Rex Medical ignored Blood Filter Defects, Jury Told

(October 11, 2019) – Rex Medical sold an inferior vena cava filter (IVCF) – designed to allegedly stop blood clots from reaching the heart – despite a study showing the product was prone to failure. That’s what a jury heard during opening arguments Oct. 8 in a trial over injuries suffered by a woman implanted with one of the devices.

Attorney David Matthews of Matthews & Associates represents Tracy Reed-Brown in the first case to go to trial against Rex Medical over its Option IVC filter. Mr. Matthews told Philadelphia jurors that Rex Medical LP had pushed back against doctors who reported problems with the filter. Rex told doctors, he said, to rethink whether their patients’ complications during a clinical trial really stemmed from problems with the device.

“They were heavy-handed with the doctors and went and convinced them they didn’t have a problem, and that it was actually a clinical success,” said Mr. Matthews. It was only after a number of doctors withdrew their criticism of the devices, he said, that the FDA agreed to clear the filters for sale via the agency’s 510k process.

Mr. Matthews told jurors that instead of pressing forward with its bid for the FDA’s blessing, Rex should have seen the light in the development of the Option filter.

“They should have stopped when they flunked that test and had to change people’s opinions,” he said.

The trial is the first in Philadelphia over the controversial vein filters. They have been the subject of several multidistrict litigation programs and mass tort trials across the country. The trial is also the first of its kind in which the plaintiff’s filter remains inside her body.

IVC Filter Injuries from “Removable” Filter

Ms. Reed-Brown was first implanted with a “removable” Option filter in September 2010 after ‘ using blood thinning meds for nearly ten years to help fight her high risk of blood clots. Six years after she received the IVC filter implant, she returned to the hospital. Doctors soon discovered that the device had perforated the vein and was poking through into her pancreas, aorta, and renal vein.

“It perforated and punctured that vein over time and is now sticking into all of the organs around that vein,” said Mr. Matthews.

“This device was supposed to be a removable device, but now it’s stuck inside of Tracy Reed-Brown. They can’t get it out,” he said. “Not only is it stuck, it’s penetrating all of her organs, and each one of those organ penetrations is a medical disaster.”

A three-and-a-half-hour surgery she underwent in January 2017 to try and remove the device proved unsuccessful.

Rex Defense Responds

An attorney for Rex Medical, Pete Swayze, countered that Ms. Reed-Brown was a perfect candidate to receive a filter. He said the device was necessary to prevent her from experiencing a potentially fatal embolism.

“In some cases people only need blood thinners, but in some cases they need something else, and the evidence will clearly show that medication was not enough for Ms. Reed-Brown,” said Mr. Swayze. “It is undisputed in this case that Ms. Reed-Brown was an appropriate candidate for an IVC filter.”

Rex Medical Blames Doctor
Mr. Swayze said that any complications Ms. Reed-Brown experienced were a result of a faulty initial implantation procedure. He claimed the device had been placed just below the suggested implantation site.

He also said that Rex recommended IVC-implant patients be monitored for potential complications, but Ms. Reed-Brown received no follow-up care after her September 2010 implantation.

“It appears from the records,” he said, “that not one doctor and not one health care professional was following the status of her filter.”

Thousands of IVC Filter Cases

While Mr. Reed-Brown’s is the first case against Rex to go to trial, it is far from the first over the filters, and is only one of thousands of cases filed in state and federal courts.

Cases over devices manufactured by Cook Medical have played out as part of a multi-district litigation court (MDL) program in federal court in Indiana, while cases over C.R. Bard filters have been consolidated into another MDL in federal court in Arizona.

Meanwhile, cases over devices made by Cardinal Health Inc. unit Cordis have been consolidated into a mass tort program in California state court.

Six trials against Cook and C.R. Bard have resulted in inconsistent results so far. IVC filter makers have won two of the cases in trials – one was tossed by a judge on a summary judgment — and lost three others.

Cook’s record is 1-1 in Indiana. A jury ordered Cook to pay $3 million to a plaintiff in one case. In the other case, which Cook won, the IVC filter had been successfully removed and the plaintiff appeared to be healthy.

In a state course case against Cook in Texas in May 2018, a Houston jury ordered Cook to pay a plaintiff $1.2 million. In that case, a Houston-area fireman had an IVC filter successfully removed, but in a most obtrusive fashion. The filter is designed and promoted to slip out with a minimal incision, but the fireman’s filter was stuck and required a full open-chest procedure.

Bard has faced three trials so far as part of the federal multi-district litigation court set up in Arizona.  Bard lost a $4 million verdict in April 2018, and then prevailed in two subsequent defense verdicts.

Ms. Reed-Brown is represented by and David Matthews of Matthews & Associates; Tim Goss of Freese & Goss; Rosemary Pinto of Feldman & Pinto.

Rex Medical is represented by Walter “Pete” Swayze and Megan Grossman of Lewis Brisbois Bisgaard & Smith LLP.

Rex Medical ignored IVC Filter Defects, Jury Told

The case is Tracy Reed-Brown v. Rex Medical LP et al., case number 170300241, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

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E-Cigarette Kills Texas Man

(Sept. 28, 2019) E-cigarettes may be promoted as a safe alternative to real cigarette smoking, but e-cigarettes can kill a person just as effectively as real ones can. Earlier this year, a 24-year-old Texas man died after a brand new vaping pen device exploded in his face. The cause of death was confirmed by the Tarrant County medical examiner’s office.

