Can Your Hip Replacement Kill You?

Angel Reyes III Defects, Medical Devices

Hip-Death-1024x768When Dr. Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson. He knew what he was asking for, but what he knew wasn’t enough to protect him from a defect in the device.

Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.

Johnson & Johnson withdrew the ASR XL model from the market in 2010, but continued to sell another similarly problematic model, the Pinnacle, until 2013.

More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdict for serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.

About 32 million Americans, or about one in 10, have at least one medical device implanted – from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.

Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.

Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.

Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.

With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

Truck Fatality Brings Death Toll From Defective Takata Air Bags to 15 in the U.S., 21 Globally

Angel Reyes III Auto Accidents, Defects, In The News

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Ford Motor Co. is warning owners of nearly 3,000 older Ranger pickup trucks not to drive them after learning that a driver was killed last year when a defective air bag made by Japanese supplier Takata Corp. ruptured in a crash.

Ford said the death happened on July 1 in West Virginia and was reported to the auto maker on Dec. 22. Ford inspectors confirmed days later that a faulty Takata air bag inflater ruptured, “resulting in a driver fatality,” the company said in a statement.

The fatality brings the death toll from defective Takata air bags to 15 in the U.S. and 21 globally, along with hundreds of injuries. Defective inflaters cause the air bags to rupture with too much force, spraying shrapnel inside the vehicle.

The faulty part has triggered the largest recall in history, covering 46 million vehicles in the U.S. and millions more globally. Less than half of the affected U.S. vehicles have been fixed, according to federal data.

The West Virginia death is the latest known fatality, according to National Highway Traffic Safety Administration, and underscores the urgency facing multiple auto makers and safety regulators as they work to get the potentially deadly air bags off the road.

Ford is urging owners of certain model-year 2006 Rangers to contact their dealers to have their trucks repaired at their homes or towed into a dealership. The company is offering free loaners while the work is done.

The auto maker said the death was the second reported fatality involving a Ford vehicle linked to a Takata inflater rupture. A South Carolina man was killed in a Ranger in January 2016.

10 Cars and Trucks that Cause the Most Injuries in a Crash

Though vehicle crash fatality rates have been steadily creeping upward with more cars – and especially trucks – hitting the road in the post-recession years, today’s models aren’t scrimping on the safety features. As many as 10 airbags are spread around a new vehicle’s cabin these days to provide maximum occupant protection in a collision, with a growing number of cars and trucks now offering advanced safety systems that can help drivers avoid getting into crashes in the first place.

But until perhaps all vehicles on the highway drive themselves, cars will still get into collisions, some due to weather conditions, others because of mechanical issues, but largely because of driver error. And while all vehicles are required to meet a set of complex federal safety standards and most cars get good grades in crash tests, as insurance loss statistics released by the Highway Loss Data Institute (HLDI) illustrate, some vehicles inherently protect their occupants better than others in a crash.

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Britax Recalls Car Seat: Chest Clip Choking Hazard

Angel Reyes III Defects

b-safe-clip-300x300Britax Child Safety has recalled several models of its B-Safe infant car seats because of a potential issue with the clasp that keeps a child restrained. The chest clip on some Britax car seats may pose a choking hazard for young children. For this reason, the company has issued a recall of dozens of models of its B-Safe car seats’ clips, including more than 200,000 affected seats in total.

Recalled clips include the ones on B-Safe 35, B-Safe 35 Elite, BOB B-Safe 35 infant seats, and accompanying travel systems, all manufactured between November 2015 and May 2017.

Britax has a fix: a kit to replace the dangerous chest clip. Customers who registered their carseats with Britax previously will automatically be sent the kit but if you have an unregistered affected car seat, you can contact Britax to get the safe clip. Either call 1-833-474-7016 or email Stroller.Recall@britax.com.

The replacement clip is more durable and less likely to come apart, according to the National Highway Traffic Safety Administration’s recall report. Once you get your replacement kit, the old hazardous clip will have “ABS” printed on it, while the new safe clip will have “PC.”

Car seats affected by the recall can be fixed using a free kit that can be provided by Britax. Check the company’s website for the model numbers of all affected car seats.

Faulty Airbags: Don’t Risk Injury or Death

Angel Reyes III Defects, In The News

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Faulty Airbags: Don’t Risk Injury or Death

 

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Airbags in the 2001-2003 Honda and Acura models shown here are the most dangerous. If you drive one of these vehicles, you face as high as a 50% chance of serious injury or death if your airbags are activated. Photo from: AirbagRecall.com

 

Tens of millions of airbags are defective. Even a minor fender-bender can cause these airbags to rupture, spraying metal shrapnel into drivers and passengers.

