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hip-joint-aseptic-loosening-ar1938-1_lHip replacement parts made by Zimmer were recently recalled because of serious adverse effects in patients. The company’s femoral stems and necks were defectively made so that excess metals can infect patient’s blood, bone and nearby tissue after implantation. Hip implant lawyers at Pintas & Mullins report on this recall below.

The recalled products’ official name is the Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks. These parts are made from a specific metal alloy blend called Tivanium, which is titanium enriched with nitrogen. Tivanium is supposed to have minimal particulate release, making it safe even for patients who are extraordinarily metal-sensitive.

Many patients have true metal allergies, which can present serious problems when they require hip or knee implants. According to a paper by a Seattle joint surgeon, patients receiving Tivanium implants perform quite well and do not have issues with metal sensitivity.

In early May 2015, Zimmer found process monitoring failures in its Tivanium hip implant manufacturing. These failures caused high amounts of metal residue on the implants, which can leak out into patients, resulting in various side effects, such as:

  • Infection
  • Pain
  • Device failure and forced revision surgery
  • Allergic reactions, or metallosis
  • Death

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child on bikeAs spring moves into summer, children and teens head outside to bike, play sports and be active. By June each year, pediatric doctors typically treat double the patients as they do in the winter months. Accident and injury lawyers at Pintas & Mullins highlight the most dangerous activities and how to prevent brain injuries, broken bones, and other serious injuries.

Injuries start increasing in April, when winter begins to subside, with most injuries occurring in children aged eight to eleven. Pediatricians note that adolescents are more vulnerable to injuries during periods of rapid growth, because bones have special areas of cartilage (called growth plates) during this time to allow the bone to grow. Hormones produced during this time also render growth plates weaker than normal, making injuries even more likely.

Fortunately, children heal much faster than adults due to better circulation and constant bone production. Children who specialize in a specific sport often over-train certain muscle groups, increasing the risk of injury. In particular, much attention has been brought on mild and traumatic brain injuries in young athletes.

Forearms injuries are the most common injuries seen in ER and urgent care clinics, normally from playground and sports injuries, when kids stick out their arms to catch their fall. Scooter and bicycle injuries are also extremely common, along with trampoline injuries and foot injuries from wearing inadequate shoes.

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hospital bedA patient suffering severe vein damage by a surgical robot recently sued the robot’s manufacturer for marketing a defective device and improperly training physicians who use it. Surgical robot injury lawyers at Pintas & Mullins detail this case and others like it we are currently handling.

This case was filed by a woman who underwent a myomectomy, a minimally-invasive surgery to remove uterine fibroids. Her surgeon used the da Vinci Surgical System, which is a remotely-controlled robotic system made by Intuitive Surgical. The doctor performed the surgery under the guidance of an Intuitive Surgical representative, Jeanette Lee, who is also named in the suit.

During the procedure the surgeon was having trouble operating the system and asked Lee for permission to switch to a traditional open procedure. Lee instructed the doctor not to switch, which is why she is named in this lawsuit. The patient suffered extensive vein damage during the surgery causing her severe pain and forced additional surgeries.

The patient’s husband claims the defective robot deprived him of consortium of his wife, as she remains disabled and unable to work. The plaintiffs claim Intuitive promotes the da Vinci System to consumers and doctors but has failed to test its long-term impacts. They also claim Intuitive improperly trains doctors on how to use the system, resulting in complications ranging from burns and tears to sepsis, organ damage and even death.

Hundreds of thousands of surgeries are performed using robots every year, with Intuitive enjoying billions in revenue. The company aggressively markets the system, pitting hospitals against each other in a race to score the next ‘it’ innovation. As the da Vinci’s popularity grows, however, so do reports of patients injuries and questions over the system’s actual safety.

Intuitive faces mounting litigation for injuries caused by the da Vinci robots; even the company’s investors have filed suit over a defect in the surgical equipment. Investors claimed the company made false financial reports in failing to warn investors about the defect. The defect caused patients to be electrocuted during surgery.

Intuitive was unaware of the defects until doctors and hospitals started filing reports of patient injuries. The company then issued secret recalls to correct the problems, resulting in an FDA safety probe in January 2013.

