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Vaginal Mesh Case Yields $11.1 Million Award Verdicts to Seriously Injured South Dakota Woman

The case is the first jury verdict in a backlog of several thousand such vaginal mesh injury cases across the United States.

A former nurse who endured multiple vaginal mesh implant surgeries which left her with serious pain and ongoing health problems for years has been awarded $11.1 million in damages for her injuries.

That was the decision of a New Jersey jury which awarded Linda Gross, 47, of Watertown, S.D., $3.35 million to compensate her for her injuries and another $7.76 million in punitive damages to further punish Johnson & Johnson, the makers of the vaginal mesh products that were used in her surgeries, according to an Associated Press (AP) story.

The financial awards were reached in two separate deliberations by the jury in the case. The woman told the court that her vaginal mesh implants gave her years of “living hell” despite unsuccessful repair surgeries, according to AP.

The case is the first verdict in about 4,000 lawsuits filed by plaintiffs against Johnson & Johnson.

A medical team conducts a surgical procedure in this stock photo. Image credit: © iStockphoto.com/uchar

The jury ruled that while the product used in Gross’ surgeries was not defectively designed, “the company did not give surgeons adequate warnings about risks of the product and that a misrepresentation was made to Gross,” reported the AP.

Johnson & Johnson said it will appeal the verdicts.

Vaginal mesh implants, which were a popular alternative to traditional hysterectomies in patients in recent years, are used to treat pelvic organ prolapse, which occurs in women when the cervix, uterus, bladder or other reproductive organs slip down into the vagina due to the weakening of pelvic muscles.

Gross underwent “18 revision surgeries — all without success — since having J&J’s Prolift vaginal mesh device implanted in 2006,” the AP reported. “Severe pain and other complications forced the hospital hospice nurse to stop working”.

“Linda Gross cannot turn back the clock and make her misery and pain disappear,” her lead attorney said in a statement reported by the AP. “But she and countless victims like her can take some comfort in knowing that a jury … decided … that the corporation responsible for their suffering should be severely punished financially.”

This is an injury that has been becoming all too common in the last few years, and it has led to an increasing number of lawsuits against the makers of other such devices, including C.R. Bard Inc. of Murray Hill, N.J., and Endo Health Solutions Inc. of Chadds Ford, Pa.

In June of 2012, Johnson & Johnson announced that it would stop selling four types of surgical mesh implant products. The mesh products had been linked to injuries and triggered about 600 lawsuits against the company at that time. J&J said the products were safe and that its action wasn’t a recall of the products, but just an end to their sales.

In November 2012, a Texas woman sued another vaginal mesh manufacturer for causing serious injuries after her procedures.

Serious injuries due to defective vaginal mesh products are a real health problem for a growing number of women across the United States. Patients who suffer from the crippling injuries caused by these defective mesh devices need skilled, compassionate and dedicated legal teams to help them recover damages for their injuries, pain and suffering.

Women have been injured through these kinds of surgeries because the vaginal mesh manufacturers released and sold products which continue to be problematic for thousands of patients. Instead of being led by concerns over clear patterns of serious medical problems from these products, the manufacturers continue to be motivated only by profit and sales, harming the patients who are being victimized by vaginal mesh implants.

We here at MyPhillyLawyer stand ready to assist you with your legal case if you or a loved one has been seriously injured in a case involving vaginal mesh devices and products anywhere in the United States. We represent the families of victims as well, to ensure that their families receive every penny of damages that they are eligible to receive.

Call MyPhillyLawyer at 215-227-2727 or toll-free at 1-866-920-0352 anytime and our experienced, aggressive team of attorneys and support staff will be there for you and your family every step of the way as we manage your case through the legal system.

When Winning Matters Most, Call MyPhillyLawyer.

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Medical Malpractice: Death of 17-Year-Old Girl After Tonsillectomy Highlights Dangers of Surgical Procedures

It was to be a routine tonsillectomy, just like most of the more than half-million such procedures done each year in the United States.

But something went very wrong following 17-year-old Mariah Edwards’ surgery on March 20, 2012 at the Abington Surgery Center in Montgomery County, according to a recent story in The Legal Intelligencer.

