Talcum Powder, Morcellators, Cancer, and the FDA

December 16, 2014,

spilled-baby-powder.jpgIn recent months several medical devices and popular products have been officially found to cause gynecological cancer in women. Talcum powder, when used in the genital area, is now associated with ovarian and uterine cancer, while power morcellators (used in hysterectomies and myomectomies) are definitively linked to uterine cancer. The team of cancer lawyers at Pintas & Mullins takes a closer look at these products and their real-life, often devastating consequences.

Talcum powder - often referred to as baby powder - is processed from a soft mineral and is commonly used to freshen the feminine genital area. Advertisements by Johnson & Johnson and other talc powder makers has persuaded women for decades that they need powder products such as this to help with odors, moisture, or friction. Because these products are easily available at stores like Walgreens, women have been using them regularly for many years of their lives.

Medical researchers first found evidence of talcum particles in ovarian tumors in the early 1970s. Their findings were confirmed by a subsequent publication in the highly esteemed medical journal The Lancet, which blatantly warned that the harmful effects of talcum in the ovaries should not be ignored. Johnson & Johnson's medical director sharply and publically contested the reports, and the company chose not to provide any warnings on their powder products labels.

Twenty years later, in 1992, Obstetrics & Gynecology published a report noting that frequent talc use to the genital area increased a woman's risk of ovarian cancer three fold. Since then, at least a dozen other publications released information on the link between talcum powder and ovarian cancer.

The fatality of ovarian cancer is sharply increasing, particularly among black women, who are reported to use talcum powder in higher rates. About 16,000 Americans die every year from ovarian cancer, making it the fourth most deadly cancer for women.

An extraordinarily high number of women use talcum powder products in the genital area, either through direct application or via powdered tampons, sanitary napkins, condoms or diaphragms. Officials from throughout the cosmetic and medical community have publically conceded that talcum powder can reach the ovaries and grow toxic in the human body.

Despite decades of warning, neither the FDA nor talc powder manufactures have shown concern about the cancer risk. Although both are aware of the medical literature associating talc use with ovarian cancer development, neither has considered restricting the products or placing extra warnings on them. More than once, the FDA has denied petitions for talcum powder/cancer risk labelling.

FDA Fails to Study Morcellator Cancer Risk

Another product that is now associated with sever cancer risk in women is known as a power morcellator. This medical device is used in minimally-invasive hysterectomies and uterine fibroid removal surgeries (myomectomies). Earlier in 2014, the FDA issued a warning urging doctors and hospitals to stop using power morcellators due to their potential to spread aggressive uterine cancer.

These devices work by breaking uterine fibroids into tiny pieces so they can be easily removed through a small incision. The problem lies within the uterine fibroids, which often contain undetected cancerous cells. Once broken down, the cancer cells spread throughout the uterine cavity, causing aggressive, late-stage cancer in women who otherwise would be leading healthy lives. There is no current reliable test to check for cancer cells in uterine fibroids before their removal, although there are many other alternatives to have them removed.

Power morcellators were first approved in 1991; since then, more than 10 types of power morcellators have been approved for market sale. The FDA did not start studying how morcellators could harm women until December 2013, after women started coming forward about their unnecessary cancer diagnoses. This illuminates massive shortcomings in the FDA's approval process.

Sadly, for many women, these power morcellator recalls, talcum powder warnings and FDA safety alerts have come too late. In one of the most recent lawsuits against Johnson & Johnson over power morcellators, a woman in South Dakota won her lawsuit against the company. The woman used J&J's baby powder for several years and consequently developed ovarian cancer. One of the medical experts who testified in that case estimated that thousands of women are diagnosed with talcum-caused ovarian cancer every year.

Continue reading "Talcum Powder, Morcellators, Cancer, and the FDA" »

Knee, Spine Device Makers Sued for Selling Defective Products

December 9, 2014,

2798025996_ce97c2ec1b_m.jpgTwo medical device manufacturers have been charged with selling defective knee and spine products, injuring patients throughout the country. The knee manufacturer, OtisMed Corp., recently pled guilty to distributing knee replacements rejected by the FDA and agreed to an $80 million fine. The spine and neck product maker, Spinal Solutions, is reported to be toxic and may break in patients.

The defective medical device lawyers at Pintas & Mullins are currently investigating cases of serious injury from faulty products like these, along with defective hip implants and transvaginal mesh implants.

The CEO of OtisMed recently admitted to intentionally selling knee replacements after the FDA rejected their application. The lawsuit played out in federal court, resulting in various fines for civil liability, criminal forfeiture, and other charges in the amount of $80 million. The CEO pled guilty to three counts of introducing adulterated medical devices into the marketplace.

The company's knee product, OtisKnee, did not receive clearance from the FDA, however, the company continued to market and sell the device. OtisKnee was used in thousands of total knee replacement surgeries between 2006 and 2009, until it was bought out by Stryker Corp. (which has been named in thousands of injury lawsuits itself over its faulty hip devices).

Counterfeit Screws Implanted in Spines

Spinal Solutions LLC, based in Southern California, was recently charged with copying medical-grade titanium screws to be used in spinal fusions and other surgeries. It took years for someone within Spinal Solutions to alert the FDA to the counterfeiting, and by 2013 the company had sold millions of dollars in toxic screws to surgeons throughout the country.