In response, vehicle manufacturers are conducting the largest safety recall in U.S. history. Authorized dealerships are replacing defective airbags for free.

Under the oversight of the National Highway Traffic Safety Administration (NHTSA), 19 automakers are recalling vehicles with certain types of driver and passenger airbag inflators.

These inflators are at risk of rupturing in the event of even a minor accident. Airbag ruptures have sprayed shrapnel into drivers and passengers–resulting in at least 11 deaths in the U.S. and hundreds of injuries.

While the recalls are national in scope, NHTSA has ordered automakers to prioritize replacing airbag inflators in older vehicles that have spent time in geographic areas of the U.S. with persistent heat and high absolute humidity. Research performed by NHTSA has shown that if your vehicle has spent time in a place with high heat and high humidity, you may be at greater risk.

How can I tell if my vehicle has been involved in this recall?

To determine if your vehicle is impacted by this recall enter your VIN on the Airbag Recall website.

What is a VIN number and where do I find it?

Your VIN is the unique identification for your vehicle and contains 17 alphanumeric characters. It may be found on your state vehicle registration, vehicle insurance, or on the vehicle itself – on the driver’s side dashboard at the bottom of the windshield or on the driver’s side doorjamb. Your VIN will not include the letter “i” or the letter “o”, but may include the number “1” or the number “0.”

What do I do if my vehicle has been recalled?

Please contact your local dealer, which will be equipped to fix the recalled part or portion of your vehicle.

What do I do if the results page says parts are unavailable for my vehicle?

NHTSA has ordered automakers to accelerate the development and production of remedy parts, and to prioritize repairs for vehicles according to risk factors identified through testing. If parts are not yet available for your vehicle you can still take action by ensuring that the manufacturer of your vehicle has their most up-to-date contact information.

 

 

Pennsylvania Awards $20M Verdict in Transvaginal Mesh Case

Angel Reyes III Defects, In The News

It was recently announced a Pennsylvania state jury has awarded a New Jersey woman a $20 million verdict for injuries she suffered after receiving a pelvic mesh implant made by Ethicon, a subsidiary of Johnson & Johnson.

J&J and its Ethicon medical device division has accrued $34.5 million in punitive damages over its transvaginal meshes in the last 15 months.

Peggy Engleman of Cinnaminson, NJ, was awarded $2.5 million compensatory damages and $17.5 million in punitive damages following a three-week trial in Philadelphia Common Pleas Court, the highest amount of punitive damages awarded so far among the transvaginal mesh cases heard in this court.

Originally filed by Stark & Stark in 2013, the suit claimed that a TVT-Secur device manufactured by Ethicon was defective and that the companies failed to warn users of the risks.

Ms. Engleman had the device implanted in 2007 to relieve stress urinary incontinence, but said the device failed within a month and her condition returned.  She began to experience pain and discomfort as the mesh started to erode inside her body and had multiple surgeries as a result. However, physicians were unable to remove all the shards of mesh in her abdomen.

The pelvic mesh litigation still has 183 cases pending, with the next one scheduled to go on trial May 22. Two earlier pelvic-mesh verdicts in Philadelphia against Johnson & Johnson/Ethicon resulted in awards of $12.5 million and $13.5 million. Johnson & Johnson also faces tens of thousands of additional lawsuits around the country regarding pelvic mesh implants.

The TVT-Secur (TVT-S) is a polypropylene mesh “hammock” that cradles the urethra to treat incontinence. It is tethered in place with two arms that extend up through the buttocks.

TVT-S was cleared for market in 2006 without any clinical trials through the U.S. Food and Drug Administration’s 510(k) clearance process.

It was removed from the market voluntarily by J&J in mid-2012 along with three other problematic pelvic meshes. The company said it was for financial reasons.

No information was included in this case about the role the Food and Drug Administration plays in clearing transvaginal mesh for market through the fast-track 510(k) approval process.

Arizona Self-Driving Crash Causes Uber to Suspend Program

Angel Reyes III Auto Accidents, Defects, In The News, Products

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A report out of Arizona said Uber has suspended its self-driving car operations after one of its vehicles was involved in a crash.

