Category: Alerts

Dow Flexes Political Muscle and Contributions to Push Trump to Ignore Pesticide Risk Study

By Emily Cox
Dow Chemical Pesticides
Photo by Baker County Tourism

Dow Chemical is exerting pressure on an already anti-regulatory Trump administration to ignore the findings of a federal study that indicates lasting ecological damage from a family of widely used pesticides.

The Associated Press released its report last week. According to the exclusive, Lawyers representing Dow and two other chemical companies sent letters to administration Cabinet officials earlier this month. The companies asked the administration “to set aside” the results of an EPA organophosphate study that show the chemicals in a poor light. These studies concluded that the pesticides chlorpyifos, diazinon, and malathion were harmful to 1,800 critically threatened or endangered species.

Dow Chemical’s Influence in the Trump White House

The companies contend that these studies are fundamentally flawed. However, these contentions may be beside the point in light of Dow’s ties to the Trump administration. Dow CEO Andrew Liveris is a close adviser to Trump and heads a White House manufacturing working group. When Trump signed a February executive order, mandating the creation of task forces at federal agencies to roll back government regulations, Liveris was at Trump’s side.

“Andrew, I would like to thank you for initially getting the group together and for the fantastic job you’ve done,” Trump said as he signed the order. Then, the president handed his pen to Liveris as a keepsake of the occasion.

Furthermore, Dow spent more than $13.6 million on lobbying in 2016 and has long held significant political power in D.C. Moreover, Dow Chemical also wrote a $1 million check to help underwrite Trump’s inaugural festivities. Nothing says a party like deregulation of pesticides and other chemicals.

May feel that Dow’s letter to ignore the EPA’s extensive study of the environmental impact of these organophosphates is the company’s latest attempt to leverage its extensive White House influence to further its economic interests at the cost of the environment and public health.

The Study Dow Chemical Wants Pushed Aside

Researchers found the pesticides appeared to endanger any species that they tested them against. This could indicate that the chemicals pose substantial future risk to humans.

“Endangered species are the canary in the coal mine,” Brett Hartl, government affairs director for the Center for Biological Diversity.

Many of the threatened species in the study are aquatic. According to Hartl, they are often the first to show the effects of long-term chemical contamination in sources of human drinking water.

Dow Chemical’s Objections to EPA Study

However, Dow maintains that the EPA was selective in the studies it examined. The company claims the agency allowed some non-scientific studies to factor in while ignoring other studies that met inclusion guidelines. Furthermore, Dow ArgoSciences, which sells chlorpyrifos, accused that the study’s “scientific basis was not reliable.”

Hartl said Dow was trying to hold EPA to an unrealistic standard of data collection that could only be achieved under “perfect laboratory conditions.”

“You can’t just take an endangered fish out of the wild, take it to the lab and then expose it to enough pesticides until it dies to get that sort of data,” Hartl said. “It’s wrong morally, and it’s illegal.”

Environmental advocates were quick to say that Dow’s criticism of the study was unfounded. The National Academy of Science developed the EPA’s methods for biological evaluations.

A coalition of environment groups has fought in court for years for the EPA to examine the risks posed to humans and endangered species by pesticides, especially organophosphates. The resulting study encompasses almost four years of research and 10,000 pages of findings. Consequently, regulators at three federal agencies responsible for enforcing the Endangered Species Act are close to issuing these finding. This should result in new limits on how much and where people can use these highly toxic pesticides. However, if Dow has its way, the Trump administration will step in to intervene on behalf of the chemical giant’s financial interests.

Dow and Organophosphates

Nazy Germany originally developed organophosphorous gas as a chemical weapon. Dow has been selling Chlorpyrifos, an organophosphate, for spraying on fruits and other crops since the 1960s. It is one of the most popular agricultural pesticides in the U.S. Dow sells about 5 million pounds domestically annually.

Consequently, traces of the chemical are common in sources of drinking water. A 2012 University of California at Berkeley study found that 87 percent of umbilical-cord blood samples tested from newborns contained detectable levels of the pesticide.

The Bush administration ordered the end of the residential use of another organophosphate, diazinon. Households used it to kill yard pests until human health risks, particularly to children, became apparent. However, the agricultural sector still uses it.

