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 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 woman from Georgia, was implanted with an Option Retrievable Inferior Vena Cava Filter made 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

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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Talcum-Mesothelioma Verdict $29 Million against Johnson & Johnson

(March 19, 2019)  A California jury awarded a woman a talcum powder-mesothelioma verdict  of $29 million against Johnson & Johnson on March 13.  The woman sued J&J over asbestos contained in the company’s baby powder which, she said, caused her to develop mesothelioma.

Plaintiff Terry Leavitt said she routinely used two of J&J’s talcum powder products in the 1960s and ’70s.  She was diagnosed with mesothelioma in 2017. Mesothelioma is a cancer linked to asbestos exposure.  The latency period for mesothelioma can be 30-40 years.

The jury deliberated for two days before finding that J&J’s talc-based products were defective and caused Ms. Leavitt’s mesothelioma.  The jury also ruled that J&J failed to warn the public about the risks. The California Superior Court jury in Oakland awarded the plaintiff and her husband $29.4 million in damages.

Thousands of Talc-Cancer Lawsuits

Johnson & Johnson faces thousands of lawsuits which allege that J&J talc-based products have harmed people.  The Leavitt lawsuit was the first to go to trial since December 2018 stories published by Reuters and The New York Times reported that, for several years, J&J had feared that its baby powder might contain asbestos.  The company still denies, as it did throughout the latest trial, that its talcum powder contains asbestos.

J&J said it would appeal the verdict.  Reuters reported that the company claimed the trial was marred by “serious procedural and evidentiary errors.”  J&J also countered in a statement:  “The jury verdicts are not medical, scientific, or regulatory conclusions about a product.”

J&J Executive:  Talc Asbestos Powder

In December 2018, documents showed that J&J knew for decades that its baby powder was laced with small amounts of asbestos.  The deadly material can occur naturally underground near talcum, which is mined.  In the 1970s, a J&J executive warned that the company’s talc mines might not be free of asbestos.  The New York Times reported that a company memo said some of J&J talc products sometimes contained materials that “might be classified as asbestos powder.”

13,000 Lawsuits over J&J Talcum Powder

Recent cases have tested talc’s link to mesothelioma, but many other cases allege talc powder has caused ovarian cancer.  According to Reuters, Johnson & Johnson now faces more than 13,000 talc-related lawsuits nationwide.

$4.7 Billion Talc-Cancer Verdict

In 2018, a jury ordered Johnson & Johnson to pay 22 women $4.7 billion after  the women alleged that they developed ovarian cancer from using J&J talcum powder products.  More than $4 billion of the jury award consisted of punitive damages, which are designed to punish a defendant for wrongdoing.  In December  2018, J&J failed to convince a judge to throw out that verdict , but the company vowed to appeal that decision.

J&J Denies Talc Contains Asbestos

Despite several jury verdicts over a talc cancer link, J&J has always denied that its talcum has ever contained asbestos.   J&J claims that decades of medical studies have demonstrated that its talc is safe.  J&J has stated:  “Research, clinical evidence and nearly 40 years of studies by independent medical experts around the world continue to support the safety of talc.”

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Shocker: FDA hides Thousands of Medical Device Problems

(March 8, 2019) A shocking report from Kaiser Health News has found that the FDA hides thousands of medical device problems from patients and their doctors.  The FDA has, for nearly two decades, allowed medical device companies to file reports of injuries and malfunctions outside the well-known public database known as MAUDE, Manufacturer And User Device Experience Database.  The FDA, in effect, has been shown to keep separate sets of books: one, a heavily-censored and incomplete public set accessible to patients and providers; the other, a private and more complete (and therefore more relevant) set accessible only to some medical device manufacturers.

