essure

Essure Female Sterilization

Essure Product

Essure is a form of permanent birth control that was developed by Conceptus Inc. in 1998 and approved for the US by the FDA in 2002. It consists of a small metal coil resembling a spring, that is placed inside each fallopian tube. Once in place, the body surrounds the implant with scar tissue and creates a barrier so that sperm can not travel into the fallopian tubes and fertilize an egg.

This product was heavily marketed to primary practitioners and OB/GYNs, as well as their patients as a simple non-invasive form of female sterilization. It could be performed in a medical office setting or in an outpatient surgical center without the need for general anesthesia or any incisions. Essure was designed to be an alternative to tubal ligation because it was less expensive and far less invasive than the conventional surgical sterilization with a recovery time of 1-2 days (Essure, 2018).

Essure Timeline

From the time of the FDA approval, there have been clinical study requirements that were attached to the initial review and final approval of the product. This was due to the fact the initial study that was submitted to the FDA was rather short (2 years) and did not involve a large number of participants (745 women). The FDA stipulated that Conceptus would be required to conduct two post-approval studies. The first was to “gather five-year follow up information on the participants in the two premarket clinical trial patient cohorts” and the second consisted of evaluating the rates of bilateral placement by newly trained physicians (FDA, 2018).

2013- Bayer AG of Germany acquired Conceptus. In this same year, patient labeling of the Essure product was updated to include risks of chronic pain and device migration. This was due to increasing concerns among thousands of women that were experiencing severe side effects and surgical removal of the devices.

2014- Bayer sales reportedly topped out over $47 billion.

2016- The FDA required physician and patient labeling changes as well as the requirement of a Patient Decision Checklist (FDA, 2016). A box warning included information about patients having experienced numerous adverse events (persistent pain, perforations of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen) and that surgical removal would be necessary to stop these. In the same year, the FDA announced that they were ordering Bayer to conduct post-market studies to determine the benefits and risks associated with the use of Essure.

2017- The European Union suspended the commercial license of Essure for a minimum of three months (Legal Reader, 2017). As a result of this action, authorities in France and Ukraine recalled the device and Bayer voluntarily recalled all implants in Canada, United Kingdom, Finland, and the Netherlands. The FDA also reported in this same year that they had received nearly 12,000 reports of adverse effects related to Essure (Reuters, 2018).

April 2018- The FDA update the physician and patient labeling again. This time, to include a restriction on the sale and distribution of Essure. This product would be restricted to only doctors and hospitals that reviewed the FDA-approved “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement” with their patients and got signed consent prior to implanting Essure devices (FDA, 2018). In a letter to Bayer, the FDA stated that they “determined that these restrictions on sale and distribution are necessary to provide reasonable assurance of the safety and effectiveness of the device” (FDA, 2018).

July 2018- The FDA issued a press release stating that the maker of Essure, Bayer, announced that they would halt sales of Essure in the US. The commissioner of the FDA stated that they had been notified by Bayer and “that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018” (FDA, 2018). Bayer stated that they would withdraw Essure from the US market. The reasoning was not due to safety concerns, but because of declining sales.

Essure Lawsuits

By the middle of 2018, more than 16,000 women had filed lawsuits against Bayer. These suits state that Bayer had knowledge that Essure was a defective product and did not provide proper warnings to those women that had the devices implanted, nor did they provide the necessary training for physicians. They also state that Bayer falsely made statements about the efficacy and safety of Essure in its marketing materials and on its website. Many of the cases include medical problems as stated by the FDA as well as complications ranging from migraines and hair loss to organ perforation from pieces of the device breaking off and unintended or dangerous pregnancies.

In 2018, there were nearly 37,000 women that chronicled their ordeal on the Facebook page Essure Problems, including the side effects and suffering that they attributed to Essure. Today, the site has over 42,000 members (Facebook, 2019).

In the same year, Netflix released “The Bleeding Edge” by Award-nominated filmmakers Kirby Dick and Amy Ziering. The documentary features women who have had a host of debilitating complications as a result of having a “non-invasive” and “medically approved” device implanted in their fallopian tubes to prevent future pregnancy. This film goes on the explain how the medical device industry has released products such as Essure with no concern for the consumers and has driven profits without proper research (Netflix, 2018).

During the ten years that Essure was marketed and sold in the US, almost 750,000 were implanted with this device (Time, 2018). This medical manufacturing giant currently has a group of 16 cases filed in the U.S. District Court for Eastern Pennsylvania and lawsuit filings are underway in California, Illinois, and Missouri. Many more are expected in the months ahead.

To date, Bayer denies any safety issues associated with Essure and sites that research conducted for nearly two decades confirms Essure’s favorable safety profile. In an interview in 2018, Christopher Loder, a company spokesperson for Bayer, went on to say that even the FDA continues to support the fact that “Essure’s benefits outweigh any potential risks” (Bloomberg, 2018).

References:

http://www.essure.com/what-is-essure

https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essurepermanentbirthcontrol/ucm452270.htm

https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/10/fda-finalizes-guidance-on-boxed-warning,-patient-decision-checklist-for-essure-devices

https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/UCM488065.pdf

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452251.htm

https://www.legalreader.com/essure-loses-commercial-license-in-european-union/

https://medicalxpress.com/news/2017-08-eu-sale-contraceptive-implant.html

https://www.reuters.com/article/us-bayer-essure/bayer-to-phase-out-essure-birth-control-device-in-u-s-idUSKBN1KA2A1

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604098.htm

https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014S051A.pdf

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614123.htm

https://www.washingtonpost.com/news/to-your-health/wp/2018/07/20/sales-of-essure-birth-control-implant-halted-by-bayer-u-s-was-last-to-sell-controversial-device/?utm_term=.c216bba44ddc

https://www.forbes.com/sites/tarahaelle/2018/07/27/bayers-removal-of-contraceptive-device-essure-praised-by-activists/#5bce6eb74a23

https://www.bloomberg.com/news/articles/2018-07-25/bayer-essure-suits-skyrocketed-as-fda-pushed-stronger-warnings

http://time.com/5344646/bayer-essure-birth-control-sales/

https://www.facebook.com/groups/Essureproblems

Tracy-Headshot

Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

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Uloric

Uloric Heart Risk

In 2009, Uloric (febuxostat) was the first new drug approved by the FDA for gout in nearly 40 years. Until then, allopurinol (Zyloprim) was the only drug available on the market for preventing the formation of the uric acid crystals that cause gout. However, many patients could not tolerate the recommended therapeutic dose of allopurinol without suffering side effects (sometimes fatal). This new drug did not get overwhelming support by the FDA advisory committee but was ultimately approved.

Clinical Trials for Uloric

Early clinical trials of Uloric showed that at a dose of 80mg, this new drug worked far better than allopurinol and at a 40mg dose, it works equally as well as allopurinol (Clinical Trials, 2005) (Clinical Trials, 2009). Research findings on this drug were submitted with an application to the FDA for approval. The FDA rejected this application sighting that there were slightly more deaths and heart problems with patients taking Uloric than were reported with patients taking allopurinol.

