidity that naturally builds up in the blood. In addition to the bicarbonate, GranuFlo and Naturalyte neutralize acid in the bloodstream. Many people, including health care professionals, are unaware of the ingredients in these products that convert to bicarbonate in the body. GranuFlo and Naturalyte consist of acetic acid plus acetate. This is what is being converted to bicarbonate by the patients’ livers. This can lead to an increased risk of a bicarbonate overdose, metabolic alkalosis and death.

In November 2011, Fresenius Medical Care sent an internal memo to physicians working in dialysis centers owned by the company. This memo stated potential side effects associated with elevated bicarbonate levels in the blood caused by these products. The memo also included the fact that 941 patients had experienced sudden cardiac arrest within their dialysis facilities after receiving dialysis treatment with GranuFlo and Naturalyte. FMC’s studies found that patients undergoing dialysis treatments with these products are six times more likely to suffer from a heart attack or sudden cardiac death. The manufacturer of these products did also notify facilities that are not owned by FMC.

On May 25, 2012 the FDA made the following warning about the risk of GranuFlo and Naturalyte:

“Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which if not appropriately treated may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”

The New York Times gives more information on the warning.

GranuFlo and Naturalyte side effects include heart attack, low blood pressure, myocardial infarction, stroke, metabolic alkalosis and cardiopulmonary arrest. More information on side effects can be found here. If you or a loved one had GranuFlo or Naturalyte dialysis treatment and are having these side effects, please consult your doctor. It is important to know what is being injected in a patient’s body. Many drugs have side effects, however those associate with GranuFlo and Naturalyte are extremely severe. Everyone deserves justice. Do not let a situation like this go unnoticed.

American Medical Systems Settle Portion of Vaginal Mesh Suits for $54. 5m

Borchardt Law Firm Team — Wed, 26 Jun 2013 05:00:00 GMT

Transvaginal mesh was introduced in the 1990’s to help fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs drop into the vagina. These organs include the bladder, rectum and uterus. Stress urinary incontinence occurs from everyday activities that put pressure on the bladder. Both of these circumstances affect older women who may have received a hysterectomy, gone through menopause, or after childbirth.

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.
Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
For easy access to blog updates, follow us on Twitter: @AttorneysMB

Intuitive Surgical Inc. Failed to Report to FDA Correction on Devices

Borchardt Law Firm Team — Wed, 26 Jun 2013 05:00:00 GMT

Intuitive Surgical Inc., maker of the Da Vinci Surgical Robot broke procedures when it warned patients and surgeons about problems with the robot without first alerting regulators. The FDA noted four observations in a Form 483 letter following inspections at Intuitive’s facility.

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.

Benefits of Drugs Outweigh the Risks

Borchardt Law Firm Team — Fri, 21 Jun 2013 05:00:00 GMT

There has been a decent amount of coverage on the prescription drugs Januvia and Byetta. Januvia (sitagliptin) and Byetta are both injectable drugs, and provide a new way of treating type 2 diabetes. They both help control blood sugar levels by encouraging production of a hormone called glucagon-like peptide 1 (GLP-1). They have potential advantages over older medications, said Dr. Peter Butler, director of the Larry L. Hillblom Islet Research Center at the University of California, Los Angeles.While the benefits of these new methods of treatment are undeniable, a side effect of these drugs is pancreatic cancer.

Every drug has side effects, even aspirin. These side effects are listed on the package insert, and are provided at the drug company’s discretion. As patients, people need to read the package insert and be aware of potential side effects that come with the use of the drugs they may be consuming.

Dr. Mary Ann Banerji, director of the Diabetes Treatment Center at SUNY Health Science Center Brooklyn in New York City, said the concerns about Januvia and Byetta should not be blown out of proportion. Doctors prescribe drugs on an individual basis, because, in the end, all of medicine is individual. Banerji goes on to say that “we should use these drugs judiciously along with metformin” because epidemiological studies have not established a significantly increased risk of pancreatitis associated with Byetta.

For more on the USA Today article please look here.

While all drugs have many side effects, they do not affect all people. In most cases, the benefits of the drugs out weigh the potential side effects. That being said, if you or a loved one may be experiencing side effects while using Januvia or Byetta, stop taking the drug and talk to your doctor.

Technology and medical breakthroughs provide humans with more opportunity to live longer and handle health conditions in a safe and timely manner. The advancement in technology provides great advantages, but there are also many disadvantages. Today, physicians are using robots to do surgery and there are countless prescription drugs to help with health issues ranging from a headache to cancer. Although great things have come from medical discoveries, the large amounts of side effects are one disadvantage of all of the medications that pharmaceutical companies are producing.