One company insider stated that Spinal Solutions would mix in authentic screws with knockoffs in surgical kits. Spinal Solutions would incentivize doctors to use their hardware with private jet trips, cash, and other monetary deals. The company particularly targeted surgeons in Wisconsin, California, Texas, Nevada, and Maryland.

The company's president has gone missing, but many of his employees have found themselves unknowingly wrapped up in the scandal. One of whom, an elderly machinist, admitted to making copies of surgical screws for the company for less than half of what the medical-grade screws cost.

Lives Altered

Many patients injured by these fraudulent screws have filed injury lawsuits. One of those most devastatingly injured, Derika Moses, lost her job and her home from the pain and illness caused by the toxic screws. A former softball star, she threw her back out in 2007 while setting up a grocery store display. She underwent spinal fusion surgery, which only caused chronic pain and infections.

In 2012 Derika had most of the hardware removed from her spine, but asked if she could keep the rods and screws. She had nearly forgotten about them until March 2014, when she received a letter stating that she may have been the victim of medical fraud. She is now one of dozens of patients who have filed lawsuits against Spinal Solutions for selling counterfeit implants, and incentivizing doctors with kickbacks.

During a meeting with the medical-grade screw manufacturer whose products were being imitated by Spinal Solutions, a General Manager identified four of the spinal screws as fakes. Derika remains angry from what happened to her: she lost her job and her home because of her debilitating pain and infections, while the Spinal Solutions CEO lived a life of luxury.

One of the doctors who bought into Spinal Solutions' perks was Dr. Cully White from Pewaukeee, Wisconsin. White took Spinal Solutions private jets to ski resorts and Mexican beaches, taking along his sales representative, who believed the company' s CEO was unsavory at best. Despite repeated warnings, Dr. White continued to use Spinal Solutions' hardware. More than a dozen operative reports confirm this.

White was federally indicted and investigated in 2013 in an unrelated incident, pleading guilty to billing for services he did not provide. He was sentenced to six months in prison. Another surgeon in Baltimore, Maryland estimated that he used the company's hardware in several hundred procedures, accepting hundreds of thousands of dollars in cash.

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This Years' Most Dangerous Toys

December 3, 2014,

9172017631_8ce8cb38ca_c.jpgAs the holidays roll around, parents throughout the country are trying to figure out what their kids will unwrap. In uncanny timing, the largest study of its kind was just released, reporting on children's hospitalization rates from toys. Product recall lawyers at Pintas & Mullins recently wrote a blog on this very subject, and hope to further detail this related study.

Researchers looked at data from the past 20 years, finding that a child received emergency treatment from a toy-related injury every three minutes in the United States during that time. On average, nearly 150,000 children were sent to emergency rooms each year.

Fortunately, the large majority (about 98%) of injuries were non-life-threatening, and the kids were treated and released. For those who had to have extended stays in the hospital, the majority of the injuries were due to ride-on toys, such as scooters.

Further reinforcing how dangerous these items are, researchers noted a significant increase in ER visits between 2000 and 2003, when scooters boomed in popularity. It is worth noting that this study analyzed only non-fatal injuries, such as falls, swallowing or inhaling, collisions, etc.

Organization Identifies 10 Worst Toys

Rideable toys, like electric-powered mini-cars, scooters, wagons and bicycles, accounted for more than a third of all toy-related injuries. As every parent knows, however, every year there is an influx of the new hot toys on the market. The organization W.A.T.C.H. releases a list of the 10 Worst Toys each year. This year, the Air Storm Firetek Bow landed the top spot.

The Air Storm shoots glowing darts, which at short range can be quite harmful, potentially causing bleeding, retinal detachment, or cataracts. The toy does not come with any kid of glasses or googles. The Radio Flyer Ziggle, a four-wheeled cycle, also made the list. On its packaging, it warns that the Ziggle should not be used near pools, sloped driveways, motor vehicles, hills, steps, or streets. This leaves many wondering how it could be used safely.

The list is not meant to punish manufacturers, merely to warn parents about the potential risks of certain products. Parents should use their best judgment when buying toys for their kids - just because it is on store shelves does not necessarily mean it is safe.

Other products making the W.A.T.C.H. list include a hammer for killing Orcs, a Bottle Rocket Party, toy gun, and a pencil-slash-catapult. These are fairly obvious just by the name, but there are others that are not as obviously dangerous: a babydoll with a removable bow, a toy with long and unsecured hair, and an alphabet pulling toy for toddlers. Check out the full list here.

The study authors noted that many injuries could be prevented if toys were better designed and more heavily regulated - often, toy companies are able to skirt regulations by labelling toys in a specific way or exploiting other loopholes.

Continue reading "This Years' Most Dangerous Toys" »

Brain Injuries Evident Without Concussions

December 2, 2014,

charlie-brown-never-learns-tagged.jpgOngoing research into traumatic brain injuries reveals that significant brain changes occur in contact sports players even in the absence of any concussions. Much of this research is focusing on high school athletes, who play during critical times of brain development. Traumatic brain injury lawyers at Pintas & Mullins detail these recent studies and their findings.

A high school association in Illinois just became the first to be hit with a potential class action because of concussion injuries in football. The lead plaintiff played for the Notre Dame College Prep football team for four years, and now claims he suffers health problems from the program. He filed suit against the Illinois High School Association for failing to establish policies that minimize concussion risks, such as when injured players should be allowed back onto the field.

