Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

As the Bush administration prepared to vacate office, the Food and Drug Administration (FDA) issued new guidelines that ease restrictions on promotion of off-label drug use by pharmaceutical companies. The rule has been severely criticized because it may lead to more dangers when pharmaceutical drugs are used in ways not approved by the FDA.

It is illegal for pharmaceutical companies to promote off-label use of their drugs, although physicians are allowed to prescribe drugs for purposes not approved by the FDA. Doctors are allowed and often do rely on published medical research to prescribe drugs for unapproved uses to their patients. In its new rule, the FDA allows pharmaceutical companies to cite medical journal research supporting off-label uses of a drug. The biggest problem with relying on medical journal articles is that such research does not go through a strict screening process. It is hardly meant to be used as a substitute for the rigorous approval procedures conducted by the FDA.  Plus, there is also the risk that pharmaceutical companies may pay medical researchers and scientists for articles that recommend promotion of the drug for off-label use, which clearly would not be genuine, in-depth research articles.

The new guideline has been criticized from both within and outside the Bush administration. The Department of Veterans Affairs, patient advocacy groups, state prosecutors and medical injury lawyers around the country stand adamant that the new guidelines will weaken an already unstable FDA and expose patients to the omnipresent dangers of off-label drug use.

Off-label drug use continues to be a major danger to patients at risk of side effects from such drugs. Recently, Eli Lilly and Company agreed to a mammoth settlement over civil and criminal lawsuits arising from off-label drug use promotion. Also, Medtronic currently faces a lawsuit arising from the same unethical practices related to its Infuse Bone Graft. The threat of massive civil and criminal liability is the only thing preventing mass off-label promotion by drug manufacturers.  In the absence of rules completely prohibiting such promotion, drug manufacturers will have the freedom to place patients at risk in order to multiply their profits.

Promotion of off-label drug use by pharmaceutical companies can expose patients to unknown side effects simply because off-label uses are not researched as extensively as approved uses and, therefore, have little research to provide help in the case of adverse effects. In such cases, patients who have been injured can file a medical injury lawsuit against the company with the help of a medical injury lawyer.

If you have been injured by the use of a defective pharmaceutical drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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If the prospect of contaminated Heparin and injuries from Avandia were not disturbing enough, an eminent cardiologist has now warned of the danger of a biological threat if the FDA does not get its act together, and fast.

Dr. Steven Nissen, a prominent Cleveland Clinic cardiologist and medical researcher, was one of the first to bring the risk of Avandia injuries caused by Glaxo's anti-diabetes drug into the spotlight. This man has a reputation for being straight forward and honest and has never shied away from calling out pharmaceutical companies and the FDA for their negligence.  He has also been named a possible contender for FDA chief.  Big pharmaceutical companies have always been wary of his announcements and the FDA has frequently been the target of Dr. Nissen's criticism. 

So, when Dr. Nissen raises concerns that terrorist organizations, like Al-Qaeda, could use the FDA's scant oversight of foreign pharmaceutical plants to mount a biological attack on the U.S., we are inclined to pay attention. Dr. Nissen insists that he is not trying to stir up paranoia. Recent instances of the FDA’s somnambular conduct of its drug safety processes, especially at foreign plants, do raise concerns that the facilities could be used by those who seek to harm Americans. China, for instance, is growing to be a significant source of drugs manufactured for Americans. Last year's heparin scandal was traced to batches of contaminated Heparin injections manufactured in China. The Heparin contamination, it is believed, came from adding a synthetic, cheaper compound in place of the original ingredient in a possible effort to cut costs. Since then, we have found that the FDA has not conducted a single inspection of the Chinese plant since it received approval several years ago. The FDA now has an inspection office in China to handle inspections of food and drug plants supplying the U.S. It seems like a reassuring first step, until you realize that the total staff strength at the Chinese FDA office is 8.

The FDA admitted that it has been unable to adapt to growing changes brought about by globalization. In a scenario where a growing number of drugs are sourced from Chinese plants, there may be reason to worry about whether a lack of FDA inspections, combined with poor regulatory standards in China could lead to the first major biological terrorist attack on the U.S. Of course, the chances of terrorists infiltrating a Chinese pharmaceutical plant and contaminating drugs meant for American consumers may seem far fetched now, but we never imagined that a group of zealots would drive aircrafts into the heart of New York City either. 

