The Injury Board Regional Blogs

Mesh Implant Update: FDA Requires More Studies and Information From Manufacturers

M. Brandon Smith — Sun, 12 Feb 2012 11:10:51 GMT

Following up on previous warnings about the safety of transvaginal mesh implants to treat pelvic organ prolapse, the FDA is now enlisting the research power of the manufacturers of these devices. On January 3, the FDA sent letters to 35 manufacturers of surgical mesh implants, mandating them to conduct a total of nearly 100 post-market studies. These studies are to address specific safety and effectiveness concerns related to surgical mesh devices used in POP treatment. Unfortunately requesting these studies comes a little too late. The products originally got approval without clinical testing and the results for many women have been disastrous.

Concerns about the use of transvaginal mesh to treat POP hit the news in July of last year, when the FDA issued a safety communication calling attention to the hundreds of reports of adverse outcomes that it had received. In just the two-year time span between 2008-2010, the FDA received 1,500 reports of complications related to mesh treatment procedures. Based on those reports and additional study, the FDA found that serious complications from the use of surgical mesh to treat POP “are not rare,” and that the use of mesh is not clearly more effective than other surgical procedures even though it may expose patients to greater risk. Since issuing that safety communication, the FDA has continued its review of the safety of transvaginal mesh implants.

Depending on the results of the review, the FDA is apparently considering reclassifying mesh implants as a riskier device than originally believed. As reported by Reuters, surgical mesh has been used since the 1950s to treat abdominal hernias, which meant that the manufacturers of transvaginal mesh implants originally got product approval without the need for doing clinical trials. But the use of those mesh implants for POP treatment only started in the 1990s and the flood of adverse reports now calls into serious question its safety. A reclassification of the device would mean manufacturers need to do clinical trials.

What does all of this mean for patients? The fact is that thousands of women—nearly 75,000 in 2010 alone—received a medical treatment that had never undergone significant safety testing. Many of them are now suffering because that treatment was unsafe and are seeking legal recourse to hold these manufacturers accountable for putting an un-tested and un-proven product on the market.

Originally posted at InjuryBoard by M. Brandon Smith

FDA warns dentists and vets that hand-held dental X-ray units may harm patients

Paul Napoli — Sun, 12 Feb 2012 10:55:40 GMT

Government regulators are warning dentists and veterinarians not to use unapproved hand-held dental X-ray devices imported from outside the United States.

Hand-held dental X-ray units, which are small, portable devices that use a form of radiation to create a picture of teeth, bones and soft tissue of the mouth, must comply with the U.S. Food and Drug Administration’s (FDA) radiation safety and medical device requirements, and receive FDA clearance before sale in this country. To ensure the radiation safety of their patients and staff, dentists and veterinarians should only be using hand-held dental X-ray units cleared by the FDA that carry a permanent certification label, ID tag and warning label.

The FDA said yesterday that the agency is aware of unapproved, illegal hand-held dental X-ray devices sold on the internet then shipped directly to customers in the U.S. and that these devices could potentially expose the user and patient to unnecessary and potentially harmful X-rays.

“Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA’s standards,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health.

To ensure this, users should:

Verify the presence of required labels on the device.
Ask vendors whether the device has been reviewed and cleared by the FDA.
Access the FDA Medical Device Approvals and Clearances searchable database to verify that the X-ray unit has been cleared by the FDA.
Contact their state regulatory agency if they become aware of a device that may be hazardous or does not meet the FDA’s requirements.

The FDA is also notifying state regulatory veterinary and dental organizations and health organizations to be aware of the illegal hand-held X-ray units and their risks.

There have been no reports of injury or adverse effects at this time.

Visit us on Facebook and follow us on Twitter @NapoliBern

Originally posted at InjuryBoard by Paul Napoli

Drugstores to Sell Over-the-Counter Sperm Analysis Test

David Mittleman — Sun, 12 Feb 2012 09:42:00 GMT

There are a plethora of products available for women attempting to conceive including ovulation predictor kits, pregnancy tests, and other fertility tests. But the fact of the matter is that it takes two to make a baby. However, men have typically had to go to the doctors to have a semen analysis conducted if they had concerns. Now, thanks to the over-the-counter availability of sperm analysis tests men will have the same option to make a convenient trip to their drugstore.

