In a video we produced, Attorney Cal Warriner discussed the practice of pain pump manufacturers promoting the use of continuous flow infusion pain pumps for uses never approved by the Food and Drug Administration. In fact, pain pump manufacturers were, in some cases, told to remove orthopedic use from their written materials.

Tragically, pain pump manufacturers went to what appears to be substantial efforts to market their pain pumps for use directly in the joint space (intra-articular) and went from doctor to doctor; from conference to conference; promoting this unapproved use.

The FDA now has issued another notification, this time in the form of a video, which concludes the manufacturers used the pain pumps in a way not approved and recommended drugs for use in the pumps for which they conducted no testing for the intended their use.

Yet, these same manufacturers continue to argue to judges that they should be dismissed from lawsuits. This is being argued before a jury can hear that their use of the pain pumps was unapproved and their selection of drugs for us in the pumps was untested. Their attitude is typical of trying to pervert the law in the interest of corporate avoidance for their poor judgment and circumvention of federal guidelines.

It only takes a quick look at the local news to realize that Florida has a drunk driving problem, just like the rest of the nation. The National Highway Traffic Safety Administration (NHTSA) recently a published a Research Note on Fatalities and Fatality Rates in Alcohol-Impaired Driving Crashes. The study looked at the total number of deaths caused by motor vehicle crashes and compared that to the number of deaths resulting from crashes where alcohol was involved. The report defined an alcohol impaired crash death as a crash involving at least one driver or operator with a blood alcohol concentration of .08 grams per deciliter.

The government estimates that 2,978 people died in motor vehicle crashes in Florida in 2008. Crashes involving drunk drivers account for 875 of the 2,978 deaths. The good news is that NHTSA reported that the alcohol impaired driving fatality rate declined in 40 states. The bad news is that Florida is one of only 10 states where the alcohol fatality rate either stayed the same or increased. From 2007 to 2008, the alcohol impaired driving fatality rate declined nationally from 0.43 to 0.40 fatalities per 100 million vehicle miles travelled. However, Florida’s alcohol impaired driving fatality rate is higher than the national average. From 2007 to 2008, it remained unchanged at 0.44 fatalities per 100 million vehicle miles travelled. Floridians should strive to reduce the alcohol impaired driving fatality rate; to do nothing will be fatal.

Floridians who want to help reduce the number of drunk driving fatalities should consider donating or volunteering with a local chapter of Mothers Against Drunk Driving (MADD).

In legal cases, a term regularly shows up: “standard of care”. It is talked about, defined and ruled on by the court. In many state statutes, the term is defined as something similar to: “that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.”

What is the standard of care in its most basic terms?

If I am a pedestrian, do I have a “standard of care” as I walk along the street? Of course I do. I must watch the pavement as I am walking so as not to trip over obvious hazards. If I come upon a blocked area of the sidewalk, where work is being done for example, I have the duty to navigate carefully and as safely as I can around that hazard in continuing my walk. I have a duty to avoid running into other pedestrians using the sidewalk. If I must cross the street, I have a number of additional duties I must fulfill.

Why do we have “duties” and “standards” by which we must act? Without them, no one would know what was expected of them and we would not be able to anticipate how to expect others to conduct themselves in given situations.

A car is traveling down a dark, deserted country road, approaching an intersection with a stop sign. The car does not stop at the stop sign and, instead travels through it at highway speed. No other cars were approaching the intersection at the time. Was the driver negligent? Did the driver deviate from the reasonable standard of care? The driver was negligent, but, luckily, caused no damage to anyone. So, if a police officer was around, a ticket would be issued, but nothing further.  So, was it excusable, since no one was hurt? Absolutely not. The same example, but the approaching driver does not see an approaching motorcycle. The motorcyclist is struck and killed. A completely different set of circumstances results, but culminate from the exact same perceptions on the part of the driver in the car. In both situations, the driver “honestly” saw no harm by running the stop sign.

This is particularly true for professionals. The public absolutely must be able to depend on certain standards of performance from professionals. For an engineer who constructs a bridge, we expect that the bridge will carry the weight reasonably expected and will not collapse with that weight. We expect that the professional will act in a manner expected from other similar professionals.

