Articles Posted in defective drugs

On the heels of a report from the U.S. Food & Drug Administration regarding the increasing list of safety standard failures at a Massachusetts compounding pharmacy blamed for a deadly national meningitis outbreak, a scathing report from Congress slams the FDA for its inaction.

Our Boston medical malpractice lawyers understand that the report, issued by House of Representative Republicans, claims the federal regulator should have acted years ago to shutter the New England Compounding Center. You may recall from earlier blog entries that contaminated pain injections produced by the company last year reportedly resulted in 53 deaths and more than 700 illnesses throughout the country. It was one of the worst outbreaks of medication-related illness in our national history.

The company was forced to close in October, and as of right now, faces more than 100 lawsuits.

Six months after the NECC was forced to close, an ongoing debate rages about whether this awful tragedy might have been preventable. The resounding answer appears to be: Yes.

A House subcommittee has been investigating the issue since last fall. What they have so far concluded is that the center should have been boarded up years ago. The House leaders pinned responsibility for the fact that it wasn’t squarely on the FDA.

The first time the federal agency inspected the facility was 13 years ago. Four years later, in 2005, the regulator submitted a warning to the firm, noting the illegal practice of mass-producing replicas of drugs that were already being manufactured.

Compounding pharmacies are tapped as sources of customized drug mixes based on individual doctor prescriptions. Mass production of other types of standard drugs by these firms is illegal.

Over the course of the next five years, the FDA was flooded with complaints about the NECC. Some were from anonymous informants. Others were from state pharmacy regulators, doctors, hospitals, drug distributors and patients. This was all backed in documents the FDA handed over to the House Energy and Commerce Subcommittee on Oversight and Investigations for its research. The fact that the FDA essentially did nothing to halt this clearly troubled operation speaks volumes about what we can expect – or can’t expect – when we receive medicine.

As Rep. Tim Murphy (R-PA) noted, the FDA had a decade of flashing red lights, warning signs and alarm bells. Yet, all of that was either blatantly ignored or resulted in a minor slap on the wrist – even though these violations could – and later did – result in serious injury or death.

The FDA’s commissioner, Margaret Hamburg, testified before the subcommittee and appealed for a greater amount of oversight when it comes to the compounding industry, which in the last 25 years has been aggressive in court challenges of federal regulatory authority. She said her agency is trying to become more active on this front, but the laws and court decisions regarding the FDA’s legal boundaries are spotty and conflicting.

House Democrats on the committee, while also critical of the FDA’s response, did concede that the agency needs clearer authority to be able to act more decisively in the future.

The late Ted Kennedy, D-Massachusetts, introduced such a bill but it was not passed by fellow members of Congress.
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Given that it’s cold and flu season, patients will no doubt be headed in droves to doctors’ offices and pharmacies in search of antibiotics – particularly a powerful one called Zithromax, also sometimes called a Z-Pak.

These prescriptions are most commonly used for bronchitis, sinus infections, pneumonia and other respiratory infections. It tends to be more popular than other similar drugs because its potency allows it to be taken for a shorter period of time.

However, our Boston personal injury lawyers have learned that the drugs are also now tied to a sudden deadly heart problem. That’s according to a recently-concluded 14-year study conducted by Vanderbilt University researchers in Tennessee.

The risk was reportedly relatively rare, but surprising, and not one that has been advertised by distributors or warned about by doctors or pharmacists.

Researchers looked at outcomes for nearly 550,000 patients who were given Zithromax between 1992 and 2006. Of those who took the five-day treatment, there were approximately 30 heart-related deaths. That was more than double the rate of what patients who had taken other antibiotics – or no antibiotics – had suffered.

So per 1 million Z-Pak patients, researchers estimated about 85 would be at risk for a sudden heart death, compared to 32 among patients who took amoxicillin and 30 among those who took no antibiotics at all. To put it another way, there would be 47 more heart-related deaths among those patients given Z-Paks versus those given amoxicillin.

Researchers said they controlled for heart risks, meaning that those in each category were no more at risk for a heart complication or problem than those in any of the other groups.