William Brown of Fort Worth had just left a vaporizing store in Keller when it happened. His grandmother, Alice Brown, told a local reporter that William had just bought the device and was using it for the first time in her car. After the explosion, she said William crawled toward the back of the car and collapsed on the pavement. He died at John Peter Smith Hospital two days later.

Mr. Brown’s cause of death was listed by the medical examiner as penetrating trauma from an exploding vaporizer pen. The report says the explosion severed his left carotid artery. Ms. Brown told a reporter that JPS doctors said William suffered a stroke inside the car and eventually suffered a brain bleed.

William was not a regular vaping pen smoker, Brown said. An asthma sufferer, he had been told a certain vape pen could help with asthma symptoms. She said she didn’t know if what he had heard was true.

On Jan. 27, 2019, William left her house intending to stop at his bank. But first, he stopped at the vape store and bought the exploding pen.

Vape Battery Exploded

An investigator in the case told Ms. Brown the battery had caused the explosion. She searched through her blood-splattered car for pieces of the exploded vape pen. She said she found a battery showing its serial number.

“That’s the important part,” she told Fort Worth Star Telegram reporter Amanda McCoy. “That’s what the investigator said he needed. (I) hope it stops someone from [smoking electronic cigarettes]. I don’t know how many more people will have to die.”

Other Vaping injuries, deaths

William Brown is thought to be at least the second person in the country killed by an exploding e-cigarette.

In May 2018, Florida authorities investigated the death of 38-year-old Tallmadge D’Elia. He suffered multiple injuries after his e-cigarette device exploded in his face. A medical examiner’s report listed his cause of death as “projectile wound of the head.” Mr. D’Elia also suffered burns over 80 percent of his body.

According to FEMA, some 195 incidents of explosions and fires caused by e-cigarettes were reported between January 2009 and December 2016. Injuries occurred in 133 of those cases, with 38 severe injuries. No deaths were reported to FEMA.

2,000+ E-Cigarette Explosions

A more recent study, done in part by Dennis Thombs, dean of the School of Public Health at UNT Health Science Center, showed that e-cigarette injuries are widely underreported across the country. Researchers found that some 2,035 e-cigarette explosions and burn injuries resulted in hospital emergency room visits from 2015 to 2017.

That number was more than 40 times higher than the number of injuries reported by the FDA from 2009 to 2015. The study also found a lack of a surveillance system to track those injuries.

Some of the more serious injuries include burns and loss of eyes or teeth. The majority of burn injuries occurred on the upper leg.Other e-cigarette injuries include strokes, a mysterious lung ailment, and nicotine addiction.

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Vaping Sickness Cases rise to 530

(Sept. 20, 2019) Federal health officials say 530 people have fallen ill from a vaping-related lung ailment. According to the U.S. government, that number has increased from 380 people who were confirmed earlier this year as having suffered lung injuries from vaping.

At Least Seven People Dead from Vaping

Seven people have died from the illness, said the CDC at a Sept. 19, 2019 briefing. Officials said they still hadn’t determined a cause of the lung ailment. They said there didn’t appear to be one product or substance involved in all the cases, which have now been identified in 38 different states.

Mitchell Zeller, director of the Center for Tobacco Products at the U.S. Food and Drug Administration, offered a well-worn cliche at the briefing: “We are leaving no stone unturned,” Mr. Zeller proclaimed.

President Trump: “Children have died. People have died.”

President Trump also weighed in on the government’s examination of the vaping problem: “We are looking at vaping very strongly,” said Mr. Trump at the White House this week. “It’s very dangerous. Children have died. People have died.”

Along with the public health investigation, Mr. Zeller said the FDA’s enforcement arm has also opened a criminal probe focused on the vaping industry’s supply chain.

Underage Vaping Explodes (pun intended)

The government has had little choice but to at least mount a public relations blitzkrieg promising to look at the problem. A sudden surge of vaping illnesses combined with an explosion of underage users sucking on e-cigarettes has forced public health officials to reassess lax regulation of the booming new industry.  Juul Labs, the most successful e-cigarette player to turn underage users and hapless others into nicotine junkies, is expected to triple its revenue this year to about $3.4 billion.

Juul reported that it made sales of over $1 billion in 2018, up from $200 million the year prior. Bloomberg News reported that Juul’s overall profit for 2018 reached $12.4 million.

Related: Reuters: Annual Juul Sales to top $3-Billion

Vaping Sickness Cases rise to 530

All those e-cigarette sales have triggered some problems. Juul and other e-cigarette vapers now routinely turn up in emergency rooms across the country. People have become suddenly stricken with dangerous respiratory damage. Their lungs looked like they’d been torn up by a disease, or  exposed to a toxic industrial chemical. What all the ravaged lungs have had in common was recent exposure to vaping products.

Vaping Devices Changes Driving Injuries?

A limited number of similar case reports occurred in the past few years. The sudden increase has raised the question of whether medical professionals may have missed other, older incidents. Some armchair quarterbacks and doctors now think the severity and the large number of recent cases suggest that something has changed in the vaping devices themselves.

The vaping illnesses have been reported most often in patients inhaling products with THC, the key psychoactive ingredient in cannabis. Some were using vaping and e-cigarette devices with both THC and nicotine, while some were using nicotine devices alone.