Myomectomy Risks

A different federal agency, the FBI, is investigating another medical device manufacturer – Johnson & Johnson – for a different device commonly used in myomectomies. We have written extensively on power morcellators and their ability to spread uterine cancer and we are currently accepting cases of uterine cancer from myomectomies and hysterectomies.

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woman-in-hospital-1051476-m.jpgThousands of women who underwent fibroid removal surgery or hysterectomies are suffering from late-stage cancer from a device used in their surgeries. Now, device manufacturers are facing liability as these women and their families file suit. Our team of uterine and ovarian cancer lawyers is constantly updating our clients as soon as new information becomes available.

The device at issue is called a power morcellator, which many top American hospitals and health insurance companies have now banned. These bans were based largely on FDA warnings on the use of power morcellators in gynecological procedures, confirming that they may spread undiagnosed uterine tumors and should not be used on most women.

HCA Holdings, Aetna, and several other insurers and hospitals have dropped use of the device. Aetna is the country’s third-largest insurer, with about 23 million health members. Power morcellation will no longer be covered under most circumstances; doctors will have to get prior approval for any procedure using the device. Exceptions include women who could suffer severe, life-threatening complications from alternative methods.

Power morcellators work to remove fibroids or the uterus by cutting them into tiny pieces to be removed through minimally-invasive incisions. However, uterine fibroids can contain cancerous cells and tumors that cannot be detected prior to surgery. If a power morcellator breaks up a fibroid that contains cancer cells, the cancer is then spread throughout the uterus, abdomen and pelvis.

Cancer spread significantly lowers the chance of survival, rendering an otherwise benign cancer contained within the uterus into a ravenous late-stage illness affecting multiple organs. The FDA estimates that about one in every 350 women undergoing fibroid surgery has cancer cells hidden in fibroids.

Olympus Sued for Morcellator Cancer Spread

After this came to light in 2014 Johnson & Johnson pulled its power morcellators from global markets. Although J&J was the largest morcellator manufacturer, other companies have kept their devices on market. One of these companies, Olympus America, was recently hit with lawsuits by women who developed cancer from morcellation surgery.

The women claim Olympus should have been aware of the cancer risks of its device, the PKS PlasmaSORD Bipolar Morcellator. They argue there was medical evidence available to Olympus, yet the company failed to respond to published studies and reports describing the risk of spreading and worsening cancer with morcellator use.

Plaintiffs point to articles published in medical journals in the 1990s that illuminate the potential for morcellators to spread cancer tissue. They argue that Olympus made it difficult for patients to know about these risks, misrepresenting the device as totally safe. Misrepresenting the device this way prevented doctors from screening for and diagnosing cancer, further worsening patient survival rates.

Still, some doctors continue to encourage the continued use of morcellators. Many doctors believe that the decision to use a morcellator should lie with the patient and her doctor and that banning them completely would be a disservice to certain patients.

This, on paper, seems a fair and reasonable argument. In reality, however, patients are not always fully informed on the true risks of their options and doctors do not always have time to make sure women completely understand the procedure, its alternatives, and their unique risks versus benefits.
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surgeon-274997-m.jpgThe TigerPaw System has been recalled after reports of heart tissue tears and severe bleeding. More than 4,000 devices, commonly used during open heart surgery, were recalled after dozens of injuries and one death. Medical device lawyers at Pintas & Mullins detail this recall below.

The device is manufactured by Maquet Medical Systems and is most commonly used to obstruct the left atrial appendage during surgery. Recently, Maquet has received reports that the device has been tearing the appendage, causing serious bleeding. This recall is considered a Class I, the most serious of its kind.

The FDA has documented many violations at Maquet in the past few years, resulting in five Class I recalls and 40 other recalls between 2009 and 2014. These violations also led to a $6 million settlement in February 2015, which stemmed from a federal lawsuit accusing Maquet of maintaining poor quality standards.

At least one of Maquet’s products involved with that settlement was associated with a suspicious patient death. The FDA requested the company stop production on several devices after its inspections, including hernia meshes and vascular grafts and patches.

