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Wynn Hotel Security Measures Point to the Future of Security

October 1st, 2017 – Las Vegas Shooting at the Mandalay Resort and Casino

At least 59 people were killed and another 527 injured by a lone gunman shooting down at a concert crowd from an upper floor at the Mandalay Resort and Casino in Las Vegas, Nevada late on October 1, 2017. The shooter later died from a self-inflicted gunshot wound. His motive for the shooting continues to remain unclear; however, the investigation is pointing to the fact that he acted alone, according to CNN.  Mandalay is owned by MGM Resorts International.

According to CNN, the shooting took somewhere between 9 to 11 minutes to complete and involved numerous weapons and 22,000 bullets. Injuries were due to both the onslaught of bullets, as well as the stampede. The gunman has been identified as Stephen Paddock. Various news sources note that this is the deadliest mass shooting to occur in modern United States history.

Paddock shot concertgoers attending the Route 91 Harvest Festival on the ground from the 32nd floor at the Mandalay. CNN notes that the attack seems to have been very carefully planned out. Paddock checked into the room in late September, bringing with him a number of weapons, setting up cameras inside the hotel suite, as well as in the hallway.

FBI Deputy Director Andrew McCabe told CNBC. “This individual … didn’t leave the sort of immediate thumbprints you find on these kinds of attacks,” adding that the FBI was considering all potential motives Paddock may have had. “We will look at every one of those lanes, pull every possible thread,” he said.

Meanwhile, Paddock had various weapons, as well as bump-fire stocks. These devices are legal and allow shooters to engage in rapid-fire shooting that is similar to what is used in automatic weapons. Paddock had installed these devices on 12 of his weapons, according to the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF), wrote CNN. Paddock also set up cameras within and outside of his suite. Police remain unclear if the cameras were transmitting elsewhere and the FBI continues to investigate for what purpose the cameras were used. The Clark County sheriff said he believes that the gunman may have been watching for anyone approaching his suite as one of the cameras was set up to view through the peephole.

Some 47 guns were recovered from the hotel suite at which Paddock was staying, as well as his homes in Verdi and Mesquite, Nevada. The weapons were purchased at multiple locations in California, Nevada, Texas, and Utah, Jill Snyder, special agent in charge of the ATF field division in San Francisco told CNN. Authorities discovered thousands of rounds of ammunition in the alleged shooter’s Mesquite home. Also found was an ingredient used in explosives found in Paddock’s car.

The attorneys at Parker Waichman LLP have long and successfully represented clients in personal injury litigation. The firm continues to offer free legal consultations to individuals with questions about filing a lawsuit and who may have been injured in the recent mass shooting in Las Vegas.

The Wynn Hotel Discusses Current and Additional Planned Security Measures

Bloomberg News reported that the Wynn Hotel in Las Vegas announced changes it will be making to its security as well as existing security measures. The news outlet suggested that “all hotels should be doing this.”

As of the afternoon of October 2, 2017, every entrance to the Wynn resort in Las Vegas, Nevada was outfitted with guards scanning hotel visitors with metal detector wands. The guards were also inspecting guests’ bags. Bloomberg News wrote that the security measures led to a 10-minute wait to enter the hotel. Bloomberg News believes measures such as these may become standard operating procedures in various locations in Las Vegas.

Steve Wynn, CEO of Wynn Resorts, described Las Vegas as a so-called “target city,” and openly discussed the security measures previously taken at Wynn Resorts, according to Fox News. “Las Vegas is a target city. We have hardened the target at the Wynn,” Wynn told 13 Action News, Fox News reported. He added that, “This is the first time I’ve ever revealed this publicly … there’s a division in the Marine Corps of special people that are specially trained to guard the embassies. That’s a whole division with separate base, separate training. There are almost 40 of them at every opening of my building, plain clothes, armed, on the look-out, changing shift, and being relieved every two hours so they don’t get bored.” He also said he put “covert security measures” in place in the summer of 2016. “We have another group of a half a dozen Seals Team Six guys and CIA guys who are a counterterrorism unit that … relate on a daily basis to Homeland Security, the FBI, and Metro,” he said. “My company has metal detectors and devices at every entrance of the building for employees and guests that are non-visible to the public. We have done extraordinary things to make that sure we protect our employees and our guests at the hotel,” Wynn also said.

Las Vegas Shooting at the Mandalay Resort and Casino

Casinos and other entertainment venues will likely have to take a more global look at security, considering potential shooting locations and at various angles, said David Shepherd, a former FBI special agent in counter-terrorism. Shepherd was also security director for Las Vegas Sands Corporation’s Venetian resort, according to Bloomberg News. “We have to start thinking like the Secret Service—start looking at tall buildings,” said Shepherd. Shepherd is also the co-author of the book “Active Shooter: Preparing for and Responding to a Growing Threat.”

Shepherd pointed out that the Las Vegas attack took place outside where there were no assigned exits; therefore, attendees who fell to the ground were at risk from the shots from above. Shepherd also noted that screening customers for weapons is not the only security measure to be taken, especially when a gunman is using weapons that have a range that exceeds one mile. Shepherd added that, “In this case he’s not even at the event,” according to Bloomberg News.

An executive from another casino operator, asking for anonymity, said that the security check at the door of Wynn Resort will likely be seen more and more at other locales going forward given that there are no other solutions for weapons screening.

Gambling locations worldwide also face security problems. For example, an arson attack at the Resorts World Manila in the Philippines in June 2017 led to a total of 38 fatalities. Now, the casino scans vehicles prior to their being permitted on premises and bags must be opened for security checks, noted Bloomberg News.

Filing A Lawsuit for Victims of Violence Associated with Mass Shootings

Parker Waichman has years of experience successfully representing clients in personal injury lawsuits. If you or someone you know is interested in filing a lawsuit, please contact one of our experienced lawyers today. Our firm offers free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).

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At Least 59 Dead and over 500 Wounded in Las Vegas Mass Shooting

On October 1, 2017 a lone gunman opened fire from a hotel room overlooking a country music outdoor concert in Las Vegas with an estimated 22,000 people in attendance. The shooting began Sunday at approximately 10 p.m. local time. The shots led to a stampede as the panicked crowd ran for cover amid what has now been identified as the deadliest mass shooting in modern United States history, reports USA TODAY.

Country music singer Jason Aldean, the festival’s headliner was on stage when the rain of bullets began and continued to play through the first extended volley when the crowd became confused, unsure of what the sound was. The music stopped at about the same time the volley did, but after several moments, another, lengthy round of gunfire started, setting off chaos in the crowd. Social media videos show people ducking for cover and fleeing amid the unrelenting barrage of bullets.

When the music event, was interrupted by the gunfire, victims fell bleeding, concertgoers screamed, ran for cover, or did whatever they could to get away. “Get down,” one shouted. “Stay down,” screamed another.

Lone Gunman

The gunman, retired accountant Stephen Craig Paddock, 64, enjoyed playing high-stakes poker and was an avid gambler. It appears he killed himself shortly before police officers stormed the 32nd floor room he had rented at the Mandalay Bay Resort and Casino, according to Clark County Sheriff Joe Lombardo.

Investigators say that Paddock’s shooting rampage was painstakingly planned and included specially modified weapons and surveillance cameras designed to spy on any police intruders who might try and stop his murderous barrage.

Parker Waichman LLP is a national law firm available and prepared to assist anyone who has suffered personal injury, property damage, or death due to the gun violence at the Mandalay Bay Resort and Casino.

Paddock’s Weapon Collection

Authorities seized more than 40 firearms that Paddock had either at his home in Mesquite, Nevada, or in his hotel room. Police also seized thousands of rounds of ammunitions along with explosives.

Sheriff Lombardo described Paddock as the son of a 1960s bank robber on the FBI’s most-wanted list after escaping from prison, as “as a distraught person intent on causing mass casualties.” Lombardo felt Paddock was likely a “lone wolf” and that a motive for the shooting spree had not yet been determined, reports USA TODAY.

Las Vegas Mayor Carolyn Goodman said, “This is a crazed lunatic full of hate. This has been a hugely traumatic time for all of us.”

Paddock had checked into the Mandalay Bay on September 28, but it was still unclear whether he specifically requested the towering room, or how Paddock was able transport almost two dozen weapons into his room without it seeming suspicious. Granted, golf club bags, and other sport-equipment paraphernalia may go unnoticed. Sheriff Lombardo reported Paddock brought at least ten suitcases “over a period of time” into his hotel room.

Jill Schneider, Bureau of Alcohol, Tobacco and Firearms Special Agent, said Paddock had nearly 50 guns – a combination of rifles, shotguns and pistols – found in three locations. Authorities said Paddock increased the attack’s deadliness by adding more lethal components to his weapons. He had devices attached to 12 semiautomatic rifles that created a sound mimicking fully automatic gunfire.

Paddock’s brother, Eric Paddock, of Orlando, Florida, says his wealthy brother was a big spender at casinos and was often given free rooms and meals there. The brother told NBC News that he was “dumbfounded” by the shooting. “He was just a guy. He lives in Mesquite, he went to the hotels, he gambled, he went to shows…. We are completely at a loss.”

Video of the actual shooting captured nine seconds of continuous rapid fire, and then 37 seconds of silence from the weapon, but with panicked screaming from the crowd. Gunfire began again in at least two more bursts, both shorter than the initial assault, according to The New York Times.

