According to new studies, the latest generation of birth control pills, including Yaz, Yasmin, and Ocella, put women at a higher risk of blood clots than other types of birth control pills.  These fourth-generation birth control pills carry a two-to-three times greater risk of venous thrombosis, also known as blood clotting, than previous generations of birth control.  The symptoms of venous thrombosis include pain, swelling, and redness in the extremity where the blood clot is located, which is often in the calves, a condition also known as deep vein thrombosis (or DVT).  Venous thrombosis can also lead to blood clots in the lungs, a life-threatening condition known as pulmonary embolism, which is characterized by shortness of breath, chest pain, and anxiety. Yaz, Yasmin, and Ocella have also been shown to cause heart attacks, strokes, and gallbladder disease.

Drospirenone is the progestin ingredient found in this fourth generation of birth control. Pills that were introduced years ago, known as second generation oral contraceptives, contain an older form of progestin called levonorgestrel, which is considered much safer than newer drugs, and lower doses of estrogen than are contained within the original birth control products first marketed decades ago.  The third generation birth control pills, which were introduced during the 1990s, contain progestins such as desogestrel and gestodene, and are perceived as also being less safe than the older second generation formulations.

Drospirenone causes venous thrombosis by increasing potassium which in turn disrupts heart rhythms and slows blood flow, leading to clotting.  According to the FDA, this latest generation of birth control pills does not possess any added benefit as compared to earlier formulations, but do subject patients to substantially higher risks.

Yaz and Yasmin both became popular very quickly after  they were introduced to the market and made Bayer, the company that produces Yaz and Yasmin, billions of dollars.  In order for a drug to become popular so quickly, there must be something that sets it apart from other drugs on the market.  But there was nothing that made Yaz or Yasmin better than second generation birth control pills, but, rather, the success of the pills stemmed solely from aggressive marketing, including marketing that was found by the FDA to be in violation of federal law as it promoted the drugs for unapproved uses.

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The recent news about the Food & Drug Administration’s (FDA) actions in connection with hip implant manufacturers demands the question: why wasn’t the action being ordered required before the hip implants were placed on the market?

The answer is that the FDA’s order to 20 device makers to study the effects of heavy metals, like cobalt and chromium, and their effect on humans was something that manufacturers should have done before placing hip implants on the market. The FDA is now ordering the study to involve patients who have already had the hips implanted, but that is simply because “the deed is done”.

The FDA relies heavily, right or wrong, on the representations of medical device manufacturers and the studies they conduct. The FDA examines the data produced by the manufacturers but the FDA has neither the personnel nor the funding to conduct their own independent studies. Instead, the FDA relies on the truthfulness of the manufacturer who, after all, should know and understand the potential risks of the very device they have manufactured.

So, why would medical device manufacturers rush their product to be implanted in unsuspecting patients?

Money.

It is not entirely a pure profit issue. Manufacturers typically have products in development and testing for lengthy periods of time and their investments have a long shelf life even before they can be sold.  Manufacturers are denied the use of the money invested; they earn no return on that money; and they often have independent investors and stockholders to whom they must answer. They are sometimes denied the ability to begin developing the next best “widget” because of funds tied up in product development. So, they sometimes rush to production.

Sometimes it is a profit issue.  Manufacturers see a particular product in development as having significant potential to generate high sales and, thus, large profits. They cut a corner here; they cut a corner there; and, all of a sudden, they have sent a dangerous product into the market.

In the case of hip implants, the FDA spokeswoman, Karen Riley said, “There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”

Is heavy metal concentration from leaching of cobalt and chromium ions into the human body something that manufacturers could have and should have anticipated and tested for? Of course they should have. Why didn’t they?

Money. Profit. Shelf life of investments.

Any one of these business motivating factors may have caused it. Did they mean to hurt people? Unlikely. They simply allowed the need to market overcome their need for caution and good judgment.

The FDA action involves 20 manufacturers, including: Johnson & Johnson (Depuy), Biomet Inc., Stryker Corp. (SYK) and Zimmer Holdings Inc. (ZMH).