 “No matter how cynical you get, you just can’t keep up.”  – Lilly Tomlin

“Alternative Summary Reporting” Subterfuge

The FDA’s bookkeeping subterfuge – which the agency euphemistically calls “alternative summary reporting” – seriously compromises any legitimacy the FDA and MAUDE may have offered, which is an alarming development, to say the least.  Many medical experts have trusted the FDA and MAUDE to identify problems that could put patients in peril.

FDA records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017. That means no doctors or patients saw those reports, or that they saw only a tiny fraction of them if they were similar to other reports made on the same type of device.

Dangerous Devices Lead to Secret Program

According to officials with FDA at the time, “alternative summary reporting” began two decades ago to cut down on redundant paperwork.  Former FDA official David Kessler said the program took shape after scandals over under-reporting of device problems spurred changes that allowed criminal penalties against medical device companies.

Thousands of injury and malfunction reports began coming to the agency each month. Kessler said some 15 staff members reviewed them. He said many reports were so similar that reviewing them individually was “mind-numbing.”  Kessler went to the FDA’s legal department and to device makers for a solution.  Medical device makers then wrote their own ticket; they would be able to seek a special “exemption” to avoid reporting certain complications to the public database. The manufacturers would instead send the FDA a spreadsheet of injury or malfunctions each quarter, half-year, or year. Nobody but the FDA would be able to put the actual injury numbers together after that, or the total number of adverse events.  The agency would no longer share those real numbers with the public, with patients and medical providers.

Kessler said reviewers could then quickly look for new problems or spikes in known issues. (They would no longer be bogged down by actual reports, real numbers, total adverse events and injuries that were “redundant.” ) When the program launched in 2000, the list of exempted devices was made public and only a few devices were involved, according to Kessler.

Few people even within the FDA knew about the program then or now, and that list Kessler mentions as being public then is no longer public. We do know, however, that transvaginal mesh makers are now part of it, able to hide the actual number of women injured by the controversial plastic mesh used for pelvic organ prolapse and stress urinary incontinence.

Starting in September, KHN filed Freedom of Information Act requests for “exemption” agreements and reports for several medical devices. Health and Human Services officials denied an appeal to provide some of the records quickly, concluding there was no “compelling need” for haste. For one request, the records were estimated to arrive in 22 months.

The FDA did provide some top-level data. It shows that from 2014 through 2017, the overall number of alternative summary reports filed by device makers rose from 431,000 to 481,000.

FDA Unplugged

The Kaiser Health News story suggests the FDA’s reporting deception was not uncovered until a surgeon performed his due diligence after a device he had used failed.

“Special Exemption” 

Dr. Douglas Kwazneski experienced a stapler malfunction during a liver surgery.  He then researched other possible adverse events involving the stapler.  He checked the FDA’s MAUDE database.  He found “there was nothing.”   But then he surveyed leading surgeons.  Two-thirds of them told him they had also experienced stapler malfunctions, or they knew a peer who had.

Dr. Kwazneski then discovered that the FDA had granted the makers of surgical staplers a special “exemption.”  This arcane arrangement allowed the device maker to file reports of malfunctions in a database hidden from both doctors and the public.

FDA Covers up 1.1 Million Events 

“[I]t seemed like a coverup,”  said Dr. Kwazneski, who practiced at the time in Pasco County, Florida.

Worse, the KHN investigation shows FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions.  At least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository since 2016.  They all but disappear there, instead of being described individually in the publically accessible MAUDE database.

The hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA. Many of those were implanted in patients or used in thousands of surgeries. The adverse event reports for surgical devices have included surgical staplers, balloon pumps for blood circulation, and mechanical breathing machines.

An FDA official said that the program is for issues that are “well-known and well-documented with the FDA” and that it was reformed in 2017 as a new voluntary summary reporting program was put in place for up to 5,600 devices.  “Voluntary?”

Secret Program

KHN notes that the FDA’s secret reporting program has been so obscure that many of the doctors and engineers dedicated to improving device safety don’t even know about it. Even a former FDA commissioner said he knew nothing about it.