Malathion helps control mosquitoes and fruit flies. Some lice treatment shampoos for children also contain the chemical.

 

 

Government Shutdown May Hinge on Trump’s Wall Demands

By Emily Cox
Trump Wall Threatens Government Shutdown
Photo by Ted Eytan

While nobody in Washington is pushing for a government shutdown Saturday, the new funding bill is contingent on funds for Trump’s border wall, and neither side is backing down.

The Washington Post reports that the President and his cabinet applied new pressure Sunday to include money for Trump’s U.S.-Mexico border wall in the critical government funding bill to prevent the impending shutdown when funds run out at the end of Friday. The shutdown would come into effect on Trump’s 100th day in office, capping off an intense start to the new administration, defined by a frenetic dash to kick-start the president’s agenda into high-gear despite possible dire political consequences.

Trump Takes Government Shutdown to Twitter – The Obvious Forum for this Discussion

Democrats said they will not approve any money for the border wall in a new spending bill.  In response Trump attacked Democrats for opposing the wall.

“The Democrats don’t want money from budget going to border wall despite the fact that it will stop drugs and very bad MS 13 gang members,” Trump tweeted Sunday.

Trump went on to suggest that Democratic opposition to funding the wall was myopic, indicating that Americans won’t be paying for it in the long run.

“Eventually, but at a later date so we can get started early, Mexico will be paying, in some form, for the badly needed border wall,” Trump tweeted.

However, Mexico strongly opposes the border wall. Mexican president Pena Nieto has said that the country “absolutely will not pay for” the wall ever. Nieto claimed the wall was an affront to Mexico’s dignity. This raises some fundamental questions on how Trump intends to fulfill this particular campaign promise.

Democratic Opposition to Trump Wall Despite Government Shutdown Threat

It remains unclear if GOP moderates will be able to sway the White House to avoid a shutdown. Meanwhile, Democrats continue to dig in their heels on the issue. They insist they won’t vote for any funding bill that gives Trump money to begin construction on his wall. They are saying that Republicans will either have to assume responsibility for the shutdown or abandon Trump’s demands.

“The burden to keep it open is on the Republican,” House Minority Leader Nancy Pelosi, D-Calif, said Sunday on NBC’s Meet the Press. “Building a wall is not an answer. Not here or any place.”

“The wall is, in my view, immoral, expensive, unwise, and when the president says, ‘Well, I promised a wall during my campaign,’ I don’t think he said he was going to pass billions of dollars of cost of the wall on to the taxpayer,” she continued.”

Government Shutdown isn’t Trump’s Only Bargaining Chip

Trump Threatens Government Shutdown and Healthcare
Photo by IoSonoUnaFotoCamera

The Trump administration isn’t only threatening a government shutdown to meet its agenda. In a nefarious twist, it appears to be holding American healthcare hostage as well.  Trump’s Office of Management and Budget director Mick Mulvaney has suggested the administration is willing to negotiate with Democrats. He said they would agree to fund insurance subsidies under the Affordable Care Act (ACA) in exchange for wall funding.

However, Democratic leaders took an affront to this negotiation tactic. Leaders feel that the administration is preying on the party’s interest at the expense of the American people.

“The White House gambit to hold hostage health care for millions of Americans, in order to force American taxpayers to foot the bill for a wall that the President said would be paid for by Mexico is a complete non-starter,” Matt House, a spokesman for Senate Minority Leader Charles E. Schumer, D-NY, said in a statement Friday.

The Senate has said that this statement still stands. In response, Trump issued a menacing warning Sunday morning to further the twist the arms of Democratic leaders.

“ObamaCare is in serious trouble,” Trump wrote. “The Dems need big money to keep it going – otherwise it dies far sooner than anyone would have thought.”

The thinly-veiled threat seems clear. Build Trump’s wall or he will tear Obamacare down, leaving millions of families without healthcare.

 

$3M Verdict Awarded Against Paxil Manufacturer for Lawyer’s Suicide

By Emily Cox
Justice for Generic  Paxil Suicide
Photo by Captain Roger Fenton

An Illinois jury found GlaxoSmithKline (GSK) liable Thursday for Stewart Dolin’s suicide and ordered the company to pay $3 million to the lawyer’s widow, claiming that a generic version of GSK’s Paxil caused Dolin to take his own life.

