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

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.


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


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

Abuse Advocate - Priest Sexual Abuse And Molestation Lawsuit

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

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


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

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.

Saunders & Walker P.A. Your Source For Accurate Information

Stryker Rejuvenate / revision comparison

With the recent announcement of a $2.47 billion settlement offer from

Johnson & Johnson over its flawed Articular Surface Replacement (ASR)

hip implant, it is important to remember that the ASR, while the most

popular, was only one of many metal-on-metal hip implants on the market.

The Rejuvenate and ABGII hip replacement systems, both made by Stryker,

were recalled in July 2012. More than 30,000 of the Stryker hip systems

have been installed worldwide, 20,000 of them in U.S. patients. The recall

came after the implant was been found to be prone to corrosion, joint

dislocation, and the release of metal ions, which can cause metallosis,

tissue inflammation, necrosis and death. The announcement has since led to

hundreds of lawsuits being filed against Stryker.

I anticipate that Stryker will eventually have to make a settlement offer,

particularly if the J&J settlement is accepted, and that any offer made would

have to take the ASR settlement into consideration. But it is important to

note here that there are additional factors that come into play regarding the

Stryker hip replacements, and the average award of $250,000 in the ASR

settlement should only provide a baseline, not a comparison.

Most significant is the increased difficulty of doing revisions. The ASR

is a modular system and revisions usually involve only replacing the

cup and ball and don't require a new stem to be fitted in the patient's


Stryker was also a modular system but revisions are much more complicated

because of problems with the stems and necks. The stems in these joints

were designed to fuse with a patient's bone, however, post market data

revealed evidence of corrosion and fretting after the devices were implanted.

Because of this, any revision of Rejuvenate and ABC II will have to involve

replacing the stem. This is a complicated procedure and often extremely

painful. In many cases the revision often requires splitting the patients femur

to remove the stem.

Revision hip replacements are more complicated surgeries and the outcomes

are not as good as the first hip replacement. Even more so when it involves

the stem replacements required for the Stryker systems. Patients receiving

replacement prosthetics often have issues with bone loss and fit. The

promise of a better quality of life is greatly diminished because revised

artificial hips rarely perform as well as the first prosthetic.

The increased difficulty of Stryker revisions would have to be taken into

consideration in any award settlement. I believe that the $250,000 average

award in the ASR settlement would only be used as a starting point in

the Stryker negotiations and that the pain and suffering caused by the

more difficult revisions should be a major consideration and increase any

settlement offer.

Some doctors have predicted the failure rate for the Rejuvenate and ABGII

hip replacement systems might go as high as 70 percent. Relief for these

patients can't come to soon.

DePuy Announces U.S. Settlement Agreement to Compensate ASR™ Hip System Patients Who Had Surgery to Replace Their ASR Hip
WARSAW, IN, November 19, 2013 - DePuy Orthopaedics, Inc. (DePuy) and the Court-appointed committee of lawyers representing ASR™ Hip System plaintiffs today announced a settlement agreement to compensate eligible ASR patients in the United States who had surgery to replace their ASR hip, known as revision surgery, as of August 31, 2013.

"We are committed to the well-being of ASR patients, as demonstrated by the voluntary recall and the program providing support for recall-related care," said Andrew Ekdahl, Worldwide President, DePuy Synthes Joint Reconstruction. "The U.S. settlement program provides compensation for eligible patients without the delay and uncertainty of protracted litigation. DePuy remains committed to our purpose of advancing innovative treatment options to serve those who need joint replacement surgery."

The U.S. settlement is valued at approximately $2.5 billion, based on an estimate of 8,000 patients participating in the program. The amount of the settlement program has been included as part of previously accrued amounts, and no additional charge to the company's earnings is being recorded in connection with this settlement. Any remaining related established product liability reserve is based on currently available information and changes to the reserve may be required in the future as additional information becomes available. The majority of the payments related to this settlement are projected to occur during 2014 from currently available cash.

U.S. Settlement Program
For U.S. ASR Patients Who Had Surgery to Remove Their ASR Hip As of August 31, 2013
The U.S. settlement program is available for U.S. ASR patients who had revision surgery for reasons related to the recall as of August 31, 2013. Patients eligible for this program can speak with their lawyer, if they have one.