SpermCheck Fertility is set to hit stores in April and Walgreen's and CVS are already selling the sperm-counting test online. The test is $40 and may save men an embarrassing trip to their doctor, although doctors also warn that the product only tests one aspect important for healthy sperm. To use the test, men mix a sample of their semen with a solution provided with the test. A reddish line means that the sperm count is above 20 million per milliliter which is considered normal. A negative test shows no line and means that the man should visit his doctor for further testing. According to tests, SpermCheck Fertility is 96% accurate compared to laboratory tests.

However, doctors say that there are four major factors that they look for when testing men's sperm: the number of the sperm, their shape, their mobility, and the volume of the ejaculate. In addition, men's sperm count can vary from week to week, causing alarm in some men and an unnecessary trip to the doctor when there may be nothing seriously wrong. In fact, doctors say that even if a man has a lower than normal sperm count, if the other factors are in place this might not matter. In general, they say to use the test with caution.

Originally posted at InjuryBoard by David Mittleman

Mandatory Arbitration Forces U.S. Citizens to Give Up Their Constitutional Right to a Jury Trial

Claude Wyle — Sat, 11 Feb 2012 22:37:00 GMT

Over the last few decades, the most important cases pertaining to mandatory binding arbitration heard by the U.S. Supreme Court have been decided 5-4 — with the dissenting four dissenting strongly. And mandatory binding arbitration clauses have just been upheld by our highest Court, to the detriment of consumers nationwide.

Why does mandatory arbitration bring up such a divisiveness, even at the highest levels of law?

“Mandatory arbitration” sounds complex, but it’s straightforward enough: instead of being allowed to take a company that has harmed you to court (filing a lawsuit) so that your case can be decided by a jury of your peers, you are required to pursue your grievance in binding arbitration. That is right, you get no jury trial.

How could we citizens give up a fundamental Constitutional right like the right to jury trial? Well, I don’t believe that most consumers do this on purpose. The binding arbitration clauses are in the fine print of many of your contracts. Even the intake sheet you sign when you go to the doctor may have a provision for binding arbitration as opposed to a civil lawsuit.

It's straightforward because your debates take place in front of an arbitrator, instead of a judge and jury. This means that people are required to act individually, which prevents them from joining together in a class action--which can often be costly, and historically favor business interests over individuals.

As an attorney looking out for consumers, it concerns me that consumers’ claims are not being heard by juries. The reality is that there are millions of consumers in America with legitimate disputes against corporations, and these claims will not ever become a part of the public record if the aggrieved party has signed a mandatory binding arbitration contract.

But, the one thing most consumers with disputes don’t do is successfully navigate the unfamiliar--and often hostile and expensive--world of forced arbitration. As a federal district court noted in one recent case, while thousands of AT&T Mobility customers had expressed great unhappiness with the corporation’s behavior, only an “infinitesimal” number of its customers would or could in reality go through its arbitration system.

Very many American consumers have potentially valid claims, and many involve illegal acts by corporations. But, so many of those claims never see the light of the day. Justice Kennedy can say that many important civil cases are going to arbitration. But for consumer cases, Justice Kennedy is wrong. Nearly all of the cases are not going to court; they are just going away.

Why is mandatory arbitration bad for consumers?

You do not get to go to court--only to an arbitrator’s office or a facility designated for arbitrations. Jurors are unbiased; however, arbitrators deal with claims against the same parties or attorneys often enough to learn that the arbitrator will make a better living if they do not hit the corporation too hard.

So, while you may have just one claim against a corporation and will never see this arbitrator again, the corporation and its attorneys may have thousands of claims and their attorneys have great economic power over the careers of the arbitrators. And, if you have an arbitrator who makes errors of law, your right to appeal is extremely limited--almost non-existent.