The accident left one of the company’s driverless Volvos on its side, but fortunately led to no serious injuries.

A picture of the crash scene shows two other damaged cars sitting next to the Volvo, one of which has smashed windows and particularly bad dent marks, suggesting the accident happened at some speed.

“The vehicles collided, causing the autonomous vehicle to roll onto its side,” Tempe Police Department spokesperson Josie Montenegro told Reuters. “There were no serious injuries.”

Two ‘safety’ drivers were sat in the front seats of the Uber car at the time of the crash, and nobody was in the back.

According to Ms Montenegro, the crash happened when the driver of a second vehicle “failed to yield” to the Uber car while making a turn.

Uber is looking into the incident, and has halted its self-driving car programs in Arizona, Pennsylvania and California – the three states in which testing was taking place – while its investigations are ongoing.

For those who use ridesharing companies like Uber, it is important to know what to do if you are ever in an accident, understand who is at fault in the event of a ridesharing crash, and how to receive payment for any injuries or other losses you sustain.

 

Johnson & Johnson Ordered to Pay More Than $1 Billion

Angel Reyes III Defects, In The News

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A federal jury in Dallas on Thursday ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay more than $1 billion to six plaintiffs who said they were injured by Pinnacle hip implants, a lawyer for the plaintiffs said.

The jurors found that the metal-on-metal Pinnacle hip implants were defectively designed, and that the companies did not warn consumers of the risks.

The six plaintiffs are California residents who were implanted with the hip devices and experienced tissue death, bone erosion and other injuries they attributed to design flaws.

The plaintiffs claim the companies promoted the devices as lasting longer than devices that include ceramic or plastic materials.

Johnson & Johnson and DePuy are facing nearly 8,400 Pinnacle-related lawsuits, which have been consolidated in federal court in Texas. Test cases have been selected for trial, and the outcomes will help gauge the value of the remaining claims.

Mark Lanier, lawyer for the plaintiffs, said the verdict was “a message loud and clear” that Johnson & Johnson has “a really nasty part of their business they need to clean up.”

As Many As 16 Deaths Caused by Takata Airbags

Angel Reyes III Defects, In The News, Personal Injury

abr-logo-web-300x107A 50-year-old woman who died after a car wreck in September in California was the 11th U.S. victim of Takata Corp.’s defective air bag inflators.

As you may remember, we have previously discussed the danger caused by GM’s decision to switch airbag suppliers from the Swedish-American company Autoliv to the much cheaper Japanese supplier, Takata.

The National Highway Traffic Safety Administration confirmed the woman’s death on Thursday but didn’t release her name. Up to five people also may have been killed by the air bags in Malaysia, bringing the number of deaths globally to as many as 16, as reported by the Associated Press.

The agency said the woman, identified in Riverside County, California, coroner’s records as Delia Robles, 50, of Corona, was driving a 2001 Honda Civic. Riverside police said in a statement that a man making a left turn in a Chevrolet pickup truck was hit head-on by the Civic. The woman was rushed to a nearby hospital, where she died from her injuries, the statement said.

“Our thoughts and deepest sympathies are with the family of the driver during this difficult time,” Honda said in a statement.

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“When we lit it off, it totally destroyed the fixture,” he said. “It turned it into shrapnel.”

Takata air bags can inflate with too much force, which causes a metal canister to rupture and spew shrapnel into the vehicle. Tokyo-based Takata, unlike other manufacturers, uses the chemical ammonium nitrate to create a small explosion that inflates air bags in a crash.

But the chemical can deteriorate when exposed to prolonged high heat and humidity and can burn faster than designed. That can blow apart a metal canister designed to contain the explosion.

Chris Hock, a former member of the Autoliv team, said he recalled carrying out testing on a mock ammonium nitrate inflater that produced explosive results rendering his team shaken. “When we lit it off, it totally destroyed the fixture,” he said. “It turned it into shrapnel.”

The problem touched off what is now the largest auto recall in U.S. history. More than 69 million inflators have been recalled in the U.S. and more than 100 million worldwide. Takata faces billions in costs.

In June, NHTSA urged owners of 313,000 older Hondas and Acuras to stop driving them and get them repaired, after new tests found that their Takata inflators are extremely dangerous. The agency said it had data showing that chances are as high as 50 percent that the inflators can explode in a crash.

Honda spokesman Chris Martin said about 300,000 have not been repaired, and that the owners have been difficult to reach.

