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22
Feb

DePuy Manufacturer Knew of High Failure Rate

In 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System due to their higher-than-usual failure rates. The failures necessitated that patients have a second surgeries to replace the replacement, but some people still ended up with severe tissue damage that left them in pain.

Before the recall, Johnson & Johnson refused to acknowledge that the medical device was flawed. But now, in an article published in The New York Times, it seems that Johnson & Johnson was aware of the high failure rate—and an email stating so was written by a DePuy vice president and sent to top executives in the corporation. In the email, Pamela Plouhar:

…reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also cautioned that providing the F.D.A. with more data might not change its stance and that it might take years to conduct new studies of the hip, known as the ASR, or articular surface replacement.

In addition, Ms. Plouhar’s email stated that there had been “a significant number of revisions in the ASR group” compared with “very few in the control group.”

That means that the FDA, Ms. Plouhar, and—after the email was sent—other J&J executives all knew that there were significant problems with the hip replacement devices. And yet, the company did not notify doctors or patients about the problems. In fact, they continued marketing and selling the device in the United States and around the world…at least until the recall was announced in August 2010. In all, about 93,000 people received a DePuy hip replacement.

Throughout the episode, DePuy blamed orthopedic surgeons for the model’s failures, saying that doctors were not positioning a component properly. But the clinical findings rejected by the F.D.A. came from A.S.R. studies run by surgeons hand-picked by DePuy, including some who had developed the implant and received royalties or consulting fees in connection with it.

This new information is not going to help Johnson & Johnson’s reputation, which has recently been turning from gleaming to rusty.  Perhaps this is why J&J CEO William C. Weldon announced that he will step down in April. Analysts believe he would rather retire by choice than be forced to resign.

HensonFuerst Video about the DePuy recall:  DePuy Orthopaedics Hip Replacement Recall

If you believe you have been injured by a DePuy hip replacement and would like to discuss your legal options, please feel free to call HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at http://www.lawmed.com/. If you have questions, HensonFuerst has answers.

RESOURCES

To read the full story in The New York TImes, click here:  Hip Maker Discussed Failures

To read our blog about the DePuy recall, click here:  DePuy Hip Replacement Recall

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16
Feb

Simulator Teaches Motorists The Dangers Of Texting And Driving

February 16, 2012

In an effort to teach motorists in the Chapel Hill area about the dangers of texting and driving, a simulator was set up on the campus of University of North Carolina, Chapel Hill earlier this week that puts a driver through a series of obstacles while they attempt to use a cellular device. According to reports from WRAL News, the event, which was sponsored by both the town and the town’s police force, was eye opening.

One University freshman who went through the simulator, called DriveSquare, stated that it took her about 10 seconds in the simulator before she crashed. The University’s head football coach who participated reported not faring much better. Both stated the simulator helped them realize that the risk of using a cell phone behind the wheel far outweighs the benefits.

It’s a realization that officials hope more drivers will come to. The state Department of Transportation estimates that 13,000 are injured and 119 die each year in distracted driving crashes.

The event comes just days before a public hearing is to be held to discuss a citywide ordinance that would make all cell phone use illegal while driving. This would be in addition to the statewide ban against texting while driving.

The North Carolina car accident lawyers with HensonFuerst ask that you put your cellphone down while driving, not only for your safety, but for the safety of those around you.

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16
Feb

More Teen Driver Deaths in 2011

A new report by the Governors Highway Safety Association (GHSA) shows that more teen drivers are dying on the road.

Researchers compared the statistics from the first six months of 2010 and the first six months of 2011. Results showed that, nationwide, the number of 16- and 17-year-old driver deaths increased from 190 to 211–an 11% increase. The states that had highest numbers of increased deaths were Illinois (+8), Missouri (+7), Florida (+6), and North Carolina (+6). This means that, sadly, North Carolina contributed to the higher statistics. In fact, our state had a 55% increase in teen deaths for the measured period. Overall, NC had the second-highest total number of deaths (17), after Texas (26).

This is a race we do NOT want to be winning.

