Thursday, 19 of October of 2017

Tag » recall

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.


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 Takes Heat for Fast-Tracking Pradaxa

By Mark Favaloro, Medical Malpractice Lawyer

What Happened:

In a recent article published in the Journal of the American Medical Association (JAMA), researchers reviewed the safety records of Pradaxa, as well as several other drugs that received approval under one of the FDA expedited approval programs designed to fast-track certain drugs to the market. According to the researchers, Pradaxa, multiple sclerosis drug Gilenya, and thyroid cancer drug Caprelsa, each “raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered and with optimal doses not determined.”

The researchers specifically mentioned the bleeding risk associated with Pradaxa, as well as its lack of an antidote, and said that bleeding in patients taking the blood thinner may be harder to treat than bleeds related to the older blood thinner warfarin. The article concluded that Pradaxa raised enough concern that the drug should have been subject to stricter scrutiny than the speedy approval by the FDA.

The researchers claim that Pradaxa, which is used to reduce the risk of stroke and blood clots in patients with atrial fibrillation, went through priority review and was thus fast-tracked by the FDA. According to the FDA, the purpose of the fast-track process is to introduce important, new medications to patients more quickly.

Unlike warfarin, Pradaxa does not require weekly doctor check-ups and dietary restrictions and was seen as the first replacement of the difficult-to-use blood thinner. Since its introduction into the market, however, Pradaxa has been at the center of a storm regarding reports of serious bleeding. In 2011 alone, the drug was responsible for 3,781 adverse events reports, more than any other drug monitored by the FDA.

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 dozens 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.

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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.


Thousands of Toy Cars Recalled Due to Risk of Fire and Burns

By Kevin Duffan, Medical Malpractice Lawyer

What Happened:

It was announced earlier this week that the U.S. Consumer Product Safety Commission would begin recalling almost 5,000 “Range Rider Ride-On Toy Cars” due to the risk of fire and burns the toys present to young children.

The products were manufactured in China and were imported into America by Bluestem Brands. The CPSC announced that the toys contain batteries that can “overheat, smoke, melt and catch on fire.”

So far there have been nine reports of such troubling incidents but thankfully no injuries. The toy cars were sold through various Fingerhut catalogs and online at Fingerhut.com and Gettington.com from September 2010 through May 2012 for between $200 and $230.

The Virginia Injury Lawyer’s Perspective:

Though something like a toy car can hardly seem dangerous, the fact is that even familiar items can pose big risks to your family, especially young children.

During my more than 25 years of personal injury work in Virginia, I have represented people injured by a wide variety of seemingly safe devices. If you or someone you love has been injured by a defective consumer product, including toy cars, consider consulting with an experienced VA injury attorney. My colleagues and I have the background to fight for the justice you deserve.

Helpful Info:

If your child has been injured by a dangerous or defective product, you may be able to hold the company that manufactured and marketed the device accountable by filing claims for compensation for medical costs, lost wages and pain and suffering. Read this article to begin learning about your legal rights and options when a faulty product leads to injuries.

Have Questions?

You can learn more by reading through this online library of lawyers’ answers to frequently asked questions regarding recalled, poorly designed and unsafe consumer goods.

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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.


DePuy forced to recall additional devices

By Shapiro, Lewis, Appleton and Favaloro, Medical Malpractice Lawyer

What Happened:

DePuy Orthopaedics is being forced to recall yet another line of hip and other artificial joint implants. This time, the Johnson & Johnson subsidiary said that it would be pulling all of its unused custom orthopedic devices due to concerns raised by the FDA. The recall notice was issued on August 24, 2012, two years after the company issued its major ASR hip-implant recall.

Earlier this year DePuy agreed to stop manufacturing the custom devices after receiving a warning letter from the FDA. The regulatory agency said the implants had not been through clinical trials and were thus being sold without federal approval. DePuy argued that the devices were exempt from the normal application process given that the FDA had approved the original devices and the custom pieces were only being modified.

The FDA disagreed and wrote that, “Although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured.” The agency said that the fact that the final specifications may differ depending on the recipient does not mean that DePuy was excused from the usual FDA approval process.

The FDA went on to accuse DePuy of using poor quality control systems in the production of the different custom implants and ordered the company to recall any implants that had already been delivered to surgeons. Though more than 8,300 customized DePuy implants have been sold since 1999, the exact number of unused devices subject to this recall is unknown.

The news comes at a bad time for the medical device maker as DePuy is dealing with the huge global recall of 93,000 ASR hip-replacement and hip-resurfacing devices that was announced in August of 2010. The all-metal devices have been shown to fail within only a few years’ time, leading to painful and costly revision surgeries. Beyond the need for additional surgery, the DePuy hips have also caused metallosis due to the release of metal shavings created when the parts rub together. Some studies have shown that these metal pieces can cause damage to patient’s bladders and kidneys.

The ASR recall has precipitated a flood of lawsuits against the company. In the U.S. alone, more than 8,000 lawsuits have been filed against DePuy, with the first cases finally making their way to a settlement.

The Virginia Injury Lawyer’s Perspective:

If you or a loved one has been seriously injured by a dangerous or defective product, you should contact an experienced 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.

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.


Consumer Reports Advises Against Taking Actos

By Richard Shapiro, Medical Malpractice Attorney

What Happened:

Recently, the FDA announced its approval of the first generic version of type 2 diabetes drug Actos (pioglitazone) despite a mounting number of lawsuits pending against the manufacturer of the brand name drug, Takeda Pharmaceuticals. A few days after that approval, Consumer Reports took the bold step of recommending that its readers avoid using both the brand name and any generic versions of the drug.

As Virginia dangerous drug injury attorneys, we were pleased to hear that the consumer watchdog group said that, “Our medical advisers say that people with diabetes should use pioglitazone, generic or brand name Actos, only as a last resort.” Consumer Reports said that Actos should not be tried unless all other options have failed. The organization went further, saying that patients, including those in Virginia and North Carolina, already taking the prescription drug should talk to their doctor about the possibility of switching to metformin or various other options.

Actos, and its new generic counterpart, can cause serious side effects, such as an increased risk of heart failure, bone fractures, and bladder cancer. Other medications to treat diabetes, such as metformin, are thus better first choices, according to Consumer Reports.

For more than a year, warnings have been around over the safety of Actos. In June of 2011, it was reported that Germany and France had banned Actos after a study indicated long-term use could increase bladder cancer occurrences by as much as 40%. In April of this year, Health Canada issued a warning after a study there showed a greater than 40% increased risk of bladder cancer from Actos use. In May, the British Medical Journal published a study which indicated that increased bladder cancer risks from long-term Actos use may actually be as high as 83%.

The Virginia Injury Lawyer’s Perspective:

As Virginia dangerous drug injury attorneys, we wonder how, given the recent studies linking Actos to bladder cancer and blurred vision, the drug is still being marketed to patients. If you or a loved one has been seriously injured by a dangerous or defective drugs, you should contact experienced Virginia injury attorneys handling dangerous drug cases 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.