Although the following was a parody published in the New York Bar Journal, it rings amazingly true for the thought process used in decisions to send products into the market place:

“Remember when some bad tires exploded and killed a few people?  Lawsuits uncovered the defect.  Nobody would have known anything about it except for what the lawyers learned in “discovery.”  No secret is safe from those damn lawsuits.  It was a shame.  Those tires were a profitable product.  And remember when two million women used those IUDs for birth control?  A very convenient device.   Sure, some had miscarriages, pelvic infections, and, yes, some even died.  But the majority didn’t.  The FDA was no problem but, once again, the lawsuits, not the regulators, are getting them off the market and another profitable product will be lost to industry.”

--NYSBA Journal: parodies tort reform in “Tort Reform and the KKK Manifesto.” July/August 2012; Pg. 44

….And that is the opinion of big business. Profit. Profit. Profit.

It comes as no surprise that beginning several years ago, corporations launched devastating un-American campaigns on our judicial system, which they call “tort reform.”  It is a coined phrase that has become a masterful campaign to whittle away the rights of the people, under the guise of progress. Brilliant! Tort reform is nothing more than a deceptive turn of a phrase to trick Americans into sacrificing their rights.

People should have equal access to justice.  Corporations across this country have quite successfully waged an unwarranted attack on our judicial system.  Don’t forget, these American corporations have billions of dollars in which to wage this war. They have unlimited amounts of money to influence politicians, to control the media, and to manipulate justice.  What’s the motive?  Control the judicial process so they won’t be financially liable for their wrongdoing.  If big business wins this war, no one will be holding them accountable. Winning to corporate America means:

“A plutocracy where Big Coal, Big Oil, Big Tobacco, Big Drugs, Big Insurance are no longer abused….A beautiful world of laissez-faire capitalism and, don’t forget, full of profit. Profit. Profit, unregulated, untaxed, unlitigated. No consumer lawsuits. Just pure profit….And that’s what tort reform is all about.”

--NYSBA Journal: “Tort Reform and the KKK Manifesto.” Pg. 47

It is incredibly scary to think of living in a country where corporations could band together to influence the courts, control the media, and own legislators to further their own ideological goals.

The attack on our judiciary and court system is extremely dangerous.  Justice is being eroded and Corporate America is trying to buy their way into our courts.  After all, our government is supposed to be by the people and for the people.

Be wary of the mastermind tort reform campaign that limits the peoples’ access to justice. Read between the lines. Pay attention to the carefully chosen semantics and resulting consequences. The bottom line is tort reform is designed to erode your rights and limit your recovery; it is not designed to fix anything in the judicial system.

Watching last night’s news, one of the stories that got only a brief mention, caught my attention. Yesterday Ford Motor Company announced a recall of 484,600 SUVs made by the manufacturer from 2001 to 2004.  As a Ford owner from a family of Ford owners, I found this story to be of particular interest and found myself remembering one of the earliest cases from my time in law school, involving the Ford Pinto.

The Ford Pinto and its fuel system, which would rupture relatively easily in rear-end collisions, is famous for causing hundreds of deaths and thousands of people to be badly burned. Perhaps one of the most well-known instances of a company putting profits before their consumers, Ford reports that were later discovered showed Ford had determined that causing 180 burn deaths and another 180 serious burn injuries and paying $200,000 per death and $67,000 per injury would be more cost effective than paying $11 per car to fix the problem.

In fact, Ford’s latest recall hardly comes as a result of a similar number of injuries as the Ford Pinto, and it doesn’t come even close to cracking the top 10 recalls in history. Nevertheless, it does involve a particular item that has been a problem in the past for the American automobile giant. In 2009, Ford recalled more than 14 million automobiles made from 1992-2003, ranging from trucks to SUVs, in what is far and away the largest recall ever. That instance involved a cruise control switch that was prone to spontaneous combustion.

The recall yesterday arises out of an investigation by the National Highway Traffic Safety Administration into the cruise control device causing the throttle to stick and making it difficult to stop or slow Ford Escape and Maverick models. Remembering the Maverick as a compact sedan that Ford discontinued in the 1970s, I discovered that it’s also the name given to the Escape’s twin version over in Europe. Thus far the defect is responsible for 99 complaints, 13 of which involved crashes, one that killed a 17 year-old girl.

The news also came with a statement by the executive director of the Center for Automotive Safety, who said that Ford has known about the problem since 2005 but has used a cheap fastener piece rather than replace the defective cruise control cable.

While Ford’s latest recall of Ford Escape and Maverick SUVs comes with a great deal less pain and suffering as the Ford Pinto case, it appears to be a reminder that often corporations look past the safety of their consumers in pursuit of another dollar.