Some side effects are unavoidable. However, as patients and consumers of prescription drugs, we need to be aware of the side effects. Reading the package insert, along with the directions for consumption is an essential step for even the simplest drugs. While not all of the side effects are serious nor will they all affect us, it is important to know what you are putting in your body and what the ratio is between the potential benefits and potential side effects.

If you or a loved one has been affected by Januvia, Byetta or any prescription drugs please call us for a free consultation. Even though the side effects are listed on the packaging, justice can still be sought.

Contaminated Pain Shots Are Resulting in Sick Patients

Borchardt Law Firm Team — Tue, 11 Jun 2013 05:00:00 GMT

A pain shot made in a Tennessee pharmacy may be contaminated and could be making people sick. This is very similar to the meningitis outbreak that happened last year. The results of this outbreak are less severe than the outbreak of the meningitis illnesses, but there are infections at the site of where the pain shot was inserted. These infections are skin and soft tissue of unclear etiology following the injection. This is leading to many patients having abscesses. An abscess occurs when white blood cells move through the walls of the blood vessels to the site of infection and collect in the area of damaged tissue. The result of this is the presence of pus. Pus is the buildup of fluid, living and dead white blood cells, dead tissue, and bacteria or other foreign substance. Abscesses can show up anywhere on the body. The most common sites are in your armpits, areas around your anus and vagina, the base of your spine, around a tooth, and in your groin. However if you have received a pain shot, abscesses would form at the site of the shot.

There have been many outbreaks in the past few years, but this particular outbreak comes from contaminated pain shots that were produced by the Main Street Family Pharmacy in Newbern, Tennessee. This shot was sent to patients in 13 states including: Texas, Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Caroline, South Caroline and Tennessee.

Recently, the Food and Drug Administration (FDA) reported that the firm was recalling all amounts of sterile injection drugs. This action was taken in response to seven patients being infected as stated on Vitals on NBC News.

This outbreak is getting so serious that Congress is getting involved. The FDA has asked Congress to pass legislation giving it more power to regulate pharmacies, most importantly large scale pharmacies that ship products in large quantities and across state lines. These shots – along with the subsequent infections – were sent nationwide and crossed state lines, which in itself puts a huge risk on the mass production of the product. As a patient, or if you know someone who was or has been affected by a contaminated shot, write to your congressperson in your state. The more support and cases they are made aware of, the quicker a bill will get passed. This will result in more regulation of the pharmacies, drugs and pharmaceutical companies.

As patients we not only put our lives in the hands of those physicians that are caring for us, but we also have faith in the prescribed drugs that physicians suggest. We have confidence in the pharmaceutical companies and pharmacies in producing prescription drugs that will help patients, not harm them. There are simple steps we as patients can take to ensure we are getting the best care possible. We can make sure our health care providers are wearing gloves, cleaning needles, inserting shots in the correct spot and following up on any procedure. However, it is difficult to ensure the pharmaceutical companies and pharmacies are doing their job correctly. It is important to ask you physician about the drugs they prescribe to you. It is recommended to research the prescribed drug and get as much information about it as possible. While it is hard to have control of the drug itself, we can try to ensure that we as patients are receiving healthy and safe drugs.

If you or a loved on has ever had a case similar or the same to the outbreak of a contaminated shot please feel free to call for a free consultation. These outbreaks have occurred in Texas and you may be affected. Do not let a situation similar to this unnoticed.

Rejuvenate Modular/Abg II Modular-Neck Stem Voluntary Recall

Borchardt Law Firm Team — Wed, 05 Jun 2013 05:00:00 GMT

In June 2012, Stryker, a medical technology company, decided to voluntarily recall its Rejuvenate and ABG II modular-neck hip stems. The modular neck-hip stems provide surgeons with the ability to correct certain aspects of a patient’s anatomy and his or her bio-mechanics. However they decided to recall these modular-neck hip systems due to the potential for fretting and corrosion at the modular-neck junction, which may result in ALTR (adverse local tissue reactions). In addition, possible pain and/or swelling at or around the hip may occur. This is due to metal-on-metal ball-and-socket components. Stryker’s two modular-neck hip stem systems do not consist of metal ball-and-sockets. However since the Stryker necks are made of chromium and cobalt and the stems are coated with titanium, they do have metal-on-metal connection. The friction caused by metal rubbing against metal deposits shards of metallic fragments into a patient’s tissues, bones or bloodstream. This is what causes the fretting, corrosion or swelling.

