Miami Injury Lawyer Blawg

If you or someone you love is considering plastic surgery of any kind, you would be best to become fully aware of all of the risks associated with surgery in general and your particular surgery in particular. As the population is aging the number of individuals seeking to change or alter their physical appearance in some way seems to be increasing.

Though most physicians are upstanding members of the medical and social communities, one should be cognizant and aware of the potential issues that could be faced as a result of trying to alter the gifts of Mother Nature (wanted or unwanted). Regardless of how simple or complex a surgery in question, surgery involves inherent risks and should be considered prior to "knife time."

Cosmetic surgeries are by far more prevalent in the United States than in the United Kingdom and Canada.
• United States - nearly 14 million
• Canada - just over 300,000
• United Kingdom - just over 43,000

Cosmetic Surgeries per 1000 citizens
• United States - 40
• Canada - 8
• United Kingdom - 0.7

By Gender and Age groups:
• 91% of Cosmetic Surgeries are performed on women
• Almost 50% of surgeries - 40 - 54 years old
• Around 25% of surgeries - 55 plus years old
• Almost 20% of surgeries - 30 - 39 years old
• Less than 5% of surgeries - 20 -29 years old
• Around 1% of surgeries - 13 -19 years old

Side effects from most things medical whether medications or surgery can occur. Always be aware of potential side-effects because some of them can spell disaster. Be aware of the facts.

• Buttock implants -40% of patients have complications
 Implant rupture
 Fluid leakage
 Nerve or skin damage
 Bleeding
 Pain and swelling
 Infection

• Rhinoplasty - 10% have complications of soft tissue and skin
 Infections
 Loss of smell
 Bone collapse

• Breast Implants
o 70% lose sensation in nipple
o 16% suffer with painful hardening breast tissue
o 3 - 5% tissue dies and requires surgical removal due to toxicity

• Teeth
o 2 - 4% have allergic reaction to resin used when fixing veneers

• Botox
o 12% suffer URIs (upper respiratory infections), back pain, dizziness, extreme coughing, inflammation of nose, muscle tensing abnormalities, change in muscle flexibility
o 10% hemorrhage, neck pain, headaches, sore throat, generalized pain, excess sweating
o 4% can suffer with an abnormality where eyelids close involuntarily (blepharophasm)
o Body can swell uncontrollably - in reaction to the Botox toxin

Medical errors occur and medical risks are inherent in surgery regardless of how good doctors are. However, there are always the outliers such the fake doctor of buttocks implants above. Be sure your surgeon is well researched, can provide examples, and patients with whom you can speak. Investigate them on the front end so you don't suffer on the backend.

• 44% of cosmetic surgeons don't have proper equipment
• 50% of patients receive inadequate care
• 1% of patients are injured in hospital

Negligent facts related to medical profession and medical errors:
• Medical errors cost $29 billion or more in the United States each year
• 100,000 death in hospitals due to medical errors
• 40,000 United Kingdom women had faulty implants fitted
• 1,500 patients have items left in their bodies each year during surgery

What is methadone?

Methadone is a man-made (synthetic) compound. It is a narcotic (opioid) analgesic. This means it's made by man for the purpose of treating pain. However, it is also used to treat opioid dependency. As an anti-addictive, this medicine may be obtained from a physician or from a methadone clinic.

Frequently used for the treatment of chronic pain and drug addiction because of:
• Low cost
• Powerful effects
• Long duration

Methadone is available in both pills and liquid forms. Pills are most often used for chronic pain while the liquid form is used to treat opiate addicts. As one of the longest acting narcotics, Methadone can stay in the system for more than 20 hours.

Although there are good points to the medication, the downsides are extreme as well.
• Combined with alcohol can increase risk of addiction and abuse leading to death
• Deaths which involve painkillers - Over 30% involve methadone
• Death toll increasing

As a percentage of all painkillers prescribed Methadone prescription numbers vary throughout the states. In varying strengths, Methadone accounts for the following median percentages throughout the nation.
• 15% - 14 states
• 10% - 11 states
• 7.6% - 13 states
• 5.5% - 12 states

One can see from the numbers this drug is used quite extensively and also contributes to a significant number of deaths throughout the nation. Anytime narcotics are used at these rates abuse and addictions are certain to follow. These manifest in both psychological and physical signs and symptoms.

The Psychology of Abuse:
• Need for money - stealing or borrowing
• Losing interest in normal activities
• Loss of interest in personal self - hygiene, general upkeep
• Becoming standoffish from friends and loved ones

Physical Presentation of Addiction:
• Sweating / flushing
• Nausea / vomiting
• Trouble sleeping / drowsy
• Seizures
• Rashes / hives
• Decreased sexual interest

Physical signs of Withdrawal:
• Very small pupils
• Limp muscles
• Shallow breathing
• Can't stay awake
• Losing consciousness
• Cold, clammy skin
• Blue tinged skin

Symptoms of Methadone Withdrawal:
• Overly anxious
• Nausea
• Dilation of pupils
• Sweating
• Pain in muscles
• Becoming paranoid
• Agitation out of context

Clinics for methadone exist throughout the nation treating around 250,000 people or more. Though treatments may be legitimate or may not be, the act of being treated does not indicate who is or may be addicted to Methadone.