As our legislators and law enforcement officers look for new and creative ways to make our roads and interstates safer by demanding better built cars and keeping drunk drivers off of the street, an often overlooked area of concern is pedestrian safety. In fact, in the United States over 47,700 pedestrians were killed in the ten-year period from 2000 to 2009. Perhaps most alarming for residents of the Sunshine State is that the top four most dangerous metropolitan areas for pedestrians are in Florida.

Data collected and published by Transportation for America found that Orlando-Kissimmee, Tampa-St. Petersburg-Clearwater, Jacksonville, and Miami-Fort Lauderdale-Pompano Beach, ranked first through fourth respectively in what’s called “Pedestrian Danger Index.” The Pedestrian Danger index takes into account the average annual pedestrian deaths per 100,000, and the percent of people who walk to work. Lest we think there is a connection between the significant senior population of Florida and the high incidence of pedestrian deaths, it should be noted that the 22% of pedestrian deaths that involve those 65 years or older is the same as the 22% national average.

Accounting for the number of people who live and walk in these metro areas is why New York-Northern New Jersey-Long Island with 3,485 deaths per year is all the way down at 50^th in the Pedestrian Danger Index. New York City’s concerted effort to better manage traffic and provide safer paths for pedestrians explains why New York is rated as safely as it is. While it should be the job of local legislators to use available funds to help protect the pedestrians of their cities, drivers and pedestrians alike must be vigilant in avoiding these preventable incidents.

Pedestrians should always look where they are going, looking left, right, and left again when crossing the street and continuing to look as they cross. Too often nowadays people walk down the street staring at their phones or texting, and this puts us in unnecessary danger. Pedestrians should always attempt to walk on sidewalks or paths, and should walk against traffic, as far to the left as possible, when walking where there is no path. Perhaps most important is that pedestrians should never assume that a driver can and does see them. Instead the pedestrian should make every effort to make eye contact with the driver when crossing directly in front of a car.

[youtube]http://www.youtube.com/watch?v=5_BmourlZ8I&feature=player_embedded#![/youtube]

Drivers must also do their part to share the road with those around them, including pedestrians and cyclists. It’s important to remember that pedestrians have the right of way, and drivers should recognize when they are entering or around areas that are heavily-foot-trafficked. This means putting down our cell phones and waiting until we are parked to send a text message, even though Florida is one of only a handful of states whose legislators have failed to enact such a statute. http://handsfreeinfo.com/florida-cell-phones-texting-laws-hands-free-info No text can possibly be worth possible consequences of driving while distracted.

Finally, after years of complaints and griping from the American Medical Association and Florida Medical Association as well as other tort reform advocates, there should no longer be an argument that there is an ongoing Medical Malpractice Crisis.

According to a study by Public Citizen and statistics from the National Practitioner Data Bank, both the number and amount of medical malpractice payments in 2011 fell to a record level not seen since 1990.  And even though the tort reform activists would try to have you believe that the “crisis” looms largest in Florida, while our doctors are fleeing the state, the statistics do not back this up.

According to the National Practitioner Date Bank, despite there being a drastic increase in the population in Florida over the last 20 years (13 million in 1990 versus 19 million in 2011), the data reveals that there was the fewest number of payouts for medical malpractice claims since 1990. Although tort reform advocates want the public to think frivolous lawsuits are rampant and need to be curtailed, the study by Public Citizen also found that more than 80% of the payments made were for catastrophic injuries that resulted in wrongful death, quadriplegia, brain damage or major or significant permanent injuries as defined by the National Practitioner Data Bank.

Despite this data, there is no evidence that patients have received any benefits (reduced medical bills or reduced insurance premiums) in exchange for the significant damage caps and other legal restrictions placed on them by tort reformers when they are injured by the medical profession.

In fact, the general public is penalized by these tort reform measures because that person who does not receive sufficient monies to pay for medical care of their injuries, will most likely seek payment form private insurance, Medicare or Medicaid. This results in higher insurance premiums or higher taxes for us all. So, while the real wrongdoer walks away with having to pay less than the actual damages, we all pay.

What is not surprising though is that even with the reduction in claims and payments, the cost of medical care is still skyrocketing and medical malpractice insurance premiums for doctors have seen only a slight reduction, which completely defies the arguments of the tort reform advocates. In fact, if you listen to the speeches of the politicians who want to attach tort reform measures to any health care bills, their usual justification is that we have a medical malpractice crisis going on and we have to stop it. Yet, they never provide any objective evidence of such a crisis.

