Big Tobacco is not only finding it hot in the great State of Florida, but also in the great State of Connecticut as well.

There, a federal court judge, Hon. Stefan Underhill, was asked by RJ Reynolds to overturn a jury verdict for the plaintiff in the amount of $28 million (Izzarelli v. RJ Reynolds Tobacco Co; case no. 3:99-cv-2338). Judge Underhill apparently did not buy what Big Tobacco was selling any more than the jury did.

Santa Smokes So It Must Be Good

This new Connecticut case is interesting in a few ways. Big Tobacco brought on its typical defenses of cigarettes are not addictive, but if they are addictive, the plaintiff could have quit if she really tried; that there were warnings about the dangers of smoking on the cigarette packages, if they are dangerous; and that if cigarettes are dangerous, they only are because of the ingredients that are naturally found in tobacco.

The court set forth a number of things brought into evidence in the case that justified the jury verdict of $28 million.

During the 1970’s, RJ Reynolds was losing market share in the new smoker group and was desirous of catching up with their competitors in the ability to addict people to cigarettes. They had known for a very long time that a cigarette is really nothing more than a delivery system for nicotine in a form that is acceptable to the user. In other words, Big Tobacco could sell something that allowed the user to inject the drug nicotine into their system through a cigarette much easier than they could by selling it in hypodermic needles. Big Tobacco had also known for quite some time that it is “free nicotine” that really gives the smoker the “kick” of nicotine into the system and, more importantly, Big Tobacco knew they could control the levels of “free nicotine” in cigarettes, thus controlling the “kick”.

What RJ Reynolds and the other manufacturers really craved for was to lure potential smokers under the age of 18 into the cigarette addicted population. Sadly for RJ Reynolds, Kool cigarettes, manufactured by Phillip Morris, had been burning them on market share. RJ Reynolds quickly undertook to fix this problem through manipulation of nicotine in their product:

“Notably, R.J.Reynolds discovered that (when altered with fructose alone or a fructose/ammonia gas mixture) the tobacco blend formulation G7 used in its Winston and Salem products increased the amount of nicotine in the cigarette as well as the percentage of nicotine transferred to the smoker.”

And:

“With respect to the effective dose range of nicotine required to maintain addiction, R.J. Reynolds understood that, although an increase in free nicotine would enhance the addictive property of the cigarette, a decrease in the nicotine yield of the cigarette would increase the number of cigarettes required to meet the addiction demand.”

“…the jury could have reasonably found that R.J. Reynolds manipulated and altered the tobacco and the chemical additives in Salem Kings to enhance the addictive nature of the product, increase the number of cigarettes smoked by the consumer, and ultimately deliver a higher level of carcinogens to the consumer as compared to other cigarette products.”

The evidence in this case set forth that not only were Big Tobacco targeting teens in hopes of adding them to the addicted masses, for 20 years after the plaintiff (Izzarelli) began smoking and as late as the mid-1990’s, Big Tobacco persisted in its efforts to “dispel the notion that cigarettes are an addictive product and to discredit health warnings about cigarettes maintain the dangers of cigarette smoking have been well known for a century, while testifying under oath that the claimed dangers of their products do not exist at all.

In Florida, Big Tobacco regularly stands before juries and tells them the same lies that their own CEO’s have previously testified about under oath. Tobacco company lawyers stand before juries and tell them all about how the dangers of smoking cigarettes have been known to everyone for ever. They claim that nicotine, although addictive, is a naturally occurring ingredient in tobacco that is, well, not THAT addictive. They tell jurors all about “free will” and that, well shucks, they are just a bunch of poor farmers trying to eke out a living.

The truth is Big Tobacco has taken a natural product (tobacco) and spent billions of dollars trying to re-engineer it into the “best drug delivery system in the world”, while they tinker with the addictive ingredients of their product to try and increase market share. All the while Big Tobacco has been telling the public things like this excerpt of a 1976 letter from Public Relations employee TK Cahill:

Big Tobacco's Script

The truth is that Tobacco companies want the public to believe its version of revised history. Big Tobacco needs the public and juries to believe they did not manipulate cigarettes to increase addictiveness and that anyone can quit anytime they want; they need them to believe the industry did not spend billions of dollars trying to convince the public that cigarettes were not just safe, but actually healthy for you; and they need them to believe that smokers who started smoking back in the 1940’s and 1950’s knew about the dangers of smoking.