Depakote is an anti-seizure medication that is taken in oral form. This medication, as the generic divalproex, was first approved in 1978 for the treatment of epilepsy and other seizure disorders. Depakote (divalproex) is also used to treat bipolar disorder. You may have also heard this drug called valproic acid because this is the active ingredient in divalproex.

These medications by whichever name you choose are classified as Category D drugs regarding birth defects. What this means is that the FDA places the drug in a category of high risk for causing potentially life-threatening birth defects. This is such a severe classification that these medications should never be given to pregnant women without extreme consideration for the likely effects on the fetus.

Besides birth defects here are the known side effects of Depakote:

• Anorexia - loss of appetite
• Polyphagia or hyperphagia - increased appetite
• Weight gain
• Loss of balance
• Dizziness
• Impaired coordination
• Dream abnormalities
• Vomiting
• Fever
• Darkened urine

As serious as these side effects sound they can get worse. There is a classification of side effects from the FDA called "Black Box" side effects. These are potentially serious side effects.

Depakote was assigned a Black Box warning in 2006. Side effects include:
• Hepatoxicity - damage to the liver from some chemical
• Teratogenicity - capability of causing birth defects
• Pancreatitis - inflammation of the pancreas (a serious illness)

Risks to unborn babies are extremely dangerous. Those could include:

• Cleft palate
• Hypoplastic right heart
• Undescended testes
• Malformation of the hands
• Dysplastic ribs
• Hypospadia
• Spina bifida
• Fetal death

These "black box" side effects can be anywhere from surgical intervention to serious lifetime consequences to death.

The same year that Depakote received the Black Box warning, it was also the second most prescribed epilepsy medication. Valproate is now the word wide leader in anti-epileptic meds.

So what's the real risk to the fetus you might wonder?

The New England Journal of Medicine published evidence to support a fourfold increased risk of birth defects when mothers took anti-seizure medications. Those risks include risk rates as follows:

• Almost 13 times the risk for Spina Bifada
• 7 times the risk of cranio-synostosis
• 5 times the risk of cleft palate
• 2.5 times the risk of atrial septal defect
• 2 times the risk of poly-dactyl

There's no doubt if you took Depakote, a generic, or valproate during pregnancy and you have a child born with birth defects, you need to talk to a Depakote attorney. Your situation and your child should be fully evaluated to see the full diagnosis, prognosis, and all costs that have been and will be associated with caring for your child.

In 2012, due to investigation outcomes and a plea of guilty, Abbot Laboratories agreed on a $1.5 billion settlement due to marketing Depakote for uses other than those approved by the FDA.

Experts studying the impact, threat, and potential effects of concussions on young athletes' leverage heavy warnings to heighten the awareness surrounding the long term effects. Consider this:

• Brain development not complete until mid-20s
• Injury to a not fully developed brain may change path of a life
• Women are more disposed to concussion maybe because necks not as strong
• Children are more prone because of weaker necks

Lobular functions

Temporal:
• Emotions
• Processing of visual and speech cues
• Short to long-term memory transference

Prefrontal cortex:
• Subtle social cue comprehension
• Social interaction and thinking abilities
• Reasoning
• Moral reasoning
• Planning
• Decision making processes
• Problem-solving
• Container thinking
• Task switching

It is a Serious Problem

Athletes need to be made aware of the serious possible repercussions of concussions. The number one reason some players don't report a concussion is they don't think it's serious.

Reality stats tracked by National Center for Catastrophic Sport Injury Research from 1995 -2004 every year
• Football head injury deaths - 44
• High school head injuries with residual lifetime effects - 43
• College players with residual lifetime effects - 5

What is SIS?

Here's how serious: SIS - Second Impact Syndrome can be.
• 5.1% of football players in college and high school suffer a concussion during a season
• 14.7% of first concussion sufferers will suffer a second concussion
• 47% of high school players report ONE concussion during a season
• 35% of high school players report more than ONE concussion during a season

When a concussion occurs, the brain nerve cells are not at peak performance. Until full recovery occurs, victims are more likely to be reinjured. If re-injury occurs the outcomes can be deadly. This is SIS.

SIS kills up to 50% of the victims who suffer with it. If they don't die, they are likely to suffer long-term brain damage and / or disability. 95% of these SIS victims are under 18 years old.

Explaining Concussions:

Sudden acceleration or deceleration of the head, sudden impact of the body causing the head to abruptly turn or twist, or bumping and/or knocking the head so the brain bumps around in the skull can all cause the phenomenon known as concussion.

Nerves or neural tissues are not mean to sustain harsh and violent shaking, banging, etc. This type of abuse can damage the tissues and blood vessels of the brain. When trauma to the brain occurs a biochemical cascade of calcium and potassium ions floods the brain. In response, blood vessels constrict and slow the energy food glucose. This lack of energy is a brain crisis and leaves the brain susceptible to further injury until recovered.