Following five weeks of testimony, the nine-person jury agreed with Wendy Dolin that generic paroxetine, an antidepressant sold as brand-name Paxil, contributed to her husband’s 2010 suicide.

Dolin alleges that her husband would still be alive today if he hadn’t started taking paroxetine mere days before jumping in front of a downtown Chicago L-train. Dolin claims her husband was restless and agitated during his final days. These are symptoms of a Paxil side effect known as akathisia. GSK denies that akathisia can lead to suicide. However, Dolin contends that the side effect sometimes causes people to act impulsively and violently.

GSK Knew About Increased Paxil Suicide Risk

Furthermore, the lawsuit claims that GSK knew about the increased suicide risk in adults taking paroxetine. This is even more pronounced in the early days of treatment. However, the company allegedly hid this data from the FDA for decades. During the trial, the widow testified that her husband was sometimes anxious. But, he had developed coping mechanisms and was seeing a therapist at the time of his suicide.

The jury awarded Dolin $3 million. They allocated $2 million for the wrongful death of her husband. The jury awarded another $1 million for the pain he suffered in the days leading up to his untimely death. While this was far less than the $39 million Dolin had sought, she said it was about spreading awareness of the drug’s dangerous side effects instead of the money.

“I started a foundation, MISSD. I go to Washington, D.C., and I sit on consumer groups so this, for me, has not just been about the money,” she said. “This has always been about awareness to a health issue, and the public has to be aware of this.”

Paxil Manufacturer Continues to Assert Suicide Was Due to Work Anxiety

GSK tried to pin her husband’s suicide on his chronic anxiety, particularly as it related to his work. However, the managing partner at Reed Smith’s Chicago office testified that it wasn’t work that drove Dolin to suicide.

“He had challenging work, but we sorted it through,” Mike LoVallo, a close friend to Dolin for decades, testified.

After his death, LoVallo searched Dolin’s office. But he found no indication that his work was a contributing factor in his suicide.

Regardless, GSK continues to contend that since they did not manufacture the generic version of the drug that the court should not hold them liable. Dolin originally brought the suit against Mylan NV, the manufacturer of the generic version of Paxil. But District Judge James Zagel ruled that GSK, as the maker of the brand-name drug Paxil, was responsible for ensuring the label was accurate. The ruling still remains controversial.

Aventis Jumps to Prevent Expanded Discovery Scope into Taxotere Marketing Fraud

By Emily Cox
Aventis Attempts to Keep Court Out in Taxotere Marketing Fraud
Photo by theilr

Following an order that expanded the Taxotere marketing fraud lawsuit’s discovery to include two additional drugs, the breast cancer drug manufacturer was quick to file a response to prevent the court from compelling the company to produce this evidence.

Judge Lawrence F. Stengel issued the order late last week to expand the discovery scope in investigating alleged Taxotere marketing fraud to include Aventis drugs Nasacort and Lovenox. The order was in response to plaintiff Yoash Gohil’s motion to compel the discovery and prevent Aventis from withholding evidence. The motion suggested that evidence related to these other drugs showed a corporate policy of illegal and fraudulent marketing activities like the ones the company is accused of in relation to Taxotere.

“[This evidence is] relevant to the defendants’ state of mind, motive, corporate intent, and/or reckless disregard for the truth or falsity of claims,” the motion states.

Gohil also asserted that this evidence proves that Aventis violated the Federal Food, Drug, and Cosmetic Act. Furthermore, the illegal and fraudulent Nasacort, Lovenox, and Taxotere marketing directives may have come from the same management. Gohil strongly indicated that this evidence shows a corporate culture of deceit, fraud, and corruption.

“[There is] extensive evidence of corporate goals to promote Taxotere and other drugs off-label; the use of corporate-wide kickbacks; systematic destruction of corporate records directed by the legal department to conceal off-label promotion and kickbacks, as well as obstruction of FDA inquiries,” the motion states.

Now, Aventis is desperate to keep the Taxotere marketing fraud investigation focused solely on Taxotere. In its response filed Tuesday, the company called the expanded discovery disproportionate to the needs of the case. Aventis pled the court to withhold this evidence.