In sum, Big Tobacco is still selling poison. They still have cigarettes on the market that addict and kill people every day. Now, though, they are also selling lies, fiction and fables to jurors and the public; well, at least to those who do not remember anything but Tobacco’s revisionist history.

On August 25, 2011, Public Citizen, a consumer safety organization founded by Ralph Nader decades ago, submitted a Consumer Petition to the Food & Drug Administration seeking a ban of transvaginal surgical mesh products that are utilized in surgeries to repair pelvic organ prolapse.  The petition was signed by Dr. Michael Carome, Deputy Director, and Dr. Sidney Wolfe, Director, of Public Citizen’s Health Research Group and Dr. Daniel Elliott, Assistant Professor of Urology, College of Medicine, and Mayo Clinic.

Pelvic organ prolapse is a common condition in women that occurs due to weakness in the tissues and muscles that support the bladder, uterus, and bowel.  There are a number of conservative as well as surgical treatments for these conditions (such as anterior or posterior colporrhaphy) that do not involve the implantation of a foreign body.  Most of the products that are being questioned are manufactured with non-absorbable synthetic polypropylene; a product that many physicians mistakenly believe (based upon representations by device manufacturers and outdated science) is inert once placed into the body.

The petition indicates that nearly 300,000 surgeries for pelvic organ prolapse were performed in 2010 in the United States, and that 70,000 of these surgeries utilized a transvaginal surgical mesh or sling product.  This statistic is particularly troubling since the FDA first sounded the alarm about potential safety issues with this entire class of devices in 2008, yet very few patients and surgeons seem aware.   The FDA’s alert on October 20, 2008, came many years after others first raised the very questionable safety record, troubling regulatory approval history, and scant data to support efficacy for these products.  An analysis of adverse event reports by the FDA from 2005 through 2008 indicated that the Agency had received more than 1,000 reports of complications associated with use of transvaginal mesh in surgeries in patients who had experienced pelvic organ prolapse or urinary incontinence.   A July 13, 2011, revised safety alert from the FDA indicated that the MAUDE database utilized by the Agency for adverse event reports included nearly 4,000 reports of injury, death or device malfunctions between 2005 and 2010, with the number of new AER reports growing exponentially (a 500% increase) over the past few years.

In urging a recall of the products, Public Citizen reviews the scientific literature that has been published since the products were first introduced in the United States many years ago.  Some studies show that patients tend to have less recurrence of pelvic organ prolapse after placement of the synthetic polypropylene devices; however, those findings alone do not justify use of these unsafe products. Most of the published scientific studies had limitations in their persuasiveness, especially since they were short-term studies, involved a limited number of patients, did not include controls, were not “blinded” to avoid bias, were not designed to evaluate safety issues, etc.  The published medical literature also shows that patients who have been implanted with transvaginal surgical mesh are suffering a number of complications, most of which are not associated with other surgical and non-surgical treatment options for pelvic organ prolapse.  These serious side effects associated with the mesh products include:  mesh erosion through the vaginal wall in 5% to 19% of patients; development of urinary incontinence; bladder perforations; pelvic hematomas; significant blood loss and post-operative complications; chronic infections; sexual dysfunction; scarring, tightening, and shrinkage of the vagina; chronic pain; urogenital fistulae formation; and the need for multiple additional surgical procedures due to mesh-related complications.