Shame on the politicians for using these scare tactics and shame on those in the public who fail to educate themselves and readily buy into their lies.

Over the past few months (and well before the recall), our law firm has been investigating Stryker Rejuvenate and ABG II failed hip implant cases on behalf of patients from Florida, Arizona, Ohio, Minnesota, Illinois, and other parts of the country where these Stryker devices were heavily marketed.  As a byproduct of our Stryker Rejuvenate investigations, we have noticed a number of patients who have experienced serious adverse effects associated with their implants (such as metallosis, elevated cobalt levels, corrosion of the device at the junction of the modular pieces, pseudotumor formation, presence of milky inflammatory fluid around the implant, etc.) and the failure of their respective hip implants is strikingly  similar to the device failures experienced by patients implanted with Rejuvenate hip implants.  However, these patients have been implanted with a different product manufactured by Stryker – Accolade TMZF implants.

The Stryker Accolade TMZF implant is a one-piece implant made of a titanium alloy. The alloy is advertised by Stryker as a proprietary blend of titanium, iron, molybdenum, and zirconium developed by Howmedica Osteonics. According to Stryker’s website, this combination of metals is supposed to have superior strength, flexibility and notch resistance when compared to other alloys used in hip implants manufactured by Stryker’s competitors.

[youtube]http://www.youtube.com/watch?v=AiLOxyXaIiY&feature=player_embedded[/youtube]

As we have discussed in several items relating to other defective and recalled hip implants (including DePuy’s ASR and Pinnacle metal-on-metal devices and Stryker’s recalled Rejuvenate and ABG II hip revision devices), this appears to be yet another example of a failed “better”  mousetrap.

True innovation in medical technology can be very beneficial for patients in need of more effective treatment options.  Our world and lives are improved daily by these medical miracles.  However, it seems that, of late, orthopedic device manufacturers are innovating for innovation’s sake, with only the device manufacturers benefitting.   These “innovations” and breakthroughs are seemingly motivated by the need for device manufacturers to have something new and improved to promote, but many have led to so much avoidable pain and suffering for patients.

We already know that the Stryker Rejuvenate hip implant was an innovation that no one needed.  Now, we have concerns that the Accolade TMZF may be headed down a similar path. With the convenience and variety afforded by modular devices comes the evil associated with mating metal devices and implanting them in the body.  For over twenty years, scientists and surgeons have been writing about failed taper neck junctions with both similar and dissimilar metals. The taper neck junction is where either the neck is inserted into the stem or the ball is attached to the neck.  Twenty years ago, scientists were warning about the risks associated with such devices and discouraging their use, only to have medical device manufacturers hoist them upon surgeons and consumers as being the latest and greatest technology.

We have received inquiries from all over the country as well as overseas regarding Accolade hip implant failures. They are failing in the exact same way as the Rejuvenate and ABG II hip implants, with the distinction being that the Accolade corrosion and galvanization appears at a different location.  To date, it appears the Rejuvenate is failing at the junction between the neck and stem. The Accolade, however, appears to be failing at the junction between the stem and ball. The failure seems to be very similar to failures described twenty years ago in the literature talking about the inherent problems with use of modular implants, with erosion of the metals occurring once the implant is placed in the body which, in turn, causes metal ions to be cast off into the local area around the device and eventually dispersed throughout the body.

The picture included here depicts an actual Accolade explant. All of the black areas are the result of metal breakdown which occurred after the device was implanted. The patient from whom this implant was removed suffered from metal toxicity, and a hip arthroplasty revision surgery had to be performed within 18 months of the original implantation surgery.   Apparently, as is obvious from the photographs, the titanium alloy in the TMZF didn’t agree with the chrome cobalt head.

School is still out on whether we are seeing isolated failures or whether our firm has uncovered the tip of another iceberg, as we did with the Rejuvenate implants a few months ago.

On Friday, June 15, 2012, President Obama announced a two year reprieve from deportation for young adults who were brought to the United States as children. Annually, 3 million students graduate from US high schools; 65,000 are undocumented. I was one of them. I was born in Honduras and brought to the United States by my mother as a child when I was ten years old. Since I was 14 years old, I dreamed of becoming an attorney. I graduated high school with a 3.4/4.0 GPA, a Criminal Justice Certificate and fifteen college credits, but I could not go to college because I was undocumented.

Fortunately for me, in 2007, I was granted Temporary Protective Status which allows immigrants to remain in the United States temporarily because it is unsafe for them to return to their home country. I was able to work legally and to attend college with Temporary Protective Status. Still, I was not eligible for any federal aid therefore I worked full time and went to Florida Atlantic University full time, graduating in 2010.  I will be starting Law School this August.