Taxotere Marketing Fraud Lawsuit

Gohil is joined by the U.S. in his qui tam lawsuit, also known as a whistle blower lawsuit. They claim that Aventis engaged in fraudulent marketing practices. They further allege that the company provided illegal kickback and other illicit incentives. This was to encourage doctors to use Taxotere as first line treatment for less aggressive cancers. The FDA has only approved Taxotere for the treatment of certain aggressive, late stage cancers when other treatments have failed. The lawsuit indicates that the company has engaged in this behavior since 1996.

Allegedly, Aventis trained and directed employees to misrepresent the safety and effectiveness of off-label Taxotere use. The company also paid healthcare providers illegal kickbacks to get doctors to prescribe Taxotere for off-label use. These kickbacks included entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and fee reimbursement.

Taxotere’s illegal promotion increased the drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. Consequently, it unnecessarily exposed thousands of women to the increased toxicity of Taxotere. This increased toxicity also comes with more severe side effects, including permanent hair loss.

In fact, the number of Taxotere lawsuits continues to skyrocket as more women discover Aventis knew about this permanent hair loss risk for more than a decade. However, the company hid it from American breast cancer victims. While the company started including permanent hair loss warnings on Taxotere in other countries, starting in 2005, it kept Americans in the dark until late 2015.

 

 

MiraLax May Cause “Horrifying” Changes in Children

By Emily Cox
MiraLax Adversely Effecting Children
Photo by Hartwig HKD

A recent report presents disturbing claims that children have developed neuro-psychiatric problems after taking MiraLax.

The FDA doesn’t recommend MiraLax for children under 17 and limits use to seven days. However, according to a recent investigative report,  families are claiming that pediatricians prescribe it like water and for extended periods of time to treat constipation in children.

While many parents view MiraLax as a godsend for their children’s constipation, several families are coming forward and reporting scary MiraLax side effects in their children. These side effects include behavioral issues, speech problems, anxiety, aggression, and depression.

6 ABC Action News reported that a doctor advised Jeanie Ward to give her three-year-old daughter, Nicole, the laxative. However, within 10 days, Nicole’s personality had drastically changed.

“Near psychiatric events with paranoia, mood swings, aggression, rage, the OCD repetitive chewing” Ward said. “It was horrifying to see my daughter change like that and to not completely go back to normal.”

Ward is not alone. Numerous other families shared similar stories with Action News.

“We saw a lot of the anger, a lot of the rage, a lot of the aggression,” parent Mike Kohler said. “I trusted the medical community, and they absolutely robbed me of part of my fatherhood.”

These sentiments are echoed by Jessica Aman and Sarah Locatelli.

“I feel like my son was absolutely robbed of most of his childhood,” she said.

“After six days on MiraLax, we noticed overnight he acted out of character,“ Locatelli said. “He had the rage, fears, phobias, anxieties.”

While Natalie Saenz had doubts due to MiraLax’s label indications, she trusted her pediatrician. He recommended MiraLax for off-label use on her daughter for eight months.

“All of a sudden, she started having these weird ticks,” Saenz said.

MiraLax Families Fight Back

These families and others complained to the FDA and formed a Facebook group with more than 3,000 members where other families have voiced similar concerns.

Ward also helped write a petition to the FDA to include a warning label and a MiraLax investigation. Consequently, the petition won a $325,000 study of a MiraLax ingredient –  Polyethylene Glycol (PEG).

“I think they are poisoning our chidren,” Ward said.

After the FDA reported 167 adverse side effects in kids, the agency awarded the study to CHOP. The FDA also found small amounts of the antifreeze ingredients in the laxative.

For now, the study is ongoing. Meanwhile, these families are urging pediatricians to avoid MiraLax recommendations. Instead, adding fiber rich foods and prune juice to a child’s diet can help move things along without the cost to mental health.

 

 

 

 

Aventis Fraud May Extend Beyond Controversial Breast Cancer Drug Taxotere

By Emily Cox
Aventis Fraud Whistleblower Lawsuit
Photo by Steven Depolo

A new order in the Aventis fraud lawsuit, alleging that the drug company engaged in illegal marketing tactics to increase Taxotere’s market share, indicates that these fraudulent and illicit practices extended to at least two of the company’s other drugs.

