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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IVC Filter Maker Cook hit with $3 Million Verdict

(Feb. 9, 2019) — An Cook Blood Clot Filter LawsuitsIVC filter company, Cook Medical, was hit with a $3 million verdict on Feb. 1 by an Indianapolis jury.  The jury returned their verdict just before midnight Friday.  They ruled that the Cook filter placed inside the plaintiff was defective.

Cook Celect Filter Trial

The case involved a 51-year-old dental hygienist whose Cook Celect inferior vena blood clot filter fractured and migrated in her body, eventually poking through her thigh and requiring open laparotomy surgery to remove.

Surgeons placed the controversial filter – which is alleged to trap blood clots – into the woman’s inferior vena cava March 2009 during lumbar spine surgery.  She complained in the next few months about hip pain, severe abdominal pain, and pain and swelling.

A CT scan in June 2011 showed her IVC filter had fractured in a prevertebral location abutting the anterior aspect of the L2-3 disc space and upper L3 vertebral body.  A follow up visit found  a “palpable mass” in the skin under her right leg.  The next day the woman pulled a 2-inch long metal object from her right thigh.  That object was part of the filter which had fractured inside of her vena cava and migrated.

In July 2010, surgeons attempted to remove the broken IVC filter but were unsuccessful.  Then, finally in October 2015, surgeons were able to remove what was left of the filter device.

Texas State Court Loss was Cook’s first

The troublesome filter in the Indianapolis trial concerned Cook’s “Celect,” which was also the subject of a jury trial and a subsequent verdict against Cook last Spring in Texas.

In May 2018, a state court jury awarded a Houston-area firefighter $1.2 million for a defective Cook Celect blood clot filter.  The case was similar in that the person implanted with the filter required open laparotomy surgery to have it removed.  And like the woman in this latest case, the plaintiff had it removed because it had migrated to where he feared it working like a “ticking time bomb” in his chest.

In the only other Cook IVC case to go to trial, an Indianapolis jury denied a woman’s claim for damages in summer 2017.  But in that case – a defense pick for trial – surgeons had been able to successfully remove the filter without resorting to open laparotomy surgery.

IVC Filter Problems

IVC filters have proven troublesome because even though they are often used as medical devices in the hopes that they will prevent DVTs, much evidence suggests that they don’t pass a risk-benefit analysis which is the gold standard of any medical device treatment.  Much evidence suggests that they have become accepted despite lacking evidence of being worth their risks.

IVC Filters give no benefit for Trauma Patients

Even though they are often used in trauma patients without the patients’ consent, there is no evidence that they offer trauma patients any benefit and are worth their risks.

No Long-term Benefits

Evidence has also shown that the longer removable IVC filters remain inside a patient’s vena cava, the more likely they are to cause problems.

In addition, evidence suggests that IVC filters don’t protect the patient from developing deep vein thrombosis (DVT) as well as their makers claim they do, while at the same time they can cause other problems which one who opts not to have a filter installed would not otherwise experience.

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Criminal Deceptions drive Drug Company Profits

Would you trust your life or the lives of your loved ones to known criminals?  Criminal deceptions drive drug company profits. Doctored studies, international bribery, deceptive marketing, outright lies, fraud, and kickbacks are the norm in the obscenely lucrative legal drug and vaccine business.  Big Pharma has been penalized with criminal fines from government far more than any other industry.  Drug companies are even dirtier, by comparison, than routine offenders such as “defense” contractors and oil companies like BP and Exxon.

