The government recently announced that it would fund a billion-dollar government-run drug development center to help create new drugs. The National Center for Advancing Translational Sciences will be tasked with creating new drugs and, according to the Director of the NIH, “any project that reaches the point of commercial appeal would be moved out of the academic support line and into the private sector.”

I already have strong feelings about the government’s involvement in the private sector and business. I have even stronger feelings about the government spending enormous amounts of taxpayer money to get into the pharmaceutical business.

We also need to ask who will be responsible and liable for the defective or dangerous drugs that will reach the market. Who will pay for the lives damaged by the unforeseen side-effects of these government-created drugs? The federal government will certainly cloak themselves with immunity. The private sector distributors or marketers will certainly negotiate their own liability to a minimum. Does this mean that all government drugs will carry a disclaimer of liability? Has anyone asked, much less answered, these questions?

I asked my nursing and Certified Legal Nurse Consultants friends on Facebook what they thought of the announcement. Here are some of their responses:

“I work in government – it seems to me if the concern is the slow pace, putting it in the hands of bureaucrats will not help.”

“The Government has absolutely no business in the private sector. Big problem currently. I would encourage everyone to go back and read the documents of our Founding Fathers and then ask yourselves these two questions. How in the world did Americans survive and thrive for the first 150 years or so? Why are Americans becoming more unhealthy and dying at younger ages? I don’t believe the increasing health issues are related to a lack of drugs that’s for sure.”

“This stinks. How many more chemicals are we going to throw into people’s bodies? How many more heart attacks, strokes, paralysis, etc are we going to cause by using invented medicines? Maybe doing research on alternative supplements would be the better suggestion. There may be more money in prevention…wow prevention.”

“If God meant us to eat from a carton or heal ourselves from a bottle, he would have hung those items on the trees or stacked them on the forest/ocean floors for us to find!”

“My first thought is that soon we will ALL be working for the government regardless of what field we are in! From my understanding, the FDA takes a long time to approve the use of any new drugs, much longer than many other countries. I wonder if this process will speed up when the government is making the new drugs?”

“I look at it this way! Where is the government when it comes to regulating cost of insurance? Well we’ve all seen what that has cost the nursing field… more patient to nursing ratio without regards to what it cost as far as quality nursing care. I feel that it will be a great injustice to the welfare of future nurse patient care. Lord Please help us all if this comes to pass.”

“No! Government is too involved in health care as it is.”

“Government has all it can handle dealing with government. They don’t need to be involved in developing drugs, banking or any other business.”

“This can best be done in the private sector. If the government would have stayed out of healthcare to start, new drug research would continue apace. Show me anything the government has done in a cost-effective efficient manner! It doesn’t happen. And where is the constitutional authority for federal government drug development?”

“I think the government has more than enough on their plate as it is without trying to branch out into places it knows just about nothing about!”

“If the government delves into research and development, who will provide oversight?”

“Although I don’t believe that the government needs to “control” our health care, I do believe that in this day and age and in this great country everyone deserves access to quality health care! The drug and insurance companies are running-or should I say ruining our country.”

“Fiscally, there is always the catch that government is spending someone else’s money for someone else’s benefit – Never a fiscally sound arrangement!”

“We have become so dependent on pharmaceuticals in this country! We want tiny little pills to fix everything – including poor decision making! Now please excuse me while I go pour another cup of coffee and snack on some potato chips!”

“The federal government should keep their hands off of drug research. The federal government shouldn’t waste their energies but rather concentrate on economic problems pertaining to healthcare like the jobless RN professionals who settle for a meager income. Think of a decent program for the new RN grads.”

“I am an RN who has thirty years of pharmaceutical clinical research experience and this is the scariest thing that I have heard yet. People may balk about the 10 years and one billion dollars in research money that it takes to develop a drug but this is how we ensure that patients are safe and our drugs are safe. Hasn’t the government gotten in the way of enough? Who makes them experts on research? Where are the statisticians, chemists, preclinical people and clinical people to develop these compounds? Scary as all heck.”

As you can see, not a single nurse thinks this is a good decision. Here’s another interesting question: Why are nurses left out of these important decisions?

Success Is Inside!