The manufacturer (Takeda) then submitted another application for approval. This 2006 application was denied as well. The committee members noted that 9 of the total 12 deaths among Uloric subjects were attributable to cardiovascular events, whereas no serious adverse cardiovascular (CV) events were linked to allopurinol or the placebo. Taketa then conducted another clinical trial and did not find these same results (Schumacher et al., 2008). They reported that most common side effects seen in these patients were liver function abnormalities, muscle and connective-tissue symptoms, nausea, and rash (FDA Prescribing Info, 2009). The drug was reported as being well tolerated, and the side effects did not increase over long-term use.

The FDA grouped the finding from all of the studies conducted by Takeda and could not determine “with much confidence” that Uloric posed a greater risk of CV events than did allopurinol. They ultimately approved the use of Uloric in the chronic management of hyperuricemia (elevated levels of uric acid) in patients with gout. With this use granted, they also stipulated that the manufacturer (Takeda) was required to conduct additional post-marketing clinical trial to determine:

  1. Whether the use of Uloric is associated with a moderate increase in the risk of serious adverse cardiovascular outcomes when compared to allopurinol.
  2. Any drug-drug interactions with Uloric and a single, oral dose of theophylline.

The results of these clinical trials also needed to be reported to the FDA according to a set schedule. The Final Report Submission for the drug-drug interaction with theophylline was due on May 31, 2010, and the Final Report Submission for cardiovascular risks was due on January 31, 2015 (FDA, 2009). They were also required to include drug warning labels.

Uloric-tab40
Uloric-tab80

Uloric Marketing

According to a report in The Pharma Letter, in the decade since Uloric was approved, the medication has been aggressively marketed to consumers and providers (Pharma Letter, 2018). Takeda reported $1.9 billion in US sales of febuxostat from fiscal years 2012 through 2017. For the one-year period ending in June 2015, there were 1.3 million US prescriptions for Uloric, making it the 46th most prescribed brand-name medication in the USA at the time. The retail price of a 30-day supply of Uloric is also roughly 20-25 times higher than allopurinol when compared on the GoodRx website (3/2019).

Uloric Cardiovascular Concerns

In 2017, serious concerns started to surface about the CV risks associated with the use of Uloric. November of that year, the FDA announced that they had received the preliminary results from the required clinical trials from Takeda and were alerting the public that they showed an increased risk of heart-related death with febuxostat (Uloric) compared to allopurinol. They stated that once the Final Report Submission was received, the information would undergo a comprehensive review. Once that was complete, they would notify the public of any additional findings (FDA, 2017).

The results of the study known as CARES was presented in March 2018, at an annual meeting of the American College of Cardiology in Orlando. This long term study compared the risk of CV events with the use of Uloric to allopurinol. They concluded that the rates were comparable for major CV events (non-fatal heart attack, stroke, rhythm problems and hospitalization for heart failure) between the two drugs (American College of Cardiology, 2018).

Following this announcement, a nonprofit consumer advocacy organization called Public Citizen Health Research Group petitioned the FDA to remove the gout medication Uloric. According to the agency’s director “The FDA almost certainly would have denied approval of febuxostat if data from this post-market trial had been available at the time of the initial submission. The only justifiable course of action to prevent further cardiovascular deaths is obvious: This medication must be removed from the U.S. market immediately.”( Public Citizen, 2018)

In February 2019, the FDA released the results of their advisory committee review. The committee members overwhelmingly voted 19 to 2 (with one abstention) to approve a Boxed Warning for Uloric due to increased risk of heart-related death and death from all causes with the use of this drug. The FDA also stated that providers should “reserve Uloric for use only in patients who have failed or do not tolerate allopurinol. Counsel patients about the cardiovascular risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms” such as:

  • Chest pain
  • Shortness of breath
  • Rapid or irregular heartbeat
  • Numbness or weakness on one side of your body
  • Dizziness
  • Trouble talking
  • Sudden severe headache

Taketa’s View of the CV Risks of Uloric

Taketa’s most recent clinical study of Uloric revealed that there were 15 deaths per year from heart-related causes and 26 deaths per year from any cause per 1,000 patients were observed (FDA, 2019). The president of Takeda responded to the FDA announcement in January 2019 by saying “We have studied the safety of Uloric for more than 15 years and remain confident in Uloric as an important option for the chronic management of hyperuricemia in gout. We look forward to additional discussions with the FDA regarding these CARES data.”

Since the risk of CV events is increased in patients with gout, it is troubling to know that Takeda presented report after report of the findings of their drug Uloric, stating that there was a risk of adverse effects that include CV events. Despite this information and additionally required clinical trials, they aggressively marketed this drug to providers and to consumers that were already at risk. This led to hundreds of thousands of patients being prescribed the drug, who were unaware of the potential dangers associated with it.

Sources:

https://clinicaltrials.gov/ct2/show/NCT00102440

https://onlinelibrary.wiley.com/doi/full/10.1002/art.24209

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000_Approv.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021856s011lbl.pdf

https://worldhistoryproject.org/2009/2/13/fda-approves-takeda-pharms-uloric

https://www.medicinenet.com/script/main/art.asp?articlekey=94500

https://www.medscape.com/viewarticle/898600

https://www.webmd.com/arthritis/news/20090216/fda-oks-new-gout-drug-uloric

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021856s000TOC.cfm

https://clinicaltrials.gov/ct2/show/results/NCT00174915?view=results

https://www.fda.gov/downloads/drugs/drugsafety/ucm584803.pdf

https://www.healio.com/rheumatology/gout/news/online/%7b5eff7ca8-878e-48de-aad2-6770ee0ef1d9%7d/fda-to-examine-heart-related-deaths-associated-with-febuxostat

https://www.acc.org/latest-in-cardiology/articles/2018/03/07/15/53/mon-8am-cares-cv-safety-of-febuxostat-and-allopurinol-in-patients-with-gout-and-cv-comorbidities-acc-2018

https://www.reuters.com/article/us-health-heart-gout-drug/newer-gout-drug-poses-risk-to-heart-patients-idUSKCN1GO26V

 

Tracy-Headshot

Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

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Opioid

Opioid Crisis

An epidemic of addiction and death across the United States.

The use of opioid drugs has reached epidemic levels and has spread to every race, gender, socioeconomic class and nearly every age group of people in the United States. The Centers for Disease Control and Prevention (CDC) reports that these addictive drugs claim about 130 American lives on a daily basis and the numbers continue to increase annually. The question is, how did we as a nation get to this point and why?

What are opioids?

According to the National Institute of Health’s National Institute on Drug Abuse, “Opioids are a class of drugs that include the illegal drug heroin, synthetic opioids such as fentanyl, and pain relievers available legally by prescription, such as oxycodone (OxyContin), hydrocodone (Vicodin), codeine, morphine, and many others”.