Perhaps sometimes these manufacturers forget they are not manufacturing “widgets”, they are manufacturing parts of peoples’ lives.

What was Bayer thinking when they came out with the birth control pill Yaz?

Based on another study, this one published in the British Medical Journal, demonstrates that the key ingredient in Yaz (also in Yasmin and Ocella) causes a six times increase for the incidence of clots in users.

Why is this important? A clot can cause serious debilitating injuries and death. The incidence of stroke, cardiac events and death are real complications in consumers using birth control, such as Yaz, that includes the ingredient drospirenone.

Did Bayer have an alternative to using drospirenone.

Yes. The ingredient, levonorgestrel, demonstrates a lower incidence of venous thrombosis (blood clotting) than does drospirenone.

What could Bayer have done if they wanted to use drospirenone in Yaz, even though they knew it carried a higher incidence of dangerous blood clots? A clear and understandable disclosure would have been called for and one not buried in the fine print.

But it was not to be. Bayer’s advertising for Yaz gave the impression that Yaz was the greatest adventure of a lifetime. Successful, beautiful young women gathering in a bar, discussing the positives and rapidly going through the negatives of Yaz might seem like disclosure, but the visual images were simply overpowering.

Balloons flying through an azure sky, floating over agreen playground, streets and sidewalks. Beautiful, successful appearing people enjoying life. Again, the visuals are over powering. Add to the visuals the powerful music and lyrics with a message of “we are not going to take it anymore” and what should be the real message is lost in the balloons floating into the stratosphere.

A drug that promised sex without the risk of pregnancy; clear, acne free skin; freedom from the pain and bloating of periods; and, well, beautiful people; what young woman could resist?

So what did Bayer probably do? They took advantage of a marketing opportunity and gambled that it would not blow up in their face. They bet that any complications would not result in lawsuits or claims that would approach the profits they calculated could be made. They appealed to young women in a way that promoted success, beauty and fun.

Bayer weighed the injuries and deaths of consumers against the bottom line profits and bet they ultimately would win.

Bloomberg has an interesting article today discussing medical device approval and where the fault lies for bad devices being approved for use.

The Food & Drug Administration (FDA) “approves” medical devices and often (some say too often) grants review and approval under Section 510(k) of the Food, Drug & Cosmetic Act. Commonly referred to as “Premarket Notification” within the industry, it is remarkable the devices that are approved for use on consumers with little or, often, no testing.

Under the 510(k) regulations, the device must be “substantially equivalent” to other similar devices already approved by the FDA and on the market. “Substantially equivalent” has a somewhat broad definition:

“The term “substantially equivalent” is not intended to be so narrow as to refer only to devices that are identical to marketed devices nor so broad as to refer to devices which are intended to be used for the same purposes as marketed products. The committee believes that the term should be construed narrowly where necessary to assure the safety and effectiveness of a device but not narrowly where differences between a new device and a marketed device do not relate to safety and effectiveness. Thus, differences between “new” and marketed devices in materials, design, or energy source, for example, would have a baring (sic) on the adequacy of information as to a new device’s safety and effectiveness, and such devices should be automatically classified into class III. On the other hand, copies of devices marketed prior to enactment, or devices whose variations are immaterial to safety and effectiveness would not necessarily fall under the automatic classification scheme.”

The FDA sets forth the elements constituting “substantial equivalence” as:

A device is substantially equivalent if, in comparison to a predicate it:

• has the same intended use as the predicate; and
• has the same technological characteristics as the predicate;
  or
• has the same intended use as the predicate; and
• has different technological characteristics and the information submitted to FDA;
  • does not raise new questions of safety and effectiveness; and
  • demonstrates that the device is at least as safe and effective as the legally marketed device.

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

So, the general nature of the definition has a foundation in good intentions. The process is intended to protect the consumer, but to not unduly delay technology that has already been tested and should be expediently approved for use on consumers.

