Wednesday, 13 of December of 2017

Tag » FDA

FDA Announces Recall At Yet Another Compounding Pharmacy Due To Worries About Drug Sterility

By Shapiro, Lewis, Appleton and Favaloro, VA/NC Med Mal Attorney

What Happened:

A Florida compounding pharmacy just announced that it would recall its entire line of sterile products after an inspection by the U.S. Food and Drug Administration raised concerns about the safety of its products.

The latest recall is one in a string of moves by compounding pharmacies to recall products after fears were raised about the sterilization processes at a wide array of facilities. The latest recall includes all the injectables produced under the Balanced Solutions Compounding Pharmacy name, a total of 53 separate products.

The company has said its products were sent to doctor’s offices across the country and that the company will now be recalling all not expired items due to concerns that they may not be sterile. The FDA has announced that during an inspection of the Balanced Solutions plant investigators witnessed poor practices and conditions which could have exposed medications to contamination.

The FDA said the inspection raised concerns about a lack of sterility assurance. A later test of one of Balanced Solutions’ products confirmed the presence of bacteria. Patients who have received drug injections produced by Balanced Solutions are being asked to contact their healthcare providers.

The Virginia Injury Attorney’s Perspective:

The latest problems with Balanced Solutions comes soon after recalls by three other compounding pharmacies across the country. The other compounding pharmacies issued the recalls after FDA inspections raised doubts about sterilization practices. The FDA has turned up the heat on compounding pharmacies across the country in the wake of the deadly fungal meningitis outbreak caused by unsanitary conditions at the New England Compounding Center. That episode left more than 50 people dead and more than 700 seriously injured.

As experienced Virginia dangerous drug attorneys, my colleagues and I have helped clients through many cases like this one. Sadly, thousands of people experience the pain of taking a medication prescribed by their doctor only to have it cause serious health problems later on. This happens far too often and the side effects can last a lifetime.

Potentially Helpful Info: 

Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective drugs recover damages from companies whose negligence or disregard for consumer safety led to injuries.

If you or a family member has been injured by a defective or dangerous drug, you can begin to learn about your legal rights and options by reading this article. The report, drafted by our experienced Virginia injury attorneys, provides examples of various kinds of dangerous drug lawsuits, common legal theories used in such cases and an explanation of how dangerous drug cases are investigated.

Have Questions? Check Out Our FAQs

If you’ve been injured due to a dangerous or defective drug, you likely have a lot of questions about how to move forward. Take a look at our firm’s library containing attorneys’ answers to frequently asked questions regarding defective or dangerous drugs.

Here’s a video discussing the settlement process in medical malpractice cases:

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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis, Appleton & Favaloro include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Attorneys with our firm have been listed among the Best Lawyers in America since 2008. Attorneys with our personal injury law firm have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of practicing attorneys receive.


FDA Issues Class I Recall Over Medical Device Used In Heart Surgery

By Kevin Duffan, VA/NC Medical Malpractice Attorney

What Happened:

The FDA recently announced a recall by St. Jude Medical. The recall, released at the end of last month, concerns a device used in heart surgery and has been given the most serious level warning by the regulatory agency.

According to the FDA, in some cases a wire in the Amplatzer TorqVue FX Delivery System can fracture while it is being implanted in the two upper chambers of a patient’s heart. This carries a risk of not only serious injury but also death.

For the devices not yet implanted in patients, St. Jude Medical sent a warning to doctors labeled “Urgent Medical Device Recall Notice” asking that they immediately stop using the device and return any unused inventory they may have.

The recent recall was labeled a Class I, meaning that it is the most serious type of recall given that there is a reasonable probability that using the product will result in adverse health consequences or death.

The Virginia Injury Lawyer’s Perspective:

Any story about dangers related to a person’s heart is shocking. We all hope that companies responsible for making such critically important devices do a good job. While most do, some companies refuse to invest the time or money needed to ensure that the products they manufacture are completely safe.