Opium

Opium became available in the US in 1775, but we believe that it has used by man since 3400 B.C. when it was first recorded in writing. The drug comes from the opium poppy (Papaver somniferum) seed pod sap, that contains various amounts of alkaloids such as morphine, codeine, thebaine, and papaverine. In the U.S. in the 1800s, opium dens started to spring up in the west (San Francisco’s Chinatown) and quickly spread east to New York. This was because of immigration and trading with other countries that cultivated the poppies and then supplied the drug. Opioids (morphine) were used to treat soldiers in the 1860s during the civil war and many soldiers became addicted to them. The US Congress banned opium in 1905 and in the following year they passed the Pure Food and Drug Act. This act required labeling of the contents on all medications.

Heroin

The Bayer Company was the first to produce heroin and in 1898, there were producing and distributing this new “miracle drug” on a commercial scale. It was found that it controlled pain levels better than codeine and morphine. However, it was also discovered that patients were developing a tolerance to the drug and quickly becoming addicted. It was eventually banned but it’s use gradually increased until the 1970s. Since that time we have seen a ten-fold increase in heroin use in the U.S.

Prescription Opioids

The Harrison Narcotics Act in 1914 regulated opioids (and coca leaves) to limit their recreational usage and by the 1970s, the stigma of addiction led doctors to avoid prescribing opioids. They opted for surgical procedures to block pain signals instead. However, in the 1980s and 1990s, opioids began to be used again to treat pain from chronic diseases. This when we saw a spike in new pain medications being approved and prescribed.

Here, we can look at the timeline of opioids that have been approved by the US Food and Drug Administration (FDA) over the years:

1947    Methadone (methadone hydrochloride) was approved as an antitussive and analgesic. In 1972 it was approved for opioid addiction treatment.

1957    Darvon (propoxyphene hydrochloride) was approved.*

1972    Darvocet (propoxyphene napsylate, acetaminophen) was approved.*

1983    Vicodin (hydrocodone bitartrate, acetaminophen) was approved.

1987    MS Contin (morphine sulfate) was approved. First opioid that allowed dosing every 12 hours instead of every 4-6 hours.

1989    Percodan (oxycodone HCI, aspirin) was approved.

1990    Duragesic (fentanyl transdermal system) was approved. First opioid “patch” that was designed to be worn for 3 days.

1995    OxyContin (oxycodone controlled-release) was approved. The first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours.

1998    Actiq (fentanyl citrate) was approved. First pain medicine approved to treat cancer breakthrough pain.

1999    Percocet (oxycodone and acetaminophen) was approved.

*Darvon and Darvocet were banned in 2010.

Most of these have become common household names, but they didn’t start that way. Many were originally designed and prescribed for severe acute pain. Prescriptions were written in very limited quantities or were mainly used in hospital settings. But by the period of 2012-2016, the sales data that was analyzed by the FDA shows that products that were sold from manufacturers to pharmacies and other settings, revealed that sales to retail settings accounted for the majority of the annual opioid analgesic sales (>80%) and injectable formulations accounted for less than 0.2% of those sales. This means that there has been an enormous shift in the sales of these drugs from in-patient settings (hospitals) to outpatient settings (pharmacies), to then be dispensed to the general public. This peaked in 2011 with doctors writing 238 million opioid analgesic prescriptions annually.

Opioid Addiction

There are some staggering statistics when we look at the number of individuals that are diagnosed with opioid use disorder (addiction) in the United States. The National Institute on Drug Abuse provides us with annual figures that include the effects that this has on public health and social and economic welfare. They estimate that nearly 1.7 million people in the United States suffer from substance use disorders related to prescription opioid pain relievers and 21 to 29 percent of all patients that are prescribed opioids for chronic pain will misuse them. Unfortunately, opioid deaths are the reality of opioid drug misuse. The CDC also has stated that around 68% of the more than 70,200 US drug overdose deaths in 2017 involved an opioid.

Opioid Deaths

We know that in the 1990s there was growing pressure in the health care industry to treat pain more aggressively and as a result, pharmaceutical companies focused on the development of new pain medications. These companies also marketed the drug aggressively to doctors. They were marketed as safe medications that provided long-term relief. These doctors were told that less than 1% of all patients that were prescribed medications abused them and they should be prescribing more to help their patient in pain. Many critics believe that there was a concerted effort by the pharmaceutical companies to mislead the public and physicians about the dangers.

Since then, millions of Americans have abused prescription opioids. The federal government reports that more than 130 people now die each day from opioid overdoses, though not all of those drugs were obtained by prescription. A study published in the Harvard Review of Psychiatry found that the death rate from opioid misuse is 6 to 20 time greater than that the general population.

The CDC estimates that the total “economic burden” of just prescription opioid misuse in the United States is $78.5 billion a year. This includes the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement. Because of this economic burden, local and state governments believe that the pharmaceutical companies should pay for the cost associated with this epidemic. Public officials hope for an outcome similar to the massive tobacco settlement of the 1990s.

Opioid Lawsuits

In an effort to reduce risk and maximize the benefits of available pain treatment options, the CDC issued comprehensive guidelines for prescribing opioids for chronic pain outside of cancer treatment, palliative care, and end-of-life care. These prescribing recommendations stated that non-opioid treatments are preferred as the first step for treatment of chronic pain. As a result of the attempts by the CDC to change opioid prescribing patterns, they have been opposed primarily by indirect intervention. This has been done by the pharmaceutical industry through lobbying and advocacy groups.

A coalition of 41 states’ attorneys general has filed lawsuits against five major opioid manufacturers (Endo International, Janssen Pharmaceuticals, Teva Pharmaceutical Industries Ltd./Cephalon Inc. and Allergan). Subpoenas have been served and they are seeking information about how these companies marketed and sold prescription opioids. This group also served a supplemental investigative subpoena to Purdue Pharma.

The coalition is also demanding documents and information related to distribution practices from three drug distributors (AmerisourceBergen, Cardinal Health and McKesson). According to reports by the Drug Channels Institute, these three companies had more than $400 billion in revenue in 2016 and manage about 90% of the country’s national drug distribution.

Forbes recently published an article that stated that they believe that “opioid lawsuits on par to the become largest civil litigation agreement in U.S. history”. To date, there are numerous lawsuits that have been filed in relation to the opioid crisis. The largest case to date is one filed in the US District Court of Ohio, in which municipalities from across the country are seeking damages from this opioid crisis. The judge, in this case,  Dan A. Polster, has called the opioid epidemic a “man-made plague, twenty years in the making” and has refused a motion by drug companies to dismiss the case. He is urging both sides to come to an agreement in what could amount to billions of dollars. 

References:

https://history.house.gov/Historical-Highlights/1901-1950/Pure-Food-and-Drug-Act/

https://www.cdc.gov/drugoverdose/epidemic/index.html

https://www.ncbi.nlm.nih.gov/pubmed/11862675

https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74769ap_appltr_prntlbl_chemr.pdf

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020747

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018248

https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-330_Oxycodone%20and%20Acetaminophen.pdf

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=010997

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/007337-S24_Percodan_toc.cfm

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=088058

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017122

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM598899.pdf

https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis#two

https://journals.lww.com/hrpjournal/Abstract/2015/03000/Long_Term_Course_of_Opioid_Addiction.3.aspx

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3021365/

https://www.abcactionnews.com/news/local-news/i-team-investigates/opioid-lawsuits-1-000-local-governments-sue-drug-makers-pharmacies

Tracy-Headshot

Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

Opioid

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roundup-weed-killer

Roundup Non-Hodgkin’s Lymphoma Risk

Exposure to the chemical glyphosate, contained in Roundup has been linked to cancer or other serious illnesses.