The teen was apparently left unmonitored in a recovery room following her tonsillectomy, and she went into respiratory distress which was not immediately noticed by the medical staff, the report stated.

Tragically, Mariah Edwards died 15 days after the surgical procedure.

“The case highlighted that there may be more risk for surgical patients in the recovery room than there is during the surgery itself,” her family’s attorney told The Legal Intelligencer.

A surgical team is in the midst of a medical procedure in this stock photo. Image credit: © iStockphoto.com/uchar

The teen was given a pain medication after the procedure which depressed her respiratory system, according to the story, and she was left alone for some 20 minutes while medical workers were with another patient. During that time, she “went into respiratory distress and suffered a brain injury that ultimately led to her death,” her attorney told the Intelligencer.

It was later learned “that the monitor placed on Edwards was either not properly set or muted so the nurse could not hear warnings of Edwards’ respiratory distress,” the story reported.

The teen’s family received a $6 million settlement in the medical malpractice case this past December, and several policies and medical procedures were changed at the surgical center to prevent a similar outcome from every happening again, the story reported. Nurses must be present and remain with each patient who comes out of surgery into a recovery room after receiving pain medicines, and patient monitors can no longer be muted by medical staff members, according to the Intelligencer. In addition, “nurses must have clear lines of sight so they can see their patients at all times,” said the report.

Tonsillectomies, in which the tonsils are removed from the back of a patient’s throat, are one of the most common surgical procedures in the United States, with more than 530,000 procedures performed annually in children younger than 15 years, according to a 2011 clinical practice guideline report by the University of Toledo Medical Center in Ohio.

And usually, it is a very safe procedure, according to a 2010 post on the ENT (Ear Nose and Throat) Blog, maintained by Fauquier Ear Nose & Throat Consultants of Virginia.

“Medical literature places the mortality rate from tonsillectomy between one in 15,000 and one in 35,000 procedures (0.03% – 0.06%), mostly from anesthesia complications, airway loss, and blood loss,” according to the blog post. That means that about 30 deaths occur per year from the procedure. “As such, tonsillectomy should ONLY be performed if they are truly causing a significant health problem such as obstructive sleep apnea or recurrent tonsillar infections and NOT just because ‘they are big.’”

A similar case occurred in Palm Harbor, Fla., in 2010 when a 12-year-old girl died after a tonsillectomy and her family filed a lawsuit alleging medical mistakes in her treatment.

These tragic cases are somber reminders of the kinds of problems that can arise when patients seek medical treatment in hospitals and other medical facilities and become innocent victims of inadequate or incorrect procedures.

Patients and their families must be vigilant about the medical care they receive so they know what is being done for a patient’s care every step of the way. But at the same time, patients and families aren’t doctors and they can’t know every question to ask.

That’s where skilled, expert, compassionate and thorough legal representation is needed by patients and their families who have been harmed by medical errors or omissions during their treatment. These kinds of cases happen on a regular basis, but they can be fought by legal teams that are prepared to battle for their clients’ rights all along the way to a fair settlement or to a just verdict.

We here at MyPhillyLawyer stand ready to assist you with your legal case if you or a loved one is ever seriously injured in a medical malpractice or related case anywhere in the United States. We represent the families of victims who die in such tragedies as well, to ensure that their families receive every penny of damages that they are eligible to receive.

Call MyPhillyLawyer at 215-227-2727 or toll-free at 1-866-920-0352 anytime and our experienced, compassionate, aggressive team of attorneys and support staff will be there for you and your family every step of the way as we manage your case through the legal system.

When Winning Matters Most, Call MyPhillyLawyer.

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Texas Woman Sues Maker of Surgical Vaginal Mesh Device Due to Serious Injuries

The maker of an implantable vaginal mesh device is being sued by a Texarkana, Texas, woman after the surgery with the device led to her suffering serious injuries.

In a case filed in the Eastern District of Texas, Sally H. York is suing Ethicon Inc., the maker of the Gynecare Prosima Pelvic Floor Repair System, which is an implantable vaginal mesh, according to a story in The Southeast Texas Record.

York’s lawsuit alleges that the Gynecare Prosima vaginal mesh product was defective and worsened the medical condition that she was being treated to correct.