Concussion Signs & Symptoms:

Early - within minutes to hours
• Nausea/vomiting
• Slow to respond to questions
• Lack of awareness
• Amnesia - forgetfulness
• Headache
• Dizzy / unsteady / clumsy

Late - days to weeks after event
• Continued headaches
• Sleep problems
• Anxiety or depression (new onset)
• Irritability
• Lack of concentration or focus
• Dizziness or light headed feeling
• Memory issues
• Tiredness
• Sensitivity to lights or noise

Can we prevent Concussions?

General prevention:
• Always wear proper head gear when playing any contact sport
• Increase awareness - educate and stay up to date on new studies
• Develop adequate policies and plans for concussion addressing
• Educate athletes and families that playing with injuries is not smart

Contact Sports Prevention:

Football:
• Enforce head cannot be used as first point of contact for tackling and/or blocking
• Coach and teach proper blocking and tackling techniques

Softball & Baseball
• Ban head first slides or teach proper technique
• Require pitches to wear helmets for batting practice

Soccer
• Anchor soccer goals
• Do not allow players to climb on goals
• Assure proper moving, storage, and maintenance of goals

Hockey
• Enforce rules against pushing/checking from behind
• Instill conditioning programs to strengthen neck muscles

Swimming & Diving
• Competitive divers must stretch and strengthen to help prevent shoulder injuries
• Enforce rules for racing dives, platform heights to water depth ratio

Common Misconceptions related to Concussions:
• Mouth guards do not prevent concussions
• You do not have to be hit in the head to get a concussion.
• You do not have to pass out to have a concussion.
• Concussions are a VERY big deal

Stats & Facts
• NFL players with history of 3 or more concussions show increased links to depression and cognition difficulties common to Alzheimer's patients
• NFL posthumous study found Chronic Traumatic Encephalopathy tangles similar to dementia victims
• Long term effects of brain injury on young brains are cause for great concern

Traumatic Brain Injuries (TBI) 1995-2001
• Unknown how many received no care or other care
• Over 1.1 million emergency department visits
• 235,000 hospital stays
• 50,000 deaths
• 300,000 sports related - grossly under reported (750,000 - 2.25 million estimated)

Ages 5-14 Emergency department visits
o 32% hit by something
o 28% fall
o 14% vehicle crash
o 7% assault
o 19% other
o Of the top 60% most recognized as sports injuries

20 most dangerous sports or recreational activities
• Cycling - 70,802
• Football - 40,825
• Basketball - 27,583
• Baseball & softball - 26,964
• Powered recreational vehicles - 25,970
• Soccer - 19,252
• Skateboards or scooters - 18,324
• Fitness or exercise club - 14,713
• Horseback riding - 11,749
• Winter sports - 11,723
• Water sports - 11,239
• Golf - 8420
• Gymnastics/dance/cheerleading - 6364
• Trampolines - 5971
• Hockey - 5272
• Rugby/lacrosse - 4387
• Other types of ball sports - 3935
• Skating - roller or inline - 3320
• Ice skating - 3115
• Wrestling - 2643

Brain injuries are begun by some type of traumatic event. Brain injury damages are compounded by swelling, pressure on and around the brain, and lack of oxygen caused from all of these factors. Causes can be such things as vehicle accidents, assaults, weapons, falls, sports, etc.

Brain injuries can be thought of in stages from primary, to secondary, to tertiary.

Primary Brain Injury

This is the actual injury that occurs. This can be a closed head injury, an open or penetrating wound, or a crushing injury. All of these injuries have different causes, symptoms, and outcomes.

• Closed Head Injury
o Most common
o Rapid acceleration / deceleration injury (sudden stop or hit from behind or side)
o Brain shifted abruptly in its enclosure
o May twist, be bruised, fibers torn, stretched, etc.
o Brain abrasion on bony ridges of skull anterior
o Brain vessel injury causes bleed

• Open or penetrating wound
o Less common
o Skull cavity is invaded / skull broken
o Brain actually exposed
o Brain itself possibly damaged
o Bullet, knife, kickstand, etc.

• Crushing
o Least common TBI
o Damages base of skull, brain stem
o Head between two solid objects (car and payment)
o Could be completely conscious

Secondary Brain Injury

When a primary injury occurs there is a high risk for secondary injury related to oxygen deprivation. The brain cannot survive in a poorly oxygenated environment without suffering damage to some of its higher processes. This oxygen disruption can occur due to:

• Airway blockage from vomit or blood
• Airway damage
• Airway obstruction
• Blood loss

Emergency treatment methods of first responders have evolved to include quick resolution for oxygen impairment. This could include removal of blockage, supplementation, or blood transfusions.

Tertiary Brain Injury

Follows primary and secondary injury but can occur days or even weeks afterward. Causes include:

• Brain swelling
• Bruising of brain tissues
• Brain bleeding

The unyielding bones of the brain do not have expansion room as leakage or brain swelling occurs. This leads to pressure being exerted on the brain causing damage and/or squeezing of the blood vessels impairing circulation within the brain. Increasing intracranial pressure must be measured during hospitalization.

