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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.

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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.

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On April 11, a charter bus crash in Irving, Texas killed three people and injured dozens more. The charter bus carried approximately 40 elderly people on their way to a scheduled outing at a Choctaw, Oklahoma casino. One of those killed was the organizer for the trip. The bus veered into a concrete barrier and flipped on its side, causing all lanes of traffic on State Highway 161 to be shut down, and nearly all of the passengers to be trapped inside the bus. Some passengers have even suffered loss of limbs and many remain hospitalized. Borchardt Law Firm is proud to represent the interests of these victims.

A DPS investigation has placed fault on the bus driver, according to The Dallas Morning News. In 1998, the driver was involved in an accident that killed a Good Samaritan helping a driver on the side of the road; he was ultimately not indicted on charges on criminally negligent homicide. In the Irving crash, the DPS has found no evidence of malfunction that could have caused the bus driver to lose control, and it has even been suggested that the driver may have blacked out before swerving across the highway. The driver, aged 65, has suffered broken ribs, a punctured lung, and several other injuries.

At least four lawsuits have already been filed; two by family members on behalf of their deceased loved ones, and two by surviving passengers. Borchardt Law Firm, LLP has years of experience representing victims of trucking accidents, catastrophic injury, and wrongful death. If you have a query relating to this accident or a similar disaster, don’t hesitate to contact Borchardt Law Firm to find out your legal rights.

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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.

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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.

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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. Although the state cap for damages on such cases is $250,000, our firm was able to obtain $550,000 on our client’s behalf. 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.

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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.

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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.

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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.

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The FDA has recently issued an urgent recall on DePuy Orthopaedics’ LPS Diaphyseal Sleeve product. The Class I recall used in this case is the most serious recall status; it denotes that there is a realistic risk of serious adverse health effects or even death. DePuy is still in the midst of defending itself against thousands of lawsuits on their metal-on-metal hip replacement devices.

The FDA defines the LPS Diaphyseal Sleeve as an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. According to DePuy, the LPS system is intended to replace “the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia.” The diaphyseal sleeve component is utilized when patients experience bone loss or defects related to the removal of bone tumors, trauma, infection or difficult reconstruction.

This product carries the risk of failure when the device cannot support sufficient weight. Even normal daily functions can cause the sleeve to fail. The San Francisco Chronicle notes that, in case of failure, the sleeve can potentially fracture. This may lead to loss of function or loss of limb, infection, compromised soft tissue or death. Some more common complications that can occur when implanted with this device include component shifting, loosening, bending, cracking, fracture, deformation or wear of components, fatigue fractions, tissue reaction to wear debris, pain, dislocation, and decreased range of motion.

The FDA has received 10 reports of the device malfunctioning. Of these, 6 patients reported fracturing and 4 complain of painful loosening of the product. The Legal Examiner reports that the affected devices were manufactured from 2008 to July 20, 2012. If you believe you may have been implanted with one of these defective medical devices, don’t hesitate to contact your doctor and find out the risks to your health it may have caused.

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