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.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
For easy access to blog updates, follow us on Twitter: @AttorneysMB

Da Vinci Surgical Robot Complications

Borchardt Law Firm Team — Tue, 28 May 2013 05:00:00 GMT

The da Vinci Surgical Robot is a large machine with arms that surgeons use to perform surgeries. A surgeon sits in a console, which gives a 3D view of the surgery while controlling the arms. The surgeries include hysterectomies, prostate removals, gastric bypasses, gall bladder removals and thyroid cancer surgeries. The da Vinci Surgical Robot provides a greater range of motion for the physicians and the ability to perform a more precise surgery. In addition, the robot surgery results to less blood loss, smaller scars and faster recovery.

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.

Improper Use of Medtronic “infuse” Bone Graft Increases Risks

Borchardt Law Firm Team — Mon, 20 May 2013 05:00:00 GMT

Over the past few years the Medtronic INFUSE Bone Graft has raised many issues and resulted in large amounts of lawsuits. The Medtronic INFUSE Bone Graft is a device that is implanted after lower back surgery to stimulate bone growth in an area of implantation. The INFUSE Bone Graft is an alternative to traditional bone graft because it prevents from painful harvesting of other parts in the body. The INFUSE Bone Graft generally treats degenerative disc disease; however it has been used in other inappropriate ways. The INFUSE Bone Graft consists of two parts. It has a sponge-type substance that is soaked in the biological fluid which is a type of synthetic liquid bone morphogenic protein. This genetically engineered protein helps build bone tissue in the fusion process, instead of using a graft of the patient’s own bone. The device is put between vertebrae and stimulates the bone growth. The sponge then dissolves and is absorbed into the body.
The INFUSE Bone Graft has been approved gradually by the FDA regarding the procedures that are compatible with the INFUSE Bone Graft. In 2002 the FDA approved the INFUSE Bone Graft only for the treatment of degenerative disc disease. In 2004 the FDA approved the INFUSE Bone Graft for various types of tibia fractures in the lower leg. In 2008 FDA published a Safety Communication warning of life threatening complications associated with the use of the INFUSE Bone Graft in cervical spine areas. Not long after the FDA came out with the Safety Communication warning, Medtronic paid $85 million in lawsuits by shareholders because Medtronic did not release information regarding the INFUSE Bone Graft that mislead people in the use of the product.

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.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
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Medicare Should Pay Closer Attention to Patient Prescriptions

Borchardt Law Firm Team — Mon, 13 May 2013 05:00:00 GMT

ProPublica is an independent, non-profit newsroom that produces investigative journalism in the public interest. A recent investigation by ProPublica has found that Medicare has failed to monitor drugs that patients are receiving. This has led to doctors and health professionals prescribing large quantities of drugs to patients that have severe risks associated with them. These drugs can potentially be “harmful, disorienting or addictive,” according to the Washington Post. Records have also revealed that some physicians have given their patients drugs that could ultimately lead to death. Other physicians are using drugs in ineffective or unsafe ways according to the records.

The Freedom of Information Act allows the prescribing practices and identities of doctors and other health care providers to be public for the first time. ProPublica is able to release information regarding healthcare professionals. The information made public does not release the patients name or the reasons why they are prescribed a particular drug. According to ProPublica, health care professionals wrote more than 500,000 prescriptions for Soma, also known as carisoprodol, that patients 65 years of age and older should avoid. Risky drugs that can be harmful for seniors are listed on ProPublica . It also states how often they are prescribed. These findings can inform patients about drugs they should avoid and information about their physician or health care professionals.

Medicare has access to data about its patients, their diagnosis and the medical services they receive. Medicare can determine if the drugs their patients are being prescribed are appropriate for their conditions.

However the Centers for Medicare and Medicaid Services said the job of monitoring the prescribing of drugs falls to the private health plans that administer the program. The government should not be in control of that according to the Centers for Medicare and Medicaid Services.

Many other experts in monitoring prescription drugs say Medicare should use its data to investigate, prevent and monitor the prescribing patterns of drugs. In addition they should take steps to restrict unsafe practices from happening. Medicare is simply putting their patients at risk for not handling the situation according to some experts.

