Essure Complications Hidden by Manufacturers For More Than a Decade

By Emily Cox
Essure Complications
Flickr/Damian Gadal

According to a new lawsuit, manufacturers of the controversial permanent birth control device have always known that many women who underwent the sterilization procedure would never fully recover from serious, life-altering Essure complications. However, Conceptus and Bayer consciously hid these significant safety risks from the public, sentencing thousands of women to the unimaginable consequences of the companies’ greed.

Shayla Happy filed the claim this past week in the Eastern District of Pennsylvania. Currently, 26 cases involving about 1,000 plaintiffs are consolidated there before Judge R. Padova for coordinated pretrial proceedings. Happy alleges that Essure has caused constant pain and unmanageable bleeding among other serious injuries that may never fully resolve. Regardless, she will most likely have to undergo a hysterectomy to halt the damages’ progression. She claims that Conceptus hid considerable Essure complications to ensure the device’s commercial success. Being Conceptus’ only product, the company’s massive debt problems fell solely on Essure to remedy. And, Conceptus was determined to achieve profitability at any cost. Including, the health and well-being of thousands of women.

“Concepts knew that any apprehensions about the safety of the Essure device on the part of physicians or patients could devastate sales and lead to the complete failure of the company,” Happy’s complaint states.

“To promote the perceived safety of the device and gain market acceptance, Conceptus devised and implemented a scheme to defraud physicians and patients, by means of false and fraudulent pretenses, representations and concealment of material facts,” her lawsuit continues.

In short, Conceptus knew that if the public knew about Essure complications and safety risks, sales of the device would falter, and the company would fail. As a result, Conceptus decided to keep these safety risks and consequences under tight lock and key.

Essure Complications and Indications

Essure is a non-incisional and non-hormonal permanent birth control system. Conceptus originally manufactured the device before Bayer acquired the company in 2013. When Conceptus first introduced that sterilization procedure in 2002, OBGYN experts hailed the fast, outpatient procedure as a female sterilization game-changer. Prior to Essure, tubal ligation, or tube tying, was the prevalent sterilization method.

During the non-surgical implantation procedure, two flexible Essure coils are inserted with a catheter through the vagina and uterus and placed inside both fallopian tubes. The coils consist of a Nitinol superelastic outer coil and a stainless steel inner coil that is covered polyethylene terephthalate (PET) fibers. These PET fibers incite an inflammatory response, causing scar tissue to form around the metal coils over the course of a few months. Eventually, this scar tissue forms a “natural” barrier in the fallopian tubes, preventing pregnancy.

Essure is the only non-surgical option for female sterilization for women who wish to permanently eliminate the possibility of pregnancy. Due to this, the FDA fast-tracked the device’s approval as it provided an alternative to surgical sterilization with a much faster recovery time. But many women are finding that Essure has a an exceptionally invasive side. However, this doesn’t kick in until the device starts causing significant harm inside recipient’s bodies. Then, surgical intervention, as well as sexual organ removal, is often necessary to stop the device’s serious side effects.

The device has caused substantial, life-altering harm for many women who received the device. These Essure complication include debilitating pain, heavy bleeding, additional surgeries, rashes, itching, swelling, autoimmune disorders, pain during sex, bloating, and headaches, as well as tooth and hair loss among other serious complications. Other women have experienced ectopic pregnancy, as well as the device moving out of place and puncturing internal organs.

Manufacturers Concealed Thousands of Serious Essure Complications from FDA

Despite knowing of thousands of reports of instances where Essure had moved out of the fallopian tubes or perforated a woman’s organs, Conceptus failed to report most of them. Then, the company fought the FDA regarding its reporting obligations when the agency discovered Conceptus’ massive under-reporting. Happy claims that manufacturers withheld these reports from the FDA to protect “the marketability of the device.”

In December 2010, the FDA conducted a “for cause” inspection of Conceptus and its reporting procedures. FDA officials found that Conceptus had concealed at least 16,399 reports between January 2008 and December 2010. The agency further found that Conceptus maintained a spreadsheet of 2,757 Essure complication complaints between July 2010 to December 2010. Conceptus did not report any of the injuries that indicated organ perforation to the FDA. In fact, Conceptus only reported 182 of these complaints to the FDA.

Unsurprisingly, Conceptus did not agree with the FDA’s position that physicians and women had a right to know about dangerous Essure complications. Instead, Conceptus officials attempted to persuade the agency that they should not be forced to report such adverse events and make them publicly available. FDA officials noted that there was no medical reason to withhold this information from the public and that it was, in fact, dangerous. However, as Essure was Conceptus’ only product, the company remained determined to protect its sales no matter what.

In 2013, the FDA discovered that Conceptus was back at it again. The FDA’s review revealed 16,047 complaints Conceptus had received between January 2011 and May 2013. Conceptus only reported about 300 of these complaints to ensure that the agency could not harm sales by making these reports public.

Conceptus Treated Essure Complications Warning Label as Marketing Tool

Happy alleges that Conceptus was also not above manipulating Essure’s warning level to achieve its lofty financial goals.

In 2008, Conceptus stated that it intended to make labeling improvements solely to increase Essure procedure adoption. At one point, Conceptus’ CEO described certain warning information as mere barriers to more sales. Despite mounting complaints of Essure allergic reactions, Conceptus drastically altered the portions of the warning label that addressed this issue. In 2011, Conceptus removed sections that encouraged women to confirm their nickel tolerance by using a skin test. However, the company did not change anything about the device itself or its nickel contents. Afterward, Conceptus’ CEO stated that this change would diminish Essure’s biggest competitive disadvantage, strengthening its standing in the global market.

Regulatory Authorities Noted Continual Essure Risk Factors and Safety Violations

Since Essure first hit the market in 2002, those pesky regulatory authorities have been a continual thorn in manufacturers’ sides. In July 2003, the FDA cited Conceptus for failing to adequately analyze data to identify substantial quality-control issues. Not entirely surprising, given that Conceptus didn’t even have a valid license to manufacture medical devices.

In 2008, The California Dept. of Public Health (CDPH) cited Conceptus for not having a license to manufacture medical devices. The CDPH also found that Conceptus had failed to maintain safety procedures for inventory transfers.

After Bayer bought Conceptus, along with its only product, in 2013, the company continued this proud tradition of regulatory aversion. In order to protect its billion-dollar investment, Bayer continued to actively hide life-threatening Essure complications. If these companies had not violated federal reporting requirements, the public would have known about these risks several years. Consequently, Bayer and Conceptus could have prevented thousands of injuries.

FDA Strengthens Warning About Essure Complications

After extensively reviewing Essure complications and safety concerns, the FDA finally  mandated that Essure carry the agency’s strongest warning. Essure’s black box warning indicates that women with the Essure device have experienced significant injuries. Furthermore, the agency warns that addressing these adverse events requires surgical intervention. In most cases, women have to have their uterus and fallopian tubes removed to experience any relief from Essure complications. The new warning received final approval in November 2016, along with a Patient Decision Checklist. This checklist ensures that potential recipients know of Essure’s serious risks.

To protect sales and revenue, Conceptus and Bayer purposefully ignored mandatory reporting requirement and actively hid safety information for as long as they could to the detriment of thousands.

Potential Taxotere Plaintiffs Need to Act Now

By Emily Cox
Taxotere Plaintiffs
Flickr/ewvasquez2001

Time is running out for potential Taxotere plaintiffs to participate in ongoing settlement considerations. This window closes today and will leave many breast cancer survivors, who received Taxotere (docetaxel) treatments and experienced permanent hair loss, behind as settlement negotiations continue to move forward. Taxotere lawyers must submit information on all pending and anticipated Taxotere plaintiffs by today to guarantee inclusion in any future settlement. This may be the last chance for many Taxotere victims to receive financial compensation for the taxane manufacturer’s inexcusable greed and negligence in its nefarious marketing of Taxotere – overstating the drug’s effectiveness, hiding side effects, and paying off doctors to prescribe the drug against FDA indications. Taxotere survivors must contact a Taxotere attorney now to secure their right to receive compensation for their injuries.