Also, if you think arbitration will be less costly, think again. While civil lawsuits may not be cheap, our tax dollars pay for the judge and the jury fees are low. Arbitrators are paid thousands of dollars per day. What happens if you have a small claim not worthy of your acting alone because of the high cost of arbitration? If many consumers have small claims for the same wrongful conduct of the same corporation, those claims may be brought together in a class action. If there is no class action in arbitration, that many people with smaller claims just go away, and their wrongs are not redressed.

The civil justice system was designed to be better than this... Right now its level is the playing field between the mighty and the weaker. Mandatory arbitration keeps the power with the mighty and saves them money, even if they have done wrong.

About the author: Claude Wyle is an aggressive advocate for San Francisco Bay Area consumers. Claude has decades of experience representing those harmed by the wrongful conduct of others, and, as a San Francisco personal injury attorney, has fought to protect the rights of individuals dealing with arbitration throughout his legal career.

Originally posted at InjuryBoard by Claude Wyle

Not Wearing a Seatbelt Can Have Devastating Consequences

Jim Lewis — Sat, 11 Feb 2012 15:36:46 GMT

A recent accident that occurred in York County, Virginia (VA) illustrates how important it is to always wear your seat belt, and make sure your children are wearing their seat belts, while in a vehicle.

A two-year-old toddler was thrown from a vehicle and injured in an accident. The crash occurred when a 2001 Chevy Malibu was attempting to make a left hand turn during a red light.

When the driver made the left to turn onto Yorktown Road, it ran into a Sienna, then hit a pickup truck which caused the toddler to be ejected from the vehicle.

A seven-year-old child was also in the car and suffered injuries, according to Pilotonline.com.

Both children were rushed to Riverside Regional Medical Center where they received treatment for serious injuries. The accident was responsible for shutting down the intersection of Yorktown Road and Hampton Highway.

The driver (the father of the two children) was charged with multiple infractions including reckless driving, running a red light and failure to secure a child in a restraint.

Unfortunately, as this accident indicates, many people still make the poor decision not to wear their seat belts. A potential contributing factor to this disregard for seat belts is the fact that Virginia is not a “secondary enforcement” state. That means a police officer cannot pull someone over if they notice that the driver is not wearing a seat belt. A driver must be violating another traffic law before the police can pull the driver over. This is a bad law and the statistics indicate that states which have categorized wearing a seat belt as a primary enforcement law, seat belt use increased 11 percent.

To learn more about the importance of wearing your seat belt, take a look at this article which was written by an experience Virginia personal injury lawyer.

About the Editors: The Shapiro, Lewis & Appleton personal injury law firm, which has offices in Virginia (VA) and North Carolina (NC), edits the injury law blogs Virginia Beach Injuryboard, Norfolk Injuryboard and Northeast North Carolina Injuryboard as pro bono services.

Originally posted at InjuryBoard by Jim Lewis

Measles Outbreak from the Super Bowl?

David Mittleman — Sat, 11 Feb 2012 11:53:00 GMT

It looks like there may be a more serious fallout from the Super Bowl than Tom Brady's disappointment over the Patriots' loss. State health officials are alerting health departments in New York and Massachusetts that an individual with Measles apparently entered the Super Bowl village last Friday before the game. Measles is a highly contagious disease, but it usually takes 10 to 12 days before symptoms appear.

There have been several reported cases of Measles around the Indiana area including one in Hamilton County North of Indianapolis and two others in nearby Boone County. Doctors urge parents to seek the MMR vaccine for their children and promise that it is not linked to Autism or other chronic conditions, although widespread fears have circulated. Furthermore, doctors also urge those who are sick and think they have had contact with someone with Measles to call their doctor immediately. They should also stay home and stay away from others.

Symptoms of Measles and complications include:

cough, runny nose, fatigue, loss of appetite, fever of 101 degrees or above, spots inside of the mouth that look like salt, and increased sensitivity to light.
complications can range from ear infections and hearing loss to pneumonia and death.

The virus spreads through the air through nose or throat secretions. People at greatest risk of contracting the illness include unvaccinated visitors from abroad, children younger than 5, adults older than 20, people with weakened immune systems, and pregnant women.