The transvaginal mesh products targeted by this Consumer Petition have been subject to litigation efforts for more than a decade, and have been on an FDA “watch list” for nearly three years.  The ban urged by Public Citizen is one that should have been instituted years ago, but, instead, the device manufacturers have continued to aggressively market these devices to unsuspecting patients while the overworked and underfunded FDA reviews mounting data showing that the devices subject patients to serious risk of injuries or death while providing little or no benefits.  The consumer organization also seeks a recall of products, and that any similar devices in the future undergo far more rigorous testing prior to being approved for marketing, including the suggestion that the products be re-categorized from Class II to Class III devices under the FDA regulations.  The current problems with the emergence of defects in these mesh devices once they are implanted into patients stems, in part, from the improper categorization of the devices in class II coupled with an abbreviated 510k approval process, which permitted them to be approved for sale and implantation with only the most rudimentary tests and did not require thorough testing to confirm that the materials utilized were truly biocompatible.  Examples of other class II devices include powered wheelchairs, infusion pumps, and surgical drapes. Unfortunately, little was known about how these devices would perform once they were implanted in women, as very little was done in the way of clinical studies and trials in humans prior to approval for marketing.  It is inexcusable that hundreds of thousands of women have become guinea pigs for these inadequately-tested devices.

This petition extends to a number of transvaginal surgical mesh products that are sold in the United States by Ethicon (a division of Johnson & Johnson), American Medical System, Boston Scientific Corp., C.R. Bard, and Proxy Biomedical.  The products for which Public Citizen requests a marketing ban and/or recall, includes:

• Gynecare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems (manufactured by Ethicon, Inc. of Somerville, New Jersey)
• Gynecare Prolift +M Total, Anterior, and Posterior Pelvic Floor Repair Systems (Ethicon, Inc.)
• Gynemesh Prolene Soft Nonabsorbable Synthetic (Ethicon, Inc.)
• AMS Elevate Anterior and Apical Prolapse Repair System (American Medical Systems, Inc., headquartered in Minnetonka, Minnesota)
• Pinnacle Pelvic Floor Repair Kits (Boston Scientific Corp., based in Marlborough, Massachusetts)
• Avaulta Support System (C.R. Bard, Inc. of Covington, Georgia)
• Polyform Synthetic Mesh (Proxy Biomedical, Ltd., baed in Galway, Ireland)

The facts regarding transvaginal mesh, as laid out in Public Citizen’s petition and talking points, are quite simple:

• “Use of surgical mesh for transvaginal POP repair provide no clinically significant benefit compared to repair without mesh using only native tissues”
• “Safety assessment:  the use of surgical mesh for transvaginal POP repair commonly causes serious complications”
• “Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable”
• “Despite a complete lack of clinical data demonstrating that these mesh devices were reasonably safe and effective for transvaginal repair of POP, these devices have been heavily promoted by industry and their highly paid physician consultants.  As a result, tens of thousands of women have been seriously harmed, many permanently”
• “Commercial interests related to surgical mesh kits for POP repair have taken precedence over patient safety and welfare”

So, what next?  One can only hope that the FDA will soon stop sifting through study after study and the stacks of adverse event reports, and move quickly to grant Public Citizen’s petition and pull these products from the market, or, although somewhat of a fantasy, that the device manufacturers would withdraw the products on their own.  The reality, however, is that the FDA is far more prone to warn, and warn, and warn again about safety issues, and leave it to patients and physicians to sift through all of the conflicting information from consumer, patient and legal advocates versus those who seek to defend these products and hope that patients make the correct decision.  I hope so too, as that is not an easy task, and is a decision that is fraught with problems if it is made poorly.

Additional Resources

August 2011 – FDA:  Continuing Concerns Relating to Transvaginal Mesh

August 2011 – Informed Decisions and the Use of Surgical Mesh

August 2010 – Mentor ObTape Vaginal Ling Overview

October 2009 – ProteGen Sling:  Overview

May 2009 – Suffering in Silence From a Medical Device – Surgical Mesh (Part 4)

April 2009 – Suffering in Silence From a Medical Device – Surgical Mesh (Part 3)

April 2009 – Suffering in Silence From a Medical Device – Surgical Mesh (Part 2)

March 2009 – Suffering in Silence From a Medical Device – Surgical Mesh (Part 1)

February 2009 – Curing Incontinence May Cause Greater Harm

December 2008 – The FDA’s Approval of ProteGen Baffles the Mind

November 2008 – The FDA Transvaginal Surgical Mesh Placement Complications Notification:  Manufacturer Identification and MAUDE Report Breakdown by Device

November 2008 – Mentor ObTape Litigation Expands

November 2008 – Tension Free Vaginal Tape (TVT or Vaginal Sling):  What is it and how is it placed?

