Study Confirms Breast Implants Increase Rare Cancer Risk

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The largest study of the link between breast implants and lymphoma to date found that there is a greatly increased risk of a rare cancer, according to the report published this month in JAMA Oncology. The study found breast implants are associated with a 421 times greater risk of anaplastic large cell lymphoma.

This scientific evidence linking breast implants to ALCL could spark another wave of class action lawsuits by women seeking compensation for their injuries. In the 1990s, women claiming injuries from silicone breast implants agreed to a $3.7 billion settlement with several companies.

BIA-ALCL, the acronym for it, is a cancer of the immune system rather than a form of breast cancer. The absolute risk of this type of non-Hodgkin lymphoma in a woman with breast implants is estimated to be 1 in 7,000. For every 7,000 women with breast implants, one will get BIA-ALCL. An article in JAMA Surgery last fall previously put the affected range from 1 in 4,000 women to 1 in 30,000 women with breast implants.

According to an FDA announcement last year, the agency received more than 350 reports of the cancer linked to breast implants between June 2010 to February 2017. The precise cause of the increased risk is not yet known. However, the study found the majority of the cases of BIA-ALCL had textured implants rather than smooth surface ones. A review of 115 scientific articles last year focusing on BIA-ALCL found 93 cases of the cancer in the medical literature.

Textured implants gained in popularity in the 1990s. The average time to diagnosis of BIA-ALCL is about 10 years after getting the breast implants. Researchers expect that the number of BIA-ALCL cases diagnosed will increase because the rates of women getting breast implants are increasing every year.

If you or a loved one have had a diagnosis of ALCL following breast implants (whether textured or smooth surface), call McEldrew Young’s attorneys at 1-800-590-4116 to speak to a personal injury attorney in a free consultation.

Ikea Relaunches Dresser Recall After Another Child Dies

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Ikea relaunched the recall of 29 million dressers and chests last week after a California toddler was found trapped underneath an Ikea Malm dresser and died in May. The recall was first announced in June 2016 and Ikea has reportedly already processed more than 1 million recalls.

The recall includes children’s chests and drawers taller than 23.5 inches and adult chests and dressers taller than 29.5 inches. This includes 8 million Malm chests and dressers sold between 2002 and 2016. The recall only applies to customers in the United States and Canada.

Customers contacting Ikea will have several options. They are offering a full refund to anyone who no longer wants their Ikea dresser. Ikea will pick them up or they can be brought into a store. For consumers who want to keep their dresser, Ikea will provide a free wall-mounting kit or send a crew to the customer home to attach the dresser to the wall.

The Consumer Product Safety Commission said in December 2016 that there had been 186 reports of incidents with Malm dressers and chests. More than 90 children had been injured before that date.

Last December, Ikea agreed to pay a $50 million settlement to the families of three toddlers who died after dressers tipped over. A Philadelphia court in April approved a settlement of over $16.6 million for one family.

Photo Credit.

Attorneys for St. Francis Center Nursing Home Abuse Victims in Darby

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Our attorneys are now investigating nursing home abuse at the St. Francis Center for Rehabilitation and Healthcare after the Pennsylvania Attorney General’s Office raided the facility on Wednesday.

If you are a resident or family member of a resident at this facility who has been injured from the care provided at St. Francis nursing home in Darby, please call 1-800-590-4116 to speak to Attorney Dan Purtell in a confidential, free consultation.

PA inspected the facility in August after receiving five complaints. The inspection found severely deficient wound care, inadequate responses to changes in medical conditions, significant weight loss from residents not eating, and other problems.

The nursing home is operated by Center Management Group, a New York company that bought the 273 bed facility and six other senior-care locations from the Archdiocese of Philadelphia.

The facility’s license was revoked by the state of Pennsylvania after an August inspection found problems. The facility was operating during the appeal process. The PA Attorney General’s Office would neither confirm nor deny the existence of an investigation.