Country singer Jake Owen, was on the stage with Mr. Aldean when the gunshots began. Owen told CNN that it was like “shooting fish in a barrel from where he was.”

Hospital Inundated

In the first hours, 90 patients arrived at Sunrise Hospital and Medical Center, which was in walking distance of the concert. By noon on Monday, the next day, the Level Two trauma center was treating 180 victims.

Of those, 124 “met the criteria for trauma activation,” said Dr. Jeff Murawsky the hospital’s chief medical officer. Injuries included single and multiple gunshot wounds to the head, face, chest, body, arms and, in one, case a finger, The Times reports.

Legal Help for Gun Violence Victims

If you or someone you know suffered injury, emotional distress, property damage, or death at the Mandalay Bay Resort and Casino, you may be eligible for valuable compensation. Parker Waichman offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

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Lawsuit Cites Faulty Batteries in St. Jude Defibrillators

Abbott Laboratories is being sued over allegations that St. Jude Medical, the Minnesota-based medical device company owned by Abbott, neglected to warn the public and regulators for years that thousands of its defibrillators contained faulty lithium batteries.

The federal lawsuit was filed in northern Illinois on September 18, alleging that St. Jude knew more than 250,000 implantable defibrillators it sold in the United States between 2011 and October 2016 had batteries that could suddenly short out and cause the vitally important devices to lose power with little or no warning. Abbott bought St. Jude three months after the recall, so was therefore responsible for the litigation, reports the Star Tribune.

Lawsuit Seeks Class-Action Status

The lawsuit is seeking class-action status to represent all self-insured and commercial insurance companies and estimates that those insurers collectively paid hundreds of millions of dollars for St. Jude Medical defibrillators. The suit seeks punitive damages as well.

Product liability attorneys at Parker Waichman LLP are actively reviewing potential lawsuits regarding allegedly defective medical devices including St. Jude defibrillators.

Formerly, St. Jude officials have defended their decision to wait until October 2016 to recall hundreds of thousands of the implantable defibrillators, saying executives and medical advisors worked as fast as possible to confirm the rare but serious problem.

The federal lawsuit makes ten claims that include failure to warn about known defects, breach of warranty, negligence, and unjust enrichment. The federal case also includes a claim that St. Jude officials violated Minnesota’s Prevention of Consumer Fraud Act when they “deceptively omitted” long-known facts about the device batteries until last October, the Star Tribune reports.

“If defendants had not omitted … or misrepresented the defects in the recalled devices, physicians would not have used the recalled devices,” the lawsuit says. “Accordingly, plaintiff and the other nationwide class members would not have incurred costs for the recalled devices and the medical costs of device removal and replacement surgery and other related costs.”

Premature Battery Depletion Leads to Deaths

St. Jude received 42 reports, the lawsuit says, showing evidence of premature battery depletion related to the lithium issue between 2011 and 2014. In 2014, St. Jude received a report that the problem had led to a patient’s death. The problem was documented in a journal article in December 2014.

St. Jude Medical made a change to its battery design on May 23, 2015, according to a Star Tribune report, in response to a problem that the company said it identified in 2014. However, the company continued selling the defibrillators that contained the old batteries until early October 2016.

This alludes to the fact that some patients received recall notices just weeks or months following surgery for a problem that St. Jude was aware of for years. St. Jude officials said they did not consider the change in battery design in 2015 to be an acknowledgment that they were aware at the time that the old devices were faulty, but rather, they felt they were taking a device that was performing well and improving on it. The decision to recall the devices in 2016 occurred only after enough cases of lithium battery defects were confirmed internally.

The 2015 design change was approved by the U.S. Food and Drug Administration (FDA). The FDA did not call for an immediate recall as the rate of problems at the time seemed low and was consistent with rates of problems with other issues in other models on the market. The increased rate of premature battery depletions was realized only later, leading to the recall.

The most recent data available was as of May 31, where 616 of the 398,740 affected defibrillators sold worldwide had depleted batteries with no other discernible cause than lithium shorting, St. Jude’s data showed. Two patients died when their defibrillators lost the ability to shock their heart back into a normal rhythm, reports the Star Tribune.

Controversy Over Immediate Device Replacement

Some doctors have remarked they would consider immediate device replacements for patients who are dependent on their defibrillators to also act as pacemakers to keep their hearts beating properly.

Not all affected devices are to be removed from patients, St. Jude’s voluntary recall announced in October. It recommends that patients consult with their doctors and use bedside remote-monitoring devices that analyze remaining battery life.

Affected recall devices include Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable defibrillators made before May 2015, according to the Star Tribune.

However, St. Jude and the FDA do not recommend “prophylactic” replacement of all recalled devices as the replacement surgery has its own risks of potentially serious complications. An October 11 FDA safety communication said, “The rate of complications following replacement surgery are higher than those associated with premature depletion.”

“However, the FDA and St. Jude Medical recognize the need to weigh individual clinical considerations. If the decision is made to replace an affected device based on individual patient circumstances, St. Jude Medical has announced they will provide a replacement device at no cost.”

Have You Been Injured by a St. Jude Defibrillator?

If you or someone you know has sustained injury associated with a defibrillator, you may be eligible for valuable compensation. Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

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Safety Warning and Recall Notice for Some Sig Sauer Rifles

On September 15, Sig Sauer arms maker announced that some Sig 716 DMR, 516 Carbon Fiber and M400 Predators with two-stage triggers may have an incorrectly heat-treated hammer. “Over time this could result in a trigger malfunction creating a significant safety hazard,” a release from the company said. The statement was to notify the mandatory recall on certain models to replace the hammer and trigger assembly, reports Guns.com

The New Hampshire-based arms manufacturer notes that potentially affected models will have a “SIG” mark etched into the hammer and has a serial number look-up tool online with instructions to follow, to determine if a particular model is subject to the recall. Sig Sauer will correct any of the affected firearms at no cost to the customer. according to ammoland.com.

This recall does not affect any law enforcement or military rifles or any SIG, MCX, or MPX products.

Sig Sauer Inc. makes a variety of products to “meet any mission parameter,” including handguns, rifles, ammunition, electro-optics, suppressors, and ASP (Advanced Sport Pellet) airguns.

National law firm Parker Waichman LLP has extensive and successful experience in all kinds of litigation, including defective firearms. Attorneys at the firm are available to answer questions for individuals seeking legal information for potential lawsuits.

Previous Sig Sauer Problem

In August 2017, a Connecticut police officer filed a multimillion-dollar lawsuit against Sig Sauer for injuries he sustained when his department-issued P320 – a version of U.S. Army’s new service pistol – accidentally discharged when he dropped it and wounded him in the leg. Shortly after the incident, Sig Sauer issued a statement that it offered a voluntary upgrade to address unintentional discharges. The gun manufacturer said, the Army’s Modular Handgun System (MHS) is not affected by the upgrade, reports Business Insider.

“As a result of input from law enforcement, government and military customers, SIG has developed a number of enhancements in function, reliability, and overall safety including drop performance. SIG SAUER is offering these enhancements to its customers.”

Multiple Surgeries due to Accidental Shot Fired

The upgrade announcement came days after the officer filed the August 4 complaint in the U.S. District Court for the District of Connecticut. The officer had been loading equipment into the back of his car in January when he dropped his holstered P320. The gun accidentally fired when it hit the pavement. The 9mm bullet struck him under his left knee, and lodged to the side “with the round protruding from his leg,” according to the firearmsblog.com.

The officer is a 34-year-old member of the Stamford, Connecticut Police Department Special Response Team. He had to undergo multiple surgeries but is back on light duty. The lawsuit may require Sig Sauer to pay the officer more than $3 million in punitive and compensatory damages.

The fact that the gun went off unintentionally when the trigger had not been pulled, is very serious and the amount in damages sought reflects that.

The three counts include violation of the Connecticut Product Liability Act; violation of the Connecticut Unfair Trade Practices Act; and a Connecticut common law tort, which is negligent infliction of emotional distress. The officer is also demanding Sig Sauer recall the pistol or include a warning that the gun is not drop safe when a round, or bullet, is in the chamber, Business Insider reports.

Sig Sauer Responds

Sig Sauer claims in its statement that the P320 meets “U.S. standards for safety, including the American National Standards Institute (ANSI)/Sporting Arms Ammunition Manufacturers’ Institute Inc. (SAAMI); National Institute of Justice (NIJ); as well as rigorous testing protocols for global military and law enforcement agencies.”

The gun manufacturer, however, concedes, that “recent events indicate that dropping the P320 beyond U.S. standards for safety may cause an unintentional discharge,” the statement said. The Stamford Police Department said it has shelved all P320s it issued to its officers because of the incident.

In July, the leadership at Glock Inc. stated publicly that the Army’s decision to choose Sig Sauer to make its new MHS was driven by cost savings, not performance.

The Government Accountability Office denied Glock’s protest of the Army’s MHS decision, which Glock officials maintain was the result of “incomplete testing” and Sig Sauer’s $102 million lower bid.

The officer’s case may be settled out of court, but there is a possibility it could go to a jury trial. It was noted that the accidental discharge from the gun could have killed the officer, or shot a bystander, so the incident was taken very seriously, according to Business Insider.