Allergan Medical – remember them? The fun folks who brought us Botox are at it again. They’ve got a new product on the market called Latisse. Does it help a medical condition? No. Does it create the perception of a medical condition? That depends on your point of view and to me it depends on whether or not you’re a consumer and then, it depends on what you think of the FDA and its “stamp” of approval.

Latisse creates thicker and longer eyelashes. According to The New York Times, since Allergan brought this into our lives, via advertising with the obviously “eyelash-inadequate” Brooke Shields, they’ve sold more than $12M worth of this new product. But before you throw away your mascara, wands and spoolies, here’s the rub, or the wiggle, if you will. You can’t buy Latisse over-the-counter; it’s available by prescription only. And, as prescription only, has been approved by the FDA. So, no quick trips to the makeup counter for you. The only “FDA-approved” way you can get fuller, longer eyelashes is with your doctor’s orders. Just try submitting that to your insurance company!

As nurses, we know that FDA approval doesn’t mean a product is safe. I’ve discussed all sorts of products here before that have achieved FDA approval but later turned out to have bad side effects. Does the average consumer understand that? Do they think that “doctor-prescribed” means it’s a good, healthy and safe thing? Do they believe that side effects won’t affect them? After all, isn’t everything that doctors prescribe good for us, and even more so if it’s got the FDA’s seal of approval? Many of us have lived through the age of “better living through chemistry” and found it to be all lies, resulting in coworkers strung out on sleeping pills, anti-depressants or worse.

If you’re like me, don’t you think it’s time for the pharmaceutical companies to stop putting those “ask your doctor about Ineeditnowacol” ads on TV and in magazines? I see these adverts and commercials and half the time don’t know what the medication is for. But I do hear and see the warning that Ineeditnowacol isn’t for everybody and may cause liver or kidney failure, high blood pressure, low blood pressure, internal bleeding, sore gums, sore bums, feelings of depression, hyper-elation or loss of appetite. But does everybody read and understand these warnings? I don’t think so.

I’ve said before it’s time to stop medicalizing conditions as an excuse to sell more drugs. I can understand remedies for allergies, arthritis pain and hay fever, but “eyelash inadequacy?” It’s time to stop hitting consumers with advertisements that make us feel inadequate and instead concentrate on real medical conditions.

While you’re figuring out what you need to have treated next (and why), I’ll be helping myself – to a big cup of healthy green tea and some real foods rich in Omega 3s.

Success Is Inside!

People, including my 85-year-old father, who suffer from aberrant heart rhythms received a shock (literally) last year when Medtronic, manufacturer of the Sprint Fidelis leads used to connect electronic defibrillators to their hearts, were malfunctioning at rates higher than those of other leads. The leads were later pulled from the market, but were not pulled from the recipients. Depending on who you believe, anywhere from 87.9%-94.3% of the leads are still functioning in patients. Many of the recalled electronic defibrillators cannot be changed or removed without a risk of harm to the patient.

Earlier this May, the Heart Rhythm Society, a heart-doctor group representing MDs who implant and extract defibrillators and their associated leads, issued policy statements calling for hospitals to better police the experience and training of the surgeons who extract defibrillator leads. They also issued a statement calling for companies that produce the leads to do a better job of tracking their performance once they’re on the market.

A Certified Legal Nurse Consultant participating in a case where there’s suspicion of a malfunctioning cardiac defibrillator, its leads or an injury that occurred while the leads were being removed, should look closely at the experience of the doctor who connected or extracted the leads. While the new guidelines have yet to take effect, the training and experience may be relevant to the injury. Defense Certified Legal Nurse Consultants may be able to raise the level of experience in the defense of the doctor while plaintiff-side CLNC^® consultants will raise lack of experience as evidence of negligence.

The medical-device manufacturers never fail to shock me!

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Homes across the U.S. are smelling like rotten eggs. There’s actually a deeper reason than a teenage boy’s socks. Depending upon the age and location of the home, it may contain defective drywall. We’re all aware of the environmental problems and issues associated with China and its pollution, chemical spills and lead paint in children’s toys. But there are other ways that defective products can get into a home. One of which includes building or repairing the home with defective products (and the watchdog in this case is not the FDA)!

