Medical Device Infecting Patients with "Super Bug"

February 27, 2015,

The FDA recently warned health care providers that improperly sterilized scopes are infecting patients with deadly, drug-resistant bacteria. The so-called "super bug" has already killed dozens of patients and caused hundreds others to fall ill. Medical device lawyers at Pintas & Mullins detail this outbreak below.

5080768357_4076960131_o.gif The drug-resistant family of bacteria is known as CRE (carbapenem-resistant Enterobacteriaceae) typically infect patients in hospitals and nursing homes - and particularly patients dependent on catheters or breathing tubes. The deaths and injuries associated with CRE have occurred at the Ronald Reagan UCLA Medical Center in Southern California and the Virginia Mason Medical Center in Seattle, Washington.

The duodenoscopes at the center of this outbreak have crevices and parts that are extremely difficult to reach with cleaning brushes, making total disinfecting almost impossible. These scopes are inserted into patients' throats, down into the stomach and small intestines to diagnose and treat liver, bile duct and pancreas diseases. About 500,000 of these types of procedures are performed each year in the U.S.

When these devices are not properly disinfected, bodily fluids and debris can remain on the scopes, exposing any patients undergoing an endoscopic procedure thereafter to contamination and infection. About 180 UCLA patients who underwent this procedure between October 2014 and January 2015 have been notified of their possible exposure.

CRE germs affect bodily systems broadly, infecting patients who are otherwise healthy and able-bodied. If CRE spreads, it can affect patients even with minor infections, like UTIs or small cuts, and cause fatal complications. Unfortunately, CRE is becoming increasingly common in American hospitals.

Currently, CRE infects about 9,300 people in the U.S. every year and kills about 610 patients. Whenever a CRE infection is confirmed, hospitals take aggressive measures to contain the bug, including: isolating patients, dedicating specific rooms, staff and equipment, and requiring higher hand-washing standards for staff.

Government Action

On February 19 the FDA issued a safety alert stating it was closely monitoring the situation and the association between these duodenoscopes and the infection of drug-resistant bacteria. The agency reportedly received about 75 complaints over the last two years regarding these duodenoscopes and bacterial infections in more than 130 patients. Almost all infections were resistant to antibiotic treatments.

The agency is stopping shy of issuing a national duodenoscope recall, since there are no alternative devices hospitals can use to treat and diagnose diseases of the liver, bile duct and pancreas. Three manufacturers sell these devices: Olympus, Fujifilm, and Pentax Medical. Nevertheless, members of congress are urging the House Committee on Oversight and Government Reform to hold a hearing on the outbreak.

The deaths in Seattle also caught the attention of Congress, enacting Washington senators who urged the FDA to provide better guidance on sanitation practices.

Injury Lawsuits Being Filed

The medical scope at the center of California outbreak is made by Olympus America, who was just hit with a lawsuit by an injured patient. The patient, Aaron Young, is alleging that Olympus failed to instruct UCLA Medical Center on how to properly disinfect the duodenoscopes. Olympus is being targeted because the hospital reportedly did sterilize the scopes according to the company's standards.

Continue reading "Medical Device Infecting Patients with "Super Bug"" »

Factory Worker's Arm Severed in Accident

February 24, 2015,

2243185736_fe84d8254e_o.jpgA 40-year-old factory employee lost his arm yesterday morning in a work accident. The factory is located in Bridgeport on Chicago's South Side. The man was taken to Stroger Hospital in critical condition. Work accident lawyers at Pintas & Mullins are currently accepting similar injury cases.

Although details of the accident were not available, we have dealt with many similar cases of catastrophic injury in the workplace. Many victims believe that the only way they can get compensation for their injuries is through their employer's workers' compensation insurance. It is important to note that there are many exceptions to this rule that employees need to know about.

If a worker suffers an extremely serious injury like a severed arm, it is likely that there was an outside factor involved in the accident. An example would be if an injury was caused by a defective or poorly maintained product. This would open up the possibility of filing a product liability lawsuit against the maintenance team or manufacturer.

Other examples where injured workers may be able to sue for additional damages include:

• Toxic exposure: many occupations and industries expose workers to toxic substances, such as asbestos, lead, diacetyl, or benzene. More information on this can be found here.