Vaping disrupts natural lung processes?

Bloomberg News reports that some patients with vaping-related lung illnesses have presented with an unusual problem in their lungs. Doctors have found immune cells called macrophages filled with oil. The cells could be absorbing ingredients from vaping devices. Some researchers think vaping may disrupt natural lung processes, causing cells to choke on lipids naturally found in the lungs.

Vitamin E Acetate a Culprit?

On Sept. 5, 2019, New York state health officials pointed to vitamin E acetate as a likely culprit. Considered harmless when used as a nutritional supplement, the vitamin could carry risks when inhaled. E-acetate has been found in some products. But other doctors Bloomberg interviewed said the culprit is still unknown.

Teenage Vaping Epidemic – Vaping as Gateway Drug

E-cigarettes have been marketed by Juul and other nicotine device sellers as a panacea to help curtail tobacco use, which kills some  480,000 people a year in the U.S.. Tobacco-related illnesses remain the leading cause of preventable death in the world. But an explosion in the use of vaping products by teenagers — many of whom said that they had never smoked cigarettes — has led the FDA to call teenage vaping an epidemic. In addition, many youngsters report going from never having smoked cigarettes to vaping, and then smoking cigarettes. So vaping for some could fairly be called a gateway drug.

Hooking Kids on Vaping

E-cigarette use by 10th and 12th graders doubled in the past two years, according to data released this month by the National Institute on Drug Abuse, which is part of the National Institutes of Health (NIH). According to the survey, 1 in 4 high school seniors reported vaping nicotine in the previous month, and 1 in 5 sophomores reported the same thing.

Hooking underage youth may be good news for Juul and other e-cigarette makers’ pocketbooks, but it’s not so good for the future (and immediate) health and wealth of the country’s young people. One 22-year-old stroke victim filed suit against Juul this summer for failing to warn him about the dangers of nicotine addiction, and the dangers of sucking on Juul’s candy-flavored e-cigarettes day and night. Few things are more miserable than nicotine addiction, and few companies have been as successful as Juul in making something terrible, something potentially life threatening, look so attractive.

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Juul Marketing hooks Kids on Nicotine

(August 9, 2019) Under the guise of helping youngsters avoid the hazards of real cigarettes, Juul marketing hooks kids on nicotine. Under a duplicitous, years-long program, the company hooks youngsters on the highly-addictive chemical drug, while it pretends to be performing a public service. Ostensibly, Juul poses as a company that wants to help everyone quit smoking real cigarettes.

Related: Juul sued for creating public health crisis

Juul Problems Grow

One problem now for Juul is that large numbers of those people targeted for smoking “correction” never smoked anything at all, or at least never had a nicotine addiction problem before Juul targeted them.

(Juul Instagram Post 2015)

Juul’s marketing campaigns have been enormously successful in making Juul products appear innocuous to the underage user. As a result of that deceptive advertising, some young people have suffered strokes, lung infections, and other serious injuries after using Juul’s e-cigarettes. Now Juul faces lawsuits from people injured by its products.

Juul Marketed Directly to Underage Users

According to a U.S. House subcommittee that met last month in Washington D.C., Juul deployed a “sophisticated program” that deliberately targeted children and teenagers at schools, summer camps, and public programs. Juul did so in a clear attempt to sell e-cigarettes, according to the subcommittee.

Juul allegedly bought access to children as young as eight, by paying schools and other public programs for an opportunity to present Juul messaging, according to the findings of the Subcommittee on Economy and Consumer Policy.

A Healthy Lifestyle Plan?

Juul even paid $134,000 to one Baltimore-based charter school to set up a five-week summer camp for 80 children in grades 3 through 12. Juul sought to provide a so-called “holistic health education program” that would engage low-income students at risk of making poor health decisions by helping them develop a personal “healthy lifestyle plan.”

Those findings are based on roughly 55,000 documents Juul provided to the subcommittee and the Massachusettes Attorney General. They are detailed in a memo released on the second day of the public hearings last month.

According to the subcommittee, Juul operated a “Youth Prevention and Education program” that paid schools at least $10,000 to access students during school hours, summer classes, or special Saturday programs. The Saturday program was ostensibly designed as a disciplinary alternative for students caught vaping at school.

Parents Against Vaping E-Cigarettes

Parents Against Vaping E-cigarettes testified to congress that Juul representatives showed children how to use an e-cigarette, and also told the children the product was “totally safe.” Emails released by the subcommittee indicate Juul administrators worried about how such programming would appear. Some Juul employees cautiously noted that Big Tobacco once sent similar “youth education” teams to so-called “health fairs.”

• Related: 22-year-old Stroke Victim sues Juul

JUUL Lawsuits Filed

At least four lawsuits were filed against Juul last year by parents, underage users, and others. The suits include allegations that Juul deceptively marketed its product as safe, and targeted underage people and nonsmokers. The lawsuits also claim that Juul is as addictive, or even more addictive, than regular cigarettes. The petitions also allege that Juul’s nicotine salt formula enables higher nicotine absorption into the body than traditional cigarettes or other e-cigarettes containing nicotine liquid.

Juul Response

A Juul spokesperson responded to the lawsuits in an email last year:  “JUUL Labs does not believe the cases have merit and will be defending them vigorously.”