RoundUp® Weed Killer

The product Roundup® is a broad spectrum herbicide that contains an isopropylamine salt of glyphosate as its active ingredient. In 1974, this product was first sold to farmers for commercial use. Since the late 1970s, the use of this herbicide has grown over 100 fold. This was especially true after Monsanto (the original developer) released Roundup® Ready Crops. These crops were resistant to Roundup® and allowed farmers to grow their crops without the fear of damage by blanket application of Roundup® for the control weeds in their fields.

Many researchers also believe that this increase in use was due to the widespread emergence of glyphosate-resistant weeds. By the year 2007, Roundup was the leading product used in commercial agriculture and the second-most popular for home, gardens, schools, government properties, industrial sites, and other commercial applications. 

Interestingly, Roundup® was developed to replace other herbicides that were causing well-documented problems. The problems included damage to crops, decreased efficacy of the products, and risks to human health. It was initially tested for industry standards including toxicity. Early reports found that glyphosate-based herbicides (GBHs) posed a relatively low threat to non-target species, including mammals. Because of this, leading worldwide regulatory agencies set high acceptable exposure limits.

Glyphosate Exposure

The current U.S. Environmental Protection Agency (EPA) Acceptable Daily Intake (defined as the Chronic Reference Dose) is 2.0 mg of glyphosate per kilogram body weight per day (mg/kg/day). In contrast, the current European Union (28 countries) Acceptable Daily Intake is more than 5 times lower at 0.3 mg/kg/day (a level adopted in 2002). The data upon which these exposure thresholds are based was supplied by the manufacturers during the registration process (in 1986) and are considered proprietary.  These reports are typically not available for any type of independent review.

Concerns about the carcinogenic properties of glyphosate-based herbicides increased after the World Health Organization’s International Agency for Research on Cancer (IARC) re-classified glyphosate as “probably carcinogenic to humans” in 2015. This decision was based on epidemiological studies that looked at occupational exposure and rodent studies which showed an association between glyphosate and renal tubule carcinoma, hemangiosarcoma, pancreatic islet cell adenoma, and/or skin tumors.

The IARC evaluation was based on the systematic selection and review of all publicly available and pertinent studies. The review of this information was conducted by independent experts that were free of any vested interests. They followed strict scientific criteria that are recognized throughout the world.

To reach these conclusions that they drew from their research, the IARC reviewed approximately 1000 studies. Some of these studies evaluated people that were exposed through employment, such as farmers. Others were experimental research related to cancer and cancer-related effects.

On April 30, 2018, the EPA closed the 60-day comment period for their Draft Human Health and Ecological Risk Assessments for Glyphosate paper that was released December 18, 2017. At the closing of this comment period, they stated that the “EPA is now evaluating the comments received and will consider any potential risk management options for this herbicide”. To date, no additional information has been released.

Researchers from the University of Washington have evaluated existing studies to look at the risk factors of exposure to the glyphosate-based herbicides including Roundup®. Their study results were recently published in the journal Mutation Research/Reviews in Mutation Research on February 10, 2019.  These scientists concluded that this exposure significantly increases the risk of non-Hodgkin lymphoma (NHL), a cancer of the immune system.

Lawsuits against Bayer

The first high-profile case that was filed against Monsanto in the U.S. District Courts, California Northern District, San Francisco. This case (Docket number 3:16-cv-01244) was filed by DeWayne Johnson a former school groundskeeper who was diagnosed with terminal non-Hodgkin lymphoma in 2014. As a groundskeeper for the school, he applied Roundup® 20 – 30 times per year. He also recalled two incidents in which he accidentally was soaked with the product.

The case was filed as a “Personal Injury-Product Liability” lawsuit and alleged that chronic exposure to the glyphosate-based herbicide Roundup® caused the cancer that the plaintiff was diagnosed with and that the manufacturer of the product (Monsanto) did not sufficiently warn consumers of this risk.

The case was filed in March 2016. After the evidence was presented to the court and jury with just three days of deliberation, in August 2018 the jury found in favor of Mr. Johnson. They found that the weed killer Roundup® was directly responsible for the non-Hodgkin lymphoma that Mr. Johnson was dying from. The jury awarded DeWayne Johnson $250 million in punitive damages and about $39 million in compensatory damages.

After the verdict, Monsanto issued a statement saying it stands by the studies that suggest Roundup® does not cause cancer. The Monsanto Vice president stated, “We will appeal this decision and continue to vigorously defend this product, which has a 40-year history of safe use and continues to be a vital, effective and safe tool for farmers and others”.

One month later, Monsanto filed an appeal for a new trial and in October 2018, a judge from the San Francisco Superior Court denied a request for a new trial by Bayer-Monsanto but reduced the total damages from $289 million to $78.5 million.

In June 2108, Bayer announced that their acquisition of Monsanto was complete. With this, they not only acquired all of the rights to the product Roundup® but also all of the lawsuits associated with this product. At the beginning of 2019, it was estimated that the number of lawsuits that had been filed against Bayer had exceeded 9000. In the wake of these lawsuits and to cut costs following the acquisition, this German drug giant has announced that they would sell some of their brands and cut 12,000 jobs worldwide.

References:

http://npic.orst.edu/factsheets/glyphogen.html

https://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/fs_PC-417300_1-Sep-93.pdf

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)70134-8/fulltext

https://www.epa.gov/pesticides/epa-releases-draft-risk-assessments-glyphosate

https://www.epa.gov/ingredients-used-pesticide-products/draft-human-health-and-ecological-risk-assessments-glyphosate

https://www.sciencedirect.com/science/article/pii/S1383574218300887https://www.courtlistener.com/?type=r&q=docket_id%3A4182663

https://www.cnn.com/2018/08/10/health/monsanto-johnson-trial-verdict/index.html

http://www.pharmtech.com/bayer-completes-monsanto-acquisition-63-billion-0

https://non-gmoreport.com/as-roundup-lawsuits-mount-bayer-cuts-12000-jobs-considers-settling-lawsuits/

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Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

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Johnson & Johnson Talcum Powder Complications

Talcum Powder Ovarian Cancer Risk

What you need to know if you or a loved one used this product.

Written by Tracy R Everhart, MSN, MS CAM

What is talcum powder?

You will hear this product referred to as talcum powder, talcum or just talc. Talcum powder is made from a mineral called talc. It has been included in many different products and was initially marketed in the 1800s along with other feminine hygiene products. This mineral has historically been added to baby products and cosmetics because of its ability to absorb moisture and reduce friction. Because of this property, talc prevents rashes from moisture and allows cosmetics to be applied smoothly.