The process in place for medical device approval is simply a very slippery slope.

Under FDA regulations, a device can also be considered appropriate for “expedited review if:

• (It) is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition.
• The device represents a breakthrough technology that provides a clinically meaningful advantage over existing technology.
• No approved alternative treatment or means of diagnosis exists.
• The device offers significant, clinically meaningful advantages over existing approved alternative treatments.
• The availability of the device is in the best interest of patients.

So, what is at the heart of the 510(k) “substantially equivalent” device approval process? Honesty, candor and transparency must be a central part of it or the process will not work and unsafe devices will be released for use on unsuspecting consumers.

Cardiovascular medical devices have accounted for a third of FDA recalls and many of those devices were originally approved through the 510(k) process. Most recently, a Johnson & Johnson company, Depuy Orthopedics, recalled 93,000 hip implants suspected of unaccounted for failure and the risk of releasing dangerous levels of cobalt and chromium into patients’ bodies.

Perhaps one of the “poster children” for 510(k) failure were intra-articularly placed pain pumps designed to inject pain killers, like bupivacaine, directly into patient joint spaces immediately after surgery. There is nothing wrong with using bupivacaine during surgery to bathe the wound site and provide for some pain reduction in the tissues immediately adjacent to the surgical site. In addition, there is nothing particularly wrong with machines that gauge the injection of pain killers into patients in an effort to both relieve pain and to control patient addiction to the drugs.

What was wrong was the way in which pain manufacturers attempted to get their new machine approved and the untested way in which they knew they would be recommending their device to be used. The various manufacturers submitted 510(k) approvals and provided documentation that their products were substantially equivalent to other similar devices already on the market. Was that true; did their statements come with candor and transparency? Well, the 510(k) submissions were, one could argue, truthful; at least as far as they went in disclosing facts. Unfortunately, it can be fairly said that the manufacturers failed to disclose “the rest of the story”.

The FDA approved the devices, but at least in one case, the FDA specifically forbid the use of the device in orthopedic patients. What the manufacturers did not fully inform the FDA about was their intentions to instruct for use of the device in post operative orthopedic patients by, for the first time, recommending the injection of pain killer directly into the joint spaces. They did not disclose to the FDA they intended to launch intensive marketing campaigns and recommend that physicians implant the drug delivering device into the joint space, but fail to disclose to the physicians that this process had never been tested for safety. They forgot to tell the FDA they would be holding seminars to explain to physicians the best methods for using the pain pumps in the joint space. That entire physician targeted presentations would be disseminated to teach physicians the best ways to code the use of their device in order to get insurance company or Medicare approval for this previously unknown treatment.

As a result, hundreds of, typically very young, athletic patients were sentenced to additional surgeries on their joints; in some cases surgeries requiring complete joint replacements more than once during their lifetimes.

The pain pump manufacturers have tried to justify their actions with a “who knew” defense. They claim that no reliable scientific evidence existed that would have provided warning for the use to which they recommended their device.

That is not entirely accurate either. At least one study did exist before the pain pumps received approval that should have caused concern for everyone. That study was not a part of any manufacturer’s submissions to the FDA. But, largely insufficient studies existed because the pain pump manufacturers failed to fully disclose how they intended to use their devices and failed to tell the FDA that the use was a new, untested and novel approach. It was the failure on the manufacturers themselves to conduct premarket testing and evaluation that created the lack of studies and their deceptive defense.

Did the system fail? Yes and no. One might argue that had all the procedures been followed and all regulation complied with, the system would have worked quite well. So, should we criticize the FDA for their failure to ask just the right questions or should manufacturers of recalled devices be held accountable for “honesty, candor and transparency”… or the lack thereof.

The Food & Drug Administration issued a Notice and Recommended Action letter to all denture adhesive manufacturers on February 23, 2011.

A simple product like denture cream. Easy to use. Nothing complicated about denture cream, right?