Juul the No. 1 E-Cigarette

The most popular e-cigarette in the U.S., Juul generated more than $1 billion in sales in 2018, which was 300% more than it had in 2017. Some Juul users are perhaps genuinely trying to use Juul products in order to stop smoking real cigarettes, because Juul has taught them that e-c igarettes are less hazardous than actual burning ones, but hundreds of thousands of teenagers also smoke Juul today. They smoke today because Juul has enticed them into developing the habit, and now hooked them on one of the world’s most dangerously addictive drugs.

A Juul Nicotine Epidemic

Medical experts have called the e-cigarette trend a Juul-driven “youth nicotine epidemic.” Even the FDA has noticed the scope of the problem. Late in 2018, the agency said it was seeking a nationwide ban on menthol cigarettes and flavored cigars. The FDA also said then that it would sharply restrict the sales of fruity-flavored nicotine vaping cartridges. Anticipating the FDA actions, Juul announced late last year that it had halted sales of its fruit-flavored nicotine pods in retail stores, though the company said it would still sell them online. Juul also moved to shut down its Facebook FB +0% and Instagram pages in the U.S.; but the horse, of course, left the barn long ago, in full view of and with an aggressive push from Juul.

Juul acknowledges problem, denies responsibility

Juul acknowledges that some underage users (below 18 or 21, depending on their state) use Juul products, but the company has repeatedly said that, in its four years on the market, it has never marketed to underage people.

Stanford University Studies Juul Marketing

However, a physician and professor at Stanford University who studies tobacco advertising has called out Juul. Dr. Robert Jackler, co-founder of a group called Stanford Research Into the Impact of Tobacco Advertising (SRITA) – a Stanford University-affiliated program – says Juul deleted most of its social media posts over several time periods before September 2018. Dr. Jackler and his group have nevertheless maintained an archive of Juul’s deleted posts (much of it available on SRITA’s site), which includes more than 2,500 tweets, 400 Facebook and Instagram posts, and material from Juul’s website, emails, and print campaigns dating back to Juul’s June 2015 launch.

Dr. Jackler: Juul marketed to Youth

Dr. Jackler says Juul’s marketing clearly appealed to youth, most obviously from mid-2015 to 2016. Forbes magazine notes that, “His archived Juul ads are filled with attractive young models socializing and flirtatiously sharing the flash-drive shaped device, displaying behavior like dancing to club-like music and wearing clothes more characteristic of teens than mature adults.”

Early Campaigns fail to mention help against real cigarette smoking

While Juul now claims that it aims to save a billion people from actual cigarette smoking and nicotine addiction, early Juul marketing campaigns contain little or no reference to Juul being an option for those trying to quit smoking real cigarettes. Juul’s launch events and parties also often featured youth-oriented bands and free tastings, says Dr. Jackler, promoted alongside ads that made pods seem like “sweet treats” and made “juuling” (now a new verb!) seem like harmless fun.

Juul uses the FDA for marketing shield

Juul has now lobbied the FDA for approval in marketing its nicotine delivery device as a means to “help” underage people avoid the dangers of real burning cigarettes.  Meanwhile, any reasonable person can wonder if Juul’s intended targets would ever have smoked at all were it not for the company’s multi-million-dollar campaigns to hook people on Juul products.

Juul Marketing Hooks Kids on Nicotine

When no less a corporate-profits champion than Forbes writes a story called “The Disturbing Focus Of Juul’s Early Marketing Campaigns,” it’s clear something is badly amiss.

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Juul Lawsuit filed for Stroke Victim

(July 29, 2019) A Juul lawsuit was filed for a stroke victim last week. Lawyers filed a Juul e-cigarette lawsuit for a 22-year-old Connecticut man. The lawsuit petition claims he smoked two Juul pods a day. He began “Juuling” in his last year of high school and continued until he stroked out roughly three years later.  The petition says that Maxwell Berger inhaled a Juul e-cigarette every ten minutes intermittently for years until he suffered a severe stroke.

The lawsuit was filed in the California Superior Court for San Francisco County. Juul is headquartered in California.

Related: Juul E-Cigarette Lawsuit

E-Cigarette Injuries

Mr. Berger  suffered a massive hemorrhagic stroke in July 2017. He spent more than 100 days in the hospital.  He suffered three brain surgeries. He still suffers left-side paralysis, speech impairment, and a 50 percent loss of vision in both his eyes.

Editor’s Note: We post this blog under Drug & Medical Device Watch because Nicotine is a Drug.

Juul Lawsuit filed for Stroke Victim

“We are hoping that Juul takes responsibility for its conduct in targeting and luring young people to use its very dangerous products, and that they are held accountable for fair and reasonable compensation to this young man,” said Mr. Berger’s attorney.

Fraudulent Concealment, Negligence alleged

The lawsuit accuses Juul of fraudulent concealment and intentional misrepresentation of the product’s risks, along with negligence in promoting and selling to younger people, specifically those under 26. The lawsuit is the most severe claim of medical harm against Juul to date.

“The teen vaping was by design, not by accident,” says the lawsuit, which accuses Juul of appealing to teenagers and making the e-cigarettes seem “fun, healthy and cool.”

The lawsuit states that Mr. Berger became addicted in 2015, when Juul had already “become ubiquitous among his high school friends.”

Seven Other Juul Lawsuits

The Juul e-cigarette company faces seven other suits from various states. Most of the suits involve teenagers.