The question pending in most minds is why physicians are prescribing drugs improperly. Most of the time physicians feel pressure from families and friends of their patients. Other physicians have relationships with drug companies that influence which drug they prescribe. This results in physicians acting in inappropriate and unprofessional ways.
ProPublica’s examination also showed that Medicare failed to act against providers who have been suspended or disciplined by other regulatory authorities. Research showed that doctors often don’t keep up with the latest studies and drug warnings.

In a recent case an elderly women was put in a nursing home under the care of a man whose license was restricted since 1998. However the family of the elder women did not know this information, nor did they understand the doctor’s history of prescribing medicine at one of the highest rates in the country. The woman experienced many health issues while under this mans care and later led to death of this woman. If the family would have known about the care of their family member, death could have been prevented.

ProPublica has created an online tool called Prescriber Checkup, to allow anyone to search for individual providers and see which drugs they prescribe. You can compare your doctor to others in his or her specialty and see which drugs they choose prescribe. This has been available to pharmaceutical companies, but never to the public.This ensures that you are a loved one is treated with the utmost professional care. Frequently asked questions about Prescriber Checkup can be found on their website.

If you or someone you know may be prescribed a drug that could be harmful, do not let it go unnoticed. Research any physician or health care professional on Prescriber Checkup for a review about your physician or health care professional to ensure you or a loved on is receiving the best care possible. It can be easy for issues like this to be over looked. Your life and other lives are too previous to let something severe happen. It is necessary to catch issues before they get worse.

Nursing Home Abuse Trial in Corpus Christi Begins

Borchardt Law Firm Team — Tue, 16 Apr 2013 05:00:00 GMT

The nursing home abuse trial for former Corpus Christi nursing home owner began last week. According to NBC News, this 69 year old woman, Najmeh Griffin, has been charged with abusing the elderly patients at her assisted living facility. She has been accused of putting urine and feces-filled bags around the necks of two of her patients. The Corpus Christi Caller-Times reports that Griffin put these bags on her patients to punish them for soiling themselves, and left these individuals in a restroom where they were eventually found by an employee.

Further investigations into Najmeh Griffin and her husband’s facility revealed that the assisted living home violated many state standards. Investigators reported that patients were regularly subjected to abuse: physical, verbal, and neglect. The Griffins had two elderly facilities; one was an assisted living home and the other an adult day care. Both facilities are the subject of a criminal investigation citing their noncompliance with state safety standards. Both of the Griffin’s facilities have been shut down.

While this case represents and extreme example of nursing home abuse, where actual physical violence threatened the health and safety of nearly 55 patients, sometimes negligence on the part of a nursing home can be just as harmful. LawyersandSettlements.com states that nursing home neglect can often go unreported, because it isn’t as obvious as physical abuse. However, emotional, psychological, and financial abuse and exploitation are extremely frequent occurrences.

It is crucial to learn to recognize signs of nursing home abuse and to learn one’s rights under elder care laws. If a loved one of yours is in an assisted living situation, be sure to keep an eye out for certain warning signs such as: behavior or personality change, depression, anxiety, unexplained accidents or injuries, bed sores resulting from infrequent movement on a nursing home bed, muscle atrophy, burns, fearfulness, rapid weight loss, unwarranted use of physical restraints, unexplained venereal disease or bruising in areas surrounding genitalia. You can also visit Texas’ Office of the Attorney General’s website at https://www.oag.state.tx.us/elder/select.shtml for more information on your rights when looking for a satisfactory nursing home.

Nursing home abuse and neglect cases can be complicated, so it is best to use a lawyer who is familiar with nursing home laws and regulations. Borchardt Law Firm has over 20 years of experience representing victims of nursing home abuse. Don’t wait until it’s too late to contact a lawyer and learn about your rights.

At Borchardt Law Firm, we wish for no family to experience incapacitating tragedies due to nursing home abuse and neglect. 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 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
For easy access to blog updates, follow us on Twitter: @AttorneysMB

Problems with Intuitive Robotic Surgeries Continue to Arise

Borchardt Law Firm Team — Wed, 03 Apr 2013 05:00:00 GMT

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.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
For easy access to blog updates, follow us on Twitter: @AttorneysMB

Medicare Paid $5. 1 Billion for Bad Nursing Home Care

Borchardt Law Firm Team — Fri, 29 Mar 2013 05:00:00 GMT

According to the Associated Press, government investigators with the Office of the Inspector General recently found that billions of taxpayer dollars to Medicare have ended up in the hands of sub-standard nursing home facilities. Although it is legally required for a nursing home to submit to the government detailed treatment plans for every patient, many were found to be either falsifying such documents, consciously creating insufficient plans, or acting in a way contradictory to their treatment plans. Medicare then reimbursed those nursing homes for their treatments, even though the actual care received was poor in quality. It has been reported that in one out of every five nursing home stays, the patient’s health had not been properly addressed in their treatment plan. This finding is shocking for a patient who might believe that government oversight would only allow Medicare to reimburse reputable and quality nursing home practices.