Between 2004 and 2007, millions of pounds of defective drywall were imported from China and used to build and repair homes in the U.S., especially in Florida (and 12 other states). The Chinese drywall in question contains large concentrations of sulfur compounds which, when exposed to humidity or moisture (like in Florida), emit sulfuric acid causing not only health problems but also damage to a home, its electrical wiring and its contents (human and otherwise).

Certified Legal Nurse Consultants screening cases in the concerned states that involve respiratory problems accompanied by persistent coughing, recurring headaches, nosebleeds and eye irritation might consider investigating whether the potential plaintiff(s) live in a home or building constructed or extensively repaired during that 2004-2007 period. Follow-up questions might include asking about a persistent rotten egg odor (smell of released sulfur), intermittent problems with electrical appliances or wiring (due to sulfuric acid exposure) and even whether the potential plaintiff has recently had to replace an air conditioning coil (new air conditioning coils should last in excess of 15 years). Jewelry and pennies turning black from corrosion is another possible indicator of exposure. The Consumer Product Safety Commission (CPSC) is investigating the problem and you can read a copy of their warning here.

Search the Internet for terms such as “Chinese drywall” to locate attorneys who are handling these cases. Legal nurse consultants should also pay attention to the news for reports on these cases and the attorneys associated with them.

Success Is Inside! (just stay outdoors),

Last year, Botox^®, a medication containing Botulinum Toxin A, was routinely injected into over 2.5 million Americans and generated $1.3 billion in sales. All this despite reports that Botox could cause symptoms similar to botulism, loss of bladder control, blurred vision, trouble breathing, swallowing and talking (not because of the size of those lips). Certified Legal Nurse Consultants working for plaintiff and defense firms should be aware that on April 30, 2009, the FDA issued a statement that all botulinum toxin products (including Botox and Botox Cosmetic) carry a black box label warning as well as a risk evaluation and mitigation strategy (REMS).

A black box is the strongest safety warning that a medication can carry and is so named for the black border that usually surrounds the text of the warning. These bold-faced labels carry risk information and are most often found on medications that have a probability of serious or life-threatening side effects. When combined with the REMS, their purpose is to alert healthcare professionals prescribing or dispensing the medication, as well as the patients receiving it, to health issues and dangers associated with its use. Botox, Botox Cosmetic, Myobloc^® and Dysport^® will all carry the FDA warning. Consumers experiencing serious adverse events (med-speak for side effects) from use of any of those products can report them to the FDA online as part of the FDA’s MedWatch Adverse Event Reporting program.

While the placement of a warning on the box does not free the manufacturer or healthcare professional from liability for damages caused by the product, it may give rise to an assumption-of-the-risk defense in certain cases. Botox and its kin are not used solely for cosmetic purposes. They do have some legitimate medical applications (treatment of cerebral palsy and cervical dystonia). I’ve always felt that we can’t insert or inject a foreign substance into our bodies without expecting some sort of side effect. So the next time a friend or relative tells you they’re considering the cosmetic use of Botulinum Toxin A to reduce wrinkles or to stop sweating, the savvy legal nurse consultant should tell them to consider that they’ve been warned.

Success Is Inside (naturally)!

I recently mentored a CLNC^® consultant on how to help her attorney-client learn whether a plaintiff had been given Zimmer Duron Cup hip replacements (sales suspended due to high rates of failures) and I started looking at the sheer number of products that have placed us all at risk.

It’s just incredible. The diversity of recalls is amazing. Foods, products, supplements and, of course, implants – everything is out to get us. Think about it, we’ve learned that the peanut butter we pack for our children’s lunches is potentially contaminated with salmonella. The pistachios we sneak into the movie theatre may also be out to get us (more salmonella). The tuna sushi we snack on at happy hour elevates our mercury levels (I can always tell Tom the current temperature) and the “heart-healthy” salmon we eat for dinner is contaminated with PCBs (if it’s not wild Alaskan). When we microwave butter-flavored popcorn to enjoy with our Netflix movies on Sundays, we risk poisoning our family’s lungs. Even the red wine we drink to forget our other problems may have more contaminants than tap water. Take note for the future, even Poligrip and Fixodent (I’m not there yet) have been linked to peripheral nerve damage (so that’s what’s wrong with grandma!).