Talc is the softest known mineral and because of its properties, it is used for many other purposes. In 2011, about 26% of the talc consumed in the United States was used in the manufacturing of plastics because of its heat resistance and its ability to stiffen and prevent shrinkage of products such as polypropylene, vinyl, polyethylene, nylon, and polyester.

Unfortunately, talc and asbestos may occur naturally in close proximity to each other in some metamorphic rocks. Studies published as early as the 1960s and 1970s identified health concerns about the use of talc that contains asbestos in some cosmetic products. According to the FDA, those studies did not conclusively demonstrate such a link, or if such a link existed, what risk factors might be involved.

Health Risks of Using Talcum Powder

The Cosmetic, Toiletry, and Fragrances Association (CTFA) is the agency that regulates the cosmetics and personal products industries and in 1976 they issued voluntary guidelines for the use of talc. These guidelines stated that it should be standard that all cosmetics produced with talc should be free of any detectable amount of asbestos.

Talcum Powder and Ovarian Cancer

In 1982, a case-control study of ovarian cancer that collected information on talc use reported an increased risk with perineal dusting. Subsequently, cosmetic grade talc was nominated to the National Toxicology Program’s (NTP) 10th Report on Carcinogens, but the decision was deferred. By 2006, the International Agency for Research on Cancer listed cosmetic (perineal) talc application as possibly carcinogenic to humans.

In the above case study, Dr. Cramer from Harvard University hypothesized that there was an association between talc and ovarian cancer. This was because of the similarity of ovarian cancer to mesotheliomas and the chemical relationship of talc to asbestos, a known cause of mesotheliomas. His research concluded that there was an association between talc and ovarian cancer. Despite these findings, manufacturers like Johnson & Johnson continued (and do to this day) to market and sell products that contain talc.

Exposure to Asbestos

Of all of the studies conducted over the years, the issue has been whether or not the talcum powder that was used for nearly a century, contained detectable amounts of asbestos. According to the National Cancer Institute, asbestos has been classified as a known human carcinogen by the U.S. Department of Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA). Exposure to asbestos has been shown through significant research to be the primary cause of mesothelioma and that there is sufficient evidence that it also causes cancer of the lung, larynx, and ovaries (International Agency for Research on Cancer).

What are the experts saying?

  • The International Agency for Research on Cancer (IARC) classifies talc that contains asbestos as “carcinogenic to humans.” The also found, based on limited human study evidence, that the perineal (genital) use of talc-based body powder as “possibly carcinogenic to humans.”
  • The US National Toxicology Program (NTP) has not thoroughly evaluated talc (with or without asbestos) as a possible carcinogen.
  • The Centers for Disease Control and Prevention (CDC) released the results of a study that was conducted in 1972. “Fiber exposure during use of baby powders, report No. IWS-36-6” has stated that during the testing of nine commercial baby powers, seven were found to contain asbestos fibers (known to be carcinogenic) that could be inhaled on a regular basis, several times each day with each diaper changes and over time it could amount to a significant number of exposures. From this information, they determined that baby powder (talcum powder) that contains asbestos could be potentially harmful if inhaled.
  • The US Food and Drug Administration (FDA) conducted a survey in 2009-2010. They identified 9 manufactures to explore and asked for their participation in the study, Only four of those manufactures agreed. The FDA does not have the equipment necessary to conduct the research that they wanted to do, so they contracted with an outside testing laboratory to complete these studies. They collected 24 talc-containing cosmetic products (including baby powder) from retailers in the Washington, D.C. metropolitan area and found that none of them contained asbestos. They admitted that while the information gathered was informative, it was also limited. They will continue to monitor as new information is reported.

Lawsuits related to talcum powder and ovarian cancer

This was the first lawsuit brought against Johnson & Johnson. Deane filed her lawsuit after being diagnosed with ovarian cancer. A federal jury sided with Berg but determined that no damages were to be awarded. They believed that there wasn’t enough evidence connecting her diagnosis to the use of talcum powder. The jury did state that they felt that Johnson & Johnson was negligent, and women should have been warned about the potential risks associated with the use of talcum powder.

 

Ms. Fox was diagnosed with terminal cancer and passed away in 2015 before a determination could be made. Her case stated that she was diagnosed with ovarian cancer after using Johnson & Johnson baby powder for years. Her family was awarded $72 million dollars. The courts determined that her attorneys had proven that Johnson & Johnson knew about studies linking its products to ovarian cancer. Furthermore, they failed to warn customers about the possible dangers associated with its use.

 

This case presented the fact that Gloria used Johnson & Johnson powders that contained talc for decades before she was diagnosed with ovarian cancer. A jury in the Missouri state court found Johnson & Johnson liable for failing to warn consumers about the risk of ovarian cancer when exposed to talc-containing powders.

 

Deborah used Johnson & Johnson’s baby powder as part of her feminine hygiene routine for over forty years. She filed a lawsuit against Johnson & Johnson in the state court in St. Louis, Missouri after she was diagnosed with ovarian cancer. The jury in her case found that Johnson & Johnson was negligent for failing to warn women about the risk of ovarian cancer related to talcum powder. The court awarded Deborah a $70 million settlement.

 

A state court jury also in St. Louis, Missouri awarded Ms. Slemp $110 million. This was the result of Johnson & Johnson failing to warn her about the risk of ovarian cancer caused by talcum powder.

 

A state court jury in Los Angeles, California granted an award to Eva in the amount of  $417 million. The jury felt that Johnson & Johnson failing to provide a warning to her about the risk of ovarian cancer with the use of talcum powder. The verdict included $347 million in punitive damages. This large award was designed to send a loud and clear message to this manufacturer.

 

This case was also filed in the state court of St Louis, Missouri. The case involved 22 women that proceeded as a joint Plaintiff against Johnson & Johnson. The jury reached a unanimous verdict in a products liability case with a verdict that is one of the largest products liability cases in the U.S. The members of the jury agreed on an award of $25 million for each of the 22 women for compensatory damages and, in addition, they awarded an additional $4.14 billion in punitive damages. This award totaled $4.69 billion.

This lawsuit included women from across the US. They were varying ages and races, but all were former users of Johnson & Johnson talcum powder that developed ovarian cancer. Since that case was settled, six of these plaintiffs have died. It is estimated that more than 9000 former talcum powder customers have filed lawsuits against Johnson & Johnson. Most of these claims have been filed for damages for ovarian cancer, but some allege that using this talcum powder led to the development of mesothelioma.