This discovery has raised considerable questions about Medicare’s oversight practices that have allowed payment to go to nursing homes that could potentially be harming their patients. Though Medicare has promised to ramp up supervision and incentive measures for nursing homes to utilize good treatment practices, the effects of such measures could take months or years to appear. Borchardt Law Firm is committed to working for the rights of nursing home abuse victims. One cannot rely on a false security that a “top-notch” nursing home provides quality care, or that the government is doing enough to ensure that nursing homes comply with federal standards.

Nursing home abuse is still a major problem in the state of Texas; there is lax oversight and enforcement of state and federal standards, and nursing homes often avoid facing major consequences for their actions (or inaction). Our firm has long been a supporter of those who have encountered nursing home abuse or neglect. In fact, Borchardt Law Firm has recently seen major success in the representation of a victim of nursing home abuse and neglect. This wonderful success demonstrates our dedication to seeking justice for victims of nursing home abuse. No one wants to entrust a loved one into someone else’s care, only to find that they have been systematically abused or neglected. Borchardt Law Firm is the firm to right these wrongs for victims and their families.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
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Diabetes Medications Byetta and Januvia May Be Linked to Pancreatic Complications

Borchardt Law Firm Team — Fri, 22 Mar 2013 05:00:00 GMT

The FDA has recently announced that they will be investigating the safety of several diabetes medications due to some troubling scientific evidence. A group of academic researchers took pancreatic tissue samples from patients who had been taking these diabetes medications found that some of the patients had inflammation and cellular changes that often precede cancer, according to the Associated Press. The FDA has previously issued warnings about the risk of pancreatitis (an inflammation of the pancreas), but this is the first time they have warned the public about the risk of developing pancreatic cancer. Byetta, made by Bristol-Myers Squibb and Januvia, manufactured by Merck are two such diabetes drugs that have caused concern.

Pancreatitis can be a very dangerous condition. Alone, the inflammation of the organ can cause serious complications like difficulty breathing and kidney failure. However, the inflammation associated with pancreatitis can actually lead to the development of cancer. In fact, Drugwatch states that all forms of pancreatitis predispose one to developing carcinoma in the pancreas.

Multiple studies have linked Byetta and Januvia to pancreatic cancer. A Johns Hopkins study found that people taking Byetta, Januvia, or another diabetes drug Bydureon had double the rate of acute pancreatitis than those not on those medications. Additionally, a study published in Gastroenteology asserts that the use of Januvia, Byetta, or Bydureon increased the odds ratio for reported pancreatitis 6-fold. Given that pancreatitis always carries the risk of the development of cancer, the correlation between these drugs and pancreatitis is quite disconcerting. Problems with Byetta and Januvia are not new. The San Francisco Chronicle reports that in 2007 the FDA warned that it had received a high volume of reports linking Byetta and pancreatitis. A similar warning was issued in 2009 for Januvia.

The pancreas is a very important bodily organ. It regulates the levels of many hormones and enzymes within the body, and controls sugar production. Don’t underestimate the risks involved with these defective medications. Too often crucial warnings about these drugs are left off of the labels or withheld from physicians, or simply overlooked in aggressive marketing schemes. No one wants themselves or a family member to be the death that finally forces a medication off the market. Contact a lawyer today if you believe you may have been adversely affected by a defective prescription drug.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medicines. 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.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
For easy access to blog updates, follow us on Twitter: @AttorneysMB

Biomet M2a-Magnum Metal-on-Metal Hip Replacements

Borchardt Law Firm Team — Wed, 13 Mar 2013 05:00:00 GMT

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.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
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Johnson & Johnson Pays $3. 35 Million in Transvaginal Mesh Case

Borchardt Law Firm Team — Wed, 06 Mar 2013 06:00:00 GMT

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.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
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Fosamax Manufacturer Pays $285,000 in Osteonecrosis Case

Borchardt Law Firm Team — Wed, 20 Feb 2013 06:00:00 GMT

Merck, the manufacturer of the bone-loss medication Fosamax, has recently been ordered to pay $285,000 to a woman who suffered osteonecrosis (dead jaw) as a result of taking this drug. Reuters reports that the plaintiff suffered from bone disease and delayed healing after a routine tooth extraction. The jury decided in favor of the plaintiff, citing that Merck failed to adequately warn the patient of the risks involved with the product.