• Third party injuries: if your job requires that you travel, a car accident that left you injured could be considered a third party injury.

• Uninsured employers: if your employer does not have workers' compensation insurance, injured workers may be able to sue in civil court or collect from a state fund.

• Intentional or negligent conduct: personal injury lawsuits are an option if your injury was caused by someone else's negligence or intentional abuse.

Bringing a lawsuit outside of the workers' compensation system can give injured victims an opportunity for recover additional damages. The money provided by workers' compensation insurance are typically as low as possible, and do not give workers a chance to recover for pain and suffering. In particularly serious cases, a lawsuit could also result in punitive damages, which are fines against companies to specifically punish them for their negligence.

Another option for seriously injured workers is Social Security Disability Insurance. This is available only to workers who suffer an injury that is disabling and prevents further employment. There are two separate benefit programs under this option: Supplemental Security Income (SSI), which is available to elderly people or those whose incomes and assets are very low, or Social Security Disability Insurance (SSDI), which is available to people who have already worked for a specific number of years.

Continue reading "Factory Worker's Arm Severed in Accident" »

Why Surgeons Defend the Power Morcellator

February 17, 2015,

graduate-medical-educationobstetrics-and-gynecology-ob-gyn-surgery-scrubs-surgery-center-looking-over-medical-notes-at-desk-in-hallway.jpgA surgical device used in hysterectomies, myomectomies and other gynecological procedures is now linked to aggressive and fatal uterine cancer. The device, called a power morcellator, has been banned my top hospitals throughout the country and subject to cancer lawsuits. A group of surgeons, however, continues to defend the power morcellator. Our team of uterine cancer lawyers explores why doctors are standing behind this device.

The link between the morcellator and uterine cancer was publically exposed in 2013, when study after study confirmed the association. One of these studies, conducted by Columbia University, found that at least 1 woman out of every 370 that undergo a hysterectomy using a power morcellator will have undetected cancer cells. During the procedure, these cancer cells are spread throughout the uterus, planting in previously healthy tissue and creating massive tumor cell spread.

This confirms the FDA warning, made in April 2014, discouraging the use of power morcellators in hysterectomies and myomectomies, or surgeries to remove uterine fibroids. Power morcellators work by shredding large masses of tissue inside the body, so the tissue can be removed through a minimally-invasive incision. It was recommended to patients who were looking for shorter recovery times and less scar tissue.

The problem with this method is the likelihood that the tissue will contain undetected cancer cells - specifically, the cancer uterine leiomyosarcoma. This is an extremely aggressive form of cancer, and many women have been diagnosed with Stage 4 uterine leiomyosarcoma just weeks after morcellation procedures. There is no test to detect these cancer cells before surgery.

During an FDA hearing on power morcellators in July 2014, however, many gynecologsts and surgeons said they still believed the benefits of morcellation surgery outweighed the risks. The American Association of Gynecologic Laparoscopists (AAGL) later released a report saying morcellation remains safe "when performed by experienced, high-volume surgeons."

Conflicts of Interest

Like most other issues in healthcare, there were outside influencing factors at play here. One of the AAGL executive officers, Arnold Advincula, who had considerable say in the report, received "consulting fees" (or more simply, cash) from a morcellator manufacturer. Specifically, Advincula - who is now the AAGL president - has received at least $50,000 in the last year for consulting services with Blue Endo, which sells power morcellators.

The former president of the AAGL, Andrew Brill, has also done considerable "consulting" for morcellator companies. He chose to step down from the FDA morcellator panel in July 2014. More than 7,500 gynecologists read reports from the AAGL closely for guidance on best practices.

Yet another former AAGL president, Ceana Nezhat, recused himself from the morcellator report due to his own financial ties with a morcellator manufacturer. He neither voted on nor discussed the report with the other AAGL members. He also requested that Advincula do the same, to no avail. After the report was published, Nezhat sent an email stating that it was misleading and that the AAGL needed a zero-tolerance conflict of interest policy.