Sanofi Exposed Taxotere Plaintiffs to Danger for Financial Gain

Taxotere’s manufacturer, Sanofi S.A., bribed physicians to prescribe the highly-toxic chemotherapy treatment for less aggressive cancers against FDA recommendations; lied about the drug’s superior effectiveness over less toxic treatments; and hid permanent hair loss risks. Sanofi’s…creative…Taxotere marketing launched the controversial taxane to the top of its drug class. It’s time to take back some of what Sanofi has taken from so many women as they balanced on the precipice of losing everything.

Many people think that the Taxotere litigation boils down to vanity. But, it’s not about permanent hair loss, in and of itself. It’s about making Big Pharma take accountability for their actions and responsibilities. It’s about showing these companies that patients are more than data points in quarterly sales reports. Most of all, it’s about doing everything possible to stop these companies from doing this to future patients. Sanofi preyed on these women when they were at their most vulnerable for financial gain. The company denied them the ability to make an informed decision regarding their care, wrenching away one of the last vestiges of control that these women had and took it straight to the bank. Sanofi took that choice away when it hid the risk of permanent alopecia, misrepresented the drug’s effectiveness, and illegally incentivized doctors to recommend Taxotere.

Taxotere Plaintiffs – Background

Taxotere is a high-potency chemotherapy drug, manufactured and marketed by Sanofi S.A. Other taxanes include Taxol (paclitaxel) and Abraxane (albumin-bound or nab-paclitaxel). Taxanes interfere with the ability of cancer cells to divide. Taxotere is usually given in combination with other chemotherapy drugs.

The FDA approved Taxotere in 1996 to treat advanced or metastatic breast cancer after other chemotherapy treatments have failed. However, somehow doctors treat the majority of breast cancer cases in the U.S. with Taxotere, indicating that the drug is also being prescribed as a first line treatment for less aggressive cancers rather than its approved uses. With about 300,000 breast cancer cases diagnosed each year, Taxotere is the most prescribed drug in its class despite the fact that studies show that less-toxic Taxol is more effective. In 2009, Sanofi made more than $3 billion from Taxotere before losing patent protection.

Not only is Taxol more effective and less toxic than Taxotere. It also doesn’t have the same permanent side effects as Taxotere. Studies have linked Taxotere with about a 10 percent occurrence of permanent hair loss. Sanofi knew about this side effect and hid it from its most profitable market – American women.

Sanofi knew about Taxotere’s alopecia risk since at least 2005. This is when the company updated Canadian warning labels to specifically include this risk. Sanofi would go on to update European warning labels in 2012. Somehow, the U.S. must just have gotten lost in the shuffle, because warning labels would not include this warning until the end of 2015. This was more than a decade after Sanofi became aware of a GEICAM study showing that 10 percent of Taxotere patients suffered permanent hair loss. Even the company’s own studies indicated more than a nine percent rate for permanent alopecia occurrence.

Taxotere Plaintiffs MDL and Allegations

The Judicial Panel on Multidistrict Litigation (JPML) consolidated all Taxotere plaintiffs in Louisiana federal court in late 2016. At the time, there were less than three dozen such cases. Since then, the multidistrict litigation has swollen to almost 1,700 women determined to take Sanofi to task for the irreparable harm the company has caused. These women’s allegations include:

  • Selling Taxotere without disclosing dangers or risks
  • Manufacturing a dangerous drug
  • Concealing information from consumers
  • Marketing Fraud
  • Providing illegal kickbacks and financial incentives for doctors to prescribe Taxotere off-label
  • Misleading the public in advertising and marketing
  • Downplaying the drug’s dangers
  • Failing to properly warn doctors and patients
  • Failing to determine if the drug was safe
  • Selling the drug without properly testing it

If you, or a loved one, experienced permanent hair loss after being treated with Taxotere for breast cancer, you need to get in touch with a lawyer today to take Sanofi to task for the irreparable physical, emotional, and financial harm the company has caused thousands of American women when they were at their most vulnerable. Call (800) 305-6000 today to secure your place in a future Taxotere settlement. Don’t let this door close. There may not be another.

Invokana Stroke Risk Highlighted in New Lawsuit

By Emily Cox
Invokana Stroke
Flickr/Viktor Brezinsky

Most of the controversial surrounding Invokana involves the rapidly mounting reports of renal failure, as well as kidney disease and injury, caused by the type 2 diabetes medication. However, as Johnson & Johnson (J&J) makes a push for the FDA to expand the drug’s indications to include reducing cardiovascular risks, a former Invokana user is calling foul. Her lawsuit indicates that J&J could be misrepresenting its billion-dollar diabetes blockbuster’s cardiovascular benefits to expand Invokana’s market share, while hiding significant Invokana stroke risks. Furthermore, the study that J&J is relying on to clinch its expanded FDA indications also found that Invokana approximately doubles lower-limb amputation risks. But, in the topsy-turvy world of J&J and its Janssen Pharmaceuticals unit, even limb loss can be a victory as long as the appendage’s pounds are counted toward their Invokana weight loss data.

Patricia Shultz filed the complaint directly into the ongoing District of New Jersey MDL on Wednesday. She alleges that the manufacturers misled the public and medical community about Invokana’s safety, minimizing unfavorable findings while screaming their victories from the rooftops and along the PR newswire to increase sales at the cost of consumers.

Schultz began taking Invokana in October 2015. Within a month, she suffered a debilitating stroke in early November 2015. According to the lawsuit, Schultz’s life will never be the same. There’s no going back to her life before Invokana. She can only try to get some closure and hopefully help force J&J’s hand to strengthen Invokana warning labels.

J&J Knew About Invokana Stroke Risks

From early clinical trial data, J&J knew that there was an elevated Invokana stroke risk. This risk is especially prevalent in older females during the first couple of months of treatment. However, J&J never warned women like Schultz. J&J placed Invokana sales above the lives of the very people the company purports to help. J&J knew many of their lives would be forfeit from its negligent Invokana marketing. But, evidently, these lives didn’t amount to much in the company’s overall cost-benefit analysis. Now, on the heels of the publication of 2013 – 2017 Invokana study, J&J is pushing for the FDA to expand Invokana’s indications to include reducing cardiovascular risks.

On October 3, J&J subsidiary Janssen submitted a supplemental New Drug Application (sNDA) for Invokana to the FDA. Although J&J and Janssen have aggressively marketed Invokana for off-label uses for years, doing it legally is unfamiliar territory for the pharmaceutical companies. They are seeking a new indication for Invokana (canagliflozen) to reduce the risk of major adverse cardiovascular events in adult type 2 diabetics who are at risk for or have cardiovascular (CV) disease. These events include CV death, as well as nonfatal myocardial infarction (MI) and stroke. This sudden interest in going legit with market expansion is due to the findings of the long-term CANagliflozin cardioVascular Assessment Study (CANVAS). However, while J&J is blasting the study’s favorable outcomes, it has completely disregarded pretty much all other data, including serious indications of early cardiovascular events and amputation risks.

Invokana Stroke Risks and Benefits from CANVAS Study

Back in June, J&J could not wait to tell the world of Invokana’s triumphant CANVAS results. The healthcare behemoth hardly waited for researchers to finish presenting their findings at a special symposium before broadcasting Invokana’s miraculous cardiovascular benefits, including stroke prevention. Quite the turn around, considering the study’s preliminary data that gave many at the FDA pause during Invokana’s initial approval.

Like a great deal of J&J’s communications, it balances on that infinitesimal line between lies and the truth. And, J&J is nothing short of an accomplished acrobat when it comes to these maneuvers.

Yes, CANVAS study results do indicate that Invokana does seem to reduce overall risk of cardiovascular death. However, as FDA official Dr. Hyon Kwon notes, there was marked increased incidence of early cardiovascular events. Almost all these cardiovascular events were thrombotic, or ischemic, stroke.