Lawsuits from Defective Medical Devices

The medical device industry reaps sales of more than $85 billion per year, and companies have the legal and ethical responsibility to ensure their devices are safe and effective. When the device is designed or manufactured improperly, or if the approval process was flawed, patients can be subject to serious injury or even death from complications.

If an injured patient decides to sue the medical device manufacturer for negligence, it is considered a product liability lawsuit. Any and all companies that manufacture products are responsible for making a safe product; therefore, the company could be liable for any injuries caused by defects or a dangerous design.

Companies are also required to warn the public about the risks associated with their products. Unfortunately, device manufacturers try to get new innovations onto market as soon as possible, often failing to adequately test for long-term complications and other serious side effects. Product liability lawsuits fall under three general categories:

1. Manufacturing defects – this applies if the design and promotions of the device were proper, but there were flaws in the manufacturing process causing the product to be defective.

2. Design defects – if the original design of the product can cause serious injury or death.

3. Marketing defects – if the company improperly markets the products, either failing to warn the public about the risks or by giving inadequate instructions to physicians.

A great example of the third type of claim is the recent deadly outbreak from a particular kind of medical device called a duodenoscope. Hundreds of patients have been infected by this medical scope and dozens have died. The duodenoscopes can infect patients with a “super bug”, or drug-resistant bacteria that can be fatal in vulnerable patients.

The devices were contaminated with this super bug because they were not properly cleaned by hospital staff. Duodenoscopes are supposed to be cleaned and disinfected with a special machine, though the instructions provided by the device manufacturer are inadequate. This makes it difficult to fully disinfect the device, causing dangerous bacteria to be transferred between patients.
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forklift-1-1125238-m.jpgIllinois ranks seventh in the nation for workers’ compensation system costs. Newly-elected Governor Bruce Rauner recently announced sweeping changes to the state workers’ compensation laws, as part of his pro-business agenda. Our team of workers’ compensation lawyers explains the serious consequences of these proposals.

Major business groups have a strident ally in Bruce Rauner, who has spent his career in private equity, buying companies and squeezing them of their assets. This is no secret, and many Illinoisans voted for Rauner based on his perceived business savvy, in hopes he could help lead us out of our financial crisis.

Instead, he has made sweeping proposals aimed against labor unions, trial lawyers, Medicare and Medcaid, and injured workers. One of his most recent proposals is to reform our state’s workers’ compensation system.

Among the changes, Rauner hopes to:

• Make it harder for employees to claim they were injured traveling to or from work
• Limit damage awards in civil suits

• Reducing the power of labor unions

• Withdraw wage laws for taxpayer-funded construction workers
• Toughen the standards workers must meet to prove their injury occurred on-the-job
• Dramatically reduce reimbursement rates for healthcare centers that treat workers
Opponents of these proposals – most vehemently employee unions – believe this is part of Rauner’s goal to take rights and benefits away from workers in favor of corporations. Opponents also point to the broad changes lawmakers made to the workers’ compensation insurance system in 2011. In total, these changes saved Illinois businesses $315 million in the first few years.

Democratic House Speaker Michael Madigan recently held a rare committee relaying the entire meeting with Rauner, so all 118 Illinois General Assembly members can hear testimony on his proposals.

How Workers’ Comp Laws Work Now

Currently, employees must prove their injury occurred during the course of their employment. Businesses often complain that this can make the responsible for covering injuries that are only semi-job-related, such as pre-existing injuries that have been aggravated.

Rauner is proposing to tighten standards so employees must prove that their job was a “major contributing cause” of their injury. Similar efforts to tighten this standard were proposed in 2011, but were blocked by labor unions.

When an employee is injured, their case goes before a board of arbitrators who decide how much and what type of benefits they will receive. Arbiters are licensed attorneys who undergo routine training on ethics, fraud, and best medical practices. At present, these arbitrators use five different factors to determine the award, including medical records, physician notes, and American Medical Association (AMA) Guidelines.