Other interventions could include:

• Ventilation to assure adequate oxygen

• Blood clot protection
o Can occur in brain (intervertebral)
o Between brain and skull (subdural or extradural)
o Even slight head injuries should be watched for this

TBI Severity can be rated according to measures of how much and to what degree there is a lack of consciousness and/or the degree of post trauma amnesia (PTA) which occurs. Generally speaking the longer one or both of these persists, the worse the injury and possible outcomes.

Effects of TBI

Brain injury can result in cognitive, physical. And/or emotional and behavioral problems. Cognitive impairment results in changes of thoughts, learning ability, and/or memories.

• Memory - face and name recognition, past learning, new learning may be affected
• Motivation - decrease in this area common. Could be depression symptoms.
• Poor concentration - inability to stay on task and complete task
• Deceased speed of information processing
• Impaired problem solving ability
• Continuous repetition - get stuck and unable to break cycle of behavior

Physical impairments are recoverable. Some may not be visible while others can be quite severe.

• Fatigue
• Mobility
• Sensory impairment
• Speech difficulty
• Epilepsy - seizures can occur following brain injury
• Paralysis and/or weakness
• Ataxia - tremors, unintended movements
• Hormonal imbalance - damage to hypothalamus or pituitary gland

Emotional impairments following TBI can significantly affect mood and emotions.

• Impaired confidence
• Mood liability
• Depression
• Sense of loss
• Anxiety
• Anger or frustration
• Obscene or abusive language or behavior
• Loss of inhibition
• Impulsive behavior
• Obsessive behaviors

Every year we sit back, like sheep to slaughter, and watch the Florida Legislature and Governor Rick Scott put their interests, ahead of the good people of Florida. I forgot, why are these people in public office??? Oh, I forgot, to help the citizens of Florida. Well apparently, Florida's population consists of Insurance companies, car dealers. and nursing homes.

Higher teacher pay-forget it, School safety-forget it, Minors and texting-forget it, Texting penalty-forget it. So what did our elected officials do In Tallahassee? The usual, they again limited access to the courts for victims of medical malpractice, they refused to abolish PIP, and the beat goes on. Every year, little by little, more rights are lost and more handouts are given to the insurance lobby.

Most of us read about the new laws in our local newspapers, and they seem like nothing more than words on a piece of paper. That is until the laws somehow apply to you.

As a Miami Medical Malpractice lawyer, I have to explain to my clients that the death of their loved one has a cap. That all the memories they shared with their father, mother, wife, son or daughter is only worth so much. If by chance their loved one was just severely injured and not dead, their loss is worth even less. At that point a client will usually tell me that they never knew that law existed-and that is exactly the way the florida legislature does it every year.

Last year they passed a law that expert witnesses' that were not licensed in Florida had to apply to state for a special license. This year, they passed a law that makes it even more difficult to retain expert witnesses to testify about what the offending doctor did wrong. The latest amendment now prohibits overlapping medical specialties from offering expert opinions. Even if two doctors perform the exact same procedure the exact same way, they cannot opine on the care rendered if their background or training is in different specialties. A cardiologist can't comment on the care of a vascular surgeon, a neurosurgeon can't comment on the care of an orthopedic surgeon-even if they do the exact same procedure.

By the way, who does this benefit? As a citizen of Florida why would I want such a law? The answer is simple; Insurance companies-and you don't want this law.

Continue reading "The Florida Legislature Strikes Again" »

Whether 10 mg or 40 mg or anywhere in between, taking Paxil while pregnant can lead to serious consequences for the baby and therefore, the family. Babies born with heart defects secondary to mother's use of Paxil during pregnancy may not live.

Some may die early, others may survive with surgery, but regardless of outcome the Paxil dangers are very serious.

Pregnant women sometimes still need to take medications. If suffering with problems such as:

• Depression
• PTSD - post traumatic stress disorder
• GAD - generalized anxiety disorder
• OCD - obsessive compulsive disorder
• Panic disorder

Paxil, a selective serotonin reuptake inhibitor (SSRI) antidepressant made by GlaxoSmithKline, came out in 1992 and was designed to address these types of problems. Antidepressants are an extremely profitable market as you can see here.

Cost of Paxil around the world. Values are approximated:

• United States $65
• Germany $55
• Denmark $40
• Austria $38
• Mexico $37
• UK $36
• France $35

Now look at the profits from all of these top selling antidepressants just in the United States alone.

1. Zoloft $29.7 million
2. Lexapro $27 million
3. Prozac $22.3 million
4. Wellbutrin $20.2 million
5. Paxil $18.1 million

This is quite a profitable market as you can see. GlaxoSmithKline rakes in a ballpark $37 billion in this profitable area alone. Even with a billion dollars in lawsuits from Paxil they still seem to be doing pretty well.

