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October 22, 2012

Fungal Meningitis Cases Linked to Contaminated Medications

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Along with the rest of the nation, our team is following the recent headlines linking an outbreak of fungal medication to contaminated medications. As a Panama City dangerous drugs law firm, we believe that Americans in the twenty-first century should be able to rest assured that medications are safe. However, the recent outbreak is a harsh reminder that this ideal is not always met.

An Overview of the Outbreak
According to a report by CNN, at least fifteen people have died due to fungal meningitis. Authorities have traced the outbreak to a contaminated drug, specifically a steroid called methylprednisolone acetate produced by the New England Compounding Center ("NECC"). Massachusetts-based NECC is a compounding pharmacy, which means they combine ingredients to make a medication specifically for a given patient. The Center for Disease Control ("CDC") estimated that 14,000 people received relevant steroid formulations that may have been contaminated. As of the CNN article, the CDC identified 214 cases of meningitis, spread across fifteen states, linked to the contaminated drugs.

Meningitis is a condition in which protective membranes that cover the brain and spinal cord become inflamed. In most cases, the root cause of the inflammation is either a virus or a bacterial infection. Less often, meningitis stems from another pathogen such as the fungus that is the cause of the current outbreak. The fungal form is often very serious. In addition to the usual symptoms associated with meningitis, including nausea, headache, fever, and stiff neck, patients infected with fungal meningitis may also experience dizziness, confusion, and trouble dealing with bright lights. Not all patients will exhibit all symptoms. While many forms of meningitis are contagious, the fungal type is not so others who have had contact with the infected patients are not at risk.

Government Response to Meningitis Outbreaks Tied to Contaminated Medicine
Congress has opened an investigation into the outbreak. A committee from the House of Representatives sent a notice to the Massachusetts Board of Registration in Pharmacy noting that this is not the first time overseers have raised concerns about NECC. In 2006, the Food and Drug Administration ("FDA") sent a warning letter to the Framingham, MA-based company detailing significant violations witnessed by agency investigators over the previous year. Responding to the current problems, Massachusetts Governor Deval Patrick also accused NECC of misleading regulators and going beyond the company's license by shipping large amounts of compounded products across the country. The state's pharmacy board is also issuing a new mandate that requires compounding pharmacies operating in Massachusetts to sign an affidavit verifying compliance with regulations requiring that medications are mixed specifically for use by particular patients.

Additionally, FDA investigators are looking into concerns that other NECC products may have been contaminated. The agency noted that a patient who received an injection of another NECC compound (triamcinolone acetonide) may also have meningitis. Another patient who underwent an open-heat procedure using an NECC produced cardioplegic solution has reportedly contracted a different form of fungal investigation. The FDA noted that the investigation into that case is ongoing and that the fungus may have come from another source.

In response to the meningitis outbreak, NECC announced a recall of all of its products. Given the contamination concerns, the FDA has stated that all patients who received the medications should be notified of the potential risk of infection.

Helping Victims of Contaminated Drugs in Panama City
We hope that no more patients fall ill as a result of the current outbreak and that those currently battling infection are successfully brought back to health. If you or someone you love has fallen ill due to an NECC product or another contaminated medication, please call our office. Our Panama City defective pharmaceuticals attorney has experience working with the victims of dangerous drugs and can help you seek justice.

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December 8, 2011

Drugmaker of Diabetes Drug Actos Facing Thousands of Lawsuits Alleging Bladder Cancer

Takeda Pharmaceutical Company is Asia's largest drugmaker. It may also be the recipient of the largest number of lawsuits in history over a drug. It makes Actos, a diabetic drug. Actos may also cause bladder cancer as alleged in hundreds of lawsuits proceeding across the country. Now, as more suits are filed, these cases may be consolidated into one legal proceeding very near to us.

U.S. regulators in June found that a Takeda sponsored study showed that some users of Actos faced an increased risk of developing potentially fatal bladder cancer. Claims against the manufacturer are being processed every day, and those investigating Actos say that the evidence is unusually clear and strong for causation of cancer.

Takeda Pharmaceutical pulled the drug off the market in Germany and France earlier this year. Actos has been marketed in the U.S. by Eli Lilly & Company of Indianapolis. Some Actos users who have gotten bladder cancer say, "If we had known what it would cause, we would have taken other drugs that are out there to treat diabetes, drugs that don't cause cancer." Proof of Actos' causation of cancer may be easier than proof of causation in most drug cases, because bladder cancer is generally considered to be a signature injury of a drug. Translating this medical-legal jargon, that means that bladder cancer rarely results from anything other than Actos. Certainly, it occurs but not often.

Few things other than Actos cause bladder cancer. In contrast, many things cause strokes or heart attacks. Unfortunately for Takeda, there is mounting evidence that Actos is responsible for heart attacks and strokes, too. Takeda is about to face a very bad time. What is behind the plethora of drug product liability cases in the world? Take, for example, Vioxx, Avandia, and many others. Now Actos. Some say greed on the part of manufacturers rushing drugs to market. We will see.

October 7, 2010

What Could the Annual Cry of Tort Reform Mean to You?

Every year, without exception, we hear about tort reform as legislative and congressional sessions approach. Should we applaud or fear? I'll give you my perspective and some examples. I admit my leanings against tort reform, because I have been a personal injury attorney representing badly hurt people for many years. As a result of that experience, I have also been privy to the huge abuses of those huge corporations called insurance companies. They are the AIG's of our world. When AIG was bailed out by our government from financial ruin, it was known to be so bad that it had to change its name. Let's reveal it. Now, it's known as Chartis Insurance.

Back to the question, should we applaud or fear the cries by some legislators for tort reform? Well, let's go beyond the recent Toyota unexpected acceleration claims to the more recent broad spread salmonella infections from contaminated eggs. It's now recognized that the egg farms' practices were despicable. Feces, rats, and every other known form of contamination were present. It's no wonder that people across this country got deathly sick.

Regulation is crucial to a level playing field for consumers, particularly in this era of growing corporate power. However, regulation alone has never been enough. Consumer agencies like the FDA, the Consumer Product Safety Administration, and the National Highway Traffic Safety Administration have been swamped by huge workloads. They cannot keep up. Furthermore, lobbyists for the corporations are skilled at weakening and fending off regulations that would protect consumers. Against this, for example, the FDA's caseload by the mid-2000s extended to more than 11,000 drugs, over 100 new drugs a year, and products spanning medical devices to vaccines. It cannot do everything.

Another example of the inability of government alone to thwart, prevent, or obtain compensation for bad products that are rampant in the market is that during last month, I was a leader in obtaining a settlement of millions of dollars in a case, because the government was unable to regulate the manufacturers of the product, guarantee the safety of people exposed to it, or get compensation for the injured people. As a result of the inability of government to ensure safety, consumers are increasingly left with the courts not only to compensate them when the regulatory system fails to protect them but also to deter manufacturers from cutting corners in the future.

The annual tort reform crusade by manufacturers weakens our efforts for public safety. Strong product liability laws remain vital to public safety and health, no matter how passionate the political debate on tort reform.