Rauner is hoping to give arbitrators the ability to use AMA guidelines as the ONLY factor in determining how much injured workers are paid. Obviously, this would make workers extremely vulnerable, as their benefits would not be determined by the unique circumstances of their case, but by blanket, standardized guidelines.

House Speaker Madigan explained this perfectly by saying “numbers on paper alone can’t tell the full story of men and women who are hurt at work through no fault of their own … these workers and their families … deserve to have their voices heard.” Injured workers face massive medical bills, lost wages, and potentially losing their life’s savings. Most Illinoisans do not have the resources to see the best doctors, physical therapists or home health aides, or furnish their homes with medical tools.

Rauner is also proposing to cut doctor and hospital reimbursements by another 30% – in addition to the 2011 cuts, which slashed reimbursements by 30%. The Illinois Hospital Association warns that this would impact the quality of care injured workers receive. Less medical care means more people put in nursing homes at the cost of taxpayers – the effects of this are not hard to predict. It would merely shift the responsibility of caring for injured workers onto taxpayers instead of the company that caused the injury.
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cyclist-1059798-m.jpgA recent study by University of California at Berkeley found that hit-and-run fatalities are more likely to occur in the West and Midwest. As warm weather approaches, our team of bicycle accident attorneys examines why hit-and-runs are on the rise and what can be done to stop it.

The reason hit-and-runs are more common in Western and Midwestern states is multi-faceted; cities in these states are far less dense, making the possibility of no witnesses more likely. These states also have much more expansive infrastructure, with long stretches of high-speed-limit roads without lights and signs to dictate behavior.

Unfortunately, cyclists have the odds stacked against them on the road. Riders need to know the laws and abide by them, as do drivers and pedestrians, to keep the roads safe. The truth is, a motorist driving recklessly will do far more harm than a cyclist behaving recklessly; when a crash occurs, cyclists bear the brunt of the impact regardless of who was at fault.

In places like Colorado and California, the rise in cyclist hit-and-runs is particularly troubling, as these states have some of the highest rates of cyclists in the country. Between 2002 and 2012, the number of hit-and-run crashes involving cyclists rose 42%. According to data compiled by the LA Times, the majority of these crashes occurred in five neighborhoods: North Hollywood, Long Beach, Van Nuys, downtown Los Angeles, and Santa Monica.

In nearly all parts of the U.S. bicycles are considered “vehicles” under the law, and must abide by all rules of the road. In the worst scenarios – such as the fatal accident between a biker and pedestrian in San Francisco in 2012 – cyclists may be charged with felony vehicular manslaughter.

In 2012, the National Highway Traffic Safety Administration (NHTSA) reported 49,000 cycling-related injuries (and many, many more unreported) and more than 725 deaths. Most fatal crashes occur at intersections, and at night.

Studies and general experience show that the greater number of cyclists on the road, the safer streets become. It makes riders more visible to motorists, as drivers become more used to negotiating space with cyclists. One university study showed that accidents involving cyclists and motorists were less likely to occur when more than 200 riders traveled through it each day.

Another university study found that drivers involved in hit-and-runs are most likely to be male, young and have prior convictions. Alcohol also plays a major factor in deciding to flee the scene of an accident. Unfortunately, types of hit-and-runs are among the most difficult cases for law enforcement to solve.

Below are some tips for cyclists involved in car collisions

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• Record the license plate number, or as much of it as possible on paper, or take a picture of it.

• Get off the road and call 911. Describe the car as accurately as possible. If the driver fled the scene, tell the dispatcher which direction the car was going and any physical attributes of the driver.

• Stay calm, some drivers may be intimidated by an angry victim and decide to flee.
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b19industry042.jpgGovernment agencies recently acknowledged a pattern among oil worker fatalities, which were previously ruled natural deaths by heart failure. The stunning similarities among these deaths are forcing industry insiders to consider the role of hydrocarbon chemicals in these fatalities.

At least ten oil-field workers have suddenly died on top of or near storage tanks in the past few years, with six fatalities in 2014 alone. There were no witnesses to these men’s deaths, all of which were initially attributed to natural causes. All ten workers died while taking oil samples or tank gauging, a task that involves opening a hatch and climbing on top of a catwalk between rows of storage tanks to measure the levels of oil and byproducts after fracking is completed.

