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Big Tobacco Caught in the Back Draft of its Scorched Earth Litigation Strategy

Cal Warriner — Fri, 20 Nov 2009 09:20:46 GMT

Big Tobacco's pants are aflame today after suffering a 300 million dollar verdict in yet another defeat in its Florida litigation war. You see, knowing it has imposed more death and suffering than modern war, pestilence and aids combined, Big Tobacco's mantra has always been millions for defense and not a dime for restitution (and a few extra hundred million thrown in for political payola and advertising). Historically the strategy has worked. The big bully with its army of well healed, silver tongued lawyers could outspend, outmaneuver, and overwhelm wheezing customers and their lawyers. Tire them out, grind them into the dust, argue every issue, appeal every ruling and intimidate lawyers into not taking up the cause. No matter the cost, Big Tobacco had to make suing it so distasteful that smokers would just die and go away quietly. I mean, what would happen if all the sick smokers sued us at once? Right?

Today however, as Phillip Morris arrogantly thumbed its nose at yet another former customer who sat in the courtroom on oxygen, the strategy cost Phillip Morris 300 million dollars. Having once again turned its back on the opportunity to settle for for less than it paid one defense expert, Phillip Morris placed its fate in a gaggle of highly skilled cigarette lawyers from Chicago and San Francisco. The juries verdict, millions for restitution, to hell with your million dollar defense.

You see, the tide has turned in Florida. Instead of unleashing its army and unlimited resources on one poor smoker, Big Tobacco faces almost 8000 filed cases that are all proceeding concurrently. The cases arise from years of class action litigation in which a jury and ultimately the Florida Supreme court finally put an end to decades of Big Tobacco's dismiss, distract, deny and deceive strategy. No longer are Tobacco's slick litigators allowed to come to court ready to contest whether nicotine is addictive or whether it causes lung disease and cancer. Nor can the companies argue that their products were not defective or that they were not guilty of negligence and fraudulently lying to the consuming public about the dangers of cigarette smoking. Remember, as late as 1994 every tobacco company CEO stood before Congress and swore that nicotine was not addictive and that there was no medical proof linking cigarette smoking to cancer. Swallow lye to perpetuate the lie, no problem. Nope, the issue for the jury to decide in Florida is now what it always should have been. Is it the smoker's fault for buying the defendants' product and using it exactly as intended (quite ironic) or is it the product's addictive qualities manipulated so adeptly by Tobacco chemists that resulted in the smoker's disease? For the first time in the history of tobacco litigation, it's a fair fight. Recent history teaches when Big Tobacco can't poke, bite or hit below the belt, it is losing its shirt.

Since members of the now decertified Florida class have been trying their cases against Big Tobacco, the smoker has won eight of ten trials many in the multiple millions of dollars with today's 300 million dollar verdict being the largest. In each case, Tobacco has flatly refused to discuss settlement many times rejecting settlement offers of as little as $10,000. As a result, all of the smoker's litigation costs and attorney's fees are being tacked on to the verdict. Tobacco already faces over fifty trials next year with more being set every day. If past is prologue, the nicotine purveyors are in for disastrous 2010.

As the saying goes, all good things must come to an end. In Florida at least, the courts have put an end to traditional Tobacco defenses. When then will the companies spin to the financial industry about its exposure in Florida tobacco litigation end. The Florida Supreme Court's Engle decision is flawed, this verdict is an aberration; we intend to appeal; we feel good about our chances on appeal; we have plenty of resources to defend ourselves; lawyers will lose interest and Engle cases will just go away like the flight attendant second hand smoke cases did. Hogwash.

With this verdict, it's time that the financial markets woke up smelled the coffee. They need to start asking probing, hard questions. Can an industry that sells an addictive product that has killed millions and continues to kill hundreds of thousands each year cheat the fates indefinitely? Will the American public stand to have its children and its children's children addicted and killed by this evil industry?