When a doctor decides to treat people, she decides to work within a reasonable standard of care accepted by other physicians. Does that mean if a physician or other professional makes a mistake that they have deviated from the acceptable standard of care? Not necessarily. It means that the professional is obliged to act reasonably as judged by similar health care providers.

If a patient arrives at the hospital with symptoms consistent with 3 or 4 different potential illnesses, it is the job of any physician to determine those illnesses, which are life threatening and try to eliminate or include those first. If the condition could be life threatening, the professional is obligated to continue their investigation until they can determine what course of treatment is best for the patient.

Physicians, like any professional, have pressures extraneous to their profession. In the case, of an engineer, it may be cost overruns and their client may be pushing to cut corners somewhere to minimize those cost overruns. With physicians, it may be a hospital or insurance company. It is the job accepted by the any professional to comply with the reasonable standard of care. In the case of physicians, it is to determine those patients who require hospitalization in order to determine their illness and those who do not need hospital care.

Professionals are required to reach reasonable, well thought, courses of action within their profession. They typically go through additional schooling to prepare them for evaluating a reasonable course of action.  The subject of a professional’s decision may seem complex, but their standard of care is no less real than the driver or pedestrian.

Jurors returned a verdict in the amount of $1,094,034.30 on Friday, February 12, 2010 for a young man tragically injured in a crash with a Palm Beach County School Bus.

The 14 year old boy, Altavious Carter, was being driven home by his basketball coach after practice. The coach made a routine stop at a red traffic light. A Palm Beach County School District bus was traveling at 45 or 50 miles per hour, approaching the unsuspecting 14 year old basketball star. For reasons still unclear, the bus failed to slow; failed to stop; and rear ended the vehicle where the 14 year old was appropriately seat belted. The 14 year old boy, who loved basketball, suffered a broken neck and other serious injuries.

Not surprisingly, the Palm Beach County School District admitted their fault in the accident and the case went to trial in Palm Beach County last week. The School District argued they should not owe the young man more than $250,000 for his very significant injuries; because they argued he had failed to suffer a permanent injury.

Searcy Denney attorneys, Brian Denney and Jack Hill, tried the case to a jury of six Palm Beach County jurors.

This young man has fought a valiant battle in coming back from his injuries. Doctors feared he would be paralyzed, but this young man has demonstrated a heroic courage. He has had very limited resources with which to rehabilitate himself and has largely been successful through sheer strength of will.

Because the School District of Palm Beach County is a “sovereign immune”, governmental entity, it is not likely they will voluntarily make payment of the verdict. It will be necessary to win a claims bill submitted to the Florida legislature before any payment will be made to Mr. Carter. Although the battle is not over Attorneys Denney and Hill are ecstatic that their client will have the funds to go forward in his life on a more positive basis than he has been able to do so far.

Japanese auto giant, Toyota, has been under fire in the last few months over recall woes for sticky brake pedals and mats that entrap the accelerator pedal. Twenty deaths have been blamed and linked to the faulty gas pedal and YouTube has videos and 911 recordings of people whose Toyota has sped out of control.

Our faith in a brand that for years has ensured safety and quality is now tarnished. The lack of importance Toyota initially put on the recalls and their quickness to repair these defects has consumers fuming. Toyota is also accused of taking far to long to recall the cars in the first place. Reports on sticky pedals in Toyota’s have been documented back to 2008. It has recently been acknowledged that Toyota has known about customers complaining about sticky accelerator pedals in the UK since late 2008.  Toyota only went public on these complaints after British government safety officials alerted US counterparts who were handling a massive deluge of complaints about the sticking accelerators. This exposure led to Toyota’s recall of 12 of its popular vehicles, with some 2004 models being involved in the recent recalls. Toyota has recalled nearly 8.5 million vehicles since November 2009 around the world.

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In a Press Conference on February 3, 2010 Sen. John McCain announced his intention to introduce a new bill that would amend DSHEA (Dietary Supplement Health Reform Act 1994) requiring manufacturers of Dietary Supplements to register and disclose all ingredients.

