Attorney Joseph Saunders Of Nationwide Law Firm Saunders & Walker P.A.

Consumer Justice Attorney Joseph Saunders Personal Injury Web Blog. Board Certified Civil Trial Lawyer by the Florida Bar Board of Legal Specialization and Education. Member of the Million Dollar Advocates Forum
 

In yet another clear sign that pharmaceutical companies are manufacturing a cure and have used the media and aggressive marketing to create a market, Clarus Therapeutics announced that they are resurrecting an IPO designed to back the launch of their new low testosterone drug Rextoro.

Clarus first mounted the IPO for Rextoro three years ago but withdrew it due to lack of market interest. Now with Low T clinics opening across the nation Clarus has mounted a bid to raise $86 million in venture capitol to launch Rextoro. In the IPO the company has announced the drug has gone through Phase III studies and was submitted to the FDA in January.

What the IPO should mention is that the FDA issued a drug safety communication in January and is currently investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products. The IPO should also mention that in recent months, two studies have linked testosterone therapy to significant cardiovascular risks, or that Public Citizen recently published an analysis of 27 studies going back as far as 20 years and of those studies, the14 that were not funded by the pharmaceutical industry showed a "highly significant" increased cardiovascular risk.

The IPO might also let investors know that lawsuits against other makers of low T drugs are being filed nationwide. They include suits against Abbott Labratories subsidiary AbbVie, the manufacturer of the popular AndroGel and Auxilium Pharmaceuticals, which manufactures the low T drug Testim. In these cases men claimed they had heart attacks and/or strokes after taking the drugs.

With the annual market for low T drugs estimated at over $2 billion, Clarus makes clear with this resurrected IPO that they want a piece of the action. No matter the risks to patients, the profits are simply too great.

In the last 10 years drug companies have shamelessly marketed their testosterone-boosting drugs to doctors and the public, promoting it as a product that can overcome a supposed disease called "low T." Never mind that low T isn't actually a disease or that the symptoms are all just natural common problems associated with aging, the makers of these dangerous drugs would have you believe there is a new low T epidemic.

Now millions of American men are risking their health and resorting to testosterone drugs as lifestyle drugs out of simple reluctance to accept the fact that they are getting older.

There is no fountain of youth. Clarus and all of the other manufacturers of low T drugs know this. But with the market at $2 billion and climbing they are going to everything they can to convince men otherwise - regardless of how dangerous these drugs may be.

Everyone in Florida is required by law to have Personal Injury Protection (PIP) automobile insurance. PIP is your personal policy for medical coverage for up to $10,000, whether you are at fault or not. Seems simple, but is it?

Not really. If your injuries are not reported by a medical doctor to be emergency-related medical condition, PIP only pays up to $2,500. To make matters worse, if you do not see a medical doctor or go to a medical facility within 14 days of your accident, your PIP claim can be completely denied. We are fighting to repeal this law, but until we succeed, this is Florida Law.

Auto Accident Medical Claims Exceeding PIP Coverage

Some auto accident victims sustain injuries which exceed $10,000 in medical treatment. Who is responsible and who is entitled to coverage?

Who is responsible for your injuries which exceed your personal injury protection coverage? Routinely, the at-fault driver is responsible for your injuries which exceed your PIP under their bodily injury coverage. A driver, such as you or any other driver, proven to be at fault is not entitled to any other driver's bodily injury coverage. However, bodily injury is not mandatory under Florida law. Uninsured/Underinsured motorist coverage is also not required by Florida law.

However, if you have it, this is when it comes in to play.
Also, what if more than one driver is involved, or a driver of one vehicle is insured with his/her own insurance, but is driving someone else's vehicle who is also insured?

And what about property damage?

Not so simple anymore, and before you get a chance to sort it all out, the insurance company is requesting your statement to record.

Before you leave all in the hands of insurance company or companies, you should know that the job of insurance companies is more than just to provide coverage due you, but also to save money for its shareholders. This means that they will search for loopholes seeking ways to cut their losses. Sometimes, these loopholes are found through inadvertent statements made by one or more party, or simply by a claimant's lack of knowledge of their rights.

Call us at (800) 748-7115 if you would like help in unraveling the complicated legal process of Florida automobile insurance law.

It was announced last week that Stephen Nichols, of Fort Collins CO, is planning to sue Abbott Laboratories subsidiary AbbVie, the manufacturer of the popular testosterone treatment AndroGel. Nichols joins the growing number of suits being filed against the makers of AndroGel including ones already filed in Illinois and Lousiana.

Nichols suffered a heart attack after he was prescribed AndroGel to treat low testosterone. It was only after the heart attack that he learned the FDA is investigating the safety of testosterone treatments. Recent studies have also linked the treatments to an increased risk of strokes, heart attack and death.

But even with the FDA investigation and studies linking testosterone treatment to health dangers, Low-T clinics are spring up across the nation. Turn on the television and be prepared for a barrage of ads warning men against the dreaded "Low-T." Many health professionals consider Low-T" to made-up disease, used to scare men into taking testosterone supplements. According to the marketing Low-T is characterized by feelings of fatigue, loss of sexual drive, depressed moods, and an increase in body fat and decrease in muscle strength, among other symptoms - all common problems associated with aging. As a result millions of American men have begun resorting to testosterone drugs as lifestyle drugs out of simple reluctance to accept the fact that they are getting older.

What the television advertisements for Low-T never mention is that often there are complex medical problems that masquerade as low energy and decreased sex drive. Those can include sleep apnea, depression and, heart disease.