October 2008 – Under the RADAR and Over to Market:  FDA 510(k) Submissions for Today’s Vaginal Slings are based on an FDA Equivalent Device That Was Actually Defective

August 2008 – Something Doesn’t Mesh

Not a week goes by without a headline reporting on yet another settlement between a multi-national pharmaceutical company and state or federal prosecutors. Medical device manufacturers are often also frequently subject to similar prosecutions.  While it is laudable that governmental authorities are finally taking action against chronic wrongdoers, the frequency of these prosecutions and settlements, and the very high recidivism rate, leads one to wonder whether drug and medical device manufacturers see these payments for wrongdoing as merely yet another cost of doing business. And, perhaps, more troubling, a very small price to pay to have a chance at marketing the next multi-billion dollar blockbuster drug or must-have medical device.

The problem is that while our government is modestly increasing its coffers with these settlements and fines, little attention has been paid by regulators to the other victims of their misrepresentations and deceptive and unfair trade practices – patients who have, at best, been defrauded and, at worst, have been harmed by defective drugs and medical devices with which they never would have come in contact but for the improper marketing.

For many years, there have been dozens of announcements of investigations and settlements involving a number of transgressions of drug and medical device manufacturers:

• Fraudulent direct-to-consumer advertising
• Unfair trade practices, price-fixing, and collusion with pharmacy benefit managers and others that has contributed to escalating drug costs
• Kickbacks and improper payments to doctors
• Pollution of scientific articles and medical literature (through “ghostwriting” and other efforts) which have the effect of preventing doctors and patients from making important decisions regarding the risks versus the benefits of drugs
• Knowingly manufacturing adulterated or contaminated products
• Promotion of drugs and devices for indications and “off-label” uses that have not been approved by the FDA because they are unsafe or have insufficient proof of safety
• Manipulation of clinical trials to under-report or mask safety issues

Just this week, yet another study was published (this time in the online medical journal of PLOS – Public Library of Science, a non-profit organization devoted to making the world’s scientific and medical literature more accessible) which found that less than 20% of the advertisements that are placed in journals by drug and medical device companies who are marketing their wares to physicians are fully compliant with FDA guidelines.  Nearly 60% of the marketing pieces minimized risks associated with the product, and almost 30% failed to provide complete information on the medical product’s efficacy, which essentially means that physicians who are charged with assisting patients in balancing risks vs. benefits of a particular drug are unable to do so because so many of the advertisements and other materials that have informed the physician were false.

If your banker failed to comply with banking laws 80% of the time, federal regulators would move swiftly to close them down.  If your car only operated as represented 30% of the time, there would no doubt be an outcry for a recall and the broadcast of TV reports from consumer fraud investigators.  If only 20% of the facts taught to our children were accurate, would we continue to permit those educators to continue to teach?  Of course, not.

So, why do drug and medical device manufacturers get a pass?

Although Big Pharma might disagree, our laws still apply to them (despite their best efforts to carve out numerous exceptions).   We still expect big corporations to follow the same lessons that we teach our children – be honest, tell the truth, admit mistakes when you make them, be cautious and safe, and protect others from harm.  Is it too much to ask that the FDA and governmental regulators get tough with drug and medical device manufacturers in hopes that they might learn their lessons this time?

Perhaps, a three-strike rule might deter the repeat offenders?

Or withholding Medicare payments and reimbursements for the drugs and medical devices that are subject to fraudulent marketing practices (which might make more of an impact on the bottom line than the fractions of pennies that are currently being paid to resolve attorney general investigations)?

Better yet, how about criminal prosecutions of corporate executives who have authorized illegal activities under the guise of marketing?

The fraud that has been perpetrated by some in the drug and medical device industry certainly is every bit as offensive as the crimes of Bernie Madoff, but far worse, in that patients have been harmed or died as a result.  One can always hope . .  .

On September 8 and 9, 2011, the Food & Drug Administration will convene a panel of experts to provide advice to the Agency with regard its regulation of gynecological medical devices.  The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will focus on evaluating the safety and effectiveness of transvaginal surgical mesh which is widely utilized to treat women who suffer pelvic organ prolapse.