Wrong and it should not have been of any surprise to denture cream manufacturers who included zinc in their formulations. The FDA notice to manufacturers is to alert them to important issues they already know about, but have failed to warn about:

Factors that may contribute to adverse events include:

1) The package labeling may not list zinc as an ingredient.

2) Users may not be aware that overexposure to zinc may lead to zinc toxicity, which may result in adverse health effects.

3) Users may continue to use these products even after experiencing adverse events because they may not associate the adverse events with the use of denture adhesives. This may  occur because adverse events may not manifest themselves for months to years while using the product and consumers may assume such events are caused by something other than the denture adhesive.

4) Users may not know how to use the product properly, resulting in an adverse event. For example, users may not be able to understand the instructions for use of the product due to confusing and potentially misleading labeling. Until recently, denture adhesive labels did not give warnings or definitions of overuse.

Humans need zinc in our diets, but it has long been known that too much zinc can result in a condition called zinc toxicity. Zic toxicity can be deadly to humans if the accumulation in the body is large enough. The symptoms most associated with zinc toxicity include:

Loss of feeling in the extremities, such as fingers, hands, toes, or feet

• Difficulty walking
• Fatigue
• Edema
• Hair loss
• Anorexia
• Diarrhea
• Lack of balance and general instability
• Sudden or long lasting pain
• Weakness in the muscles
• Skin sores
• Difficulty moving arms, legs, or hand
• Numbness
• Slowed growth
• Dermatitis
• Paralysis
• Anemia
• Paleness
• Bone marrow failure

If you use denture adhesives, carefully read the ingredients and the warnings contained on the package.

If you use denture creams that contain zinc, inquire with your physician about the advisability of continued use.

If you develop any of the above symptoms, immediately seek the advice of your physician.

What if you were prescribed a medicine that actually made your already difficult illness worse?

That is precisely what has happened to hundreds of patients suffering from osteoporosis, osteopenia, and other bone loss conditions. Patients who took a class of drug known as “bisphosphonates” have suffered severe bone fractures, such as long bone femur fractures, as a direct result of their use of these drugs.

Over the past few years, there have been numerous safety concerns relating to the entire class of bisphosphonate drugs, which have been used by millions to treat osteoporosis, osteopenia, and other bone loss conditions.  This class of drug includes:

• Skelid
• Didronel
• Aredia
• Fosamax
• Boniva
• Actonel
• Aclasta
• Bondronat
• Fosavance
• Reclast
• Atelvia
• Zometa

Fosamax is the best known and most popular of these medications. It was approved for use in the United States in 1995.  The safety concerns have raised such significant alarm that many prescribing physicians and patients are questioning whether the risks of the drugs outweigh the benefits, especially for patients with osteopenia. Patients with osteoporosis are questioning whether long-term use of the drugs provides sufficient benefit, given the severe complications.

The first safety concern regarding these osteoporosis drugs related to the development of osteonecrosis of the jaw (also known as “ONJ” or “bisphossy-jaw”).  This very serious condition involves necrosis (death of bone) in the jaw bone.   This condition can rarely occur spontaneously, but tends to come about after major dental procedures, such as tooth extractions.  Early symptoms include pain and inflammation of the gums or oral tissue, drainage and infection, and leads to lesions and exposed bone.  Sadly, there is no cure for ONJ, and patients who suffer extreme cases usually end up having portions of their jaw resected.  It was not until 2005 that Bisphosphonate manufacturers finally acknowledged these adverse effects and added the risks to the drug labels.  Even today, many patients and dentists are ill-informed about this potential for harm, and, given the drugs’ extremely long half-life, patients may be at risk for the development of osteonecrosis for up to 10 years after discontinuing the medications. Thislong half-life is especially true for patients receiving the high-dose IV bisphosphonates Aredia and Zometa, which are often given to patients as a part of their chemotherapy regimen for bone metastases.