Ironically, the litigation strategy that has served Big Tobacco so well for so long has exposed its biggest weakness. Tobacco cases are very winnable. They are even more winnable when filed en masse by just a fraction of its victims. Juries no longer buy Tobaccos' lies. Ironically, for less than the cost of corporate jet fuel, Big Tobacco could have resolved the entire Florida litigation. Now, it must live with the consequences of an archaic philosophy, hatched moons ago by dead men, each made rich by the very cigarettes that ultimately killed them.

Originally posted at InjuryBoard by Cal Warriner

Tobacco Held Responsible for Placing Profits Ahead of...Everything

Brenda Fulmer — Thu, 19 Nov 2009 17:16:34 GMT

Philip Morris suffered yet another blow in the latest post-Engle tobacco trial. A Fort Lauderdale jury rendered a verdict on November 19, 2009, for $300 million against the tobacco manufacturers on behalf of a living smoker who suffers from severe emphysema. The verdict included $246 million in punitive damages.

This verdict is one of a number of verdicts that have been entered in completed jury trials in Broward and Escambia Counties this year.

More than 8,000 claimants and their survivors have individual lawsuits pending in courts throughout Florida. These claims stem from the Engle class action which was filed in 1994 and resulted in a verdict of more than $145 billion after one of the longest trials in history. Currently, there are dozens of trials scheduled for 2010 in Miami, Fort Lauderdale, Bronson, Jacksonville, Gainesville, Bradenton, Tampa, Pensacola, and Daytona Beach.

Thousands of additional smokers and their survivors are hopeful that the current scheduling and budgetary problems facing the Florida court system are overcome so that they may have their day in court in the not too distant future.

Originally posted at InjuryBoard by Brenda Fulmer

Heparin or Over Sulfated Chondroitin Sulfate? That is the Question.

Armand Rossetti — Fri, 07 Nov 2008 10:51:58 GMT

In its natural form, chondroitin sulfate (itself a glycosaminoglycan) is used as a natural dietary supplement for the palliation of osteoarthritis. In fact, natural chondroitin sulfate is not a blood thinner like its analog, “over-sulfated chondroitin sulfate” (OSCS). Heparin is also a highly sulfated glycosaminoglycan.

A large unregulated Chinese manufacturer, Changsou, made the cheap heparin-like OSCS, mixed it with raw heparin (cut the heparin), and then sold the adulterated heparin at attractive prices to well-respected drug companies like Baxter International. Early on in the discovery of the OSCS contamination, many severe allergic reactions while using contaminated heparin, including 19 deaths resulted. To get a better understanding of how events surrounding the OSCS contamination unfolded, let’s take a look at the following, brief news, scholarly journal and FDA alert timeline:

February 11, 2008:

FDA News released an advisory warning that Baxter’s multiple-dose vial heparin was kinked to severe allergic reactions. Baxter stopped manufacturing the product while the FDA continued to investigate the root cause of the product’s adverse reactions. However, rather than issuing a recall, the FDA compromised and issued recommendations to physicians who might have to use the product that Baxter had already distributed.

February 16, 2008:

Because Changhou SPL had no drug certification, China’s drug agency did not inspect it. The US FDA said this week that it had not inspected the plant, either-a violation of its own policy-before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.”

February 28, 2008:

The US FDA issued an alert to inform the public about reports of serious adverse events in patients who had received bolus injections of Baxter’s heparin. The FDA recommended not using Baxter’s heparin, but if there was no other source in an emergent situation to: not use a bolus dose; use the lowest dose necessary; closely monitor the patient for adverse events; and to consider pre-treating with corticosteroids or antihistamines before administering heparin.

The alert mentioned that Baxter, a major heparin supplier with over 50% market share, had withdrawn nine lots of heparin in January 2008 after receiving 350 adverse events, 40% of which were serious.

March 1, 2008:

Up until late February 2008, neither China nor the FDA had regulated China’s largest Heparin raw material ingredient producer, Changhou Scientific Protein Laboratories. The failure to regulate Changhou was a violation of the US FDA’s own inspection policy (CBS Video).