District Judge Lawrence F. Stengel issued the order late last week. He issued the order in response to plaintiff Yoash Gohil’s Motion to Compel Discovery. Gohil’s motion strongly indicates that evidence related to the drugs Nasacort and Lovenox shows that the sort of illicit and fraudulent activities surrounding Taxotere’s marketing is a matter of corporate policy.

Judge Stengel’s order mandates that Aventis produce this evidence by May 22. This expanded evidentiary scope applies to all future discovery as well.

“For purposes of all future discovery conducted in this matter, Aventis shall not withhold any documents or testimony from Plaintiff on the basis that the documents or testimony pertain to drugs other than Taxotere in connection with these requests,” Judge Stengel wrote.

Aventis Fraud Does Not Appear Limited to Taxotere

This order comes after Aventis refused to produce certain evidence in February. This evidence pertained to Aventis management’s knowledge of off-label marketing of Nasacourt and Lovenox. The company had agreed to produce certain responsive documents. However, they refused to procure compliance documents related to drugs other than Taxotere. Regardless, the court has decreed that these documents are discoverable.

“[This evidence is] relevant to the defendants’ state of mind, motive, corporate intent, and/or reckless disregard for the truth or falsity of claims,” the motion states.

Furthermore, these documents show that Aventis violated the Federal Food, Drug, and Cosmetic Act. Gohil further contended the Nasacort, Lovenox, and Taxotere marketing directives may have come from the same management. The motion suggests a corporate culture of deceit, fraud, and corruption.

“[There is] extensive evidence of corporate goals to promote Taxotere and other drugs off-label; the use of corporate-wide kickbacks; systematic destruction of corporate records directed by the legal department to conceal off-label promotion and kickbacks, as well as obstruction of FDA inquiries,” the motion states.

Aventis Fraud Lawsuit

Gohil is joined by the U.S. in his Aventis fraud “whistleblower” lawsuit. They allege that Aventis engaged in fraudulent marketing, as well as provided illegal kickback and other illegal incentives to encourage Taxotere as a first line treatment for less aggressive cancers since 1996. Taxotere is only approved for the treatment of certain aggressive cancers when other treatments have failed.

Allegedly, Aventis trained and directed employees to misrepresent the safety and effectiveness of off-label Taxotere use. The company also paid healthcare providers illegal kickbacks such as entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and free reimbursement to get doctors to prescribe Taxotere for off-label uses.

Taxotere’s illegal promotion increased the drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. Consequently, it exposed thousands of women to the increased toxicity of Taxotere and its more severe side effects, including permanent hair loss.

Taxotere Hair Loss Lawsuits

Taxotere is a high potency breast cancer chemotherapy treatment. The drug has recently come under fire for not disclosing its severe side effects, including permanent hair loss. It has also received scrutiny from the FDA. It received a warning from the agency for claiming superiority over other treatments. However, studies clearly show less toxic treatments to be just as or more effective than Taxotere.

The number of Taxotere lawsuits continues to skyrocket as more women discover that Aventis knew about the permanent hair loss risk for more than a decade. The company updated its warning labels to include this risk in Canada and Europe in 2005 and 2012 respectively. However, it kept U.S. breast cancer victims in the dark until late 2015.

Many of these women assert that they may have chosen a different treatment if they had known about the side effects and that other, less toxic treatments were equally or more effective.

 

 

 

 

 

California Supreme Court Limits Citibank Arbitration Agreement

By Emily Cox
Citibank Arbitration Agreement Unenforceable
Photo by Mike Mozart

The California Supreme Court ruled Thursday that an arbitration agreement that waives the right to public injunction relief runs contrary to the state’s public policy and is unenforceable under California state law.

This reverses a state appellate’s 2014 interpretation that the U.S. Supreme Court’s 2011 Concepcion decision supersedes state-law arbitration rules in McGill v. Citibank, NA.