The second and third waves of safety issues relating to osteoporosis drugs related to reports of arrhythmias and a possible link to esophageal cancer.  Many patients have discontinued taking oral bisphosphonates or switched to injectable forms of the drugs due to esophageal irritation and discomfort.  In fact, patients should take the medication on an empty stomach, swallow the pill with water, and remain upright for at least thirty minutes afterward in order to minimize the irritation. These recommendations are supposed to reduce the risk of inflammation in the esophagus, which has been theorized to be related to the development of esophageal cancer.    The FDA has documented at least 68 cases of esophageal cancer in patients using oral bisphosphonates, many of whom died, but has not yet drawn a clear link.  Early studies indicate that patients taking these osteoporosis drugs face twice the risk of esophageal cancer than the general population, especially when used long-term.

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It is disappointing when otherwise intelligent, insightful people simply choose to ignore facts and fail to protect the very people they have sworn to serve.

It is no secret that many industry-wed lawmakers have been working for a long time to place damage caps on injuries caused by the negligence of others.

Those same industry-owned lawmakers stand for protecting the profits of hospitals and insurance companies over the protection of citizens. These are legislators and executive branch folks who are willing to sacrifice our rights in the interests of promises to lobbyists or keeping alive their favorite bill.

Currently, Congress, state legislators and governors are busy trying to protect corporate healthcare and insurance companies on the backs of victimized patients. Add to that a concerted effort to dismantle the only attempt, albeit flawed, to fix a flawed and dysfunctional health care system. These politicians are not builders; they seek to create or enhance nothing. These lawmakers want to dismantle anything lobbyists tell them to defeat in the best interests of their corporate constituents.

Fact: It has been estimated that medical errors cause $17 – $29 billion every year in lost income, disability and healthcare.

Fact: The Department of health & Human Services estimates that medical errors result in $4.4 billion in additional Medicare costs.

Fact: Patient rights have been taken away or diminished in 48 of the 50 states already. This has done nothing to improve health care quality or costs in any of those 48 states.

Fact: In the 48 states already enacting limits on the rights of the injured there has been no tangible savings in terms of insurance reductions or health care cost reduction.

Fact: Preventable medical errors cause the death of 98,000 people each year (Institute of Medicine). Limiting the constitutional right of injured victims has done nothing to improve the quality of health care or to reduce the numbers of injured people or the number of patients killed by preventable medical care errors.

Fact: Defensive medicine is a myth dreamed up by those who desire increased corporate profits. Defensive medicine may be motivated more by a desire to increase profits to doctors and hospitals as the alleged defensive medicine.

Fact: The “lawsuit crisis” is a well conducted campaign of propaganda, spin and lies.

Fact: Lawsuits filed by injured people represent a very small percentage of the total burden on the court system. Actually, the largest numbers of lawsuits involve divorce, estates and corporations suing each other.

Fact: Passing laws to protect one special class of Americans to the detriment of the majority of Americans is in violation of the constitution. Protecting doctors, hospitals and insurance companies while denying patients their rights, is simply unfair and unlawful.

Fact: The groups fighting the hardest to infringe on the rights of citizens of individual states are the same groups who have repeatedly told Americans that “Big Government” is bad and that the federal government should stay out of the business of the states. So much for smaller government.

Fact: People in favor of tort reform can not use facts to support their arguments. They rely on hyperbole and spin fed to them by groups supported by business interests.

Fact: Who will pay for the costs of medical care, lost income and rehabilitation caused by medical errors if the rights of victims to pursue legal remedies are taken away? You and I will pay through increased taxes to fund medicare, social security and increased insurance premiums.

Fact: Who will benefit from taking away rights? Hospitals, insurance companies and corporations.

Before you take a position on this very important constitutional battle, educate yourself, be informed, and do not blindly accept information given to you by anyone.

Read, research and rely on your own common sense.

Who is paying for all these campaigns and lobbyists who have the ears of YOUR law makers?

Can bath salts cause severe brain damage?

Can bath salts cause severe psychotic episodes?

Can bath salts kill you?

Not the type of warnings you will find on “bath salts” or, for that matter, the types of warnings I would have ever imagined appearing on bath salts.