If you are a resident or family member of a resident at this facility who has been injured from the care provided at St. Francis nursing home, please call 1-800-590-4116 to speak to Attorney Dan Purtell in a confidential, free consultation.

Simultaneous Surgeries Create Potential Liability for Medical Malpractice, Fraud

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The practice of concurrent and overlapping procedures by medical surgeons has come into the spotlight over the past two years due to injuries resulting from the practice. Since this practice can sometimes involve fraud or medical malpractice, we thought we would take a look at it here and speak about how it interacts with our law practice.

These practices are still relatively obscure outside of the medical community. A March 2017 report by Fox News found that only 4% of 1,454 people surveyed were aware of what the terms meant.

So what are these surgical practices?

In short, the practices involve a surgeon scheduling and conducting operations on two different patients during the same period of time.

An overlapping surgery involves an operation performed by the same primary surgeon that is performing an operation on another patient and the surgeries overlap with each other at some point in time. The practice of overlapping surgery will often mean that preparation of one patient for surgery is beginning while a surgeon or surgical team is finishing care of another patient.

Concurrent surgery involves a surgery where the primary surgeon is responsible for two surgeries and some or all of the “critical parts” of the operations overlap.

Controversy over the practice of simultaneous surgeries came to light around the beginning of last year when a Massachusetts General patient brought a medical malpractice lawsuit alleging that he suffered an injury in a simultaneous surgery. More recently, federal prosecutors are reportedly investigating a top billing surgeon in New York for running concurrent prostate surgeries, according to the Boston Globe.

Where is double-booking done?

A Washington Post article published in July 2017 titled, “Is your surgeon double-booked?” identified the types of practices where running two rooms was more common. One area where it is seen is in teaching hospitals, where senior attending surgeons delegate parts of the surgery to residents or fellows. The practice is more common in certain specialties, such as neurosurgery, cardio surgery and orthopedics.

How could double-booking be medical malpractice?

One way that the practice could be malpractice is if the doctor does not obtain informed consent. In April 2016, the American College of Surgeons updated its Statements on Principles to require the patient to be informed beforehand when there will be overlapping operations as part of obtaining patient consent.

In circumstances where a patient is not advised of the key risks of a procedure and they end up suffering harm as a result of the procedure, they may have a viable medical malpractice lawsuit.

If a patient is injured because trainees are alone for critical portions of the surgery or the primary surgeon was not truly available, that could also form the basis of a medical malpractice claim.

Additionally, the performance of overlapping or concurrent surgeries can lead to issues as a result of unplanned circumstances that can develop during a surgery. For example, if a patient is under anesthesia longer longer than anticipated because the surgeon is performing surgery on another patient, any injuries as a result of the unnecessary anesthesia could be the basis for a medical malpractice lawsuit.

When is concurrent surgery fraud?

Medicare allows a teaching physician to bill Medicare for two overlapping surgeries if the physician is physically present during all critical portions of the procedure and immediately available during the entire procedure. CMS’s Medicare Claims Processing Manual defines the critical portion to state that it does not generally include the opening or closing and it concerns the parts which the surgeon determines to be critical.

According to footnote 13 of the Senate Finance Committee Staff report, a surgeon is not immediately available if they are performing another procedure. If circumstances prevent immediate availability, the doctor must arrange for another qualified surgeon to be immediately available to assist during the non-critical or non-key portions. ACS guidance defines “immediate availability” as reachable through a paging system or other electronic means.

If a surgeon at a teaching hospital bills Medicare for a procedure where he or she is not present for the critical parts or not immediately available (without assigning another surgeon to be immediately available), then billing for the procedure could bring liability under the False Claims Act.  The FCA is the nation’s leading law in the fight against health care fraud and provides rewards for whistleblowers to bring such evidence to the attention of the Department of Justice.

What Happens if a Surgeon is Performing Overlapping or Concurrent Surgery?