If you or a loved has been injured by a medical device and have questions, come talk to one of our Virginia personal injury attorneys about what possible legal options you have to receive compensation. Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective products recover damages from companies whose negligence or disregard for consumer safety led to injuries.

Helpful Info:

If you’ve been injured by a defective product it’s essential that you consult with a Virginia personal injury attorney who has experience handling similar cases. Our firm has successfully represented a variety of clients who have been injured by defective or dangerous products.

To begin to learn about your rights and possible options for filing a civil claim for compensation, read through the following article about defective products written by our firm’s personal injury attorneys.

Got Questions? 

Those who have been injured by a medical device or fear they may be impacted by a medical device recall surely have lots of questions. You might be wondering about what you should do if you’ve been injured by a medical device, what the legal definition of a “defective product” is, or what the requirements of a successful product liability are. For answers to these and other frequently asked questions regarding recalled products check out the following guide.

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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis, Appleton & Favaloro include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Attorneys with our firm have been listed among the Best Lawyers in America since 2008. Attorneys with our personal injury law firm have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of practicing attorneys receive.


FDA Recommends Lower Dosage of Ambien After Decades of Side-Effect Complaints

By Mark Favaloro, VA  Medical Malpractice Attorney

What happened:

After years of receiving complaints about the sleeping pill Ambien, the FDA has recently issued a recommendation that doses for women should be lower than what is typically prescribed now. Many users complain of drowsiness in the morning, which has sometimes led to car accidents. In addition to the sleepy driving, other strange behaviors caused by side effects of the drug include texting, eating or having sex in the night without any memory of it in the morning. Many in the medical community question why it took the FDA so long to act.

The FDA recommends the lower does in any drug which contains the active ingredient zolpidem. Studies have shown that women take longer to metabolize the drug than men. An official from the agency’s Center for Drug Evaluation and Research told New York Times an estimated 10 percent to 15 percent of women will have a level of zolpidem in their blood that could impair driving eight hours after taking the pill, while only about 3 percent of men do.

 

The Virginia Injury Lawyer Perspective:   

The documented incidents resulting from the side-effects of Ambien are numerous. Medical issues and heavy weight gain from the night binges, hallucinations, amnesia, all leading to the person “waking up” and having no recollection of what they said or did. Many people have ended up in jail for causing accidents and damage that they have no recall about.

The Wisconsin Law Journal recounted one woman’s experience, which is similar to many of the other incidents uses of the drug have experienced. In 2005, she was prescribed Ambien for insomnia. After three days of taking her prescribed dose, she woke up on the concrete floor of a jail cell. The police report said she got out of bed around 6 a.m., left her house, drove her mother’s car into a parked vehicle, left the scene and ran into another vehicle. She left that scene as well, returned home, had a chat with her mother and was arrested in her bedroom later that morning. She remembers neither the accident, nor anything else from the morning of her arrest.

Helpful Info:

If you or a family member has been injured by a defective or dangerous drug, you can begin to learn about your legal rights and options by reading this article.

Have Questions?

We maintain a library of attorneys’ answers to frequently asked questions regarding defective or dangerous drugs.

About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis, Appleton & Favaloro include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Attorneys with our firm have been listed among the Best Lawyers in America since 2008. Attorneys with our personal injury law firm have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of practicing attorneys receive.


Concerns Raised about Blood Thinner Xarelto

By Jim Lewis, VA/NC Medical Malpractice Attorney

What Happened:

Federal drug regulators have received a number of reports involving blood clots associated with the new anticoagulant Xarelto, a surprising twist given that other blood thinners such as Pradaxa have been more often associated with episodes of uncontrolled bleeding.

Xarelto (rivaroxaban) was introduced to the market by Johnson & Johnson’s Janssen Pharmaceuticals in July of 2011 and the drug was billed as a superior alternative to warfarin for prevention of blood clots in certain cases, as patients who use the new drug are supposed to require less monitoring.

Another drug from the same class, Pradaxa, was introduced in October 2010 and since has been linked to a shocking number of severe bleeding events, hemorrhages and deaths. Since its introduction, Pradaxa has become one of the medications most often associated with adverse events according to FDA reports.