Now let's talk about risks. Because approximately 1/4 of pregnant women can suffer from depression, it's important that meds are safe if marketed to them and for them. Risks to unborn infants is a high consideration because half of these women wind up taking some type of antidepressant during a pregnancy. Making sure medications marketed to pregnant women are safe is critical. See below for why.

It was found that women taking Paxil during a pregnancy had six times the risk of having a baby with persistent pulmonary hypertension (PPHN). That's double the risk to the baby as compared with women never taking an antidepressant during pregnancy.

PPHN can be in the form of VSD - ventricular septal defect or ASD - atrial septal defect

These defects must be repaired and/or can lead to death. The ventricles are the lower heart chambers and the atria are the upper heart chambers. The septum is a division between each atria and between the ventricles. When there is a defect, there is a hole in the septum which allows blood to flow from ventricle to ventricle and/or from atria to atria.
This is not supposed to ever occur. This leads to poor oxygenation in the blood and can lead to inability to sustain life, if severe enough. Hence the Paxil birth defect phenomenon can be an extremely serious situation for a baby who is affected by it.

Biomet hip replacements have run into more than one serious issue over the last several years. When the M2a metal-on-metal replacement system was birthed in 1996, it quickly became a popular. Second in line only to the DePuy ASR device (which has also seen rocky waters), the Biomet M2a-Magnum hit the ground running to the tune of million in profits.

Biomet advertises the M2a-Magnum extensively on its website claiming the metal-on-metal large head device provides enhanced stability and suffers from less wear than other devices. Many medical studies dispute the claims of Biomet instead suggesting instead that the large head is a danger. The studies suggest the can cause increased metal ion concentrations in the bloodstream. Further, it has been shown that metal-on-metal devices such as the M2a-Magnum and even the DePuy ASR are much higher fail rates than over replacement devices.

Biomet has a selection of seven metal-on-metal devices:

• M2a-Magnum
• M2a-38
• M2a-Taper
• M2a-28mm
• Stanmore
• Exceed ABT

There are some common side effects with Biomet products including pain and swelling. However, the serious side effects are called just that because they are not so common:

• Fractures
• Device dislocation
• Osteonecrosis - bones loose blood supply; leads to pain and collapse
• Ossification - new bone forms in tissues where they shouldn't
• Debris buildup
• Device loosening

The Biomet Hip Replacement history on a timeline:

1996 - M2a metal-on-metal hip replacement comes to market
2001 - Zirconia Ceramic Femoral Head hip devices recalled by Biomet due to linked with fracture within 13 -27 months of implantation
2004 - M2a-Magnum comes to the United States
2009 - After 10 years on the market, more than 110,000 M2a hip replacement devices had been implanted.
2012 - Fail rate of metal-on-metal hip replacement devices revealed to be 14%. British Medical Journal published article with claims.
2012 - Biomet settled lawsuit filed against them by the Securities and Exchange Commission to the tune of $22.9 million. The lawsuit alleged Biomet bribed physicians in Argentina, Brazil, and China into using their products from 2000 - 2008.
2012 - A published medical study in the Journal of Bone and Joint Surgery reported that 39% of patients with large diameter head metal-to-metal implants, like Biomet's M2a-Magnum, developed pseudo tumors.
2013 - FDA became the recipient of more than 500 adverse event reports on the Biomet M2a-Magnum

With the evidence and the progression of occurrences, it appears Biomet may be on the verge of further dismay. The company's fate is not what is in question, however. Patients who have received implantation of the Biomet M2a-Magnum would be advised to discuss this evidence with a trained professional.

When Actos, a type-2 diabetes medication, first hit the market in the late 1990s it was ranted and raved as the next best thing to peanut butter. Okay, well, not quite that good, but it was thought to be nearly a godsend to many diabetics. But...at what cost?

As with any medication there are always potential side effects. Common side effects include shortness of breath, weight gain, swelling, and hypoglycemia (too much decrease in blood sugar). Other more serious side effects could include such things as eye or bone problems, bladder cancer, or cardiovascular events such as stroke, heart problems, or a heart attack. Yep, those are pretty serious!

The exponential growth of the Actos medication timeline is no less than astronomical. Within just a few short weeks of its 1999 release to the wondrous medical marketplace this drug had grossed over $48 million. Just nine short years later, Actos had exceeded $4.6 billion.

Actos might be good at helping control blood sugar, but is it really that good? Or was it sly marketing, physician purchasing, and the host of other tactics used by pharmaceutical companies that pushed the product and forgot the patient once again?

The Actos timeline from 2008 forward presents an interesting picture beyond the unprecedented dollars in growth across proportionate years. Watch as the good and the bad unfold. Good for the profits, bad for the patient.