York was originally treated for pelvic organ prolapse, which occurs in women when the cervix, uterus, bladder or other reproductive organs slip down into the vagina due to the weakening of pelvic muscles. Her original diagnosis was made In December 2010 at Christus St. Michael Health System in Texarkana, according to the story.

A medical team conducts a surgical procedure in this stock photo. Image credit: © iStockphoto.com/uchar

A medical team conducts a surgical procedure in this stock photo. Image credit: © iStockphoto.com/uchar

“According to the lawsuit, her medical conditions were not remedied by this procedure but she became physical worse,” the story reported. “York began to suffer from chronic urine leakage and other physical problems.”

The lawsuit charges Ethicon with negligence, breach of warranty for defective design and related charges.

This is an injury that has been becoming all too common in the last few years, and it has led to an increasing number of lawsuits against the makers of other such devices, including C.R. Bard Inc. of Murray Hill, N.J., and Endo Health Solutions Inc. of Chadds Ford, Pa.

In June, consumer goods manufacturer Johnson & Johnson (J&J) announced that it will stop selling four types of surgical mesh implant products. The mesh products had been linked to injuries and triggered about 600 lawsuits against the company. J&J said the products were safe and that its action wasn’t a recall of the products, but just an end to their sales.

In some cases, surgical mesh products that were surgically implanted in women to treat pelvic organ prolapse caused higher rates of pain, bleeding and infection than surgery involving traditional stitches, according to a U.S. Food and Drug Administration (FDA) report. About 75,000 women had this kind of surgery in 2011.

Thirty to fifty percent of women may experience pelvic organ prolapse (POP) in their lifetimes, with two percent developing symptoms, the FDA reported.

In July of 2011, the FDA issued a “safety communication” that reiterated warnings about “serious complications associated with surgical mesh placed through the vagina” to treat the problem. The FDA “identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.”

The FDA alert also updated an earlier FDA advisory which was issued back in 2008, the agency said. The complications from surgical mesh being used to treat POP “are not rare,” the FDA stated (emphasis added by the FDA).

In a list of recommendations for health care providers, the FDA suggests that they obtain “specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.” The agency also recommends that doctors are “vigilant for potential adverse events from the mesh, especially erosion and infection, as well as “for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.”

Another key, the FDA recommends, is that doctors should “recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”

The FDA also recommends that patients who suffer adverse effects from the use of the surgical mesh promptly report their case to the agency through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The FDA has received “more than 1,500 reports of complications related to the mesh from 2008 to 2010, including cases where the it eroded into the vagina or caused bleeding and infection,” according to a story by Reuters. “The rate of problems was five times the rate reported from 2005 to 2007.”

Serious injuries due to defective vaginal mesh products are a real health problem for a growing number of women across the United States. Patients who suffer from the crippling injuries caused by these defective mesh devices need skilled, compassionate and dedicated legal teams to help them recover damages for their injuries, pain and suffering.

We here at MyPhillyLawyer stand ready to assist you with your legal case if you or a loved one is ever seriously injured in a case involving vaginal mesh devices and products anywhere in the United States. We represent the families of victims as well, to ensure that their families receive every penny of damages that they are eligible to receive.

Call MyPhillyLawyer at 215-227-2727 or toll-free at 1-866-920-0352 anytime and our experienced, aggressive team of attorneys and support staff will be there for you and your family every step of the way as we manage your case through the legal system.

When Winning Matters Most, Call MyPhillyLawyer.

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Surgical Items Left inside Patients 4,000 times Each Year: What You Need to Know When Having Surgery

Each year, some 4,000 surgical patients in the United States are seriously injured when items used during their procedures, from sponges to medical instruments, are accidentally left inside their bodies when their medical teams sew them back up.

The problem of retained surgical items has been an issue for years and has led surgeons and medical facilities to look for new methods to prevent such items being left behind inside patients in the first place, according to a story in The New York Times.

“In most operating rooms, a nurse keeps a manual count of the sponges a surgeon uses in a procedure,” the story reported. “But in that busy and sometimes chaotic environment, miscounts occur, and every so often a sponge ends up on the wrong side of the stitches.”