There have been calls for closer scrutiny of testosterone treatments yet Low-T clinics continue to draw thousands. The drug companies are waging an all out media blitz to convince American men they need to be treated for Low-T, and it is working. Sales of Low -T drugs have tripled in the last ten years.

There are valid medical reasons to prescribe testosterone treatment, but the supposed "Low-T" isn't one of them. It is a marketing tool the drug companies have created and continue to use with great effect. In spite of the dangers, they still continue to place their profit margin above the health of the patients they serve.

Father Greg Reynolds of Melbourne, Australia publically advocated for the ordination of women and was excommunicated by Pope Francis.

Father Carlos Urrutigoity was accused of molesting boys in Shohola and Moscow, PA, and was transferred to a parish in Paraguay - where he now holds the number 2 position in his diocese.

Neither of these cases surprises me, nor did the testimony of the Vatican's U.N. ambassador to the U.N.'s Convention Against Torture in Geneva yesterday. When pressed about the Catholic Church's responsibility in cases of priests sexually abusing children, Archbishop Silvano Tomasi responded strongly, "It should be stressed, particularly in light of much confusion, that the Holy See has no jurisdiction over every member of the Catholic Church."

Tomasi continued "The Holy See wishes to reiterate that the persons who live in a particular country are under the jurisdiction of the legitimate authorities of that country and are thus subject to the domestic law and the consequences contained therein. State authorities are obligated to protect, and when necessary, prosecute persons under their jurisdiction."

Tomasi might have well told the U.N. Committee, "It's not our problem."

The difficulty here is in understanding how a church insists on total jurisdiction over all doctrinal issues, but then claims none when the shepherds of the faith sexually abuse children?

There has been much attention paid to Pope Francis since his ordination. He has publically apologized to the victims of sexual abuse, and established a Vatican committee to look into the problem of sexual abuse by priests. But apologies do little to help victims or prevent further abuse, and the Vatican Committee on Abuse has done nothing to date.

Which is why Tomasi's testiomony before the U.N. came as no surprise. Since the ordination of Pope Francis the Vatican has waged an all out PR war in trying to convince the world they want to fight sexual abuse. In reality they have done very little, and Archbishop Tomasi put the world on notice yesterday that it is back to business as usual.

If you are in the employ of the Catholic Church and speak out in support of gay marriage, the ordination of women, or birth control you will lose your job.

If you rape a child, you can put in for a transfer.

On April 24, 2014, Zimmer Holdings announced that it will purchase Biomet, Inc., for $13.35 billion. The sale is expected to go through by the first quarter of 2015.

Zimmer Holdings has agreed to include Biomet's "net debt" in the purchase. In the meantime, Biomet is being sued nationally and globally over its Magnum M2a Hip Replacement System. The pending sale may be one reason Biomet agreed to a $56 million settlement of all its U.S. Magnum M2a lawsuits in an effort to reduce its net debt.

Despite the push-back from Plaintiffs' attorneys and injured consumers, ASR DePuy & Stryker have managed to add rigid conditions into their settlement agreements. Some of these conditions are reductions to each Plaintiff's settlement determined by weight, history of smoking. Another factor that may be considered is whether or not the patient has had the original implant replaced. Biomet is expected to follow along the same lines, although the specific conditions are not yet known.

Biomet is the medical device manufacturer of the M2a Magnum Hip Replacement System. The M2a Magnum is a metal femoral head and metal pelvic cup system. Lawsuits against medical device manufacturers who market metal-on-metal hip replacement systems have been rising globally. Many of those devices have been recalled and most that have not are not now being implanted by physicians.

Metal-on-metal hip replacements may cause your blood to contain dangerously toxic levels of metal. Ask your doctor to order blood tests to determine your cobalt and chromium levels.

There are three indications for surgery to remove and/or replace a defective metal-on-metal hip replacement product:
1. Pain
2. High levels of Cobalt and Chromium in the blood
3. MRI showing fluid build-up or pseudo tumor of the hip.

If you are having problems with a hip implant and know or suspect it to be a recalled product, please call (800) 748-7115.

The New York Times reported yesterday that Endo International agreed to pay $830 million to resolve legal claims from women who say they were injured by transvaginal mesh devices marketed by the company..

The company still refuses to admit liability or fault for the defective devices, but announced that the agreement would cover most of the mesh litigation brought against its American Medical Systems subsidiary.

The claims Endo is agreeing to settle are among thousands that have been filed against medical device makers. Along with Endo and American Medical Systems, suits have been brought against C.R. Bard, Boston Scientific, and Johnson & Johnson's Ethicon unit.

These lawsuits have been filed across the country by thousands of women who suffered horrific complications following implantation of pelvic mesh during uro-gynecological surgeries to treat pelvic organ prolapse and stress urinary incontinence.

Last year Endo agreed to pay $54.5 million to settle an undisclosed number of mesh cases, and indicated in their most recent SEC filing - that Endo and American Medical together face about 22,000 lawsuits over the devices.

Endo and the other manufacturers of transvaginal mesh continue to deny responsibility for the horrible problems experienced by women who have received their faulty devices. Yet Endo is willing to pay almost $900 million to victims, and still try and maintain the façade that they are neither liable or at fault?

How many more women will have to suffer? How much money will it take for Endo to admit they sold a dangerous product that was defectively manufactured and inadequately tested?