Legal Information Concerning Potential Lawsuits

If you or someone you know has been injured by a defective firearm, you may be eligible for valuable compensation. Parker Waichman offers free, no-obligation case evaluations. We urge you to contact the attorneys at 1-800-YOURLAWYER (1-800-968-7529).

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Three Inmate Deaths in Nassau Jail Linked to Inadequate Care

A state oversight agency has found the Nassau County jail’s former medical vendor failed to give adequate health care treatment that directly resulted in the deaths of three inmates in 2016. The vendor, Armor Correctional Health Services, are fighting four federal lawsuits connected to other Nassau inmate deaths, according to the New York State Commission of Correction.

Armor, the Florida-based, for-profit company has worked with the Nassau County jail in East Meadow for six years. That affiliation ended August 31 when the Nassau University Medical Center resumed control of inmate health care under a two-year contract, reports Newsday.

NY State Agency Findings

After investigating the 2016 deaths of three inmates at Nassau County jail, the state commission concluded that Armor was “incapable of providing competent medical care.” The commission found one of the fatalities preventable, another inmate was suffering from cancer that went unrecognized by a doctor, and that medical staff committed “professional misconduct” and acted with “gross incompetence” while treating the other late inmate, according to records.

The state commission disclosed three final reports after investigations into the deaths of inmates William Satchell, 63, Emanuel McElveen, 20, and Michael Cullum, 62 in 2016. In each case, the agency’s final reports on the deaths cited “systemic deficiencies in the delivery of adequate medical care,” and Armor’s “continued failure and unwillingness” to address problems after the commission’s probes into inmate deaths since mid-2011.

National law firm Parker Waichman LLP has extensive and successful experience in all kinds of litigation. Attorneys at the firm are available to answer questions for individuals seeking legal information for potential lawsuits.

Letter Exchange Between Commission Chairman and Armor Executive

In a letter referencing the then-preliminary findings, commission Chairman Thomas Beilein wrote in March to Gonsalves (R-East Meadow), “The Board has found in each instance that failures of Armor Inc.’s staff to perform to minimally accepted community medical standards has directly resulted in these terminal outcomes.”

Documents related to the reports also reveal the recent investigations led the commission’s chairman to conclude that the Sheriff’s Department shares responsibility with Armor for neglecting to initiate meaningful reforms after previous jail custody fatalities. The commission found Armor provided inadequate care in a minimum of eight of the 14 Nassau inmate deaths during the company’s tenure. The panel is still investigating four of the deaths. In two of the deaths, the commission found no treatment inadequacies – one involving a natural death by stroke, and one a deadly assault by another inmate.

Armor executive Karen Davies, wrote in a letter in May to the commission defending Armor insisting its staff showed no negligence or incompetence with its care of the three deceased inmates, according to Newsday.

Armor settled the suit by paying a $350,000 fine, agreeing to a three-year ban on new business in New York, and admitting no wrongdoing.

Reported Details of Three Inmates’ Deaths

One of the deceased, Satchell, died on March 24, 2016, from cardiac arrest due to an artery blockage in his lungs. The commission concluded the death “was preventable if not for the shocking level of inadequate medical care and negligence of the medical staff” of Armor. It said Armor repeatedly failed to recognize “life-threatening manifestations” of “a new onset medical condition” – or diabetes. The inmate was also given an antipsychotic known to increase blood sugar level, possibly triggering the onset of his “unstable condition,” the commission found. It was alleged that the inmate did not get medication until three days after his jailing and Armor failed to do a routine screening that led to a delay in the inmate’s diabetes treatment.

The report on McElveen said, the inmate died July 5, 2016 of respiratory failure. It concluded the man’s death was caused by a preexisting medical condition, but the negligence of Armor “were contributory to his worsening health.” The report said Armor did not adequately identify and treat his illnesses or follow up on medication issues. The report shows one of McElveen’s illnesses was large cell lymphoma, or cancer, that involved multiple organs.

The commission also concluded an Armor doctor neglected to provide proper medical supervision, did not do thorough exams or follow-ups on lab tests, and failed to detect McElveen’s developing cancer. McElveen had been serving a one-year jail sentence for a misdemeanor charge of unauthorized vehicle use, reports Newsday.

One week before he died, McElveen said in a jail grievance that Armor staff had not seen him following several requests. He had pain all over, hearing loss, swollen feet, facial numbness, and an allergic reaction, according to the report.

The third inmate, Cullum, died September 5, 2016, after a blood clot formed in his leg and went to his lungs. The commission said pancreatitis and opioid dependency also were contributing factors to his death. The commission found Cullum’s death was “impacted’ by Armor’s failure to adequately treat chronic illness, recognize and treat serious changes in his condition, or to transfer him to a higher level of care.

The inmate had been in a methadone treatment program, according to records. The commission found an Armor doctor showed gross incompetence by failing to see the need to send Cullum to the hospital when his condition worsened, and an Armor licensed practical nurse showed “unprofessional conduct by breaking detoxification protocol.”

Legal Information Concerning Potential Lawsuits

If you or someone you know is seeking legal information, Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact the attorneys at 1-800-YOURLAWYER (1-800-968-7529).

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Australian Officials Report 56 Cases of Breast Implant Cancer

Breast implant-associated anaplastic large-cell lymphoma (ALCL) is a rare type of cancer that develops around breast implants. Australian health officials reported 56 cases of ALCL, including three deaths since 2007. The U.S. Food and Drug Administration (FDA) has reported eight deaths and more than 359 cases in the United States of ALCL in women with breast implants, reports the Daily Hornet.

Textured breasts implants, were more likely to cause cancer than smooth-surfaced breast implants, warns the FDA. Australian researchers published a study recently estimating that textured breast implants were 14 times more likely to cause ALCL than implants that are smooth-surfaced. In Australia, 90 percent of women with breast implants have textured-surface implants.

Textured Breast Implants are More Prone to Cause Cancer

Another study in Australia in 2014, revealed that textured breast implants were more likely to develop a bacterial coating called “biofilm.” This may cause low-level inflammation and immune system reactions that may cause lymphoma to develop in the fluid surrounding the implant.

Textured implants, which are treated with chemicals that etch the pouch surface, were introduced in the early 1990s. This was approximately five years before the first report of implant lymphoma. Texturing keeps the device firmly in place because scar tissue grows into the rough surface.

ALCL is a cancer that grows rapidly and it can be deadly if not treated. Symptoms include fever, fatigue, loss of appetite, night sweats, weight loss, and swollen lymph nodes in the neck, armpit, or groin, according to the Daily Hornet.

National law firm Parker Waichman LLP has extensive experience representing clients in all kinds of litigation. Our lawyers are available to answer questions for anyone seeking legal information about filing a lawsuit.

ALCL Case Histories

A Southern California woman decided to have a breast augmentation in 2000 and opted to get silicone pouches filled with saline. She considered this a safe choice, but in 2011, she experienced a “stabbing pain” in her left breast, which had ballooned because of swelling around the implant. She was diagnosed with a new type of lymphoma – a cancer of the immune system = caused by implants. The malignancy is distinct from breast cancer and very rare.

The FDA had first warned of a link in 2011. The lymphoma has been connected to both saline and gel implants, for enlargement as well as for reconstruction after breast cancer. Most patients in these cases had textured rather than smooth implants.

Since implants were introduced in the 1960s, for the first time, medical authorities, including the World Health Organization (WHO), agree that the prosthetics give rise to a disease in susceptible women. Some experts believe the controversial theory that implants can trigger debilitating autoimmune illnesses such as lupus, scleroderma, and fibromyalgia, as many women have contended since the 1990s, according to the Inquirer.

Robert Miranda, a pathologist at MD Anderson Cancer Center in Texas said, “To me that has to be evaluated again.” The Cancer Center has treated approximately 40 women with implant-related lymphoma.

The first recognized implant-related case of lymphoma was in California in 1997. By 2010, after a few dozen more case reports, Miranda and some other researchers noted it was a new disease entity: a rare blood cell malignancy, with even rarer genetic hallmarks, that developed around breast implants

In late 2016, the National Comprehensive Cancer Network, based in Fort Washington, issued diagnosis and treatment guidelines. Since the lymphoma is typically not aggressive, it can usually be treated by removing the implant, fluid, and the capsule of scar tissue that naturally forms around the prosthetic, the Inquirer reports.

However, the cancer can become life-threatening, as a woman from Ontario, Canada found out. She had no symptoms until the day after her first mammogram at age 50 in 2015. Her results were normal, but she felt lumps under an armpit. Her physician assumed the mammogram had ruptured her six-year-old textured gel implants. Ultimately, an MRI and biopsy revealed lymphoma that had spread to her bowel and lymph nodes.

Following two chemotherapy regimens that failed, doctors estimated the woman had six months left to live. A newer, targeted Hodgkin’s lymphoma drug saved her, but she still had to undergo a risky stem cell transplant as well as chest radiation.

Through her ordeal, she has become an activist. The woman founded a Facebook group for implant lymphoma patients, made a YouTube video, and recently met with the FDA about improving patient information, the Inquirer wrote.

“We want women to have objective, seamless information,” she said. “Implants are described as FDA approved. The truth is, implants were conditionally approved in 2006, and as of today, these conditions have not been met.”

Legal Information and Advice for Women

If you or someone you know has developed an illness as a result of a breast implant, you may have valuable legal rights. Parker Waichman LLP personal injury lawyers offer free, no-obligation case evaluations. We urge you to contact our attorneys at 1-800-YOURLAWYER (1-800-968-7529).