But, these are not the type of bath salts most of us would be thinking about with those terms.

Cloud 9, Bliss and Tranquility don’t sound like they would be a substance that might make you want to take a skinning knife and repeatedly slice your face and stomach, causing near mortal wounds. That is what a Mississippi resident did after he got high on these bath salts.

Reportedly, abusers are ingesting, injecting and snorting the powders contained in products which many of us would assume intended to be used while soaking in the tub.

Hundreds of people across the country are becoming sick, being sent to emergency rooms or being found dead after using “bath salts” sold in convenience stores, gas stations and “head shops” under a number of imaginative names, including:

• Ivory White
• Ocean
• Charge+
• White Lightning
• Scarface
• Hurricane Charlie
• Vanilla Sky
• Red Dove
• Cloud 9
• White Dove

Some law enforcement agents say that the ingredients in some bath salts, mephedrone and methylenedioxypyrovalerone, can be as dangerous or more dangerous, when abused, than the methamphetamine. Methamphetamine is the drug abused as crank, crystal meth, speed, poor man’s coke, and ice.

Mephedrone is a synthetic stimulant, which is a psychoactive drug. It is based upon the compounds (such as cathinone) contained in a African plant called the Khat plant. Khat is a slow growing shrub and, until it was synthetically reproduced, its use was confined to places in which it grew. The stimulating effects of the plant are only effective from fresh plants and, so transporting the actual leaves would have been of little value. Unfortunately, synthetic duplication has removed that barrier to its spread.

Methylenedioxypyrovalerone is a psychoactive stimulant with over (4) times the potency of the drug Ritalin. Methylenedioxypyrovalerone is not a scheduled drug in the United States, except in Louisiana, and so is not regulated.

Abusing the bath salts can cause serious consequences, including:

• Hallucinations
• Severe panic attacks
• Psychosis
• Racing heart
• Cardiac arrhythmia
• Suicidal thoughts
• Death

Unfortunately, the ingredients, which seem to be the danger, are not regulated by the Food & Drug Administration. Officials with the FDA have indicated that banning unregulated substances for sale is a process that can sometimes take years.

Louisiana has moved to ban the sale of these compounds under an emergency measure, after over 125 calls were made to the state’s poison control center about the compounds.

The “bath salts” are being marketed under that category as a way to circumvent regulation. Obviously, actual bath salts were intended to be soaked in and not snorted or ingested.

Parents and family members should be vigilante and take note if they see any of the above products in a loved one’s possession.

Yesterday, the administrator of the 20 Billion dollar Gulf Oil Spill Claims Fund, Ken Feinberg, was attending town hall meetings in Fort Walton Beach, Florida and will be addressing certain affected industries in Tampa, Florida.  He noted that over 70,000 people have filed for “quick claims” with the fund, an option that reportedly requires you to waive any future damages claims.  Since the experts appointed to assess the causes and consequences have found that the damages will be epidemic and on-going, one has to wonder at that sort of claim process.

On June 27^th, Co-Chairs of the National Commission on the BP Deepwater Horizon oil Spill and Offshore Drilling will be discussing their exclusive findings in Orlando, Florida.  Their comments on the report, which were released on January 11^th, have been made public as recently as yesterday.  In a recent interview, former Florida Governor Bob Graham stated that the oil spill “was not the product of some cosmic force. It was caused by human beings who made a series of bad decisions which were unnecessary.”  He also noted that while the industry has made huge strides in technology focused on getting oil out, they have never been concerned with making advances in dealing with any disasters that might occur.

Interestingly, Feinberg has not appeared to address the Commission’s report entitled “Deep Water, the Gulf Oil Diaster and the Future of Offshore Drilling.”  The report is large (over 350 pages) and has been available for over a week.  It sheds light on many topics of concern including:

a.) the causes of the disaster;

b.) the public consequence of what has largely been determined post-incident false reporting, and

c.) the need for greater regulatory oversight and scientific understanding of the potential impacts of the event.