Stryker SEC pt. 1

Reading through Stryker's 2013 SEC report, I was shocked to find this in the Risk Factors section on page 5,

We may be adversely affected by product liability claims, unfavorable court decisions or legal settlements. Our business exposes us to potential product liability risks that are inherent in the design, manufacture and marketing of medical devices, many of which are intended to be implanted in the human body for long periods of time or indefinitely.

What troubles me most are terms like "adversely affected" and "risks that are inherent" that attempt to downplay the catastrophic failure of their Rejuvenate and ABGII hip replacement systems, and summarily discount the pain and suffering of the 30,000 people worldwide who received the defective implants.

Patients in the U.S. account for 20,000 of these faulty implants which Stryker recalled in 2012 after they were found to be prone to corrosion, joint dislocation, and the release of metal ions which can cause metallosis, tissue inflammation, necrosis and death. Doctors who have performed hip replacements with the Stryker implants have been shocked at the failure rate, which has been predicted by some to go as high as 70 percent. This could mean that in the U.S. alone, 14,000 patients might be required to undergo painful revision surgery on top of the excruciating complications they've already endured.

The Stryker Rejuvenate and ABGII hip prosthesis recall are part one of the more serious medical device failures in recent history. Metal-on-metal hip joints have failed at catastrophic rates. The DePuy A.S.R. was the first to be recalled in 2010. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty and Lineage are also failing at unacceptably high rate.

The failure of Stryker's recalled Rejuvenate and ABG II modular-neck hip implant products has since led to hundreds of lawsuits being filed and urrently they are moving forward in a consolidated litigation in New Jersey's Bergen County Superior Court and in U.S. District Court, District of Minnesota.

These lawsuits and the horror endured by thousands of patients come as a direct result of the negligence of Stryker Corp., who upon the recall admitted that the artificial hips were subject to fret, corrode, loosen and ultimately fail.

So yes, I find it troubling when Stryker, a company whose net earnings in 2013 topped $1 billion, can diminish the pain and suffering of thousands of patients to something so simple as "inherent risk"

CDC cost of child abuse

$124,000,000,000

That figure represents what one year of child abuse cases will cost the United States according to the Centers for Disease Control. For context, consider how that dollar amount is more than the annual budgets for 47 of our 50 states.

It may seem crass to speak of child abuse in financial terms but money talks, and perhaps if a cost is put on the long-term damage child abuse does to our society, it will finally become a public health priority.

Public health policy has long been dominated by discussions of the untold human misery diseases cause in tandem with the economic costs they inflict on society. There needs to be these same types of discussions in the fight against child sexual abuse and it needs to be made crystal clear that the horror of child abuse affects us all, whether we choose to admit it or not.

In the CDC report, they found that children who survive neglect, physical abuse, psychological abuse or sexual abuse cost the country an estimated $210,012 during their lifetimes. Those costs come from increased strain on the country's criminal justice, education, health care and welfare systems. An abuse-related death costs the country an estimated $1.27 million, most of which comes from "productivity losses."

Billions are spent each year successfully reducing the incidences of cancer, heart disease, smoking, and diabetes. The money is spent in an effort to give people not only a better quality of life, but also with the knowledge that the money being spent now will save having to invest more in the future.

The CDC's findings illustrate how important it is to understand the entire impacts and costs of child abuse. The abuse is can be prevented, but only if it is treated like the public health crises it is and resources are pledged to fight it.

The CDC report mirrors recent similar findings by the Catholic Church. A 2013 audit presented to the U.S. Conference of Catholic Bishops revealed that in the ten years prior the Church spent a total of $2,744,876,843 in costs related to abuse allegations, which includes settlements, therapy for victims, support for offenders, attorneys' fees, and other costs.

After generations of dismissing allegations of sexual abuse by clergy and sheltering pedophile priests in their midst, the Catholic church has begun to take steps to fight child *sex* abuse. I have no doubt the realization they have spent almost $3 billion in the U.S. alone has been a prime motivation.

Child abuse needs to be a public health priority and the number one social challenge of our day. Prevention, offender treatment, and public education demand resources and this CDC report illustrates all to clearly that if we don't pay now - we will pay dearly later.

Pope Francis Apology

On Friday April 11, shortly before the beginning of Holy Week, Pope Francis did what no Pope before him has ever done and took personal responsibility for the pedophile priests that have plagued the Catholic Church.

In remarks made at his library in the Vatican to members of a Catholic nongovernmental organization, the International Catholic Child Bureau, the Pope for forgiveness and pledged to impose penalties on "men of the church" who have harmed children.

The Pope's comments are a positive step, but how much change in the church will they really bring? His words mean little to the children who are still being abused by priests around the world. If the Pope is sincere about wanting to end the epidemic of sexual abuse by priests he needs to take immediate action. The Vatican still refuses to open its archives and release records on abusive priests. The Vatican still refuses to fully expose the Bishops who sheltered abusive priests from prosecution and are thereby complicit in the abuse.

Since becoming Pope Francis has been lauded for his actions on fighting abuse - these comments, the creation of a committee to advise the church on how to protect children - but he has not taken one concrete step that has resulted in protecting children or exposing predators. Meanwhile the plague continues and the children abused by priests in recent cases uncovered in Puerto Rico, New Jersey and Milwaukee are unlikely to find much comfort in the Pope's comments.

Critics note that Francis' approach to dealing with the abuse scandal is evolving, but the church doesn't need evolution, it needs action. Lest anyone forget that since becoming Pope, he has refused to meet with abuse victims, been roundly criticized for his inaction by the United Nations, and last month complained to an Italian newspaper that the church has been unfairly attacked for its response to sexual abuse cases.

