Articles Posted in Medical Malpractice

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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:

1. Peripheral edema (fluid retention in the lower limbs)
2. Stomatitis (inflammation of the mucus of the mouth)
3. Rash
4. Mouth ulceration
5. 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.

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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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It is becoming very clear that financial incentives may be more influential in the actions of physicians than most would like. Pharmaceutical companies actively persuade doctors to make certain decisions in order to sell their products; doctors often agree in order to gain some monetary benefit as well. Many physicians today are engaged in the pharmaceutical industry in some way. This involvement could take the form of receiving payment for speaking engagements, consultations, and even by-lining an article that a pharmaceutical representative has written in order to pass it off as expert testimony.

It seems apparent that such a relationship between doctors and drug representatives creates a conflict of interest. Introducing the desire for profit and competition brings in an element that should certainly be absent in unbiased, professional and service-oriented medical care. The American Association for Justice recently published an article highlighting the comments of renowned physician and academic Dr. Jerome Kassirer. He says, “The evidence is really quite clear that money has a major influence on decisions doctors make.” This conflict of interest goes beyond the decisions of individual physicians; many physicians that serve on FDA drug advisory boards also have ties with the pharmaceutical industry. This introduces biases into both the drugs on the market as well as the drugs being prescribed. Examples of major problems created by unduly influenced physicians include many cases that Borchardt Law Firm currently handles: Yasmin birth control, the da Vinci surgical robot and Medtronic’s Infuse bone graft have led to serious complications after pharmaceutical companies pushed such drugs and devices onto the market without consideration of patient welfare. In fact, the highly questionable relationship between doctors and drug representatives has begun to cause a serious deterioration in the public’s trust in medicine.

While many argue that the medical profession ought to be responsible for containing this problem, it has failed to take decisive action on the matter. There must be greater repercussions for pharmaceutical companies’ fraud, off-label marketing, ghostwriting, and regulation violations. Medical schools should also train future physicians on how to resist pressure and adequately deal with the intrusion of the drug industry. Finally, it may be that the pharmaceutical industry should recognize the consequences of their actions (beyond harming countless innocent patients); Dr. Kassirer states, “I don’t think that the drug and medical device industry has understood the fact that, by engaging physicians the way they do, they tend to denigrate the profession, and that’s bad for them.” If self-interest and unencumbered profit seeking got them to this point, perhaps self-interest will entice them to curb their own behavior.

Ultimately, patients are entitled to unbiased medical care. The relationship between doctors and the drug industry creates the potential that a patient will not receive the best treatment because financial interests shadow a physician’s judgment. This could cause deadly consequences, and in many cases it already has. The influence of pharmaceutical representatives in medical care tarnishes the quality, neutrality, and transparency of medical treatment. No one should have to die because their well-being was not always the top priority.

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Many people view the hospital as a safe haven; somewhere they will receive the best possible treatment and care. Few realize the extent of the mistakes, misjudgments and neglect that are always possibilities in a hospital environment. In fact, according to the Fort Worth Star Telegram, “Authorities say more than 400 Americans die every day because of preventable accidents, errors and infections suffered in hospitals.” Given such an alarming statistic, it is no surprise that medical malpractice suits continue to soar. Recently, The Leapfrog Group, a non-profit quality improvement organization has applied a study and grading system to thousands of hospitals all over the country. A grade from A to F is assigned to a hospital on the basis of 26 scores that range from surveys to preventable instances of infection, falls and post-operation complications. There is even a score given for the level of cooperative teamwork amongst hospital staff, because in crisis situations a communication error can often mean life or death for a patient.

Leapfrog surveyed 219 hospitals in Texas, and the results may surprise many. While five Tarrant County hospitals received A’s, eight received B’s and C’s (no hospital has received a D or F as of yet). An A is awarded to hospitals that exceed national averages on the 26 measures, while C’s are given to hospitals that fall below the national average. Notable hospitals with A grades include Texas Health Harris Methodist Hospital Fort Worth and Huguley Memorial Medical Center.

So, what does all of this mean? While there are many criticisms of the Leapfrog survey, claiming that its results are too simple to reflect the complexities of overall hospital quality, it is a powerful reminder not to assume that you are always safe and well taken care of when you enter a given hospital. The fact that several Tarrant County hospitals have failed to meet the safety standards of even just one study is cause enough for greater awareness of the risks one takes in choosing a hospital. It can be difficult for a patient to accurately judge their potential safety, and studies like this are a step in the right direction for giving patients a better understanding of and control over their own well-being. It is essential for patients to do the proper research before choosing any treatment option, because despite recent efforts to increase medical transparency, a true understanding of personal risk can be difficult to glean from the extensive jargon and chaos of a hospital visit. While it should be the job of the medical community to ensure patient safety, such a responsibility can often go overlooked.

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As hip replacement lawsuits continue to rise, so do serious health concerns about metal-on-metal hip replacements. According to the New York Times, a top Boston surgeon went in to replace his 53-year-old patient’s hip and found devastating results. What researchers had warned patients of years ago has finally sunk in. The patient’s metal-on-metal hip replacement had been shedding tiny pieces of metallic debris that eventually led to what looked like a “biological dead zone. There were matted strands of tissue stained gray and black; and a large strip of muscle near the hip no longer contracted.” (New York Times) The damage was far worse than test results had shown and looked to be permanent.