In its boasting over Invokana’s spectacular cardiovascular benefits, J&J only mentioned two specific risks that Invokana seemed to reduce – nonfatal MI and nonfatal stroke. However, the nonfatal stroke benefits don’t quite kick in until 1-6 months after starting treatment. Until then, these risks actually increase. Initial CANVAS data indicated a 46 percent elevated Invokana stroke risk, especially within the first 30 days of treatment. Dr. Sidney Wolfe, an FDA adviser, provided a possible explanation for this phenomenon. He noted that study patients had abnormal increases in the balance of red blood cells to plasma. This is also known as hematocrit.

Drugs like Invokana increase urine production to flush dangerously high levels of blood glucose out of the body. However, this increased urination not only puts extraordinary strain on the kidneys. It also can lead to increases in hematocrit. The blood becomes literally thicker. This tends to gunk up the gears, leading to blood clot formation, strokes, and heart attacks.

Beyond Invokana Stroke Risks

Since the FDA approved Invokana in 2013, the agency has revisted the drug’s side effects numerous times. Due to high rates of various injuries, the agency has added several additional warnings to Invokana. And, almost every new warning seems determined to outdo the previous one, as the risks became progressively more horrifying.

In September 2015, the FDA announced that Invokana causes premature bone loss and fractures. Then, in December 2015, the agency warned that Invokana causes diabetic ketoacidosis, kidney infections, and urosepsis. This was followed by March 2016’s warning that Invokana causes severe renal impairment, angioedema, and anaphylaxis. Finally, in May 2017, an Invokana side effect warning was granted the ultimate crowning achievement – its own prominent black box to make sure that patients and doctors cannot help but see it. Invokana-related amputations took top honors for doubling patients’ risk of losing a lower extremity. This side effect isn’t present in any of the other SGLT2 drugs in Invokana’s drug class. It’s truly what sets Invokana apart from the crowd.

Despite the horror show of risks and side effects, Invokana brings in more than $1 billion annually. However, sales fell a little flat at $1.31 billion in 2016. So, J&J is hedging its bets that, if the FDA approves Invokana to prevent CV death, then either patients will ignore the cavalcade of conditions that the drug causes, or that they see the black box warning and are looking to lose 5-20 pounds by any means necessary.

 

 

 

Taxotere Settlement Door is Closing. Potential Plaintiffs Must Act Now.

By Emily Cox
Taxotere Settlement
It’s time for Taxotere survivors to get moving before they get left behind. (Flickr/vizeur_photos)

As the Taxotere permanent hair loss multidistrict litigation (MDL) continues to gain momentum with the selection and scheduling of bellwether trials, behind-the-scenes Taxotere settlement negotiations are kicking into high gear. According to a recent pre-trial order, attorneys need to submit information on all pending and anticipated Taxotere lawsuits by Monday, October 16, to guarantee inclusion in any future settlement. This means that women who experienced permanent hair loss after undergoing Taxotere treatments for breast cancer and haven’t already spoken with a Taxotere attorney need to reach out immediately to ensure their places in a settlement agreement.

District Judge Kurt D. Engelhardt issued the pre-trial order September 7 with an original deadline of September 30. Fortunately, the court granted an extension until October 16. But the door is still quickly closing on potential Taxotere settlement participants. However, this doesn’t necessarily mean that the door will actually slam shut this coming Monday. The court requires that lawyers update informational filings with the court regularly, so there still may be some fluidity after the deadline. But, all guarantees are off-the-table. Engelhardt is directly compelling Taxotere lawyers. However, the implications to potential plaintiffs are clear. Attorneys can’t submit information that they don’t have. Plaintiffs need to file now or risk exclusion from Taxotere settlement compensation.

Taxotere Settlement Alopecia Allegations

Thousands of women are currently standing together in the ongoing MDL to take Taxotere manufacturer Sanofi S.A. to task for its greed and negligence. All these women allege that they have experienced permanent hair loss, also known as alopecia, due to Taxotere. Furthermore, if Sanofi S.A., had been honest about the chemotherapy drug’s efficacy and side effects, then most women may never have every chosen Taxotere as a treatment options. According to MDL plaintiffs, Sanofi S.A. concealed Taxotere’s more unsettling side effects, including permanent baldness, to maximize profits while marginalizing these women’s ability to return to a normal life after breast cancer.

According to MDL allegations… and common sense, Sanofi S.A. knew about Taxotere’s alopecia risk since at least 2005. This is when the company updated Canadian warning labels to specifically include this risk. Sanofi S.A. would go on to update European warning labels in 2012. Somehow, the U.S. must just have gotten lost in the shuffle, because warning labels would not include this warning until the end of 2015. This was more than a decade after Sanofi-Aventis became aware of a GEICAM study showing that 10 percent of Taxotere patients suffered permanent hair loss. Even the company’s own studies indicated more than a nine percent rate for permanent alopecia occurrence.

Taxotere Settlement – Egregious Effectiveness Exaggerations

Hair loss risks aside. Given the choice, any sane woman is going to choose life over hair if it’s her best chance at survival. Sanofi S.A. told the medical community and women who were fighting for their lives that Taxotere was their best shot. It was a great marketing move. But, it was also a complete fabrication. Sanofi S.A. actively concealed unfavorable findings from studies that showed that the less toxic chemotheraphy treatment Taxol was more effective than Taxotere. Despite these post market studies, Sanofi S.A. continued to promote Taxotere’s “superior efficacy” over Taxol. Consequently, Sanofi S.A. exposed thousands of women to the higher toxicity of Taxotere and its side effects for absolutely no personal benefit.

The FDA finally intervened in 2009 and issued a warning to Sanofi S.A. The agency cited the company for “false and misleading” claims of superiority, which constitutes product misbranding – a federal crime. The FDA demanded that the company immediately stop distributing any materials that even hinted at superior effectiveness.

Beyond the Taxotere Settlement

Beyond the potential Taxotere settlement, Sanofi S.A. is also facing allegations from a former employee and the U.S. government for fraudulent marketing practices to increase sales. The FDA only approved Taxotere for the treatment of certain aggressive, late stage cancers after other treatments have failed. However, Sanofi S.A. took extraordinary measures to expand Taxotere’s use…and damage.

In 1996, Sanofi S.A. started paying illegal kickbacks and providing other unlawful incentives to encourage doctors to use Taxotere as first-line treatment for less aggressive cancers. These kickbacks included entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and fee reimbursement. The company also trained and directed employees to deliberately misrepresent the safety and effectiveness of off-label Taxotere use. Consequently, Taxotere quickly became the most common treatment for all types and stages of breast cancer. And, the breast cancer drug’s revenue skyrocketed from $424 million in 2000 to $1.4 billion in 2004.

Taxotere Settlement MDL

There are currently almost 1,700 women with Taxotere lawsuits pending in the ongoing Eastern District of Louisiana MDL. However, hundreds, maybe thousands, more women like them are out there. Some may not even know that Sanofi wronged them and thousands of other breast cancer survivors just like them. These women deserve retribution, significant compensation, and closure. They’ve all more than earned it. But, time is running short. The time to step up is now.

If you, or a loved one, experienced permanent hair loss after receiving Taxotere treatments for breast cancer, do not hesitate. Call (800)305-6000 now for a free consultation to discuss your legal rights to participate in this settlement. This door closes Monday, October 16. It’s about time that Taxotere victims got some closure too.

 

 

Heartburn PPI MDL Over Kidney Injuries Starts to Take Shape

By Emily Cox
Heartburn PPI
Flickr/Chris Dart

Lawyers in the new proton pump inhibitor (PPI) multidistrict litigation (MDL) will have their work cut out for them today. They meet with the MDL’s District Court Judge to flesh out numerous structural and organizational facets that are essential to moving forward in the litigation against numerous heartburn PPI manufacturers over not disclosing significant kidney risks associated with Nexium, Prilosec, Prevacid, and other omeprazole drugs meant to regulate stomach acids to treat heartburn, gastroesophageal reflux disease (GERD), acid reflux, and stomach ulcers. Today’s grueling agenda will help shape the very foundation and core of the fledgling litigation. Everything going forward will be built on from this meeting. Consequently, the decisions made today will set the tone for the litigation moving forward.