There have been similar actions filed against the NFL and NCAA, which represent professional and collegiate football teams, respectively. The NCAA class action resulted in a $75 million settlement in July 2014. The NFL action ended in a $756 million settlement, which will fund medical exams, research, and preexisting injuries from concussions, like Alzheimer's and traumatic encephalopathy.

For every one NFL player, however, there are about 2,000 high school players in the U.S. Recently, researchers at Wake Forest University attempted to study this population, analyzing nearly 25 student athletes aged 16 to 18 at a North Carolina high school. Scientists used a helmet-mounted system to measure the severity and frequency of players' impacts during practices and games.

They found that the heaviest hitters showed the most brain changes, even in the absence of concussion symptoms. They now plan to pursue the long-term consequences of these impacts, including changes in cognitive function or behavior.

Death at Ohio State

Brain injuries enact brain changes more quickly in some than in others. An Ohio State University football player and wrestler was recently found after being reported missing for over a week. Police believe he shot himself. He was only 22 years old.

According to his friends and family, the athlete suffered from confusion spells after repeated concussions. Although he was a reserve defensive lineman and wrestler, he did not have any documented concussions during his three years at Ohio State. The County Coroner stated his brain will be tested for evidence of damage.

More than 173,000 sports-related TBIs are treated in emergency departments every year in the U.S. in kids and teens up to age 19. Aside from football, some of the other sports that commonly cause TBIs are lacrosse, wrestling, hockey, cheerleading, snowboarding and basketball.

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Largest U.S. Hospital Chain Stops Power Morcellator Use

November 26, 2014,

a-silent-calling.jpgThe biggest for-profit hospital operator in the country, HCA Holdings, recently announced that power morcellators will no longer be used to remove uterine fibroids in its hospitals. Uterine cancer lawyers at Pintas & Mullins explain why this announcement was made and how it will impact patients.

Power morcellators have just recently come under public scrutiny - most Americans had no idea what they were until about a year ago. A laparoscopic power morcellator is used in several types of minimally-invasive surgeries, to pulverize tissue before it is removed from the body through a small opening. In women, power morcellators are often used during hysterectomies or myomectomies, which are surgeries to remove the uterus or uterine fibroids.

Morcellation refers to the process of breaking down tissue to make it easier to remove through a small incision, which is why most physicians recommended this type of procedure over more invasive alternatives. Very few doctors were concerned about the risks of morcellation, believing the adverse events were too few and far between.

Now, mounting evidence to the contrary has prompted hospitals, doctors, medical journals, and even the FDA to issue warnings against power morcellation. In mid-November, 2014, the FDA released its strongest warning against power morcellators, urging doctors not to use them during hysterectomy or myomectomy surgeries. The agency also ordered new a "black box" warning label the device.

HCA hospitals, which runs 165 hospitals and 113 surgical centers, now prohibits the use of power morcellators. Many other hospitals have implemented similar bans.

The Spread of Uterine Cancer

The strengthened warnings and bans against these devices are in response to the potential for morcellation to spread undetected uterine cancer. During the morcellation procedure, the device breaks up the uterine tissue - which may or may not have undetected cancer cells - spreading it throughout the uterus. If there is cancer present, and the FDA estimates that about 1 in every 350 women do have uterine cancer tissue, morcellation would spread that cancerous tissue, seeding it in the uterus and abdomen.

Cancer is much more deadly when it has spread. Therefore, for women who do have undetected cancer, the likelihood of long-term survival is significantly decreased after a morcellation procedure. Making matters worse, there is no test or other method to predict whether a woman would have cancerous tissue in her uterus before such a procedure.

Now that this potential has come to light, cancer patients and their families have started coming forward, telling their devastating stories. In nearly every situation, the patient was never told about the risk of cancer when deciding to undergo her surgery, and some did not find out that power morcellators were to blame until long after their diagnosis.

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FDA Warns of Uterine Cancer Risk for Hysterectomy, Myomectomy

November 24, 2014,

6025359063_81a0b67b4c_b.jpgWomen who undergo hysterectomies or myomectomies using a specific medical device called a power morcellator are at significant risk of developing uterine cancer. The FDA and several news outlets are releasing safety updates to women who are thinking of having these surgeries. Uterine cancer lawyers at Pintas & Mullins are currently investigating cases involving power morcellator devices.

The link between uterine cancer and these medical devices was just recently discovered and confirmed by several studies; one of which found that women who underwent surgeries with power morcellators were 20-30% more likely to suffer uterine cancer than those who did not have such surgeries. In response to these findings, the FDA released a Safety Communication on April 17, 2014, and again on November 24, 2014.

The FDA estimates that 1 in every 350 women who undergo a hysterectomy or myomectomy have undetected uterine cancer.

Power Morcellators

These medical devices are used during different types of minimally invasive (laparoscopic) procedures, such as to remove uterine fibroids or the uterus. Power morcellators work by breaking uterine tissue into small pieces or fragments, to make removal easier. When these devices are used in women with uterine fibroids, power morcellators can spread and seed undetected uterine cancer tissue.

What makes this so dangerous is that there is no way to reliably detect cancerous tissue in uterine fibroids. If a power morcellator is used on a woman with undetected cancer, there is a serious risk that the surgery will spread cancer throughout the abdomen and pelvis, significantly worsening her chance of long-term survival.