For more than a decade there has been serious concerns about the safety of these devices and whether they have been over-utilized in treating women who have suffered a dropped bladder or other organ prolapse.  More than a decade ago, there was litigation over the ProteGen bladder sling, a device that was actually used as a predicate device for the summary approval of newer mesh products that are currently on the market, yet the products continued to be approved by government regulators and aggressively marketed to surgeons and their patients.

The Food & Drug Administration first sounded the alarm about these mesh products in October of 2008 with the publication of a Safety Alert  informing physicians that the FDA had, at that time, received more than 1,000 reports of complications associated with use of the mesh in surgeries for pelvic organ prolapse and stress urinary incontinence.  At that time, physicians were encouraged to seek specialized training for implantation of the mesh products and to be hyper-vigilant in monitoring patients with potential complications, including: bowel perforation, bladder perforation, blood vessel perforation, vaginal scarring, erosion of the mesh through the vagina, chronic infections, pelvic pain, and dyspareunia.  Unfortunately, most patients did not receive this important safety information, and many physicians were either unaware of the FDA alert or were unable to appreciate its significance amidst lots of contrary information regarding the properties of the vaginal mesh, the questionable regulatory history behind many of the products that had been approved for sale, and the spotty safety history of these devices.   The medical literature, as is so often the case, did not provide clear information on the true safety profile of the products, because it had become polluted with far too many “puff pieces” masquerading as scientific research.  Also, despite more than a decade of implanting products in women, very little was known about the long-term complications, safety, or advisability of using these products in the pelvic region.

On July 13, 2011, the FDA again issued a safety alert to both patients and healthcare providers.  This time, the Agency indicated that its concerns about the safety of the product has increased since the October of 2008 safety alert, and that adverse event reports and other data indicated that serious complications stemming from implantation of the mesh are far more common than had been previously understood or disclosed to patients.   From January of 2008 through December of 2010, the FDA received nearly 2,900 adverse event reports for serious complications associated with the use of transvaginal mesh in surgeries for pelvic organ prolapse (POP) as well as stress urinary incontinence (SUI).   In addition to the organ perforation, infections, dyspareunia, and mesh erosion noted earlier, the more recent adverse event report data also indicated that patients were suffering a recurrence of their pelvic organ prolapse, neuro-muscular problems, vaginal scarring or shrinkage, and emotional problems.

This data led the FDA to conduct a more thorough review of the safety profile of the devices from 1996 through 2011, which was quite illuminating.  The Food & Drug Administration concluded that the mesh used in the pelvis posed patients to risks not noted with the use of mesh in other parts of the body; that there was no evidence to substantiate that use of transvaginal mesh (especially in apical or posterior repairs) provided any benefit over traditional surgical methods which do not utilize mesh; and that the benefits, if any, of use of the mesh in an anterior repair pale in comparison to the risks associated with the medical devices.  In essence, there is no reason why these products should be implanted in women.

Hopefully, the Advisory Committee that meets next month will also agree, and support the FDA in efforts to limit or ban use of these products.  While this would be good news for future patients, it will be little solace to the tens of thousands of women who have had needless suffering over the past 15 years due to medical devices that should have been withdrawn years ago or, better yet, never sold at all.

Diabetes is a scourge that has prematurely taken my father and other dear members of my family.  It is a disease that many others in my family deal with each and every day.  We leave in fear of the devastating complications suffered by our loved ones – amputations, heart attacks, blindness, etc.  For decades, this fear has become a driving force in our search for cures, answers, and treatments.  We have read with interest all of the reports of new breakthroughs in science and medicine, have tried to enroll in clinical studies in hopes of finding a cure, participated in the walk-a-thons and other fundraisers, and have been excited, time and again, as new drugs were brought to market.  With each new drug came lots of promises, promises so significant that we were willing to pay top-dollar in hopes of better health and a better life.