A surgical team is in the midst of a medical procedure in this stock photo. Image credit: © iStockphoto.com/uchar

A surgical team is in the midst of a medical procedure in this stock photo. Image credit: © iStockphoto.com/uchar

Systems are now available that can track every sponge and instrument used inside a patient with tiny Radio-Frequency Identification tags that can automatically report when every sponge and instrument is removed. Dozens of sponges might be used inside a patient during a procedure, which makes them vulnerable to being forgotten during surgery.

“In a study published in the October issue of The Journal of the American College of Surgeons, researchers at the University of North Carolina at Chapel Hill looked at 2,285 cases in which sponges were tracked using a system called RF Assure Detection,” The New York Times reported. “At the end of an operation, a detector alerts the surgical team if any sponges remain inside the patient. In the U.N.C. study, the system helped recover 23 forgotten sponges from almost 3,000 patients over 11 months.”

The RFID tag system adds about $10 to the cost of a surgical procedure, the story reported.

Another system designed to prevent such medical mistakes uses barcodes on sponges and medical instruments that are scanned as they are used on a patient and then scanned again as they are removed. If something is left behind, the surgical teams will know it because the inventory of items used and then removed will be off.

For victims, these kinds of medical mistakes can be intensely painful and lead to major health problems.

One such victim was a nurse in Kentucky who became ill with crushing pain in her abdomen one night while she was working in 2005, the Times reported. The next day, a CT scan discovered a surgical sponge that had been left behind inside her abdomen when she had undergone a hysterectomy four years before. When doctors went in to remove it, they found that it caused a spreading infection that required the removal of a large section of her intestine. The patient sued the hospital and won a $2.5 million verdict, but the award was appealed and remains in legal limbo.

In August, a Fresno, Calif.-based hospital was fined $50,000 by state investigators after surgeons accidentally left a surgical towel inside a patient which was discovered four months later after she suffered serious health problems post-surgery, according to a story by KFSN News. It was the fourth violation reported against the hospital, Saint Agnes Medical Center, since 2007, according to the story.

Since that case, “the hospital developed a policy to inventory objects, such as instruments and sponges used during surgeries,” the story reported. “Hospital staff also switched operating room towels from the color blue, to white towels that can be detected in x-rays.”

In December of 2011, a New Philadelphia, Ohio man won a $275,000 settlement from a veteran’s hospital after two surgical towels were left inside his abdomen during kidney cancer surgery in 2008, according to a story by CBS News.

The tragedy is that these kinds of medical mistakes could be prevented through electronic tracking systems that are presently available such as the RFID and barcode systems, but many hospitals continue to fight such fixes, the Times reported.

One hospital that is doing proactive work to prevent these kinds of medical errors is Harrison Medical Center in Bremerton, Wash., where they in 2010 adopted a patient safety program called NoThing Left Behind.

“The issue of foreign objects, and most specifically sponges, being left behind in surgical cases is a serious issue,” the hospital states on its website. The program “provides a three-level approach to accounting for surgical objects,” including the mandatory use of X-ray detectable sponges or towels during surgeries, as well as manual sponge counts by surgical team members. Also required are the use of hanging sponge holders and a white board to carefully and accurately track the sponges that are used, as well as confirmation by the surgeons that all devices have been extracted, the hospital states.

“Those efforts paid off,” the hospital reported. “In 2011, Harrison had no items, including sponges, being unaccounted for at the end of the surgery.”

NoThing Left Behind was started in October of 2004 by Dr. Verna C. Gibbs, a professor of surgery at the University of California in San Francisco, to fight against such medical mistakes.

For patients who suffer serious medical traumas and long-term medical complications from incidents of medical sponges and devices that are left behind, such changes cannot come quickly enough.

These kinds of medical errors can be prevented simply through the use of tracking systems that are available, affordable and smart.

No surgical patients should have to suffer from these kinds of injuries in the future.

It’s time to make such systems mandatory for patient safety.

Meanwhile, if you or a family member is ever injured due to a medical error, you should get the best legal advice you can find to learn your legal options so you can recover damages for your injuries and suffering.

