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.

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Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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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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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.

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Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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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.

Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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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.

Borchardt Law Firm represent clients in Texas in cases similar to this one. Feel free to give us a call.
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801 Cherry St #1005
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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.

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
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801 Cherry St #1005
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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.

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
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Fax: 817.332.9301
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Multidistrict Litigation (MDL) on the problematic drug Pradaxa has been moved up to begin in March of 2014, as opposed to previously scheduled August 2014. There are currently over 175 cases pending in this MDL in Southern Illinois. In preparation for the upcoming proceedings, both the plaintiffs and Boehringer Ingelheim, the manufacturer of the anticoagulant Pradaxa, have begun compiling documents and records pertaining to the case. Chief Judge David Herndon, the presiding judge over this MDL, reported to The Madison-St. Clair Record that, “We’re really starting now to get to the meat of the litigation … [the] pace is picking up more.”

Pradaxa hit the market in 2010 as an alternative to warfarin, the more traditional medication designed to treat atrial fibrillation (an irregular heartbeat) and other conditions associated with blood clots. Pradaxa was touted (and heavily marketed) as requiring fewer doctor visits, dietary restrictions, and blood tests to adjust dosage than warfarin. However, this is the very reason Pradaxa may be trouble, because consumers are not properly administering the drug or performing thorough oversight of its effects, under the assumption that Pradaxa is a “one size fits all” medication. Both Pradaxa and warfarin may cause uncontrolled bleeding, however, there is an antidote to stop bleeding caused by warfarin, but no such antidote for Pradaxa exists. Many plaintiffs note that once bleeding begins, there is nothing doctors can do to stop it, and family members may have to simply watch a loved one bleed to death. The combination of improper usage and oversight and the lack of antidote for uncontrollable bleeding makes this drug exceptionally dangerous.

According to Drugwatch, after just two years on the market, Pradaxa has been linked to over 500 deaths and nearly 4,000 adverse effects in patients, including reports of stroke, hemorrhage, acute kidney failure and about a dozen cases of liver failure. Although hundreds of lawsuits are currently pending, some attorneys involved with the litigation predict that Boehringer Ingelheim will face thousands more claims over the next few years.

The aggressive marketing of Pradaxa makes the dangers of this drug a particular problem. Boehringer Ingelheim reportedly spent $464 million on advertising to promote the drug. This marketing was highly effective and, as many claim, highly deceptive. Plaintiffs allege that Pradaxa failed to label the product and warn consumers of the drug’s actual dangers and the lack of treatment method in cases of uncontrolled bleeding, and to properly warn consumers of dosage restrictions and hazards for at-risk populations such as older people or those with preexisting gastrointestinal problems. These are just a few among many complaints filed against Pradaxa and its marketing practices.

The take home message from this article is one of caution and opportunity. Consumers must be aware of the potential dangers when taking a new drug, as risks may be much more serious than drug manufacturers assert. However, it is not too late to file your claim against this defective medicine. As litigation builds momentum, make sure you know what justice you might be entitled to due to the devastating effects this drug may have.

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
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801 Cherry St #1005
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Drug-industry analysts, such as JPMorgan Chase & Co.’s Richard Vosser, have said that Bayer may have to pay more than 2 billion Euros (approximately 2.6 billion US dollars) in order to resolve all of these cases. Bayer recently made a statement telling its investors it is currently settling only those cases alleging blood clot injuries, which is said to number around 6,000 of the total cases.

The federal litigation over Yaz and Yasmin is currently consolidated for pretrial proceedings before U.S. district Judge David R. Herndon in the Southern District Court of Illinois as part of an MDL, or multidistrict litigation. The Yaz and Yasmin MDL has recently grown to become the largest pending litigation in the federal court system.
New information came out on September 12, 2012 that a woman in California has filed a Yaz lawsuit alleging that Yaz was the underlying cause of her developing kidney stones. This appears to be the first Yaz or Yasmin lawsuit that claims that either of these medications can cause kidney stones. It is currently unknown whether or not the California woman and her lawyer will choose to add their case to the existing Yaz and Yasmin MDL in Illinois. Kidney stones may not be the last medical issue to arise with a possible link to Yaz or Yasmin. Any medication that causes blood clots or affects the body’s ability to correctly coagulate blood could lead to any number of medical issues. Some of these issues and complications could develop quickly, while it could possibly take years for other issues to be realized and addressed.