In the Press conference McCain was quoted “All we’re saying is, list the ingredients, OK?” “And register so people will know what they’re taking into their bodies. It’s not really outrageous when you think about it.”

Council for Nutrition CEO, Steve Mister, responded “The responsible dietary supplement industry represents the health and wellness interests of more than 150 million Americans who use dietary supplements each year. We have consumers’ health and best interests at heart because we recognize that without our consumers, we would not exist as an industry. ”

According to the Bill the definition of “new dietary ingredients.” Would be replaced by “‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary.

If the Bill gets passed the  FDA will have authority for mandatory recall as it has now only with medical devices and prescription drugs. The FDA could then determine and act  if there was reasonable that a product marketed and/or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded.

Presently the FDA, even with the new CGMP (Good Manufacturing Process) rule to fully roll out in 2010, has no power to enforce or recall a suspected dangerous product or conduct testing on any product for safety and efficacy. Interestingly as more reports of dangerous tainted dietary products hit the news even some manufacturers of Dietary Supplements have an voiced support legislation to ensure the health of the billion dollar supplement Industry by slowing the erosion of trust in the safety of their products.

The bill outlines proposed new changes that include:

• New facility registration requirements to identify all brands, products, and ingredients
• A revised definition of new dietary ingredients (NDIs) that would rely on an FDA-generated positive list of allowed ingredients
• Extension of existing adverse event report (AER) requirements, such that even minor AERs would need to be submitted to FDA annually
• Policing and record maintenance obligations for downstream manufactures and retailers, who will be obliged to obtain written confirmation, from ingredient suppliers or from supplement brand marketers, respectively, of compliance with facility registration and product notification and rules.
• Obligations and authority for FDA with regard to removing products that present the risk of serious adverse health consequences or death, or are adulterated or misbranded

Pain pump manufacturers did it wrong. If we are practical, the conclusion is inescapable… pain pump manufacturers have been sued in hundreds of cases because they deserved it. They gambled…they were caught… and they should pay patients who have suffered devastating injuries. Opinion? I suppose, but let’s look at the facts and you decide.

The manufacturers would tell you they are the victims of trial lawyers and that no scientific data exists that will reliably relate use of their pain pumps to a condition called chondrolysis. In fact, pain pump manufacturers across the country have been telling judges, opposing counsel and anyone else they can that any evidence their pumps caused chondrolysis is simple coincidence, happenstance, accident. In other words, do not look at the little man behind the curtain; listen only to the “great and mighty Oz”.

Is this true? Has the mighty Oz spoken? No and yes. The mighty Oz is certainly speaking, but the truth is certainly not found in the Land of Oz.

Pain pumps work, at least as sold by the manufacturers, by the use of a catheter attached to a pump at one end and inserted into the joint space at the other end. Pain medications, typically marcaine or bupivacaine, are inserted in the pump and injected into the joint space over a period of 48 to 72 hours. Based on this design and the use promoted by pain pump manufacturers, what is the one thing, amongst all others, you would want to know? Go ahead, you know, say it — right, you would want to know if it is safe to inject these drugs into the joint for the length of time suggested.

Did pain pump manufacturers conduct studies to determine whether using their pain pumps in the ways they recommended would cause injury to patients? They did not. I know, I was shocked, too. That’s right, they sold the product, recommended to physicians the way to use the product, but they never studied what complications to which patients might be subjected.

In 1985, a study was conducted, which gauged the effect of bupivacaine on articular cartilage. As a result of that study, the investigators determined that increasing concentrations of bupivacaine caused damage to cartilage. They recommended further study. Did pain pump manufacturers know about this study in 2000? Of course they did.

A study was published in June of 2009, Postoperative Chondrolysis of the Knee; 3 Case Reports and a Review of the Literature, by Eric Fester et al. In that study, the authors review all the literature relating chondrolysis to pain pump use and their own findings in (3) patients.