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New Study Examines Flu Vaccine Connection to Miscarriages

A new study published in Vaccine on September 13 is causing some concern for pregnant women who have received the flu vaccine or are considering it. The study of pregnancies in the United States found that women who had miscarriages between 2010 and 2012 were more likely to have had back-to-back annual flu shots that included protections against the H1N1 virus (swine flu).

The Centers for Disease Control and Prevention (CDC) has reached out to a doctor’s group, the American Congress of Obstetricians and Gynecologists, to warn them the study is coming out and help them prepare for a potential wave of worry from expectant mothers, CDC officials said.

Increased Incidence After Repeat Vaccine

“We are not saying this is a causal relationship,” said James Donahue, DVM, PhD, MPH, a senior epidemiologist at the Marshfield Clinic in Wisconsin and the lead author of the study, meaning the data does not necessarily show that the flu vaccine causes miscarriages. “There’s no biological basis for this phenomenon, so the study represents something that wasn’t expected.”

The study was conducted over two flu seasons (2010 to 2012), and involved 485 women. These women who experienced spontaneous abortion, or miscarriage, were matched with those who delivered full-term or stillbirths. Donahue and fellow researchers were examining if miscarriages were more apt to occur if a woman received the flu vaccine in the 28 days prior to the spontaneous abortions. The case-control study was funded by the CDC, according to CIDRAP (Center for Infectious Disease and Research Policy) News.

It was found by researchers that no association between miscarriage and flu vaccine appeared if a woman had not received a vaccine in the previous year, but in women who had consecutively gotten a flu vaccine containing the 2009 H1N1 virus, the investigators found an adjusted odds ratio (aOR) of 7.7. The women not vaccinated in the previous season had an aOR of 1.3. This increased association was seen in both seasons studies.

In the 28-day window, the overall aOR was 2.0, or double the risk, however those findings, in contrast to the H1N1 subset, were not statistically significant. There was no visible association in any other exposure window, reports CIDRAP News.

National law firm Parker Waichman LLP has extensive experience and success representing clients in all kinds of litigation. Lawyers at the firm are available to answer any questions you may have about pursuing a case.

Previous Studies Involving Flu Vaccine and Miscarriage

“In a previous study conducted on flu vaccine and miscarriage, we did not see a risk,” Donahue said, referring to research done from 2005 to 2007. That study was performed after the CDC made the recommendation 2004 that all pregnant women in all trimesters get the seasonal flu shot. After the 2009 H1N1 pandemic, the CDC requested a follow-up study.

“We can speculate that what we see here is vaccination with H1N1pdmo9 for the first time is like getting primed, then boosted,” said Donahue. “But now H1N1 is just a circulating seasonal virus; most children and young adults have been exposed by infection or vaccination.” In other words, there may have been a real effect in the seasons on the heels of the 2009 pandemic, however, further study will fail to show this association. Donahue and his co-workers are planning a follow-up study that examines more recent flu seasons and triples the number of cases, reports CIDRAP News.

Further Investigation Necessary

A research professor of global health at George Washington University, Lone Simonsen, PhD, said the timing of the study is of interest. She has done her own research showing that in 1918, when the world had another H1N1 pandemic that was worse than in 2009, the number of women who miscarried were as many as one in ten.

“In this case getting the flu vaccine can be like being introduced to a virus that was evolutionarily quite similar to the virus from 1918, she told CIDRAP News.

However, she also said the new study included only women with documented miscarriage. “Who are the women that document a miscarriage at 5 weeks?” asked Simonsen. “Probably someone who is also likely to get a flu shot.” If this is true, that may throw off numbers showing an association.

In an accompanying commentary in the same journal, three United States experts not taking part in the study said that miscarriage is one of the hardest birth outcomes to study in observational research.

“Among other factors, the high proportion of [spontaneous] abortions [SAbs] that take place in clinically-unrecognized pregnancies and the lack of consistency in accurate capture of these events in medical records when SAbs do occur, make such research difficult to carry out,” they write. After pointing out what they see as limitations of the study, and the implausibility of the prime-boost hypothesis, the experts write, “One important take-away message from this study is that seasonal vaccine formulations are not all the same.”

Both Donahue and Edward Belongia, M.D., the director of the Center for Clinical Epidemiology & Population Health at the Marshfield Clinic and a study coauthor, said this study in no way suggests reversing or revising the CDC’s advisories relating to pregnant women and flu shots.

“It’s very well known that getting the flu is bad for pregnant women and bad for the baby, and we have a vast amount of safety data on the vaccine,” said Belongia.

Legal Information and Advice About Flu Shots

If you or someone you know has been negatively affected by a flu vaccination, you may have valuable legal rights. The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

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Brixat Recalls Infant Car Seats due to Potential Choking Hazard

Britax Child Safety is recalling over 207,000 rear-facing infant car seats because part of a clip can break and cause a choking hazard. Britax says in government documents that since February, three customers found broken chest clips in the mouths of children but no choking injuries were reported, according to the Daily Hornet.

The company traced the cause to customers putting pressure on the clips, which help to properly position the harness straps. Britax advises that customers can safely continue using the seats if they remove the chest clip or monitor a center tab for signs of breakage. Britax will notify owners and provide a new chest clip, reports the Seattle Times. Britax has set up a website for owners to determine whether their seats are being recalled and for additional information.

The following model numbers are affected, if they were manufactured between November 1, 2015, or after May 31, 2017:

B-Safe 35 & Travel Systems E1A183F, E1A185M, E1A185P, E1A186R, E1A203F, E1A205M, E1A205P, E1A206X, E1A206Z, E1A207E, E9LU65V, E9LU66X, E9LU66Z, E9LU67D, E9LU67E, EXA185M, S02063600, S02063700, S03803400, S03803500, S03803700, S03803800, S03803900, S04144400, S04144500, S04144600, S04145000, S04402800, S04884200, S04884300, S04975600, S04978900, S05260200, S06020300, S06020400, S06020500, S06020600, S06020700, S06020800, S06020900, S06147100, S921800, E1A193F, E1A195M, E1A195P, E1A196X, E1A196Z, E9LV16R, E9LV17D, S04144700, S04144800, S04144900, S04183700, S04183800, S04437700, S04884400, S04884500, S06051400, S06051500, S06051600, S06051700, S06051800, E1A233F, E1A235M, E1A235P, E1A236X.

Warranty Replacement Part: S03421600

B-Safe 35 Elite & Travel Systems E1A215T, E1A215U, E1A216P, E1A221Q, E1A225C, E1A225U, E1A226L, E9LS51Q, E9LS56C, E9LS56L, E9LS57F, E9LS57G, E9LS57H, EXA216L, S01298600, S02063800, S02063900, S02064000, S04281200, S04281300, S04628500, S06018800, S06020000, S06020200, S92370, E9LV21Q, E9LV26C, E9LV26L, E9LV27F, E9LV27G, E9LV2Q8, S01298700, S04184000, S06051300, E9LT15U, E9LT16C, E9LT16L.

BOB B-Safe 35 by Britax E9LT34A, E9LT34C, E9LT35X, EXLT34A, E9LT54A, E9LT54C, E9LT55X

Britax reported that it began seeing an increase in warranty claims due to chest clip damage in October 2016, one year after the company changed the material it used to make the clips in response that they were too easily opened. “The chest clip is not a required safety device: it is added to the harness system to help position the shoulder straps,” the notice said.

  National law firm Parker Waichman LLP has extensive experience and success in representing clients in product liability litigation. Our attorneys are actively reviewing cases on behalf of individuals who are seeking information for those interested in filing a potential lawsuit.

Prior Britax Car Seat Recall

In January 2016, Britax received reports of cracks developing around the carry handle on some infant car seats. This could allow the handle to break and a baby to be injured. This does not affect the crash-worthiness of the car seat. Do not use the carry until you have received and installed the repair kit. Affected car seats were manufactured between October 1, 2014, and July 1, 2015. For a complete list of B-Safe 35, B-Safe35 Elite, and B-Safe 35 Travel System model numbers affected, please visit the Britax website.

  Car seat recalls are not very common, but on occasion, companies must recall car seats in order to better protect your baby. You should register your car seats with the manufacturer to receive the fastest notification of any applicable recalls. If your car seat is not yet registered, you can do so easily by calling the manufacturer (there should be a phone number right on one of the car seat labels) or visiting their website.

It is also recommended to check National Highway Safety and Traffic Administration’s (NHTSA’s) extensive recall list if you borrow a car seat from a friend or have to use an older car a seat again after a period of non-use.

Graco My Ride 65

On May 10, 2017, over 25,000 Graco My Ride 65 convertible car seats were recalled because the harness webbing may n adequately restrain a child in a crash.  Graco will provide registered owners with a replacement harness.

Baby Trend Hybrid LX 3-in-1 Centennial

December 19, 2016, a small number of Baby Trend Centennial 3-in-1 boosters were recalled because the center adjuster rivet could pull through or break if it is used with a child that weighs more than 40 pounds.

Kiddy World Plus

Nearly 1,500 Kiddy World Plus combination car seats were recalled on April 29, 2016, because the buckle may only partially engage, and may not sufficiently protect a child in case of a crash.