A significant part of the report deals with the extent of the damage—a topic that many might assume is the fund’s domain.    Yet, as is implied by the commission’s report, the situation is far too complex for such a solution and far too vast for a fund to handle.  Unlike disasters of the past, the damage here was not actually caused by a single event; instead, it is as President Obama termed it, an “epidemic.”

If you are one of the many whose livelihood and/or life has been directly injured by the events, the jostling contradictions do nothing but add to your nauseating reality:  things are going to be worse before they are better.  In such situations, people have traditionally sought the advice of counsel.  Sadly, in this instance, many are being told that this dauntingly murky situation can be handled without expert guidance.  The report of the President’s own advisers implies otherwise.

President Obama created the National Commission on the BP Deepwater Horizon oil Spill and Offshore Drilling on May 22, 2010.   As stated by the Commission itself, its task was to be an independent undertaking:

“The President charged the Commission to determine the causes of the disaster, and to improve the country’s ability to respond to spills, and the recommend reforms to make energy production safer.  And the President said we were to follow the facts wherever they led.”

Appropriately, the President appointed co-chairs for the commission:  Democrat Bob Graham, Florida’s former Governor and former Senator and Republican William K. Reilly, former EPA administrator under George H.W. Bush, and former president of the World Wildlife Fund.

On June 15^th, as cited in the Report, President Obama squarely addressed the reality of the situation facing the Commission and the nation entirely:

“Already, this oil spill is the worst environmental diaster America has ever faced.  And unlike an earthquake or a hurricane it’s not a single event that does it’s damage in a matter of minutes or days.  The millions of gallons of oil that have spilled into the Gulf of Mexico are more like an epidemic, one that we will be fighting for months, even years.”

After an “intense six-month effort to fulfill the President’s charge,” the facts led to many startlingly sad conclusions.   The news that such an atrocity could have been avoided and that a repeat of such an occurrence is still so likely is not at all surprising, but the sadness of that reality remains a shock to the system. Amidst its conclusions, the Commission offers snapshots of individuals whose lives have been turned upside down.  From the most obvious, such as fishermen and oyster farmers, to the more remote, like wedding coordinators, the commission seems to understand that amidst these large, sweepingly affective conclusions, individual victims will bear the cost.

The commission is also willing to confront the unknowns and the decisions that were made even more agonizing in light of our lack of knowledge.  For instance, the report discusses the angst in the decision to use dispersing chemicals when the effects of the chemicals were unknown; it acknowledges how that angst grows when the companies who make them have been unwilling to share what little information they have about them.

Of the many conclusions it draws, a few are of significance to the Gulf community and its advocates:

• The explosive loss of the Macondo could have been prevented.
• The immediate causes of the Macondo well blowout can be traced to a series of identifiable mistakes made by BP, Halliburton, and Transocean that reveal such systematic failures in risk management that they place in doubt the safety culture of the entire industry.
• Because regulatory oversight alone will not be sufficient to ensure adequate safety, the oil and gas industry will need to take its own unilateral steps to increase dramatically safety through the industry, including self-policing mechanisms that supplement government enforcement.
• Scientific understanding of environmental conditions in sensitive environments in deep Gulf waters, along the region’s coastal habitats, and in areas proposed for more drilling, such as the Arctic,  is inadequate.  The same is true of the human and natural impacts of oil spills.

So while the accident was foreseeable and could (and should) have been prevented, there is no way of knowing how big the impacts and injuries will be and there is little reassurance that it won’t happen again.  Usually when a corporation disregards safety, those who are wronged seek remedy in Court.  A jury of their peers determines the extent of the damage and, if relevant, the gravity of the wrong.  A judgement is then rendered that will not only remedy the injured, but will deter future calamities by bringing the corporate wrong-doer a fiscal awareness of the risks that they had previously put upon the public to suffer.  The hoped for and usually achieved reaction is that the relevant industry creates internal guidelines, procedures and policies that keep the risk from happening.  As the commission understands, and as their report states, regulations on their own just don’t do it.  If they had, we would not be in the mess we find ourselves in today.