• 2008 - becomes 10th most prescribed drug
• 2008 - A Swiss medical study published by the Archives of Internal Medicine found glitazone diabetes drugs (Actos and Avandia) could cause a double or even tripled risk for fractured or broken bones
• 2010 - FDA reports 2.3 million patients filled a prescription for either Actos or similar drugs in one year
• 2010 - A Whistleblower Lawsuit with Helen Ge accused Takeda, a Japanese pharmaceutical company and manufacturer of Actos, failed to report all of the Actos adverse events and falsely led the FDA and the public into believing Actos was safer than it was
• 2010 - Actos linked to 243 cases of heart failure and 121 heart attacks by Circulation: Cardiovascular Quality and Outcomes. 217 of these case ended in death.
• 2011 - Takeda embroiled in more than 10,000 lawsuits

In a 10 year investigation on Actos performed by Kaiser Permanente Northern California, Actos was further found to increase patients' risk of bladder cancer by 40%; patients on Actos more than 1 year.

Again mega money, mega profit result in mega remorse for the innocent.

It's saddening to say that all too often it's hard to know whom the medical industry finds more important; the patient or themselves. Perhaps that is not fair to say across all spectrums, but frequently this seems to be the case when it comes to certain medical paraphernalia and care.

With the DePuy ASR, DePuy and Johnson & Johnson fell flat into this controversial question as to whether they put profits ahead of their patients care and safety. The combination of a dangerous metal-on-metal combination between the DePuy ASR and Pinnacle systems led to a high failure rate, hip fractures, loosened implants, and device dislocations.

Though internal human implants are not without controversy and dismay throughout history, care must be taken to align with best principles. The fact that DePuy took the ASR to market without clinical trials and used a known risk method such as metal-on-metal leads to strong conclusive evidence that the almighty dollar was in sight and not the patient.

In 2005, the FDA actually granted DePuy approval for sale of the ASR without demanding they undergo clinical trial first.

In 2007, there began the reports of DePuy ASR controversial findings when the Australian Orthopaedic's National Joint Replacement Registry reported failures rates double that of industry standards. Within the first five years following implantation the DePuy ASR failed at a 13% rate compared to the industry standard of 3%. Even in 2007, those are not good odds.

In 2008, it found England and Wales National Joint Registry at odds with the DePuy ASR. They reported over a 3-year time period the ASR had the highest failure rate among all hip implants and required further surgery to fix the associated issues.
Because of a lifetime teamed with worsening statistical evidence, in 2010, DePuy and Johnson & Johnson issued a worldwide recall for the DePuy ASR. Around the world there were an estimated 93,000 patients who received the questionable ASR before the companies finally pulled it from the marketplace.

Lawsuits abound related to the DePuy ASR and Pinnacle devices. As of 2010, over 10,000 lawsuits had already been filed. In 2011, the company had already set aside three billion dollars to address lawsuits with $800 million considered to pay for the medical recall itself.

If you know someone who has a hip implant or perhaps you do yourself, be sure it's not a DePuy ASR. This product has been recalled and places anyone with the product at high risk for injury.

Contraceptive devices have long been a point of contention and controversy. NuvaRing is not the first to find its product involved in heated debates and injurious discoveries. Besides issues related to side effects, injuries, and responsibilities, NuvaRing also suffers from ill-effects of design. Designed to be worn for 3 weeks and the removed for one, if the device is accidentally or intentionally removed the protection is reduced.

NuvaRing came to market with FDA approval both marketed and manufactured by Merck in 2001. This flexible plastic ring is a contraceptive device inserted into the vagina by the user. Emitting low doses of both estrogen and progestin into the bloodstream, the hormones effect the female reproductive cycle in such a way as to prevent contraception.

NuvaRing, as is common with hormonal contraceptive devices, is not without side effects. This self-administered monthly birth control method may be convenient, but is it safe? Hormonal contraceptives have been known to be associated with increased risk of cardio events which could include heart related events, strokes, or blood clots. With NuvaRing, both common side effects and serious side effects are not uncommon (5,000 reports of adverse side effects received by FDA). The serious side effects have even caused death.

Here is a list of common side effects associated with NuvaRing:

o Headache
o Weight gain in 14% of women
o Nausea, cramping, and bloating
o Breast tenderness
o Vaginal infections
o Irregular bleeding
o Depression

Here is a list of serious side effects that have been linked to death:

o Blood clots
o Organ damage
o Strokes and heart attacks
o Cervical cancer risk increase
o Aggravation of pre-existing conditions

The NuvaRing timeline summary:

• 2001 - FDA approval
• 2010 - "10vor10" a Swiss television program with permission of the FDA received access to an FDA databank and linked NuvaRing to 40 deaths
• 2011 - FDA linked NuvaRing and other vaginal ring contraceptives to increased risk of blood clots. Study published stating the increase of 56% was further multiplied by nearly five times after one year of use when compared to other hormonal contraceptives.
• 2012 - New England Journal of Medicine and the British Journal of Medicine published unfavorable medical studies related to NuvaRing.

It is also a worthy notation that NuvaRing is the recipient of at least 950 current and pending lawsuits.

The Medtronic Infuse bone graft has a colorful history from beginning to wherever it ends. For many patients who received the product, the story will never end.

After filing for approval for their Infuse bone graft product in January 2001, Medtronic received expedited review status from the FDA. In July 2002, they were approved to use the Infuse bone graft for an anterior approach lumbar fusion. In just 1.5 years this product went from approval filing to approval. Hence, possibly the reason for the limited usage approval.