Heartburn PPI MDL Gets Down to Business

The MDL parties submitted their Joint Status Report and Agenda this past Friday. The report indicated that lawyers for both sides will be conferring to resolve a number of structural and organizational elements that are necessary for the heartburn PPI MDL to move forward. Much of the attorneys’ work today will involve the creation and coordination of various schedules to make sure that pretrial proceedings are conducted as efficiently as possible. These various schedules include those for pretrial discovery, discovery demands, recurring status conferences, and telephonic conference calls for open court conferences.

They will also be touching on the protocol and timing for a potential “Science Day.” These non-adversarial presentations are common in complex pharmaceutical litigation to educate the court on key technical issues that are at the very heart of the mass tort). Additionally, the lawyers will also try to reach agreements regarding injury diagnosis and product identification records, as well as, Plaintiff and Defendant Fact Sheets.

Meanwhile, Judge Claire C. Cecchi will hear and decide on oral arguments related to proposed orders for dealing with Electronically Stored Information (ESI) and the Privilege Log. She will also review a direct filing order’s status so that lawyers can start filing additional cases directly into the MDL rather than incur costly delays by having to transfer cases from District Courts nationwide.

Heartburn PPI Medication Allegations

Currently, there are almost 300 product liability lawsuits over allegations that popular heartburn PPI drugs caused extensive kidney damage. Allegedly, heartburn PPI drug makers actively concealed significant health risks to further their own financial agendas. They also fostered off-label, long-term use to retain consumers as long as possible. Consequently, countless people with mild conditions are now living with acute kidney injury, acute interstitial nephritis, chronic kidney disease, and even end-stage renal failure. By downplaying these serious concerns, these drug makers put patients at considerable risk for permanent injury and even death.

These heartburn drugs are some of the leading brand medications on the U.S. market. PPIs, as a whole, are among the most commercially successful groups of medications in the U.S. Between 2008 and 2013, prescription PPIs raked in more than $50 billion dollars. And, this number doesn’t even include over-the-counter (OTC) drug sales. Nearly every one of these prescription medications have OTC counterparts. Millions are using these OTC Heartburn PPI drugs indefinitely to treat heartburn at the encouragement of companies that have not seen patients as actual people in a long time.

Heartburn PPI MDL

In August, the Judicial Panel on Multidistrict Litigation (JPML) granted the plaintiffs’ renewed federal consolidation request. The JPML had denied a previous request due to issues with the number of manufacturers involved in the litigation. However, as plaintiffs continued to come forward, the JPML finally conceded to centralize the litigation before District Judge Claire C. Cecchi in the District of New Jersey.

Consolidation can bee an invaluable tool in streamlining these types of mass torts. Limiting nationwide federal lawsuits to one court and one judge helps eliminate stumbling blocks inherent to a scattered litigation. Different districts and different judges introduce a whole host of variables in how these cases are approached. Consequently, pretrial rulings can be contradictory, which does nothing to further the litigation as a whole. Furthermore, discovery takes a great deal of resources for all parties. Without centralization, lawyers doing this separately in different courts for each case. With consolidation, parties can pool their collective resources to serve judicial efficiency.

Heartburn PPI Bellwethers

Going forward, Judge Cecchi will likely set the wheels in motion for a bellwether program. Generally, all parties will confer and agree to an early trial schedule. These early trials will consist of small groups of Nexium, Priloxec, Protonix, and other heartburn PPI cases. The court will allow both sides to submit trial candidate nominations. An equal portion of candidates from each side will prepare for early trial dates. If plaintiffs are overwhelmingly successful during the bellwether process, then settlement agreements may be on the table. However, this is never a guarantee. Regardless, these early trials help everyone involved get a feel for how the litigation could likely play out in the future. It also helps juxtapose the relative strengths and weaknesses on both sides of the v.

Due to the massive popularity of PPIs, experts expect that MDL plaintiffs will ultimately number well into the thousands.

Judge Shuts Down J&J Talcum Powder Asbestos Contamination Trial

By Emily Cox
talcum powder asbestos contamination
J&J maintains that it’s Baby Powder is as pure as the driven snow… looks about right. (Flickr/Michael)

A California judge declared a mistrial Tuesday in the talc-mesothelioma trial over allegations that a woman developed the deadly cancer due to talcum powder asbestos contamination in Johnson & Johnson’s iconic Baby Powder and Shower-to-Shower product lines. The judge cut the trial short barely outthe gates after the plaintiff mentioned the connection between J&J’s talc products and ovarian cancer during her testimony Friday.

Los Angeles County Superior Court Judge C. Edward Simpson did even let the trial go into its second day of testimony. Before trial proceedings could get under way Tuesday morning, Judge Simpson told the jury that he was declaring a mistrial. But, he also announced that he was empaneling a new jury to hear the case. The plaintiffs, Tina Herford, and her husband, Douglas Herford, allege that J&J’s talc-based products caused Tina Herford’s mesothelioma. Furthermore, the couple claim that J&J actively conspired to hide its ongoing talcum powder asbestos contamination from the public, as well as the medical and scientific communities for nearly a century.

Judge Simpson decided a mistrial was the best course of action after Tina Herford’s statements during her testimony. Herford took the stand as the first witness in her case Friday. However, she violated a standing court order when she mentioned the link between J&J’s talcum powder and ovarian cancer.

During her testimony, Herford told the court she had stopped using talc products due to ovarian cancer risks. Not only did this violate the court order barring all ovarian and uterine cancer testimony. The judge also ruled that it was inadmissible anyway, since Herford is not levying any ovarian cancer allegations. Consequently, the talcum powder asbestos contamination parties will be selecting a new jury next week.

Talcum Powder Asbestos Contamination and Mesothelioma

If the Herfords are correct (and J&J internal documents dating back to the dawn of the 20th century indicate that they are) and J&J concealed ongoing talcum powder asbestos contamination, then this could blow the ongoing investigation into the safety of J&J’s iconic talc products wide open. It would also mean that J&J knowingly exposed countless people and their infants to a virulent cancer-causing agent. Not only that. America’s “family company” brainwashed parents into believing that dumping this stuff on their infants was a hallmark of good parenting.

To maximize market share, J&J also convinced women that its Baby Powder was necessary for basic hygiene. The company exploited feminine insecurities and encouraged women to dust themselves as often as possible to stay clean and fresh. The company indicated that the powder was essential to mask embarrassing odors, eliminate excess moisture, and prevent friction.

Talcum Powder Asbestos Contamination Trial

The Herfords filed their lawsuit in January against Johnson & Johnson and its talc supplier Imerys. They claim these companies are responsible for the asbestos exposure that led to Tina Herford’s mesothelioma diagnosis.

Friday’s opening statement indicated that Herford not only used J&J’s talc products on herself throughout her life. She also used its Baby Powder on her daughters from the 1980’s until 1993. Consequently, Herford was breathing in J&J’s talc powder after every diaper change and every personal use, breathing in slow death for more than four decades as deadly asbestos fibers methodically turned her own lungs against her on a cellular level. Herford literally trusted J&J with her and her children’s lives.

“Herford believed that Johnson’s Baby Powder was something that was safe for her to use. And, the evidence will show that it was not,” a plaintiffs’ attorney said.  “And the evidence will show that J&J has concealed the fact that their talc contains asbestos for about one hundred years. This case is about a betrayal of trust.”

However, the company she trusted doesn’t exist. America’s family company is a carefully crafted illusion, concealing the voracious, gaping maw of J&J’s insatiable greed until it’s too late.