Medical Injury Lawyers

The FDA's poor oversight of drug makers and poor regulatory practices, combined with pharmaceutical companies' negligence, have time and again placed American consumers at risk of tainted or defective pharmaceutical drugs. If you have been injured as a result of using a dangerous drug or defective medical device, you will need the help of a medical injury lawyer to recover the compensation you deserve.

To get the help you need contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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Generic drug manufacturer, Ethex Corporation, has suspended the manufacturing and sales of dozens of defective pharmaceutical drugs from its line, including several brands of isosorbide mononitrate, amlodipine and nitroglycerin, among others.

The company, which is a subsidiary of St. Louis-based KV Pharmaceuticals, took the step after inspections of the company's facilities by the U.S. Food and Drug Administration. This second massive recall comes just a few months after the company announced a recall of some of its products in 2008. The earlier recalls were the result of several anomalies in the manufacturing of drugs, including oversized tablets that contained twice the required amount of the drug. The extra sized tablets included Morphine Sulphate Extended Release, Morphine Sulphate Immediate Release, Propafenone HCI, Isosorbide Mononitrate Extended Release, Hydromorphone HCI tablets, and Dextroamphetamine Sulphate. There have been several medical injury lawsuits already filed against the company related to morphine over-dosage, due to the oversized morphine tablets. Morphine over-dosage can lead to decelerated heart beat, disorientation, confusion, lightheadedness, fainting and convulsions.

The new recall by Ethex includes almost the entire line of drugs manufactured by the company. The products recalled include generic versions of the pain killer OxyContin, anti-depressant medication Toprol XL and cough medicines.  Most of the drugs have been recalled from wholesale agencies, while some have also been recalled from retailers.  A press release issued by the company asks patients who are using the medications to continue using them due to the health risks of suddenly stopping the medication. The company has also asked patients to consult with their doctors and be observant for any side effects; any side effects noticed should be reported through the FDA's MedWatch program.

Hiring a Medical Injury Lawyer

When it comes to injuries caused by unsafe pharmaceutical drugs, it is important to save the bottles or containers of the medication. We advise you to discontinue use of the medication after consulting with your doctor and talk to a medical injury lawyer. It's important to hire an attorney who has an established record of pursuing and winning claims against major pharmaceutical companies. The medical injury lawyers at Arnold & Itkin LLP have successfully represented dozens of victims of unsafe pharmaceutical drugs. 

If you have been injured by the use of a defective drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

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A series of e-mails confirm what medical injury lawyers have suspected for months now - that GlaxoSmithKline has been long aware of the side effects associated with the use of its diabetes medication, Avandia.

In 2007, a study by pioneering Cleveland Clinic cardiologist Dr. Steven Nissen, published in the New England Journal of Medicine, revealed that patients who took Avandia are at a higher risk of developing cardiac disease. Doctor Nissen studied the effects of Avandia use in more than 15,000 patients, monitoring 12,283 subjects in a control group. He found 86 cases of myocardial infarction in the group that was given Avandia, compared to 72 cases in the control group, and 39 deaths among Avandia users as opposed to 22 deaths in the control group. At the time, Dr. Nissen acknowledged that a few deaths in more than 15 thousand subjects may seem like an inconsequential number, but because the studies were conducted over a short period of time and because of the increased risk of heart disease in diabetic patients, the enhanced incidence of heart attacks in Avandia users was cause for worry. Glaxo was quick to refute the findings of the study. The company released a statement questioning the methods used by Dr. Nissen, but the FDA quickly issued a safety alert on Avandia.

Since then, the link between Avandia and heart disease has become stronger with more numbers of people killed and hundred of cases of heart failure. Now, reports indicate that the company was aware of the increased risk all along. According to reports, senior GlaxoSmithKline scientists wrote e-mails just before the publication of Doctor Nissan's study admitting that his findings were "very similar" to the conclusions reached by GlaxoSmithKline. The company, at the time, was under scrutiny because of the Vioxx scandal which associated Merck's painkiller with an increased risk of heart disease. The Vioxx concerns ended with the company withdrawing the drug and hundreds of medical injury lawsuits filed by patients who suffered heart attacks after taking Vioxx.  Desperate to avoid Merck's fate, Glaxo went all out to criticize Dr. Nissen's findings almost immediately after publication of the study. Avandia use has decreased dramatically since then, but it remains on the market and thousands of patients continue to take the drug.