References:

https://geology.com/minerals/talc.shtml

https://www.sciencedirect.com/science/article/pii/0013935167900084

https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1111/j.1471-0528.1971.tb00267.x

https://onlinelibrary.wiley.com/doi/abs/10.1002/1097-0142(19820715)50:2%3C372::AID-CNCR2820500235%3E3.0.CO;2S

ftp://ftp.cdc.gov/pub/Documents/OEL/02.%20Kuempel/References/IARC_2010-Vol%2093.pdfhttps://ntp.niehs.nih.gov/testing/status/agents/ts-10167-p.html

https://www.cdc.gov/niosh/nioshtic-2/00106056.html

https://www.fda.gov/cosmetics/productsingredients/ingredients/ucm293184.htm

https://monographs.iarc.fr/wp-content/uploads/2018/06/mono100C.pdf

https://www.washingtonpost.com/news/morning-mix/wp/2016/02/24/johnson-johnson-ordered-to-pay-72m-in-suit-linking-talcum-powder-to-ovarian-cancer/?noredirect=on&utm_term=.c167f342707d

https://cvn.com/proceedings/gloria-ristesund-v-johnson-johnson-trial-2016-04-11

https://www.cnn.com/2018/04/11/health/talc-ovarian-cancer-cases/index.html

https://www.cnn.com/2018/04/11/health/talc-ovarian-cancer-cases/index.html

https://www.bna.com/jj-face-nonmissouri-n73014472672/

https://images.law.com/contrib/content/uploads/documents/403/18584/Talc-appeal-7-18.pdf

https://www.npr.org/2018/07/13/628684038/jury-awards-4-7-billion-to-women-in-johnson-johnson-talcum-powder-suit

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Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

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valsartan-recall

Valsartan Recall

The reason this blood pressure medication has been recalled, and the complications associated with it.

Written by Tracy R Everhart, MSN, MS CAM

Valsartan®

This medication is prescribed to individuals that have been diagnosed with high blood pressure (hypertension) and congestive heart failure. Valsartan® is part of a class of medication that are called Angiotensin II receptor blocker (ARB) and is available in several different forms. These include:

  • Valsartan® tablets (40, 80, 160 and 320mg)
  • Valsartan® and hydrochlorothiazide (HCTZ) tablets (80mg/12.5 mg, 160mg/12.5 mg, 160mg/25 mg, 320mg/12.5 mg, and 320mg/25 mg)
  • Amlodipine and valsartan tablets (5mg/160mg, 5mg/320mg, 10mg/160mg and 10mg/320mg)
  • Amlodipine, valsartan and hydrochlorothiazide tablets (5mg/160mg/12.5 mg, 5mg/160mg/25mg, 10mg/160mg/12.5mg, 10mg/160mg/25mg, and 10mg/320mg/25mg

Why has this drug been recalled?

In July 2018, the U.S. Food and Drug Administration (FDA) announced a voluntary recall of several medications that contained the active ingredient valsartan. The companies listed in this original release included Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries, Inc.  The FDA made it very clear at the time, that not all valsartan-containing medication sold in the U.S. were part of the recalled.

These products contained valsartan that was supplied to these manufacturers by Zhejiang Huahai Pharmaceuticals (Linhai, China) and were found to contain an impurity known as N-nitrosodimethylamine (NDMA). Patients were advised to contact their physician or pharmacy if they had any questions about the brand of Valsartan® that they were taking.

Based on laboratory studies, NDMA is classified as a likely human carcinogen (a substance that could cause cancer) and the Environmental Protection Agency (EPA) classifies NDMA as a probable human carcinogen and that exposure to high levels of NDMA may cause liver damage.

By the end of 2018, another carcinogen was found in samples that were recalled (N-Nitrosodiethylamine (NDEA)) and the number of recalled medications containing Valsartan® had increased so significantly that the FDA set up a webpage containing a list of those drugs. This list includes the manufacturer’s name, the drug, the dose, the lot numbers, and the expiration dates.

Carcinogenic effects of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)

Numerous studies conducted in the early 1990s indicated the carcinogenic effects of NDMA. During this time nitrates and nitrites were routinely used as food additives in processed meats such as ham, bacon, sausages, and hot dogs. These were added to prevent spoilage and preserve the appearance and flavor of these meat products. High consumption of processed meats has been shown to be linked to an increase in gastric cancer risk, and many researchers consider nitrates/nitrites as the main cause.

Nitrosamines are produced by chemical reactions of nitrates, nitrites and other proteins and (NDMA) is one of the most frequently occurring nitrosamines found in foods. NDMA is known to be a potent carcinogen. It is capable of inducing malignant tumors in different laboratory animal species. The cancer induced in these laboratory animals was seen in a variety of tissues, including liver, lung, and stomach.

Nitrosodiethylamine (NDEA) is classified by the Environmental Protection Agency (EPA) as a probable human carcinogen and has primarily been used in research studies of laboratory rats when it is necessary to induce liver cancer.  The EPA fact sheet for NDEA states that chronic (long-term) exposure may cause liver damage and low platelet counts. They go on to say that animal studies suggest that chronic ingestion may cause liver tumors or other tumors, but the data of the carcinogenic effects of NDEA in humans are limited.

Impact on patients taking Valsartan®

  • Since the discovery of NDMA and NDEA impurities in valsartan, the FDA recommended that those patients who were taking one of the affected drugs continue taking the medication until their physician or pharmacist provided an alternative medication or replaced it with a different brand. They continue to make this recommendation based on the fact that the risk of stopping the medication outweighs the risk of continued use.

It is unknown how the exposer to the different levels of these two carcinogens will affect the patients that took the various versions of this drug. However, the first case was filed in New York against manufacturers of these drugs and the pharmacies that dispensed them. The case, Duffy vs Prinston Pharmaceutical, Inc., Solco Healthcare U.S., L.L.C., Throggs Neck Pharmacy and  Walgreen Co. (Walgreens) was filed on August 16, 2018, and on October 11, 2018, it was transferred to the United States District Court for the District of New Jersey.

This case (1:18-cv-07460-RJS) has been filed as a class action lawsuit, sighting that the manufacturers of the recalled drugs produced and distributed a generic version of valsartan that contained carcinogenic impurities and that these impurities went undetected for six years. The filing states that this case seeks equitable relief and to recover damages and restitution for: 

  • Breach of express warranty,
  • Breach of the implied warranty of merchantability,
  • Violation of New York’s General Business Law §§ 349, 350 (Consumer Protection From Deceptive Acts and Practices),
  • Unjust enrichment,
  • Fraudulent concealment,
  • Fraud,
  • Conversion,
  • Strict products liability
  • Gross negligence,
  • Negligence, and
  • Battery

The plaintiffs, in this case, were prescribed valsartan for an extended period of time and each time that they refilled their prescriptions, they received information about the medication, including “representations and warranties that the medication was properly manufactured and free from contaminants and defects”. They also received notification via U.S. Mail advising him that the valsartan-containing medication that they were taking was affected by the recall. It is unknown at this time how many manufacturers have produced contaminated valsartan as the list continues to grow. It is also unknown how many individuals will be affected by these carcinogenic impurities.