Since its release, the AAGL report has been used to credit the use of power morcellators and even persuade hospital administrators to continue offering morcellation surgeries.
Despite this report, the FDA has repeatedly warned doctors not to use morcellators on women, and most hospitals have stopped using them in gynecologic procedures. Johnson & Johnson, a major maker of power morcellators, pulled its devices from global markets.

Continue reading "Why Surgeons Defend the Power Morcellator" »

Some Doctors Untrained with Mirena, IUDs

February 16, 2015,

5007140130_e1d665e5ef_b.jpgIntrauterine devices, or IUDs, have become the most popular reversible form of birth control in the world. This is despite massive lawsuits, subpar research, bad press, and the improper training for doctors. The Mirena lawyers at Pintas & Mullins are currently investigating cases of serious injury from IUD use.

Since 2002, the number of American women using an IUD like Mirena has tripled, accounting for more than 10% of all contraceptives prescribed by doctors. When they were first introduced, IUDs were recommended only to women who were done having children due to the risks of infertility, hysterectomy, and infections. This practice changed quite recently, resulting in the device's new popularity, particularly among young, unmarried, childless women.

There are two types of IUDs available in the U.S.: ParaGuard, which is non-hormonal and releases tiny amounts of copper to prevent pregnancy, and Mirena, which uses small amounts of a synthetic hormone called levonorgestrel. Unlike the pill, IUDs do not prevent ovulation; rather, they prevent egg fertilization and implantation.

ParaGuard costs about $300, is considered extremely safe, lasts for 10 to 12 years, and uses copper to stimulate a natural fluid that kills sperm and prevents implantation. Mirena costs upwards of $1,000, lasts for five years and prevents pregnancy by thickening a fluid in the cervix, stopping sperm from entering the fallopian tubes where fertilization occurs. Unlike ParaGuard, the side effects of Muirena can be devastating.

Doctors not Confident with IUDs

All IUDs must be inserted and removed by trained health professionals. Some pediatricians and other doctors are concerned because their basic medical training never included proper insertion of an IUD. Ob/gyns are most competent in inserting IUDs, but for young women and teens, privacy can certainly be an issue. A teenager may not be able to tell her parents she needs birth control, and in places where doctors are harder to reach, geography could also play a role.

Experts are attempting to change this by making IUD insertion a mandatory aspect of medical residencies, particularly for pediatricians. The bottom line here is that training needs to be improved in the best interest of patient health and safety.

For thousands of women, the call for proper doctor training has come far too late. Among the more serious and life-altering complications of Mirena, most can be attributed to improper insertion and monitoring. Mirena's risks include:

• Perforation of internal organs, such as the uterus
• Expulsion
• Pelvic infections, such as pelvic inflammatory disesae
• Inflammation of the endometrium
• Endometrial or cervical cancer
• Blood pressure increase
• Ectopic pregnancy
• Painful intercourse

Some women have been forced to undergo hysterectomies due to these complications - many of whom were women in their 20s without children, but who wished to eventually have children. The most devastating Mirena injuries occur when the IUD perforates the uterus and migrates through the abdomen or other organs. This results in scar tissue, infections, cysts, and organ blockages.

In addition to the pain, Mirena perforation also requires extensive, repeated, invasive surgeries that often leave young women infertile. Thousands of women have suffered this life-changing complication, resulting in massive lawsuits against Bayer, the manufacturer of Mirena.

Continue reading "Some Doctors Untrained with Mirena, IUDs" »

TVM Lawsuit Updates

February 12, 2015,

Thumbnail image for Thumbnail image for gavel-6_l.jpgThe federal transvaginal mesh (TVM) litigation is underway in West Virginia, where Johnson & Johnson's Ethicon unit is defending its mesh products. Our team of TVM attorneys is keeping a close eye on this litigation as it moves forward. Here are some of the most recent developments.

Johnson & Johnson recently submitted a request to investigate the source of phone calls made to women across the country, soliciting information on their medical history with TVM products. The company was concerned these phone calls resulted in "baseless" lawsuits over its TVM devices. Yesterday, Reuters reported that the company dropped its request. Many believe the request was merely a delay tactic.