Tank gauging is typically done every few hours alone in remote areas. When the worker opens the hatch, hydro chemicals that have vaporized and built up in the tanks burst through the hatch in an invisible but dense plume. When inhaled in large quantities, hydrocarbon chemicals can cause immediate asphyxiation and heart failure.

All ten workers were found dead on the catwalks near storage tanks they were testing – all were relatively young, not in the age range of high heart failure risk. Yet all deaths were attributed to natural heart failure, though a few have retroactively attributed the cause of death to hydrocarbons.

What Is Being Done?

Acknowledging the pattern between these deaths, federal agencies and industry groups plan to send a joint alert to the oil industry, warning of the risk of inhaling hydrocarbon chemicals. New recommendations for how to work with storage tanks are also expected – insiders state the industry has been ignoring warning the risks for years.

The CDC first recognized the pattern in May 2014. In one small sample, federal investigators found some of the chemicals vaporizing in the tanks exceeded levels that could cause death or permanent health effects. Evidence like this proves that both government and industry insiders knew the tank emissions could be dangerous, yet companies failed to require workers to monitor chemical levels.

A former industrial hygienist told the Wall Street Journal that he tried to get workers into safety respirators as early as 2009, but industry executives refused his requests, telling him this was how everyone else did it.

A safety consultant for North Dakota oil companies said that, from his perspective, there is “no question,” that the risk of dangerously toxic fumes “was absolutely known” by the companies.

There are several ways employers can control exposure, including providing protective equipment, applying administrative or engineering controls, or substituting a less hazardous chemical. Safety fixes to reduce chemical hazards are commonplace in other countries, such as Canada, with large oil producing industries.

One method that is used regularly in other countries is using automated or remote methods to read tank levels, instead of having live workers check the gauges. Of course, this adds cost to the process. In investigation related to a worker death, Marathon Oil was found to be using pipes that were too narrow to properly measure the pressure of gas coming through them. This created an excess of gas buildup in the tanks.

In a lawsuit regarding his death, an environmental engineer for the company said he asked Marathon to redesign some of its piping systems so there would be a more steady flow, but was ignored. Marathon Oil took no responsibility for the death of 21-year-old Dustin Bergsing and did not admit liability, ultimately settling with Bergsing’s family out of court. More on Bergsing’s death and his family’s lawsuit can be found here.
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usg-1-262481-m.jpgIn Governor Rauner’s State of the State Address in February 2015, he made direct remarks about his plans to reform the personal injury legal system in Illinois. Among his remarks, he proposed prohibiting trial lawyers from contributing to judge’s campaigns. Injury attorneys at Pintas & Mullins explain how this proposal would critically jeopardize the rights of injured citizens.

Not once in his campaign for governor did Rauner mention his intention for radical change in the legal system. He is now proposing to prevent trial lawyers – those advocating for injured plaintiffs against corporate wrongdoers – from contributing donations to judge’s campaigns. His proposal targets trial lawyers exclusively, not defense lawyers, or counsel working on behalf of Big Business or its allies.

In Illinois, judges are chosen by popular vote, making campaigns as important as those for other public office. In recent years, these judicial elections have become as expensive as any other campaigns, forcing candidates to rely on outside supporters. Judicial elections are also dominated by Big Business including insurance companies and others who make no secret of electing judges who will decide in favor of corporations at the expense of everyday citizens.

Affecting Real People

To put this in realistic terms, let’s say someone catastrophically injured by a pharmaceutical drug chose to sue Pfizer. This patient now suffers a severe disabiliy and is largely unable to work because of it. Because of a defective drug, they require a lifetime of medical care, with little to no money to pay for it. This is already a David-and-Goliath scenario.

Rauner is now proposing to prevent the lawyers representing this injured plaintiff from making campaign contributions to judges. His proposal would not, however, prevent the lawyer defending Pfizer from making contributions. This is not only corrupt and immoral, but it is plainly unconstitutional. It is preventing a member of society from participating in democracy based on their profession.