According to an article in The New York Times, the trend has been a decrease in teen deaths over the years. That’s why these new numbers are frightening.

“I think it’s going to be a wake-up call,” Dr. Allan Williams, a road safety consultant and the former chief scientist at the Insurance Institute for Highway Safety. Mr. Williams prepared the report released Thursday. “What’s remarkable is that in the last few years, deaths in those age groups plummeted, so even a slight reverse is a matter of concern,” he said.

What’s even worse, past analyses have shown that more road fatalities occurred in the second half of the year than the first half… and overall motor vehicle deaths for all age groups declined 0.9%. This makes the teen death increase highly disturbing.

Troy E. Costales, Chairman of GHSA, said:

“As the parent of a young driver and a soon-to-be-driver, I know firsthand the pressures parents face in allowing their teens behind the wheel. As parents, we must set and enforce strict rules for our new drivers, making sure risks are minimized. This includes limiting other teens in the car, limiting nighttime driving and absolutely prohibiting any type of cell phone or electronic device use while driving.”

Wise words, but follow-through can be difficult. The education process doesn’t stop once a teenager has his or her drivers license.

What do you do to encourage your child to drive safely? Please post your thoughts on our Facebook page: (http://www.facebook.com/HensonFuerst)

RESOURCES

To read the full article in The New York Times, click here:  Fatalities among teenage drives rose in first half of 2011

To see full report by the GHSA, including a state-by-state chart of numbers, click here:  Teenage driver fatalities by state

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15
Feb

High-Failure Hip Replacements Sold Overseas

On August 24, 2010, DePuy Orthopaedics, a division of Johnson & Johnson, sent a letter to doctors announcing a recall of two of their hip replacement systems, the ASR XL Acetabular System, and the ASR Hip Resurfacing System. Why? Because they have a higher-than-usual failure rates, causing people to have to have second surgeries to replace the replacement. Since then, we’ve written extensively about DePuy and other metal-on-metal hip replacement devices, and the sometimes-extensive destruction they can cause in the human body.

Now, The New York Times reveals that Johnson & Johnson continued to market the defective devices in Europe and elsewhere overseas. In addition, the company also continued to sell a related model in the United States, which earlier went on the market using a regulatory loophole. However, the U.S. Food and Drug Administration (FDA) wrote a confidential letter to Johnson & Johnson in August 2009 basically saying that the agency couldn’t determine the implant’s safety and effectiveness, and therefore couldn’t approve it for sale in the U.S.

According to the article:

There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.

However, the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants.

There seem to be two moral issues at stake here:  The morality of Johnson & Johnson continuing to sell a product that was clearly raising safety flags…and the morality of the FDA, which keeps its evaluations secret and confidential. A lawyer who specializes in FDA regulation said that companies that withhold a non approval letter containing important safety information could face damage to its brand. Funny, that doesn’t seem quite as important as the damage done to the unwitting patients who received these potentially harmful devices. And if the FDA is keeping secrets on behalf of corporations, who is looking out for our health?

To read the full article in The New York Times, click here:  Hip Implants U.S. Rejected Sold Overseas

If you believe you have been injured as the result of a metal-on-metal hip implant and would like to investigate your legal options, feel free to contact HensonFuerst Attorneys at 1-800-4-LAWMED, or visit our website at http://www.lawmed.com/.

Previous HensonFuerst blogs:

DePuy Hip Replacement Recall Raises More Questions

Hip Replacements to be Evaluated for Safety

Hip Replacements Fail, Sometimes Without Symptoms

Diagnosing Hip Replacement Injury

VIDEO: DePuy Hip Replacement Recall (http://www.youtube.com/watch?v=18BkrJnKf3g)

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9
Feb

NC State Bus Driver Died Of Carbon Monoxide Poisoning

February 9, 2012

A 50-year-old bus driver for the North Carolina State University died of carbon monoxide poisoning on her bus. According to reports from WRAL News, the woman had made numerous complaints before passing away that she smelled fumes on the bus.

On December 21 of last year, two other drivers made complaints of smelling fumes on the same bus. Hours later, the 50-year-old woman pulled the bus over on the University’s Centennial Campus and called 911. She was taken to a local hospital where she died three days later form what coroners have determined was carbon monoxide poisoning.