Originally posted at InjuryBoard by David Mittleman

Come See Real Trials, Hearings, Cases and Races

Doug Landau — Sat, 11 Feb 2012 05:53:00 GMT

Call us courageous or call us crazy, we publish our trial, hearing, case and race scehdule so that clients and others can watch, learn and be prepared. In order to make important decisions about your own case, you have to have seen one like yours. So at the Herndon law firm ABRAMS LANDAU, we ask every client to take the time and visit with us not only at our "Law Shop" in Old Town Herndon, but also to see us at work in Court. The bailiffs at our last several court appearances have had to get extra chairs to accommodate clients, family members, friends and witnesses who have attended Hearings in Fairfax, Manassas, Richmond Virginia as well in Washington, D.C. ! EVERY SINGLE CLIENT who has attended a Hearing weeks and months before their own "day in court" has agreed that it helped them enormously. These Hearings are nothing like what you might see on television and the best preparation for your own case is a "scouting trip" to see the best judges and lawyers in Virginia try real injury and disability cases in court. In keeping with our promise to enable injured workers and accident victims to "SEE US IN ACTION," upcoming trials, cases, races and programs are set forth below. You will not see this from any of the advertising lawyers. In fact, we know of no other plaintiff's personal injury law firm that has the courage to: (1) Encourage their clients to come to court BEFORE their trial to see their lawyer "in action," and (2) Actually publish the calendar of their public appearances, court cases, races and Continuing Legal Education programming. But remember,

Always call the day before you come to see us in action !

Cases set on a court's schedule can be cancelled (like when the storms struck in September !), continued, postponed, settled, re-scheduled for mediation or arbitration. So, always call our office the day before you want to come and watch to make sure the insurance company has not paid for the losses caused by the negligent defendant or unsafe employer at "the 24th hour." Your time is valuable. We do not want any client, family member, friend or neighbor to make a wasted trip. Doug Landau has even encouraged people to observe other cases that are not from the Herndon Reston law firm ABRAMS LANDAU, Ltd., when there is little time before a client's own Hearing or trial. To that end, here are some upcoming dates:

Date Place Case, Race &/or Program

2/2/2012 Social Security Disability Hearing, Richmond office of Hearings and Appeals, VA

2/9-15/2012 American Association for Justice, (formerly the Association of Trial Lawyers of America) Winter Convention, Phoenix, AZ

2/12/2012 "Double Down" races for Downs Syndrome, Phoenix, AZ

2/23/2012 Social Security Disability Income Administrative Law Judge Hearing, Washington D.C.

2/24/2012 Prince William County Circuit court, Manassas, VA Motion to Compel Discovery in a fast food slip and fall case

2/26/2012 Jack Corkey Memorial Aquathon at the Herndon Virginia Community Center, sponsored by ABRAMS LANDAU, Ltd.

2/27/2012 Hanover, VA - Hanover Junior Idol Competition (spectator, not as a competitor !)

2/27-3/1/2012 Depositions in Jacksonville, FL and Atlanta, GA for an disabled trucker's Fulton County, GA injury case

2/28/2012 Annual Science Fair (Judge), The Madeira School, McLean, VA

3/9/2012 Social Security Disability Hearing before an Administrative Law Judge, Washington, D.C.

3/13/2012 Social Security Disability Hearing before an Administrative Law Judge, Washington, D.C.

3/30-4/2/2012 Virginia Trial Lawyers Association Annual Convention, The Greenbrier, White Sulphur Springs, West Virginia

4/12/2012 Virginia Workers Compensation Hearing, Northern Virginia Regional Office (Employers Application cutting worker off)

4/16/2012 Spotsylvania, Virginia Hearing before senior Deputy Commissioner (RSD or CRPS as a "compensable consequence")

Originally posted at InjuryBoard by Doug Landau

Study Shows Doctors Often Distort the Truth with Patients

John Lowery — Fri, 10 Feb 2012 23:08:34 GMT

A study discussed in Friday's Tennessean shows that many physicians withhold the truth from patients to avoid being held accountable through a lawsuit:

"More than half admitted describing someone’s prognosis in a way they knew was too rosy. Nearly 20 percent said they hadn’t fully disclosed a medical mistake for fear of being sued. And 1 in 10 of those surveyed said they’d told a patient something that wasn’t true in the past year."