The judge overseeing this case, Judge Goodwin, told lawyers that this request was not helpful in establishing mutual trust between the company and the injured plaintiffs. Johnson & Johnson is just one of seven TVM manufacturers subject to injury lawsuits, though it is certainly the largest. More than 70,000 lawsuits have been filed on behalf of women injured by mesh products, about 35,000 of which are against J&J.

TVM products are implanted in women to treat pelvic organ prolapse and stress urinary incontinence. These products, which appear as plastic surgical mesh, were minimally tested and so poorly designed that the injuries are devastating women and their families. Some of the complications of TVM devices include:

• Multiple corrective surgeries
• Mesh erosion or perforation
• Painful sexual intercourse
• Extreme abdominal and pelvic pain
• Recurrence of stress urinary incontinence or pelvic organ prolapse
• Infection
• Nerve damage
• Bleeding

These side effects impact every aspect of women's lives, causing extensive emotional harm along with physical. Adding insult to injury, most women were never informed of the massive risks they were taking before undergoing the TVM procedure.

Due to this extreme negligence, injured women across the country are filing lawsuits against TVM manufacturers. In addition to Johnson & Johnson, the other manufacturers are: American Medical Systems, C.R. Bard, Boston Scientific, Neomedic, Cook Medical, and Coloplast.

Continue reading "TVM Lawsuit Updates" »

Hormone Therapy after Knee, Hip Replacements Help Recovery

February 10, 2015,

8737563510_1c23d5c3da_o.pngOne of the most painful, expensive and dangerous complications of knee and hip replacements is the possibility of a revision surgery. Revisions are second surgeries performed on the implant site because of early complications or device failure. Our team of hip and knee implant lawyers reports on recent research that may help preserve joint implants.

Hormone replacement therapy, or HRT, is commonly used by women after menopause. Patients take medications containing female hormones to replace those lost, to treat hot flashes and other menopause symptoms. One recent study found that women who undergo HRT after total knee or hip replacements had at least a 40% decrease risk of revision surgery.

The study was conducted at the University of Oxford and published in the Annals of the Rheumatic Diseases. Researchers found that, compared to non-HRT users, women who regularly took HRT in the year after hip or knee surgery reached a 50% reduction in revision risk. Nearly 25,000 women undergoing knee or hip surgery were used in this study. Mean age was 65, with a BMI of 28.5.

The most common reason knee or hip implants fail is because of device loosening, which causes pain, bone loss and other symptoms. Revision surgeries are not only expensive, risky and painful, but they result in less than ideal outcomes for patients compared to those who only need the original surgery.

According to the Oxford researchers, the mechanisms underlying device loosening are still obscure, but related to chronic inflammation and bone loss. HRT medications are thought to protect against bone loss. Those patients who strongly adhered to the HRT treatment had significantly decreased risk of revision compared to patients with low levels of adherence.

HRT comes with its own risks and side effects, however. Among the most serious include heart disease, stroke, blood clots, and breast cancer. More information can be found here, on the Mayo Clinic's website.

Hip and Knee Implants Recalled

A few years ago, a new breed of hip replacements, called metal-on-metal implants (MoM), were introduced to the market. MoM implants were originally marketed to younger patients under the guise that they would allow for increased mobility in more active people. The reality, however, is that these MoM implants are extraordinarily dangerous and have been subject to massive recalls.

In 2013, the FDA confirmed that MoM hip implants have unique risks in addition to the general risks of all hip implants. Because these devices are made entirely of metal, when the ball and cup slide against each other during daily use metal releases from the implant. Metal release can cause particles to wear off into the space around the implant. This can lead to bone erosion, blood metal toxicity, and other serious complications.

Three types of MoM hip implants have been recalled:

DePuy ASR TM XL Acetabular System
• Smith & Nephew R3 Metal Liners
Zimmer Durom Acetabular Component

There are many other types of MoM hips that are injuring patients across the country. Stryker is one of the largest medical device companies that has yet to recall its MoM hip system, despite thousands of premature failures and forced revision surgeries. Companies like Stryker, DePuy, Zimmer and Smith & Nephew are now subject to lawsuits because of these MoM devices.