If you discover that your surgeon performed a concurrent surgery without consent or failed to be present for critical aspects of the surgery, call McEldrew Young at 1-800-590-4116 for a free, initial consultation.

NTSB Details Tesla’s Role in First Self-Driving Car Fatality

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The National Transportation Safety Board held a hearing today concerning the Florida self-driving car accident in May 2016 that resulted in the nation’s first fatality involving an auto-driving system. According to media reports, the semi-autonomous driving system had a “major role” in the crash because of “operational limitations”.

The NTSB said that the autopilot system did not do enough to require the driver to pay attention to the road. It also found that the monitoring of driver attention was inadequate because touching the steering wheel was a “poor surrogate” for being ready to take over driving. According to the NTSB, the Tesla driver had at least 10 seconds to observe and respond to the truck it hit.

Tesla also did not place appropriate limits on the operation of the system. Drivers could use the self-driving features at up to 90 miles per hour and the system did not limit operation to certain roadways despite its inability to reliably detect cross traffic. In the accident, the semi made a left hand turn across a divided highway and the autopilot system failed to recognize and avoid the truck.

A certain amount of blame will no doubt be placed on the driver. According to the data, the driver had the system engaged for 37 of the 41 minutes of the trip and only had his hands on the wheel while Autopilot 7 times for a total of 25 seconds. The federal panel said that the driver placed too much reliance on the car’s technology.

The NTSB issued a preliminary report in July 2016 with the details of the accident, including photos of the minor collision traffic to the semitrailer and a photo of the passenger car. The car struck the truck, which was making a left hand turn, at a 90 degree angle. The driver was using the Tesla Model S advanced driver assistance features and was traveling at 74 mph (in a 65 mph zone) just prior to the accident.

The National Highway Traffic Safety Administration conducted a separate investigation and concluded that no recall was warranted. Tesla has reportedly made changes to its system as a result of the crash.

This case is being closely watched by the car industry, automotive enthusiasts and personal injury lawyers. Self-driving cars are expected to become increasingly commonplace on the roads over the next decade or two as automobile manufacturers release cars for sale and regulators approve them for operation on the role.  The implications on a personal injury lawyer’s practice are obvious.

The second reason we are watching this case is because of our practice representing employees reporting delayed recalls or other safety issues pursuant to the Motor Vehicle Safety Whistleblower Act.  Businesses in rapidly shifting industries have been known to challenge or break the law, so we expect there will be quite a few auto whistleblowers reporting defects in self-driving cars as they are released on to the road.

Earlier this month, the U.S. House of Representatives passed the Safely Ensuring Lives Future Deployment and Research In Vehicle Evolution Act (SELF DRIVE Act) to provide authority to the NHTSA to regulate the technology and start the process of developing regulations for the use of self-driving technology on the road.  The bill will need to pass the Senate before it can be sent to President Trump for signature.

OIG Alert Details Elder Abuse at Skilled Nursing Facilities

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The Office of the Inspector General (OIG) issued an Early Alert in late August following disturbing reports of abuse against Medicare Beneficiaries during stays in Skilled Nursing Facilities (SNFs). The Alert explained that an estimated 22 percent of Medicare beneficiaries experienced adverse events while at an SNF and 69 percent of these incidents could have been prevented with better care.

Elder abuse can take many forms, including sexual assault, pressure ulcers, medication-induced bleeding and infections. According to OIG, more than half of the Medicare beneficiaries experiencing an adverse event required hospital care for treatment.

OIG also found that a significant number of instances involving abuse or neglect may not have been reported to law enforcement. SNFs are required to ensure that the administrator of the facility receives reports of abuse, investigate the allegations, and report the results to the administrator within 5 days. Local hospitals are also required to report potential incidents of abuse or neglect. Notwithstanding these requirements, OIG found 38 out of 134 incidents (28 percent) where there were no evidence in hospital records that the incident was reported to local law enforcement.