For U.S. ASR Patients Who Have Surgery to Remove Their ASR Hip After August 31, 2013
For U.S. patients who have revision surgery after August 31, 2013, the existing Broadspire program providing support for recall-related care is available. U.S. patients are encouraged to call 1-888-627-2677 for more information.

For more information about the U.S. settlement program, please visit

Status of Litigation
Judge David Katz of the U.S. District Court of the Northern District of Ohio is presiding over the federal multidistrict litigation. The consolidated state litigations are presided over by: Judge Brian Martinotti of the Superior Court of New Jersey, Bergen County; Judge Deborah Mary Dooling of the Circuit Court of Cook County, Illinois; and Judge Richard Kramer of the San Francisco County Superior Court, California. The settlement agreement was presented to these judges and Maryland State Court Judge, the Honorable Crystal Dixon Mittelstaedt, at a court hearing today.

The settlement agreement will help bring to a close significant ASR litigation activity in the U.S. However, some lawsuits in the U.S. will remain. DePuy will continue to defend against remaining claims and believes its actions related to the ASR Hip System have been appropriate and responsible.

Recall Background
In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry as part of the company's ongoing surveillance of post-market data concerning the ASR Hip System, which showed a revision rate that was not in line with data previously reported in that registry. The product continues to perform well in some patients. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need, including the global program providing support for recall-related care, which has thus far resulted in thousands of payments to patients.

DePuy Orthopaedics, Inc. is part of DePuy Synthes Companies of Johnson & Johnson.

(This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Orthopaedics, Inc. and Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; complex global supply chains with increasing regulatory requirements; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online

johnson-and-johnson-lawsuit-settlement.jpg Today, Monday November 18, 2013, the federal court docket reflected for the first time that there is a settlement in the Johns & Johnson ASR metal on metal hip implant litigation. The New York Times and Bloomberg Financial News had reported based upon unnamed sources a $4 billion dollar settlement of the 12,000 lawsuits brought against DePuy and Johnson & Johnson for failures of the ASR metal on metal hip implants. There had been no confirmation of any settlement by Johnson & Johnson, DePuy or any of the lawyers negotiating the deal. Further, the court filings had not provided any confirmation of a settlement. However, several scheduled jury trials involving the ASR had recently been settled or postponed leading to speculation that there had been a "stand down" of litigation in anticipation of a settlement.

A hearing was scheduled for tomorrow November 19, 2013 at 4:30pm EST but not subject matter has been indicated. It was widely believed that this hearing might be to discuss or release information about a settlement of the litigation. The late hearing time is unusual and it is possible that the hearing was scheduled for late in the day because the financial markets would be closed. Such a large settlement would include information that could influence investors decisions about Johnson & Johnson and public release of the information is regulated by securities laws to prevent insider trading on the stock.

This afternoon the federal court's docket sheet reflected that a sealed order was filed re: Settlement Oversight Committee. The Order was filed by U.S. District Judge David A Katz who is the judge assigned to the ASR litigation. This is the first official confirmation that there is a settlement in the ASR litigation.

The DePuy ASR was recalled in 2010 as a result of high failure rates caused by metal leaching from the implants. The leaching metal causes a condition called metallosis. Metallosis is damage to tissue and bone in the hip compartment from chromium and cobalt leaching from the implants. Most of the lawsuits that have been filed against DePuy allege that the metallosis has cause the hips implant to fail and require a revision surgery to replace the hip implant with a new implant of a different design.

Our law firm is continuing to accept metal hip implant cases involving all manufacturers. Call us at 800-748-7115.

Below is the federal court docket sheet confirming the settlement:

Johnson & Johnson DePuy ASR Hip Replacement Implant Lawsuit Settlement Signup Information

Visit our main firm website or call us directly for signup information. (800) 748 - 7115

Click Here To Contact Us

Johnson & Johnson will pay more than $4 billion to resolve more than 12,000

lawsuits in federal and state courts over defective DePuy ASR hip implants. Once

approved, this settlement will be the largest US settlement of legal claims for a

medical device, dwarfing the 2001 settlement of claims involving defective Sulzer

hip and knee implants that cost $1 billion.

We expect the announcement will be made next week in federal court in Toledo,

Ohio, where U.S. District Judge David Katz coordinates federal litigation. Judge

Katz must approve the settlement.