Last month the Institute for Safe Medication Practices released their QuarterWatch Report, which uncovered a number of alarming reports revealing problems with Xarelto. The new report indicates that there have been at least 356 adverse event reports submitted to the FDA during the first quarter of 2012 alone. This represents a doubling of the number of reports submitted to the agency about the drug in the final quarter of 2011.

Unlike Pradaxa, the most common problem with Xarelto is not uncontrolled bleeding, but instead serious blood clots. The risk is especially pronounced among patients under the age of 66, many of whom were taking the drug after hip or knee surgery. The FDA received 158 reports about the drug associated with blood clots during the first three months of the year. The big problem is, of course, that this is the precise event the drug has been designed to prevent.

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, has told reporters that the high number of blood clot reports were simply a function of how well the drug was doing commercially. Sadly, the popularity appears to be coming at a high cost to innocent consumers.

The Virginia Injury Lawyer’s Perspective:

Given the recent studies showing the risks of Xarelto, it’s surprising that the drug is still being marketed to patients. If you or a loved one has been seriously injured by a dangerous or defective drug, you should contact an experienced VA personal injury lawyer as soon as possible. Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective drugs recover damages from companies whose negligence or disregard for consumer safety led to injuries.

Helpful Info:

If you or a family member has been injured by a defective or dangerous drug, you can begin to learn about your legal rights and options by reading this article.

Have Questions?

We maintain a library of attorneys’ answers to frequently asked questions regarding defective or dangerous drugs.

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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.


Recent Study Warns About Metal Hip Implant Dangers

By Rick Shapiro, Virginia Medical Malpractice Lawyer

A new study shows that all-metal hip implants can release particles of cobalt into a patient’s bloodstream, possibly leading to terrible medical problems down the road. To learn more, read the full story here…

“Study Offers More Bad News For Virginians With All-Metal Hip Implants”

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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.


Warnings about dangers of all-metal hips have been around for a while

By Kevin Duffan, Medical Malpractice Lawyer

What Happened:

According to a new report UK regulators were aware of problems associated with the all-metal implants long before they were ever recalled.

According to a report by the news site Wales Online, problems with metal-on-metal hip implants have been around since at least 2007, which is when regulators in Australia first uncovered the issues associated with the devices. The first recall was announced in 2009 by the Australian government. A larger, worldwide recall was not issued until August of 2010, a delay which may have caused injury to countless patients who were not aware of the trouble they could be facing down the road.

A report on the Regulation of Medical Implants in the EU and UK by the Science and Technology Committee leveled serious criticisms against the British Ministry of Health for delaying action against the dangerous metal-on-metal devices. The report pointed out that many people knew of the damage all-metal implants could cause and yet the government failed to take action as early as other countries, a delay that caused citizens to suffer needlessly. The same issue could be raised against American regulators, given that the FDA allowed the device to continue to be sold and implanted in patients for years after the first concerns were raised about their effectiveness.

The DePuy ASR was finally recalled due to poor performance in a large number of patients. The problem with the implant is that as it is used, tiny pieces of metal fragments are released into a patient’s blood stream. These pieces of metal contain cobalt and chromium that are absorbed into the blood and nearby tissues. The damage this can do has not been fully understood, but reports indicate it can cause muscle, bone and even neurological damage.

Though the recall began with the DePuy device, studies indicate that the problem applies to an entire class of all-metal implant products. Earlier this year the FDA asked all manufacturers to conduct a study of their metal-on-metal products to assess their long-term safety. Experts have recommended that those with the devices already implanted should undergo annual physicals and imagining scans to detect any bone lose or tissue damage. Patients are also advised to screen for metal ions in their blood.

The Virginia Injury Lawyer’s Perspective:

About one million of these all-metal devices have been implanted in patients across the world over the past 15 years. This means that far too many patients are at possible risk of the dangerous effects of cobalt exposure.