As a trial lawyer, I'm not surprised that this many doctors are cutting corners with the truth and/or outright lying to their patients about deadly mistakes. I would wager that, among the 5% of doctors who commit the most malpractice, the percentage is much higher.

Originally posted at InjuryBoard by John Lowery

Captain Schettino of Costa Concordia Remains Under House Arrest

Brett Rivkind — Fri, 10 Feb 2012 17:07:10 GMT

An Italian Court ruled on Tuesday that Captain Schettino must remain under house arrest. He was the captain of Costa Concordia that killed at least 17 people because the captain sailed too close to island. Schettino has been under house arrest since January 17. The Florence Court rejected both sides of the argument in determining the outcome for the captain. According to Fox news “Prosecutors had argued that Schettino -- who is accused of manslaughter and abandoning his ship ahead of his passengers -- is a flight risk and that he should be incarcerated rather than continue to be held under house arrest at his home in Meta di Sorrento, near Naples. On the other hand, Schettino's lawyers argued he should be freed on bail and that he posed no immediate threat of re-offending, as he was suspended from his job as ship captain.”

The captain faces 2500 years in prison if convicted. Schettino could receive an 8-year sentence for each and every one of the 300 passengers left on the ship after he selfishly abandoned. The investigation ended last week leaving 15 people still unaccounted for in this tragic disaster.

Our firm is currently assisting crewmembers and passengers who were onboard the Costa Concordia. We remind everyone that the 30 day time deadline is on Sunday, February 12, 2012, to claims for property loss. We have been helping passengers get this filed.

I have been a Miami maritime and cruise ship attorney for 30 years. This disaster is the worst disaster I have seen during this time. I previously testified in Congress about cruise ship safety, and I am hopeful I will do so again as there definitely needs to be changes made for the safety of all passengers and crew on cruise ships.

Originally posted at InjuryBoard by Brett Rivkind

Could Inhaled Caffeine Become the New Club Drug?

David Mittleman — Fri, 10 Feb 2012 11:33:00 GMT

Areoshot may be caffeine addicts' biggest fantasy: by simply taking a deep breath, you can get your caffeine fix for the day or for a little while, at least. The device was created by a Harvard professor and is on the market in New York and Massachusetts as well as in France and online. It is typically sold at convenience stores, costs about $2.99 and delivers 100 mg of caffeine and B6 vitamins. Experts are beginning to worry that the convenience of the product may lead college students to turn it when they want to keep drinking without stopping.

While the creator of the product Dr. David Edwards of Biomedical Engineering at Harvard says it is safe, it has caught some negative attention from lawmakers. US Senator Charles Schumer of NY wants an FDA review of Areoshot, but Dr. Edwards says it is a typical knee-jerk response to a new product.

The Areoshot works by delivering a puff of lemon-lime flavored powder into the mouth when you press down on the lipstick size container. The airborne energy particles coat the inside of your mouth, dissolve quickly, and don't actually get into your lungs according to Dr. Edwards. Critics fear that hard-partying college students will use the product much like Four Loko drinks or so-called "blackout in a can" that laces alcohol with caffeine. Combining alcohol with caffeine can trick the body into thinking it is less intoxicated than it actually is, leading to more dangerous levels of alcohol consumption. However, Dr. Edwards says the products is simply a faster, easier way of getting a caffeine jolt at inconvenient locations to drink coffee such as at a library, at a sports game, or in an airport. Each container holds the equivalent of ten cups of coffee and has a warning label instructing users not to use more than three puffs a day (or about three cups of coffee). The problem that experts see is that it is a lot harder to drink ten cups of coffee straight than ten puffs of Areoshot, which is too much caffeine for one day.

Originally posted at InjuryBoard by David Mittleman