DePuy recalled 93,000 ASR hip implants worldwide in August 2010, citing a 12

percent failure rate in the first five years. However, internal J&J documents show

37 percent of ASR hips failed after 4.6 years. In 2012, the failure rate in Australia

rose to 44 percent within seven years. Unfortunately this is a poor prognosis for

any recipient of a DePuy ASR hip system.

We expect that Judge Katz will approve the settlement and that 94 percent of

eligible claimants will sign up warding off a DePuy withdrawal from the deal.

There will be a timeframe within which clients will decide whether or not to

participate in the settlement. Clients will have the opportunity to "opt out" and

continue their litigation in court. It is expected that payments to individuals with

one revised hip will be between $300,000 and $350,000. Individuals with bilateral

revisions or those who suffered complications during revision or re-revisions will

receive more money. The settlement will probably be scaled based upon age so a

person with a revision who is 40 years old will receive more than someone who is

80 years old. We expect that those who have an ASR hip that has not been revised

will not receive a substantial amount but that the settlement will remain open to

pay them if their hip fails in the future and a revision is needed.

In related news:

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Recently the Daily Telegraph reported that National Health Service Hospitals in Great Britain are to be banned from fitting most metal-on-metal hip replacements after a study found unacceptably high failure rates among implants in 17,000 patients.

The National Institute for Health and Care Excellence (NICE) has issued a warning that high failure rates in metal-on-metal joints were discovered, as high as 43 percent in some of the implants. This came after an audit of all hip surgery in England, Wales, and Northern Ireland was conducted with alarming results.

In particular it was found that The DePuy ASR, which had already been withdrawn when the manufacturers admitted to a failure rate of 13 percent within five years, had an astonishing estimated failure rate of 43 percent at nine years.

These findings resulted in regulators drawing up new guidelines recommending that the NHS stop using any hip implant with a failure rate higher than five percent at five years. This means that every type of metal-on-metal hip replacement joint, including five still in use, will no longer be implanted in patients. Among the metal-on-metal devices listed in the ban include DePuy ASR and Pinnacle implants, Zurom Durom Cup devices, and the Biomet Recap-Magnum.

The study also included models used in hip resurfacing procedure, usually used in younger more active patients. Failure rates in this category were 14 percent after five years and as high as 36 percent after nine years. The metal-on-metal resurfacing models found to have such high failure rates are: the Adept; Cormet 2000; Durom; Recap Magnum; and Conserve Plus.

I applaud the steps taken by NICE. Metal-on-metal hip joints represent the largest medical device failure in history. The pain and suffering endured by patients who have received these joints will go on for years. In the United States earlier this year The FDA issued new safety guidelines regarding metal-on-metal hip problems that recommends continued monitoring of implant patients for possible metal poisoning. The agency also warns physicians to be on the lookout for symptoms of metal, which might include pain or swelling near the hip joint, reduced mobility, and noise from the joint.

The Telegraph report indicates that the scope of the problem is only now becoming clear and the full scale of the failings has yet to be realized. Dr. Martyn Porter, past president of the British Orthopedic Association said surgeons first started becoming aware of the problem about three years ago, "We were starting to see high revision rates but this is like watching a car crash in slow motion - at first, you just don't know how bad it is going to be.

The tragedy is that much of it could have been avoided. Many of the manufacturers knew early on of problems with metal-on-metal joints yet ignored reports from doctors and continued to let profits, not patient safety, guide their decision-making. In a lawsuit earlier this year against Johnson & Johnson, parent company of DePuy Orthopedics, it was revealed that internal documents showed the company aggressively kept marketing the ASR replacement joint after it learned of high failure rates. Most disturbing was the revelation that after the ASR was denied approval by the FDA in the United States in 2009, DePuy continued to market the ASR overseas for almost another year.

Great Britain is taking the correct steps to protect patients by banning the use of metal-on-metal implants. In the United States - even as thousands of hip replacement lawsuits are being filed against manufacturers such as DePuy, Stryker, and Zimmer - metal-on-metal implants continue to be used.

How many revision surgeries will it take here before we decide enough is enough?


This week global health-care giant Johnson & Johnson agreed to pay more than $2.2 billion to settle allegations that it misrepresented drugs and used kickbacks to promote their sales.

It is one of the largest health-care fraud settlements in US history. According to U.S. Justice Department, the criminal and civil fine covers 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).

