Monday, 19 of February of 2018

Tag » FDA

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.


Compounding Pharmacies Receive Scrutiny After Fungal Meningitis Outbreak

By Randy Appleton, Virginia Medical Malpractice Lawyer

Compounding pharmacies and their loose regulations are in the spotlight after dozens were sickened and eight died from fungal meningitis associated with steroid injections. To learn more, read the full story here…

“Fungal Meningitis Scare Puts Spotlight on Compounding Pharmacies”

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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.


Number of Medical Device Recalls Reaches Two-Year High

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

What Happened:

According to one recent article, this past year has seen a massive number of medical device recalls. According to ExpertRecall, a company that tracks food, drug and device recalls, a whopping 123 million such devices were recalled in the most recent quarter of the year, representing a nearly two-year high.

The total number of individual units affected by the recalls passed the 100 million mark for the first time since the third quarter of 2010. The 123 million units recalled last quarter represent an astounding 50% increase on the 82 million units recalled in the first quarter of the year. Stepping even further back in time, the second quarter of 2011 saw recalls for only 16 million devices, about 1/8 as many as last quarter

It wasn’t just medical devices that saw millions of recalls last quarter, the group revealed that there were 69 pharmaceutical recalls in the second quarter of 2012 affecting a total of 12 million units of prescription drugs.

Companies involved in the recalls include Coviden PLC, which recently announced a voluntary recall of some DGPHP RFA high-power single use grounding pads. It also announced a voluntary global recall of some adult tracheostomy tubes.

CareFusion Corporation launched a recall earlier this summer of its EnVe ventilator due to potential risks that the device could compromise patient ventilation. The company also announced a voluntary recall of its AirLife Infant Breathing Circuit.

DePuy Orthopaedics has also been 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.

Abbott Laboratories recalled some Architect Toco IGG Reagent kits while General Electric’s medical systems unit recalled X-ray machines due to faulty wheels. Perhaps most uncomfortable of all, Johnson & Johnson announced just this week that they would be recalling certain hemorrhoidal circular staplers due to the potential risks of a misfire.

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.


Medical Malpractice Lawyer Shares Shocking Info about Retained Surgical Instruments

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

Many people think that a surgeon is duty-bound to state in the operation report if a surgical item was broken off or simply left inside a patient’s body. Wrong. There are no mandatory reporting requirements in operative reports about such incidents in Virginia and many states.  If a patient suffers complications, it’s basically a hide & seek game.  To learn more, read the story here…

“Hide & Seek” When Surgical Tools or Devices are Left Inside Patients

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 medical/hospital malpractice focus on personal injury and accident law and 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.


Abbott Laboratories to Pay $1.5 Billion for Illegally Marketing Depakote to Nursing Homes

By Jim Lewis, Nursing Home Abuse Attorney in Virginia

Mark Favaloro, an attorney with the Shapiro, Lewis & Appleton law firm, recently wrote about Abbott Laboratories’ guilty plea regarding the illegal marketing of Depakote (divalproex sodium) to nursing homes. To learn more, read “Pharmaceutical Company Fined $1.5 Billion for Wrongfully Promoting Depakote to Nursing Homes.”

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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 medical/hospital malpractice focus on personal injury and accident law and 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 Advisory Committee Recommends Banning Percocet, Vicodin

Drug products containing combinations of opioids and acetaminophen can be incredibly dangerous if used the wrong way.

By Jim Lewis, Virginia Dangerous Drugs Attorney

Powerful prescription drug products containing combinations of opioids and acetaminophen that help control severe pain for victims of accidents can be incredibly dangerous if used the wrong way. To find out why, visit “FDA Advisory Panel: Ban Vicodin and Percocet.”

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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 medical/hospital malpractice focus on personal injury and accident law and 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 have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.


Watch Out for Multaq Side Effects

Some patients taking the drug to control atrial fibulation have experienced liver damage so severe they required a liver transplant.

By John Cooper, Medical Negligence Injury Lawyer

My colleague Shapiro, Lewis, Appleton and Favaloro has written about the serious side effects that can occur when taking Multaq (dronedarone from Sanofi-Aventis). Some patients taking the drug to control atrial fibrillation have experienced liver damage so severe they required a liver transplant. To learn more, check out “Multaq May Cause Serious Liver Damage.”

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About the Editors: Shapiro, Cooper, Lewis & Appleton is a law firm whose Virginia/Carolina attorneys focus on injury and accident law and have experience handling medical malpractice cases involving hospital and doctor mistakes and nursing home abuse and neglect. Check out our case results to see for yourself. Though not every case meets our criteria, we offer free initial consultations. Give us a call at (800) 752-0042. If you can’t get through due to high call volume, leave a message so we can return your call. Also be sure to check out our free special report Top 10 Tips From a Medical Malpractice Insider. Our primary office is in Virginia Beach, Virginia (VA), but we also have offices in Hampton, VA, and Elizabeth City, North Carolina (NC). Our lawyers hold licenses in VA, NC, South Carolina (SC), West Virginia (WV), Kentucky (KY), Florida (FL) and Washington, DC. Rick Shapiro and James Lewis were included in the 2011 issue of Best Lawyers in America. They, along with fellow attorney John M. Cooper, were also named 2011 Virginia Super Lawyers for Personal Injury Law, an honor which fewer than 5 percent of outstanding lawyers receive. We also host an extensive injury law video library on Youtube. Further, our lawyers proudly edit the Virginia Beach Injuryboard, Norfolk Injuryboard and Northeast North Carolina Injuryboard blogs as pro bono public information services.


Surgical Mesh Safety Reviewed After Patients’ Deaths and Injuries

A U.S. Food and Drug Administration advisory panel is reviewing whether the surgical mesh should be more closely regulated.

By Shapiro, Lewis, Appleton and Favaloro, Virginia Medical Malpractice Attorney

My colleague Jim Lewis has posted a new blog to our Virginia personal injury lawyers’  website about increased concerns over the use of surgical mesh used to treat pelvic organ prolapse in women. A U.S. Food and Drug Administration advisory panel is reviewing whether, in light of multiple reports of patient injuries and deaths, the surgical mesh should be more closely regulated.

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About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm whose Virginia/Carolina attorneys focus on injury and accident law and have experience handling medical malpractice cases involving hospital and doctor mistakes and nursing home abuse and neglect. Check out our case results to see for yourself. Though not every case meets our criteria, we offer free initial consultations. Give us a call at (800) 752-0042. If you can’t get through due to high call volume, leave a message so we can return your call. Also be sure to check out our free special report Top 10 Tips From a Medical Malpractice Insider. Our primary office is in Virginia Beach, Virginia (VA), but we also have offices in Hampton, VA, and Elizabeth City, North Carolina (NC). Our lawyers hold licenses in VA, NC, South Carolina (SC), West Virginia (WV), Kentucky (KY), Florida (FL) and Washington, DC. Rick Shapiro and James Lewis were included in the 2011 issue of Best Lawyers in America. They, along with fellow attorney John M. Cooper, were also named 2011 Virginia Super Lawyers for Personal Injury Law, an honor which fewer than 5 percent of outstanding lawyers receive. We also host an extensive injury law video library on Youtube. Further, our lawyers proudly edit the Virginia Beach Injuryboard, Norfolk Injuryboard and Northeast North Carolina Injuryboard blogs as pro bono public information services.