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Pradaxa is a new blood thinning drug touted as an alternative to the traditional (and problematic) warfarin, a drug in use since the 1950’s. It is an oral treatment that has been approved in preventing strokes in patients who suffer from atrial fibrillation, an irregular heartbeat. Pradaxa’s main goal is to avoid the complications associated with use of warfarin, including brain hemorrhages and other bleeding. However, use of Pradaxa may not be as promising as it seems; in fact, there is great debate over whether it is any safer than using warfarin. The FDA has been investigating reports of serious bleeding since its approval in 2010, and Japan and Australia have already issued safety warnings.

The problems of Pradaxa come in the form of heart attack and other heart disease symptoms. Recent studies report frightening findings such as a 33% greater risk of heart attack while using Pradaxa versus warfarin. The Huffington Post also states that in 2011 there were 542 reports of death while using Pradaxa, a number higher than any other medicine (warfarin only produced 72 reports). The FDA has also noted that Pradaxa can begin to break down very quickly once it is removed from its original container. Overall, Pradaxa seems to have very similar problems to its predecessor, warfarin.

Some downplay such statistics, claiming that such a death rate is actually normal for a newly marketed drug, so a comparison to the 60 year old warfarin is not appropriate. Some also claim that the problems of Pradaxa are associated mainly with improper use of the drug, not the drug’s inherent danger. However, necessary safety procedures such as close blood monitoring and frequent follow-up appointments are not required by everyday use of Pradaxa, leaving the concerning potential for a patient to unknowingly use the drug improperly. Finally, some doctors believe that Pradaxa’s absolute risk is rather low compared to its benefits.

Ultimately, the debate over the safety of Pradaxa leads to justified concern about its place in the market. Each patient deserves safe and dependable treatment. It would be a shame for a patient to suffer a heart attack or serious bleeding because they were not properly informed of the risks involved. It should be the job of the FDA and the medical community to properly notify patients of such risks, but this responsibility is often unfulfilled.

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

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

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

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

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Actos, an oral diabetes drug produced by Takeda Pharmaceuticals, may increase the risk of developing bladder cancer. Several studies have noted a connection between high and long-term doses of Actos and prevalence of bladder cancer. There have recently been many lawsuits filed seeking redress for physical and mental distress caused by this drug’s reported tendency to promote the disease. Takeda has been targeted by federal multidistrict litigation (MDL) in Louisiana, and state court cases in Illinois and California. France and Germany have already been prompted by research evidence to pull Actos from their markets.

Why bladder cancer? The body disposes of oral agents such as Actos through the urine. Because such substances may be stored for considerable periods of time near the cellular lining of the bladder, if proven carcinogenic they may be contributing factors in the development of cancers in this region.

According to the American Association for Justice, one study that took place from 2004 to 2009 suggested that the risk of bladder cancer when taking Actos is increased by 330%. However, other research has failed to find a statistically significant link between the two. Most research attempts have found that as dosages continue over the years and the size of dosages increase, the correlation between Actos and bladder cancer becomes stronger. Ultimately, such evidence led FDA in 2011 to issue a warning regarding the possible risk of bladder cancer that Actos carries. They also required Takeda to add a warning on all Actos labels. Thus, patients who have been taking Actos for an extended period of time or are taking large amounts should understand completely the risk to their health they are allowing. While studies remain somewhat undecided on the exact risks of ingesting Actos, a very compelling case can be made if bladder cancer occurs after one year of exposure to the drug and absence of an overwhelming predisposition to develop bladder cancer exists.

It should be noted that several conditions may cause one to be at a heightened risk for bladder cancer, regardless of Actos usage. Age, race, smoking, chemical exposure, and radiation therapy could all play a roll in causing bladder cancer and presence of such factors could inhibit the ability to prove Actos as the source of an occurrence of bladder cancer. Every patient should be aware of their own risk factors as well as the potential risks of taking Actos. There are other drugs that effectively fight diabetes, and the controversy surrounding this one seems enough to warrant serious reconsideration of the safety of its production and distribution. Physicians, medicine producers, the FDA and the government must be more vigilant of the life-threatening potential risks of prescribing Actos to unknowing patients.

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The Senate has recently passed a bill that would require greater oversight of drug manufacturing facilities overseas. This bill is concerned with increasing the safety and quality of imported medicine. The FDA is responsible for inspecting all U.S. drug manufacturers, but it has failed to account for the complexities of today’s industrial environment. According to the Fort Worth Star Telegram, “Today, roughly 80 percent of the ingredients used in U.S. medicines are made overseas.” The considerable amount of imported drugs and the increasing outsourcing of drug manufacturing make stepping up international regulations and safety assurance an absolute necessity for modern drug consumers. In fact, while U.S. facilities are inspected every two years, the average foreign facility only receives inspection once every nine years.

One notable case in 2008 highlighted the problem of defective medicine and the need for foreign inspections. Heparin, a blood thinner, was distributed widely in the United States, though it was originally produced in Chinese plants. Many contaminated batches were exported without any question. In the United States, the FDA traced hundreds of adverse reactions and several deaths to these shipments of heparin. When FDA officials visited one of the twelve questionable heparin manufacturers in China, they quickly realized that this facility lacked proper equipment, effective mechanizations for removing contaminants, and sufficient oversight of their own ingredient suppliers. This disaster clearly illustrates the problem of leaving internationally produced drugs and drug facilities uninspected.