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Big Pharma: Earth’s Most Corrupt Corporations

This is a hard fact on which your life may depend:  the pharmaceutical industry has the worst record of any industry for illegal violations of the law.  Drug companies make billions of dollars selling antidepressants and many other drugs that offer no demonstrable value but plenty of provable harm.  Here is a list of just a few bad Big Pharma actors and recent fines they’ve paid for their transgressions:

  • GlaxoSmithKline (GSK):  nearly $8 billion in 31 settlements
  • Pfizer: nearly $4 billion in 31 settlements
  • Johnson & Johnson: more than $2.8 billion in 19 settlements
  • Merck:  nearly $2 billion in 30 settlements
  • Abbott:  more than $1.7 billion in 16 settlements
  • Eli Lilly: more than $1.4 billion in 15 settlements
  • Teva:  nearly $1.5 billion in 13 settlements
  • Schering-Plough:  more than $1.3 billion in 6 settlements
  • Novartis:  $1.25 billion in 20 settlements
  • Astra Zeneca:  more than $1 billion in 20 settlements

An Insider Exclusive Special reveals how:

  1. The Pharmaceutical Industry – generating $650 plus billion dollar a year  – has been the most profitable business in the U.S. by treating “disease” as an industry. It accounts for nearly 30 percent of the Gross Domestic product.
  2. Much of Big Pharma’s ‘success’ lies in the connections between the companies and the ‘symptoms management’ health care industry.  Encouraging symptoms and treating them pays; preventing diseases or symptoms does not pay.
  3. The medical establishment works closely with multinational drug companies focused first on profits.  Healthy people don’t add to profits.
  4. Lots of drugs MUST be sold. In order to achieve sales, anything goes: lies, fraud, kickbacks, ghostwritten medical “literature,” studies made with predetermined outcomes, you name it. Doctors function primarily as the principal salespeople of the drug companies, which is the way the entire scam was all set up more than 100 years ago, beginning with Rockefeller medicine’s Flexner Report published in 1910. This “Report” was used to effectively establish a monopoly on “healthcare”  that continues today.  Doctors who continue to promote Rockefeller medicine today are rewarded with research grants, gifts, and lavish perks.
  5. International bribery, corruption, and fraud run rampant in the testing of drugs. Criminal negligence exists in the unsafe manufacture of drugs, and not just in China.
  6. Many people don’t realize how drug companies are accused today of endangering public health through wide scale fraudulent marketing schemes. Drug company scams include covertly attempting to persuade consumers that they are ill. Drug companies also bribe doctors, and misrepresent safety test results on their products.

Today the drug industry continues to get away with deceptive “Off Label Marketing.”  Sadly, the American Medical Association (which was convicted of conspiracy to destroy its competition) and the FDA are complicit in allowing doctors to continue to prescribe drugs for “off label” purposes.  Because of this broken system, drug companies continue to get away with deceptive drug marketing.  After they pocket billions of dollars in profits for dangerous or worthless drugs, they then often pay only a small percentage of those billions in fines and settlements.

Medical-Pharmaceutical Complex

Make no mistake: there exists today a Medical-Pharmaceutical Complex that does not work for the long-term betterment of peoples’ health.  This Complex works instead for the short- and long-term goal of drug company profits.  Hence the billion-dollar fines, but it is hardly enough to fix the broken system rigged against the health and betterment of the individual.

The pharmaceutical industry has strayed from its original mission of discovering and manufacturing useful drugs – if that were ever its goal.  It has become, instead, a vast marketing monster with unprecedented control over our fortunes, which are inextricably tied up with the enormous amounts of insurance money we all are now required to pay regardless of how little we use the broken system.

Drug Companies control the Healthcare System

Drug companies now exercise nearly limitless influence over medical research, education, and the behavior of individual doctors. Those who don’t do what Big Pharma dictates that they do – prescribe dubious or dangerous drugs for marginal or even imaginary maladies encouraged by slick advertising campaigns – are ostracized from the medical profession and even driven out altogether.

Only in America can a drug company executive or lobbyist charged with a laundry list of morally repugnant behaviors – medical fraud, criminal salesmanship, gaming the insurance industries, lying to federal officials, manipulating the data of drugs that have killed people – get away with a fine, then receive a financial bonus while enjoying a surge in his company’s stock price after a settlement.  China fines and even executes individuals for such transgressions, but in America it’s all about financial rewards, as long as the criminal fines don’t exceed the profits.