Continue reading "Hormone Therapy after Knee, Hip Replacements Help Recovery" »

NFL Commercials Highlights Importance of Household Accidents

February 2, 2015,

3466081918_fa60844c87_o.pngDuring the Super Bowl last night, a controversial commercial for Nationwide Insurance captured the attention of viewers throughout the country. Some were outraged by the ad, which is narrated by a little boy explaining all the things he will miss in live because he died in an accident. Although the ad angered many people, it highlights a supremely important issue that is too often overlooked: preventable accidents and deaths.

Our accident and injury attorneys have written about this topic on this blog many times before, usually in response to a massive child product recall. In these blogs we often cite the nonprofit group Kids in Danger, which is one of the leaders in product safety. The group places much of its focus on recalled and needlessly dangerous children's products, which are highly unregulated.

In one of their studies, Kids in Danger found that only 10% of recalled children's products are ever returned or replaced. The remaining 90 out of 100 products remain in family homes like a ticking time bomb. Why so many recalled products remain in homes involves a complex web of factors, including a lack of transparency, regulation and oversight failure, and public negligence.

The truth that the commercial is trying to convey is that preventable accidents are the number one cause of childhood deaths. The ad showed fallen televisions, spilled household cleaning products, and overflowing bathtubs to demonstrate the most common accidents leading to death and injury among children, and prompts viewers to visit for tips and resources. The website is intended to help educate caregivers and parents on how to make the home safer.

People on social media were, not surprisingly, extremely critical about the ad. Although the ad was dark, it certainly serves a higher purpose: to get people talking about a tough issue. One of the most important hurdles to curbing these preventable accidents is to reform how our product recalls system works.

Furniture is one of the most common causes of child injuries and deaths. Typically, it takes about 14 reported incidents and two injuries to incite a product recall - but these need to be reported to the federal Consumer Product Safety Commission (CPSC) to be effective.

After reports are submitted, the government informs the product manufacturer that they should initiate a recall, but there is no guarantee the company will comply quickly, if at all. The CPSC cannot mandate a recall itself; if a company is refusing to recall the CPSC must take the issue to court, which can then require a recall.

Continue reading "NFL Commercials Highlights Importance of Household Accidents" »

Salmonella and Foodborne Illness Lawsuits

January 28, 2015,

3338894006_813f327ffc_o.jpgMost Americans heard about the Salmonella outbreak from Foster Farms chicken in 2013 and 2014. The contamination sickened thousands of people and sent hundreds to the hospital for serious illness. What most Americans do not know is how important food contamination litigation is to keeping our food safe. Salmonella lawyers at Pintas & Mullins explain exactly how food recalls are conducted in the U.S., and who is holding negligent companies responsible for selling unsafe food.

Experts estimate that, for every reported case of foodborne illness, about 28 go unreported. About 690 people reported Salmonella sickness from the Foster Farms chicken, meaning the outbreak actually affected as many as 18,000 people. Fortunately, no deaths were reported, but there were immense losses from the outbreak for thousands of families.

Victims of food contamination - whether it is Salmonella, Listeria, E.coli, or any other contaminant - suffer a myriad of ailments, from organ failure to paralysis. In more serious cases, victims can be hospitalized for months and never fully recover from the infection.

As System of Epidemics

Every year, tens of millions of Americans are sickened, hundreds of thousands are hospitalized, and about 3,000 die from contaminated food. Most of the bacterium and viruses that infect our food is potentially lethal, particularly for the elderly, infants, and those with compromised immune systems. Salmonella kills more people than any other foodborne pathogen, as an increasing number of strains are becoming drug-resistant.

This may not be news to some readers; most Americans know that certain levels of salmonella contamination are permitted in the U.S. food supply. Most people do not know exactly how the food recall system works, who it is run by, and what incentives food companies have to keep our food safe.

When an foodborne outbreak occurs, identifying the source is relatively simple with modern technology. Stopping the outbreak, however, is much more complicated, and falls on the shoulders of the U.S.D.A.'s Food Safety and Inspection Service (FSIS). The FSIS does not have power to force food recalls - they can only ask companies to voluntarily remove the product. And they can only ask companies for a voluntary recall if they have definitive proof that the meat is making consumers sick, by genetic matching between a victims' salmonella and the salmonella in packaged meat. The meat still has to be in the victims' possession, with the labels still attached.