The manufacturers that created these all-metal implants that have caused harm to patients should be held responsible for their actions. Some companies, such as DePuy Orthopaedics, Stryker, Zimmer, Biomet and Wright Medical Technology have already begun recalls to try and stop their products from causing further harm. Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective products recover damages from companies whose negligence or disregard for consumer safety led to injuries.

Helpful Info: 

If you or a family member has been injured by a defective or dangerous product, you can begin to learn about your legal rights and options by reading this article.

Got Questions?

We maintain a library of attorneys’ answers to frequently asked questions regarding recalled products.

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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.


Women at Increased Risk of Trouble in Hip Resurfacing

By Jim Lewis, Medical Malpractice Lawyer

What Happened:

Last month a respected medical journal, The Lancet, published a new study revealing higher failure rates of metal-on-metal hip resurfacing when compared with conventional total hip replacement (THR). Shockingly, the failure rates were up to six times higher compared with more traditional techniques.

First, a little bit of explanation is needed to understand the difference between hip resurfacing and a total hip replacement. In hip resurfacing, the surgeon reshapes the pelvic ball or head and then places a metal cap over the newly shaped head. Then the surgeon places a metal cup on the inside of the pelvic socket or cup, which is supposed to allow that joint to function smoothly.

With a THR, the surgeon removes the entire hip joint and replaces it with an artificial joint consisting of a femoral head that is attached to a femoral stem that is drilled into the upper thighbone and a plastic liner that goes between the ball and the socket.

The Lancet revealed that in 55-year-old women, the revision rates were 8.3% for resurfaced hips and only 1.5% for THRs with metal-on-polyethylene implants, according to the study. Meanwhile in 55-year-old men, the revisions rates were 4.1% for resurfaced hips and 1.9% for THRs with metal-on-polyethylene implants.

One surgeon who took part in this study noted that the failure rates in women were unacceptably high and that, as a result, the panel recommended that resurfacing not be undertaken in women. The surgeon further noted that due to the higher failure rate of the procedure in men, preoperative measures should be used to fully assess the suitability for male patients.

The fact that the study involved failure rates of metal-on-polyethylene THR implants is critically important because of the overwhelming evidence that indicates that metal-on-metal THR implants also suffer abnormally high failure rates. For example, earlier this year The Lancet published yet another study showing that all-metal hip implants failed at an increased rate than other types of hip implants, with a five-year revision rate of 6.2%. This compared with 2.3% for ceramic-on-ceramic implants and 1.7% for metal-on-plastic types.

Some manufacturers of these all-metal implants have already recalled certain devices and are the subject of a number of lawsuits. Manufacturers include DePuy Orthopaedics, Stryker, Zimmer, Biomet and Wright Medical Technology.

The Virginia Injury Lawyer’s Perspective:

If you or a loved one has been seriously injured by a dangerous or defective product, particularly a metal-on-metal hip implant, you should contact an experienced Virginia personal injury lawyer as soon as possible. There is a finite period of time to take legal action against those responsible for manufacturing the device and once the statute of limitations expires, you are barred from seeking compensation.

Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective products recover damages from companies whose negligence or disregard for consumer safety led to injuries.

Helpful Info:

If you or a family member has been injured by a defective or dangerous product, you can begin to learn about your legal rights and options by reading this article.

Have Questions?

We maintain a library of attorneys’ answers to frequently asked questions regarding recalled products.

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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.


FDA Publishes Study Regarding Pradaxa’s Risk of Bleeding

By Randy Appleton, Virginia Medical Malpractice Lawyer

What Happened:

According to the Food and Drug Administration, the risk of serious bleeding among new users of Pradaxa appears to be no higher than in patients on other widely used blood thinners. The announcement by the FDA concerned the controversial blood-clot preventer made by Boehringer Ingelheim and said that Pradaxa’s risk of bleeding is in line with the more commonly prescribed drug, warfarin.

The news was meant to reduce worries among the many patients, including those in Virginia, who have used the drug, however the results were not based on any new clinical study. Instead, the FDA said they based their assessment on insurance claims and other data about patient healthcare outcomes.

