Product Liability Update: Pelvic Mesh Trials

Fulton & Barr, Attorneys at Law
Fulton & Barr: The Legal Pad
Wednesday, September 10, 2014

vaginal mesh in hand

Transvaginal mesh devices came onto the market in 1996, as a way for doctors to help patients suffering from pelvic organ prolapse and femalestress urinary incontinence.

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are medical conditions that mostly occur when the pelvic floor muscles and tissues become weak, which is predominately a consequence of childbirth. Pelvic organ prolapse can cause varying levels of pain, the bulging of organs at the vaginal opening, sexual difficulties and urine leakage in association with stress urinary incontinence.

According to the FDA, surgical mesh started being used in the 1950s to repair abdominal hernias; however, in the 1990s gynecologist began using it to for the surgical treatment of SUIs and repairing POPs. Eventually, medical manufacturers responded to this demand by creating transvaginal mesh kits that cater specifically to that type of surgery.

The creation of these “kits” gradually went from just including the specifically designed transvaginal surgical mesh to including insertion tools, tissue anchors and surgical technique instructions.

Unfortunately, these medical devices that were designed to help have caused more harm than good.

The FDA issued its first warning about transvaginal mesh device complications in October 2008, after reviewing over 1,000 reports from nine surgical mesh manufacturers. More warnings were issued in 2011 and again this year.

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In May, the FDA issued a proposal to reclassify transvaginal mesh devices used for POP from class II to class III, which calls for stricter pre-market testing of new products. Until being questioned now, products have been able to appear on the market without rigorous pre-market testing—obtaining FDA approval based on their similarities to formerly approved devices.

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This proposal comes out during the multidistrict litigations (MDLs) of six transvaginal mesh manufacturers in the U.S. District Court for the Southern District of West Virginia. The six manufacturers associated with these cases are American Medical Systems, Boston Scientific, C.R. Bard, Johnson & Johnson’s Ethicon, Coloplast Corp. and Cook Medical. More than 22,000 lawsuits were included in these MDLs and Chief Judge Joseph R. Goodwin will preside over all of them. Thousands of state lawsuits have been filed as well.

In most recent MDLs news, Huskey v. Ethicon No. 12-5201 , the federal jury awarded 52-year-old Jo Huskey 3.27 million dollars for medical costs, past and future pain and suffering, and loss of consortium for her husband. Her case provided enough evidence to prove that Johnson & Johnson’s Ethicon Inc. unit negligently failed to warn her doctor about the defectiveness of the device.

This was the second case to go to trial in Western Virginia federal court. Ethicon won the first case back in February.

Jane Akre, National News Editor of Mesh Medical Device News Desk made this statement about the results of Huskey v. Ethicon: “This verdict is critically important to women and their families from across the U.S. who have needlessly suffered from injuries related to pelvic mesh implants.”

Akre exclusively covers the medical mesh trials for We are Mesh Survivors—a united group of vaginal implant survivors who are using their stories to warn others about defective transvaginal mesh devices and pushing for these medical products to be removed from the market until proven safe for use.

One survivor Teresa from Ohio expresses on their website, “Mesh nearly killed me and nearly took everything I owned away from me…. I want an answer from JNJ as to why their profits are more important than my life and other injured women’s’ lives.”

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S.C. organization gives ‘kids a chance’

Fulton & Barr, Attorney at Law
Fulton & Barr: The Legal Pad
Wednesday, September 03, 2014

When someone is injured or killed on the job, it can be devastating in so many ways, especially financially. The first thought that comes to mind is taking care of the initial needs of the family— medical expenses, burial costs, debt, mortgage/home, day-to-day living expenses, etc…

What happens 5, 10, 15 years down the line, if the injury victim has children who want to attend college? Should their dreams of success be crushed because one of their parents was catastrophically injured or killed while working?

In 1988, Georgia workers’ compensation attorney Robert Clyatt decided that one devastating event shouldn’t foretell another. With the encouragement and financial assistance of the Workers’ Compensation Section of the Georgia Bar, he founded the first Kids’ Chance organization.