In the face of a report stating that the injuries will be in the hundreds of billions of dollars; that we are still not certain even of the causative effects of the oil, the gas, the dispsersants and other pollutants; that the industry needs to find motivation to self-govern; and  that the industry let this happen through preventable mistakes, what’s the plan of action for remedying the whole thing?  What has happened?

Our politicians are considering opening more off-shore territory to oil drilling.  The fund would like you to think that the wrongdoers have fairly determined the limits of their liability to the public.  Administrator Feinberg has stated that the damages are not as far-reaching or great as we originally feared and that the fund will be able to fully compensate the injuries.    The Claims fund has created a “quick Pay” option which offers reasonably desperate claimants the right to a quick lump sum payment in exchange for a waiver.  BP’s link offers directions “For Info On How To Make A Claim w/out A Lawyer.”

The reaction is unequivocally contradictory:  The Commission and the President himself have stated that this is a long-term problem; meanwhile,  the fund and the industry act as though there is a “quick fix” option.  And although there are three claims options to choose from, each of which require documented causation, the wrongdoers are actually advising that you go through the process without an attorney, as though they have the injured community’s  interest at heart and individual counsel is superfluous.

Apparently, they have NEVER had the community’s interest at heart.  One has to wonder, in a situation where such learned politicians can recommend diametrically opposing view points, how can the average person find justice  without an attorney?

When my 47-year old friend from my college days had to have her hip replaced last year, because of wear and tear on the joint, I doubt very much that anyone said to her, “I’ve got some good news and some bad news.  The good news is the state-of-the-art in hip replacement has come a long way since the days of your mom or your grandmother and, once we have replaced your hip, your pain should diminish.  The bad news is we’re using a DePuy ASR Hip System and they are not quite present day state-of-the-art, so you’ve got a pretty good chance of needing a new one five years from now.”

Last summer, a recall of two DePuy Orthopaedics hip replacement systems was announced after testing data showed the two systems have a 1 in 8 chance of requiring replacement within five years.  The two systems, developed by DePuy, a division of Johnson & Johnson, are the ASR (which stands for Articular Surface Replacement) Hip Resurfacing System and ASR XL Acetabular System total hip replacement.   Both of these systems became available in July of 2003, so only those manufactured after that date are the subject of the recall.

Replacement of any joint is quite obviously a surgery not to be undertaken lightly.  While the surgical techniques have developed and improved over the years, the rehabilitation following the surgery is still difficult, involving weeks and sometimes months of physical therapy.  For most joint replacement systems, the life expectancy of the artificial joint is between fifteen and twenty years – certainly not the five years projected for a significant percentage of these DePuy joint systems. In fact it is estimated that a staggering 1 out of every 8 patients will require a second surgery.

The approximately 30,000 recipients who received either one of the DePuy systems recalled last summer need to be evaluated and monitored by their implanting surgeon to evaluate failure of the joint system.  Because of this unusually high failure rate, DePuy has offered to pay for the “reasonable and customary” (their words not mine) costs associated with the “revision” (again, their word) surgery.

After years of pain, which affects every aspect of one’s life prior to the first surgery, then the surgery and finally the weeks (and sometimes months) of rehabilitation following the surgery, I am not sure “reasonable and customary” compensates someone who has to be told that they, once again, must go through weeks of pain and physical therapy because a manufacturer did not properly evaluate a medical device placed in you. These patients not only face repeated physical pain, but also will be denied, again, the experiences of working to earn a living; chasing their kids or grandkids around the yard; the enjoyment of travel; and will be restricted in many aspects of their life.

How can this happen? It is about a corporate citizen, like Johnson & Johnson, choosing profits over the safety of patients. It is about minimizing development costs and rushing a product to market, for use inside human bodies, before appropriate testing and evaluation is done by the manufacturer.

The good news is….well, there is no good news.