Evenflo Transitions 3-in-1

Transition car seats manufactured before January 29, 2016, were recalled because a child could reach the center front harness adjuster and loosen the harness. This could allow a child to be improperly restrained, which might lead to injury in a crash. Evenflo provides a remedy kit to prevent a child from reaching the harness adjuster.

  Information on Filing a Product Liability Lawsuit

If you or someone you know has been injured by a defective or recalled product, you may have valuable legal rights. Attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information contact us at 1-800-YOURLAWYER (1-800-968-7529).

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Medtronic Recalls Insulin Sets due to Hypoglycemia Risk

On September 11, Medtronic announced that it has begun to inform patients worldwide of a voluntary recall of certain lots of infusion sets used with all models of Medtronic insulin pumps. Infusion sets help connect an insulin pump device to the body. The recall involves a certain discontinued component in these infusion sets and does not include glucose sensors or insulin pumps.

Insulin Over-Delivery Risk

Medtronic determined that a component, the vent membrane, in the recalled infusion sets may be prone to being blocked by fluid during the process of priming, or the removal of air bubbles. This may lead to potential over-delivery of insulin shortly after an infusion set change, which may bring on hypoglycemia (low blood sugar). The Dublin-based company received reports of hypoglycemia requiring medical intervention, potentially linked to this issue, Medtronic said.

Now manufactured infusion sets, available since April 2017, include a design update of this component which Medtronic believes reduces the risk of insulin over-delivery after an infusion set change.

National law firm Parker Waichman LLP has extensive experience and success in representing clients in defective medical device litigation. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit.

“Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients,” said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic. “Our Medtronic Diabetes team will work as quickly as possible to complete all exchanges to the new and enhanced set and fully support our customers throughout this process.”

Pump Malfunction and Severe Hypoglycemia Case

In July 2015, a product liability lawsuit was filed by a New York man who alleged that a Medtronic MiniMed Paradigm insulin pump caused him to suffer severe hypoglycemia due to a pump malfunction. The complaint was filed in the Southern District of New York alleging that the Medtronic MiniMed pump had a faulty design, resulting in a failure to deliver the appropriate amounts of insulin to control his diabetes.

The plaintiff indicated that he began using the MiniMed Paradigm insulin pump in 2010, in an effort to manage and control his type 2 diabetes. In June 2012, the complaint indicates that the plaintiff lost consciousness in his bathroom, falling and injuring his face and hip. He was diagnosed with hypoglycemia, which the lawsuit maintained was due to the malfunctioning insulin pump.

The plaintiff accused Medtronic of failure to warn, designing and manufacturing a defective product, negligence, and breach of warranty, seeking both punitive and compensatory damages.

During the Medtronic MiniMed pump lawsuit, allegations were raised that there have been known issues with the device for years, but Medtronic neglected to take appropriate actions to prevent consumers from suffering serious injuries.

Prior Medtronic Complaints and Recalls

In 2009, the FDA accused Medtronic of dragging its feet on addressing customer complaints in a warning letter that revealed that the company waited 18 months before reporting a MiniMed Paradigm Insulin Pump device malfunction. The company is required to report an incident within 30 days.

In September 2014, Medtronic issued a MiniMed Paradigm insulin pump recall for over half a million units following reports that programming errors led to patients receiving an incorrect dose of insulin. At least one report of hypoglycemia was associated with the problem, which caused some users to inadvertently give themselves the maximum insulin dose.

Medtronic issued a MiniMed Paradigm infusion set recall in June 2013, because fluid could get into vents, preventing the pump from priming properly, which could cause severe or even fatal health problems for diabetics. It was one of four recalls or urgent device notifications regarding Medtronic’s insulin pumps that year alone.

In 2009, Medtronic Inc., issued a similar recall for approximately three million Quick-set infusion sets used with its MiniMed Paradigm insulin pumps, due to a manufacturing defect that could result in the delivery of incorrect doses of insulin and cause injury or death for diabetics using the Medtronic insulin pumps.

After that recall, a number of Medtronic infusion set lawsuits were filed on behalf of patients who suffered serious injury or death when they received too little or too much insulin.

Legal Help for Diabetes Medication Issues

If you or someone you know has been affected by defective diabetes devices or medications, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).

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Cook IVC Filter Complications Lead to Massive MDL

A complaint by a South Carolina woman involving a Cook IVC filter joins a multidistrict litigation (MDL) against the medical device manufacturer. The plaintiff alleges that the Cook Celect Vena Cava (IVC) Filter she had implanted in July 2010 has caused her serious injury. She claims that Cook was aware of the problems associated with the devices and intentionally failed to warn patients and the medical community of the dangers and disadvantages of its IVC filters.

IVC filters are small, spider-like medical devices implanted into the vena cava, and have been used since the 1960s. By 2012, about 259,000 filters had been inserted as a temporary measure to impede blood clots before they have an opportunity to travel from the legs and pelvic region to the lungs or heart. The inferior vena cava is a major vein that returns blood to the heart from the lower part of the body. The IVC is used as an alternative for those patients for whom anticoagulants or blood thinners are not an option, according to the Mayo Clinic.

Cook IVC Filter Complications

The Cook Celect IVC filter has four struts to anchor the device and eight independent secondary struts to center the mechanism and trap potential blood clots. Plaintiffs in the Cook IVC MDL allege the company was aware the struts could break off as they were not affixed strongly enough to withstand normal anatomical and physiological movement within the body. Despite knowing this, the IVC filters were widely promoted as a safe and effective treatment for the prevention of pulmonary embolisms by way of placement in the vena cava.

The Cook filters were designed as a temporary measure and to be retrievable, but a study revealed that of 130 retrieval efforts made between July 2006 and February 2008, 33 failed. Either the struts had penetrated the vena cava wall, or tissue grew around the small hooks of the IVC filters.

The product liability lawyers and personal injury attorneys at Parker Waichman are closely monitoring events in IVC filter litigation. Associates at the firm are available to answer any questions for individuals seeking information about filing a potential lawsuit.

Vena Caval Penetration

Between August 2007 and June 2008, a study of 73 patients implanted with the Celect filter found a “high incidence of caval filter leg penetration.” Caval penetration is a frequent, but clinically underrecognized complication of IVC filter placement, according to PubMed. Immediately after placement of a fluoroscopy-guided filter in 61 patients, four filters (6.5 percent) showed significant tilt. A subsequent abdominal CT (computed tomography) scan in 18 patients demonstrated filter related issues in seven (39 percent), which included penetration of filter legs in four and fracture/migration of filter components in one.

A story published in the March 30, 2011 journal Cardiovascular Interventional Radiology revealed that one hundred percent of Cook Celect and Guther Tulip IVC filters imaged after 71 days of implantation “caused some degree of filter perforation of the vena caval wall.” The filters that were studied had been implanted in 2009 between July and May. The same study showed that 40 percent of the filters had tilted, and that all the tilted filters had vena caval wall penetration.

Based on studies such as these, the Cook filter MDL says that Cook knew or should have known that their IVC filters were probably going to perforate the vena cava wall. An MDL is a type of mass tort that transfers lawsuits with common questions of fact to one court before one judge. This type of consolidation makes the legal process faster and more efficient because it eliminates duplicate discovery and streamlines proceedings. The Cook IVC Filter MDL case will take place in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.

FDA’s Controversial 510(k) Approval

Plaintiffs in the Cook litigation point out that IVC filters were approved through 510(k), meaning manufacturers did not have to submit clinical test data proving that devices were safe and effective prior to obtaining approval. This contrasts to the FDA’s normally strict premarket approval process which does mandate clinical testing. The 510(k) process is a fast-track route that only requires products to be “substantially equivalent” to a previously approved device, even if that device had safety issues of its own.

Substantial equivalence means that a product is at least as safe as its predicate. However, safety advocates have argued that 510(k) is not appropriate for certain medical products. The route was never intended for high-risk devices. Due to a regulatory loophole, however, some high-risk devices have been cleared through 510(k).

Have You been Injured by a Cook IVC Filter?

If you or someone you know has sustained injury associated with a Cook IVC filter, you may be eligible for valuable compensation. Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

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Jury Awards Record $57.1 Million in Transvaginal Mesh Case

On September 7, 2017, a Philadelphia jury awarded $57.1 million in damages to a Pennsylvania woman who was injured by pelvic mesh implants made by Johnson & Johnson’s Ethicon division.

The 51-year-old woman suffers constant pain and incontinence because the mesh migrated from the insertion site and damaged her urethra, Philly.com reports. Doctors operated three times to remove two devices.

This verdict is the largest awarded in a pelvic mesh suit. The award includes $50 million in punitive damages. In December 2015, an Indiana woman was awarded $12.5 million; a New Jersey woman received $13.5 million in February 2016. In April 2017, another New Jersey woman received $20, and a Pennsylvania woman received $2.1 million in June.

National law firm Parker Waichman notes that Ethicon is not the only mesh manufacturer facing legal action. Boston Scientific, C.R. Bard, Cook Medical, Coloplast, and American Medical Systems also face substantial numbers of lawsuits over their mesh products.

Pelvic Mesh Devices

Pelvic mesh—transvaginal mesh—is used to treat women’s pelvic organ prolapse (POP) and stress urinary incontinence (SUI). SUI and POP occur when the pelvic structures that support a woman’s uterus, bladder and intestines weaken due to childbirth, surgery, or aging. The organs drop (prolapse) into the vagina, causing incontinence and bowel and sexual problems.