The first of these “breakthroughs” was Rezulin (troglitazone), which was approved by the FDA in 1997 as the first of a new class of insulin-sensitizing drugs.  It held so much promise for my family and others.  In 1999, however, the FDA held hearings regarding safety concerns over Warner-Lambert’s blockbuster.  Rezulin was saved in 1999, but ultimately pulled from the market in 2000 after a number of patients suffered liver failure and a reported 90 patients died due to hepatic toxicity associated with the drug.  At that time, however, patients were reassured that they should not mourn the recall of Rezulin as both Avandia and Actos were newly-approved drugs in the same class, both of which touted themselves as being far safer than Rezulin.

Diabetics and their family members, including me, brushed ourselves off, and developed a new zeal for Avandia (rosiglitazone), which was approved by the FDA in 1999, amid as much if not more hype than had accompanied the approval of Rezulin a few years prior.  That hope, however, was quickly dashed when reports of patients suffering congestive heart failure started to mount.  By 2007, a number of Avandia patients had suffered heart attacks, strokes, and other serious cardiovascular injuries.  Consumer groups and patient advocates screamed for the drug manufacturer and/or the FDA to pull the drug from the market.  Instead, the tiny print on the drug warning label, one rarely seen by patients, was enhanced, while GlaxoSmithKline continued to prey upon diabetics desperate for a cure and sold billions of dollars worth of the drugs to one of the most fragile patient populations.  It wasn’t until 2010-2011, after numerous diabetics died or suffered Avandia-induced injuries, that steps were implemented to withdraw rosiglitazone from widespread use.  Truth be told, the drug was entering its twilight years anyway, so most of the benefit had already been reaped by the GlaxoSmithKline anyway.

I will always remember when Actos, the third drug in this class, made its big splash.  The day after the safety risks associated with Avandia were widely disseminated by the media, Takeda, the manufacturer of Actos, took out full page, color advertisements in newspapers across the country to reassure diabetics that Actos would fulfill the promise that Rezulin and Avandia once held.  Apparently, between 2007 and 2010, Takeda worked very hard to gain market share from GlaxoSmithKline by claiming that its drug was safer than Avandia and did not pose the same cardiovascular risks to patients, which apparently even led to legal/regulatory proceedings in the United Kingdom.  Again, diabetics lined up, eager for a cure.  Unfortunately, Actos may actually have failed patients even more than Avandia and Rezulin, yet, inexplicably, the drug remains on the market.

Takeda’s web site touts that it is currently the #1 prescribed brand-name diabetes drug, that more than 100 million prescriptions have been written, and that it is supported by more than 11 years of patient experiences.  What is not prominent in these promotional pieces for the Actos family (which includes ACTOS, ACTOplus met, ACTOplus met XR, and Duetact) are the warnings for the very real safety issues associated with these drugs:

• Cardiovascular Injuries – Heart Attacks, Strokes, Congestive Heart Failure, Cardiovascular Death
• Macular Edema or Blindness
• Bladder Cancer

The marketing materials don’t clearly mention the numerous FDA safety alerts regarding issues with this drug from 2007 to the present:

• August 2007 Safety Alert regarding risk of drug exacerbating heart failure
• September 2010 Safety Alert regarding increased risk of bladder cancer in patients taking Actos (pioglitazone) for more than two years
• June 2011 Safety Alert regarding increased risk of bladder cancer in patients taking Actos for more than one year
• August 2011 Safety Alert regarding increased risk of bladder cancer in patients taking Actos for more than one year

The flashy materials on Takeda’s web site don’t mention that consumer watch groups and patient advocates, such as Public Citizen, have been raising concerns for years regarding the safety of ACTOS, Avandia and Rezulin:

• May 22, 2007 – Letter from Public Citizen to FDA regarding internal FDA data from 2002 expressing concern over an increased risk of heart failure in patients taking both Avandia as well as Actos
• July 15, 2000 – Letter from Public Citizen to the editors of Lancet, a leading British medical journal, noting that very few studies to support the effectiveness of thiazolidinediones (the drug class which includes Avandia, Actos, and Rezulin) were submitted to regulatory agencies prior to approval

So now what?  Well, like Rezulin and Avandia before it, the final chapter for ACTOS will likely be written in our court system.  With the recent announcements regarding the risks of bladder cancer associated with the drug, a number of patients, failed by the drug manufacturer and our drug safety system, have turned to our justice system.  One can only hope that regulators and/or the drug manufacturer put patient safety first and remove this drug from the market before more diabetics are unnecessarily victimized by another unsafe drug.