Sources:

https://www.epa.gov/sites/production/files/2014-03/documents/ffrrofactsheet_contaminant_ndma_january2014_final.pdf

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm

https://www.mdpi.com/2072-6643/7/12/5505/htm#B10-nutrients-07-05505

https://onlinelibrary.wiley.com/doi/abs/10.1002/(SICI)1097-0215(19960328)66:1%3C130::AID-IJC22%3E3.0.CO;2-G

https://www.sciencedirect.com/science/article/abs/pii/0165121891901234

https://www.tci-thaijo.org/index.php/vis/article/view/124770

https://www.epa.gov/sites/production/files/2016-09/documents/n-nitrosodimethylamine.pdf

https://dockets.justia.com/docket/new-york/nysdce/1:2018cv07460/499403

https://law.justia.com/codes/new-york/2013/gbs/article-22-a/

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Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

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Case Review

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Onglyza Heart Failure Complications

Onglyza Heart Failure Complications

Written by April Klazema

Onglyza Heart Failure Complications

On July 21, 2009, the Food and Drug Administration approved saxagliptin, a drug marketed under the trade names Onglyza and Kombiglyze XR by its developers Bristol-Myers Squibb and AstraZeneca. Targeted at assisting type 2 diabetics to manage their ailment, Onglyza has since been shown to increase by at least 27% the possibility that patients will require hospitalization for complications related to heart failure. By 2017, both companies faced more than a dozen lawsuits from plaintiffs who alleged AstraZeneca ignored — or did not investigate — the drug’s effect on cardiovascular health.

 

A year later in February of 2018, docket reporting indicated the number of active suits concerning Onglyza had grown to 84. By July of the same year, that number had exceeded 200 as more individuals confront saxagliptin’s risks and ramifications. If you or a loved one is or has been taking Onglyza, understanding all the facts and what your options may be is very important.

What is Onglyza, AKA Saxagliptin?

Type 2 diabetes is a common concern, with almost 1.5 million new cases diagnosed in the United States every year. Characterized by increased physical resistance to insulin and its ability to regulate blood sugar, this disease increases the risk of nerve damage, damage to the kidneys, and even the potential to lose extremities due to complications. A wide variety of pharmaceutical products exist to help address various aspects of this disease. Onglyza is one, intended for use with changes in the patient’s diet and exercise habits. In some cases, it is administered as part of a combination drug therapy.

 

The active compound in the drug, saxagliptin, works by stimulating the body’s natural ability to create insulin through specialized cells called incretins. In other words, Onglyza attempts to treat type 2 diabetes by causing the body to produce enough insulin to overcome the body’s resistance. In combination with lifestyle changes, the aim is to preclude the possibility of kidney damage. However, other types of drugs in this class, called “incretin mimetics” for their ability to act like natural incretics, have faced recalls in Europe and widespread concerns over side effects more severe than anticipated. These are the same concerns now levelled at Onglyza through ongoing litigation.

onglyza

Typical and Expected Side Effects

Like all drugs, however, some side effects are considered “normal” or “expected,” and received sufficient study and documentation during the trial process for the FDA to grant its approval. Typically, individuals who take Onglyza can expect to experience some side effect symptoms, such as:

 

  • Headaches
  • Upper respiratory or urinary tract infections
  • Nasopharyngitis
  • Bloating

 

A growing number of patients who have relied on Onglyza now allege that the risk of other, more serious side effects was negligently concealed or downplayed during the initial FDA review process. While some patients report the development of pancreatic and thyroid cancers as a result of taking Onglyza, by far the most widespread concern involves an elevated risk of heart and/or kidney failure, especially for those already suffering from diseases of these organs. Typical signs of heart failure can include:

  • Shortness of breath, especially during routine activity
  • Unusual fatigue or persistent exhaustion
  • Sudden weight gain accompanied by swelling, especially in the legs or stomach area

Do not abruptly discontinue medication without advice and consent from your doctor; seek medical assistance without delay if you take Onglyza and experience any of these symptoms.

Heart Failure Concerns Prompt Litigation

Given the FDA’s own 2008 guidance that drugs should not unacceptably raise cardiovascular risks, more patients and doctors expressed concern. A 2013 paper published in the New England Journal of Medicine examined more than 16,000 patients and concluded that while Onglyza itself was not directly responsible for adverse cardiac events, it did significantly increase how frequently patients went to the hospital for heart failure-related problems. The researchers concluded that the increased risk required further study and more vigilance from doctors in managing said risk.

By 2014, the FDA announced that it would take another look at Onglyza with a thorough review of the full clinical trial data. The result of this review was the determination of a small increase in the risk of hospitalization versus patients who received a placebo. In the FDA’s view, this increased risk did not outweigh the potential advantages of administering Onglyza, and thus the drug retained its approval and remains available for sale.

New Black Box Labels and Ongoing Events

While the FDA did not act against Onglyza’s developers and issued no recall, they did recommend the inclusion of a stronger warning concerning the risks. In 2016, the agency took more direct action, mandating a new black box warning label concerning the increased risk of heart failure for not only Onglyza and Kombiglyze XR but also several other drugs for the treatment of diabetes. By the following year, though, the first lawsuits against Bristol Myers-Squibb and AstraZeneca began.

A suit filed in the Southern District of Texas alleges that during drug development, the manufacturers ignored FDA guidance about minimizing cardiovascular risks carried by new drugs. In fact, the filing contends that in their rush to market the manufacturers did not carry out the necessary heart-related studies whatsoever.

The plaintiff in the case says that as a result of these actions and the drug’s availability on the market, he suffered severe and permanent deleterious health effects. AstraZeneca maintains that the company carried out all its required due diligence. Nonetheless, dozens and then hundreds more lawsuits quickly flooded into the courts as more patients from the 2010-2015 period before the new warnings sounded the alarm about their conditions.

Should You Seek an Attorney for an
Onglyza-related Claim?

Individuals who took Onglyza before the inclusion of the new warnings may be eligible to file or join a lawsuit related to the drug makers’ alleged malfeasance. However, drug liability litigation is many-layered and complex, and navigating these murky waters requires a clear understanding of the law, your case, and the state of other ongoing lawsuits. For these reasons, if you believe you may have a valid claim related to undisclosed saxagliptin side effects from heart failure to certain types of cancer, it is essential you connect with an experienced legal professional.

Sources

https://www.webmd.com/drugs/2/drug-152753/onglyza-oral/details

https://www.fda.gov/Drugs/DrugSafety/ucm486096.htm

https://www.fiercepharma.com/pharma/az-bms-slapped-14-lawsuits-over-onglyza-heart-failure-risks

https://www.drugs.com/history/onglyza.html

https://www.drugs.com/nda/onglyza_090402.html

https://topclassactions.com/lawsuit-settlements/lawsuit-news/56768-onglyza-study-shows-potential-heart-failure-side-effects/

http://www.diabetesincontrol.com/fda-extends-review-timeline-for-onglyzasaxagliptin-by-90-days/

https://www.spglawfirm.com/defective-drugs/onglyza-lawsuit/

https://www.everydayhealth.com/drugs/onglyza

https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1042/onglyza-saxagliptin

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3M-Combat-Earplugs

3M Defective Earplugs

The U.S. Department of Justice announced that 3M agreed to pay a settlement in the amount of $9.1 million for knowingly supplying the U.S. military with defective earplugs.

Written by Tracy Everhart

United States vs 3M Company

From 2003 to 2015 the 3M Company had a contract to supply earplugs to the United States military. The contract included a product that is known as the dual-ended Combat Arms Earplugs, Version 2 (CAEv2) which was standard issue to certain personnel during foreign conflicts. The Defense Criminal Investigative Service investigated allegations of a defective product and a petition was filed in the United States District Court in South Carolina on May 12, 2016. 