“Alternative” Medicine Canard

It is a function of the dysfunction of our medical system that the AMA and the Medical-Pharmaceutical Complex has succeeded in calling any approach to health not sanctioned by the state “alternative” medicine.  That term is meant to function pejoratively to dismiss anything not sanctioned by the Complex as anti-scientific, but it is also a term which the medical monopoly has used to keep us all from exercising our God-given right to choose whatever therapy we would like.

It should be clear to anyone capable of thought that whatever one chooses is an “alternative.” Chemotherapy, for just one example, is only one “alternative,”  and not a very good one at that, failing 97% of those who consent to it.  But chemo is not called an “alternative” where insurance companies are concerned.  Insurance companies work hand in fist with the Complex to pay only for those drugs or therapies which Big Pharma and its D.C. lackeys dictate will be paid for.  This situation constitutes a medical insurance monopoly, but no mainstream publication will call it that, because the five outlets which own and operate our mainstream “news” are owned by the same multi-national conglomerates which own the drug companies and run the Medical-Pharmaceutical Complex.

Good News

The good news is that more and more people are waking up to the scam, to the medical monopoly controlled by the pharmaceutical industry.  Someday, we may even be able to retake our own rights to medical choice, have our insurance company pay for treatments that we choose, according to our own lights, instead of only those “choices” dictated to us by Big Pharma and the medical monopoly that still controls our broken “healthcare” system.

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3M pays $9 Million for Soldiers’ Defective Earplugs

Earplugs Linked to Hearing Loss

(Jan. 7, 2019) The 3M company agreed to pay the U.S. government $9.1 Million last summer to settle a lawsuit over defective earplugs that allegedly caused our soldiers hearing loss and/or tinnitus. That sum included $1.9 Million for a whistleblower who said the company knew the plugs were defective.

Related:  Defective Earplug Lawsuit

Minnesota-based 3M made the earplugs for U. S. soldiers stationed mostly in Iraq and Afghanistan from 2003 to 2015.  The Dual-Ended Combat Arms™ Earplugs (CAEv2) – now discontinued – were standard equipment for soldiers during those years.

Acting in good faith that the plugs would do what the company claimed, the U.S. Defense Logistics Agency distributed millions of dollars’ worth of them to thousands of service members, putting them at risk for permanent hearing loss or impairment.

The Defective CAEv2 Earplugs

The plugs featured a dual-ended design. They were meant to be used as either traditional earplugs, or they could be flipped over to provide normal hearing while protecting the wearer’s eardrums from gunfire noise and explosions.

The main complaint was that the earplugs were too short to be effectively inserted into a user’s ears. The too-short design led to the plugs gradually loosening in some ears, effectively rendering them useless to protect from hearing damage.

Whistleblower:  3M Knew Earplugs Defective

Though 3M has admitted no wrongdoing in the settlement, a whistleblower said 3M and its predecessor, Aearo Technologies, knew about the plugs’ design problems as early as 2000.  The earplugs failed to pass safety tests then.

Defective Earplug Lawsuit

The defective earplug lawsuit’s allegations were issued under whistleblower provisions of the False Claims Act.  That law allows private parties to sue on behalf of the U.S. government if they believe the lawsuit’s defendants submitted false claims for government funds. The law also allows whistleblowers to share in any funds recovered from a successful lawsuit.

As part of the defective earplug lawsuit resolution, the whistleblower will receive $1,911,000, according to the Department of Justice.

Legal Help for Soldiers with Hearing Loss

More than 2.6 million veterans are receiving disability compensation for hearing loss and tinnitus (ringing or buzzing in the ears), according to the Veterans Administration (VA).

Our law firm is investigating defective earplug hearing loss lawsuits.   We are considering legal action for anyone who meets the following criteria:

  • Served in the military 2003-2015
  • Was issued earplugs during service
  • Suffers from permanent hearing loss or tinnitus

Contact Matthews & Associates for a free legal consultation in a potential defective earplug lawsuit. Our attorneys and legal assistants may be able to help you take legal action for your hearing loss.

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