Perhaps the abysmal performance of the Toyota executives in their delay in recalling vehicles with sudden acceleration and braking problems has led to an increase in vehicle manufacturer vigilance in monitoring their own vehicles for possible safety problems.

On the National Highway Traffic Safety Administration site is found the July 8, 2011 publication, “Safety Defect/Non-compliance Notices”. It appears there are several manufacturers who have self-recalled vehicles with problems. If this is the case, then kudos to those manufacturers; not for the manufacturing defects, but for their honesty and apparent concern (even if only economic) for the potential injuries these defects could cause.

Here are some of the recalled vehicles involved:

• Porsche. 2010 – 2011 911 Turbo. Equipped with locking hubs; the hubs can prematurely wear resulting in wheel loosening. The defect could result in loss of control of the vehicle.
• Volvo. 2012 S60 cars. Defective software can result in improper fuel regulation and engine hesitation or stalling. The failure of the fuel flow could result in a crash occurring
• Toyota. 2001 – 2003 Prius. A defect in the steering linkage can result in reduced steering and loss of power steering. An increased potential for an accident exists.
• Toyota. 2011 Venza and Sienna. Possibility for breakage of the front, right, drive shaft. The defect will result in complete power loss.
• GM. 2011 Cadillac SRX. Airbags at the right side roof rail are programmed to turn off when the front passenger seat is sensed to be unoccupied. This could result in injury to passengers in the rear seats. This defect could be especially dangerous in roll over crash events.
• Volvo. 2012 S60. A manufacturing defect in the fuel line assembly can result in a disconnect of the fuel line and sudden deceleration. The defect can result in engine stall and increase accident potential.
• Volkswagen. 2012 CC. Factory installed wheels and tires were replaced when imported with non-factory equipment. The replaced equipment does not include tire pressure monitoring; which could result in dangerously low tire pressure.
• Chrysler. 2011 Dodge Journey, Jeep Wrangler, Chrysler 200, Chrysler 200 Convertible, Dodge Avenger, Dodge Nitro, Jeep Liberty, Dodge Caliber, Jeep Compass, Jeep Patriot, Dodge Grand Caravan And Chrysler Town & Country Vehicles. These vehicles may have been assembled with missing or incorrect steering column components. The defect could compromise the ability to steer the vehicle and decrease the effectiveness of the frontal impact system. This manufacturing defect could result in both increase in potential for accident and more severe injuries in the event of a crash.

The report from the NHTSA includes a number of other automotive recalls; as well as motorcycles, trailers and other vehicle related products.

A product that should have carried a very clear and detailed warning of its dangers is causing severe injuries. The product is called “Napafire”, distributed through Bed, Bath & Beyond (and other national distributors); and is packaged and distributed by Napa Home & Garden, Inc.

The NAPA product is manufactured with a gelatin type consistency and contains ethanol as its primary flammable component. NAPA promotes the product as “clean burning” and good for the environment. The victims of what becomes an explosive fire ball have described it differently:

• A Molotov cocktail.
• Like gasoline in a bottle.
• A lethal weapon.

Every flammable compound has a “flash point” and each varies from substance to substance. The “flash point” is the temperature at which a compound, liquid or material can ignite into flame and begin to combust. Gasoline, for example, has a flash point at a much lower temperature than does fuel oil.

Napafire is a compound with a reasonably low flash point. It oxidizes into a gaseous form slower than many compounds and ignites slow. It does, however, burn at a high temperature and results in heating the containing vessel to high temperatures. As a result, whatever Napafire is contained within is going to heat to significant temperatures and will probably remain there for a period of time. So, it is not only the compound burning, but its container that provides a hazard for flash ignition.

Add to these issues, Napafire burns relatively hot and clean and can burn with what the manufacturer describes as a “nearly invisible flame.” This presents a hazard for the consumer in determining whether the Napafire flame is extinguished or not.