The bus company, First Transit, confirmed that the vehicle was taken out of commission pending an investigation by the North Carolina Department of Labor.

This isn’t the only incident though. Last month, another driver and several of the bus’s passengers complained of smelling fumes while riding. Although the company’s maintenance department examined the bus, they found nothing wrong and the vehicle continues to run.

Another driver reported quitting the company in the months prior to the death of her colleague because she felt the managers were not properly addressing safety concerns after she made numerous complaints of the fumes and nothing was done.

The North Carolina toxic exposure attorneys with HensonFuerst often handle numerous cases where people have been hurt or killed by poisons in their environment. If dangerous toxins have caused you harm, we may be able to help.

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2
Feb

Pfizer, Inc. Recalls One Million Birth Control Pill Packets

February 2, 2012

The Drug manufacturing giant, Pfizer, Inc., announced a recall of nearly one million packets of birth control pills Tuesday due to a manufacturing mix-up that could put women at an increased risk of unwanted pregnancy. Reports form WRAL News say that 14 lots of Lo/Ovral-28 tablets and another 14 lots of Norgestrel and Ethinyl Estradiol tablets had placebo tablets placed in the wrong order the tablets are to be taken in.

The mix-up was discovered last year when a customer called after noticing the pills were in the wrong order. The company fixed the problem immediately. Then, in December, Pfizer contacted pharmacies asking them to pull the specific recalled lots from the shelves. The recall was announced publicly on Tuesday only after the Food and Drug Administration (FDA) made a request that Pfizer do so. Women who have been using affected pills are advised to begin use other forms of contraception immediately.

Experts say that the manufacturing mix-up could put the drug-maker at risk of a multi-million dollar lawsuit. An article by FOX News says the lawsuit could stand on the same grounds as several lawsuits in the past that have been won after a man’s vasectomy did not take and his partner became pregnant.

The North Carolina drug injury lawyers with HensonFuerst are here to answer any questions you may have if you have been affected by a mistake or side effect of a medication prescribed to you by a doctor.

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1
Feb

NC Troopers Crack Down on Distracted Drivers…Finally!

from WRAL.com

Wednesday, February 2, is Groundhog Day. Two important things will be happening:  Puxatawny Phil and groundhogs everywhere will be looking for their shadow… and NC State Troopers will begin cracking down on distracted drivers.

According to an article on WRAL.com, nearly 58,000 people are involved in a distracted-driving crash in North Carolina every year…more than 13,000 are injured…and 119 people die. Got that? People die because someone is texting (even though texting is illegal), or talking on a cell phone, or reading, or eating, or adjusting the radio, or applying makeup.

“I see a lot of people driving with their elbows on the steering wheel, texting with one hand,” Highway Patrol Sgt. Jeff Gordon said.

Troopers will be conducting a two day campaign, looking for distracted drivers. They will focus on portions of Interstates 95, 85 and 40 from the Virginia state line through Wake, Durham, and Johnston counties.

It’s a shame that we need a special campaign to stop distracted drivers. People shouldn’t die because another driver decides to answer a phone call.

To read the full article on WRAL.com, click here:  Crack Down

If you have been involved in a car wreck and would like to discuss your legal options, please visit the HensonFuerst Attorneys website at http://www.lawmed.com/north-carolina-auto-accident-lawyer.php. If you have questions, HensonFuerst has answers.

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31
Jan

Love Your Car? It May Lead to Aggressive Driving

If you believe the marketing hype, the model car you drive says a lot about you. Are you a shark…a jungle cat…a rugged adventurer…a road warrior…or a road princess? What made you choose your car? Does it make you feel powerful, or eco-friendly? Like a sports star, or a soccer mom?

What does your car say about you? Or, more important, how your car make you feel? According to an article on ScienceDaily,  a scientific study shows that people who view their car as an extension of themselves have stronger aggressive driving tendencies.