Just over 1 million Hondas originally had the risky type of inflators.

NHTSA’s urgent advisory covers vehicles that are up to 16 years old including 2001 and 2002 Honda Civics and Accords, the 2002 and 2003 Acura TL, the 2002 Honda Odyssey and CR-V, and the 2003 Acura CL and Honda Pilot, NHTSA said. They were recalled from 2008 to 2011, and about 70 percent of them already have been repaired, the agency said.

Honda says it has sufficient supplies of replacement air bags for owners who still need them.

The older the inflators are, and the more time they spend in heat and humidity, the more likely they are to malfunction.

The government urged people to go to safercar.gov and enter their vehicle identification number to see if their car or truck is being recalled.

Thank you to the Associated Press for distribution of this news release.

Affected Automakers: BMW, Chrystler, Mazda, Mercedes, Volkswagen, Jaguar, Ford, Honda, Mitsubishi, Nissan, Subaru, Toyota, G.M. and Ferrari.

Reyes Browne Reilley is a Dallas, Texas, based Martindale-Hubbell AV-Rated personal injury law firm. Our Dallas personal injury lawyers have a nearly combined 100 years experience representing plaintiffs in personal injury, business, and dangerous prescription drug & device litigation. Call us today for a free consult to find out more.

Takata Airbags Center of Auto Industry’s Biggest Recall

Angel Reyes III Defects, Products

Reyes Law Takata Airbags Center of Auto Industry’s Biggest Recall In the late 1990s, General Motors switched airbag suppliers from the Swedish-American company Autoliv to the much cheaper Japanese supplier, Takata.

Prior to the switch, GM asked Autoliv to match the cheaper design, according to Linda Rink, who was a senior scientist at Autoliv assigned to the G.M. account at the time.

But when Autoliv’s scientists studied the Takata airbag, they found that it relied on a dangerously volatile compound in its inflater, a critical part that causes the airbag to expand.

“We just said, ‘No, we can’t do it. We’re not going to use it,’” said Robert Taylor, Autoliv’s head chemist until 2010.

Today, that compound is at the heart of the largest automotive safety recall in history. At least 14 people have been killed and more than 100 have been injured by faulty inflaters made by Takata. More than 100 million of its airbags have been installed in cars in the United States by General Motors and 16 other automakers.

“General Motors told us they were going to buy Takata’s inflaters unless we could make a cheaper one,” Ms. Rink said. Her team was told that the Takata inflaters were as much as 30 percent cheaper per module, she added, a potential savings of several dollars per airbag. “That set off a big panic on how to compete.”

Even with the record recall, deadly accidents and research critical of ammonium nitrate, Takata continues to manufacture airbags with the compound — and automakers continue to buy them. The airbags appear in the 2016 models of seven automakers, and they are also being installed in cars as replacement airbags for those being recalled.

A previous generation of airbags supplied to Nissan had the problem of deploying too forcefully and were linked to at least 40 eye injuries in the 1990s.

Takata began experimenting with alternative propellants but in the late ‘90s their inflater plant experienced a series of explosions that destroyed equipment and derailed production greatly. It was in front of this backdrop that Takata embraced the cheaper new compound, ammonium nitrate.

It was around this time the team at Autoliv was asked to study the Takata design.

“We tore the Takata airbags apart, analyzed all the fuel, identified all the ingredients,” he said. The takeaway, he said, was that when the airbag was detonated, “the gas is generated so fast, it blows the inflater to bits.”

Chris Hock, a former member of Mr. Taylor’s team, said he recalled carrying out testing on a mock ammonium nitrate inflater that produced explosive results that left his team shaken. “When we lit it off, it totally destroyed the fixture,” he said. “It turned it into shrapnel.”

These defective airbags made by Takata have been tied to 14 deaths and more than 100 injuries. The ensuing recall has turned out to be messy, confusing and frustrating for car owners.

Affected Automakers: BMW, Chrystler, Mazda, Mercedes, Volkswagen, Jaguar, Ford, Honda, Mitsubishi, Nissan, Subaru, Toyota, G.M. and Ferrari.

Reyes Browne Reilley is a Dallas, Texas, based Martindale-Hubbell AV-Rated personal injury law firm. Our Dallas defective product lawyers have a nearly combined 100 years experience representing plaintiffs in personal injury, business, and dangerous prescription drug & device litigation. Call us today for a free consult to find out more.

Thanks to: The New York Times