In their study, through their own experience, training, and a review of the available literature, they concluded that chondrolysis suffered by their patients was caused by the use of pain pumps with bupivacaine. The conclusions drawn by these researchers are interesting:

“In summary, there is currently a significant amount of in vitro and in vivo evidence that the use of pain pumps with bupivacaine and epinephrine may lead to significant chondrolysis when placed into a joint. We agree with Bruce Reidel that one contemplating the use of intra-articular medications must be confident with their morbidity. Until this association between intra-articular pain pumps and chondrolysis is better understood and characterized, we do not recommend the use of intra-articular pain pumps. Also, further research is necessary on the potential deleterious effects of single bupivacaine joint injections, as well as other local anesthetics placed intra-articularly.”

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The federal government’s Center for Disease Control confirmed on Monday what many have believed and feared for months — the incidence of cancer among children living in the Acreage is substantially higher than would reasonably be expected based on national statistics- three times higher. The bad news is that the federal government has confirmed the existence of a “cancer cluster”. The good news is that the federal government has confirmed the existence of a “cancer cluster”.

The news is bad because behind the finding is the terrible tragedy that many Acreage families are already suffering. It is bad because of the terrible dilemma that confronts so many others faced with having to choose whether to abandon their homes to protect their family’s health. It is bad news because it reinforces the fear that already exists that leaving the Acreage now might already be too late.

However, the CDC’s “cancer cluster” confirmation is good news because it opens the door to additional federal resources essential to the welfare of the Acreage community. The need for a very careful and thorough investigation is now undeniable.

We now know for sure there is a serious health problem. The very important question of who or what has caused that problem remains unanswered, but Monday’s announcement raises the level of confidence that private and public efforts will find the answer.

Palm Beach County Health Officials plan to hold a forum:

What: Palm Beach County health officials plan to discuss their interviews and population research at a public meeting.

When: 6:30 to 8:30 p.m. Feb. 9.

Where: Seminole Ridge High School, 4601 Seminole Pratt Whitney Road, Loxahatchee, FL

A jury in Oregon state court delivered a verdict of $5.5 million against I-Flow Corporation for causing devastating, permanent injuries to Matthew Beale by promoting the use of I-Flow pain pumps in joints.

The pain pumps, like those used on Mr. Beale, were promoted by manufacturers including Breg, Stryker, McKinley and I-Flow to physicians for use after joint surgeries.  The theory was insertion of a delivery system that would place pain medicine at the area of surgery would allow for greater pain relief for shoulder, knee and other joint surgery patients.

As with drugs and other medical devices, the theory sounded very good, but, as the FDA told manufacturers, testing would be required in order to safely market the devices for placement in the joints.

Pain pump manufacturers ignored the FDA by conforming labels to FDA requirements and then sending their marketing force out to promote the off label use inside joints. So, sales forces were sent out by each manufacturer in a frenzied effort by each to gain market share. What the manufacturers did not do is any meaningful studies on the results of injecting pain medicine directly into patient joints.

Effectively what pain manufacturers decided is to allow the public to be the guinea pigs for testing and not to tell physicians the pumps had not been approved for in joint placement.

When manufacturers were caught and it was clear their untested devices were causing devastating injuries to young, active people, they were slow to pull the devices or to alert physicians. Instead, they spent their energies trying to find ways to bury discredit the findings. Finally, as the result of lawsuits, they were forced to alert physicians and to withdraw their devices from use inside joints.

Sadly, the pain pump manufacturers’ decision to discourage the unapproved use they had previously promoted was far too late for hundreds, perhaps thousands, of innocent victims.

Now, relatively young people in the age group of 20 to 55 will be forced to undergo multiple surgeries in attempts to correct the devastating damage done by the unapproved use of the pain pumps. Many patients will be forced to experience full joint replacements and, because of their young ages, possibly one, two or three additional joint replacements or revision surgeries during their life will be required.

It seems pretty clear to any informed person that chondrolysis, a relatively rare condition before pain pump use was promoted, has now resulted in significant increases in damaged cartilage. Chondrolysis is a condition in which the cartilage is essentially destroyed and the patient is left with no protection inside the joint. In plain terms, imagine pouring battery acid on the cartilage inside a patient’s joint and you have the damage caused by pain pumps inserted inside the joint. The results are severely damaged joints and hundreds of thousands of dollars in medical care.