We here at MyPhillyLawyer stand ready to assist you with your legal case if you or a loved one is ever seriously injured in a medical malpractice or related case anywhere in the United States. We represent the families of victims who die in such tragedies as well, to ensure that their families receive every penny of damages that they are eligible to receive.

Call MyPhillyLawyer at 215-227-2727 or toll-free at 1-866-920-0352 anytime and our experienced, compassionate, aggressive team of attorneys and support staff will be there for you and your family every step of the way as we manage your case through the legal system.

When Winning Matters Most, Call MyPhillyLawyer.

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Meningitis Death Toll from Contamination Steroid Injections Hits 21, New Cases Continue to Surface

After getting routine steroid shots to treat various aches and pains, 21 patients from across the United States have died from fungal meningitis connected to contaminated steroid medications provided by a Boston-area pharmacy.

So far, 268 cases of the fungal meningitis from the contaminated injectable medications have been reported with more continuing to come in, according to a story from Reuters, while ongoing investigations into the outbreak continue.

Now a lawsuit has been filed on behalf of one of the victims of the tragedy against the pharmacy, New England Compounding Center (NECC).

“U.S. health regulators confirmed on Thursday the presence of the deadly Exserohilum fungus in vials of the NECC steroid used for the pain injections,” Reuters reported. “They estimate that as many as 14,000 people may have been exposed to the contaminated medication.”

Image credit: © iStockphoto.com/Oxford

The outbreak appears to be connected to three potentially contaminated lots of the drug, methylprednisolone, which were shipped to 76 facilities in 23 states, the report stated.

NECC suspended operations earlier this month as the investigation into the outbreak continued, and the company recalled its products, according to a story by Bloomberg Businessweek.

Meningitis is a disease caused by the inflammation of the protective membranes covering the brain and spinal cord known as the meninges, according to the U.S. Centers for Disease Control and Prevention.  The inflammation is usually caused by an infection of the fluid surrounding the brain and spinal cord.

Unlike other forms of meningitis, the fungal meningitis infection in these cases is not contagious, according to the CDC. But left untreated, it can cause serious health problems and is potentially deadly.

Several patients have suffered strokes that are believed to have resulted from their infections, according to the CDC, which other patients have developed fungal infections associated with injections in a peripheral joint, such as a knee, shoulder or ankle.

“CDC and public health officials are referring any patients who have symptoms that suggest possible fungal infection to their physicians, who can evaluate them further,” the agency stated. “Patients who received injections in peripheral joints only are not believed to be at risk for meningitis, but they could be at risk for joint infection.”

As many as 14,000 patients may have received injections using the contaminated steroids, according to the CDC.

“Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop” the agency reported. “In this outbreak symptoms typically have appeared 1 to 4 weeks following injection, but it’s important to know that longer and shorter periods of time between injection and onset of symptoms have been reported. “

Patients and their doctors should watch closely for symptoms of problems for at least several months following the injection, the CDC recommends.

What’s particularly worrisome about the outbreak from a legal standpoint is that there is apparently little federal oversight for so-called compounding pharmacies like NECC, which take ingredients and make their own batches of drugs, usually for lower prices than major drug manufacturers, according to a story in The New York Times.

“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” Kevin Outterson, an associate professor of law at Boston University, told The Times.

At the same time, “many compounding pharmacies perform well, producing formulations of drugs for specialized needs,” The Times reported. “Compounders have also provided hospitals and doctors with cheaper alternatives to F.D.A.-approved drugs.”

In the case of NECC, “the Massachusetts company itself has a troubled past,” The Times reported. “A series of complaints had been lodged against New England Compounding over the past decade. The State Health Department inspected in 2006. According to a warning letter sent by the F.D.A. from that year, the company was accused of illegally producing a standardized anesthetic topical cream, inappropriately repackaging a drug, and telling doctors that using an office staff member’s name was enough to put in an order, even though rules require a prescription for a particular patient.”

For patients who have been receiving steroid injections, all of this is sobering news.

You should talk with your doctor to find out if it is possible that your injections included medications that are involved in the current meningitis outbreak, and you should work out a plan for follow-up care and monitoring to ensure your health and safety.

It is imperative that patients ask lots of questions and demand answers about their medical care from their doctors and other clinicians during every step of their care.