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 whether you may be entitled to legal compensation. Borchardt Law Firm represents clients over many areas in Texas; feel free to give us a call.

Toll Free: 866.832.9300
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The birth control drugs Yaz, Yasmin and Ocella are facing increasing litigation citing some serious complications. According to the San Francisco Chronicle, a recent study listed Yaz and Yasmin as the second worst drugs on the market for adverse events. Between Yaz and Yasmin alone, over 8,000 adverse side effects were reported to the FDA in 2011. A recent FDA study suggested that Yaz and other similar drugs could increase the risk of blood clots, deep vein thrombosis, and pulmonary embolism by up to 74%. Even though all oral contraceptives carry the risk for blood clots, these new and supposedly more advanced drugs may actually create a much higher incidence of blood clots and other related complications. Such strong experimental evidence and high rate of side effect complaints led the FDA to order stronger warning labels on Yaz, Yasmin and Ocella in April of this year.

What are deep vein thrombosis and pulmonary embolism? Deep vein thrombosis refers to a blood clot that forms in a deep vein. This usually occurs in the legs or pelvis and can cause swelling, pain, and even ulcers. This situation can become very serious when the blood clot dislodges and travels through the bloodstream, eventually blocking lung arteries; this is known as pulmonary embolism. Some symptoms include difficulty breathing, chest pain, and palpitations, but in extreme cases effects of pulmonary embolism can be collapse, extremely low blood pressure, and sudden death.

Drospirenone, an active ingredient in these contraceptive drugs, is the culprit of such adverse effects. It is a synthetic progestin that has been linked with forming blood clots, deep vein thrombosis, and stroke. Two 2011 studies reported finding a two-to-three times increased risk for blood clots when using drospirenone contraceptives.

Bayer, the manufacturer of these drugs, has already paid millions in settling lawsuits against their drospirenone oral contraceptive products. The company faces over 12,000 lawsuits. As of this April, Bayer pledged to pay out over $400 million to settle nearly 2,000 cases, at an average of around $200,000 per case. If you or a loved one has developed blood clots or even more serious related complications while using Yaz, Yasmin or Ocella, don’t hesitate to contact a lawyer about your case’s potential. Due to Bayer’s pledge, now could be a very good time to file your claim.

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
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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.

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

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

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.

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 have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.

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

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.

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

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

Coumadin, similar to other drugs, must be carefully monitored almost everyday during a patients first month on the drug. Since the drug is a blood thinner, doctors must be extremely cautious in watching how thin the blood gets. When blood becomes too thin, it could eventually cause a patient to bleed to death, whether or not they have open wounds. If the blood does not thin, a patient could suffer from blood clots, possibly leading to a heart attack, stroke or even death. Once blood clots have formed, there is very little doctors can do in order to stop them, which is why patients taking Coumadin need to be carefully monitored.

During a patients first month on the drug, every day they should undergo either a prothrombin time (PT) test or an international normalized ratio (INR) test. Both tests are blood tests that measure how long it takes for the patient’s blood to clot. The tests also check for bleeding problems and determine how well the blood thinning medicine is working. The only difference between the tests is the INR test is a way of standardizing the results of the PT tests, allowing doctors to understand results even if they come from different testing methods or different labs. The PT and INR tests are crucial for doctors, nurses, hospitals, nursing homes and care providers to maintain in order to monitor the safety and effectiveness of the medicine.

As all medicines do, Coumadin affects each patient differently. Age and health backgrounds may alter the performance and side effects of the drug for each person. Those responsible for the testing, whether it is the primary care doctor, hospital or nursing home, should know the risks and warnings that come with the drug.