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Kids’ Chance is a non-profit organization that raises money and provides need-based scholarships for college and vocational education bound children of workers who’ve been fatally or catastrophically injured in a work-related accident.

South Carolina is one of 25 states that have also incorporated Kids’ Chance.

Since its inception in 1993, Kids’ Chance of South Carolina has awarded 331 scholarships, providing more than $868,476 in educational financial support to the children of injured S.C. workers.

One past recipient Taylor Hancock starts her second year teaching English in Kuwait this month. She credits Kids’ Chance of S.C. to her success.

“Not a day goes by that I don’t remember that it is because of you that I was given this opportunity to attend college and pursue my career as a teacher,” she said.

14 students are attending college across South Carolina with the help of Kids’ Chance of S.C.; five of those attend their first year this fall.

President of Kids’ Chance of S.C. Rebecca Halberg, Esq. said, “As a workers’ compensation attorney, I see the devastating impact both emotionally and financially on a family when a work-related injury results in permanent disability or death. One always wishes they could do more, particularly for the children that are involved.”

According to South Carolina’s Occupational Health and Safety Administration (SCOSHA), 47,000 cases of non-fatal occupational work injuries and illnesses occurred in South Carolina in 2012. The U.S. Department of Labor, Bureau of Statistics confirms that 63 people in S.C. died in work-related accidents in 2012.

In October, Kids’ Chance of South Carolina will host its yearly silent auction at theSouth Carolina Workers’ Compensation Educational Association’s annual conference. Support the organization without attending by making donations for the raffle. They accept everything from cash to gift baskets to electronics and various tangible goods. This year’s signature sponsor is Eastern Alliance Insurance Company with a cash donation of $1,500.

You can also make tax-deductible financial donations, directly contributing to the scholarship fund.

For more information, visit http://www.kidschancesc.org/, send an email toinfo@kidschancesc.org or call (843) 546-5837.

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How to Get Workers’ Compensation is Five Easy Steps

Fulton & Barr, Attorneys at Law
Fulton & Barr: The Legal Pad
Wednesday, August 20, 2014

If you become injured at work, please know that you are not alone.

According to South Carolina’s Occupational Health and Safety Administration (SCOSHA), over 47,000 cases of non-fatal occupational work injuries and illnesses occurred in South Carolina in 2012. That equals over 125 non-fatal work injuries and illnesses occurring every day in SC in 2012. Those injuries range from falls and cuts to repetitive-strain injuries (ex. Carpal Tunnel Syndrome) to more serious hazardous injuries.

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Regardless of the type of injury endured and industry you work in, you should not suffer in silence. All employees deserve compensation for work-injury accidents, but it takes more than having the right to receive compensation. The system can be confusing and we want to help you get through it.

Follow these five, simple steps below to ensure that you correctly inform your employer and prepare yourself to get the compensation you deserve.

  1. Be informed, know your rights before you get injured.

The SC Bar states, “…an employee [who] suffers injury by accident arising out of and in the course of employment, that individual is entitled to recover medical expenses, temporary total compensation, and specifically permanent and total disability benefits.”

This means that any accident that happens while you are employed and working should be covered under workers’ compensation. It doesn’t matter if you caused the accident, the employer caused the accident or another employee caused the accident. It’s all covered under workers’ compensation law.

Note: If the injury was caused by malfunctioning machinery or defective products, you may be eligible for a product liability case against the third party manufacturer; however, you still need to file the initial workers’ compensation claim.

Your workers’ compensation benefits could include: medical expenses, paid leave/time-off, a differential for personal miles traveled for medical treatment, and potentially permanent and total disability income.

  1. Tell your employer about the injury right away.

As soon as the injury occurs, tell your employer immediately.

Note: If you are suffering from a repetitive-strain injury (RSI), it’s important to let your employer know as soon as you think this could be a problem. Since RSI’s happen over a period of mini-accidents, determining the onset of this injury will take additional medical review.

In S.C., employers have the right to select the doctor who treats you. If you go to your own doctor, they could refuse to pay for it. Notify your employer and they can coordinate your care from the beginning, then you don’t have to worry about them disputing the charges later.