There are so many legal questions that arise in medical treatment cases like the meningitis outbreak. That’s why you and your family should immediately seek professional and compassionate legal advice and assistance so you can quickly learn your legal options to recover damages if you are seriously injured in such a situation.

We here at MyPhillyLawyer stand ready to assist you with your legal case if you or a loved one is ever seriously injured in a medical injury or related case anywhere in the United States. We represent the families of victims who die in such tragedies as well, to ensure that their families receive every penny of damages that they are eligible to receive.

Call MyPhillyLawyer at 215-227-2727 or toll-free at 1-866-920-0352 anytime and our experienced, compassionate, aggressive team of attorneys and support staff will be there for you and your family every step of the way as we manage your case through the legal system.

When Winning Matters Most, Call MyPhillyLawyer.

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York County Jury Awards $6 Million in Wrongful Death Case

The family of a 53-year-old woman who died after surgery won a $6 million jury verdict in York County in a recent wrongful death case against the medical team that treated her.

In what is believed to be the largest York County jury award in several years, the jury ruled in favor of the family of the victim, 53-year-old Sherrie Ann Burkhardt, who died Dec. 19, 2007, two days after she underwent emergency surgery at York Hospital, according to a story in The York Daily Record.

Burkhardt, of Seven Valleys, Pa., had been admitted to the hospital complaining of chest pains.

After she arrived at the hospital, a surgeon examined her and performed a cardiac catheterization on the patient, according to a story in The Legal Intelligencer.  The examination found that Burkhardt’s right heart artery was almost completely obstructed and required three stents.

Image credit: © iStockphoto.com/babyblueut

Image credit: © iStockphoto.com/babyblueut

Complications began after the patient was moved to the hospital’s medical surgical intensive care unit following the surgery, according to The Legal Intelligencer.  During court testimony, one of the doctors on Burkhardt’s medical team said he told another doctor about observing abnormal abdominal bleeding in the patient after the surgery.  The other doctor, however, testified that he was “only made aware of a transient drop in blood pressure and would have ordered all the proper tests had he known Burkhardt’s full list of symptoms.”

That poor communication between the doctors was a key part of the Burkhardt family’s case against the medical team and the hospital. “The complaint alleged her death was the post-surgery result of a lack of communication and violation of patient safety rules by doctors at York Hospital and Cardiac Diagnostic Associates,” reported The York Daily Record.

Ultimately, that meant that the victim didn’t receive adequate care following the surgery.

In a pre-trial memorandum, the Burckhardt family alleged that neither doctor “continued to inform any cardiologist, as had been ordered, about the drop in blood pressure and increase in heart rate, nor did they advise of the hallmark symptoms of bleeding, back pain, abdominal pain, distension and tenderness, gray skin pallor, anxiety, agitation and labored respirations,” according to The Legal Intelligencer. “Either way, all the symptoms the plaintiff pled as hallmark signs of internal bleeding were documented in Sherrie Burkhardt’s medical records only 10 minutes after she arrived in the intensive care unit and three hours before she coded and went into cardiac arrest.”

The Burkhardt family was awarded $5 million for wrongful death and $1 million for any treatment injuries that Burkhardt suffered before she died, according to the paper.

This tragic case illustrates the dangers and risks that patients can face when undergoing medical procedures in emergencies. Split-second decisions made by doctors, nurses and other medical staff members can have huge and instant negative impacts on patients when they are most vulnerable during medical emergencies. And poor communication about patients and their ongoing treatment among medical team members can be devastating, and deadly.

That’s why if you or a family member is ever involved in such a situation you should get the best legal advice you can find to learn your legal options so you can recover damages for your injuries and suffering.

We here at MyPhillyLawyer stand ready to assist you with your legal case if you or a loved one is ever seriously injured in a medical malpractice or related case anywhere in the United States. We represent the families of victims who die in such tragedies as well, to ensure that their families receive every penny of damages that they are eligible to receive.

Call MyPhillyLawyer at 215-227-2727 or toll-free at 1-866-920-0352 anytime and our experienced, compassionate, aggressive team of attorneys and support staff will be there for you and your family every step of the way as we manage your case through the legal system.

When Winning Matters Most, Call MyPhillyLawyer.

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