What’s a Certified Legal Nurse Consultant to do? We can’t live in a cave or go underground (due to Radon) until all this passes us by – because it won’t. Legal nurse consultants live and practice in a wide, wide world of torts and this world is just going to keep getting more complicated. I don’t believe drugs are the answer to all our problems as the pharmaceutical industry would have us believe. In the past I’ve discussed the medicalization of health issues and feel that the more we come up with cures or medications for conditions, that may not really be conditions, the more side effects we’ll see.

I agree that some people may need Digitek^® to control abnormal heart rhythms (recalled 4/25/09), Fosamax^® for osteoporosis (linked to ostenoecrosis of the jaw) or Ortho Evra^® birth control patches (for you know what) which are possibly exposing women to excessive estrogen (which has been linked to blood clotting, stroke and heart attacks). I don’t even know what Gadolinium is or what it’s used for but I’ll be sure to avoid it because there’s a warning out for it!

Products liability is a great field for Certified Legal Nurse Consultants and there are lots of attorneys practicing in this area – on both the plaintiff and defense sides. Accutane^®, Cipro, Byetta^®, Raptiva^®, Darvon^®, Oral Sodium Phosphate and Avandia^® are all subject to warnings, recalls or worse and the list just keeps growing. Just type any one of these drug names into Google and you’ll find lots of attorneys practicing in this field.

The Internet certainly makes things easier for us – not only to locate clients but to get the word out about what’s possibly harmful to us. Certainly, some of these warnings may end up being overblown, and may cause some panic or anxiety, but don’t you think we as consumers would rather be warned than taken by surprise? Shouldn’t we have the right to choose our drugs after we read about the potential side effects?

We live in tumultuous times and they’re being made into dangerous times. Take advantage of the resources available to us these days and learn about these harmful products not only to grow your legal nurse consulting business, but also to avoid harm to your family.

Success Is Inside!

P.S. Comment on your most recent products liability case.

When I was a young girl, my father didn’t eat leftovers (still doesn’t). That caused my mom to be very careful about how much food she would prepare for meals. My sister, Karen, still jokes with me that mom would prepare only five pork chops (one of our favorite dishes) and not one more (despite our pleas). I hadn’t really thought about pork since my letter to President Obama or pork chops since the last time Karen and I talked about Mom’s pork chops.

That all changed this week when I was having a skylight repaired in my bathroom. The ceiling is pretty high so it required a long ladder and two repairmen – one to do the work and one to steady the ladder. Naturally the guy holding the ladder got bored quickly and became quite chatty. At one point, apropos of nothing, he mentioned that he couldn’t wait for lunch. I overheard him and asked him if he’d had breakfast (healthy green tea and a healthy breakfast is an important way to start your day). He told me he’d had a small one – his wife didn’t cook him any bacon to go with his eggs. I replied that he was lucky on two fronts: (1) his wife cooked him breakfast (I was glad Tom didn’t hear him say that) and (2) she’s helping him watch his diet.

He replied that it wasn’t his diet she was worried about, it was catching swine flu from the bacon. I laughed and told him he could safely tell his wife that you can’t get the swine flu from eating bacon or other pork products. In fact, I went on to tell him that unless she was sleeping with an infected pig or had a sick pig running around the house she was safe. Just as I was getting started on a lecture regarding the facts surrounding swine flu, I noticed his eyes began glazing over (just like an attorney’s do when a legal nurse consultant goes on too long about their services without engaging in their positioning strategies). I cut to the chase and said, “Tell your wife that the best way to beat the H1N1 Influenza A virus (we can’t call it swine flu anymore because we’re apparently offending pigs) and just about any superbug, is to follow the hygiene practices championed by that 19th Century nurse, Florence Nightingale. Her practices are still valid today: vigilantly wash your hands and stay clear of anyone who is ill.”

For attorneys who are reading this blog, before you call our office, any Certified Legal Nurse Consultant can tell you there is no product liability suit against a pork producer for an H1N1-infected piggy. Those same Certified Legal Nurse Consultants also know that there might be a medical malpractice case for failure to diagnose, since the symptoms of H1N1 Influenza A are so close to those of “normal” flu.