Note: During an emergency situation, you have more leeway to get whatever assistance you can, as soon as you possibly can. But, if you are on work premises, do your best to inform your employer and allow them to call for emergency assistance.

  1. Seek medical assistance right away.

The longer you wait it out, the harder it will be to prove that the injury occurred while at work. Save yourself the run-around—tell your employer and get it checked out right away. What may at-first seem like something minor, could develop into a major health issue. This is not the time to “tough it out,” no matter what anyone says to you (employers included!), report the injury and get help.

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  1. Be your own bookkeeper.

From the onset of injury, keep track of all forms and medical files.

Ask for copies of everything and date and time stamp every paper to keep a timeline of what’s happening.

Keep a contact list and call/email log of all interactions with doctors, specialists, nurses, HR personnel, workers’ compensation claim management, and witnesses and managers on-duty during the accident. Remember to update your log right after any interaction (So you don’t forget any important information!) include the date and time of interactions, summary of discussion and copies of any written correspondence (For example: email, letter, text message etc…).

Be thorough when filing out the work-injury accident report. Be your own investigative reporter, tell your story by covering everything from what lead up to the injury, to how the injury occurred and what happened immediately afterward—duly noting that you notified your employer right away. Don’t forget to include the names of witnesses, so they can confirm what happened during the incident as well.

Note: If you have temporary memory loss, due to being unconscious during/after the accident, make sure you state that on the report—just in case, you recall more from the situation after filing the report.

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Most important of all: Keep copies of all medical records related to the accident, injury and treatment. This should also include information about previous injuries or conditions aggravated by the accidental work injury.

Store all of this information in one file or folder and keep it in a safe place. This is YOUR evidence and is vital to receiving worker’s compensation benefits.

  1. Get help from experienced workers’ compensation attorneys.

Call Fulton & Barr for a free initial consultation of your workers’ compensation claim. Bring your evidence file and they can review your case and help you get what’s rightfully yours.

With 40 years of combined experience in helping workers receive benefits from on-the-job injuries, they will work hard to get you the compensation you deserve.

You don’t have to fight this battle alone, call Fulton & Barr, Attorneys at Law today, toll-free (800) 868-2110.

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Hot cars are no place for children

Fulton & Barr, Attorneys at Law
Fulton & Barr: The Legal Pad
Wednesday, August 13, 2014

18 children have died of heatstroke from being left behind in cars by parents and caregivers so far this year. Three of those children died in South Carolina.

Kids and Cars, national nonprofit working to prevent children’s death and injuries in and around vehicles, states that over 670 children have died from vehicular heatstroke since 1991.

100 percent of those deaths are preventable.

On July 24th, US Secretary of Transportation Anthony Foxx and National Highway Safety Traffic Administration Admin David Friedman held a public education outreach event at Rosemount Early Childhood Development Center in Northwest Washington to continue the conversation of NHSTA’s two-year campaign, “Where’s Baby? Look before you lock.”

“The majority of these cases are accidental tragedies that can strike even the most conscientious and loving parents and caregivers, but they can be stopped,” said Secretary Foxx. “Even one heatstroke death is one too many because every death caused by leaving a child unattended in a hot car is 100 percent avoidable.”

The NHSTA urges parents to never leave kids unattended in cars.

Credited to National Highway Safety Traffic Administration

According to their “Where’s Baby? Look Before you lock”campaign:

  • It only takes 10 minutes for a parked car to heat up an additional 20 degrees Fahrenheit.
  • Children’s body temperatures rise five times faster than adults.
  • Cracking the windows doesn’t work.
  • Children die when their body temperature reaches 107 degrees.

While there are no laws against leaving children unattended in vehicles in SC, intentionally endangering a child’s life is a criminal act. Worse than that, however, is living with the consequences.

This is something David Richard Gray III of Hartsville, S.C. knows all too well.

On May 8, 2014, Gray left his 13-month-old, Sophia Goyeneche-Gray unattended in his truck, while he was working for several hours. Once he’d remembered she was still in the truck, it was too late.