Juul CEO apologizes to Parents

In July 2019, the CEO of Juul apologized to parents whose teenage children had begun smoking. He claimed Juul’s products were never intended for their children. He admitted, however, that Juul has not done any long-term research on its products’ health effects.

Juul Labs has, for a long period of time, faced accusations of using fruity flavors and eye-catching packaging to market its products to teenagers. At the same time, Juul has repeatedly denied these claims.

Juul Class Action Lawsuit

In other Juul lawsuit action, a 15-year-old Sarasota, Florida girl and her family have filed a class action lawsuit against Juul Labs and the tobacco company Altria Group, which owns Philip Morris.  That suit alleges that Juul purposefully targeted teenagers. The company plan was to to hook teens on Juul vaping products with deceptive marketing tactics.

According to the Florida lawsuit — which lists the family as plaintiffs, as well as “those similarly situated” — the family accuses the manufacturers of these products of racketeering. The suit petition seeks damages for the named plaintiffs and potentially for anonymous plaintiffs not yet listed. The suit claims  Juul knew its “e-cigarettes were not safe for nonsmokers, and posed a risk of aggravating addiction in those already addicted to cigarettes.” Altria is included in the petition because it owns a 35% stake in Juul.

The underage girl is identified as A.N in the Florida class action suit. Ms. A.N. claims that she started using Juul when she was 14. She said she enjoyed using Juul’s device because of its fruity mango flavor. At the time, says the suit, she was unaware that the device contained nicotine. One year after beginning steady use of the product, she became addicted to it. She now suffers seizures that are a rare potential side effect of nicotine addiction.

Defendants Prey on Youth

“Health authorities consider youth e-cigarette use an epidemic, and defendants are to blame,” states the complaint. The petition further claims: “Mimicking Big Tobacco’s past marketing practices, Defendants prey on youth to recruit replacement smokers for financial gain.”

Teen Vaping Epidemic

A recent National Institutes of Health study shows the number of teenagers smoking e-cigarettes has risen wildly. Nearly 21% of teenagers in 2018 reporting they had vaped within the past 30 days, up from 11% the previous year. The CDC has also reported that 4.9 million middle- and high-school students have reported using a tobacco product within the past 30 days, up from 1.3 million users in 2017. And although some users and promoters of vaping consider it safer than smoking regular burning cigarettes, e-cigarettes contain high doses of nicotine. Juul delivers as much nicotine as real cigarettes. New research has pointed to a range of potential health risks, including an increased risk of stroke and heart attacks.

Juul leads Teen Vaping Epidemic

From its Silicon Valley base, Juul sells the most popular vaping products. The company commands nearly 75% of the entire e-cigarette market. With its slick packaging disguised as a USB drive easy to conceal from parents or teachers, its broad choice of fruity flavors, its slick social media-based marketing campaigns (which Stanford researchers call “patently youth-oriented”), the Juul has specifically been accused by the FDA of trying to appeal to teenagers. In an effort to curb what FDA commissioner Scott Gottlieb has referred to as a teen vaping “epidemic,” the FDA has issued more than 60 warning letters to Juul distributors which have sold to underage consumers.

FDA Warning Letters

While Juul has denied the FDA’s claims, the company has also taken small public steps to address the FDA’s criticisms. Juul has removed most flavored vapes from stores.

“Our intent was never to have youth use Juul,” Kevin Burns, the chief executive of Juul Labs, said in a statement last year. “But intent is not enough. The numbers are what matter and the numbers tell us underage use of e-cigarettes is a problem.”

Juul has repeatedly denied claims that the company was intentionally marketing to young users. Juul told Rolling Stone magazine: “JUUL Labs is committed to eliminating combustible cigarettes, the number one cause of preventable death in the world.”

The Juul spokesman further stated: “Our product is intended to be a viable alternative for current adult smokers only. We do not want non-nicotine users, especially youth, to ever try our product. To this end, we have launched an aggressive action plan to combat underage use as it is antithetical to our mission. To the extent these cases allege otherwise, they are without merit and we will defend our mission throughout this process.”

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IVC Filter case filed against Rex Medical

(June 15, 2019)  Matthews & Associates Law Firm, attorney Tim Goss, and Philadelphia attorney Rosemary Pinto filed an IVC filter lawsuit against Rex Medical L.P. and Argon Medical Devices, Inc. on March 6, 2017 in the Court of Common Pleas in Philadelphia County.  A jury trial for the case is set to begin Oct. 2, 2019.

The lawsuit petition states the plaintiff, a Georgia woman, was implanted with a Rex Argon Option Retrievable Inferior Vena Cava Filter. The alleged defective filter was by Rex Medical, and marketed and distributed by Argon. That IVC filter has caused, and continues to cause, significant injuries.

After the plaintiff reported abdominal pain, she underwent a CT scan in Dec. 2016.  That scan showed that her Rex’ Option Retrievable Inferior Vena Cava Filter (IVCF) had perforated through the walls of the vena cava. Two physicians denied repair or removal of the device due to the potential complication levels.

Rex’ Option Retrievable Filter caused Significant Injuries

As a direct result of the IVCF’s intractable position, the plaintiff suffered injuries that include  perforation of the Option Retrievable Inferior Vena Cava Filter. The petition says that the struts of the filter have perforated to the fullest extent possible, resulting in severe pain and life-threatening complications. The most medial strut of the filter perforates the woman’s aorta, which could cause death from loss of blood should the aorta perforate further. The most lateral strut of the filter perforates the right renal veins, which leaves the plaintiff at risk of kidney failure. The three anterior struts perforate the small bowel and could cause gastrointestinal problems.