March 19, 2008:

China’s State Food and Drug Administration (SFDA) and the US FDA both identified OSCS in Baxter’s Heparin. The US FDA was investigating whether the chemical was purposefully or inadvertently added during manufacturing in China. The over-sulfated version of chondroitin sulfate does not occur in nature and must be manufactured. The FDA was attempting to determine whether the synthetic chondroitin sulfate was the cause of 19 deaths, hundreds of serious breathing problems and other reactions reported in the United States.

In March 2008, the US FDA knew that over sulfating chondroitin, which is substantially more abundant and available from a wide range of animal sources, was cheaper than processing raw heparin from pig intestines.

March 22, 2008:

China’s SFDA ordered its local bureaus to increase supervision over heparin production. Producers would now have to obtain raw material from registered suppliers. The US FDA called on importing countries to take responsibility for insuring heparin’s safety. China is the largest heparin material supplier in the world.

However, regulation would be a daunting task for the Chinese, because much of the then current supply chain included thousands of small workshops that gathered heparin from pig intestines and sold it to larger chemical companies (not drug companies) that produced the pure active ingredient in heparin. Here is a quote from the New York Times article:

“Much of China’s production of raw heparin begins in homes and tiny factories, where teams of three to five people transform pig intestines into a dry substance that is eventually sold to major pharmaceutical companies.

Most of the small factories are unlicensed and unregulated. They sell to traders and consolidators, who sell the raw heparin to companies like SPL that, purify it to produce the active ingredients. Many of them are not regulated by the Chinese drug agency, since they are considered chemical companies, not drug makers.

The active ingredients, in turn, are sold to pharmaceutical companies like Baxter that produce the finished drug.”

April 2, 2008:

After receiving notification from Scientific Protein Laboratories, LLC (SPL), Covidien, formerly Tyco Healthcare, voluntarily recalled its injectable heparin products.

April 20, 2008:

Baxter International had begun distributing contaminated heparin in November 2007. The contaminated heparin base had reached nine countries not including the United States. The US FDA had traced the contaminated heparin to 12 Chinese manufacturers. Now there were 81 deaths due to the contaminated heparin. Yet, the Chinese remained skeptical that investigators could make a connection between OSCS and the illness and deaths that had resulted.

The FDA still did not know where in the Chinese supply chain processors had introduced the OSCS, but the FDA was fairly certain that OSCS had caused the illnesses and deaths. Investigators had observed similar reactions in animal studies and had conducted in vitro testing that had confirmed that such reactions might occur.

April 23, 2008 (published in June 2008)

National Biotechnology published Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events, suggesting that traditional methods of analysis could not OSCS detect contamination:

“Given the nature of this contaminant, traditional screening tests cannot differentiate between affected and unaffected lots. Our analysis suggests effective screening methods that can be used to determine whether or not heparin lots contain the contaminant reported here.”

May 15, 2008:

Atrium Medical Corporation and Medtronic, Inc. initiated voluntary recalls for their contaminated heparin products.

October 18, 2008:

The FDA requested that US Marshals enter Celsus, an Ohio heparin Manufacturer and seize 11 lots of heparin contaminated with OSCS. The seized material had entered the US prior to import controls that were established earlier in 2008. Celsus President Case Van Gorp informed CNN that Celsus had quarantined the contaminated lots at least since April 2008, and had notified its customers of the problem in March.

The FDA had inspected Celsus in April and May, and that since then no contaminants had been identified in Celsus heparin products. However, the FDA had told Celsus that its actions to notify customers about the company’s contaminated heparin were insufficient to assure an effective recall.