Because there are many alternative options for women who need a hysterectomy or myomectomy, the FDA is now urging against the use of power morcellators in most women. Johnson & Johnson has pulled three of its power morcellators from global markets, and many top hospitals have banned them.

Uterine Fibroids

Most women develop uterine fibroids at some point, often during pregnancy, and they can range in size from undetectable to bulky masses. Many fibroids do not cause any symptoms and go away on their own, while others cause serious symptoms. Among the most common are:

• Heavy or prolonged menstrual bleeding
• Frequent or difficult urination
• Pelvic pressure or pain
• Constipation
• Backache or leg pains
• Enlarged uterus and abdomen

Many women who need to have their uterus or uterine fibroids removed choose laparoscopic surgeries with power morcellators because they are associated with shorter recover times and less risk of infection. Now that the cancer risks are known, however, doctors need to inform their patients about the risk of spreading undetected cancer.

Cancer experts state that there is a far greater chance of full recovery and survival if surgeons remove the uterus intact, instead of with a morcellator through small incisions. This means a more invasive surgery, but a much better chance of beating uterine cancer. Once cancer spreads, it is far less likely to be cured, and morcellators spread tissue like wildfire.

For too many women, these warnings are too late. Linda Interlichia, who underwent a hysterectomy in 2013, was recently profiled by the Wall Street Journal. Linda was diagnosed with aggressive uterine cancer (leiomyosarcoma) after her surgery, which was performed using a power morcellator. She was never told that her surgery would involve a morcellator.

Eight weeks after her surgery, a doctor found a softball-sized mass of tumors in her pelvis that were not there before her surgery. Cancerous fragments left behind after morcellation had embedded in her abdomen, spreading widely. The hospital where she underwent the surgery has suspended power morcellation. Linda died on Halloween of this year, at age 55.

Continue reading "FDA Warns of Uterine Cancer Risk for Hysterectomy, Myomectomy " »

Fires Erupted in Chicago Area

November 14, 2014,

after-the-blaze.jpgThere have been three serious fires in the Chicago area in as many days, causing heavy damage, displacing families, and injuring several victims. Fire injury lawyers at Pintas & Mullins would like to take this opportunity to outline some basic tips for keeping your family safe and warm during the winter season, and remind those injured in fires that compensation may be available.

The most recent fire occurred in the Greater Grand Crossing neighborhood on Chicago's South Side around 10:00 at night. A four-story apartment building erupted in flames, causing one man in his 50s to jump from the second floor and receive emergency medical care. Twelve other residents, though fortunately not injured, are now without a home. The cause of this fire remains under investigation.

The other two fires were in suburban Chicago, in Island Lake and Berwyn. The Island Lake fire caused heavy damage to a Sikh temple, which erupted around 8:00 pm. According to the Chicago Sun-Times, the temple was a very old building and fortunately no one was believed to be in the temple when the fire started. The cause of this fire is also under investigation by federal and state agencies.

Four people were injured in a fire and explosion accident in Oak Park / Berwyn at the Turano Bakery commercial building. The fire began in Turano's truck maintenance garage around 2:00 pm, where four workers were injured and taken to a nearby hospital. It is believed that the fire occurred when the Turano employees were working on a truck propane tank. They were changing a tank in one of the trucks and mistakenly thought it was empty.

While trying to remove the full propane tank, fuel shot out of the tank and hit a heating unit in the garage, which then exploded. The injuries to the workers are not serious, but the Turano building itself is badly damaged, nearly blown apart by the explosion. A residential home next to the bakery was also damaged. Smoke enveloped much of the surrounding area in the aftermath of the explosion, affecting residents within at least a full square mile of Turano Bakery.

Legal Options after Fires

Our lawyers have been representing victims injured in fire and explosion accidents for several decades. For these types of cases, we work with experienced investigators and specialists who will get to the root of the eruption. If the fire is caused by someone else's negligence, anyone injured in the fire can receive compensation for their medical bills, time away from work, or even the loss of a loved one.

Some examples of fires caused by negligence include: faulty wiring, gas explosions, and defective or nonexistent smoke detectors. Each case is different, so depending on the unique circumstances of the fire, there are a number of parties who can be held liable for the fire.

Among the parties who could be liable are: the landlord, the manufacturer of a defective appliance or device, the builder or contractor of the home, an electrician or their employer, a propane or gas company, and many other possibilities.

Every year in the United States fires kill more people than all other natural disasters combined. About 80% of all deaths linked to fires occur in residential homes, and cooking and careless smoking are the leading causes of these fires.

Throughout the winter, particularly in Chicago and other northern cities, heating plays a big role in fire safety. These types of fires are especially common in single-family homes, where maintenance is less overseen. The elderly and children under the age of five are most likely to suffer fatal injuries in a fire.

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Nutek Baby Wipes Recalled

November 13, 2014,

Several brands of baby wipes made by Nutek Disposables are being recalled due to bacterial infections. The recalled brands include: Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings. The team of product recall lawyers at Pintas & Mullins warn parents to check the labels of their baby wipes immediately.

ucm420520.jpg The recall was announced on October 3, 2014 by Nutek. These baby wipes were sold at popular retail stores such as Diapers.com, Family Dollar, Fred's, Sam's Club, and Walgreens. The recall was prompted by consumer complaints of odor and discoloration when using the wipes, which is now attributed to the presence of bacteria; specifically, the bacteria Burkholderia cepacia (also known as B. cepacia).