Talcum Powder Asbestos Contamination Vs. Ovarian Cancer Litigation

The Herford’s talcum powder asbestos contamination trial stands apart from the massive ongoing litigation over allegations that J&J’s talc-products cause ovarian cancer. However, it will be interesting to see if future talcum powder ovarian cancer trials will be allowed to submit J&J internal documentation regarding its century old policies of simply sweeping inconvenient information, like talcum powder asbestos contamination, under the rug instead of addressing life-threatening issues with its talc products. After all, it does establish a pattern of behavior, and asbestos does cause ovarian cancer.

Statistically, the rates of ovarian cancer associated with talcum powder asbestos contamination would likely be much higher than general exposure. The once-popular insulation material never quite gained traction in the feminine undergarment or winterwear markets. So, not much direct asbestos exposure under the clothes before Baby Powder. Then, talc hit the scene and became a mainstay in children’s diapers and women’s unmentionables.

J&J must have introduced its baby powder at the exact point in time that frustration over excess skin moisture and body odor had driven society to its breaking point. Because, hardworking, innocent people practically scrambled over themselves to build J&J an indomitable empire on the foundation of its iconic baby powder. Meanwhile, the healthcare behemoth forfeited countless lives to maintain the “wholesome” corporate image that had driven its early success.

 

Preserving an Illusion at All Costs – How Far Will J&J Go?

How far will J&J go to preserve this image though? Until the ovarian cancer litigation, the company only had consumer blood on its hands. Now J&J is hemorrhaging money into a losing fight against the mounting verdicts, as juries continue to find J&J did hide talcum powder risks and award staggering punitive damages for the company’s reprehensible behavior.  J&J has already lost more than $700 million to talcum powder ovarian cancer plaintiffs in the fledgling litigation and that’s not counting its own attorney costs for trials, motions, and appeals. This is more than talcum powder products bring in to the company in two years. In fact, cumulatively, all of J&J’s talcum products only account for .005 percent of the company’s more than $70 billion annual revenue.

Furthermore, each new trial brings with it a new avalanche of incontrovertible internal documents that prove J&J casually accepted human lives as necessary business expenditures. Regardless, J&J seems determined to see this through to the bitter end to preserve its Baby Powder’s reputation. However, if the previous trials are any indication, then it seems more like a death march than a battle. Not just for J&J either. Many of these plaintiffs are just trying to hold on long enough to see justice before they die. Even more consumers are still using these products without any warning of the dire consequences that could be on the horizon.

1st J&J Talcum Powder Mesothelioma Trial Commences

By Emily Cox
Talcum Powder Mesothelioma
Now Introducing – Free Nursery Room Decals with Every Lifetime Supply of J&J Baby Powder! (Flickr/Aaron Suggs & M Sundstrom – Two image composite)

A new front in the ongoing baby powder legal battle against pharmaceutical giant Johnson & Johnson opened this past week. So far, juries have found overwhelmingly for plaintiffs who allege Johnson & Johnson hid ovarian cancer risks associated with its flagship talc-products to maintain its wholesome corporate image. Collectively, Missouri and California juries have awarded a grand total of more than $700 million for ovarian cancer damages caused by J&J’s callous disregard for human life in its ruthless pursuit of the all-mighty dollar. Now, it looks like ovarian cancer might just be the tip of the iceberg in this litigation. The first talcum powder mesothelioma trial got underway Oct. 6.

Opening statements and J&J internal documents the court released in September indicate that J&J actively conspired to hide talcum powder asbestos contamination for almost a century. Since J&J first introduced its iconic Baby Powder at the dawn of the 20th century and until, at least, the 1970’s, J&J amassed an impressive body of evidence against itself showing that the company knew that the talc it was using in its products may contain asbestos. However, J&J never passed these warnings on to the medical community or its loyal consumer base. Instead, the company elected to play a twisted version of Russian roulette with its customers’ lives. J&J even actively worked to keep this information from the public. The company spearheaded a task force with Luzenac to influence legislation to keep talc unregulated. The task force even manipulated unfavorable research findings to meet its own nefarious ends.

Talcum Powder Mesothelioma Trial

The talcum powder mesothelioma trial will focus on Tina Herford’s devastating diagnosis after using J&J’s talc products for decades. Herford used J&J’s Baby Powder in the 1950’s but switched to the company’s Shower-to-Shower product for decades until the 1980’s. From the 1980’s until 1993, she used J&J’s Baby Powder on her daughters. Consequently, Herford could have breathed in asbestos from contaminated talcum powder during every diaper change and every personal use for decades. Herford literally trusted J&J with her and her children’s lives.

“Tina Herford believed that Johnson’s Baby Powder was something that was safe for her to use, and the evidence will show that it was not,” a plaintiffs’ attorney said.  “And the evidence will show that J&J has concealed the fact that their talc contains asbestos for about one hundred years. This case is about a betrayal of trust.”

While asbestos occurs naturally in the deposits of talc that J&J uses to create its products, the company has always maintained that it has a zero-tolerance policy for asbest, os in its talc. However, internal communications, as well as studies dating back to the 1970sindicate that this policy was just another one of J&J’s masks to conceal the ugliness beneath its wholesome facade.

“Now it was in the public domain, and the evidence will show that Johnson & Johnson did absolutely everything it could to discredit that result,” the plaintiffs’ lawyer promised.

Plaintiffs are seeking tens of millions of dollars in talcum powder mesothelioma damages for everything they’ve gone through since Herford’s October 2016 diagnosis. She filed her talcum powder mesothelioma claim January 10, 2017, in Califonia state court. Her trial with claims against J&J and its talc supplier, Imerys Talc America, is taking place in Pasadena, CA state court.

Asbestos-Tainted Talcum Powder Mesothelioma

Talc products began gaining serious market traction at the turn of the 20th century and continued to remain extremely popular until the mid-1970s. During this time, J&J instituted its baby-care products as hallmarks of good parenting, raising its Baby Powder to iconic status. J&J also began working to increase market share. Borrowing on its wholesome image and reputation in healthcare expertise, J&J captured the adult talcum powder market. By the 1980’s,  70 percent of J&J’s Baby Powder users were adults. Not only did J&J gain lifetime users, but these adults would go on to teach their children to use these products, feeding the corporate machine generations of lifetime users. If you discount the horrific diseases and early deaths, it’s a great model for a self-reproducing consumer base.

Talc is among the world’s softest natural minerals. It is found in pharmaceuticals and cosmetics, as well as in chalk, rubber, and ceramics. Unfortunately, a great deal of talc is naturally interwoven with asbestos fibers. So, contamination reports are nothing new. However, concealing and not acting on these reports are a decidedly novel approach on J&J’s part.

J&J Knew Talc May Be Contaminated

According to internal documents, J&J officials expressed concerns over possible asbestos contamination from talc mined in Vermont and Italy.

One official suggested that the company switch to a safer cornstarch formula instead of risking an asbestos-contamination scandal. However, this suggestion fell on deaf ears.

A J&J scientist persuaded one of its talc suppliers, the Val Chisone mine in Italy, to stop distributing English-language version of a 1974 booklet until J&J could “edit” the material appropriately. The original booklet revealed that the mine’s talc contained asbestos. Unsurprisingly, J&J’s edits consisted solely of striking all mention of asbestos from the brochure.

“The business threat is that it can raise doubts on the validity of the documentation of purity and safety of talc,” the scientist wrote at the time.

Talcum Powder Mesothelioma

Asbestos is extremely toxic and a known carcinogenic. Inhaling or ingesting even trace amounts of asbestos fibers can cause plethora of horrific, life-threatening diseases. However, the mineral’s claim to fame is mesothelioma. Mesothelioma is an exceptionally deadly cancer with most patients dying within a year of diagnosis. The cancer’s primary cause is asbestos exposure. There are cases where radiation has led to the disease. However, these cases are few and far between.

Dr. Barry Casteman, an asbestos risk consultant, told Bloomberg that even trace amounts of asbestos in talcum powder products like baby powder can pose a cancer risk.

“It is a problem even if it’s found in small amounts in talc, especially because it’s used by children and women,” Castleman said.