The U.S. Supreme Court’s AT&T Mobility LLC v. Concepcion 2011 ruling held that the Federal Arbitration Act preempts state-law rules that equate to an outright ban on arbitration. This struck down California’s Broughton-Cruz rule, which allowed plaintiffs to avoid arbitration in cases involving claims for relief in the form of “public injunction.” Consequently, the appeals court determined the trial judge couldn’t rely on Broughton-Cruz to deny Citibank’s bid compelling the class’ injunctive relief claims to arbitration.

Supreme Court Citibank Arbitration Agreement Opinion

However, in unanimous decision Thursday, California’s high court determined that public injunctive relief remains a remedy available to private plaintiffs under the state’s Unfair Competition and False Advertising Law, as well as its Consumer Legal Remedies Act. These legislations include clear provisions for public injunctive relief that have the primary purpose of prohibiting unlawful acts that threaten future injury to the public.

Citibank’s arbitration agreement had a provision that denied the right to seek these statutory remedies in any forum. In October 2001, Citibank changed its consumer account agreement to include these provisions.

“All Claims are subject to arbitration, no matter what legal theory they are based on or what remedy (damages, or injunctive or declaratory relief) they seek,” the terms state. This includes Claims based on contract, tort (including intentional tort), fraud, agency, your or our negligence, statutory or regulatory provisions, or any other sources of law… nor may such Claim be pursued on your or our behalf in any litigation in any court.”

Consequently, the Supreme Court held that these provisions run contrary to California protection laws. Thus, “arbitration provision here is invalid and unenforceable under state law so far as it purports to waive [the consumers’] statutory right to seek relief.”

“We further hold that the Federal Arbitration Act does not preempt this rule of California law or require enforcement of the waiver provision,” Justice Ming Chin wrote in the opinion. “We therefore reverse the judgment of the court of appeal.”

Senate Republicans Go Nuclear to Clear the Way for Gorsuch Confirmation

By Emily Cox
Republicans Get Gorsuch Confirmation by Changing the Rules
Photo by James Palinsad

Senate Republicans bypassed a precedent-breaking Democratic filibuster and deployed the “nuclear option” Thursday to change longstanding chamber rules and clear the way for President Donald Trump’s Supreme Court nominee, Neil Gorsuch, to be confirmed Friday.

Gorsuch Opposition

Democrats opposed Gorsuch for a variety of reasons. These include his conservative judicial philosophy and dissatisfaction with his confirmation hearing responses. Furthermore, there is a tangible resentment toward Majority Leader Mitch McConnell, R-KY, blocking any consideration of President Obama’s nominee, Merrick Garland, last year. After Supreme Court Justice Antonin Scalia died in February 2016, McConnell blockaded the vacancy. He claimed neither party would approve a Supreme Court justice during an election year. However, he later admitted that it was not actual policy and based on something Joe Biden once said in 1992. In an interview with NBC News, he wasn’t willing to apply the principal to all circumstances going forward either.

“We believe that what Republicans did to Merrick Garland was worse than a filibuster,” said Senate Minority Leader Charles Schumer, D-N.Y.

The Rule Change that Saved Gorsuch’s Confirmation

Under traditional Senate rules, Republicans needed 60 votes to advance Gorsuch. This means at least eight Democrats and independents would have to join the 52-seat majority. However, Republicans were unable to defect nearly enough Democrats, leaving the vote at 55-45. Instead of choosing to allow the president’s nominee to fail, the GOP chose to bulldoze a long-held Senate practice and change the threshold on Supreme Court nominations from 60 to 51 votes. This would entail a simple majority. The Senate approved the landmark rule change 52-48. All Democrats opposed it.

“They have no interest in playing by the rules,” Patrick J. Leahy, D-VT, said Wednesday. “They prefer to break them.”

This fundamentally changes one of the Senate’s most significant duties after decades of at least relative bipartisanship on Supreme Court matters. If confirmation only requires a simple majority, both parties predict that the shift will result in more ideologically extreme judges.

Senate Democrats first changed the Senate rules in 2013 to prevent Republican filibusters of presidential nominees to lower courts and other government positions. However, they left Supreme Court nominee filibusters intact to acknowledge the high court’s sacrosanct role. Now a simple majority vote can confirm all presidential nominees. This means that Senate majority all but controls which nominations are advanced, while the minority has no recourse.