In other parts of his speech, Rauner stated that workers’ compensation and liability costs needed to be reformed. Illinois has one of the most worker-friendly compensation systems in the country, which Big Business views as an immense threat to wealth. Millionaires and billionaires like Rauner disapprove of the plaintiff-friendly nature of our courts because it properly compensates injured workers, instead of keep the lower and middle classes in their place.

Insurance companies, Big Pharma, and nursing home corporate owners are all allies of Rauner. In fact, Rauner was recently involved in a scandal for his work with a decrepit nursing home chain in Florida. The nursing homes were responsible for numerous deaths and atrocious injuries and named Rauner’s firm, GTCR, as helping mastermind the nursing home’s operations.

The nursing home chain, Trans Healthcare, was hit with $1 billion in liability after several deaths and rampant resident abuse claims. GTCR, Rauner’s firm, co-founded Trans Healthcare in 1998. Rauner sat on the nursing home chain’s board for four years, during the time Trans was actively and knowingly understaffing its facilities to boost profits. More on this scandal can be found here.

Rauner and his firm depended entirely on defense attorneys to get them out of this $1 billion liability. Is it any surprise that now, with his new election to governor, he is supporting those lawyers, judges and special interest groups that stood beside him? In doing so, he is muting the voices of those who need their rights protected the most: the elderly, sick, injured, and poor.
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cruise-ship-1193456-m.jpgMore than 200 passengers aboard two Royal Caribbean cruise ships have been infected with norovirus, causing the ships to dock for medical care. Cruise ship injury lawyers at Pintas & Mullins explain how personal injury cases are argued against cruise lines.

Both ships have docked in the U.S., one in San Diego and the other in Fort Lauderdale, Florida, after massive outbreaks of norovirus. Norovirus infection is highly contagious and is most often spread through contaminated food and water, or through close contact with an infected person. Symptoms include severe vomiting and diarrhea, and can last one to three days.

Cruise ships are common places of norovirus infection, as it most frequently occurs in closed and contained environments. The CDC requires cruise ships to report the total number of illnesses onboard before ships may arrive at a U.S. port. Outbreaks are posted on the CDC’s website, here, when they meet certain criteria. So far in 2015 there have been five outbreaks in ships arriving in the U.S.

Some passengers on the Celebrity Infinity line told reporters they believed the virus came from a port in Guatemala. The CDC sent crews aboard both ships to determine the cause of the outbreak.

In some people, particularly the elderly and those with compromised immune systems, norovirus can cause malnutrition, dehydration, and even death. Recovery depends on the strength of the individual’s immune system, as there is no specific treatment for norovirus infection.

Cruise Ship Injury Claims

Cruise ship litigation is much more complex than regular personal injury claims, as they fall under maritime law. Common injuries on ships include falls, sexual assaults, battery, medical negligence, and injuries during shore excursions. Maritime law requires that cruise lines exercise reasonable care for passenger safety.

Most cruise passenger tickets have a one-year statute of limitations for filing an injury claim, meaning the claim must be officially filed within one year from when the injury occurred. Each cruise line is different, but most tickets – which serve as passenger contracts with the line – require that lawsuit notices must be made within six months of the incident.

These are two small but very important details. Many if not most passengers do not read the detailed contracts on the back of the tickets and wait too long to notify the cruise line or hire an injury attorney, preventing them from collecting any damages whatsoever.

In many ways, however, injury claims against cruise ships are similar to other injury cases. Plaintiffs must prove that the injury they suffered was legitimate and occurred as a result of the cruise line’s negligence. To prove this there must be detailed factual records, such as accident reports, eyewitness statements, photographs, and medical records.

Cruise tickets also may reference a treaty called the Athens Convention. This only applies to ships that do not ever dock in a U.S. port. The U.S. has not ratified the Athens Conventions, so it does not apply if the cruise itinerary ever included a U.S. port.

If the cruise was entirely foreign, the Athens Convention limits damages plaintiffs can receive to about $70,000 per person. This applies to damages suffered due to the cruise ship’s neglect or fault – any behavior that was intentional or reckless would not be subject to this limit.
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