Conclusion:

While it is evident that the US FDA did pay close attention to developments concerning contaminated heparin after the problem arose, it is evident that the FDA did not do enough to prevent the possibility of such widespread contamination from occurring in the first place. However, the FDA is not alone in its inability to prevent such pharmaceutical manufacturing disasters. In addition to China, India provides a good example of a country that is not currently prepared to deal with untoward manufacturing problems. Here is an excerpt from “Story of Heparin Recall: What India can do?” published in the Journal of Postgraduate Medicine (one of the oldest medical journals from India):

“Traditionally very little is done to address drug safety issues in India by pharmaceutical companies. Implementation of amended Schedule 'Y' of the Drugs and Cosmetics Act, has not improved the situation yet. The NPP has achieved very little, if anything, until now. A lot needs to be done to put in place a pharmacovigilance system robust enough to verify such important medication safety signals as observed in case of heparin. Also, we are way behind the western countries in identifying safety signals to new drugs and quantifying the risks.”

Regarding the US FDA's inability to address foreign active ingredient supply problems, perhaps Susan Briones said it best in her essay, Heparin Recall: Another Crisis for China & the FDA:

“And what of the FDA’s own admission of failing to follow its own procedures? Can injured patients hold it accountable? -Probably not. The FDA is one of many overburdened, under-funded, and liability immune government agencies that let consumers fall through the cracks. This time, however, the result was the death of Americans. It is imperative that the FDA be better funded and managed so that inspections of production facilities outside of the U.S. can be done on a comprehensive level. The U.S. and Europe have been expanding their production of medical products globally for several years because it is cheaper to do so. Approximately 40% of drugs and 80% of their chemical ingredients are imported from countries like China and India that do not have ample inspection and safety procedures in place. According to Dr. Bryan Liang, an advisor to the Partnership for Safe Medicines, “the problem is only going to get worse as more materials come from suspect sources.”This is not news, however. The FDA knows it does not have the manpower or resources to inspect every overseas facility, as do Congress and the President, all of whom have been calling for more funding. Perhaps holding the FDA liable for the damages experienced by the harmed patients is the only way to prod our government into properly funding this all-important agency and keeping American consumers safe.”

Originally posted at InjuryBoard by Armand Rossetti

Profit Over Safety -- A $20 Decision

John Hopkins — Tue, 01 Dec 2009 10:04:27 GMT

A 46 year old woman is paralyzed when her sport utility vehicle rolls over and the roof collapses onto her. The manufacturer knew their SUV was prone to rollovers and in the event of a rollover, the roof was insufficiently reinforced to prevent the very injuries suffered by the woman. In the case, the woman alleges that a fix to the roof stability would have cost the SUV maker approximately $20 per vehicle.

This story sounds a great deal like a car prone to catching on fire and exploding when rear ended at relatively low speeds. In those cases, the auto maker consciously chose not to spend the money to recall and retrofit the vehicles. That decision unnecessarily cost many lives.

Oh, yeah, in both instances it was Ford. In the earlier case it was a little car called the Pinto and in this most recent case, a little SUV called the Explorer.

It boils down to making “business decisions” in the best interest of stock holders is what Big Corporations say. They are forced to weigh their overhead against the need for design modifications. They are charged with answering to stockholders who have hitched some portion of their financial future to these very decisions.

It boils down to making decisions that do not place profits over safety is what I say. Sorry Corporate America, but it should not be acceptable to place the public in peril of life or limb for $20. In fact, it should not be OK with anyone to have a 46 year old woman and mother of two children who will never walk again because it was not expedient or economical to either, first design or second retrofit a product to make it as safe as possible.

When Ford was hit with this jury verdict amounting to over $350 million for both compensatory and punitive damages, they appealed. The courts reduced the jury verdict to $82 million, for both compensatory and punitive damages. Ford cried foul and appealed; arguing that they made reasonable judgments in the design of the SUV and they should not be responsible for punitive damages.

When Corporate America demonstrates a conscious disregard for the safety of consumers, punitive damages are appropriate. When an industry makes billions marketing a 3000 pound object that moves at 70 mph “reasonable judgments” that include the failure to spend $20 additional for safety most certainly justifies these damages.

Originally posted at InjuryBoard by John Hopkins

Circulating Levaquin leaves the bloodstream, deposits in Achilles’ tendons, and alters tendon cells

Armand Rossetti — Tue, 02 Dec 2008 10:42:57 GMT

Both short and long term treatment with fluoroquinolone antibiotics may cause tendon matrix alteration that can lead to tendinopathy with subsequent rupture. Tendinopathy is newer all-inclusive medical term that encompasses tendonitis, tendonosis and tendon rupture.