As RNs we can and should contribute to this public health issue by reminding everyone around us (not just our spouses and children) to wash their hands. We should also remember that nursing and medical personnel can be a source of infection.

I’ll be washing all the way up to the elbows for a long time to come. Stay clean and healthy!

Success Is Inside!

P.S. When I walked over to Starbucks this morning for my “free” coffee, the staff must have read my blog about them because they had my tall “red-eye” (bold coffee with a shot of expresso) on the counter by the time I got to the register (darn)!

On March 4^th the U.S. Supreme Court decided a case in favor of consumer rights, one that has the potential to reach further than first appearance. In the case of Wyeth v. Levine the Court upheld a $6.7 million verdict in which the jury found that Wyeth’s label had inadequate warnings, thus ruling against the drug manufacturer Wyeth. In doing so, the court allowed state juries to award damages for harm done by unsafe drugs, even in cases where the drugs had been approved by the Food and Drug Administration (FDA).

In 2000, Ms. Levine, attended a health clinic for treatment of a migraine, received Phenergan^® via IV-push (despite the warnings) directly into a vein, reaching an artery and causing gangrene. She eventually lost her arm. She had previously settled with the clinic.

Wyeth had argued that Ms. Levine was preempted from suing because Phenergan^® was FDA approved. They argued that FDA approval freed Wyeth from liability for damages caused by the drug. Unlike certain medical device cases (see Riegel v. Medtronic) in which federal statutory law expressly barred certain state claims, in this case Wyeth relied on what could be termed an implied preemption from the federal approval, not on any express language in a statute enacted by Congress. Wyeth claimed in part that it could not comply with its state law duties of providing clear instruction and stricter warnings on the label or the federal labeling requirements.

The Court disagreed (6-3) and may have opened the door for more products liability lawsuits, or a flood of companies seeking direct regulation and protection. Drug companies and other businesses have sought federal regulation believing it would shield them from liability damage caused by their products.

For the Certified Legal Nurse Consultant this helps widen the field of products liability cases to include those products that are not specifically exempted by federal statute. Both plaintiff and defense will have plenty to keep busy for years after this case. Remember as a legal nurse consultant, your job is not to know the law, but to know what caused the injury, its extent and how it could have been prevented.

Success Is Inside!

As I’ve grown older I’ve learned to appreciate the difficulty of keeping my body (and mind) in great physical (and mental) shape. I hit the gym three days a week to lift weights with a trainer. On the odd-date days I really stretch myself by doing yoga or speed-walking to the Starbucks^® a couple of miles from my home. As my age has increased so has my strength and muscle-mass. I only wish I’d been as dedicated when I was in nursing school.

Before I became a nurse, my exercise consisted of scrambling for Mardi Gras beads and doubloons in the crowded parades of New Orleans (a true contact sport), playing intramural basketball for my high school, playing neighborhood touch football and baseball in the streets, and wrestling with my twin brother Vince (and sometimes his friends, wink-wink). Closest I ever came to an injury was burning my mouth on a bowl of my Grandma’s seafood gumbo.

In nursing school I got a whole different education in exercise that involved weightlifting – lifting patients, lifting more patients and when we were done, lifting even more patients. At 5′ 2 ½”, 110lbs I was hardly Arnold. No training could really prepare me to lift and/or turn patients twice my size. The result? Nursing school turned out to be more hazardous than a childhood of physical activity! It was in the hospital that I strained my back trying to lift and turn a patient. Being the good old days I was prescribed a period of bed rest and, of course, Darvon. I remember telling my nursing student peers, “what a worthless drug it was despite all the hype.” Obviously I’m not much of a drugstore cowgirl. All it did was make me feel fuzzy – it didn’t touch my back pain.

An FDA advisory committee recently recommended a ban on Darvon, Darvocet and their generics, notably after they have been in use for more than 50 years (check out the presentations from the meeting). According to the testimony, Darvon and Darvocet have been associated with over 10,000 confirmed deaths and 2,110 reported accidental deaths in the United States, and the risk of death, overdose, addiction and life-threatening side effects, outweighs the minimal benefits provided by these drugs over other available painkillers.