Obviously, this makes recalls difficult to come by, even when the government knows that a certain company's food is making people sick. In the Foster Farms case, FSIS officials were not able to request a recall until more than a year after the outbreak began.

Food safety in the U.S. is a complex (and, many argue, broken) system: responsibility is divided among 15 federal agencies, consumer watchdog groups, food industry, and legal enforcement. Unfortunately, the legal side of the system, meaning the injury lawsuits that are filed after-the-fact, is the only part of the system that functions properly, actually incentivizing companies to sell safe food.

How Filing a Lawsuit Helps Change the System

Lawsuits are major players in changing food safety policy in ways that government, industry, and consumer groups cannot. The costs handed down by judges and juries are the strongest penalties food companies are subjected to, stronger than any regulation. The government cannot even mandate a food recall. When regulation fails (as it does, time and time again), litigation is the only way food companies are held accountable.

Take, for example, one of the largest food-poisoning claims in U.S. history, which occurred in the 90s against Jack in the Box. By cutting corners, not cooking food properly, and ignoring state guidelines, the fast food chain sold E.coli-contaminated burgers to consumers, killing four children, and sickening hundreds of others. Jack in the Box ultimately agreed to more than $50 million in settlements, $15.6 million of which went to a ten-year-old girl who spent 40 days in a coma.

Another example was the 2011 Listeria outbreak from cantaloupe farmed in Colorado. At least 33 people died from Listeria, which contaminated the cantaloupes when they were washed with tap water at the manufacturing plant instead of the FDA-recommended antimicrobial solution. Dozens of victims filed suit, not only against the Colorado farm, but also against retailers like Kroger and Walmart, and the private company that reviewed the farm's safety practices, PrimusLabs.

Continue reading "Salmonella and Foodborne Illness Lawsuits" »

Dog Attack Victim Wins $36 Million

January 23, 2015,

293195837_7dd74d58fb_o.jpgAn eight-year-old girl who was critically injured in a dog attack was recently awarded $36 million by a jury in Georgia. The girl was attacked by several dogs, causing one of her arms to be amputated. Dog bite injury lawyers at Pintas & Mullins detail this case and dog attack liability.

The jury in this case initially awarded the girl and her family $72 million in her injury lawsuit, however, the judge later reduced the amount to $36 million. The suit was filed against the owner of the dogs that attacked the little girl and left her permanently disabled. The woman was charged with reckless conduct, violation of vicious dog ordinances, and failing to have his dogs vaccinated for rabies. She was also sentenced to 16 months in jail.

Most states have what's known as strict liability dog statutes, meaning that the dog owners are liable if their dog causes an injury regardless of whether or not they knew it was dangerous. Many cover any kind of dog-inflicted injuries, not just bites or attacks. These are called "strict liability" because the injured victim does not have to prove that the owner was negligent or did anything wrong to cause the injury.

To file a successful lawsuit in a state with this type of dog bite law, victims have to prove four things:

1. The victim did not provoke the dog to bite or attack
2. The victim was indeed attack, and it caused an injury
3. The owner is the person being sued
4. The victim was acting peacefully in a place they could lawfully be (so not trespassing on someone's property)

In many cases, a claim can be filed even if the injury is not directly from a bite. For example, if a dog ran out and frightened someone, or started chasing someone and they fell and were injured, they may still be able to recover compensation.

Some states do only cover dog bites and attacks, however, and some states allow a dog owner to escape liability if they can prove that the dog was provoked. The victim has to prove that the injury was caused by a dog biting, attacking, wounding, killing, or chasing someone or something (such as another dog).

In Illinois, injured victims must only prove that they were not provoking the dog or trespassing to have a successful liability claim.

According to the CDC, more than 4.5 million Americans are bitten by dogs each year, and hundreds of thousands require serious medical attention. About half of those bitten are children, and since they are closer to dogs' mouths, their faces are more vulnerable to serious bites.