Herein begins a story of illegalities, corruption, dishonestly, and much pain and suffering:
In 2004, Medtronic begins promoting off-label use of the Infuse Bone Graft System. If you are not familiar with off-label use, this is not an uncommon practice. It is not uncommon that pharmaceutical and other medical manufacturing entities will promote an off-line use in order to boost sales and profits. However, there are certain lines that should not and must not be crossed. This is where the plot thickens.

The Infuse product was not approved for any spine surgery except the anterior approach lumbar fusion. It was NOT approved for others such as a lateral/posterior approach lumbar fusion or surgery on the neck or cervical spine. Despite this lack of approval, Medtronic paid out over 60 million dollars to promote these "not approved" methods. Fifteen doctors were paid quite handsomely to endorse the use of Infuse.

This physician endorsement and subsequent multi-million dollar promotion helped increase the total sales for the Infuse bone graft system to somewhere in the vicinity of $800 million. Take note that 82.5% of these sales were for off-label use (the not FDA approved kind).

With the increase in off-label sales and uses, therein came the increased reports of problems, side effects, life threatening problems, and thus subsequent lawsuits. Between 2004 and July 2008, complications from off-label use began to roll in.

• Cancer
• Nerve injury
• Uninhibited bone growth
• Sexual side effects
• Neck and throat swelling

There were 280 reports of side effects due to the Infuse system and 38 reports that were life threatening. Three-fourths of these side effects were associated with the off-label uses. Is anyone seeing a problem here?

Well, in July 2008, the FDA must have thought so. They issue a warning regarding off-label Infuse bone graft use. Citing nearly 200 adverse reports of serious complications related to off-label Infuse bone graft use on the cervical spine, they warned of risks.

In November of this same year, the Department of Justice (DOJ) got involved and began investigating Medtronic for illegal advertisements of the Infuse graft. Also, in November 2008, Medtronic paid out 40 million dollars in whistleblower lawsuits related to Infuse.

July 2011 found life not improving for Medtronic when The Spine Journal published negative findings on Medtronic's integrity. They reported that Medtronic had paid researchers to not report negative findings including bones dissolution, cancer, sterility in men, increased pain in back and legs, and infections. They ignored the fact that in 13 clinical trials paid for by Medtronic across a 10 year time span from 2000 to 2010, these complications occurred in anywhere from 10 - 50% of patients.

The story ends at this point in May of 2012 when the DOJ closed their investigation into the Medtronic practices. Alleging Medtronic paid physicians to publish good Infuse studies, the investigation also claimed failing to reveal that 85% of Infuse sales were dependent on off-label use.

What is transvaginal and what is the mesh patch designed for?

This mesh product was originally approved by the FDA 501(k) approval process program for Boston Scientific to manufacture as Protegen. The mesh would be inserted through the vagina and help permanently treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). It was believed to be the solution that would help solve POP and SUI and help return women suffering with this condition to a normal functioning life.

POP and SUI are caused when a woman's pelvic muscles weaken secondary to childbirth or other causes. When this occurs, abdominal organs can fall and a woman's life can be seriously disturbed, surgery required, etc.

Thus, the story of the transvaginal mesh patch began.

• 1996 - FDA approves Protegen
• 1998 - FDA discovers 2/3 of complaints against Boston Scientific related to transvaginal mesh
• 1999 - Boston Scientific recalled Protegen after complaints of pain during intercourse and erosion of vaginal tissue
• 2003 - Undisclosed settlement amounts in 738 lawsuits related to transvaginal mesh for Boston Scientific
• 2007 - FDA besieged with over 1,000 reports regarding signs and symptoms of complications related to transvaginal mesh. Signs and symptoms included: erosion of vaginal tissue, pain, infection, urinary problems, and the recurrence of POP and SUI (which the mesh was supposed to fix).
• 2008 - FDA does not pull the product, but issues warning. Transvaginal mesh may cause rare adverse effects but are potentially serious
• 2010 - Almost 3,000 reports of transvaginal mesh adverse reactions. 7 reports of death. 300,000 women now have mesh implants according to FDA.

• 2011 - FDA recommends transvaginal mesh moved to high-risk classification
o Manufacturers must conduct human studies
o Investigated 110 studies which included data on almost 12,000 women to determine that about 10% of women who had mesh implant for POP repair had occurrence of erosion within 1 year

• 2012 - 35 vaginal mesh manufacturers ordered by FDA to study the complications related to transvaginal mesh products. Because of this C.R. Bard stopped marketing the mesh in the U.S.
• 2013 - With greater than 8,000 transvaginal mesh implant claims in process, the first trial begins. Plaintiff claims 18 surgeries to correct problems associated with Johnson & Johnson's transvaginal mesh product.

With such rapid, consistent progression from concept to court, the transvaginal mesh will likely hit the law history books this year. Though POP and SUI are surely a problem for those women suffering from these conditions, the "fix" of the transvaginal mesh is truly no "fix" at all.