This settlement comes while J&J is also widely rumored to be negotiating another record settlement regarding the ASR hip replacement joint produced by the company's DePuy Orthopedics division. The ASR is part of the largest medical device failures in history and the settlement in this case is expected to be over $3 billion.

What is appalling to me throughout both these cases is the reckless disregard Johnson & Johnson continues to exhibit for the wellbeing of the patients they serve. With both Risperdal and the ASR joint the company learned of problems with the products early on, yet continued to market them aggressively. With both products it was corporate profit, not patient safety that guided their decision-making.

With Risperdal Johnson & Johnson, federal 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.

Johnson & Johnson's behavior in the ASR failure is eerily similar. Internal company documents have shown that shortly after the release of the A.S.R., complaints started coming from patients and doctors about implant failure, and tissue and bone damage caused by metallic debris. Patients cited intense pain and were often immobilized by joint dislocations, infections and bone fractures.

Johnson & Johnson's response was to downplay and suppress these reports and then increase marketing efforts for ASR. Even after the ASR had stopped being used in the United States out of safety concerns the company continued to market the replacement joint overseas.
Shortly before Johnson & Johnson became a publically traded company in 1943, the founder, Robert Wood Johnson, sat down and crafted the company credo. "Put simply, Our Credo challenges us to put the needs and well-being of the people we serve first."
At Johnson & Johnson they have abandoned this credo in the insatiable quest for more corporate profit. Along with this week's settlement, if the ASR cases are also settled, the company will pay over $5 billion to the patients they have harmed. This pain and suffering could have been avoided and now Johnson & Jonson will have to face the sobering reality that being a "responsible manufacturer," means placing patients, not profits at the forefront of their concerns

Middle Age Men Facing Low T Crisis of Epidemic Proportions

Or are they?

According to an October 15, 2013 New York Times article, low testosterone levels, or Low T, in men are basically an invented condition. Dr. Joel Finkelstein, an Associate Professor at Harvard Medical School, told the New York Times that there was "no such disease" as low T. Once used for older men with hormonal deficiencies caused by medical problems, the Low T gels are now being sold 'as a lifestyle product'. Furthermore, the article states that Low T is rarely the cause of erectile dysfunction.

The article goes on to state that Dr. Eric Topol, Cardiologist and Chief Academic Officer at Scripps Health in San Diego was alarmed at the number of his patients who use underarm roll-on testosterone medications, stating that the medications come with a high risk of coronary artery disease and possible side effect of an enlarged prostrate.

If doctors are alarmed and there is a risk of an enlarged prostate, along with a high risk of heart disease, then why are millions of men using testosterone gels? The simple truth is that pharmaceutical companies invest enormous amounts of energy, money and time into learning the psychology of consumers. Pharmaceutical companies spend billions of dollars parlaying the results of their research into strategies for direct-to-consumer pharmaceutical advertising, called DTCPA by the FDA. Whether we are in our car, or on our phones, computers or televisions, DTCPA soaks the market from almost any electronic device. Not one lobe of our cerebral cortex is forgotten. We are enticed visually, seduced orally, and lured through our own imaginations to conjure pictures of material and sexual success, and suddenly, "Hey Doc! I think I have that!"

Costs for some of these overpriced medications can amount to $400 - $500 month, usually picked up in part, by insurance companies. That may sound good for us in the short-term, but what are we actually paying for? In this case, it is a well-funded psychological warfare designed to keep us addicted to a commercially created illness, as well as an increase overall to our already overpriced healthcare costs.

Some of the adverse effects of testosterone gels do not only include the prescribed user, but children who come in contact with the gels. Medical literature in the Journal of Pediatric and Endocrinology and Metabolism, chronicles two incidents of a 21-month-old boy and 4-year-old girl who grew pubic hair and had other adult-related physical reactions.

Morry B. Smulevitz, Director of Communications for Lilly, stated that low testosterone was a "recognized clinical condition with signs and symptoms that could impact millions of patients." The article does not identify Smulevitz as a medical professional, nor does it indicate where the clinical data he refers to originated. I guess we're just supposed to ignore the medical professionals from Harvard and Scripps, and take his word for it.

In August Bloomberg news reported that Johnson & Johnson was reportedly considering a $3 billion settlement regarding more than 11,000 DePuy ASR hip lawsuits. Bloomberg went on to report that the settlement offer would depend on the outcome of a series of ASR trials that were to take place this Fall.