If you or a loved one have ever taken Coumadin and have suffered from the drug not properly being monitored or have had serious side effects that you were not warned about, don’t hesitate to contact an attorney. At Borchardt Law Firm, we have seen and dealt with many cases involving Coumadin and several other failed prescription drugs due to the negligence of those responsible for the monitoring. We wish no family has to ever experience a tragedy caused by negligence, but feel the work we do will continue to protect future generations of Texans. 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
Sources:
http://www.drugs.com/coumadin.html

The FDA (Food and Drug Administration) continues to express concern about the potential side effects of Yaz birth control. Over the past few years health experts and the FDA have shown an increased apprehension over the once-a-day pill. Yaz, unlike older contraceptive pills, contains drospirenone, an ingredient that may be a leading factor in an increased risk in blood clots. Though all birth controls come with a risk of blood clots, studies have suggested that pills containing drospirenone slightly enhance that risk. Yaz, one of Bayers leading products, was approved in 2006. By 2008 it was the top selling birth control pill in the U.S. Due to its reputation of helping with acne and PMS symptoms millions of women became prescribed to the pill.

By 2009 Bayer’s sales for Yaz quickly began to fall. Several women filed complaints that Yaz was the leading factor in blood clots and that the Bayer did not properly inform their patients of this risk. Since then, sales of Yaz have decreased by almost 80 percent, creating a much higher threat of concern and a significant increase in lawsuits. Today, there is an estimated 4,000-6,000 patients suing Bayer for not being properly informed of the possibly severe side effects of Yaz. Blood clots can cause life threatening problems such as stroke and heart attack. There have also been reported cases of fatal blood clots. If it is a possibility that drospirenone increases the risk of what can be fatal blood clots, Bayer needs to immediately update all of Yaz’s labels to accurately inform their patients.

Though health experts still struggle to find clear evidence that drospirenone is the leading factor in an increase in blood clots the FDA panel of experts voted 21-5 that Bayer did not properly inform their patients of potential side effects. The labeling on each drug is not clearly stated and needs more detail when referring to impending severe side effects such as the increased risk of blood clots.

The FDA is still working to set an official deadline for Bayer to change all of Yaz’s labeling and predict the drug will continue to be on the shelves until clear evidence is found that drospirenone is the leading factor in blood clots. However, the FDA continues to advise all women taking birth control to consult their doctor for alternative options. Unfortunately, with most birth controls there are always risks that patients need to be aware of. If you feel that you or someone you know has suffered from side effects that were not properly warned about don’t hesitate to contact a lawyer to discuss your legal options. At Borchardt Law Firm we have seen and dealt with many defective prescription drug cases and feel the work we do will better protect future generations of Texans. Feel free to give us a call.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
Burnett Building
801 Cherry St #1005
Fort Worth, Texas 76102
firm@attorneysmb.com
Sources:
http://www.huffingtonpost.com/2011/12/09/yaz-birth-control-risks-fda-warning_n_1138872.html

https://www.youtube.com/watch?v=DVy-uDadBx4

As more complaints were filed the FDA, Food and Drug Administration, took a closer look at the advertisement and results of the pill. After studies found that Yaz was never actually proven to treat severe PMS symptoms, Bayer launched a corrected ad that reinstated the pill should be used “for the treatment of premenstrual dysphonic disorder, or PMDD, and moderate acne, not for the treatment of PMS or mild acne.” Though Bayer had corrected their misleading ad, the FDA still had concerns about the pill. While looking over studies the FDA noted that Yaz, unlike most birth control pills, contains the use of drospirenone, a synthetic progestin that helps prevent ovulation. Though drospirenone works well for preventing pregnancy, the FDA has shown concern that the synthetic progestin may lead to a higher risk of blood clots.