B.cepacia is a group of bacteria strains that is commonly found in the environment, in wet soil and decaying plants. Once B.cepacia enters the body, it poses little risk to healthy adults, however, those with certain medical conditions or who have weakened immune systems (like infants) are more susceptible to infections.

In children, the symptoms most associated with B. cepacia infection include:

• Rash
• Fever
• Gastro-intestinal issues
• Respiratory issues (cough, shortness of breath, wheezing)
• Rash

This bacterium is a significant threat to those with cystic fibrosis and other chronic lung diseases. This is because B.cepacia colonizes in the lungs, which can either cause no symptoms or cause damaging infections and inflammation that can, in the most severe cases, deteriorate lung function. In these extreme cases, a condition called cepacia syndrome may develop, which does not always respond to treatment and can lead to death within a few weeks.

The only way to diagnose a B.cepacia infection is to examine the sputum, or mucus in the lower airways. Sputum cultures are routine laboratory tests; if a patient test positive, they will have to avoid close contact with susceptible people.

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Stryker Agrees to $1 Billion Settlement With Hip Patients

November 7, 2014,

91201736_f0cc7f3329_o.jpgIn an effort to avoid thousands of trials over its defective hip implants, Stryker recently agreed to pay at least $1.43 billion to patients implanted with the metal-on-metal devices. This agreement was the result of an unusual "bellwether mediation" meetings, which involved negotiations between plaintiffs and Stryker. Metal on metal hip implant lawyers at Pintas & Mullins detail this settlement and who is eligible to take part.

The bellwether mediation between Stryker and patients harmed by its hip implants has been ongoing for over a year. This billion-dollar settlement will resolve about 4,000 lawsuits filed by patients who needed to have revision surgeries after their Stryker hip implants failed prematurely. The Stryker implants at the center of these cases are the Rejuvenate and ABG II modular neck stems.

Generally speaking, according to the settlement, each Stryker patient who had to undergo a revision surgery will receive an average of $300,000. Both of these hip implants were recalled in 2012 after mounting evidence of their defects. Metal-on-metal hip implants were only recently introduced to markets and marketed to younger, more active patients as better alternatives to traditional implants. In reality, the implants have proven to fail early, cause immense pain, shed metal debris into the body, and require corrective surgeries.

Stryker is just one of the companies that sold these defective metal-on-metal devices. Johnson & Johnson, the world's largest health-care product seller, recently agreed to a similar settlement of at least $2.5 billion. This settlement will compensate patients implanted with the company's ASR hips.

Unlike Johnson & Johnson, Stryker agreed to this settlement before any of the lawsuits went to trial. Experts believe that Stryker purposefully chose to settle the cases in mediation to avoid an even larger financial loss. J&J lost millions of dollars in its initial trials regarding the ASR metal-on-metal systems; the company then decided to a multi-billion dollar settlement, though it is still facing thousands of cases for the ASR device and another metal-on-metal hip, the Pinnacle.

Other companies that sold metal-on-metal hips are: Wright Medical, Biomet, Zimmer, and Smith & Nephew. Anyone who was implanted with a metal-on-metal hip, regardless of the manufacturer, may be entitled to compensation from the manufacturer. These companies sold devices that they were inherently dangerous and defective, injuring patients who were already vulnerable to infection.

Revision surgeries, particularly in the elderly, can be extraordinarily painful, risky, and expensive. This is the reason why hip devices that fail early and in extremely high rates are so dangerous and require such extensive litigation. A clear message needs to be sent to these manufacturers to ensure that they never let a situation like this occur again.

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DaVita Employee's Whistleblower Suit Ends in $389 Million Settlement

October 24, 2014,

12857222344_037d571444_o.jpgA whistleblower lawsuit filed against DaVita HealthCare Partners recently concluded in a $389 million settlement. The kidney dialysis company agreed to settle investigations into transactions it made with doctors over the last ten years. Whistleblower lawyers at Pintas & Mullins highlight this case as an example of how average citizens can help improve American healthcare.

This suit was brought by a former DaVita employee, David Barbetta, who was a senior financial analyst in the company's mergers and acquisitions department. Barbetta filed the whistleblower lawsuit on behalf of the federal government in 2009, and will receive a substantial percentage of the $389 settlement.

DaVita operates thousands of outpatient dialysis clinics throughout the country, treating approximately 170,000 Americans. The company is accused of carrying out a complex scheme to pay doctors for referring patients to DaVita's clinics, a practice known as "kickbacks," which is illegal. Federal anti-kickback laws ensure that patients receive the best possible care from their doctors, who make their referral decisions based on the best interest of the patient and not on any financial incentives.

According to the investigations, DaVita has been paying doctors for referrals since 2005. The company's kickback scheme involved targeting physicians who treated a lot of dialysis patients and gathering information about those physicians to determine if they could be incentivized. For example, DaVita identified one physicians group to receive kickbacks because the doctors were "young and in debt."

Once physicians were identified, DaVita would offer them lucrative opportunities to refer their patients to DaVita's clinics. The company would pay physicians to perform various tasks and had them sign noncompete agreements. These agreements were contracts that forbade the doctors from sending patients to any of DaVita's competitors. These schemes took place throughout the country, in places like Central Florida and Denver, where the company is based.