The regulatory agency said over a year ago that it would launch an investigation into reports of serious bleeding among patients who had been prescribed Pradaxa. The drug was originally meant to prevent strokes in patients with an irregular heartbeat, a condition known as atrial fibrillation. Reports surfaced describing instances of gastrointestinal bleeding and uncontrolled bleeding in the brain, some of which resulted in death, which prompted a new look at the drug.

The FDA has said that while the information they reviewed indicates that there is a bleeding risk associated with Pradaxa, it is similar to the risk posed by warfarin. This does not mean the end of the investigation into the drug. On the contrary, the FDA announced it was planning to assess Pradaxa’s bleeding risks by other means and would report back on its findings.

Despite this seemingly good news about Pradaxa, another recent announcement highlights the lingering concerns about the blood thinner. A report issued by the Institute for Safe Medicine Practices’ QuarterWatch reveals that prescription drug complaints to the FDA have risen 90% in the past four years, and two drugs, Pradaxa and Chantix (a smoking cessation drug), are responsible for 37% of that increase.

The Virginia Injury Lawyer’s Perspective:

Since the news of the negative affects of the drug came to light, Pradaxa has been in the spotlight as thousands of lawsuits have been filed against the drug’s manufacturer, Boehringer Ingelheim. Sickened Virginia patients have alleged that the drug led to serious and even fatal bleeding, a problem that they say they were never properly warned about.

Given the recent studies showing the downsides of Pradaxa, it’s a wonder that the drug is still being marketed to patients. If you or a loved one has been seriously injured by a dangerous or defective drug, you should contact an experienced VA personal injury lawyer as soon as possible. Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective drugs recover damages from companies whose negligence or disregard for consumer safety led to injuries. 

Helpful Info:

If you or a family member has been injured by a defective or dangerous drug, you can begin to learn about your legal rights and options by reading this article.

Have Questions? 

We maintain a library of attorneys’ answers to frequently asked questions regarding defective or dangerous drugs.

CA

About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.

 

 


Study Reveals Dangers of Yaz/Yasmin Birth Control

By Jim Lewis, Medical Malpractice Lawyer

What Happened:

It’s been a week of bad news for the maker of the birth control drugs Yasmin and Yaz, as Bayer AG announced in its most recent financial report that it had agreed to pay a combined $750 million thus far to settle thousands of claims regarding its birth control drugs causing blood clots.

Adding insult to injury, a new study has found increased risk of blood clots with the use of birth control pills such as Yaz and Yasmin. According to the most recent study published in the journal Contraception, women who take oral contraceptives containing the synthetic hormone drospirenone are more likely to suffer from potentially fatal blood-clotting complications compared to those who were taking another type birth control.

Researchers at the Kaiser Permanente Northern California Division of Research gathered data on 573,680 women between the ages of 10 and 55 between 2001 and 2007. The study looked at women who were new users of combined hormonal contraceptives (CHCs), and compared the rate of blood clot related events among women who did or did not take contraceptives containing drospirenone. Overall, the study found that women who took birth control pills containing drospirenone were 77% more likely to experience blood clot related conditions such as deep vein thrombosis and pulmonary embolism.

Deep vein thrombosis is when a blood clot becomes lodged in the veins of the leg; this can lead to a pulmonary embolism when part of the clot breaks away and travels to blood vessels in the lungs. The study also found that women who take birth control pills containing drospirenone had double the risk of suffering a blockage in their arteries.

According to the Wall Street Journal, the latest financial report from Bayer indicates the company has put aside an additional $262.5 million to settle Yaz and Yasmin lawsuits over blood clots. This follows a Bloomberg report over the summer that found that Bayer had reserved $610 million to settle cases, leading to an average of nearly $212,000 per case.

Yaz and Yasmin were among the most commonly named drugs in personal injury lawsuits last year, according to the Institute for Safe Medication Practices’ QuarterWatch Report; there were over 8,300 claims involving the medications in 2011 alone. Given the number of problems it’s perhaps not a surprise that the company is facing some 12,000 lawsuits alleging Yaz or Yasmin caused blood clots, gallbladder damage and other injuries.