OIG also declared CMS procedures inadequate to ensure incidents are reported. Section 1150B of the Social Security Act provides that certain individuals in federally funded long-term care facilities must report immediately any reasonable suspicion of a crime against a resident of the facility. The failure to report an incident can bring civil monetary penalties of up to $300,000 and possible exclusion from Federal health care programs. But Centers for Medicare and Medicaid Services (CMS) has not been enforcing this law, which became effective on March 23, 2011.

There are a few potential legal remedies for victims. For those who are seriously injured, a personal injury lawsuit to seek compensation is a possibility. This is an option where there is negligence or a deviation from the standard of care on the part of the medical professionals.

For employees or residents of facilities consistently providing inadequate care to Medicare and Medicaid patients, reporting through the False Claims Act is also an option. The False Claims Act allows for an individual to bring a lawsuit on behalf of the United States seeking return of money spent by the Government due to fraud. The government is paying a fee for the care of these individuals and when that care falls below the government’s expectation of care, it can be a violation of the law.

If you are aware of an skilled nursing facility providing inadequate care or a family member has been a victim of elder abuse, please call the attorneys of McEldrew Young at 1-800-590-4116 for a confidential consultation.

SEPTA NHSL Crash at 69th Street: Dozens Injured

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Dozens of SEPTA passengers and the conductor were injured last night when a Norristown High Speed Line train crashed into a parked train car at 69th Street Station in Upper Darby after midnight. Four were reportedly critically injured but SEPTA said none of the injuries appeared life threatening. The injured were taken to eight area hospitals following mobilization for a mass casualty incident.

SEPTA is investigating the cause of the accident. According to one report published by CBS Philly, the train conductor overshot the train platform at both Gulph Mills and Bryn Mawr prior to hitting the train at 69th Street as passengers were preparing to depart. The conductor was among the injured and was taken to the hospital, according to Upper Darby Mayor Thomas Micozzie. Philadelphia Inquirer reported this morning that the conductor was released from the hospital.

A SEPTA spokeswoman told NBC 10 that the Norristown High Speed Line is equipped with Automatic Train Control. ATC provides a train operator with an in-cab warning if they violate the speed limit and takes over within a few seconds if they fail to slow the train.  Positive Train Control, a more advanced version of the technology that was installed on Amtrak lines following the 2015 Philadelphia derailment, was not in use.

69th Street Terminal hasn’t had a great safety record this year. This train station was also the location of a crash in the rail yard in February where two out-of-service Market-Frankford line train collided after dropping off passengers at the station. One of the trains derailed in that accident and four were injured.

If you or a family member were injured on the train, please call 1-800-590-4116 for a free consultation with Jim McEldrew or another McEldrew Young railroad attorney.

Carbon Monoxide Poisoning of Philadelphia Firefighters Reminds of Dangers

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Five Philadelphia firefighters were rushed to the hospital after suffering carbon monoxide poisoning while fighting an underground electrical fire in West Chester yesterday. Six other firefighters were evaluated and monitored on the scene after high levels of carbon monoxide were released by an underground transformer. One firefighter was kept overnight in the hospital for monitoring. All are expected to recover.

CO poisoning is normally a winter event caused by household appliances that burn gas, oil, coal and wood. It can also happen by running a car engine in an enclosed space such as a garage. CDC statistics released in 2014 indicate there are approximately 500 deaths from unintentional, non-fire-related carbon monoxide poisoning a year.

The firefighters were in a basement of a nearby home. The fire had spread from the underground transformer via the cable to an electrical box in the home. Local residents and businesses in the vicinity were evacuated for a few hours and the fire department said it would go door-to-door to check carbon monoxide levels of the homes and businesses in the area.

The symptoms of carbon monoxide poisoning are headaches, dizziness, upset stomach, confusion, weakness, vomiting, and chest pain. Prolonged exposure to the colorless, odorless gas can be fatal.