Ethics Complaints Ignored

Barbetta, the whistleblower in this case, was a key witness in the government investigations. The former DaVita employee gave prosecutors e-mails, sales spreadsheets, and insider knowledge of DaVita's illegal schemes. Barbetta worked as a senior financial analyst from 2007 to 2009; during that time he frequently complained to upper management about the kickbacks and warned about the ethics of the schemes. His complaints were either ignored or drew scorn from higher-ups.

In one of the internal emails, DaVita executives explained how the "deals" with physicians were manipulated to funnel cash into their pockets in exchange for referrals. In 2009, Barbetta found another job and quit DaVita, fed up with the company's hypocrisy.

DaVita's marketing and sales tactics tout the company as a high-quality, fair, and compassionate resource for dialysis patients. Barbetta was tired of seeing these messages and having to work at the company every day, experiencing what actually happens behind closed doors. He made the decision to file a whistleblower lawsuit because, although everyone knew what was going on, no one else was willing to do anything about it.

Continue reading "DaVita Employee's Whistleblower Suit Ends in $389 Million Settlement" »

Lawsuit Accuses Hip Implant Maker of Putting Sales Before Safety

October 22, 2014,

91201736_f0cc7f3329_o.jpgPatients implanted with metal-on-metal hip implants are suffering serious health consequences from the devices and accusing manufacturers of putting marketing before patient safety. Thousands of patients have filed lawsuits against these companies, including Johnson & Johnson subsidiary DePuy Orthopaedics, which recently recalled many of its all-metal devices. Hip implant lawyers at Pintas & Mullins detail one of the most recent cases against DePuy currently in trial.

This latest trial against DePuy is considered a bellwether trial, which are used in large-scale litigation (there are about 6,500 hip cases pending against DePuy). In a bellwether trial, a judge selects a few cases to represent the majority of plaintiffs. These cases are then fully prepared on both sides and tried before a jury. They are meant to be representative of issues that arise in most injured peoples' cases, to give everyone an indication of what is likely to happen in future trials.

For the DePuy cases, one of the plaintiffs selected as a bellwether is coming to a close in Dallas. Over the past eight weeks, the client has accused DePuy of prioritizing marketing and sales over patient safety in its Pinnacle line of all-metal hip implants. She is also accusing the company of negligence, designing a defective product, failing to warn, and violating laws related to marketing.

DePuy stopped selling the Pinnacle implant in 2013 once it became clear the devices were failing in extremely high rates. DePuy sold two other metal-on-metal hip systems, the ASR Hip Resurfacing System and ASR XL Acetabular System, which were both recalled in 2010.

This is the first case to go to trial over the Pinnacle device, and the jury is currently in deliberation. We will update this blog once they make a decision. The plaintiff is asking the jury to recognize that DePuy hid the safety risks of all-metal devices, failed to warn doctors and patients that the implants could shed metal ions into the bloodstream, infecting the surrounding tissue and causing metal toxicity in some patients.

More Metal More Problems

Regarding its marketing, DePuy is accused of pushing the metal-on-metal devices specifically to younger, more active patients, claiming the all-metal devices would provide better mobility and would last longer. The opposite turned out to be true, with several studies pointing to early failure rates much higher than traditional hip implants.

Medical experts estimate that at least 10% of Pinnacle hips will fail within two to three years of implantation. When hip implants fail, doctors must go in for a revision surgery, which are often expensive and painful. Since such a high number of all-metal hips failed, there is much evidence that the implants were causing even more destruction in the body than they realized.

Patients implanted with defective metal-on-metal were showing signs of severe tissue death, ruptured tendons, fluid pockets, and other serious health effects. Additionally, as mentioned above, the metal implants release chromium and cobalt particles into the body, causing inflammation, pain, and difficulty moving. Long term effects of metal poisoning include brain and heart problems.

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Medical Device Makers No Longer Required to Report Product Changes

October 15, 2014,

laproscopic-surgery-robot.jpgCompanies that manufacture medical devices used to have to report any changes they made to the devices to the FDA. On Tuesday, the FDA announced that it would no longer make companies report this information, except when they apply to recalls or safety concerns. Defective medical device lawyers at Pintas & Mullins highlight the importance of this news and how it will affect patients.

The requirement was called an "806 report," which device makers considered a burden because of the extra paperwork and tasks companies had to perform. It was also a legal burden, as all the documentation would provide ammunition for anyone injured by the medical devices that chose to file a product liability claim against the device maker.

The reports could be used in trial to suggest or even prove that certain versions of a product were dangerous or unsafe. Companies would also have to submit copies of all written correspondence discussing changes made to medical devices.

The FDA proposed the 806 report to make sure device makers kept the FDA informed on any device tweaks that were intended to reduce health risks. It would have included any changes made to previously sold products and those that are not yet being sold. On Tuesday, however, the agency deleted the 806 reporting requirement, likely to appease controversy with device manufacturers. The FDA also nixed many other proposals that would affect recall reporting requirements.

Medical Robots More Costly and More Dangerous

A perfect example of how more reported data from medical device makers could be problematic for them in court is the da Vinci Surgical System. Many hospitals now have surgical robots, which cost millions and are marketed as being safe, more efficient alternatives for minimally-invasive surgeries.

Surgical robots are most often used in gynecologic procedures, such as to remove bladder cancer and ovarian cysts. The company that makes these da Vinci robots, Intuitive Surgical, have long-claimed that they lead to fewer complications and shorter hospital stays, despite a glaring lack of evidence to prove this.