The mesh device is implanted to provide support for the organs and relieve pain and other symptoms. Before transvaginal mesh came to market, surgery for POP and SUI involved creating support for the organs using the woman’s own tissues. Surgeons began using surgical mesh in the 1950s for hernia repair. Several decades later mesh products gained U.S. Food and Drug Administration (FDA) approval for POP and SUI surgeries.

Injuries and Complications

Women who have filed transvaginal mesh lawsuits allege they have suffered complications including

mesh protrusion into the vagina

infection

inflammation

nerve damage

scar tissue

organ perforation

painful intercourse

urinary and bowel incontinence

Many women who have experienced transvaginal mesh complications have needed additional surgery to attempt to remove the mesh and to repair organ damage. Often, however, these surgeries are not successful. Some women are caught in a cycle of repeated episodes of mesh erosion and surgery to remove protruding mesh. In other cases, the mesh has become embedded in the woman’s organs and cannot be removed. In legal documents, women have said they felt they were worse off after the surgery.

J&J Withheld Information about Complications and Injuries

Evidence introduced during the trial indicated that J&J manipulated the literature about problems with its pelvic mesh products and withheld information about complications and injuries from doctors, Philly.com reports.

Many of the lawsuits allege that Ethicon failed to warn the women and the medical community about potential complications. With adequate warnings about pelvic mesh complications, women say they would have chosen the older surgical technique.

In a 2011 safety communication for women and health care providers, the FDA said serious complications associated with transvaginal mesh “are not rare.” Further, the agency said, it is “not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

In January 2016, in response to thousands of lawsuits and reports of mesh failure and complications, the FDA issued two orders for transvaginal mesh devices. The first order reclassifies vaginal mesh devices from Class II, the moderate-risk device category to Class III, the high-risk category. The categories are assigned depending on how likely it is that a particular device will cause serious and permanent health consequences or even death. The second FDA order requires vaginal mesh manufacturers to submit premarket approval (PMA) applications to support the safety and effectiveness of their vaginal mesh devices.

Carl Tobias, who teaches product liability law at the University of Richmond in Virginia, believes Johnson & Johnson should consider a comprehensive settlement for all the pending pelvic mesh cases. “There’s no sense in continuing to shell out for the defense costs and suffer the reputation damage that comes with each win by the plaintiffs.” Tobias explains.

Help for Women Who Have Suffered Transvaginal Mesh Injuries

If you or someone you know has suffered injuries or complications from a transvaginal mesh device or have undergone additional surgery to remove the mesh or repair organ damage, the attorneys at Parker Waichman LLP can evaluate your legal options. For a free, no-obligation consultation, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

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Class 1 Recall for Some Datascope Intra-Aortic Balloon Pumps

A recall has been issued for CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps made before June 30, 2017 due to the risk of a valve failure which prevents the balloon from inflating and deflating. The U.S. Food and Drug Administration (FDA) has categorized this as a Class 1 recall. This is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Datascope Corp. and MAQUET expanded a recall issued earlier in the year to include 12,319 units of the CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps that were made from July 1, 2003 through June 16, 2017. The FDA warns that “device failure may result in immediate and serious adverse health consequences, including death” for patients who need circulatory support to survive. Electrical failure of the pump is linked to the death of one patient, reports the Daily Hornet.

According to the manufacturer, “The device failed to pump due to an electrical test failure, which has been associated to a patient death due to the failure of the device to initiate therapy.” The problem with the devices is a “false blood-detection alarm and ingress of fluid” into the Intra-Aortic Balloon Pump, said the FDA when it initiated the Class 1 designation, its highest level of safety recall.

The FDA warns that the balloon should not remain inactive in the patient (not inflating or deflating), for more than 30 minutes due to the potential for thrombus (blood clot) formation.

National law firm Parker Waichman LLP has extensive and successful experience representing clients in defective medical device litigation. Attorneys at the firm are available to answer any legal questions for individuals seeking to file a potential lawsuit.

Preventative Design Change

Datascope Corp./MAQUET initiated a design change in June 2013 to prevent the electrical failure that stops the balloon from inflating or deflating. The problem is that not all devices that were manufactured before June 13, 2013, were upgraded or serviced, the Daily Hornet reports.

In March 2011, the FDA announced a defective fan in the power supply could cause overheating and shut down the Intra-Aortic Balloon Catheter Pump without visible or audible alarms. The recall was designated as Class 1.

Function of an Intra-Aortic Balloon Pump

An intra-aortic balloon pump (IABP) is a mechanical device that helps the heart pump blood. The balloon pump is inserted into the aorta, the body’s biggest artery. It is a thin, long tube called a catheter with a balloon on the end of it. Done typically in a hospital setting, the doctor will insert an IABP. The area of the leg should be numbed by the physician who would then thread the IABP through the femoral artery in the leg, into the aorta. The IABP will then be positioned at the center of the aorta, below the heart. An X-ray machine used during this procedure will help to accurately position the IABP, according to WebMD.

An IABP is normally used for a short period of time, such as hours or days. A long-term treatment will likely be needed, such as valve surgery or the insertion of a left ventricular assist device (LVAD).

How an Intra-Aortic Balloon Pump Works

The IABP reduces the workload on the heart, which allows the heart to pump more blood. The IABP is inserted into the aorta, the artery that takes blood from the heart to the rest of the body. The balloon on the end of the catheter inflates and deflates with the rhythm of the heart.

The IABP improves the function of only the left ventricle, as this is the chamber that pumps blood into the aorta. After the left ventricle has contracted, the balloon inflates. This inflation helps increase blood flow to the heart and the entire body. As the left ventricle is about to pump out blood, the balloon deflates. This deflation creates extra space in the aorta, allowing the heart to pump out more blood.

IABPs may have some adverse side effects. An IABP may cause an infection in the bloodstream if it is used for too long. The balloon may overinflate and tear the aorta. The IABP is also somewhat uncomfortable. When this device is in place, the patient must lie extremely still, according to WebMD.

Legal Information and Advice Regarding IABPs

If you or someone you know has been involved in an incident involving medical negligence or complications with a medical device, such as an Intra-Aortic Balloon Pump, you may have valuable legal rights. Parker Waichman law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

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Research Finds Kids Near Ground Zero Face Increased Health Risks

Children who lived in lower Manhattan and were exposed to toxic clouds of debris from the terrorist attacks of September 11th are already showing signs of increased risk of future heart disease. It has been almost 16 years since the attacks, but a new analysis published in the journal Environment International studied blood tests of 308 children, half of whom were in contact with the toxic dust, the New York Post reports.

Recent Research Findings

The researchers from NYU Langone Health found that children whose blood contained chemicals known to have been in the debris had raised levels of artery-hardening fats in their blood. If left unchecked, higher levels of fat in their blood may lead to blood-vessel hardening, blockage, and heart attacks.

Chemicals that came from the particles of pulverized building materials, electronics, and the fires that incinerated the debris, released any number of disease-causing chemicals into the air. Children who lived near the World Trade Center were exposed to massive amounts of chemicals when compared with children who were not in the city on the day of the attack, according to the Post.

“Since 9/11, we have focused a lot of attention on the psychological and mental fallout from witnessing the tragedy, but only now are the potential physical consequences of being within the disaster zone itself becoming clear,” says lead study investigator and health epidemiologist Leonardo Trasande, an associate professor at NYU School of Medicine.

Study Advocates Early Intervention

However, the damage is not necessarily irreparable. According to Trasande, these risk factors can be addressed through diet and exercise. “[Our study] offers hope that early intervention can alleviate some of the dangers to health posed by disaster.”

Parker Waichman is a national law firm that has spent many years fighting to ensure that heroes and survivors of the September 11th terrorist attacks are never forgotten. The firm is committed to helping anyone seeking legal information concerning a potential lawsuit.

Previous Studies Involving Toxic Dust

Researchers have determined that dust and debris that hovered over lower Manhattan contained a toxic mix of compounds, including asbestos, pulverized cement, polychlorinated biphenyls (PCBs), benzene, dioxin, glass fibers, gypsum, fiberglass, jet fuel, heavy metals (including lead), irritants, toxins, and carcinogens. More than 90 health conditions, including 60 types of cancer, are believed to be a direct result of toxic exposure.

When the World Trade Center (WTC) towers collapsed on September 11, 2001, a massive cloud of toxic dust was produced. The dust, debris, and smoke from the burning rubble suspended over downtown Manhattan, exposed first responders, rescue and recovery workers and people who lived and worked in the area to toxins, irritants, and carcinogens. Particularly in the early days after the attacks, many rescue and recovery workers worked without proper protective equipment.

Many people exposed to 9/11 toxins became ill shortly after 9/11, but for others, illnesses emerged over time. Toxic 9/11 exposures frequently contributed to the worsening of previously existing health problems.

World Trade Center Health Program

As of June 30, 2016, 5,441 people enrolled in the World Trade Center Health Program had been diagnosed with 6,378 separate cancers, with some people suffering from more than one kind of cancer. Researchers say the 9/11 community is experiencing prostate and thyroid cancers, leukemia, lymphoma and multiple myeloma at a significantly higher rate than expected in the general population. Health experts expect 9/11 cancers as well as other serious health conditions to continue to emerge for years to come.