While this change does not affect legislative filibuster, there is speculation that this rule change could be the beginning of the end. However, Senate Republican leaders have vowed that this will not happen under their leadership.

“I’d rather lose than be part of killing the Senate,” Sen. Lindsey Graham told Buzzfeed.

However, it seems that Republicans have taken a significant step in that very direction by refusing to lose on the Gorsuch vote.

Mylan EpiPen Recall Goes Global

By Emily Cox
EpiPen Voluntary Recall
Photo by Greg Friese

Mylan’s voluntary EpiPen recall hits stateside and abroad this week, as certain models are failing to work properly and may not deploy life-saving medication effectively.

Last week, around 81,000 EpiPen devices were voluntarily recalled in seven different countries outside the U.S, including Japan, Australia, and Norway. However, now the EpiPen recall hits stateside with the latest announcement from the FDA. In its announcement, the FDA identified 13 lots of EpiPens in the U.S. that aren’t activating correctly. This could be life-threatening for those who rely on the devices for severe allergic reactions.

Meridian Medical Technologies, which makes Mylan’s EpiPen injector, issued the voluntary recall, which includes the children’s version, EpiPen Jr.

“The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis),” the company said in a statement.

The recall will also extend to Europe, Asia, North and South America. Mylan will replace the recalled EpiPens at no cost. Consumers can contact the company on Mylan.com/EpiPenRecall for updates on product return and replacement instructions

EpiPen Recall Comes at the Heels of Price Fixing Scandal

In 2016, Mylan came under fire for raising the price of the life-saving EpiPen allergy treatment by raising its price by 500%. Critics accused Mylan and CEO Heather Bresch of taking advantage of a virtual monopoly on the allergy treatment. Congressional and public outcry forced Mylan to pay a $465 million settlement and launch a cheaper, generic version of the injection drive. Rivals and regulators have been striving to get more injectors market to lower the market price for the devices ever since.

Mylan EpiPen Recall – Affected Lots

The 0.15-mg EpiPen Jr auto-injectors affected by the U.S. recall are:

  • Lot 5GN767, with expiration date of April 2017
  • Lot 5GN773, with expiration date of April 2017
  • Lot 6GN215, with expiration date of September 2017

The 0.3-mg EpiPen auto-injectors affected by the U.S. recall are:

  • Lot 5GM631, with expiration date of April 2017
  • Lot 5GM640, with expiration date of May 2017
  • Lot 6GM082, with expiration date of September 2017
  • Lot 6GM072, with expiration date of September 2017
  • Lot 6GM081, with expiration date of September 2017
  • Lot 6GM088, with expiration date of October 2017
  • Lot 6GM199, with expiration date of October 2017
  • Lot 6GM091, with expiration date of October 2017
  • Lot 6GM198, with expiration date of October 2017
  • Lot 6GM087, with expiration date of October 2017

 

More Than 100,000 Johnson & Johnson Lawsuits Over Defective Products Stink of Corporate Corruption

By Emily Cox
Johnson & Johnson Lawsuits
Photo by Open Grid Scheduler/Grid Engine

The staggering number of Johnson & Johnson lawsuits, alleging harm from product defects, suggests that the baby powder company does care but not about people. These lawsuits indicate the company was only looking after its financial interests instead of the consumers they purport to help.

In its most recent U.S. Securities and Exchange Commission Filings, the company indicated there are almost 103,000 Johnson & Johnson lawsuits pending against five of its products. This includes 54,800 pelvic mesh lawsuits; 18,500 Risperdal claims; 16,900 Xarelto lawsuits; 9,400 Pinnacle hip replacement claims; and 3,100 talcum powder cases.

In 2016, the company lost six of the seven largest jury verdicts in the U.S. over product defects. Comparatively, companies rarely have more than two to three product defect verdicts above $20 million in any given year. Johnson & Johnson lost six of more than $50 million. The company lost all three talcum powder cases that went to trial in 2016. These included verdicts for $72 million, $70 million, and $55 million. It lost two hip implant cases, as well. One was for $1 billion, and the other was for $500 million. It also lost the largest ever Risperdal verdict for $70 million. The previous record  was $2.5 million.

While these lawsuits are for different products, they all allege that the company knew that these products were dangerous but chose to conceal the risks to continue to profit from them.