By simply asking for forgiveness Pope Francis is doing more than his predecessors, but it is still not enough. The church needs to take action and open records, identify abusive priests and complicit bishops. Children don't need forgiveness, they need to be protected.

Risperdal AK

This week Arkansas Attorney General Dustin McDaniel asked for the reinstatement of a $1.2 billion Risperdal fine overturned by the state's Supreme Court last month. The associated press reported on April 3rd that Attorney General Dustin McDaniel told the Arkansas Code Revision Commission on Thursday that he would file a petition asking the Court to revisit the decision.

In the petition McDaniel said that justices did "significant harm" to the state and broke from 170 years of precedent. The $1.2 billion verdict had been levied against Johnson & Johnson and its Janssen Pharmaceuticals unit in April 2012, after an Arkansas jury found that the companies had violated state laws governing Medicaid fraud and deceptive trade practice by improperly marketing Risperdal. The Supreme Court overturned that verdict last month claiming that McDaniel's office had misapplied the state's Medicaid fraud law.

It was the marketing of Risperdal for off-label uses that was at the center of the Arkansas suit. Johnson & Johnson admitted that they had deceptively marketed Risperdal. This included marketing the drug - which had originally been approved as an anti-seizure medication - to treat ADHD in childen and dementia in elderly patients. This came even after internal research at J&J showed that the drug heightened the risk of strokes in the elderly and boys and men at risk of developing gynecomastia - the development of breasts.

The Arkansas lawsuit wasn't the first time the company's questionable marketing techniques had come under fire. Last November the global health care giant agreed to pay more than $2.2 billion - one of the largest health-care fraud settlements in US history - to settle allegations that it misrepresented drugs and used kickbacks to promote the sales of the antipsychotic drugs Risperdal and Invega -- as well as the heart drug Natrecor.

Johnson & Johnson has shown repeatedly that it will continue to place profits before the welfare of its patients and go to great lengths to keep justice from being served. In filing to reinstate the $1.2 billion Risperdal fine, Arkansas Attorney General Dustin McDaniel is sending a clear message to the company that his first concern is the safety of the state's citizens.

Actos Verdict

On Tuesday April, 8, a Louisiana Jury ordered drug makers Eli Lily and Takeda Pharmaceutical Company to pay a total of $9 billion in punitive damages after they judged the companies did not disclose known cancer risks of their diabetes medicine Actos. In the award, Japan-based Takeda was ordered to pay $6 billion, and Eli Lilly, which helped promote and market the drug, was ordered to pay $3 billion. The jury also awarded nearly $1.5 million to the plaintiffs in compensatory damages.

The prescription drug pioglitazone, which was sold under the name Actos, was prescribed to treat patients with Type 2 Diabetes. An FDA review in 2011 discovered that patients taking Actos for more than a year had an increased risk of bladder cancer. That same year the drug was banned in several European countries over the same concerns.

Former Actos user Terrence Allen, who blamed the drug for his bladder cancer, brought the lawsuit. According to court dockets, more than 2,700 more Actos suits have also been consolidated before U.S. District Judge Rebecca Doherty in Louisiana for pretrial information exchanges.

I believe this verdict handed down by the Lousiana jury sends a clear message to more than just Takada and Eli Lilly. It puts all pharmaceutical companies who sell drugs in the United States on notice that the health and safety of Americans is paramount to profits.

Takeda had downplayed rising concerns about the risk of bladder cancer in patients taking Actos. In 2004, experts showed a clear cancer link, yet it wasn't until 2011 that Takeda began to provide a specific cancer warning for Actos. E-mails released in the trial showed company executives dragging their feet with the warning because the profit stream from Actos was "vital to the company's survival."

Even more disturbing was the lengths the company went to to hide their actions regarding Actos. The trial revealed that corporate officers at Takeda intentionally destroyed documents about the development, marking and sales of Actos - including those of top executives in Japan and the U.S.

It is the duty of every pharmaceutical company to produce safe products and warn doctors and patients of any adverse health effects their dugs may cause. Takeda and Eli Lilly violated these duties and caused irreversible harm and suffering to the patients taking Actos. The damages awarded by the Louisiana jury send a clear message that the time has come to pay for their misdeeds.

FL MedMal cap

On March 13, the Florida Supreme Court overturned the centerpiece of the 2003 medical malpractice overhaul law. In the opinion the court strongly criticized the Florida Legislature and even went so far as to accuse them of creating an "alleged medical malpractice crisis."

The justices ruled in the 5-2 opinion that Florida's controversial 2003 medical malpractice reform violated survivors' equal protection rights, because hard caps on noneconomic damages were limited to no more than $1 million in the event of a death or permanent vegetative state -- regardless of the number of practitioners or survivors.

The 2003 law limited individual family members to damages not determined by the actual pain and suffering they endured but rather by how many other relatives were also entitled to part of the $1 million in noneconomic damages. When multiple parties were found at fault the burden was even further lessened - regardless of severity - because there were more parties to contribute toward the damage award.

The Court struck down the law on equal protection grounds, with Justice Fred R. Lewis writing for the majority, "We hold that to reduce damages in this fashion is not only arbitrary, but irrational, and we conclude that it 'offends the fundamental notion of equal justice under the law.' "

Former Governor Jeb Bush had pushed for the damage caps in 2003 at the behest of insurance companies, hospitals, and doctors. In spite of being warned by legislative staffers that the bill might implicate equal protection concerns under the Florida Constitution. Bush was adamant and argued then that the reforms were needed to curb the explosion of medical malpractice costs.