This case was filed under the whistleblower provisions of the False Claims Act. The lawsuit alleged that 3M and its predecessor (Aearo Technologies, Inc) knew that the Combat Arms Earplugs were defective and did not inform the Defense Department prior to contracting with and selling products to the Defense Logistics Agency. They further alleged that these defective earplugs could directly impact the service members’ health and welfare, exposing millions to potential hearing loss and tinnitus.  

Combat Arms Defect

The Combat Arms Earplugs, Version 2 (CAEv2) are double-ended earplugs that were designed as a non-linear or selective attenuation device. This means that the service member using them would be able to have two options for attenuation (noise canceling), depending on how the earplugs were worn.

What 3M did not divulge to the U.S. military, is that they (3M) knew that the CAEv2 was too short. They could not be inserted properly into the user’s ears and would loosen. This loosening was not perceived by the user and the earplug did not work as designed for some individuals.

An important note is that in 2012 3M issued a press release touting their contract with the U.S. Military to provide the CAEv2 earplugs. In this press release, they spoke about the importance of proper protection against excessive noise levels and how 3M was committed to protecting “warriors and workers from noise-induced hearing loss”.

They went on to state what happens when you are exposed to excessive levels of noise and do not have effective hearing protection. They stated that:

“Military personnel are exposed to excessive noise levels during combat and training on a variety of land, air and sea missions. This noise exposure has led many personnel to experience hearing loss and tinnitus, which is currently the number-one service-related disability for veterans. Tinnitus, often referred to as “ringing in the ears,” and noise-induced hearing loss can be caused by a one-time exposure to hazardous impulse noise, or by repeated exposure to excessive noise over an extended period of time.” 

Hearing Loss and Tinnitus Among Veterans

In the United States, hearing impairments are the most common service-connected disabilities among military veterans. According to the Centers for Disease Control and Prevention (CDC), veterans, in general, are 30 percent more likely to experience severe hearing impairment (SHI) when compared to nonveteran adults. The CDC has also determined that veterans who served overseas during Operations Enduring Freedom and Iraqi Freedom (September 2001- March 2010) are four times more likely to experience SHI than nonveterans. This is during the same time in which the CAEv2 earplugs were standard issue to military personnel.

Research Findings

According to an article published in Epidemiologic Reviews, veterans of Operations Enduring Freedom, Iraqi Freedom, and New Dawn were exposed to numerous conditions (most notably high levels of noise) that could lead to hearing loss and tinnitus (the most common service-related disabilities among U.S. veterans).

The findings of their systemic review found 13 studies that presented data related to the prevalence of hearing loss and tinnitus and 4 studies related to risks and protective factors. They concluded that there is reason to believe that individuals that serviced in Operations Enduring Freedom, Iraqi Freedom, and New Dawn will have a greater likelihood of experiencing hearing health issues than those that did military service prior to these conflicts.

They hypothesized that this is most likely related to the fact that approximately 75% of the service member combat injuries during this time period were a result of blasts. They stated that the correlation was currently unknown due to the lack of research about the prevalence or effects of blast-related ear trauma. Since this article in Epidemiologic Reviews was published, the results of additional studies have been released that confirm these findings.

In 2016, a study was published in Scientific Reports. It describes what happens to the inner ear after a person is exposed to blast from an improvised explosive device (IED). They explain that the auditory system is the organ that is most commonly damaged by blast overpressure.

Similar injuries were seen following the Boston Marathon bombings and resulted in temporary and permanent hearing loss, tinnitus, and hyperacusis (a reduced tolerance to usual environmental sounds). They concluded that the principle cause of noise-induced hearing loss (NIHL) is damage to cochlear hair cells and associated cochlear synaptopathy (hidden hearing loss).

An additional study was published in 2017,  stated that “blast-injured personnel are at a higher risk for hearing loss in both ears and should receive a postinjury audiometric test”. They also stated that to the best of their knowledge “this is the first report of the true hearing-shift and hearing-loss risk rate for a post-deployment, injured cohort that is based on audiometric data.”

Sources:

3M Company, 3M News Center (2012). 3M Hearing Protection Devices Now Added to the Federal Procurement List. Retrieved from https://news.3m.com/press-release/3m-hearing-protection-devices-now-added-federal-procurement-list

Centers for Disease Control and Prevention (CDC. (2011). Severe hearing impairment among military veterans–United States, 2010. MMWR. Morbidity and mortality weekly report, 60(28), 955. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6028a4.htm

Joseph, A. R., Shaw, J. L., Clouser, M. C., MacGregor, A. J., & Galarneau, M. R. (2017). Impact of blast injury on hearing in a screened male military population. American Journal of Epidemiology, 187(1), 7-15. https://doi.org/10.1093/aje/kwx199

Rempfer, K. (2018). Company to pay $9 million after allegedly selling defective combat earplugs to US military. Military Times. https://www.militarytimes.com/news/your-military/2018/07/26/company-to-pay-9-million-after-allegedly-selling-defective-combat-earplugs-to-us-military/

Theodoroff, S. M., Lewis, M. S., Folmer, R. L., Henry, J. A., & Carlson, K. F. (2015). Hearing impairment and tinnitus: prevalence, risk factors, and outcomes in US service members and veterans deployed to the Iraq and Afghanistan wars. Epidemiologic Reviews, 37(1), 71-85.

United States ex rel. Moldex-Metric v. 3M Company, Case No. 3:16-cv-1533-MBS.(2016). Retrieved from https://wwwcache.wral.com/asset/news/local/2019/01/22/18141196/15356-3M_Earplug_Complaint-DMID1-5hka47ucb.pdf

U.S. Department of Justice. (2011). The False Claims Act: A Primer. Retrieved from https://www.justice.gov/sites/default/files/civil/legacy/2011/04/22/C-FRAUDS_FCA_Primer.pdf

U.S. Department of Justice. (2018). 3M Company Agrees to Pay $9.1 Million to Resolve Allegations That it Supplied the United States With Defective Dual-Ended Combat Arms Earplugs. Retrieved from https://www.justice.gov/opa/pr/3m-company-agrees-pay-91-million-resolve-allegations-it-supplied-united-states-defective-dual

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Tracy R Everhart, MSN, MS CAM

For more than 20 years I've had the opportunity to work in numerous rolls within the medical field, including the last 7 years as a professional medical writer. With an undergraduate degree in biology/microbiology, postgraduate education in allopathic and complementary alternative medicine, my education has afforded me career opportunities with direct patient care, medical research and clinical oversight of statewide projects to improve the health of patients of all ages. I have a broad and deep knowledge of illnesses and conditions that can affect the human body. Even more important is that I have learned traditional treatment methodologies combined with alternative forms, to make the most informed decision about options that may be available.

Compensation is Available for 3M Military Earplugs Lawsuits

If you or a loved one served in the military from 2003 – 2015 and experienced any hearing damage after using 3M Combat Arms Earplugs, you may be able to submit a legal claim.

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