A 2009 – 2010 FDA study found no traces of asbestos in cosmetic-grade raw material talc from suppliers. However, only four of the nine requested talc suppliers submitted samples. Consequently, the agency determined the study results were inconclusive. None of J&J’s talc suppliers submitted a sample for the study.

“For these reasons, [these results] do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United States are likely to be free of asbestos contamination,” the agency concluded.

1stTalcum Powder Mesothelioma Trial for J&J…But Not for Litigation Itself

This may be the first time that J&J is going to bat against talcum powder mesothelioma allegations. However, this is hardly new ground. There have been several notable talcum powder mesothelioma trials with decisive victories for the plaintiffs against some heavy hitting opponents.

2015 saw two such victories. In April 2015, a jury ruled that Judith Winkel developed mesothelioma from asbestos in Colgate-Palmolive’s Cashmere talcum powder. The court awarded her $13 million. Later that year, a New York jury awarded $10.55 million in a wrongful death talcum powder mesothelioma case against R.T. Vanderbilt.

In a record setting case against Whittaker, Clark & Daniels in 2016, a Los Angeles Superior Court jury determined that Philip Depoian developed mesothelioma from exposure to asbestos-contaminated talc his father brought home from working in a barber shop. Consequently, the jury awarded Philip Depoian $18 million. This remains the largest talcum powder mesothelioma ruling to date. However, given the evident insidious machinations in J&J’s internal dialogues, the jury in Herford’s talcum powder mesothelioma trial may feel inclined to levy substantial punitive damages to punish the company for its reprehensible behavior.

Outside of Talcum Powder Mesothelioma Cases, J&J Continues to Fight Ovarian Cancer Allegations

Currently, J&J is facing more than 5,000 lawsuits in the U.S., alleging its iconic baby powder products caused women to develop ovarian cancer. So far, five juries have held J&J liable for failing to warn about its talc products’ substantial ovarian cancer risks. In the past two years, juries have hit J&J with more than $700 million in awards over consciously exposing its core consumers to egregious harm for financial gain. This includes August’s landmark $417 million verdict in California’s first J&J talcum powder trial.

In fact, J&J has only emerged victorious once in the Missouri litigation. And, that was only on a technicality. After a critical Supreme Court jurisdiction ruling, the company moved for an immediate mistrial. The Bristol-Squid Myers decision placed strict limits on state court jurisdiction for nonresident claims. Only one plaintiff attached to the case was a Missouri resident. Consequently, the judge was forced to declare a mistrial. However, the Missouri plaintiff returns to court this next Monday on October 16. The 22nd Circuit Court for St. Louis granted Michael Blaes another chance to take J&J to task for essentially sentencing his wife to death when her only crime was trusting in America’s “family company.”

Testosterone Trial Punitive Damages Verdicts Send a Clear Message

By Emily Cox
Testosterone Trial Sends Clear Message
Flickr/Mike Lowe

In the latest testosterone trial, a federal jury ruled Thursday that AbbVie must pay more than $140 million in punitive damages for aggressively expanding Androgel’s market share through insidious machinations and flagrant misrepresentations of the testosterone gel’s safety.

This is the second testosterone trial in the multidistrict litigation (MDL) over manufacturers specifically targeting and exploiting aging men to increase sales despite serious cardiovascular risks. The plaintiff, Jeffrey Konrad, alleged that AbbVie had evidence connecting testosterone to significant cardiovascular events but never warned the medical community or general public. Instead, AbbVie put its desire to grow Androgel’s market before patients’ very lives. On its website, AbbVie claims that patients are what matter most. Where was this ideology when AbbVie was promoting its testosterone gel to aging men without mentioning the risks, conducting proper testing, or even getting FDA approval for expanding indications?

Konrad sued AbbVie five years after suffering a heart attack while using Androgel. However, the jury did not find AbbVie liable for his heart attack. But, it did find AbbVie guilty of negligence, intentional misrepresentation, and misrepresentation by concealment. The jury awarded Konrad $140,000 in compensatory damages. These cover $40,000 for medical care following his 2010 heart attack and an additional $100,000 for pain and suffering. However, these compensatory damages are merely a footnote in the punitive damages the jury levied against AbbVie.

The jury ordered AbbVie to pay $140 million dollars in punitive damages for its “reprehensible” behavior. Punitive damages punish companies for immoral business practices in the hopes that these companies will rectify these behaviors and at least try to act in a manner consistent with normal human beings rather than soulless corporate monsters that only see patients in terms of sales potential.

Testosterone Trial Punitive Damages Speak Volumes About Depths of AbbVie’s Depravity

Currently, there are almost 7,500 testosterone trial cases pending against AbbVie and other drug companies in the ongoing MDL in the Northern District of Illinois. Konrad’s trial concluded mere months after the MDL’s first bellwether trial. The first testosterone trial involved Jesse Mitchell’s heart attack while using Androgel. Like Konrad, the jury found that Mitchell already had significant pre-existing cardiovascular risk factors that negated product liability claims…in a product liability case. In fact, the jury did not even award any compensatory damages for Mitchell’s injuries. However, it did levy a $150 million punitive damages verdict against AbbVie for its outrageously misleading advertising. Unfortunately, it’s still unclear if punitive damages are even enforceable without accompanying compensatory ones. But, regardless, juries are sending a clear message about the morality of AbbVie’s business practices with these punitive damages verdicts.

Generally, liability is kind of crucial in a product liability case. Based on the name itself, one could argue that it’s pretty much the foundation of these kinds of cases. And, so far, plaintiffs are batting a thousand despite losing at trial over product liability claims. It is a true testament to the very depravity of AbbVie’s business practices. These verdicts indicate that there is a fundamental immorality in AbbVie’s motivations and actions that run contrary to our most basic moral sensibilities.

Testosterone Trial Jurors’ Outrage Over AbbVie’s Egregious Behavior Could Be Decisive in Overall Litigation

The juries in both trials concluded that that they could not attribute the plaintiffs’ injuries to the testosterone gel. But, their mutual decisions to punish the company for the morality of its actions could shape up to be an insurmountable obstacle for AbbVie as the litigation continues.

“I’d be really concerned about how my behavior was going to be judged by the juries,” a plaintiff attorney said.  “It definitely shows them they’re at huge risk.”

In the long run, fixing plaintiff problems is far easier than fixing the jury’s outrage over AbbVie’s actions. While plaintiffs change case-to-case, AbbVie’s marketing strategy will remain the same throughout the litigation.

“Correcting the anger, that’s the bigger mountain to climb,” a plaintiff attorney said.

Consequently, the incendiary response that AbbVie’s behavior ignites could weigh heavily into any jury decision regardless of the actual strength of the case at hand.

Testosterone Trial Indicates AbbVie Created Market for Androgel

Before the FDA even approved AndroGel, AbbVie was already pouring millions to raise awareness for a condition the company called “Low T.” Low-T’s symptoms are remarkably similar to those of the normal male aging process. Occasionally grumpy? Not as strong as you were 20 years ago? Have you ever fallen asleep after dinner? Good news! You’re not old. You just have Low-T, and, luckily, testosterone gel will fix all that and more! AbbVie didn’t just create a market for Androgel with its premarketing messages. It created a medical condition.

Before AbbVie raised awareness for Low-T, losing muscle and/or sex drive were undesirable but predictable signs of aging. AbbVie blatantly preyed on older men’s insecurities and took them straight to the bank. IMS Health data shows testosterone sales skyrocketed from $324 million in 2002 to nearly $2.3 billion in 2012.

However, the FDA never cleared AbbVie’s testosterone gel for treating Low-T. And AbbVie even had evidence linking testosterone to serious cardiovascular events. However, these kinds of mundane considerations had absolutely no bearing on AbbVie’s determination to get its testosterone gel into the hands of as many occasionally tired men as possible.