Researchers have started taking the matter into their own labs. One of the more recent studies, conducted by Columbia University, found that surgical robots actually caused higher rates of complications, particularly in surgeries to remove ovaries and ovarian cysts. The study was recently published in the journal Obstetrics & Gynecology. In 2013, Columbia researchers also noted that robotic surgery for hysterectomies did not provide better patient outcomes yet resulted in exorbitant costs.

We recently reported on another similar study done by Johns Hopkins, which found dozens of examples of horrible-gone-wrong surgeries that were never reported to the FDA. Based on the information they were able to gather, Johns Hopkins researchers determined that serious incidents from da Vinci robots were vastly underreported.

Researchers analyzing data from da Vinci robots encourage patients to stop and seriously consider whether using this expensive technology will actually benefit them. The types of surgeries robots are meant to replace (called laparoscopic surgeries) are already minimally invasive, using tiny incisions and are not especially painful. On average, the complication rate for ovarian cyst removal is about 2.7% for laparoscopic surgeries; for robotic surgeries 3.7% of patients suffer complications, despite costing $3,000 more to perform. So, at least for ovarian procedures, using robots turn out to be more expensive and result in more complications that traditional surgery.

Da Vinci robots cost millions of dollars and many experts believe that hospitals are only buying them to stay ahead of the curve in the ultra-competitive healthcare field. Researchers believe that much more research needs to be done before surgical robots are accepted as the standard of care in U.S. hospitals.

Complications resulting from robotic surgeries can also be much more dangerous than those suffered in traditional procedures. The FDA database points to problems in software, battery function, and issues with the robotic lens clarity. There are also reports of "freak accidents," when robots would not let go of tissue or severely burned patients.

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Boeing Whistleblowers Cause $23 Million Settlement

October 13, 2014,

5480437205_8f5c4d3f81_b.jpgChicago-based aerospace company Boeing recently settled a labor law violations lawsuit in the amount of $23 million. The lawsuit was filed after four present and former Boeing employees acted as whistleblowers, exposing false labor submissions regarding contract maintenance workers. Whistleblower lawyers at Pintas & Mullins detail this lawsuit and how other employees who suffer labor violations can file similar claims.

In accordance to federal whistleblower laws (also called qui tam laws), each Boeing employee that came forward about the false labor charges will receive about $4 million. This will settle all allegations against Boeing that it submitted false labor charges on maintenance performed by contract workers on its C-17 Globemaster transport aircrafts.

The C-17 Globemaster is a large military airplane developed for the U.S. Air Force. In a statement, Boeing did not admit to committing any wrongdoing but merely a matter of "inadequate charging discipline." Aside from the $4 million that will be divided up among the whistleblowers, the rest of the settlement will go back to the federal government.

What is a Whistleblower?

Whistleblowers can be any private citizen who has knowledge of fraudulent practices toward the federal government to sue on behalf of the government. The lawsuits are filed under the False Claims Act, which allows the whistleblower to receive a significantly percentage of the ultimate award or settlement, typically between 15-25%.

Claims submitted under the False Claims Act most commonly involve health care, military, or other government spending program. The pharmaceutical industry drive the largest settlements year in and year out, with whistleblowers expose fraudulent claims made to Medicare and Medicaid. These types of pharmaceutical whistleblower cases typically involve marketing drugs for off-label uses not approved by the FDA.

Perhaps the most famous whistleblower lawsuit of this type involved antidepressant drugs manufactured by GlaxoSmithKline. Whistleblowers in that case accused GSK of promoting Paxil, Wellbutrin, Avandia and similar drug for off-label purposes. The company was also charged with failing to disclose critical safety data on these antidepressants, paying physicians to prescribe the drugs, and making false statements about Avandia. GSK was ultimately fined $3 billion for its fraudulent schemes.

It is important to note that doctors are allowed to prescribe drugs for any purpose, including those not approved by the FDA. This only becomes illegal if the doctor is receiving payments directly from the drug companies for prescribing off-label, or if the companies market drugs for non-approved uses. There are federal laws against this type of marketing, which drug companies routinely ignore.

Other types of Medicare fraud are quite prevalent in nursing homes and other elderly healthcare sectors. These can include billing for services not provided (such as if a nursing home resident on Medicaid is supposed to receive physical therapy sessions and the government is billed, but the resident never actually receives them), billing for higher reimbursement rates, and other similar false claims.

One example of this recently occurred in Illinois, when two former nursing home employees filed a whistleblower lawsuit against the facility. The employees allege that, although many residents were receiving grossly inadequate care, the facility was billing Medicare and Medicaid for above-average services. Employees were also directed to forge patient and medication records to reflect false care. Staffing records were falsified as well, to show minimum staffing levels were met but in fact were not.

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TVM Company Agrees to $400 Million Settlement

October 9, 2014,

Thumbnail image for 1409594_gavel_4.jpgEndo International, one of the major manufacturers of tranvaginal mesh products, recently agreed to pay more than $400 million to women who were harmed by the devices. More than 10,000 lawsuits will be resolved in this settlement, with an average payout of about $48,000 per plaintiff. Transvaginal mesh lawyers at Pintas & Mullins are happy to report on this settlement and who may be affected by it.