President Obama’s new change in immigration policy will temporarily benefit more than 800,000 young adults nationally. It will temporarily benefit 200,000 young adults in Florida. But, it will not grant a pathway to permanent status. Consequently, Senator Dick Durbin from Illinois has been urging the U.S. Congress for the last decade to pass the DREAM Act which would allow a select group of undocumented students who have proved themselves as well as students with great potential to contribute more fully to America.

[youtube]http://www.youtube.com/watch?v=CNkhv7rZRpE&feature=youtu.be[/youtube]

The DREAM Act would give these students a chance to earn a pathway to citizenship if they:

• Came to the U.S. as children (15 or under)
• Are long-term U.S. residents (continuous physical presence for at least five years)
• Have good moral character
• Graduate from high school or obtain a GED
• Complete two years of college or military service in good standing
• Be under the age of 29 years old when the bill becomes law.

The DREAM Act has broad bipartisan support in Congress and from United States citizens. In the 111th Congress, the DREAM Act passed the House and received a strong bipartisan majority vote from 55 Senators. But the bill failed to reach the 60-vote threshold necessary to end debate on the Senate floor on December 2010.

My experience with the immigration system has inspired me to pursue a career as an immigration attorney. I desire to help others to pursue their passion, to fight for their dreams, and to make a positive difference so we may find a pathway to citizenship.

Whatever visions the words blue and late night may have conjured in your mind before, we now know that blue can keep us up late into the night.

A recent Chicago Tribune article sets forth medical evidence from the AMA, Harvard and Stanford, about sleep disorders for those addicted to late night use of tablets, laptops and smart phone devices.

Apparently, this new evidence points to the fact that ‘melatonin’, a naturally produced hormone in our body that helps us regulate sleep, is not sufficiently produced because the late night use of our electronic devices fools our body into thinking it is daytime and, therefore, inhibits the melatonin and creates sleep disorders. This regulation, or deregulation, of melatonin, occurs via light-sensitive cells in the eye which contain a photopigment called melanopsin which, apparently, is particularly sensitive to blue light.

So, in addition to an over-worked society, we have created a generation of electronic users who inadvertently have begun to fool their bodies into believing night is day.

Cancer from excessive cell phone use? Now sleep deprivation from late night use of PDA’a, tablets and other similar devices.

Enough is enough. Your email will wait for the morning.

Go to sleep!

Finasteride, one of the most popular drug used in the fight against baldness, has been linked to long-lasting sexual dysfunction in men using the drug.  Commercially sold as Propecia, the drug was originally approved by the Food and Drug Administration (FDA) to treat prostate issues.  One side effect was that it caused hair growth in many of its users and in 1997 the FDA approved the drug for treatment in male pattern baldness.  At the time of the clinical trials for Propecia, Merk, the company which manufactures Propecia, noted that some men reported sexual side effects.  The FDA reported that those issues resolved once the man stopped taking the drug.

But after receiving more than 400 reports of sexual dysfunction from Propecia users, earlier this year the FDA required the makers of Propecia to add a label to the product warning of sexual side effects.  The label indicated that the side effects could continue after use of Propecia stopped

Reports surfaced this week after scientists and researchers at George Washington University reported that men using the drug reported problems with sexual dysfunction.  Side effects relating to sexual dysfunction have long been reported by users, but until this week, every indication was that stopping use of the drug led to the symptoms dissipating and ending.   This week’s report, however, following the publication of a new study, has concluded that for many of the men who stopped using finasteride, they continued to report problems with sexual dysfunction, including erectile dysfunction, low libido, problems with orgasm and shrinking and painful genitals long after use of the drug ceased.

[youtube]http://www.youtube.com/watch?v=xAZ3-t7vJeg[/youtube]

George Washington researcher, Dr. Michael Irwig, has published a new study in the Journal of Sexual Medicine entitled “Persistent Sexual Side Effects of Finasteride: Could They Be Permanent?” detailing the findings related to his study of 54 men who had experienced sexual problems at least three months after they stopped using Propecia.  Although based on a small number of former users, the study has some startling results.  One finding stated, “In a group of 54 otherwise healthy former users of finasteride who developed persistent sexual side effects that lasted for at least 3 months, 96% continued to experience these effects when reassessed after 9-16 months (mean 14 months), raising the possibility of permanent effects.”  Many of the men interviewed also reported neurological and mental changes, relating to depression and changes in their sleep patterns.

Whether the conclusions of this study will be bolstered when new studies increase the number of former users being studied is unknown.  Researchers who participated in preparing the report concluded, “prescribers of finasteride and men contemplating its use should be made aware of the potential adverse medication effects.”