The petition accusing Rex Medical reads, in part:

“(The) perforated filter places the plaintiff at an increased and continual risk of complications, such as the potential for the filter to become embedded and occluded with blood clots, thereby disrupting the normal flow of blood to the heart and lungs. The perforated filter also poses an increased and continual risk of fracturing. Fractured portions could travel to the lungs or heart, possibly causing immediate death or serious injury. The plaintiff needs the perforated filter removed, but doing so could cause severe complications and even death. 

The plaintiff is now forced to live with severe pain and complications caused by the filter, as well as the possibility that the filter could, at any moment, cause any of the aforementioned or other complications. That reality has led to severe fear, stress, and anxiety.” 

Nature of the Case – General Allegations

The petition further states that prior to the plaintiff’s being implanted with the filter, the defendants knew and should have known that the device was defective and unreasonably dangerous for the following reasons:

  1. Defendants failed to conduct sufficient clinical testing, such as animal studies, to determine how the device would function once permanently implanted in a human.
  2. Defendants knew (the) Option filter had a high rate of embedment, fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted in the human body. Defendants (knew) such failures exposed patients to serious injuries, including: death; hemorrhage; cardiac/pericardial tamponade; cardiac arrhythmia; other symptoms similar to myocardial infarction; severe and persistent pain; perforations of tissue, vessels, organs; inability to remove the device.
  3. Defendants also knew or should have known that certain conditions or post-implant procedures, such as morbid obesity or open abdominal procedures, could affect the safety and integrity of the device.
  4. The risks for the Option Vena Cava Filter were and are substantially higher than other similar devices.
  5. The Option filter contained conditions, which Defendants did not intend, that resulted in the device not performing as safely as the ordinary customer would expect.
  6. Despite being aware of these risks, Defendants misrepresented, omitted, and/or failed to provide adequate warnings of these risks or instructions for safe use.
  7. Even as Defendants designed, marketed and sold what they alleged to be a device that specifically reduced these risks of the Filter, they nonetheless failed to issue a recall of the Filter or otherwise notify customers that a safer device was available.

Causes of Action Charged

  • Negligence
  • Strict Products Liability — Failure to warn
  • Strict Product Liability — Design Defect
  • Strict Product Liability — Manufacturing Defect
  • Breach of Implied Warranty of Merchantability
  • Negligent misrepresentation
  • Punitive damages allegations

IVC Filter case filed against Rex Argon for Option Elite Filter

The jury trial beginning Oct. 2 is expected to last at least three weeks. The case is  # 170300241.

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HIV Drug Lawsuits filed over Tenofovir

Gilead’s TDF Drugs cause Serious Side Effects

Men claim HIV drug caused bone and kidney problems. Lawyers have also filed a related class action lawsuit against Gilead.

(May 15, 2019) Two California men living with HIV filed a personal injury lawsuit last May against Gilead Sciences. The men claim Gilead intentionally delayed the development of a safer version of the HIV medicine called tenofovir. Tenofovir disoproxil fumarate (TDF) – the original form of the drug – is sold under the brand name Viread. It is found in Truvada, Atripla, Stribild, and Complera.

Gilead HIV Drug Kidney & Bone Injuries

The LA Times reported that the lawsuit also claims Gilead hid the risks of the less-safe version of tenofovir while letting people with HIV take the more dangerous medicine which harmed their kidneys and bones.

Related: Truvada Lawsuit

AIDS Healthcare Foundation (AHF), which operates HIV clinics around the world, is funding the two men’s lawsuits. An AHF press release read: “[A] class action lawsuit against Gilead by two other Californians living with HIV who suffered bone and kidney damage from taking TDF was filed on behalf of all persons located within California who were prescribed and ingested Viread, Truvada, or Atripla from October 26, 2001, through the present, who were personally or whose physician was exposed to Gilead’s misrepresentations.”

AHF also filed a previous lawsuit against Gilead over tenofovir. A judge who heard a similar case in 2016 ruled that Gilead did not illegally manipulate the patent system, but an appeal is pending.

What is Tenofovir?

The FDA approved Gilead’s TDF as an HIV med in 2001. The FDA approved TAF in 2015 as part of Gilead’s single-tablet combo pill Genvoya. Since then, TAF has been included in other HIV single-tablet regimens, such as Biktarvy and Descovy

At issue, says the lawsuit, is that Gilead had already begun research on an improved version called tenofovir alafemanide fumarate (TAF).  Gilead wrongly withheld that research and delayed the release of TAF. According to the Times, the lawsuit claims, “[B]y holding on to its research and shelving TAF, Gilead could patent TAF separately and save it for development when their patent and exclusivity on TDF ran out, in 20 years.”

The Times reports that both men named in the lawsuit took the older tenofovir and developed related health issues. Michael Lujano of Los Angeles County took TDF from 2004 to 2015. He  developed osteopenia and osteoporosis of the spine, neck and hip. Jonathan C. Gary of San Diego County took TDF for 10 years starting in 2001. In 2010, he was diagnosed with the rare kidney disorder Fanconi syndrome, and last year was also diagnosed with osteopenia and osteoporosis.