Zadroga Act and Victim Compensation Fund

The James L. Zadroga 9/11 Health & Compensation Act, became law in 2010 in order to provide aid to sick responders and survivors. It provides compensation, as well as medical treatment and monitoring. The Act was named to honor an NYPD officer who died of respiratory disease that developed as a result of his work at Ground Zero.

The 2015 Zadroga reauthorization extended health benefits for 75 years, until 2090, to ensure that all those who become ill because of September 11 would have the monitoring and care they deserve.

The Zadroga Act reopened the September 11th Victim Compensation Fund (VCF), which provides compensation to individuals who became ill and their families, as well as to the families of rescue workers who died due to a 9/11-related illness.

Legal Help for Those with WTC-Related Health Conditions

If you or someone you know has developed cancer or another illness that may be linked to 9/11 toxic exposure, the attorneys at Parker Waichman LLP can offer a free, no-obligation consultation on your right to compensation. For more information contact us at 1-800-YOURLAWYER (1-800-968-7529).

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Xarelto Anticoagulant Makers Face Internal Bleeding Lawsuits

An Alabama man was prescribed the anticoagulant Xarelto to treat his pulmonary embolism (blood clot in the lungs), but in a lawsuit the man claims the drug caused him to develop potentially fatal internal bleeding. Bayer HealthCare and Johnson & Johnson (J&J), the manufacturers of the medication, are facing a growing multidistrict litigation (MDL) as Xarelto lawsuits continue to increase in number.

The plaintiff had used the drug as prescribed, for its intended purpose only, had taken the medication according to prescription instructions, and followed medical advice. According to his Xarelto gastrointestinal bleeding lawsuit, he had only been taking the medication between April 2, 2016 and April 13, 2016.

Plaintiff’s Bleeding Complications

Despite following all instructions for use of Xarelto, the plaintiff reportedly suffered a number of internal bleeding complications including gastrointestinal bleeding, secondary gastrointestinal bleeding, acute anemia, and melena. Melena is the passage of dark, tarry stools containing decomposing blood that is typically an indication of bleeding in the upper part of the digestive tract.

The plaintiff had to undergo a number of blood transfusions and prolonged hospitalization due to these complications. The plaintiff’s doctor immediately stopped his Xarelto prescription and the plaintiff decided to file the Xarelto gastrointestinal bleeding lawsuit against the pharmaceutical giants after he found out other patients had suffered severe internal bleeding injuries.

National law firm Parker Waichman has extensive and successful experience representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer any questions for individuals seeking information about filing a potential lawsuit.

Xarelto Overview

The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. It was made available to patients as a joint effort between Bayer HealthCare and J&J to come into the established anticoagulant market. The approval of Xarelto came one year after Pradaxa, the first medication to be released since warfarin (brand name Coumadin) over 60 years ago. Xarelto, Pradaxa, Eliquis, and other more recently released blood thinners, are called the new generation anticoagulants.

The new generation blood thinners became popular rapidly as the tried and true warfarin requires regular monitoring and dietary restrictions, so the newer drugs were more convenient. However, plaintiffs remark that warfarin has a reversal agent to stop excessive bleeding, while, at this point, the newer blood thinners, other than Pradaxa, do not have a reversal agent to stop bleeding. Lawsuits allege that Xarelto manufacturers promoted the benefits of the drug while neglecting to warn about the lack of an antidote.

Praxbind was released in 2015 as Pradaxa’s bleeding antidote, five years after Pradaxa was approved and brought to market.

How Anticoagulants Work

Most often, Xarelto is prescribed to treat atrial fibrillation (an abnormal heart rhythm that increases the risk of a blood clot), for stroke prevention, deep vein thrombosis (DVT) and other blood clot risks. Xarelto is also used to prevent blood clots in patients undergoing a hip or knee replacement surgery.

Anticoagulants, including Xarelto, work by impairing the blood’s ability to clot. This is necessary to prevent serious, potentially fatal complications in some patients. However, there are situations where physicians may need to counteract the drug’s blood thinning effects, such as during an uncontrollable brain or GI (gastrointestinal) bleed, or emergency surgery in case of an accident. However, this also prevents the body from recovering from internal bleeding injuries which could result in fatalities.

Failure to Disclose Potential Risks

At the time of Xarelto’s release, Pradaxa was dealing with intense criticism for internal bleeding issues. Patients maintain that J&J and Bayer were absolutely aware of potential problems and they knew or should have known about the potential Xarelto internal bleeding issues.

Purpose of MDL

The Alabama man’s Xarelto gastrointestinal bleeding lawsuit is joining an MDL where it will stand with other claims alleging similar complaints. By joining the MDL, the Xarelto gastrointestinal bleeding lawsuit will be streamlined through the court process consolidating cases and proceeding in one court before one judge. This lowers court costs, avoids duplicate evidence, allows a faster outcome, and is typically more efficient.

In this case, the plaintiff is seeking compensation for medical costs and is alleging multiple counts of negligence and failure to warn. The trial will take place in the U.S. District Court for the Eastern District of Louisiana. The plaintiff says he would never have used Xarelto if he had been aware of the risks of potentially fatal Xarelto internal bleeding occurrences.

Legal Help for Xarelto Users

If you or someone you know suffered adverse side effects, such as uncontrollable bleeding due to the use of Xarelto, you may have valuable legal rights. The attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, contact our personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).

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Surgical Hernia Mesh May Increase Patient’s Problems

The decision to have surgery is always a difficult one, especially if there is controversy in the medical device involved. A woman in Canada suffering from a hernia was advised by her physician to have abdominal mesh surgically implanted to avoid possible hernia complications, including bowel obstruction. What was meant to be a routine surgical procedure has resulted in the patient suffering debilitating pain and thinking she might have been better off if she had avoided the surgery.

What increased the woman’s frustration was that after she had the surgery, she found out that not all hernias need surgery and in some cases, it is better to wait. In 2006, studies revealed that “watchful waiting” may be an acceptable alternative to surgery, according to research published in the Journal of the American Medical Association. The researchers based this on men with inguinal (groin) hernias who have few or no symptoms.

Studies Involving Hernia Mesh Surgery  

Based on a statement from researcher Dr. Robert J. Fitzgibbons, Jr., historically, hernias that have no symptoms should be surgically repaired as they become more difficult to fix with time, reports WebMD. However, he went on to say, that is not the case. David R. Flum, MD, MPH, a gastrointestinal surgeon said this study confirms that watchful waiting is a suitable strategy for the treatment of hernias that do not have symptoms other than bulging.

The question arises who to blame: the doctor, the hospital, or the mesh manufacturer. The woman who had crippling pain after receiving the hernia mesh, maintains she had a large lump in that area significantly larger than before her mesh implant surgery. She also was constantly fatigued and had a low-grade fever. She decided her only option was to have the mesh removed, and that the mesh device was most likely defective.

The product liability attorneys at Parker Waichman LLP have extensive experience representing clients in medical device injury litigation. Associates at the firm are available to answer questions for anyone seeking legal information for filing a hernia mesh lawsuit.

Potentially Permanent Damage

It is necessary for the woman to follow up on her suspicion to determine if the hernia mesh is truly defective and the reason for her bowel obstruction. There is a possibility that some of the damage caused by a potentially defective mesh, especially nerve damage, may be permanent. The woman maintains that she was never told about any possible risks linked to this mesh and believes her doctor was unaware of those risks.

Scar tissue typically forms post-surgery at the stitching or surgical site. This is to be expected and is normal, according to the Journal of the Society of Laparoendoscopic Surgeons (JSLS). However, any foreign body, such as a faulty hernia mesh, may produce enough scar tissue to interfere with nearby organs like the small and large intestines. These adhesions, or scar tissue may in turn be the trigger for a bowel obstruction.

Statistics in Canada

In Canada, in April 2017, CTV News reported that hernia mesh complications are a serious concern. Since 2000, some 12 brands of hernia mesh have been removed or recalled from the Canadian market, according to data from health regulators. Reported injuries include perforations and infections. Hernia mesh implant devices were linked to 185 reports of serious injury, including three fatalities.

The president of the Canadian Hernia Society, Dr. John Morrison remarked, “I’ve seen pictures of it in the bladder, I’ve seen mesh in the stomach. The mesh can erode into other organs over a period of time.” Dr. Morrison added that studies suggest that 10 to 20 percent of hernia mesh patients are left with chronic pain.

Lawsuits Against Hernia Mesh Manufacturers

Hernia mesh lawsuits are being filed against Johnson & Johnson and Ethicon over the Physiomesh Flexible Composite Hernia Mesh. In May 2016, the device was withdrawn from the market subsequent to data from two large, independent hernia mesh registries that revealed that Physiomesh was associated with higher rates of recurrence and reoperation.

Physiomesh plaintiffs claim that the device is defective and caused injuries. Ethicon is accused of failing to warn about the potential risks. The first Physiomesh trial in the United States is scheduled to begin January 22, 2018, according to court documents. The plaintiff is a man who suffered an infection, two years after having the hernia mesh implanted. His infection led to subsequent complications, including intestinal fistulas and two abdominal abscesses.

