The United States Department of Justice and numerous state governments have intervened in numerous qui tam whistleblower suits, including one brought by Philadelphia based law firm McEldrew Young against INSYS Therapeutics, Inc. . The suit alleges, among other things, that INSYS engaged in a nationwide illegal scheme to increase profits from Subsys, a fentanyl sublingual spray and schedule II controlled substance.
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.
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.
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.
A study in the Journal of Bone and Joint Surgery last month identified five cases of catastrophic trunnion dissociation in Stryker Accolade TMZ Femoral Hip Stems. What does that mean in lay terms? It means that the hip implant device fails painfully in a small percentage of patients with certain risk factors approximately 7 to 7.5 years after surgery. And the $1.4 billion settlement for patients with defective Stryker hip implants following hip replacement surgery may not be the end of the lawsuits for the company.
Further information now available from Australia suggests the problem is with Stryker’s LFIT Anatomic CoCR V40 femoral head which was a component of Stryker Accolade TMZF, Accolade 2, Meridian and Citation hip implants.
If you experience hip implant failure or crippling pain with one of these Stryker hips, particularly if it includes the LFIT Anatomic CoCR V40 femoral head, you may be entitled to compensation through a personal injury lawsuit. Our Philadelphia trial lawyers are prepared to review your medical records, evaluate your options with you, and file a lawsuit to recover compensation, if necessary. If you suffer a metal-on-metal hip implant failure, call 1-800-590-4116 to speak to Jim McEldrew or one of our other attorneys.
About the Metal-on-Metal Hip Implant Defects
Stryker is a manufacturer of hip replacement systems. Several models of Stryker hip implants have already been in litigation over patient injuries for a few years. These patients have reported debilitating pain, crippling tissue and muscle damage, and premature failure of their hip replacement.
Metal-on-metal hip implants like these have experienced failures across several manufacturers. In addition to the Stryker implants, the other potentially problematic devices include the Zimmer Durom Cup, Wright Profemur-Z hip system, the DePuy ASR and certain DePuy Pinnacle metal implants.
The new Stryker Hip Implant
The Accolade TMZ Femoral Hips at issue in the study were available for use from 2001 to 2011. In the patients experiencing failure, the adverse event was clustered around 7 to 7.5 years after surgery. It is believed that severe corrosion led to the dissociation of the femoral head from the trunnion (trunnionosis). In addition to the five patients identified, the journal article mentions two previously known cases of catastrophic trunnion dissociation in total hip arthroplasty.
The journal article suggests that there may be other patients who have not come forward yet or who have not experienced this problem yet but will in the future. The typical patient who might suffer this problem after modular total hip arthroplasty is male, taller than 5 ft 10 inch and weighing greater than 180 pounds. It is estimated that this demographic puts greater load on the femoral head-trunnion interface. The patient group explored had cobalt-chromium alloy femoral heads combined with a titanium trunnion.
Update: The Australia Stryker LFIT
Australia has issued a hazard alert for certain femoral heads used in hip replacement surgeries. Specifically, a range of LFIT Anatomic CoCR V40 femoral heads manufactured by Stryker before 2011. Australia, in consultation with Stryker Orthopaedics, expressed concerns about a higher than expected incidence of taper lock failures.
The taper lock connects the femoral head to the femoral neck. If it fails, a patient can experience broken bones, joint instability, pain, inflammation, loss of mobility, leg length discrepancy and the need for revision surgery.
The impacted component was used in the Stryker Accolade TMZF, Accolade 2, Meridian and Citation hip implants. The Australian alert urged orthopedic surgeons to monitor patients with the component at issue for fractured hip stem trunnion, increased metallic debris, bone fixation strength, and disassociation of the femoral head from the hip stem.
Some legal commentary in the United States is already suggesting that a recall by Stryker is imminent. Stryker has already recalled other lines of its metal-on-metal hip implants due to complaints of inflammation, metal poisoning, inflammation and organ damage. Stryker is expected to pay out more than $1 billion total to plaintiffs in the previous litigation.
The Stryker Hip Implant Lawsuits
Stryker previously recalled its Rejuvenate Modular and ABG II Modular-Neck Hip Stems in 2012. It also recalled the Accolade TMZF Plus Hip Stem for packaging and manufacturing errors in 2012 and 2013. The defective metal-on-metal hip devices resulted in the implant loosening for some patients and toxic metals release into their bodies. Stryker has been in litigation with these patients over the past few years. The lawsuits allege that the company inadequately tested the products and failed to warn patients and doctors about the risk of side effects. Stryker previously agreed to pay at least $1 billion to settle these lawsuits.
About McEldrew Young
Jim McEldrew and Eric Young engage in litigation against large pharmaceutical and medical device manufacturers on behalf of patients and whistleblowers. If you have been injured by a defective drug, medical device or other form of medical malpractice, please call 1-215-545-800 to speak to Jim McEldrew concerning your legal rights.
The Senate investigation released today (Jan 13, 2016) indicates at least 141 patents were infected during a three year delay in reporting of the dangers of duodenoscopes, a medical scope used in ERCP procedures. The investigation identified 25 outbreaks across the country, which was “far more” than previously reported according to the Los Angeles Times coverage. Across the world, at least 250 people were infected with life-threatening illnesses, including the CRE superbug, after medical procedures with duodenoscopes. The CRE superbug is resistant to most antibiotics and has a high mortality rate (approximately half die from it).
The Senate investigation report concludes that patients were needlessly infected with deadly bacteria because of failures by manufacturers, hospitals and regulators to report outbreak. The report details how the largest manufacturer of devices, Olympus, knew of potential flaws in the spring of 2012 because of an investigation into a Netherlands outbreak. But Olympus and the FDA did not warn hospitals about the problem until February 2015.
The report called on the FDA to consider a phased recall of the scopes for disinfection and repair or modification. The FDA previously decided that it would not recall the devices because of the importance of the ERCP procedure, which is performed hundreds of thousands of times a year.
Our firm filed the first lawsuit in Philadelphia alleging an infection from an Olympus duodenoscope. If you or a family member suffered a potentially deadly infection following a medical scope procedure, please call our office at (800) 590-4116 to speak to Jim McEldrew or one of our personal injury attorneys.
Inferior Vena Cava (IVC) filters are designed to stop blood clots from entering the lungs and cause a pulmonary embolism. About a quarter of a million are implanted in patients each year. However, there have been reports of pieces of the medical devices breaking off and causing death or other serious injuries in patients.
The C.R. Bard’s IVC filters have been specifically identified as among those invoking concern. There are reports of fracturing and migration in patients with both the Recovery IVC filter and G2 IVC Filter System made by Bard (now a unit of Johnson & Johnson).
The FDA warned as far back as 2010 about side effects of the IVC filters including blood clots and organ perforation. In 2014, the FDA issued updated guidance about the appropriate use of the filters. Recently, an NBC report has exposed insider allegations that C.R. Bard’s knew about problems with the safety of the device and forged a signature on the FDA application for clearance of the device.
If you or a family member have suffered an injury as a result of an implanted IVC filter by Bard’s or another medical device manufacturer, contact one of our personal injury attorneys for a free, confidential consultation.