“A company I trusted with my life took advantage of that trust by misrepresenting the side effects of TDF, calling it the ‘Miracle Drug’ and using other deceptive marketing strategies,” Mr. Lujano said in the AHF press release. “Gilead shelved a far safer drug, TAF, simply to increase its long-term profits. I’m bringing this lawsuit to try to hold Gilead responsible for their reckless focus on profits over patient safety.”

Rebuttal?

In related news, one recent analysis found that the updated version of tenofovir may not offer any more safety benefits than the first version. Please see the POZ feature: “Is Gilead’s Entire HIV Enterprise Built on a False Promise?

HIV Drug Lawsuits filed over Tenofovir

Plaintiffs’ attorneys are filing lawsuits for people with HIV who took one or more of Gilead’s tenofovir disoproxil fumarate (TDF) drugs –Truvada, Viread, Atripla, Complera, and Stribild –and then allegedly suffered kidney disease and/or bone density loss.

Nearly 20,000 people with HIV were allegedly diagnosed with kidney disease after taking TDF-based antiretroviral drugs. Studies have also shown TDF drugs may increase the risk of bone fractures. Nearly 6,000 bone breaks are alleged to be linked to the drug compound.

What Gilead Knew and When

Gilead allegedly knew that TDF could cause serious side effects as early as 2001. In 2002, the company allegedly tested a new formula – tenofovir alafenamide fumarate (TAF), later marketed as Genvoya and Odefsey – that achieves the therapeutic effect of TDF but uses a safer, lower dose. Plaintiffs believe the new formula isn’t linked to the same risk of kidney and bone injuries as the earlier version. Lawsuits are being considered for those who took Gilead’s Tenofovir drugs and then developed problems that include:

Kidney Injuries

  • Chronic kidney disease (CKD) or declining kidney function
  • Acute kidney injury (AKI) or acute renal failure (ARF)
  • Fanconi syndrome
  • Tubular dysfunction

Bone Injuries

  • Osteopenia
  • Osteoporosis
  • Bone fractures

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Uloric Gout Drug Lawsuits

Uloric Cardiovascular Injuries – Heart Attacks & Strokes

Gout drug lawsuits are being filed over Uloric, a medication designed to help treat chronic gout. A Uloric gout drug lawsuit alleges the maker of Uloric failed to warn users of the increased risk of heart attacks and strokes. Our law firm is representing people who have suffered cardiovascular issues while taking – or after taking – Uloric for at least 30 days.

Uloric Drug Lawsuits

Uloric (Febuxostat) is a xanthine oxidase inhibitor prescribed for the management of chronic hyperuricemia (excess uric acid) in adult patients suffering from gout. Takeda Pharmaceuticals brought Uloric to the market after it received FDA approval in February 2009.

When the FDA approved Uloric in 2009, the agency required a warning label to include the information that it raised risk of cardiovascular events. The FDA also required Takeda to perform a mandatory post-marketing cardiovascular safety study.

The 6,000-patient safety trial saw its results published in the New England Journal of Medicine on March 12, 2018. The study’s authors found a statistically significant increased risk of cardiovascular death for users of Uloric compared with users of allopurinol.

Gout Symptoms & Causes

Gout is a form of arthritis characterized by sudden, severe attacks of pain, swelling, redness, tenderness in the joints. Pain and swelling often manifest in the  in the feet and toes.  The pain and swelling are caused by elevated uric acid levels in the bloodstream.

Patients with hyperuricemia and gout already face an elevated risk of cardiovascular events.  The cause is not entirely understood, but may be linked to chronic inflammation associated with the underlying disease process. Most gout patients also suffer from various comorbidities which are also associated with an increased risk for cardiovascular events.

Gout is a disease state for which only a few medical therapies are available. Allopurinol has long been the standard of treatment. Brought to market first by Casper Pharma LLC in 1966, allopurinol has an established safety profile and has been available in generic form since at least September 1984.

Uloric Indications

Uloric is indicated only for those patients with severe renal dysfunction or those who cannot tolerate allopurinol. By comparison, allopurinol is at least as efficacious as Uloric, if not moreso, and it costs far less.

Uloric Lawsuit Compensation

For those who have experienced a heart attack or stroke while taking Uloric, we pursue damages for several losses. They include:

  1. Past and future medical and funeral expenses resulting from injuries.
  2. Past and future pain and suffering for injuries, treatment and recovery processes.
  3. Past and future wage loss, and loss of estate.
  4. Past and future loss of earning capacity.
  5. Past and future loss of enjoyment of life.
  6. Punitive damages, if applicable and warranted.

FDA Science regarding Uloric

On November 15, 2017, the FDA issued a Drug Safety Communication to the public:

“[P]reliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol” and noted it would be conducting a comprehensive review of Uloric’s safety.

The FDA held a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee on January 11, 2019, during which the safety of Uloric was discussed. While the committee agreed that biological plausibility for cardiovascular death was unclear, they “agreed that there is a consistent signal of cardiovascular death associated with febuxostat”.

Most committee members agreed Uloric should no longer be designated as a first-line therapy for gout. Most agreed Uloric should be reserved for patients who cannot tolerate allopurinol or who found allopurinol ineffective. Most members also noted Uloric should not be used in the general gout population or in patients with a history of cardiovascular events or those at high risk for cardiovascular events.