October seems to be a month of good news for those suffering from TVM complications; another major manufacturer, C.R. Bard, reported on a similar settlement agreement. This is a significantly smaller settlement, affecting about 500 plaintiffs who filed injury lawsuits against Bard. The company agreed to resolve these suits for about $21 million, averaging about $42,000 per plaintiff. The specific TVM product affected by this $21 million settlement is C.R. Bard's Avaulta Transvaginal Mesh product, which has been removed from U.S. markets.

Generally, mass settlements like these have to be agreed to by 90-95% of those affected by it. Every woman who has filed a lawsuit against a TVM manufacturer - or is at all considering it - should carefully consider their options when a settlement is announced. Each case is different, with unique injuries and circumstances, and some cases may be better off going to a jury trial. This is something that should be discussed with your TVM attorney.

In one jury case against C.R. Bard, the plaintiff, Christine Scott, was awarded $5.5 million for her injuries. Only two other cases have been heard in jury trials over C.R. Bard TVM products. The company also makes the Composix Kugel hernia mesh, which is now named in hundreds of lawsuits.

Endo International to Pay Billions

The $400 million settlement mentioned above is just the latest in a series of settlements offered by Endo International. Endo manufactured the following TVM products:

• Apogee Vault Suspension System
• Elevate Prolapse Repair System
• Monarc Sling System
• Perigee System
• Sparc Sling System

Despite billions of dollars in settlements, about 5,000 Endo TVM lawsuits remain pending in federal court.

Johnson & Johnson Facing TVM Suits

Ethicon Inc., a subsidiary of Johnson & Johnson, is also facing hundreds of TVM cases, currently consolidated in federal court in Pennsylvania. The location is actually quite important in this litigation group, because of the extensive business J&J conducts in Pennsylvania, including with a polypropylene manufacturer that provided TVM parts to the company. That manufacturer, Secant Medical, has also been named as a defendant in the TVM cases.

J&J has tried several times to have the mesh cases dismissed completely, without success. There are nine other companies currently fighting TVM lawsuits in court. These products were officially deemed unsafe around 2008, after the FDA issued a safety alert about the serious complications associated with mesh products.

Another safety alert was issued in 2009, and by 2010 thousands of voluntary reports were submitted to the FDA. Two years later the agency ordered all nine TVM manufacturers to conduct official studies on the products to determine their actual risks. It is important to note that TVM products inserted through the abdomen were not subject to this FDA request.

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Criticism Over Da Vinci Robotic Systems Continues

October 6, 2014,

fort-belvoir-community-hospital-astounds-with-groundbreaking-technology-and-devotion-to-patient-care.jpgOver the last decades, technology surrounding surgeries have focused on improving how operations are conducted, with emphasis on making surgeries as minimally-invasive as possible. These are often referred to as laparoscopic surgeries, and have been topics of heated medical debates and injury lawsuits throughout the country. Our team of da Vinci surgical robot lawyers can answer any questions patients may have about these legal issues.

The New York Times recently published a piece on a series of reports that criticize the da Vinci surgical robots. The piece begins with the story of a woman, Erin Izumi, who underwent a surgery using robotics in 2009. During the 11-hour surgery, which was to treat endometriosis, the robotic arms tore her rectum and colon. She was rushed to the ER more than a week after the initial surgery, and was hospitalized for five weeks.

In a situation like this, both the hospital and the robotic system company are required to report the injury to the FDA. Despite this requirement no report was made about Izumi's injury in 2009, and a spokesperson for da Vinci told the paper that it became aware of the incident only after Izumi filed a lawsuit.

The da Vinci robots are manufactured by a California-based company called Intuitive Surgical. More than one million surgeries have been conducted using a da Vinci robotic system, with varying consequences. Thousands of incidents have been reported to the FDA, however, as the above situation illustrates, it is certainly possible this is only a miniscule reflection of that actual numbers.

At least one new study attempted to analyze the lapse in reporting, which was recently published in the Journal for Healthcare Quality. Researchers involved in that study are affiliated with Johns Hopkins, and were able to locate examples of horribly-gone-wrong surgeries using da Vinci robots. Based on these findings, they concluded that serious incidents in da Vinci operations were vastly underreported.

This is incredibly important because Intuitive markets this robotic device as an incredibly safe and less intrusive alternative to traditional surgery, although it is increasingly obvious how misleading this is. In reality, very little is known about the disadvantages of the system and the true rates of injury and death.

The Johns Hopkins study followed reports that involved robotic surgeries throughout the country, locating documents specifically mentioning lawsuits filed by injured patients. In many of these legal papers, plaintiffs alleged that Intuitive was aggressively marketing the robots despite lackluster training for physicians. There were also numerous mentions of the immense pressure placed on hospitals and doctors to "keep up," with new and emerging technologies

Doctors Speak Out

Due to this combination of aggressive marketing and pressure to stay ahead of the innovation curve, robotic surgery is growing dramatically in the U.S. Many medical experts argue that this growth is occurring without proper oversight and monitoring. The lead author of the Johns Hopkins study take this one step further, stating that this trend is indicative of a larger problem in American healthcare: lack of adequate evaluation.

The study author, Dr. Martin Makery, said that doctors and hospitals blindly adopt new expensive technologies without knowing what they're actually getting out of it, whether it will be beneficial to patients in the long run. A large part of the problem is that the federal "requirement" for hospitals and companies to report adverse events is not at all enforced. Makery states that the reports have "no oversight, no enforcement, and no consequences."

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