In fact, it has been proven that usage of Fosamax is linked to developing osteonecrosis. This condition, often called dead jaw, occurs after dental work or some other procedure in which the jaw bone might be exposed. After infection with osteonecrosis, surrounding tissue begins to erode, blood flow to the jaw stops, and tiny breaks can occur which lead to collapse of the jaw bone.

Additionally, random bone fractures can occur while taking this medication. Femur fractures are an especially common ailment that users of this drug may encounter. Researchers have suggested that Fosamax is linked to bone fracturing during low impact repetitive force, but some people claim that fractures occurred in the absence of even a fall. Drugwatch notes that women have reported simply turning their bodies the wrong way, coming to a short stop in the car or simply walking and suffering a broken femur.

Fosamax is also linked to several other side effects. One potentially dangerous side effect is the risk of developing esophageal problems. Patients might develop irritation, inflammation, or bleeding ulcers in the esophagus. Esophageal problems such as esophagus bleeding, erosion, and perforation may occur. These side effects have even been linked to esophageal cancer. Low blood calcium may also occur as a result of taking Fosamax. Appendage spasms, muscle cramps, abdominal cramps, soft bones, nausea, fatigue, muscle weakness, and even seizures are possible in the event of low blood calcium. Severe bone, muscle, and joint pain can occur within days of taking the drug.

According to the Jere Beasley Report, there are already over 3,000 cases against Merck alleging either development of osteonecrosis or femur fracture. While the femur fracture cases have yet to begin, at least two juries have decided in favor of victims of osteonecrosis. With the most recent victory of $285,000, Fosamax suits may only continue to pick up speed. It’s not too late to file your claim if you have suffered adverse effects after using Fosamax; contact Borchardt Law Firm today.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
801 Cherry St #1005
Fort Worth, Texas 76102
For easy access to blog updates, follow us on Twitter: @AttorneysMB

American Trucking Association Lobbying to Increase Semi-Truck Weight Limits

Borchardt Law Firm Team — Wed, 13 Feb 2013 06:00:00 GMT

The American Trucking Association has recently been lobbying Congress to expand current weight limits for semi trucks. The Jere Beasley Report states that, since 1991, the weight limit for such trucks has been 80,000 pounds. The industry is now hoping to increase that weight limit to nearly 100,000 pounds. Many trucking manufacturers firmly assert that this change would be beneficial for everyone, but the proposal has been met with criticism from many safety advocates.

The American Trucking Association defends a weight increase by suggesting that, by increasing the amount of products each truck could carry, it would actually decrease the number of trucks on the road. This could result in fewer emissions, and solve the current problem of driver shortage, according to the Athens Banner-Herald. The organization also states that when heavy trucks are allowed on highways, they will not have to take side-roads in order to avoid weight regulations. The ATA has implied that this might increase safety by keeping large trucks from entering residential areas and thus remaining on highways where infrastructure is better equipped to handle their weight. According to the Knoxville News Sentinel, Michael Robinson, Director of Legislative Affairs for the American Trucking Association, said “We think it’s important for the economy and for the environment.”

Despite the ATA’s promising view of an increase in weight limitations, such a shift would pose some very serious problems. It would certainly increase the stress and strain on highway infrastructure, which is a major safety concern. Considering federal funding for such maintenance is decreasing, the problems created by heavier vehicles could prove quite severe. Heavier trucks would also be more difficult to stop in emergencies. The fatality rate in heavy truck crashes is 50-60%, already twice that of smaller vehicles.

Additionally, truck manufacturers do not undergo strenuous safety testing the way other vehicles do. It is also unlikely that the trucking industry would change design processes to improve crashworthiness to accommodate these heavier weights. So, even with the purported benefits of increasing the weight of semi-trucks, the fatality statistics in truck crashes would likely only continue to rise.

Ultimately, the safety threat of larger and heavier trucks is very real. If you feel strongly about keeping these trucks off the road, contact your Congressional representative. It is imperative that the safety of the average citizen is protected, not the safety of big business’ profit.

At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to truck accidents. 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 that your safety was overlooked, 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
For easy access to blog updates, follow us on Twitter: @AttorneysMB