Continue reading "Dog Attack Victim Wins $36 Million " »

Whistleblower Lawsuit Exposes Healthcare Startup

January 19, 2015,

14212355607_9271292a26_c.jpgThe world's richest doctor, Patrick Soon-Shiong, recently established a healthcare startup called NantHealth. The company intends to improve cancer treatment and care, however, whistleblowers in Florida have filed suit saying it is engaged massive in fraud. Whistleblower lawyers at Pintas & Mullins explain this case and others like it throughout the country.

NantHealth has been featured on 60 Minutes, along with its founder who claims he has the technology to improve cancer patients' quality of life. A few of NantHealth's operations teams are based in Florida, where two former employees recently filed the whistleblower lawsuit.

These employees claim that NantHealth and its parent company, NantWorks, are engaged in a "multitude of fraudulent activities," including billing and privacy violations. They also accuse the company of exposing patients to products it knew to be harmful. The whistleblowers both previously held senior roles at NantHealth, as Senior Vice President of Professional Services and Senior Director of Marketing, respectively.

NantHealth makes next-generation medical devices and software that are meant to link different hospitals together - for example, it would enable hospitals to link their electronic medical records together so a patients' entire medical history is known. This way, every device and medication a patient is on would automatically collect and store data in real time.

According to the whistleblowers, however, NantHealth's technology violates federal privacy requirements; specifically, the Health Insurance Portability and Accountability Act of 1996 and the FDA's regulations. Furthermore, the former employees allege that an executive at Piedmont Healthcare, a client of Nant's, threatening to stop working with Nant and warned other hospitals not to work with the company. They claim more than a dozen clients made similar threats.

On the marketing side, the whistleblowers claim that the company made misleading claims in its product advertisements. They believe many customers paid huge costs as a result of Nant's products not working as promised.

Billions Lost in Medicare Fraud

The whistleblowers also claim that Nant was using money it received from Medicare and Medicaid unlawfully, including back-handed contributions to charities. Unfortunately, Medicare and Medicaid fraud is quite common in the healthcare industry. In fact, it is so prevalent in the United States that it costs taxpayers billions of dollars every year.

Most of this fraud is committed by a few people for smaller amounts of money. In 2012, however, federal authorities reported that they had arrested over 100 healthcare workers, including doctors and nurses, and charged them with defrauding Medicare for more than $450 million. Two years earlier, about 94 health workers were charged with Medicare fraud in the amount of over $250 million.

Florida is widely considered ground-zero of Medicare fraud - in fact, one of New York's crime families recently moved to Florida because defrauding Medicare was less dangerous and more lucrative. The federal government set up the Medicare Fraud Strike Force in 2007, and its first task was visiting thousands of businesses in Miami that were billing Medicare for medical equipment. Officials discovered that about one-third of these businesses did not exist, yet were billing Medicare for millions in medical equipment.

The five states with the highest incidence of Medicaid fraud are:

1. California
2. Kentucky
3. Texas
4. New York
5. Ohio

Whistleblowers and private citizens play an important role in exposing this fraud and getting billions of dollars back from criminals. Under the law, those who come forward with evidence of government fraud - whistleblowers - are entitled to a percentage of the money ultimately won in the case. Typically, whistleblowers receive between 15 - 30%, which can amount to millions of dollars.

Continue reading "Whistleblower Lawsuit Exposes Healthcare Startup " »

Caramel Apples Contaminated With Listeria Causing Death, Illness

December 31, 2014,

caramel-apples.jpgThe FDA recently issued a safety warning on a batch of caramel apples that are causing illness and death in at least 10 states. The commercially-produced, prepackaged caramel apples are sold by the Happy Apple Company and labeled as Karm'l Dapples. Wrongful death lawyers at Pintas & Mullins report on this outbreak and who is most vulnerable.

Posted on Christmas morning, the FDA's warning states that at least 29 people in 10 states have been infected with Listeria monocytogenes from the apples. All 29 victims were hospitalized, and five people have died. About nine of the reported illnesses were in pregnant women.

Pregnant women and are among those most at-risk of serious and fatal Listeria infections. Others in the high-risk group include the elderly, people with weakened immune systems, those with chronic medical conditions, and newborns. The FDA is working to identify exactly what products are contaminated with Listeria and how the contamination occurred.