The Court was specific in refuting these claims and wrote, "...the finding by the Legislature and the Task Force that Florida was in the midst of a bona fide medical malpractice crisis, threatening the access of Floridians to health care, is dubious and questionable at the very best."

The Court then went even further and noted that between 2003 and 2010 there were four medical malpractice insurance companies with an increase in their net income of more than 4300 percent. "The insurance industry should pass savings onto Florida physicians in the form of reduced malpractice insurance premiums," the court wrote regarding their inflated incomes.

The irony was that in spite of the damage caps designed to control malpractice insurance, premiums have continued to rise dramatically. This was not lost on Judge Lewis, who concluded that, "it's not even clear doctors got rate relief due to the law's caveats that allowed insurance companies to keep raising rates."
According to the Florida Justice Association there are currently more than 700 medical malpractice cases pending statewide. This decision by the Florida Supreme Court will ensure that the survivors of these victims, and those of future victims of medical malpractice will be given damages commensurate with their actual pain and suffering, and not just a fixed amount based on the number of survivors.

Androgel

Shortly after the FDA announced last month that they were investigating the safety of testosterone therapy drugs five men filed claims against an Abbott Labratories subsidiary AbbVie, the manufacturer of the popular AndroGel. Three of the men claimed they had heart attacks and two had strokes after they began taking AndroGel. 

Another case was recently filed in California federal court in which a male patient alleges he suffered a stroke after taking the testosterone therapy drug Testim.

In recent years drug companies have heavily promoted testosterone replacement drugs as a product that can overcome a supposed disease called "low T." According to the marketing low T is characterized by feelings of fatigue, loss of sexual drive, depressed moods, an increase in body fat and decrease in muscle strength, among other symptoms - all common problems associated with aging. As a result of this aggressive marketing American men have resorted to testosterone drugs as lifestyle drugs out of simple reluctance to accept the fact that they are getting older . 

The FDA alert FD said it was investigating the risk of stroke, heart attack and death in men taking testosterone drugs based on the recent publication of two studies that suggested increased cardiac risk. 

The consumer advocacy group Public Citizen has gone even further and petitioned the U.S. Food and Drug Administration to add a black box warning, the most serious possible, to the product labels of the drugs. Their petition was based on the growing body of evidence of the risks of heart attacks and other cardiac dangers from studies dating back to 2010 and a recently published analysis of 27 studies going back as far as 20 years. According to Public Citizen, of the 27 studies, 14 that were not funded by the pharmaceutical industry showed a "highly significant" increased risk,. Drug companies funded thirteen and those studies showed no increased cardiovascular risk. 

Bowing to pressure the FDA has soft pedaled the alert and said it has not concluded that testosterone does, in fact, increase heart problems. A senior adviser at Public Citizen's health group, Dr. Sidney Wolfe, claims the the FDA's statement is "reckless" and "a betrayal of the FDA's role as an agency in the U.S. Public Health Service."treatment increases the risks of cardiovascular diseases, including heart attacks," he said. 

In spite of this evidence, each day almost 13,000 prescriptions are filled for testosterone replacement drugs. In 2012, more than 5.5 million men filled prescriptions for low-T drugs like AndroGel, Axiron, Testim and AndroDerm. AbbVie Inc's AndroGel, the market leader, generated about $1.2 billion in sales. 

With that kind of money at stake it is not surprising that drug companies willcontinue to promote the fake disease "Low T", and market these dangerous drugs as a cure. Your health is a only secondary concern to their bottom line.

Recently I had the opportunity to address the court on behalf of a 28-year-old victim whose images of childhood sexual abuse were among those discovered on the computer of child porn trader Michael D Meister.

On December 20 Meister was sentenced in Federal Court to seven years in prison for collecting and sharing child pornography. But it was also ruled that Meister, who has high-risk multiple myeloma, a blood cancer, would be allowed to remain free during appeal.

Speaking on behalf of one of the victims I sought restitution for a young man whose life has been devastated by graphic photos and videos of him being sexually abused as a boy of 12 to 14. The victim suffers from panic attacks, sleep disorders, rarely leaves home, and is unable to afford private counseling.

Initially U.S. District Judge Richard A. Lazzara indicated that he didn't think the 11th circuit court allowed restitution for such victims. But I was able to locate other cases where restitution was permitted. To avoid rescheduling the sentencing hearing to accommodate a restitution hearing Meister, through his attorney, agreed to pay $25,000 to the victim.

Under a 1994 Federal statute full restitution is mandatory in cases involving the sexual exploitation of minors. The law lists examples of qualifying losses as psychological care, lost income, and attorney fees. The last item listed is "any other losses suffered by the victim as a proximate result of the offense." This phrase has been interpreted differently in Federal courts.

At question is whether the collective viewing of child pornography causes all losses, or does each individual viewing or sharing child pornography cause them. Federal courts have interpreted the phrase both ways and the Supreme Court is set to hear arguments later this month regarding the issue.