The Virginia Injury Lawyer’s Perspective:

As experienced Virginia dangerous drug and device attorneys, my colleagues and I have helped clients through many cases like this. Sadly, thousands of people experience the pain of taking a medication prescribed by their doctor only to have it cause serious health problems later on. This happens far too often and the side effects can last a lifetime.

Helpful Info:

If you have been injured by a dangerous or defective drug, you may be able to hold the company that manufactured and marketed the drug accountable by filing claims for compensation. Read this article to begin learning about your legal rights and options when a faulty product leads to injuries.

Have Questions?

To learn more about how to proceed if you have been injured as a result of a prescription drug in Virginia, please read this free report

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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.


What Caused the Recent Fungal Meningitis Outbreak?

By Jim Lewis, Medical Malpractice Lawyer

What Happened:

The recent outbreak of fungal meningitis has many in the medical community desperate to get to the bottom of the cause. Possibilities abound and everyone appears to have a theory. Could it have been some moldy ceiling tiles? What about the dirty shoes of a careless employee? How about a contaminated ingredient?

There are many ways the fungus could have gotten inside the New England Compounding Center, a pharmacy in Massachusetts that has been blamed for the outbreak. The steroid injections made by the compounding pharmacy have already been recalled after leading to the death of 25 people and sickness in nearly 350 more.

So far regulators from both state and federal agencies have been quiet about what problem may have led to the contamination. It has been revealed that inspectors found fungus growing in more than 50 vials from the pharmacy. FDA investigators remain on the scene in Farmingham, Massachusetts in an attempt to better understand what went wrong.

Despite the lack of information, outside experts tend to agree that dirty conditions in the plant are likely to blame. This could include a number of possible sources of contamination, including faulty sterilizing equipment, tainted ingredients or sloppiness on the part of employees.

One problem for the pharmacy is that the drug used in the steroid injection is made without preservatives meaning there is no additive that is able to kill germs lurking in the medicine. Given this lack of preservative, it’s critical that the drug be manufactured under incredibly sterile conditions.

Though compounding pharmacies aren’t as tightly regulated as major manufacturers, they are supposed to follow certain basic rules including cleaning the floors and all other surfaces daily, monitoring the air supply in “clean rooms” where the drugs are actually made, ensuring that employees wear gloves and gowns and testing samples from each lot. These rules of standard practice exist in the U.S. Pharmacopeia, a national standards book for compounding medicines that is written by a nonprofit scientific organization.

To make the steroid used in this case, a chemical powder from a supplier was mixed with a liquid, sterilized through heating, then pumped into vials. It’s possible that the powder was contaminated, either at the New England Compounding Center or another location. Given the vast amount of the medicine produced, the time it would take to make the batches might allow the medicine time to be contaminated. It’s also possible that if a worker took a break for coffee or to go to the bathroom that they could have hurried back into the lab without properly washing up, thus introducing contamination.

Though this event has received a significant amount of media attention, it’s important to note that it’s not as uncommon as many people would think. In fact, just last year there were three similar incidents. At least 33 patients came down with fungal eye infections linked to a compounding pharmacy in Florida; a dozen patients were blinded after an outbreak caused by another compounder in Florida; and nine people in Alabama died from taking IV nutritional supplements made by a compounder in that state.

The North Carolina Injury Lawyer’s Perspective:

As experienced North Carolina dangerous drug attorneys, my colleagues and I have helped clients through many cases like this one. Sadly, thousands of people experience the pain of taking a medication prescribed by their doctor only to have it cause serious health problems later on. This happens far too often and the side effects can last a lifetime.

Helpful Info:

If you have been injured by a dangerous or defective drug, you may be able to hold the company that manufactured and marketed the drug accountable by filing claims for compensation. Read this article to begin learning about your legal rights and options when a faulty product leads to injuries.

Have Questions?

To learn more about how to proceed if you have been injured as a result of a prescription drug in North Carolina, please read the following FAQs.

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About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.