Asbestos is one of the most known causes of man-made cancers. This product, identified over half a century ago as a carcinogen responsible for mesothelioma cancers and other asbestos-related illnesses and deaths is still being manufactured.

Really? YES!

Do you know about asbestos? Do you really know about asbestos?

• 1979-2001 - contributed to 230,000 deaths
• Tied to mesothelioma, asbestosis, lung cancer, and GI cancers
• 30 people die every day from asbestos-related illness
• IS NOT banned in U.S.

United States consumption increased 35% in 2011. Of the 820 metric tons of asbestos consumed in the U.S. in 2010, 72% was for roofing products.

Where is all this Asbestos?

First of all, it's everywhere. Home, work, gym, church, grocery, and more. There are few places that it probably doesn't reside. In newer buildings and dwellings, the chances are decreased, but could still sneak in if you are not conscious of the products used for building.

One in three occupational cancers is believed to be caused by asbestos. Home asbestos exposure is believed to account for thousands of death, as well. Remember...30 people die every day! There is no safe way to be exposed!

Older homes built before the 1970s are more likely to have asbestos in them. Here are some home areas to be wary of:

• Roofing materials, gutters, furnace flu, siding, paint, window putty
• HVAC duct insulation, insulation, wiring & pipe insulation
• Paint, recessed lighting, acoustic ceilings, floor tiles, cement wallboard
• Generators, fertilizers,
• Range hoods, dishwashers, clothes dryers, outlets

After reading this list, it makes you more wonder what is safe.

What about professions?

Many manufacturing, construction, tradesmen, and industry professions are high risk for asbestos exposure.

Manufacturing Construction Tradesmen Industry
Machinists Roofers Shipbuilders Coal miners
Boiler operators HVAC Welders Power plant workers
Sanders Painters Firefighters Iron workers

There are literally hundreds of professions at risk and therefore thousands, possibly millions of people. Actually, it's estimated there are up to 35 million homes and other building which contain Zonolite, an asbestos-containing insulation.

Zonolite is not the only widespread asbestos product. Touted as the next great scientific discovery for many years, asbestos found its way into many everyday products.

• Vinyl flooring
• Sheetrock
• Paints
• Brake linings
• Oil filters
• Certain piping
• Snow - this was actually used in the Wizard of Oz

Since 90% of mesothelioma cases are linked to this dangerous killer, remember most importantly that asbestos is dangerous. No level is safe, no matter what. Most asbestos abatement professionals agree that if asbestos is present and stable, LEAVE IT ALONE. Asbestos is more dangerous when it becomes unstable. Get away and stay away, if possible.

Pradaxa is an anticoagulant. This type of drug helps prevent blood clots which can lead to life-threatening conditions such as heart attack, strokes, and occlusions of other vessels secondary to blood clots. Pradaxa is manufactured by Boehringer Ingelheim.

Patients receiving any type of anticoagulant therapy must be closely monitored for side effects. Diets must be monitored as well because certain foods and drugs can increase or decrease the effectiveness of this type of medication regimen.

Warfarin, a long-standing favorite in the anticoagulant industry and care of patients requiring anticoagulation therapy has long been the envy of many industry competitors. Therefore it is not surprising that Pradaxa was marketed as being superior to the age-old warfarin. However, it has been suggested in medical studies that Pradaxa is likely far more dangerous.

Common side effects include:

• Increased risk of nose bleeds and headaches
• Unusual bleeding and bruising
• Coughing up blood
• Bloody stool
• Discolored urine
• Swelling of legs
• Indigestion

Listed Serious side effects include:

• Gastrointestinal (GI) bleed
• Heart attack
• Brain hemorrhage
• Death

Despite claims from Boehringer Ingelheim that Pradaxa is superior to warfarin, the risks inherent in its young history appear not to worth the risk of the pill. However, Boehringer themselves reports Pradaxa to have caused 50 deaths but believes this to be reasonable.

Statistically, 50 deaths may be reasonable over an entire population for some specific reason. However, when affording that quantity of loss of life to a medication one would hardly consider it so. Further statistical findings continue to shine a graying light on this anticoagulant therapy newcomer.

• Medical journal, Therapeutics Initiative published a statement to the effect that Pradaxa should never have been approved because their clinical trials were flawed.
• A published medical study by Cleveland Clinic called Annals of Internal Medicine reported a 33% increased risk of myocardial infarction (heart attack) with Pradaxa
• Since Pradaxa's birth in the marketplace in 2010, nearly 18,000 adverse effect reports have been made

Much worse than the medical journals and the studies and beyond the adverse effects the statistical evidence against Pradaxa is nothing less than astounding.

• 35% increased risk of GI bleed (these can be deadly)
• 16.6% of all patients suffered abnormal bleeding

The worst statistic of all is this: a drug purported to save lives, trusted by many to save them or decrease their risk for life-altering events, is suspected as the primary cause in 1847 deaths.

Drugs, money, claims, risks, journal, and published papers mean nothing at this point. Dead is dead and Pradaxa is believed to be responsible for over 1,800 of them.