Legal Help for a Hernia Mesh Lawsuit

If you or someone you know suffered injuries related to the use of a hernia mesh device, you may be eligible for compensation. The lawyers at Parker Waichman offer free, no-obligation case evaluations. For more information, we urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

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JPML Approves Proton Pump Inhibitor MDL

PPI Multidistrict Litigation Assigned in U.S. District Court New Jersey

The Judicial Panel on Multidistrict Litigation (JPML) entered an Order consolidating the Proton Pump Inhibitor (PPI) multidistrict litigation (MDL) 2757 (Nexium, Prevacid, et. al) on August 2, 2017. The PPI MDL has been assigned to Judge Claire C. Cecchi, United States District Court of New Jersey.

The consolidation was based on July 27, 2017 consolidation hearings held at the Los Angeles Federal Courthouse. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757. The case filings have significantly increased since the first JPML hearing took place on January 26, 2017 in Miami, Florida.

The medications at issue are Prilosec, Nexium, Protonix, and Dexilant as well as numerous generic versions of PPIs. The Order lists over 163 cases in 28 federal district courts. The defendants in the litigation are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc., and Pfizer subsidiary, Wyeth.

MDLs are created to help make complex litigation, such as this PPI litigation, more efficient. MDLs are a type of mass tort that centralizes lawsuits with common factual allegations. MDLs are organized in one court and are heard before one judge for consolidated, pretrial proceedings. Such centralization enables for more rapid movement of the legal process by streamlining litigation, eliminating the need for duplicate discovery, and eradicating inconsistent pretrial rulings. Lawsuits in an MDL remain separate and plaintiffs are treated individually. This is unlike a class action lawsuit in which the entire class is treated in the same way. In MDLs, plaintiffs share the same basic allegations; however, the seriousness of plaintiffs’ injuries may vary between cases.

Parker Waichman continues to offer free legal consultations to individuals who suffered kidney injuries, including acute interstitial nephritis, chronic kidney disease, and renal failure after taking a PPI product. Contact one of our experienced drug injury attorneys today for more information.

PPI Injuries, Research

PPI medications are used to prevent and treat acid-related conditions such as esophageal, duodenal, and stomach ulcers; nonsteroidal anti-inflammatory drug- (NSAID) associated ulcer; ulcers; gastroesophageal reflux disease (GERD); and Zollinger-Ellison syndrome (a rare condition in which gastrinomas [tumors that form in the pancreas or duondenum (upper small intestine) secrete the hormone, gastrin, causing the stomach to produce too much acid). PPIs in combination with antibiotics are also sometimes prescribed to patients diagnosed with helicobacter pylori, a bacterium that, with acid, causes ulcers of the stomach and duodenum.

The plaintiffs involved in this litigation similarly allege that PPI medication cause kidney injuries that include acute interstitial nephritis, chronic kidney disease, and end-stage renal disease.

In 2011, consumer advocacy group, Public Citizen, brought concerns about these drugs having harmful side effects for users’ kidneys to the attention of the U.S. Food and Drug Administration (FDA). The Agency mandated warnings about risks of acute interstitial nephritis on PPI medication labels in 2014, according to the plaintiffs’ MDL brief; however, the labels have never been revised to indicate any other potential kidney side effects. Plaintiffs also allege suffering renal failure due to taking a PPI. To date, more than 5,000 PPI cases are under investigation by plaintiff’s counsel. More are expected as awareness of the association between PPI use and kidney damage continues to increase.

More recent research have led to additional findings concerning a tie between PPI and kidney diseases and kidney failure. Over 15 million Americans used prescription proton pump inhibitors; however, estimates indicate that, between 25 percent and 70 percent of these PPI prescriptions have no appropriate indication. Meanwhile, research has revealed ties between proton pump inhibitors and various adverse side effect, including fractures, dementia, kidney damage, heart disease, and birth defects. The drug class first received FDA approval in 1989. The plaintiff’s brief indicate that several studies have made a tie between the use of PPIs and kidney damage over the past 25 years, including a 1992 study conducted by the University of Arizona Health Sciences Center and a 2006 study conducted at the Yale School of Medicine.

In 2016 and 2017, the following research was conducted:

2016: Research published in the American Medical Association’s (AMA) journal JAMA Internal Medicine suggested that PPIs potentially increase risks for chronic kidney disease by as much as 50 percent. Research on proton pump inhibitor use, especially long-term PPI use, tied the drugs to increases in bone fracture, pneumonia, and Clostridium difficile. Researchers concluded that PPI use was associated with a 20-50 percent increased risk of developing chronic kidney disease.

2016: Research published in CMAJ Open tied PPIs to an increase in the risk for acute interstitial nephritis by three times and a 2.5 times increased risk of developing acute kidney injury.

2016: JAMA Internal Medicine published a research revealing that PPI use was tied to a greater risk of chronic kidney disease and that PPIs are associated with acute kidney injury. Researchers reviewed data from over 10,400 patients and conducted a 12-year follow-up for the study. The findings were replicated in a cohort of over 248,000 patients.

2016: A Medical Daily report revealed evidence that tied PPI use to increased risks for developing chronic kidney disease, disease progression, and end-stage renal disease. The review of a national, comprehensive database revealed that, the proton pump inhibitor risks increased the longer the drug was taken. A prior observational study published by JAMA Internal Medicine and reported by Medscape Medical News revealed what was described as a significant 35 percent increase in developing chronic kidney disease risks associated with ever use of a PPI versus never use of a PPI.

2016: A paper published in the Journal of the American Society of Nephrologyreported that long-term users of proton pump inhibitors may make patients 96 percent likelier to develop kidney failure and 28 percent likelier to develop chronic kidney disease when compared to patients taking H2-blockers.

2017: Research published in Kidney International suggested that proton pump inhibitor users who develop chronic kidney disease may not experience any acute renal problems early on, leaving many PPI users unaware of the decline in their kidney function.

Filing a PPI Lawsuit

If you or someone you know is interested in filing a personal injury lawsuit involving a proton pump inhibitor such as Nexium, Prevacid, or Prilosec, please contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

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FDA Defends Use of Forced Air Thermal System During Surgery

The U.S. Food and Drug Administration (FDA) is reminding healthcare providers that use of the thermoregulation devices during surgery result in less bleeding, faster recovery times, and decreased risk for infection for patients. Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, help regulate a patient’s temperature during surgery. An electrical blower is used to circulate filtered temperature-controlled air through a hose into a blanket placed either over or under a patient., according to Medscape.

“The FDA recently became aware that some healthcare providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery),” wrote William Maisel, M.D., acting director of FDA’s Office of Device Evaluation, in an August 30 letter to providers.

FDA Assessment of Infection Risk

In their assessment of potential risk for surgical site infection with forced air thermal regulating systems, the FDA collected and analyzed the latest data available from multiple sources, including medical device reports, information from manufacturers, and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements.

National law firm Parker Waichman notes that the Bair Hugger surgical warming blanket is associated with hundreds of post-operative infections in patients who had joint replacement surgery. Attorneys at the firm are available to answer any questions for a potential lawsuit.

“After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infections,” Dr. Maisel wrote.

“Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process,” he said.

Thousands of Pending Lawsuits

Despite thousands of lawsuits that allege the device increases the risk of serious surgical infections, the FDA still finds a significant benefit to using the forced-air warming blankets. The Bair Huger Forced Air Warming Device, manufactured by Maplewood-based 3M Co., is a widely used system that is supposed to promote post-surgical healing and cut down on infections by maintaining a patient’s body temperature during surgery.

Over 2,000 people have sued 3M, claiming the company has covered up evidence that the device actually increases infection risk by spreading contaminants with blown air and waste heat. These concerns have led some hospitals to shy away from using the system. The FDA, however, has concluded from all the available evidence that hospitals and patients should continue to use the system in cases where it is “clinically warranted,” such as during joint replacement surgery, according to the Star Tribune.

“The agency has no conclusive evidence to establish an association between use of a forced air thermal regulating systems and an increased risk of surgical-site infection,” FDA spokeswoman Stephanie Caccomo said via e-mail.

General anesthesia can compromise the body’s ability to maintain a normal temperature, especially during major surgeries in which internal tissues are exposed to open air for long lengths of time. This unintentional hypothermia during surgery can increase infection risk, recovery times, and mortality rates, according to studies cited by 3M on its Bair Hugger website. Over 80 percent of U.S. hospitals have a Bair Hugger unit.

Bair Hugger Defends Its Importance

Those who are skeptical allege that the system may promote infection by moving contaminated particles around the patient, particularly bacteria from the non-sterile floor of the operating room. The lawsuits say 3M was aware of these risks yet failed to fix them. It was also alleged 3M tried to silence critics who could have exposed it.

According to the Star Tribune, over 2,600 patient lawsuits from all 50 states have been consolidated into a single federal case in Minnesota. Minnesota residents have also filed additional cases in state court. Judges in the state and federals courts in the past two months, have ruled evidence so far is not strong enough to grant requests to seek punitive damages against 3M.

“While it is undisputed that surgeries have been conducted using the Bair Hugger system for more than 25 years, plaintiffs present no evidence that any doctor has ever reported to 3M or (3M subsidiary) Arizant, that the Bair Hugger system cause his or her patient to develop a surgical site infection,” Ramsey County District Judge William H. Leary III wrote, August 18, in an order denying permission to seek punitive damages, the Star Tribune reports.

Have You been Negatively Affected by a Forced-Air Warming Blanket?

If you or someone you know has become ill from a forced-air warming blanket infection, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations.  We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).

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