Articles Posted in Defective Medicine

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

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

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

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There has been a decent amount of coverage on the prescription drugs Januvia and Byetta. Januvia (sitagliptin) and Byetta are both injectable drugs, and provide a new way of treating type 2 diabetes. They both help control blood sugar levels by encouraging production of a hormone called glucagon-like peptide 1 (GLP-1). They have potential advantages over older medications, said Dr. Peter Butler, director of the Larry L. Hillblom Islet Research Center at the University of California, Los Angeles781607_vitamins.jpg.While the benefits of these new methods of treatment are undeniable, a side effect of these drugs is pancreatic cancer.

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

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

For more on the USA Today article please look here.

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

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

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

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

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syringe.jpgA 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.

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

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

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

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

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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.

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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.

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Screen shot 2012-11-05 at 10.52.34 AMA North Carolina widow filed a lawsuit last month against Takeda, the manufacturer of Actos. Norma Faique, widow of the late John Faique, is suing the company for her husband’s death. Actos is a prescription drug created to treat Type II diabetes.

As a Type II diabetes patient, Faique was prescribed Actos for three years before he was diagnosed with bladder cancer in October 2010. He died a month after his diagnosis on November 10, 2010. His widow is charging 18 counts against Takeda Pharmaceuticals including wrongful death, strict liability and negligence. She claims that if the company had properly warned consumers of the drug’s risks, her husband never would have taken it.

It wasn’t until seven months after John Faique’s death that the FDA (U.S. Food and Drug Administration) issued a warning stating “the use of the diabetes medication Actos (Pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”

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Bayer could have to pay up to or more than $1.2 billion in order to settle personal injury lawsuits over the company’s Yaz and Yasmin oral contraceptives. For Bayer’s second quarter stockholder update, Bayer told its investors that it is currently facing nearly 13,000 Yaz and Yasmin lawsuits. In July 2012, Bayer accepted a settlement totaling just over $400 million. The German company paid this amount in order to settle approximately a third of the total number of Yaz and Yasmin lawsuits filed against them at that time. Bloomberg reported on July 31st that Bayer has settled 1,877 Yaz lawsuits for $402.6 million, at an average of around $212,000 per case. In addition, Bayer has more than doubled its reserves for settling these cases to over $610 million, which could prove to be positive news for those negatively affected by the drug that have yet to file a claim.

These lawsuits were filed by users of Yaz or Yasmin oral contraceptives, who suffered from venous thrombo-embolic blood clot injuries, such as a pulmonary embolism and/or deep vein thrombosis. Attorneys defending the women who have been hurt by these drugs have cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Bayer failed to warn that users of Yaz and Yasmin were much more likely to suffer these types of injuries than users of older, less expensive birth control pills.

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.