Give the Kaiser Health News team all the credit.  They dug through abstruse piles of public records to find “oblique references to reporting exemptions.”  They had to ask the FDA questions for months before the erstwhile “public” agency finally confirmed that it supervised “reporting-exemption” programs and helped hide thousands of never-before-acknowledged instances of malfunctions or harm.

FDA Information Blackout Harms People

FDA records show that amid the agency’s blackout on information regarding device risks, patients have been injured, in some cases hundreds of times.

A former FDA official. Dr. Lori S. Brown, who accessed the data for her research, said doctors who relied solely on the FDA’s incomplete public reports could easily reach the wrong conclusion about a device’s safety record.

KHN wrote, “The FDA has also opened additional – and equally obscure – pathways for device makers to report thousands of injuries brought to light by lawsuits or even deaths that appear in private registries that medical societies use to track patients. Those exemptions apply to risky and controversial products, including pelvic mesh and devices implanted in the heart.”

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations.  “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

That’s hardly the stuff to build consumer confidence about medical device safety.

480,000 Hidden Reports in 2017

FDA records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

FDA spokeswoman Alison Hunt said the majority of device makers’ “exemptions” were revoked that year as a program took shape that requires a “placeholder” report to be filed publicly.

1 Million+ Reports Hidden by FDA

More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA.  But with the agency’s alleged new “transparency” push,” anyone unlucky enough to need a medical device (there are always alternatives)  might be able to find a public report and submit a Freedom of Information Act request to get information about incidents.  A response can take up to two years.

Ms. Hunt said in an email to KHN that the exemption program “has allowed the FDA to more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive.”

The “quality” of the FDA’s review of any medical device is so obviously compromised with the unveiling of the agency’s secret reporting program that such explanations would be laughable if the situation it has created weren’t so dangerous and irresponsible.

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Defibrillators Recalled by Stryker

The Stryker company is recalling thousands of defibrillators due to a malfunction of the device.  The US FDA reported that Stryker’s LIFEPAK 15 device may lock up after delivering a defibrillation shock.  The company said the malfunction may delay delivery of therapy, which can cause serious injury or death.

58 Complaints, 6 Deaths

Since 2009, nearly 60 complaints have been reported to the FDA over the Stryker device.  At least six people have reportedly died from the machine’s malfunction.  According to the FDA, Stryker is “instructing customers to continue to use their (device) according to the operating instructions until the correction can be completed.”

Stryker Recalls LIFEPAK 15 Defibrillator

Stryker itself said the six deaths appear to be related to the defibrillator’s lockup malfunction.   The company said it has become aware that certain LIFEPAK 15 Monitor/Defibrillators have been reported to experience a lock-up condition after a defibrillation shock was delivered. This condition is defined as a blank monitor display with LED lights on, which indicates power to the device, but no corresponding response in the keypad and device functions.

Stryker is contacting people affected by the recall and pledging to fix the problem.  The company says that if the device “exhibits the lockup condition during patient use, the steps from the General Troubleshooting Section (page 10) of the (device) should be immediately followed.”

More than 13,000 devices are potentially impacted by the recall.  Stryker is advising patients to continue using their LIFEPAK 15 devices as usual until the company can fix the problem.

Defibrillators are common throughout the civilized world.  The paddle-fitted, electrical devices are used to shock and revive people whose hearts have suddenly stopped beating. The National Institutes of Health explains that these devices are meant to “restore a normal heartbeat by sending an electric pulse or shock to the heart.  They are used to prevent or correct an arrhythmia, a heartbeat that is uneven, or that is too slow, or too fast.  Defibrillators can also restore the heart’s beating if the heart suddenly stops.

Heart experts at Johns Hopkins claim that at least 522 lives can be saved yearly in the U.S. and Canada by the widespread placement of automated external defibrillators. There is general consensus in the medical community that defibrillators are helpful devices when they are properly designed and used, and are functioning properly.

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