Uloric Boxed Warning

The FDA issued a second Drug Safety Communication re: Uloric on February 21, 2019. The agency announced there was an increased risk of death associated with Uloric when compared with allopurinol. Consequently, the FDA required the addition of a boxed warning for cardiovascular death. It also required a Limitation of Use, which reserved treatment only for those patients with symptomatic hyperuricemia.

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FDA won’t Ban Implants Linked to Cancer

(May 2, 2019)   The U.S. FDA said yesterday that it won’t ban a certain textured breast implant linked to a type of cancer.  The agency has, however, strengthened warnings on textured breast implants.

Related: Breast Implant Lymphoma Warning

The FDA announcement followed a March 2019 safety hearing over breast implants linked with breast implant-associated anaplastic large cell lymphoma.  BIA-ALCL is specifically associated with textured breast implants. The FDA said that based on all currently available data, it doesn’t believe these breast implants meet the legal standard to require their banning under the Food, Drug and Cosmetic Act.

Some other countries, however, have banned or restricted sales of some textured breast implants due to BIA-ALCL concerns. According to FDA, implants sold in those markets aren’t sold in the United States.

By comparison, some 80% of breast implants sold outside the U.S. are textured, according to FDA, compared to less than 10% of breast implants in the U.S..  In addition, the type of textured implants banned or limited by foreign regulators represents less than 5% of domestic breast implants.

Cancer, Chronic Fatigue, Joint & Muscle Pain
The FDA vowed it will take steps to improve information about the risks of breast implants and BIA-ALCL with textured implants.  The agency also said it will investigate reports of chronic fatigue and joint and muscle pain symptoms some women report from textured breast implants.

Breast Implant Illness
Some women have told the FDA they are concerned about how their immune systems react to their implants.  Some women have experienced a variety of symptoms sometimes called “breast implant illness,” said the agency. The FDA, however, said it doesn’t have definitive evidence that implants cause these symptoms, though current evidence supports the notion that these symptoms may be resolved with the implants’ removal.

The FDA said it will explore ways to include product information on the implants’ labels that patients can understand.

Lymphoma Testing, Boxed Warning, Report Filings
The FDA announced, “We also plan to work with the pathology community to educate pathologists about testing for this lymphoma specific to breast implants.”  The agency further said it will work with stakeholder groups on any labeling changes, including a possible boxed warning. The agency also said it is changing how breast implant makers file medical device reports. They will now file individual reports with the FDA instead of “alternative summary reporting.”

The FDA said, “This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks.”

The “alternative summary reporting” program, said the FDA, was established in 1997 to review adverse events for well-established risks, but not patient deaths or unusual adverse events. In  the case of breast implants, that includes BIA-ALCL, which means the agency was not getting all of the actual data that it really needs to oversee the safety of these implants.

According to the FDA, these individual reports will now be available in the agency’s public database for medical device reports.  In addition, the FDA said it will be making past reports public in the coming weeks.

FDA won’t ban Implants linked to Cancer

“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” the FDA said.

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J & J settles 3 More Talc-Mesothelioma Lawsuits

(April 25, 2019) Johnson & Johnson settled three more talcum powder-mesothelioma lawsuits this week.  All three cases were in the midst of trials brought by women who claimed they were exposed to asbestos while using J&J’s Baby Powder products. Their lawsuit petitions said that exposure led to their developing mesothelioma. Though Johnson agreed to pay the women’s suits, a company spokesman claims they were a “one-off” (though they seem more like a “three-off”) and still denies there was ever asbestos in J&J talcum powder.

The settlements come as New Jersey-based giant Johnson & Johnson faces thousands of talcum powder mesothelioma lawsuits filed by plaintiffs who claim to have developed mesothelioma or ovarian cancer from the products.

The three latest settlements:

  • Plaintiff Sharon Pipes reached a settlement as her Oklahoma jury had begun deliberating after a two-and-a-half-week trial.
  • Plaintiff, Gail Koretoff reached a settlement agreement after jurors had deliberated for two days on her case.
  • Plaintiff Jenny Shulman reached a settlement as her case was scheduled to begin trial this month. She was diagnosed with peritoneal mesothelioma after using J&J’s talcum powder for feminine hygiene. An expert witness was set to testify about finding talc and asbestos in her ovarian and fallopian tissue. Peritoneal Mesothelioma

Peritoneal Mesothelioma

All three plaintiffs had developed peritoneal mesothelioma and claimed to have used J&J’s talc powder products for long periods of time, mostly for feminine hygiene.

Johnson officials have denied rumors that J&J is shifting its talc powder litigation strategy. The company told Bloomberg News that these settlements were “one-off situations.”

J&J maintains its talcum powder products do not contain asbestos. Several juries have nevertheless found J&J responsible for some plaintiffs’ ovarian cancer and mesothelioma.

More than 20 talcum powder trials are scheduled this year in the U.S. Virtually all of the cases involve plaintiffs with a mesothelioma diagnosis.

In December 2018, J&J and Imerys SA, the company’s talc supplier, came to a $1.5-million settlement in a similar mesothelioma case. Imerys later declared bankruptcy which the company said was brought on by all the talc cancer litigation in the country.

Related

•  Talc Mesothelioma Verdict $29 Million against J&J

•  Talcum-Mesothelioma Cancer Lawsuit

•  Imerys seeks Bankruptcy over Talc Lawsuits

•  J & J settles 3 More Talc-Mesothelioma Lawsuits

 

 

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