AbbVie began marketing the drug aggressively to doctors and consumers as the miracle solution to Low-T after the company won FDA approval to market the medication to treat hypogonadism, or primary testicular failure. Despite clear FDA indications, television and print ads suggested that the testosterone therapy could also be used to treat typical signs of aging.

The company was far more aggressive in its marketing to the medical community. AbbVie experts and direct sales staff flooded medical conferences, convincing drug company employees that Androgel was “the fountain of youth.”

“Everywhere doctors went…[they got] AbbVie’s message,” a plaintiff attorney told the jury. “That’s how you build a billion-dollar market.”

Testosterone Trial Exposes Significant Androgel Risks

T therapy was initially just for men who can’t produce enough testosterone due to testicle injury, cancer, or genetic defects. However, AbbVie opened the flood gates, convincing countless men to take the hormone to feel and look younger. Critics say that this exposes otherwise healthy bodies to serious side effects.

The Journal of American Medical Association published a study in 2013. Researchers found a 30 percent jump in the risk of stroke, heart attack, and death among men undergoing testosterone therapy. Testosterone therapy also makes the body shut down its own production of the hormone. Consequently, testicles may shrink, effectively creating life-long customers, while increasing the toll on patients’ bank accounts and physical health exponentially.

AbbVie Tries to Dodge Accountability for Hiding Risks

At trial, AbbVie tried to claim that there was no evidence of testosterone gel-related cardiovascular risks until a trio of studies were published in 2013 and 2014. Following these publications, the FDA investigated and updated the label for all testosterone therapy drugs to include a warning about the risk of “major adverse cardiovascular events.”

However, attorneys to the plaintiffs were quick to point out the multitude of other studies from before 2013 that AbbVie consciously ignored. These studies revealed a substantial connection between Androgel and heart attacks. AbbVie also never performed its own cardiovascular studies before pushing the drug on an at-risk population. Other cases in the ongoing testosterone MDL accuse AbbVie and other companies of hiding pulmonary embolism and stroke risks, as well as cardiovascular ones.

During closing statements, a plaintiff attorney reminded the jury that AbbVie is responsible for the drugs it sells. AbbVie was too concerned with its financial security that it lost sight of patient safety and ignored signs that called Androgel’s safety into question.  Instead of testing to evaluate these signs, the company pushed the drugs on ever more men, stealing their ability to make informed medical decisions by hiding significant health risks. Instead, their desire to expand market share was put before everything – including patient health. Now, juries are making sure they pay.

 

Hernia Mesh Complications Prevent Woman from Healing

Emily Cox
Hernia Mesh Complications
Flickr/Kurt Haubrich

According to a new lawsuit, hernia mesh complications made quick work of unravelling one California woman’s life, devolving her world into a never-ending nightmare of surgeries and packing wounds that may never heal.

Cindy Sunseri filed the claim September 30 in the Northern District of California. She alleges that Johnson & Johnson (J&J) and Ethicon knew that their Prolene Hernia Mesh System (PHMS) was defective. Given that J&J is currently facing more than 100,000 lawsuits in the U.S. over concealing  considerably dangerous defects in its pelvic mesh, Risperdal, Xarelto, Pinnacle hip, and talcum powder products, the companies’ decision to press forward with the manufacturing, fraudulent marketing, and eager distribution of the defective device is almost expected at this point. While their products continue to cause irreparable harm to patients, it’s just another day at the office for J&J. Safety is clearly not an issue if there’s a chance to maximize sales and profits. This clearly shows a conscious disregard to foreseeable serious hernia mesh complications for the sake of the all-mighty dollar.

PHMS Hernia Mesh Complications

In September 2010, Sunseri underwent umbilical hernia repair with J&J and Ethicon’s PHMS. At her post-operative check-up, the hernia mesh was already showing signs of failure. Sunseri had an abscess and cellulitis, which is a bacterial skin infection. Consequently, her physician performed an incision and drainage (I&D) surgery to treat her symptoms but was unable to address the real culprit. The PHMS device is not only defective. It is almost impossible to remove. Even when removal is possible, serious risk factors make most physicians hesitant to attempt removal.

In August 2015, Sunseri developed another abscess and cellulitis at the surgical site. Once again, physicians only treated the hernia mesh complications, working around the mesh causing them. Sunseri quickly developed another serious infection. Doctors determined that a piece of her failed PHMS had detached, causing the infection. Consequently, Sunseri underwent yet another surgery to remove the errant piece of plastic mesh. However, despite the fact that the hernia mesh had clearly failed and was now shedding pieces of plastic into her body, surgeons determined it would be more dangerous to remove the mesh than leaving it in place. Besides, what else could possibly go wrong?

An October 2015 CT scan showed exactly what else could go wrong. Sunseri now had a small bowel adhesion to another sloughed-off piece of the failed mesh, sending her back to the operating room once more. Doctors still elected not to remove the PHMS or any of its various discarded pieces due to high rates of complications with explantation of the device. Unsurprisingly, Sunseri’s hernia mesh complications have not subsided. If anything, despite no surgical interventions for two years, her nightmare was only beginning in 2015.

Ongoing Hernia Mesh Complications Require Surgical Site to Remain Open Indefinitely

Due to her extensive surgeries, the hernia itself has not healed. Consequently, the abdominal surgical site has remained open since at least 2015, indefinitely exposing her abdominal cavity’s interior. Not only does this place her in significant danger for life-threatening infections. Her open wound requires constant maintenance. This includes daily wound dressing changes at home and weekly dressing changes at a specialized wound care clinic. These dressing changes require Sunseri to pull dirty gauze out of the hole in her abdomen before painfully packing it back up with fresh, sterile gauze.

Merely tending to her hernia mesh complications leaves Sunseri in a constant state of excruciating abdominal pain. And, there’s no end in sight. Furthermore, she remains at significant risk for recurrent infections and complications from the remnant pieces of the failed PHMS.

PHMS Hernia Mesh Complications Exacerbated by Mesh Removal Risks

At first glance, the doctors’ steadfast refusal to remove a defective hernia mesh implant that is clearly causing egregious harm is unfathomable. However, for the most part, once a patient receives a PHMS, it is there for life. PHMS is extremely difficult to remove once it has been implanted. It requires severely invasive surgery with a high probability of organ loss. Even then, since the mesh incorporates itself so thoroughly into the tissue, complete removal of mesh remnants is difficult at best but often impossible.

The PHMS is approximately 50 percent more flexible than standard polypropylene meshes. Consequently, the medical community hailed the product as a “revolutionary breakthrough” when it first hit the market. However, it’s now known to cause serious hernia mesh complications. These include mesh erosion, infections, pain, painful sexual intercourse, organ perforation, and urinary problems. And, for many of the men and women with the defective device, there’s no way to ever remove it, leaving patients to a lifetime of pain and suffering. Despite their knowledge of these shocking complications, J&J and Ethicon continued to advertise the PHMS as the “ideal” mesh for inguinal hernia surgery, profiting from hernia patients’ trust, while remaining immune to the irrevocable damage from the defective device.

Suneri joins a growing number of individuals currently trying to take J&J and Ethicon to task for ruining the lives of countless innocent people for financial gain with variety of defective mesh products. Hopefully, these brave individuals can start to break down some of this immunity these reprehensible companies have to the pain they have caused…even if it’s just in the form of taking back some of their ill-begotten profits.

J&J Hid Talcum Powder Asbestos Contamination in 40+ Year Conspiracy

By Emily Cox
Talcum Powder Asbestos
Flickr/Austin Kirk

Recently unsealed internal documents from yet another lawsuit against America’s “family company” show that Johnson & Johnson (J&J) knew about talcum powder asbestos contamination at a number of its talc-sources since the early 1970’s. Instead of alerting at-risk women and children or switching to a safer cornstarch-based formula, the consumer goods and pharmaceutical giant conspired for decades to bury significant talcum powder asbestos risks from the public. The court unsealed the internal documents as part of pretrial proceedings in Ingham et all v. Johnson & Johnson et all. The case, involving more than 50 women, will be going to trial January 31, 2018, in St. Louis.