As an advocate for the victims of childhood sexual abuse I believe that every individual who views or trades child pornography should be prosecuted and held liable for the damage they inflict. In a masterful Tampa Bay Times profile of the victim in this case, writer Patty Ryan shows how the victim continues to be tormented over a decade after the abuse occurred. His photos still circulate on the Internet and each week he receives between 10 to 30 victim notices he can barely force himself to go through. Worldwide, thousands of people have been caught with images of this victim and each time it happens he has to relive that horror all over again. He questions if the nightmare will ever end. Because of this he hasn't been able to hold a steady job, dropped out of college, and is reluctant to form friendships out of fear that he will have to divulge his past.

Meister remains free, and in spite of having multiple cars and a boat registered in his name, pleaded poverty and the Judge's order allows for a $100 per month payment plan. His first payment to the victim, due on January 1, was late.

Meanwhile the victim is still unable to afford private counseling.

Pope Francis Sexual Abuse

Early December 2013 was the first time Pope Francis publicly discussed the issue of sex abuse by clergy. In a meeting with Dutch Bishops he expressed sympathy for victims.

"I promise compassion and prayer for every victim of sexual abuse and their families," the Pope told the prelates in remarks prepared in French.

While the Pope offers compassion for the victims of sexual abuse, I find it

disturbing that he makes no mention of prosecuting members of his own

church who have perpetrated these heinous crimes. Prayer is simply not

enough. The victims deserve justice and the Catholic Church needs to end

the plague of sexual abuse committed by its own clergy. If the Pope is truly

sincere, there needs to be an investigation of every Cardinal, Archbishop,

and Bishop who have been complicit in covering up abuse, protecting

predator priests, and exposing children to dangerous priests.


Pope Francis has been vocal in his opposition to poverty, inequality, and

global capitalism. But after eight months as Pope, it is shocking that these

short remarks in the Netherlands mark the only time he has spoken about the

biggest crisis facing the church.


As if to further underscore the Pope's failure, on the same day he was

speaking to the prelates in Holland the Vatican officially refused to provide

information requested by the United Nations on the alleged sexual abuse of

children by Priests, nuns, or monks.


In July the UN Committee on the Rights of the Child put a wide-ranging

questionnaire to the Holy See - the city state's diplomatic entity - asking

for detailed information about the particulars of all sexual abuse cases

notified to the Vatican since 1995. The questions included whether priests,

nuns and monks guilty of sexual crime were allowed to remain in contact

with children, what legal action had been taken against them, whether the

Church required clergy to report abuse to secular authorities and whether

complainants were silenced.


The Holy See responded by insisting that it was "separate and distinct"

from the Roman Catholic Church, and that it was not its practice to disclose

information about the religious discipline of clergy unless specifically

requested to by the authorities in the country where they were serving.

The irony is that on every other issue the Vatican insists on operating firm

command and control structure over the worldwide Church. Only when

confronted about the sexual predators within the church - and how the

Catholic Church has sheltered them - do they attempt to obfuscate and defer

to local authorities.


If Pope Francis intends to make headway on the child sex abuse crisis in the

Catholic Church he must offer more to the victims than prayers. He must

offer them justice, and the promise that these horrible crimes never happen

again.


For More Information About Catholic Church Sexual Abuse And Molestation Please Visit:

Abuse Advocate - Priest Sexual Abuse And Molestation Lawsuit

www.abuseadvocate.com

stryker hip lawsuit.jpg


There has been an increase in filings in product liability lawsuits against Stryker Orthopedics over the Rejuvenate and ABG II modular neck hip implants. These hip implants were recalled on July 6, 2012. The Stryker Rejuvenate and ABG II were not strictly speaking metal on metal implants because they have a polyethylene on metal interface between the cup and the ball. However, these implant are causing injuries to the hip tissue from metallosis just like the metal on metal implants such as the DePuy ASR, the Wright Converse and the Biomet Magnum.

The recalled Stryker hips leak metal from the joints in the modular neck where it connects with the ball and the modular neck where it is inserted into the femoral stem. The surgeries required to replace the Rejuvenate and the AGB II are more extensive that the surgery required to revise the other types of hips because with the Stryker implants the femoral stem has to be removed frequently requiring an osteotomy which is a splitting of the femur to get the stem out.

Lawsuits are being filed both in New Jersey State Court where Stryker is located and in a national federal litigation assigned to Minneapolis. Set forth below is a sample of one of the lawsuits filed in federal court against Stryker.

Please click the following link to view the actual PDF file:

Stryker Rejuvenate and ABG II Modular Neck Lawsuit PDF File

http://www.strykerrecallattorney.com/stryker-lawsuit-docs/Stryker-Rejuvenate-Lawsuit.pdf

Pradaxa Drug Side Effects

Since the FDA approved the blood-thinner Pradaxa in 2010 the drug has

come under scrutiny for adverse bleeding events. In the United States the

drug has exceeded $2 billion in sales. But out of the 850,000 patients it has

been prescribed to it has also been linked to more than 1,000 deaths.

When it was first approved, Pradaxa was the first in a new category of

replacements for Warfarin (Coumadin), the decades-old drug used to prevent

strokes in people with a heart-rhythm disorder known as atrial fibrillation.

Patients prescribed Warfarin needed to be monitored closely, undergoing

frequent blood tests to ensure the drug was working. Pradaxa required

no monitoring and in early tests it appeared to be better than Warfarin at

presenting strokes.

But almost immediately after the drug started being prescribed doctors

and patients became concerned about its safety. In 2011, 542 deaths were

reported to the FDA in which Pradaxa was suspected as the cause. The

nonprofit Institute for Safe Medication Practices listed Pradaxa as the

leading cause of injury or death out of the more than 800 drugs it monitors.