Structure:

Tendons are tropocollagen connective tissue bundles that attach muscle to bone. Stress between bone and muscle is longitudinal. That is why chains of tropocollagen combine to make longitudinally arranged fibers that bundle together as fibrils. Groups of fibrils form endotenon covered groups of fascicles that have a loose connective tissue packing called the epitenon which also contains blood vessels. Here is a drawing.

The Achilles’ tendon is the largest tendon in the body and please bear in mind that it has a limited blood supply. The Achilles is also the strongest and toughest tendon and capable of lifting the entire body weight against a severely adverse leverage ratio.

Toxicity:

It is interesting to note that 7 – 10 days after a tendon injury, there is little or no inflammatory response. Likewise, 2 – 3 weeks after fluoroquinolone ingestion, no inflammatory cells are present.

The toxic effects of fluoroquinolones cause dysplasia (abnormal cell development and maturation) of a tendon’s collagen fibrils leading to a reduction in tensile strength (the tendon’s ability to stretch and not rupture). Reportedly, fluoroquinolones, such as Levaquin alter the amount of glycoproteins found in tendon cells and fragment nuclear DNA apoptosis markers. DNA fragmentation may explain fluoroquinolone-induced tendinopathy.

In addition, investigators have reported that fluoroquinolone drugs, such as Levaquin, can cause biochemical changes (affecting magnesium chelation). Reportedly, those biochemical changes interfere with the process that contributes to tendon healing (proteoglycan synthesis). As a result of those changes, Levaquin ingestion has the same physiological characteristics as tendon overuse, and that conclusion is evident because of the presence of giant cells and structural abnormalities in tenocytes (tendon cells).

Distribution:

Fluoroquinolones leave the bloodstream, deposit in tendons, and cause localized tendon toxicity (Meissner, A., Borner, K., & Koeppe, P. (1990); Concentration of ofloxacin in human bone and cartilage, Journal of Antimicrobials and Chemotherapy). Therefore, Levaquin takes up residence at the very site that it affects.

A Thought:

In light of all of the above, the FDA has extended marketing “pediatric exclusivity” to Ortho-McNeil for Levaquin based on five company-sponsored pediatric studies that the FDA requested.

Originally posted at InjuryBoard by Armand Rossetti

Zicam Nasal Gel: Questions about Efficacy, Risk of Use, and Timing of the Warning

Armand Rossetti — Fri, 19 Jun 2009 17:14:06 GMT

The three Zicam products included in the recent FDA warning letter that Matrixx received in June 2009 are:

Zicam Cold Remedy Nasal Gel (NDC 62750-003-10)
Zicam Cold Remedy Swabs (NDC 62750-003-20)
Zicam Cold Remedy Swabs, Kids Size (NDC 62750-003-21) (discontinued)

Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Nasal Gel were both introduced in 1999 and each contain the active ingredient, zinc gluconate (10% ).

There are many questions to consider when analyzing the reason for, and the timing of the FDA’s warning. However, it might be best to take a brief look at whether zinc products such as Zicam Cold Remedy actually work as homeopathic remedies.

The trademark, Zicam, is taken from “Z” for zinc and I-CAM, a type of receptor site found on epithelial cells and in viruses. Purportedly, Zn2+ ions complex with intercellular adhesion molecular receptor sites on rhinovirus surfaces, and prevent cold viruses from binding to human cells. In other words, zinc allegedly prevents cold viruses from gaining entry to human cells and causing cold symptoms.

It all looks pretty simple and straight forward. However over the years, Zinc’s efficacy as a virus blocker has been the subject of notable controversy.

In 2000, Michael Hirt’s group published a study in the Ear, Nose & Throat Journal that suggested that zinc lozenges shortened the number of days from onset to the complete resolution of common colds. Hirt found that zinc lozenges reduced the duration of symptoms by 75%, which was consistent with the 85% figure that Hensley (in an unpublished zinc nasal gel study) had reported. However, another investigator found otherwise.