In 2008, a 24-year-old woman taking Yaz for just three months suffered from a nearly fatal blood clot that she believes also might be the cause of her blindness. The woman began taking Yaz after seeing the convincing commercial that Yaz would treat all severe PMS and mild acne symptoms. After a few months on the pill she began to feel aching pain in her legs, assuming it was simply exhaustion. Shortly after, she suffered from severe blood clots the next evening. The clots had traveled from her legs up to her lungs causing a double pulmonary embolism. As she was rushed to the hospital her heart stopped and she slipped into a coma. The 24-year-old awakened about two weeks later to realize she no longer had her vision. Doctors are not positive what exactly lead to the blood clots and the loss of vision but the woman believes it had to do with the drospirenone in the pill. (read full story)

The FDA has yet to complete their study about the possible increased risk for blood clots while using birth control that contains drospirenone. However, they continue to advise all women taking birth control to consult their doctor for alternative options. Unfortunately, with most birth controls there are always risks that patients need to be aware of. If you feel that you or someone you know has suffered from side effects that were not properly warned about don’t hesitate to contact a lawyer to discuss your legal options. At Borchardt Law Firm we have seen and dealt with many defective prescription drug cases and feel the work we do will better protect future generations of Texans. Feel free to give us a call.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
Burnett Building
801 Cherry St #1005
Fort Worth, Texas 76102
firm@attorneysmb.com
Sources:
http://abcnews.go.com/TheLaw/studies-find-yaz-risky-leading-birth-control-pills/story?id=14741760#.Tsqus7Iizcs

http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm

• 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)

If you think your child is a victim to birthing negligence which led to the development of their Cerebral palsy, have an experienced medical malpractice attorney review your situation to discuss your legal options. At Borchardt Law Firm we feel the work we do will protect future generations of Texans. Feel free to give us a call.

Burnett Building
801 Cherry St #1005
Fort Worth, Texas 76102
Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301
firm@attorneysmb.com
Sources
(http://www.cerebralpalsysource.com/cp_quickfacts/index.html)

http://www.cerebralpalsysource.com/News_and_Articles/index.html

http://www.cerebralpalsy.org/

According to the American Diabetes Association, type 2 diabetes is the most common form of diabetes; it affects millions of Americans every day. With type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary for the body to be able to use glucose for energy. When you eat food, the body breaks down all of the sugars and starches into glucose, which is the basic fuel for the cells in the body. Insulin takes the sugar from the blood into the cells.

Untreated patients with type 2 diabetes may experience constant fatigue, weight loss, blurred vision, increased thirst and several other serious side effects. “Actos focuses on two of the common problems that lead to high blood sugar in type 2 diabetes. The medication helps your body better use the insulin it makes, and also stops your liver from making more sugar when it doesn’t need to. By treating these problems, the sugar in your blood can get to where it needs to go so it doesn’t continue to build up in the bloodstream” (Actos Website) Actos appeals to patients due to the ease of taking it and the short term results but now the drug proves to have much more serious long term side effects that Takeda failed to mention to their patients. “The FDA analyzed data from the first five years of a 10-year Actos safe study Takeda begun in 2001 and concluded this June that the risk of bladder cancer was 40 percent higher for patients taking Actos for at least a year, although still small: an extra 28 cases a year for every 100,000 people taking it.” (CBS News)

(Visit the Mayo Clinic site to read more about bladder cancer symptoms)

Over the last 2 months lawyers across the U.S. have seen hundreds of filed complaints about Actos leading to bladder cancer. Don’t hesitate to contact your Dallas Fort Worth Actos lawyer. At Borchardt Law Firm we want to make sure the medicine patients are taking is safe. We have dealt with several defective prescription drug cases and feel the work we do will protect future generations of Texans. If you feel you may have been negatively effected after taking Actos please give us a call to learn more about your legal options.

Toll Free: 866.832.9300
Phone: 817.332.9300
Fax: 817.332.9301Burnett Building
801 Cherry St #1005
Fort Worth, Texas 76102
firm@attorneysmb.com
Sources:
http://www.diabetes.org/
http://www.actos.com/HowItWorks.aspx
http://www.cbc.ca/news/health/story/2011/08/05/actos-bladder-cancer.html