Most alarming to critics is that Pradaxa was released with no antidote

available to stop its side effects. Warfarin could be reversed with vitamin

K or other substances, and while still deadly at times, still gave doctors

options. Pradaxa offered no antidote or options and doctors described being

helpless as they watched patients bleed out in front of them.

Now it has been reported (New Emails in Pradaxa Case Show Concern

Over Profit, Feb. 7, 2014), that employees of Boehringer Ingelheim, the

German drug maker who makes Pradaxa were privately expressing concern

whether sales would suffer if patients knew they might need to undergo

regular testing for safety reasons.

The company e-mails were ordered released by Chief Judge David R.

Herndon, of the United States District Court in East St. Louis. Herndon is

overseeing thousands of lawsuits filed by patients and families who claimed

Boehringer Ingelheim failed to properly warn them about the risks of taking

Pradaxa.

In light of early concerns after Pradaxa's release, Boehringer Ingelheim had

conducted internal testing that showed some patients using the drug would

benefit from closer monitoring of their blood. By monitoring absorption

levels of the drug, the safety of the patients would be better ensured. These

conclusions caused a robust discussion within the company, with employees

expressing concern that - since no testing was a major marketing point - by

recommending testing of patients sales would suffer.

What is abundantly clear in all the company e-mails released is that the

employees of Boehringer Ingelheim were - in spite of over 1000 deaths

linked to Pradaxa - more concerned with sales and profit than they were

about the safety and welfare of the patients they served.

heart attack lawsuit.jpg

A recent study has provided new evidence that widely prescribed testosterone drugs Androgel and Axiron - advertised as a way to help men improve a low sex drive and reclaim diminished energy - might increase the risk of heart attacks.

The new study, conducted by researchers at the University of California, Los Angeles; the National Institutes of Health; and Consolidated Research, was published last week in the online journal PLoS One. The study provides compelling evidence that testosterone is being overprescribed to American men and that pharmaceutical companies continue to aggressively market the drug in spite of dangerous side effects associated with it.

In an excellent piece in the New York Times by Roni Caryn Rabin, (Weighing Testosterone's Benefits and Risks, Februry 3, 2014), she outlines how testosterone replacement drugs for men have been heavily promoted by drug companies in a manner that is eerily reminiscent of how hormone replacement drugs (estrogen) for women were aggressively marketed before a federal study in 2002 showed how dangerous they were.

Testosterone has traditionally been prescribed to treat abnormally low levels of the hormone because of genetic or pathological causes, a condition known as hypogonadism. But in recent years drug companies have begun to shamelessly market their testosterone-boosting drugs to doctors and the public, promoting it as a product that can overcome a supposed disease called "low T." According to the marketing low T is characterized by feelings of fatigue, loss of sexual drive, depressed moods, an increase in body fat and decrease in muscle strength, among other symptoms - all common problems associated with aging.

As men age, their production of natural testosterone declines - approximately 1 percent per year after age 30 - but it is rare for testosterone levels to drop low enough to become a medical problem. Instead, millions of American men are resorting to testosterone drugs as lifestyle drugs out of simple reluctance to accept the fact that they are getting older .

Drug companies have seized on this insecurity and waged extensive marketing campaigns designed to help men fight the dreaded "low T." This has led to a tripling of the number of testosterone prescriptions given to American men since 2001. Physicians are now more willing to prescribe testosterone to people who don't fit the classical diagnosis of hypogonadism and have only borderline low levels that may be related to normal age-related hormonal declines. Many of these prescriptions are given without ever determining the patient's hormone levels and one in four prescriptions are given without a blood test.

The study released in PLoS One found taking testosterone replacement drugs caused dangerous health problems. Within three months, taking the hormone doubled the rate of heart attacks in men 65 and older, as well as in younger men who had heart disease. In light of this study, and a similar one conducted in 2010 officials at the Food and Drug Administration announced that they were reassessing testosterone replacement products and will begin investigating rates of stroke, heart attack and death in men using the drugs.

Indeed the 2010 study was actually cancelled early because of risk to patients. William Finkle, lead author the newly released study wants the FDA to require warnings on the labels of testosterone drugs such as Androgel and Axiron. "We have a 2010 study that was canceled because of unexpected cardiovascular risks. I think that was sufficient to justify a warning. Why withhold that from the patient?" he asks. At the very least he thinks the risk of heart attack should be added to the discussion between patients and physicians before anyone starts testosterone treatment.

Drug companies have reacted predictably and shown they continue to place profits above the welfare of their patients. Advocates of testosterone therapy immediately attacked the study and claimed the evidence of risks was overblown. They also criticized the new study for not following patients long enough and encouraged a long-term study. This would be in their best interest to have a trial continue for years since it would allow them to continue to market and sell testosterone replacement drugs.

The stakes are high, testosterone drugs routinely average $300 to $400 a month per patient. Drug companies frequently offer to cover patients' insurance copayments and often give away the first month's supply. Sales of all testosterone-boosting drugs are estimated to have been $2 billion in 2012, and are projected to hit $5 billion by 2017.

What the drug companies never mention in their marketing is that there are other factors aside from aging that cause a decline in testosterone levels. Chief among them are being overweight and lack of exercise. According to the New York Times, "Losing weight is a tried and true way to naturally boost testosterone levels. According to findings presented at the annual meeting of the Endocrine Society in 2012, obese men who lost an average of 17 pounds saw their testosterone levels increase by 15 percent. In general, a man's waist should be half his height."