Johnson & Johnson is facing at least 17 trials in state and federal courts this year against these products.

Johnson & Johnson Lawsuits – Overview

Pinnacle hip implant cases allege that the company’s Pinnacle products fail, resulting in heavy metal poisoning, pain and additional replacement surgeries. Pelvic mesh plaintiffs claim the mesh erodes, necessitating additional surgery. Women with ovarian cancer are filing claims against the company’s flagship baby powder and Shower-to-Shower products. They allege the talc in these products caused their illnesses. Boys who took Risperdal claim the anti-psychotic drug caused them to grow female breasts. Finally, lawsuits over Xarelto allege the blood thinner can cause uncontrollable bleeding, resulting in hospitalizations and even death. Lawsuits over Xarelto have more than tripled in the past year from 5,000 to 16,900.

In all these Johnson & Johnson lawsuits, plaintiffs maintain that company knew the risks of its products but refused to disclose them, putting their own financial interests before human lives.

Johnson & Johnson denies any product liability and is refusing to settle. This isn’t necessarily because the company truly believes itself right. The longer it can draw out the process, the more likely of discouraging plaintiffs and whittling down claims.

Johnson & Johnson Lawsuits – DePuy Pinnacle Hip

The Pinnacle hip is a metal-on-metal hip replacement system. These lawsuits claim the friction from the metal components rubbing together results in the near-immediate systemic release of high level of toxic metal ions into patients’ bodies. As of 2011, there were approximately 1,086 adverse events reports with the FDA regarding failures or complications from DePuy Pinnacle devices. Despite patients reporting severe pain, complicated revision surgeries, and life-long health problems, Johnson & Johnson continues to sell Depuy Pinnacle hip replacement components.

Johnson & Johnson Lawsuits – Pelvic Mesh

Pelvic mesh, or transvaginal mesh, and bladder sling products are used to treat pelvic organ prolapse and female urinary incontinence by supporting internal organs. Ethicon is one of about a half-dozen different manufacturers of these products, facing product liability, with more than 100,000 lawsuits, alleging serious harm from the devices.

The U.S. Federal Drug Administration has received almost 130,000 adverse event reports regarding pelvic mesh products for complications including nerve damage, organ perforation, vaginal scarring, infection, severe pain, and fistulas, as well as mesh erosion and migration. Mesh erosion is one of the most serious complications related to pelvic mesh. It occurs when the mesh device moves through the vaginal wall and into other organs.

Johnson & Johnson Lawsuits – Talcum Powder

Since 1971, more than 20 studies have generated evidence that there is a significant connection between talc and ovarian cancer.  In 1993, the U.S. National Toxicology Program published a study that showed talc was a carcinogen. Consequently, numerous organizations classified talc as a carcinogen in 2006. Due to this, Johnson & Johnson’s talc supplier began including warnings with its talc shipments that same year. However, Johnson & Johnson still does not pass these warnings on to its consumers. In fact, the company specifically targets women to use it on their entire bodies, including their genital region.

Johnson & Johnson Lawsuits – Risperdal

Currently, there are several thousand pending Risperdal lawsuits against Johnson & Johnson involving the occurrence of abnormal breast growth in young men and boys as the result of taking the atypical antipsychotic. Plaintiffs claim that Johnson & Johnson and its Ortho-McNewil Janssen Pharmaceuticals subsidiary knew or should have known about the abnormal breast growth, also known as gynecomastia, risk from Risperdal and willfully decided to hide this side effect from the general public and the medical community, failing to protect the consuming public.

Johnson & Johnson Lawsuits – Xarelto

The current lawsuits against the popular blood thinners claim that the manufacturers failed to warn that clinical trials had shown more gastrointestinal bleeds and more blood transfusions with Xarelto than warfarin. Warfarin was the most popular blood thinner on the market before the introduction of Xarelto.

While manufacturers indicated that there was a bleeding risk, plaintiffs claim they were not warned that there was no antidote to Xarelto to reverse uncontrolled bleeding caused by Xarelto. Whereas, uncontrolled bleeding with warfarin can be reversed with vitamin K. Consequently, even mild bleeding incidents can become exceptionally dangerous.

 

 

 

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