In 2013, a jury verdict against an apartment company in Wyoming awarded $28.2 million to a woman poisoned by carbon monoxide that suffered permanent brain injury.

There are many potential sources of liability in the event of carbon monoxide poisoning. If you are a tenant in a building, your landlord may have a duty to install and maintain a working carbon monoxide detector. If carbon monoxide is leaking because of a malfunctioning appliance, the manufacturer, home builder or installation team may be liable.

If you or a family member are seriously injured by carbon monoxide, please call our office at 800-590-4116 to discuss whether a lawsuit against the owner or manufacturer of the source of the carbon monoxide is appropriate.

Duodenoscope News: Olympus Pays $6.6 Million; Fujifilm Recalls ED-530XT

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There have been two recent developments regarding the spread of CRE Superbugs via duodenoscopes used in ERCP procedures that the FDA warned about in February 2016.

In the first trial related to allegations of a contaminated duodenoscope, a Washington State jury found Olympus responsible for $6.6 million in damages and the hospital (Virginia Mason Medical Center) responsible for $1.1 million to the family of a patient that died in a deadly superbug outbreak. The jury concluded that the company failed to provide adequate warnings about the scope or instructions for its use after it was manufactured.

Fujifilm issued a voluntary recall of all of its ED-530XT duodenoscopes. The FDA has cleared an updated design and labeling for the Fujifilm duodenoscopes, and it is now replacing the forceps elevator mechanism including the O-ring seal, the distal end cap and providing new Operation Manuals. The new manual will instruct users of the ED-530XT duodenoscope to send the device away for annual inspection of the forceps elevator mechanism.

In January, Pentax warned customers that its ED-3490K video duodenoscope can develop cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip, making it difficult to clean/disinfect. If customers do not remove duodenoscopes showing signs of physical damage, then it may increase the risk of infection transmission between patients.

The FDA has expressed concerns that Carbapenam-resistant Enterobacteriaceae (CRE) superbugs can spread between patients through the use of an infected duodenoscope. If you or a family member experiences a superbug infection following an ERCP (Endoscopic Retrograde Cholangio-Pancreatography) procedure, please call our office at 1-800-590-4116 to speak to an attorney about pursuing compensation for your injuries during a free initial consultation.

Remove Medical Malpractice Reform from Trump Budget

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The Trump Administration’s budget proposal for 2018 includes another attempt to pass tort reform for medical malpractice lawsuits. We strongly oppose this effort to weaken compensation for injury victims and urge you to inform your elected representatives that you do not support it.

The proposal includes a $250,000 cap on noneconomic damages. This means that if are injured as a result of your doctor’s malpractice, your maximum compensation for pain and suffering because of permanent disability, disfigurement, blindness, loss of a limb, paralysis and other injuries is limited. Non-economic damages like these are typically not easily quantified by a damage amount.

The $250,000 amount is extremely low. California capped its non-economic damages at $250,000 in 1975. Adjusted for inflation, the amount would now be more than $1.1 million.

The Trump Administration is unlikely to see the $55 billion in savings it estimates because of its tort reforms. A 2017 study on medical malpractice reform in the Journal of Health Economics found that states that pass damage caps see a 4% increase in Medicare Part B spending and that caps could increase total Medicare spending by 2-3%. If patients are unable to recover for their injuries from doctors and medical facilities, their only option is to rely more on government programs such as Medicare, Medicaid and Social Security Disability Insurance.

Medical errors are the third leading cause of death claiming more than 251,000 lives a year according to research by Johns Hopkins. Medical malpractice reform in some states, such as Wisconsin, have made lawsuits from medical errors nearly impossible to win.

The net effect of the proposed reform is that individuals injured by medical malpractice will have a tougher time finding an attorney willing to advance the costs of their litigation to recover for their injuries. The potential budget savings are simply not worth the cost to the families of victims suffering medical errors.