In 2001, Ronald Turner found that there was no significant effect, i.e., no difference in common cold duration between active zinc treated and placebo treated subjects. Turner noted that the infection rate in challenge volunteers was 93% while it was 90% the placebo volunteers. During the study, Turner measured signs and symptoms such as rhinovirus severity, nasal obstruction, and headache. In 2002 Samuel Yiu corresponded with Turner. While Yiu supported Turner’s challenge model, he found fault with the sample population number and protocol of the study. In his correspondence, Yiu also suggested that further evaluation was necessary in order to draw any conclusion regarding efficacy.

In 2004, Hulisz published an overview concerning zinc’s efficacy against the common cold Hulisz found that zinc attached to “I-CAM receptor sites found on retroviruses and on nasal epithelial cells. However, Hulisz also determined that there was a 24-hour window, beginning onset, for the most effective treatment to occur. A question might arise whether the average consumer can accurately determine when that window opens and when it closes.

Is nasal zinc treatment worth the risk? We have seen some evidence (above) that zinc may or may not work under certain circumstances. However, what is the risk of using nasal zinc products?

In 1938, amidst a polio epidemic that prompted physicians to arrive at ways to prevent the poliovirus from spreading, Smith submitted a study to the Canadian Medical Association Journal that addressed epithelial treatment with 1% zinc sulphate. Although zinc sulphate is not exactly the same as zinc gluconate, it seems evident that both are severe irritants at higher concentrations.

In his basic science study, Smith found evidence that zinc sulfate at 1% destroyed the three types of cells in the olfactory sensory epithelium that gives humans the ability to smell known in scientific circles as “anosmia.” More importantly, those sensory cells disappeared forever because they cannot regenerate. Instead, regular non-sensory epithelial cells replaced those sensory cells.

Given all of the above, it is not unreasonable to question whether the risk of using nasal zinc treatment might outweigh the benefit of receiving such treatment. After all, the FDA’s concerns about reported adverse events of anosmia were underscored by published scientific literature that provided evidence, such as the 1938 Smith study, showing a connection between intranasal zinc and anosmia.

Next we should question when the risk of using Zicam gel nasal spray became obvious.

As early as October 2003, Zicam, LLC and parent, Matrixx Initiatives, Inc. became defendants in a lawsuit that alleged that the plaintiff had lost his sense of smell after only a single treatment with Zicam. In fact by 2004, large numbers of similar complaints prompted the FDA to inquire about Zicam’s safety.

As time progressed, claimants continued filing complaints, alleging that treatment with Zicam nasal spray (a gel) had caused loss of smell. It is interesting to know that that FDA was not regulating homeopathic zinc preparations such as the Zicam Cold Remedy.

Later on in February 2006, Matrixx settled 340 anosmia-related Zicam lawsuits. Then, as previously mentioned, more than three years later on June 16, 2009, the FDA issued a warning letter to Matrixx . The warning letter notified Matrixx that it had crossed the line when making efficacy claims for its self-declared “homeopathic,” nasal zinc products. Therefore, Matrixx could no longer qualify those products as being homeopathic preparations. According to the FDA, Matrixx had taken a step further and was actually marketing new drugs intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, all without FDA approval. As required before marketing Zicam Cold Remedy Nasal Gel and Swabs, Matrix had not submitted a new drug application (NDA), and it had not participated in the FDA approval process. As a result, the FDA suggested that Matrixx promptly remove Zicam Cold Remedy nasal products from store shelves.

To this day, however, Matrixx maintains its original position that Zicam nasal preparations are scientifically proven to be safe and efficacious, and that they do not cause anosmia. Yet, only three days after receiving the FDA warning, Matrixx issued a message, suggesting, among other actions, that consumers discard any previously purchased Zicam Cold Remedy Nasal Gel or Zicam Cold Remedy Gel Swabs.