According to an internal memo, J&J trained employees to assure those concerned about talcum powder asbestos contamination that the dangerous, cancer-causing mineral “has never been and it never will be” in its flagship baby powder. However, plaintiffs in the litigation are calling foul. Other internal documents indicate that J&J has known for more than 40 years that its talcum powder products may contain traces of asbestos fibers and that this exposure can cause ovarian cancer. According to the lawsuit, the mine that supplies J&J’s talc also contains dangerous cancer-causing agents like asbestos. Furthermore, J&J’s testing methods are “incapable” of detecting if a consumer product has been purified to be asbestos free. Consequently, the talc J&J uses to make its products, “is not now, nor has it ever been, free from asbestos and asbestiform fibers,” according to the lawsuit.

J&J Alerted to Talcum Powder Asbestos Contamination in Early 1970’s

The court unsealed the documents this past month. They included a 1973  J&J report on its Windsor Material talc mine in Vermont. The report indicated that mine and federal officials were working together to check for asbestos fibers at the site. A J&J official wrote that the company’s baby powder “contains talc fragments classifiable as fiber. Occasionally sub-trace quantities of [two types of asbestos] are identifiable and these might be classified as asbestos fiber.”

Concerned over the possible talcum powder asbestos contamination, a J&J official suggested replacing talc with cornstarch in the company’s consumer products. However, the report and official’s call-to-action fell on deaf ears. J&J continued business-as-usual – striving to ever-increase talc sales, while making no moves to improve consumer safety measures.

According another of these documents, in May 1974, an official at the Windsor talc mine recommended “the use of citric acid in the depression of chrysotile asbestos” for talc extracted from the mine.

“The use of these systems is strongly urged by this writer to provide protection against what are currently considered to be materials presenting a severe health hazard and are potentially present in all talc ores in use at this time,’’ the Windsor mine’s director of research and development wrote.

So much for the company’s adamant assertions pertaining to its talc’s purity. That’s twice in two years that mine officials alerted J&J about talcum powder asbestos contamination. Again, inaction was the only discernible response from J&J pertaining to the potentially tainted talc. That is, until 1974, when the owners of the Val Chisone mine near Turin, Italy produced a booklet revealing the discovery of trace amounts of asbestos in the talc that it supplied to J&J.

 “Trace Amounts” of Talcum Powder Asbestos Contamination – Always Bad for Your Health, But Only Bad for Business if You Get Caught

“The [Italian publication’s] business threat is that it can raise doubts on the validity of the documentation of purity and safety in talc,” wrote a J&J research scientist.

The threat of anyone looking too closely into J&J’s talc testing and documentation practices finally spurred the company into action. The scientist convinced the mine’s owners to halt English-language distributions of the booklet until J&J officials could rewrite it. The owner’s began distribution again with J&J’s blessing after the company had completed its revisions. These revisions included the removal of all direct and indirect references to asbestos.

According to asbestos expert and consultant Dr. Barry Castleman, even trace amounts of asbestos in talcum powder products poses serious cancer risks.

“It is a problem even if it’s found in small amounts in talc, especially because it’s used by children and women,” Castleman said.

While asbestos causes a large assortment of cancers, it’s strongest connection is with mesothelioma. Mesothelioma is an exceptionally deadly cancer with most patients dying within a year of diagnosis. Not so coincidentally, the next most common cancer from asbestos exposure is none other than the one that dozens of studies since the 1970’s have found that talcum powder causes.

Ovarian cancer is the deadliest of the gynecological cancers. The 5-year relative survival rate for all types and stages of ovarian cancer is 45 percent. And, this figure is bolstered by higher early detection survival rates. Unfortunately, ovarian cancer is rarely detected before it reaches its more advance and deadly stages.

J&J Expands Market Share to Adult Feminine Hygiene Despite Talcum Powder Asbestos Risks

In 1972, Castleman wrote J&J, pleading with the conglomerate to consider the implications of using talc, given its inherent proximity to asbestos in nature. In 1982, ovarian cancer researcher Dr. Daniel Cramer advised a J&J official that the company should include cancer warning labels on its talcum powder products. However, two more scientists further validating numerous other studies and J&J’s own findings didn’t exactly send shock waves through a company where execs are casually comparing talcum powder to cigarettes in terms of cancer risks, while continuing to market the dangerous substance to women and children. Consequently, J&J  waved away these suggestions and continued plotting on how to sell even more talcum powder.

These monsters finally contrived to expand its market share to adult women with aggressive marketing messages. Borrowing on its wholesome image and nostalgic associations with its baby powder products, J&J manipulated women to use as much of its talc products as possible all over their bodies and for feminine hygiene to maximize freshness…and sales. And, it worked in spades. By the 1980’s,  70 percent of J&J’s Baby Powder users were adults.

Talcum Powder Revenue is a Microscopic Fraction of One Percent of J&J’s Total Revenue

The company sentenced countless women to ovarian cancer and exposed generations of infants to known carcinogens. And, for what? Money, of course, but how much? The corporation’s entire empire must have been at stake to go so far and harm so many people, right? Not so much. J&J makes more than 90 percent of its money from pharmaceutical drugs and medical devices.

All of J&J’s talcum powder products combined contribute about .005 percent to the multinational company’s approximately $72 billion annual revenue. This means that if J&J had $100, then they would not even risk half a penny to keep women and children safe from egregious harm and deadly diseases. Even if J&J stopped selling these products entirely, the company’s annual revenue would still round out to $72 billion.

J&J Gives Back

There’s no question that J&J worked hard to gain its customers’ unflagging devotion, trust, and loyalty. This is reflected in product reviews on J&J’s website.

“When we shop for our children we look for a Johnson [& Johnson] product we trust with our lives,” a California woman wrote in her review of J&J’s baby powder.

And how does J&J repay this loyalty and trust? By manipulating mothers into believing that using their talcum powder products on infants is a hallmark of good parenting. Also, through exploiting insecurities over feminine odor to move more product. And, don’t forget the best gift of all – exposing as many women and children as possible to serious, life-threatening risks for revenue that has absolutely no real bearing on J&J’s overall financial health at all.

Talcum Powder Asbestos Contamination – Can J&J Be Stopped?

There is a deep well of depravity at the very heart of America’s “family company.”  And, as evidence continues to mount in the numerous litigations against the company, the yawning abyss grows ever darker and deeper. The company’s only real loyalty is to its products, image, and the all-mighty dollar. Those are J&J’s idols, and the consumers are but sacrificial lambs to the slaughter. Since common human decency is not on the table, hopefully, the ever-increasing verdicts for women harmed by J&J’s talc and pelvic mesh products will appeal to the company’s avarice to make a change in how it develops, evaluates, and markets its products. Hopefully, we’ll be the last generation of J&J’s guinea pigs. If so, chances are that we have the brave women standing up to one of the world’s biggest bullies today to thank for it.

Talcum Powder Verdicts

The newly released documents could have a significant impact on the ongoing talcum powder litigation. Currently, J&J is facing more than 5,000 lawsuits in the U.S., alleging its iconic baby powder products caused women to develop ovarian cancer. Overwhelmingly, juries have already sided with injured plaintiffs without additional asbestos allegations, ruling that J&J irrefutably hid ovarian cancer risks from women for financial gain. Five juries have ruled against J&J with verdicts upwards of $417 million. However, the company was able to finagle one mistrial based on a technicality. Regardless, the healthcare conglomerate has still already racked up a grand total of $700 million in talcum powder damages.

But, J&J is appealing the recent $417 million Los Angeles verdict. In its appeal, the company blamed everyone except for itself for losing at trial. In their response to the appeal, plaintiffs discounted J&J’s assertions.

“Defendants did not lose because of something the jury did, the court did, or plaintiff’s counsel did,” the motion states. “They lost because the evidence showed what they did.”

The court has set a hearing to review J&J’s motions for October 12. The next Missouri talcum powder trial will begin the following Monday on October 16.

 

 

 

 

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