One third of all car accidents that result in injures and two thirds of all fatal car wrecks are caused by aggressive driving. According to the research, people who think of their car as a reflection of their self-identity—regardless of what that identity is—are more likely to behave aggressively on the road, breaking the law in the process. Similarly, people who value their possessions (cars and other things) and have a greater sense of materialism also drive more aggressively. And young people who are just beginning to drive or who have purchased their first vehicle are more likely to show off and drive aggressively.

The study findings suggest that:

“…the perception of the car as an extension of the self leads to more aggressive behavior on the road rather than increased driving cautiousness,” the authors wrote, adding that “individuals may view cars and the road space they occupy as their territory and will seek to maintain control over it and defend it as necessary.”

Unfortunately, they research just correlated attitude and driving behavior; it didn’t offer any advice. Some take-away thoughts:  Be especially watchful of flashy sports cars on the road, the kind that might make their owners feel more powerful…a teen’s first car should be purchased with safety in mind, as opposed to image…and remind yourself daily that your car is nothing more than a tool to get you from place to place. It’s okay to love your car, just not too much!

To read the full article on ScienceDaily, click here:  People Who Really Identify With Their Car

To learn more about safe driving tips, visit our website here: HensonFuerst Auto Accident page. If you have question, HensonFuerst has answers. http://www.lawmed.com/

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30
Jan

2012 Tour de Cure: Get Ready for the Ride of Your Life!

The mission of the American Diabetes Association (ADA) is:  To prevent and cure diabetes, and to improve the lives of all people affected by diabetes.

Every year, the ADA holds a series of fundraising cycling events called the Tour de Cure. The Tour—held in 44 states nationwide—is a ride, not a race. During the two-day event, cyclists can ride 10 miles or 150 miles. The object is to ride, not to “endure.”

In 2011, more than 55,000 cyclists in 80 events raised more than $18 million to support the ADA. The HensonFuerst Cycling Team raised more than $34,000, making it the 34th top fundraising teams in the United States. The team, captained by Thomas Henson, who has had type 1 diabetes since age 9, is now preparing for the 2012 race.

The local 2012 Tour de Cure will be held on June 2-3, beginning in Cary, North Carolina. If you would like to join the HensonFuerst Cycling Team, we’re taking on new members! Currently, the HensonFuerst Cycling Team has 40 members, of all skill levels—beginners, recreational riders, and triathletes. While the Tour is our premiere cycling event, we participate in other charity rides throughout the year. To join us, or for more information, please contact Thomas Henson at ThomasHenson@lawmed.com.

If you don’t want to ride with us, you can still participate. We invite everyone to come watch the ride and cheer on the cyclists. And, of course, we welcome donations to benefit this very worthwhile cause. Our goal this year is ambitious:  $5o,000. To support the HensonFuerst Cycling Team in the Tour de Cure, visit the personal Tour page of team captain Thomas Henson here:  Donate to help stop diabetes!

Thank you!

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26
Jan

Youth In Raleigh Charged In Connection With Fatal Accident

January 26, 2012

Several young people in Raleigh, North Carolina, are learning the hard way that you don’t have to be the person behind the wheel in a fatal accident to be responsible for a wrongful death. According to WRAL News, three teens and a young adult have been charged with crimes in connection to a fatal single vehicle accident that happened earlier this month.

The accident happened on the morning of January 7th on Rainwater Road in Wake County. The driver, a 16-year-old boy, and several of his friends illegally acquired alcohol for an underage drinking party. After attending the party and drinking for several hours, the driver and the 17-year-old female victim got into his Jeep to head home. Reports from the accident show that the vehicle was traveling at 75 MPH in a 30 MPH zone when the boy lost control of the vehicle and slammed into a tree. The female victim in the passenger seat died at the scene.

In the weeks following the crash, not only has the driver of the Jeep been charged in connection with the girl’s death, but also, so have the 21-year-old man who bought the alcohol for the teens, the host of the party, and the minors who contributed money to have the alcohol purchased.

The North Carolina wrongful death lawyers with HensonFuerst may be able to help you if you have lost a loved one because of the negligence of a drunk driver. Contact an experienced attorney today.

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