Since that initial report, events have unfolded that lead me to believe that Johnson & Johnson is strongly considering a settlement.

The first trial in the federal consolidation was scheduled to begin on Sept. 24 in Cleveland, Ohio. U.S. District judge David Katz granted a 90 day delay to allow more time for pre-trial processes and scheduling for expert witnesses. In my experience Federal Judges are reluctant to grant delays over witness scheduling conflicts. The more likely reason is that a realistic settlement offer from Johnson & Johnson is on the horizon and more time is needed for negotiations.

In California on October 1, Johnson & Johnson settled with a plaintiff for an undisclosed sum. This settlement happened before the start of 2000 cases that were consolidated and to be heard before Judge Richard Kramer in San Francisco.

On October 8, another ASR suit was deemed resolved by the Bergen County District Dourt in New Jersey and removed from the trial calendar

In Las Vegas last year three DePuy ASR cases were settled before verdict

Only two ASR cases have gone to trial. In the first trial Johnson & Johnson lost an $8.3 million verdict. A California jury awarded damages to a Montana prison guard and ruled that J&J's DePuy Orthopedics division designed of the device was defective.

Six weeks later a Chicago jury ruled for DePuy and rejected a defective design claim by an Illinois nurse.

It was though that the win in Chicago would help prolong DePuy's strategy of proceeding on a case-by-case basis in an effort to avoid any type of settlement. But since the Chicago trial DePuy has quietly settled a handful of cases and had a major trial delayed.

I think that the DePuy is leveraging the Chicago verdict in a few individual settlements, while at the same time trying to negotiate a larger class action settlement. Any further rulings against them would weaken their negotiating platform so it is their best interest to delay any trials before a settlement can be reached.

The ASR is part of the largest medical device failure in history, and Johnson & Johnson needs to be held accountable and take responsibility for the pain and the suffering they have caused. The time has come for them to settle this horrible tragedy and help the people they have harmed.

Medical Device Tax

Medical device manufacturers scream that the medical device tax of the Affordable Care Act tax is unfair and they are willing to spend what it takes to buy politicians to defeat it. This is legal and is called lobbying. Republicans demanding repeal of the medical device tax state the tax will increase healthcare costs and inhibit new methods and ideas.

Johnson & Johnson, owner of DePuy, a medical device manufacturer, earned a total (pharmaceuticals included) of $2.98 billion for the third quarter, compared with $2.97 billion, in 2012. This is in spite of the 2 percent decline of sales in the medical devices division and lawsuits involving metal on metal hip replacement implants. Johnson & Johnson was reported in the New York Times as stating the reason was due to people being reluctant to undergo elective surgeries.

Despite having made millions in profits, Johnson & Johnson has not lowered healthcare costs. Furthermore, what new technology has been introduced?

According to an article on Medical Device Development posted on the American Heart Association's website, "Although large medical device companies typically develop successive iterations of existing devices, most new device categories are typically developed by venture-backed start-up companies."

Medical manufacturers spend very little of their total profits in new technology. Most of the time, they simply piggyback reworked devices on prior approval of similar devices. One could even insinuate that medical device manufacturers expect some devices to fail and are willing to pay the cost of the fallout.

Finding out the actual cost of a medical device may require the services of Sherlock Holmes. According to the New York Times, prices are confidential, many times even to the physicians. Manufacturers lobby medical providers just as they do politicians, except that it is legal to provide gifts to doctors and medical facilities. The incentive of gain is enough for healthcare providers to attempt to use one or more medical device manufacturers exclusively. We may not find out how much the devices cost, but we do know that the market mark-up for the United States is higher than many other countries.

The New York Times stated that with Johnson & Johnson's profit of $7.2 billion in 2012, the medical device tax would have cost them about $300 million, its research and development investment, $1.7 billion, leaving them a a profit of $5.7 billion. Remember, their profit went up this year.

The New York Times reported that Senator Charles E. Grassley, Republican of Iowa, sponsored legislation to post online price information for implantable medical devices. This would encourage competition, something currently sadly missing, between manufacturers.

If manufacturers are so worried about the bottom line, perhaps they should stop spending their profits in Washington, stop rushing reconfigured products through the FDA, and start exercising fair commercial practices.

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