Although the risk at first glance may appear to be relatively low, consider that some 40 million people in this country are prescribed the drug annually. That means that on average, we’re talking about 3,400 deaths a year from sudden heart problems caused by this drug. That is a significant number.

Those with existing heart complications undoubtedly should be steered away from the drug, as should those with lower-than-normal levels of magnesium or potassium in their blood.

Doctors worry what the longer-term effects might be of this news, and whether there are other potential risks involving the drug that we don’t yet know about. Z-Paks, which are marketed by Pfizer Inc., have only been around for about 20 years, which means we may yet have a lot to learn. Sales last year alone for the drug topped nearly $465 million.

There has been past research that has shown that Z-Pak’s might benefit people who have severe lung disease, but in light of this new information, it’s not clear whether those individuals should continue to take it.

In response to the study, which was recently published in the New England Journal of Medicine, federal authorities with the U.S. Food and Drug Administration have issued a formal notice to doctors. Additionally, the agency announced that new labels warning of the risk would be added to the prescription bottles, so they could be easily read by patients.
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The federal government has issued a permanent injunction against an Ohio drugmaker for numerous violations related to cleanliness, appropriate practices and investigations.

Our Boston personal injury lawyers know that the U.S. Food and Drug Administration has really given Ben Venue Laboratories Inc. more chances than it ever deserved to get its act together. That the FDA has taken such a strong stance in actually shutting down operations speaks volumes not only of the severity of violations here, but also of a repeated and blatant unwillingness or inability to address these problems.

The FDA has a list of minimum requirements that drugmakers have to meet in order for operations to be considered abiding by good manufacturing practices. The end goal is that the companies will ensure both the purity and quality that the company advertises is actually what patients are getting.

These minimum requirements include things like sterile work environments, efforts to minimize contamination and proper training and protocol for staffers. Drugmakers really should be going above and beyond these standards, as they are a minimum.

But Ben Venue, a primary manufacturer of certain cancer drugs, including Doxil, apparently couldn’t even do that, according to the government, and this move was a long time in coming.

Since February 2002, the firm has had no fewer than 40 recalls of its products and drugs. Ten of those have occurred just in the last handful of years, and France and Germany have actually forbidden Ben Venue’s drugs to be sold. About a quarter of those recalls were prompted by reports of serious negative health effects and the risk of death.

Back in 2010, the FDA conducted an inspection of the company and found that a leaking roof caused metal contamination in two different medications. That inspection also reportedly found mold in areas where the drugs were made, equipment that was rusted, glass contamination and a huge bucket in the manufacturing area that contained urine. A number of the medications were found to have been contaminated with bacteria.

This was followed by another inspection in the spring of 2011. Following that, FDA inspectors reported some 48 violations that included untimely and insufficient investigations, failure to prevent contamination of products, inadequate quality control and employee practices that were sorely lacking.

Another month-long inspection at the end of 2011 prompted company officials to voluntarily shut down operations, where some 1,300 people were employed. A number of drugs were also recalled, including those used to treat patients with ovarian cancer, AIDS, viral eye infections and those with myelodysplastic syndromes (bone marrow diseases).

But the halting of operations at the lab created a huge problem: exacerbation of the serious shortage of Doxil, which already had a waiting list of cancer patients hoping to gain access to the drug.

So as part of the injunction, FDA is allowing the firm to continue making Doxil and a few other in-demand drugs, but under an extremely intense microscope and only after adopting a number of corrective actions. Before the firm can fully resume operations, it must:

• Hire an outside expert to regularly inspect the facility and to conduct batch-by-batch quality control tests;
• Develop and implement a remediation plan;
• Undergo an in-depth FDA inspection to make sure that operations are in full compliance with the law.

Unless and until these criteria are met, Ben Venue will not be able to resume full operations.

That it took such severe and repeated violations for the firm to be ordered into compliance is beyond disappointing. Those who have been harmed by Ben Venue’s products should contact an attorney to discuss the potential for compensation.
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