Pursuing Medical Injury Claims

Pharmaceutical companies may often hide important safety information about their drugs in order to remove obstacles in their marketing plan. Such suppression of information may be grounds for a medical injury lawsuit against the drug maker in the event of injuries caused by the drug.

If you or a loved one have suffered heart problems after taking Avandia, you may have grounds for compensation. Contact the medical injury lawyers at Arnold & Itkin LLP for a free evaluation of your case.

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A report titled Outbreak of Adverse Reactions Associated with Contaminated Heparin issued by the Centers for Disease Control and Prevention has confirmed the worst fears of the public – that Heparin injuries and deaths were caused by a synthetic chemical that was added to the drug at a Chinese plant.

According to a followup article published in the Washington Post, the CDC has found strong evidence linking the chemical oversulfated chondroitin sulphate and the symptoms that patients who had been given Heparin, Baxter's blood thinner began to suffer in November last year. Allergic reactions to the product included nausea, breathing difficulties and a rapid drop in blood reassure. In the United States alone, 81 people are confirmed to have died from the contaminated Heparin, and there have been hundreds of reactions to the medical product.  There are fears that more side effects could lie potentially hidden in a patient's system, to erupt later in unrecognizable forms. 

Oversulfated chondroitin sulphate is a processed form of chondroitin sulphate, an animal sourced product that is used in arthritis medications. Chondroitin sulphate is much cheaper to produce, and it's believed that this is why the Chinese producers added it to the drug to replicate the blood thinning properties of the original ingredient.  The recalled contaminated heparin continued to sit on shelves in hospitals in many states even after a recall was announced in early 2008, and it's entirely possible that there may be more injuries resulting from the contamination that are still under the radar. It's not easy to connect a contaminated drug to symptoms, and for months the FDA was unaware that the allergic reactions that patients were suffering were due to any contaminant in the Heparin.

Baxter's failure to maintain quality control at its Chinese supply plant, combined with the FDA's inadequate inspection procedures ensured that hundreds of people suffered violent reactions to the drug before experts were able to point to the source. An increasing dependence on foreign drug suppliers whose facilities are rarely put through FDA inspections has meant that Americans can hardly use a medication without worrying if it's going to cause extreme reactions or in worst case scenarios, even death. The FDA has had a particularly worrisome couple of years with numerous tainted drugs entering the market, many of them manufactured at overseas plants. It doesn't help that the agency barely has enough resources to inspect facilities at home, let alone plants that are located thousands of miles away.

Heparin Injury Numbers Continue to Rise

Contaminated Heparin has caused serious injuries in patients that may have long term implications, including organ damage, low blood pressure, and even death. There may be other little known effects that manifest themselves weeks and months after the administration of the drug. Across the country, dozens of patients have filed medical injury lawsuits against Baxter to protect their rights and obtain compensation for their suffering.

Pursuing claims for damages against large pharmaceutical companies like Baxter can be a complex and expensive process. Victims benefit from the expertise of a specialized pharmaceutical liability lawyer who has both the experience and the resources to pursue the claim.

If you've suffered adverse reactions to Heparin or another dangerous pharmaceutical drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case. Our lawyers handle most cases on a contingency basis so there is no fee unless we prevail on your behalf.

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The FDA confirmed today in a media briefing on the recall of contaminated Heparin that a total of 81 deaths are now known to have occurred as a result of adverse reactions to the contaminated product. The new total is an increase over the previously reported number of 62 deaths.

The FDA has also announced that Heparin's active ingredient was contaminated at Chinese manufacturing facilities where it was made, with a chemically altered form of chondroitin sulfate, a dietary supplement made from animal cartilage that is widely used to treat joint pain.

Laws in most states provide for several personal injury claims for persons who have been seriously injured due to defective prescription drugs and treatments.  If you are a loved one have been seriously injured by a defective product like contaminated Heparin, you can learn more about options for claiming compensation from those responsible for your Heparin injury.

Contact a medical injury lawyer from the Arnold & Itkin LLP law firm in Houston, Texas. We can answer questions and help you understand your options.

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