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Surgeons across the U.S. have found this problem to be significantly increasing with metal-on-metal hip replacements. The Boston surgeon, Dr. Young-Min Kwon stated that this could be one of the country’s biggest medical device failures yet. Though all orthopedic implants shed debris after a few years, the metal-on-metal poses a higher threat that can lead to permanent damage of the tissue, muscle and bone due to the metallic ions that are being shed. (read full article)

As studies continue to prove metal-on-metal hip replacements aren’t working properly, doctors and surgeons are trying new tests to find better results before the problem worsens. Patients are encouraged to be aggressive about consistently testing their results for metal levels and to speak to their doctors about recent recalls.

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Choosing a nursing home for your loved one can be a very difficult process. Unfortunately, nursing home abuse and negligence cases are much more common than the public is aware of. According to CBS News, in 2009 a congressional report stated that nearly one-third of all U.S. nursing homes have been cited for abuse. If you think your loved one has been or is being abused in a nursing home, don’t hesitate to contact a nursing home negligence lawyer. At Borchardt Law Firm, we strive to help families who have been victims of nursing home abuse or neglect.

When abuse is suspected our firm recommends families to immediately become in contact with the Texas Department of Aging and Disability Services (DADS). “The Texas Department of Aging and Disability Services was created to administer long-term services and support for people who are aging and who have cognitive and physical disabilities. The department also licenses and regulates providers of these services, and administers the state’s guardianship program. They began formal operations on Sept. 1, 2004.”(DADS website) The department endeavors to keep elders safe.

First Steps to Report Abuse

1. By contacting the Texas Department of Aging and Disablity Services victims are able to file a complaint by calling their hotline at 1-800-458-9858. The complaints are anonymous and all of the names (including the name of your loved one) will be redacted from the report. DADS, the state agency, track these reports by a control number. Be sure to explain to the state all of your issues, and to get the control number. This will allow you to get a copy of the report once it is finished. Retaliation by a nursing home for making a complaint is illegal so you shouldn’t hesitate to file a complaint.
2. Move your loved one to another facility that is feasible. Don’t wait to make the move, you don’t want matters to worsen.
3. After you have filed your complaint and moved your loved one to a new home, contact an experienced lawyer who handles nursing home negligence cases.

How to Pick the Right Nursing Home Negligence Lawyer

1. Meet with potential lawyers to handle your nursing home negligence case. At Borchardt Law Firm, all of our initial consultations are free of charge.
a. Ask the lawyer and/or law firm about their experience in handling nursing home negligence cases. Texas law has changed dramatically in this area, it is important to hire a lawyer with some experience. Visit our firm’s website to read about prior experience. Borchardt Law Firm
b. Ask the lawyer and/or law firm about their trial experience in handling nursing home negligence cases. You want to hire a lawyer who takes and has taken these types of cases to trial.
c. Ask the lawyer and/or law firm about their staff’s experience. At Borchardt Law Firm, we have a full time nurse on staff who can quickly read and review medical records to determine if a case has a merit.
2. Don’t be afraid to meet with more than one lawyer. Going through a nursing home negligence case is difficult, and you want to know that you have selected a lawyer who you feel comfortable with and can trust.
3. Remember, any lawyer who makes representations about the value of your case is probably not the lawyer you want to hire.
4. If you are a lawyer reading this blog and have a Texas nursing home case, please contact Borchardt Law Firm. Within the parameters of Texas law, we are happy to assist other lawyers with nursing home cases.

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About one out of every 400 Americans born is diagnosed with Cerebral palsy. If your child suffers from Cerebral palsy that developed during the early stages of life or during childbirth contact our law firm Borchardt Law Firm to discuss your legal options. Cerebral palsy is a complex affliction that involves damage to the part of the brain that controls posture and movement. While the precise cause of Cerebral palsy may be difficult to identify, many experts believe that medical negligence during the birthing process can cause or exacerbate the severity of the diagnosis. According to a Cerebral palsy source, Cerebral palsy is classified into four categories: Spastic, Athetoid (dyskinetic), Ataxic and Mixed.

•Spastic Cerebral palsy affects 70 to 80 percent of patients and is characterized by stiff or permanently contracted muscles.

• Athetoid Cerebral palsy affects 10 to 20 percent of patients and is characterized by uncontrolled, slow, writhing movements.

• Ataxic Cerebral pasly is a rare form that affects 5 to 10 percent of patients. This form of cerebral palsy affects the sense of depth and perception and results in poor coordination and difficulty with quick or precise movements.

• Mixed Cerebral palsy occurs when a patient has symptoms of two or more of these forms. Many combinations are possible, but the most common mixed form is a blend of the Spastic and Athetoid forms.

To learn more about Cerebral palsy, please watch the following video.

Though it can be uncommon, one of the most severe causes can happen due to a medical malpractice during childbirth. In 2002 an Illinois mother was given medication in order to induce her labor to her son. However, the medication caused severe stress on her baby causing his heart rate to drop dangerously low. The mother should have received an immediate C-section by her OBGYN but rather her primary care physician attempted to deliver the baby himself. Tragically, the delivery was unsuccessful and the OBGYN stepped in and performed a C-section. “The boy had already been seriously deprived of oxygen, causing him to suffer from the irreversible brain damage that resulted in his severe Cerebral Palsy.” (cerebralpalsysource.com) His condition is so grave he will never be able to walk, talk or feed himself. He will need constant medical care for the rest of his life. After taking this case to court, the mother was recently awarded a $5.5 million settlement which includes the cost of long-term care for her son. (Read the full article)

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Is DePuy Orthopaedics facing yet another possible recall due to a defective medical device? August of 2010, the DePuy ASR XL Acetabular was recalled due to unusually high rates of hip implant failure within only a few years of surgery. DePuy estimated the failure rate to be about 12-13 percent and was designed to last up to 15 years. However, results showed otherwise. Several patients ended up in constant pain resulting to a revision surgery.

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

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

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

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

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