The committee’s recommendation is nonbinding on the FDA which has 90 days to act on it and either pull the drug from the market or let it go on killing people. Hard to believe but, yes, a drug that according to the AMA is less effective than two adult-strength aspirin, kills.

As of the date of this posting I haven’t seen any cases filed yet, but plaintiff attorneys are already advertising for potential clients. This is where you, the savvy Certified Legal Nurse Consultant, come in.

If you are interested in consulting on these potential products liability cases, research the plaintiff attorneys who are advertising for these cases and market yourself to them. Defense firms are a potential market too. There will be plenty of issues for both sides in these cases as the drug is often prescribed to elderly patients, it’s addictive, it doesn’t mix well with other drugs and a good portion of the deaths are suicides.

If you’re looking to get involved in pharmaceutical cases – Darvon will probably be a good starting place. Just do your research and watch your back.

Success Is Inside!

How do you start your day? Does your breakfast contain a line of pills (and I don’t mean vitamins) longer than your middle finger? If you open your medicine cabinet too quickly is there an “orange avalanche” of pill bottles? Have you succumbed to the slick marketing of pharmaceutical companies like many of my baby boomer friends who daily whip out an array of drugs for restless leg syndrome, elevated cholesterol, reduced bone density and sleep deprivation?

If you read any magazine and look at the ads, you’ll see that the pharmaceutical companies have medicalized just about every illness, condition and quirk. Not only are drugs shamelessly marketed directly to potential “patients” but to the physicians who would and do prescribe them. My 27 years of experience consulting on products liability and medical malpractice cases as a legal nurse consultant have caused me to be very suspicious of pharmaceutical companies and the diseases they create, and of course, very agitating to my personal doctors.

My Italian grandmother lived a long life and never took a single prescription drug. In Italy, food is the drug, and she proved to me first hand that what I shove into my mouth directly impacts my energy level and the state of my health. Relax, this isn’t a blog on diet. I don’t advocate any particular diet but I try and stick to a Mediterranean diet (mainly for the spaghetti), it’s what keeps me a healthy size 4 (I wish).

I’m a small woman at 5′ 2½”. When I was diagnosed with osteopenia my physician immediately recommended Fosamax^®. Considering all the side effects of Fosamax, which I’m intimately familiar with because of products liability litigation, I rejected it outright, but I know others who haven’t and others who won’t when their time comes (good luck chewing your steak).

Instead I increased my vitamin D, calcium and vitamin K intake; hit the weights in the gym a lot harder and added a little jump roping; all without the help of estrogen (natural, artificial or otherwise). It took some serious discipline but in one year I had gained significant bone mass – at a time and at an age at which the vast majority of women lose bone mass.

My physician couldn’t believe it and in fact, seemed almost upset that I did it without her help (or her meds). Surely I was an anomaly. No matter the evidence, there was no way she was a believer. She continues to practice medicine like the typical pill-pushing physician who’s been brainwashed by the pharmaceutical companies. Thank God I’m a nurse and can think for myself.

But most consumers can’t, so that’s why the book Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs by Melody Petersen is one of my favorites on the pharmaceutical industry. Not a day goes by that I don’t read about a new drug’s serious side effects and the products liability cases generating from them. This book focuses on the institutional deception of pharmaceutical companies and is a must read for all Certified Legal Nurse Consultants who consult on pharmaceutical products liability cases, and even medical malpractice cases. The author discusses physicians’ less-than-appropriate relationships with the pharmaceutical industry and how it’s marketing, not science that drives these companies.

You won’t need this book to tell you what you probably already know, but it will help you think differently about your legal nurse consulting business and the CLNC^® services you provide to your attorney-clients in this drug-dependent age.

Add this book to your “must reads.” And be careful what you put in your mouth – remember doctors used to endorse cigarettes once upon a time.

Success Is Inside!

P.S. If you want a truly eye-opening book on food and diet, try this one: Good Calories, Bad Calories by Gary Taubes – it’s not a diet book and not a light read but will change your thinking (it got Tom off beer).