The Senate’s bill, for which the House of Representatives is currently drafting companion legislation, would decrease the FDA’s requirement to inspect U.S. manufacturers every two years and allow them more time and discretion to inspect overseas. It also cracks down on drug counterfeiting and allows the FDA to hire additional scientists and researchers for the task. The goal of this bill is to directly address the increasingly international nature of drug production and distribution and modernize the United States’ investigations into the medicine that is allowed to be consumed in this country.

The take-home message from this is to create awareness about the drug safety reality in the United States. Most would be shocked to find out that the prescriptions they receive from their physicians may or may not have been submitted to any kind of safety inspection. While this legislation is a step in the right direction, such a law will take months and months to enter into effect. Drug consumption in the United States is not going to slow down, so steps to increase awareness must be taken now. Each citizen has the right to know and understand where his or her drugs come from and the government and business must continue to strive to make medicine in this country a safe and accountable industry. There is no room for cutting corners and slacking on safety when it comes to health.

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The Medtronic Infuse Bone Graft is a bone growth stimulator used during surgery. “Infuse” is a bone morphogenetic protein, a genetically engineered form of a naturally occurring protein. It is applied in liquid form via sponge; it is meant to grow into bone in order to facilitate re-growth and replace damage. It was originally marketed as an alternative to the traditional procedure of harvesting bone grafts from the hip. The Infuse Bone Graft was approved by the FDA in 2002. But, there’s a catch: it was only approved for a very limited set of surgical procedures. The trouble with the Infuse Bone Graft is when it is used for off-label procedures for which it is not approved. A number of lawsuits have already been filed for botched surgeries that used the Infuse Bone Graft for operations it was not intended for.

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

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

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Exide Technologies is a prominent producer, distributor and recycler of lead-acid batteries. Their plant in Frisco, Texas has been in commission since 1965. This facility has been under scrutiny for continually producing and disseminating into surrounding areas lead emissions well over the legal limit (the limit for lead emission is .15 micrograms monthly). Regardless of the legality of lead emissions, there has been no affirmed threshold for lead exposure safety, and even very low levels can be especially dangerous for children. This is highly problematic given that homes, apartments, and even Frisco High School are located near the Exide plant.

Proposals were drafted in 2011 for review by the Texas Commission on Environmental Quality (TCEQ) that outline a plan of implementation geared toward decreasing Exide’s lead emission levels. This agreement would support an intensification of regulation efforts; Exide has promised to “…spend up to $20 million and would reduce lead emissions by 90 percent by November 2012”, according to CBS DFW. Despite last year’s promising rhetoric, citizens were already disgruntled, claiming the proposal is not enough to rectify the lead emission problem in Frisco. A group of active and concerned citizens formed a coalition called Get the Lead Out of Frisco aimed at fighting Exide’s polluting practices, government inactivity, and public education on the matter.

In more recent news, The Dallas Morning News has updated this information, reporting that the proposals have been pulled from TCEQ’s agenda for next week’s vote. Little explanation was given for the delay, other than that they require further review. The proposals were originally set to be considered in December of 2011 and were delayed until this spring. Now consideration is once again delayed until June of 2012. Additionally, although Exide claims it has been following the proposal’s regulations without official direction since 2011, it has been reported that Exide has once again exceeded legal limits for lead emissions the last two months in a row. Frisco citizens remain skeptical of an eventual proposal’s passage and of said proposal’s actual effectiveness once approved.

Lead emissions can be a serious health hazard to communities. Studies have shown that lead exposure in children can cause intellectual impairments even when present at very low levels. In adults, an increase in blood-lead levels can lead to cardiovascular issues and even fatality. The journal Clinical Biochemist Reviews asserts that, “…low level environmental lead exposure remains a significant public health concern.” Because lead is a proven toxic chemical and its disastrous effects have occurred even when trace amounts are present, massive emission of lead by a major corporation should not be tolerated. Businesses and the government must take greater steps to protect citizens from the systematic poisoning of their air, soil, and water.

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Intuitive Surgical, Inc.’s da Vinci Surgical System is the target of several recent lawsuits beginning in Alabama, Mississippi and New York. This device was cleared by the FDA in 2000 and claims to be a much-desired minimally invasive alternative to traditional surgery. The da Vinci robot performs surgery through a remote-controlled robotic arm with powerful electricity at the tip, meant to “burn” away specified tissue. 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.”

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

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

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

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

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Recent reports have shown that the FDA is stepping up in strengthening the approval and research of post-approval drug safety. The administration has created a post market drug safety program that has shown to be extremely effective. The Center for Drug Evaluation and Research (CDER), the administration’s program, focuses on further research and testing of drugs once they’ve hit the American market. CDER has come out with new technology and research methods that have proven to be a success for both the drug makers and the administration. The program is also benefitting the public by releasing potential drug safety information much earlier, hoping to avoid patients from unknown side effects or problems. According to the FDA, “in 2011, CDER issued 68 drug safety communications – up from 39 in 2010. The communications provide early information to patients and health care professionals about drug safety issues as they emerge.”

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The FDA is pleased to see that this program has benefitted not only the public, but their program as a whole. The administration feels programs similar to CDER will continue to emerge and increase the quality and effectiveness of keeping patients safe and informed in a timely manner. Though the administration has received pressure from several sources about the time it takes to clear medical devices, the FDA hopes with programs like CDER, medical devices and medicines will be cleared at a faster and safer rate. (read full article)

Not being properly informed about potential side effects of certain medications or deciding on a surgery with a medical device that little research has been done on, can lead to severe life changing problems, sometimes even death. One can never be too careful when it comes to taking medicine or undergoing surgery. Our firm has seen many patients suffer from the results of negligence when dealing with failed medical devices and harmful prescriptions.

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