The recalled Happy Apples have a "best use by date" between August 25th and November 23rd, 2014. They were sold in single, three, four, and eight packs, and the "best by" date is on the front of the label. The caramel apples were sold at popular grocery and discount club stores, generally in the produce section.

The caramel apples were distributed in the following states: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.

Consumers should not eat commercially-produced, prepackaged caramel apples, including those with nuts, sprinkles, chocolate or other toppings until more details are known. Any caramel apples that have already been purchased should be thrown away.

Signs and symptoms of Listeria infection include:

• Fever
• Muscle aches
• Diarrhea or other gastrointestinal symptoms
• Chills
• Stiff neck
• Confusion or changes in alertness
• Loss of balance
• Convulsions

For pregnant women and newborns a Listeria infection can be devastating. In newborns, the signs and symptoms of a Listeria infection may include:

• Irritability
• Little interest in feeding
• Vomiting
• Fever

Continue reading "Caramel Apples Contaminated With Listeria Causing Death, Illness " »

Holiday Decorations Sending Thousands to ERs

December 23, 2014,

a1774988_6ac40e9473_b.jpgPutting up holiday decorations is a ritual many families look forward to all year; although there is no national collection of data on the subject, it is estimated that about 15,000 Americans are taken to emergency rooms every year from decorating-related accidents. Injury attorneys at Pintas & Mullins explain how this estimation was calculated and how the worst accidents can be avoided.

The National Electronic Injury Surveillance System (NEISS) is a product database that tracks emergency room visits and which products cause them. NEISS data shows that about one-fifth of all injuries involve holiday lights, and half of injuries are from non-electronic decorations, like trees, ornaments, and wreaths.

Families typically begin decorating as soon as Thanksgiving is over, though hospital visits begin in early November. Emergency room visits are most prevalent between December 4th and the 7th, and there is another jump between January 1st and 5th, presumably when people are removing their decorations.

Many injuries involve falls from ladders or chairs, causing head injuries, broken bones, lacerations, and muscle strains. Another major cause of injury is children who accidentally swallow toxic products. According to the NEISS data, one-year-olds are most susceptible to accidental ingestion, however, even middle-aged adults have been sent to ERs for ingesting ornaments and other objects.

Burn Injuries, Drunken Driving, and DUI

Aside from the most obvious culprits, there are many other hazards Americans need to look out for over the holidays. Cooking is the leading cause of burn injuries during the holiday season, ranging from minor to fatal. Whether it's from unattended cooking, frying food, or loose clothing, the kitchen is far and away the most dangerous place during the holidays, particularly for children.

About one-third of home fires are caused by space heaters; the most important step families can take to prevent a space heater fire is to keep it clear of blankets, clothing, and furniture. Never fall asleep while a space heater is on, as it should always be monitored, kept away from children, and turned off when no one is in the room.

Christmas trees are involved in hundreds of fires every year. To avoid fire hazards, keep the tree well-watered and away from candles and fireplaces. Make sure to check the tree lights for frayed wires, broken bulbs or any other electrical defects.

Between mulled wine, spiced eggnog, and poinsettia martinis, there is no shortage of holiday-themed cocktails. Like any other holiday, Christmas and New Years have higher-than normal drunk driving accidents, which too often result in life-threatening injuries. Even the most cautious of drivers could be victim of a drunk driver, whether they are driving the wrong side of the road, swerving in and out of traffic, or not paying attention to ice and weather conditions.

There is another kind of DUI putting Americans at risk over the holidays - decorating under the influence. Trying to decorate anything besides a gingerbread house during or after drinking is a recipe for disaster. For more information on decorating safety, visit the Consumer Product Safety Commission's guide, located here.

The injury lawyers at Pintas & Mullins have been working on these types of cases for over 30 years. If you have any questions about a serious injury or death of a loved one, contact our firm today. Our legal consultations are always free and available to potential clients in all 50 states.

Continue reading "Holiday Decorations Sending Thousands to ERs" »

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.

Continue reading "Knee, Spine Device Makers Sued for Selling Defective Products" »

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" »