Instead of promoting a healthy lifestyle the drug companies will continue to promote dangerous drugs for a trumped up disease.

The profits are better.

Please click here to read more

http://www.saunderslawyers.com/practice-areas/harmful-drugs/androgel-side-effects.html

http://www.saunderslawyers.com/practice-areas/harmful-drugs/axiron-side-effects.html

Januvia and Byetta are two of the most popular drugs on the market prescribed to treat type 2 diabetes. But ever since their introduction reports of dangerous side effects including pancreatitis and pancreatic cancer have surfaced. These reports spurred concerns of whether the drugs risks outweigh their effectiveness and have led to numerous lawsuits being filed against the drug makers.

This week the American Diabetes Association (ADA) called for a new evaluation of the clinical data on many of the popular drugs used to control blood sugar in patients with type 2 diabetes. These drugs include Merck & Company's Januvia , Novo Nordisk's Victoza, Byetta and Onglyza from Bristol-Myers Squibb, and AstraZeneca Plc, among others, and have sales of more than $9 billion annually

The new evaluation is based on the research of Dr. Peter C. Butler, chief of the division of endocrinology at the University of California, Los Angeles. In his study, and in follow-up studies he found worrisome changes in the pancreases of laboratory rats used in the study that could lead to pancreatic cancer. Based on his studies, both the FDA and the European Medicines Agency have also begun investigations that could lead to new warnings on the drugs, or even to their removal from the market.

Since being approved - Byetta in 2005 and Januvia in 2006 - the FDA has issued warnings about potential links between the drugs and serious complications such as pancreatic diseases but the drugs were allowed to remain on the market and continue putting patients at risk.

Hundreds of thousands of people have been prescribed these drugs, with Januvia and Byetta being the two most popular. The high incidence people who took the drugs and then developed pancreatic diseases has since led to numerous lawsuits being filed nationwide against the drug's manufacturers.

In California there are so many cases on file that the U.S. District Court for the Southern District of California has grouped more than a dozen of the cases together for discovery. In the cases the plaintiffs allege that that Merck, Amylin and Eli Lilly failed to exercise reasonable care and created unreasonable risks of personal injury to others. They also go on to allege that the drug makers knew or should have known that the drugs created a high risk of unreasonable, dangerous side effects, including causing and increasing the risk of developing pancreatic cancer.

Type 2 diabetes is a disease, which when treated properly patients can still expect to live a full and rewarding life. Pancreatic cancer is virtually untreatable and kills most victims within a year.

Risperdal update

Risperdal update

Lawsuits over Risperdal continue to move forward. The Arkansas Supreme Court has scheduled oral arguments in Johnson & Johnson's request to overturn a verdict and $1.2 billion fine over the marketing of the antipsychotic drug Risperdal.

Oral arguments are set for Feb. 27 in Little Rock for the appeal from Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. Attorney General Dustin McDaniel successfully sued the companies, claiming they downplayed and hid risks associated with taking Risperdal.

The Risperdal lawsuit in Arkansas accused Johnson & Johnson and its Janssen Pharmaceuticals unit of concealing the risks associated with the medication. The state also charged that the companies had deceptively marketed Risperdal as being better and safer than competing medications. In 2012, the Arkansas state court judge overseeing the case levied a $5,000 fine against the drug makers for each Risperdal prescription purchased through the state Medicaid program over a 3 ½ year period. The companies were also ordered to pay a fine of $2,500 for each of the more than 4,500 letters Janssen sent to Arkansas doctors to promote the use of Risperdal.

This appeal comes after the makers of Risperdal, the global health-care giant Johnson & Johnson, agreed to pay more than $2.2 billion in November 2013 to settle allegations with the U.S. Department of Justice that it misrepresented drugs and used kickbacks to promote their sales.

That was one of the largest health-care fraud settlements in US history. According to the Justice Department, the criminal and civil fine covered allegations that J&J promoted the antipsychotic drugs Risperdal and Invega -- as well as the heart drug Natrecor and other Johnson & Johnson products - for uses not approved as safe and effective by the Food and Drug Administration (FDA).

With Risperdal Johnson & Johns actively pursued the market for geriatric patients even after the FDA rejected efforts by the company to expand the drug's use to older dementia patients. The company even went so far as to create a dedicated sales force, ElderCare, to promote the drug and others to doctors who primarily treated older patients. In sales literature the company claimed Risperdal could address symptoms that made treating elderly patients a challenge, especially in a nursing home setting. However, while the sales literature highlighted the drugs ability to treat agitation, confusion, hostility and impulsiveness, it scarcely mentioned that the drug was approved only to treat schizophrenia.

Federal officials also revealed that J&J knew Risperdal posed serious health risks for older adults, like an increased risk of strokes, but continued to play them down. Only later was the drug's label updated to warn against use in older patients with dementia.

It was also revealed by Federal Officials, that Johnson & Johnson promoted the use of Risperdal in people with mental disabilities and children. This in spite of the fact that it wasn't until 2006 the company received FDA approval to market to children. The drug was promoted as a safe treatment for ADHD and obsessive-compulsive disorder, yet J&J knew that children were susceptible to certain health risks from taking Risperdal. These included the possibility that boys could develop breasts through elevated production of the hormone prolactin.
There will be much attention paid to the Arkansas appeal. Johnson & Johnson has shown that it consistently places profits before the welfare of its patients. The company has also repeatedly shown that, even after it has been found guilty in the Risperdal case, it will go to great lengths to keep justice from being served.

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