When participants left a two-day public hearing convened by the U.S. Food and Drug Administration (FDA) to discuss metal-on-metal hips (MoM) there were few answers and a lot of questions. The goal of the 18-member FDA advisory panel made up of surgeons, industry reps, and consumer advocates was to try and come up with some policy recommendations for use of the MoM hip implants that have left so many with life-altering complications.

The panel was also convened, not to consider a recall or reclassification, but to provide recommendations to doctors caring for MoM hip injured patients.  MoM hips were originally marketed as an alternative to the traditional ceramic or plastic hips and were targeted for the younger, more active hip recipient. Many patients are in their 40s and 50s  and face a lifetime of injury and complications.

There was no consensus on how to treat patients who suffer from toxic levels of chromium or cobalt, caused by metal debris which can get into the bloodstream in patients implanted with MoM hips. 

The FDA was urged to avoid making any blanket recommendation that might interfere with the doctor-patient relationship, but really, why convene a panel unless some guidance is issued?  There was agreement that the current data was not sufficient given that none came from prospective randomized trials.

The bottom line and the reason the panel was convened was that MoM hips have had a significantly higher failure rate than metal-on-ceramic or metal-on-polyethylene implants where the failure rates including deterioration and pain at 5-years are in excess of 10 percent.

There was also consensus that the larger the head size of the implant, the more failures, and that women seem to be experiencing a higher failure rate than men. There is also a difference in failure rate between the MoM total hip replacements and resurfacing, which had a higher success rate.

So what is a clinician to do?  With almost 17,000 complication reports sent to the FDA, there were largely few answers. However, a skin patch test for metal sensitivity was recommended. Once a patient shows elevated levels of chromium and cobalt, no one can say what level is too high or what should be done. Chromium and cobalt ions can damage the lymph nodes, liver, kidneys and spleen. The metal ions are linked to cancers.

So the FDA convenes an expert panel with disappointing results, even as the DePuy Orthopaedics A.S.R. hips have been recalled from the market because of patient complications.

Read more about how this issue may affect Stryker Rejuvenate hip systems.

I read this recent USA Today article in total disbelief. The article talks about the shortage of truck drivers, and the industry’s attempts at shifting the problem onto that yucky little issue called “safety.”

Apparently, when the federal government actually began posting safety ratings, the industry started to think it might be wise to consider, dare I say it, a safe driving history as a requirement to get a job as a truck driver. Rosalyn Wilson, a senior business analyst of a consulting firm called Delcan, says that truck drivers must be at least 21. This, of course, leads many 18-year-old high school graduates who might consider trucking to instead pursue plumbing or other trades. Oh no, say it’s not true! Perhaps it’s a good thing that an 18 year old might not be considered “ripe” enough to take a loaded 70,000lb rig across the country without a few more years of driving experience under his or her belt.

I have also seen this mentality in the pharmaceutical industry. Hiring cheap, untrained labor does not work in every industry. Ms. Wilson also says that many unemployed construction and factory workers can’t afford the $4,000 to $6,000 cost of a six-week driver-training course. When I first started working at Allstate, they hired me and then paid for my training. The novel concept of investing in an employee apparently is lost on an industry who is now also upset that the Federal Government is limiting the number of hours truck drivers can drive in any given period of time.

It’s both sad and amusing how this article does not mention the 500,000 trucking accidents that occur every year in the United States. Of these 500,000 trucking accidents, approximately 5,000 result in fatalities. In fact, one out of every eight traffic fatalities involves a trucking collision. Oh, and by the way, trucking revenues totaled $610 billion last year and revenues are estimated to nearly double by 2015. It is amazing how we can put a man on the moon, and yet the trucking industry is resigned to believing that they are simply unable to make our trucking system safe.

I am not a huge fan of regulation, but in this case, I know it’s needed. I have seen firsthand the death and destruction caused by poorly maintained trucks driven by drivers with horrible driving records, or worse yet, impaired in order to stay awake longer to make their “goals.” Once again, fast and cheap might be great for the occasional burger or my weekend frisbee and disposable cooler, but one size (or speed) does not fit all. I don’t want my heart surgery fast and cheap. I don’t want a nuclear submarine to be built fast and cheap. And truthfully, I don’t want the trucks on our nation’s highways to be fast, cheap, and unsafe.

Hopefully the next time this type of self-serving diatribe is rolled out by the trucking industry and their cronies, we will see journalistic efforts that at least attempt to portray the other side of the story. Of course, writing about the human toll is never as easy as writing from the glib perspective of a large industry with its eyes’ on profit.