Napafire might fairly be compared to napalm. Napalm was a highly flammable weapon used in Vietnam extensively. Napalm was used primarily because of its gel-like consistency. When ignited and dispersed, it would adhere to everything it touched with a hot, searing burn. Efforts to extinguish napalm are largely unsuccessful and the burning gel flows along everything it touches.

These are some of the problems, which have led to serious injuries resulting in explosions and serious burns caused by the fuel-gel burning pots, Napafire.

Our firm is currently investigating the details of serious  and tragic injury to a person in South Florida recently. Immediately, our analysis has led us to identify very significant design, use and warning problems with these devices and the fuel gel being used in them, such as this pictured below.

Napa Home & Garden’s president, Jerry Cunningham has admitted that the “warning label on the firepot was a small sticker on part of the pot’s packaging,” which was meant to be thrown away.”

Take great care in using these fuel gel burning pots, including not trying to refill them unless you are absolutely sure they are extinguished and have had ample time to cool before adding additional fuel gel to them. Better advice would be to simply not use these devices at all.

Reports of other incidents include:

• June 10, Granger, Ind.: A contractor, was at his neighbors house watching their dogs romp in the yard when his neighbor tried to refill a firepot and it erupted with a fireball into his lap. Nothing would put it out, he said from his hospital bed on Monday.
• June 3, Omaha, Neb.: A food-industry executive, tried to refill a Napa Home & Garden firepot that he was sure had burned out. It sent a fireball streaming out of the fuel bottle like a flamethrower, Mr. McCutcheon said, seriously wounding his wife, his 9-year-old daughter, and his sister-in-law.
• May 28, Huntingtown, Md.: A woman was visiting old high school friends for a cookout when someone tried to refill a Napa Home & Garden firepot that seemed to have run out of fuel. It exploded on her. Tragically, this lady is still on a respirator at Washington Hospital Centers burn unit, according to Maryland fire marshals.
• March 31, Encino, Calif.: A nine year old girl was with a friend when the friends father started performing tricks with a Napa Home & Garden firepot, according to a lawsuit accusing the hosts of gross negligence. When the man poured more fuel into the pot, it erupted onto the young girl, sending her to the hospital for 14 days with severe burns.
• June 10, 2010, Carlstadt, N.J.: A teenager was seriously burned on more than a third of her body when a firepot made by a different company, BirdBrain Inc., erupted as her mother refilled it. She spent more than five weeks in the hospital.
• April 3, 2010, Baltimore: A young boy was in his aunts backyard when a BirdBrain firepot tipped over, spilling flaming fuel gel over his left side and leg. He spent 51 days in the hospital. His arduous rehabilitation has been chronicled in videos on YouTube by his mother.

Now that summer is upon us, many South Floridians will cool off by jumping into the pool.  But be careful before you dive in.

On May 26, 2011, the U.S. Consumer Product Safety Commission announced that eight manufacturers have voluntarily recalled one million pool and in-ground spa drain covers due to faulty water flow ratings.  According to the Commission, the recalled drain covers pose an entrapment hazard to swimmers.

The drain covers were required by law after young children continued to get stuck in pool drains and many were very seriously injured.  However, many of these covers have failed safety tests.  Additionally, the lab that certified most of the drain covers did not accurately recreate the suction found in a pool or a spa.

The manufacturers who have recalled their products include A&A Manufacturing and Color Match Pool Fittings of Arizona, AquaStar Pool Products Inc. and Waterway Plastic of California, Custom Molded Products of Georgia, Hayward Pool Products of New Jersey, Pentair Water Pool and Spa of North Carolina, and Rising Dragon USA of Tennessee.

The Consumer Product Safety Commission is urging that pools across the country to remain closed until new drain covers are put in place.

The majority of the defective drain covers were manufactured between December 2008 and April 2011.  Consumers who have purchased a drain cover that has been recalled should contact the manufacturer in order to receive a replacement.  If you are unsure who has manufactured your pool cover, it is best to contact a professional to assist you.  You can also learn more about the recall on the Association of Pool & Spa Professionals website or contact the Association’s drain cover recall hotline at (866) 478-3521.

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.