Sophia died of hyperthermia, due to extreme heat. The death was ruled accidental and Gray was charged unlawful conduct towards a child.

Gray stated on NBC News: “There’s a massive amount of guilt that you feel … As the father, you’re the protector, you know? You’re daddy… It’s an unimaginable loss.”

For David Gray and Sophia’s mother, Amanda Goyeneche the unimaginable loss has fueled a campaign to save other children from dying like Sophia.

With the advisement of Children’s Trust of South Carolina, Goyeneche and Gray created Remembering Sophia’s “It takes a village to raise a child” awareness campaign.

Thousands of free pink elephant stickers with the phrase “It takes a village” have been shipped to 37 states and three countries. Goyeneche and Gray ask that stickers be placed in the front left windshield to serve as a reminder for drivers to check the car seat when exiting the vehicle.

 

http://www.remembersophia.org/

Another awareness campaign started simply on YouTube. Father Terry Brantley of Greensboro, NC urged parents and all adults to take the Hot Car Challenge and experience what it’s like to be stuck inside a hot car for at least 15 minutes.

Brantley said to ABC News that he didn’t expect the challenge to get so much attention, but he hopes it save lives.

Since its launch, The Hot Car Challenge has received over 2 million views and now over 50 people have responded by sharing a video of their own “hot car challenge” experience.

With attention and intention, no more children have to die from this preventable tragedy.

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Charlotte wounded veterans to get free home

The Charlotte Observer
Lake Norman News (University City)
Thursday, August 08, 2013

On Nov. 8, a wounded U.S. military veteran will be honored with a mortgage-free home from Fairway Independent Mortgage of the Carolinas, the Boot Campaign and the Military Warriors Support Foundation.

Since May 2012, Fairway Independent Mortgage Corp. – a mortgage banking corporation headquartered in Sun Prairie, Wis., that has 150 locations nationwide – has donated more than $250,000 to help provide seven homes in alliance with the Boot Campaign and the Military Warriors Support Foundation.

Kelly Yale, director of marketing at Fairway Independent Mortgage of the Carolinas, said this is the first Charlotte Wounded Veteran Home Giveaway. She also said that the home recipient would receive a home that matched their specific housing needs, as well as three years of family and financial mentoring.

Yale said the recipient will also be honored that same day during a Fairway “Boot Camp,” which is a free Realtor training course in south Charlotte and Lake Norman for real estate agents to teach them how to help U.S. military service members and veterans overcome homeownership challenges.

There will be presentations by Capt. Sean Parnell, author of “Outlaw Platoon”; Louise Thaxton, branch manager and national director of the Military Mortgage Specialists Division at Fairway Independent Mortgage Corp.; Terri Murphy, real estate speaker and consultant; and Tom Tousignant, a 22-year U.S. Air Force veteran who is the regional branch manager and a military mortgage specialist at Fairway Independent Mortgage of the Carolinas.

“We could not be more excited to honor a family that has helped ensure the safety and freedom of all Americans, particularly on Veteran’s Day weekend,”Tousignant said.

Yale also said that several local companies have donated products and services for the home, such as Sherwin Williams, Sensibly Chic Designs for Life, Seize the Day Designs, Carolinas Landscape Management and Creative Home Stagers. She said that they still need volunteers, and anyone who wants to help can email help@fairwaync.com.

To apply for the home giveaway, the candidate must be a combat-wounded veteran (Purple Heart preferred) who was deployed in Iraq or Afghanistan for Operation Enduring Freedom or Operation Iraqi Freedom. The home recipient must also be honorably retired or separated from the military and cannot have a current mortgage.

The Military Warriors Support Foundation is a nonprofit organization founded by retired Lt. Gen. Leroy Sisco in 2007 to provide housing, education, job opportunities and recreational events for wounded U.S. military veterans and Gold Star Families.

In 2009, the Boot Campaign – a national nonprofit organization that raises funds and awareness for active and retired military – became a charity partner with the Military Warriors Support Foundation. Since then, the groups have sponsored 20 mortgage-free houses with the help of several companies, such as Fairway Independent Mortgage Corp.

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