These precautions are all “good and well,” but at what point should consumers have received a formal manufacturer’s warning concerning the possible danger associated with nasal application of Zicam Cold Remedy? Would the right time have been in 1999, when Matrixx introduced Zicam nasal zinc products? How about in 2003, when plaintiffs allegedly suffering with anosmia filed 340 lawsuits? Should Matrixx have issued a voluntary preliminary warning in 2004, when the FDA began investigating complaints; or should Matrixx have then instructed consumers concerning proper application and use?

It seems plausible that Matrixx might have issued a voluntary warning in 2006, when it settled 340 Zicam lawsuits for 12 million dollars. In fact, George Eby submitted an article to Alternative Therapies in 2006 that contained the following statement:

“We contend that it is unethical to introduce any potentially permanent anosmia-inducing agent such as zinc or other heavy metals into the interior of the nose in a manner that could result in contact with the olfactory region to treat a temporary discomfort such as a common cold or allergy. We found no reason to recommend intranasal zinc gluconate or zinc orotate lozenges in treating common colds. (Altern Ther Health Med. 2006;12(1):34-38.) [Emphasis added].”

In 2006, additional information about the danger in using Zicam gel continued emerging. For example, the Denver Naturopathic Clinic issued a Zicam caution in 2006; the clinic provided a well reasoned opinion why Zicam was not homeopathic, and at least one clinic had raised a question about Zicam’s efficacy.

Maybe after receiving 800 aftermarket consumer complaints involving anosmia, the FDA might have suggested that Matrixx issue a warning in 2007 or 2008. What standard would be necessary to analyze whether a warning was warranted?

Perhaps Justice Royal in McClain v. Metabolife, 401 F.3d 1233 (11^th Cir. 2005) mentioned the difference between assessing consumer risk (a lower, more encompassing standard) and determining scientifically based causation (a more demanding and higher standard):

“The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or the more-like-than-not standard used to assess tort liability. The methodology employed by a government agency results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances....”

Therefore in Matrixx' case, it should be reasonable to conclude that whenever that lesser showing of harm occurred, and I suspect that it occurred at least a few years before 2009, Matrixx should have issued a voluntarily warning, or the FDA should have suggested that it do so.

Originally posted at InjuryBoard by Armand Rossetti

A Closer Look at Gadolinium-Related Nephrogenic Systemic Fibrosis (NSF) also known as Nephrogenic Fibrosing Dermopathy (NFD)

Armand Rossetti — Mon, 10 Nov 2008 09:28:48 GMT

For example, the Prohance brand of Gadolinium is more stable than and clears more completely than the Omniscan brand of Gadolinium. This difference in stability is due to the chemical structure of the two different brands of Gadolinium contrast agent. Prohance is a non-linear form of gadolinium where the organic protective shell (the chelate) is attached in four places around the gadolinium. With Omniscan, we have a linear complexed coating. What does this mean?

The body attacks the Omniscan shell mush easier because it is easier to break single linear bonds than it is to break four bonds that form around the Prohance brand gadolinium Evidently, GE Healthcare was aware of this problem because it included extra chelating agent in with the Omniscan contrast agent in an attempt to reduce the chance of free gadolinium3+ (which is very toxic) to remain behind in the system. Bracco Diagnostics manufacturers Prohance. (For an in-depth discussion of the difference, please access this Digital Medical Services website and advance the video to 9.22 minutes [and wait for the video to download]). The 9.22 minute point in the video (the second of four grand rounds presentations) is where this important NSF/gadolinium discussion begins.

Signs of NSF:

Here is a series of four figures that you may review by clicking on “next figure” at the top and right side of each figure frame. Notice that Figure 1 represents a long term manifestation of NSF. That contrasts with Figure 2, which shows early signs of NSF. Figure 3 displays a histopathology slide of the usual thickened skin that results from free gadolinium poisoning. For comparison, (here is a slide representing normal skin [or dermis]). Figure 4 shows how the gadolinium causes an increase in interstitial mucin. You can see the introduction of fibrocytes and swollen collagen bundles and a degeneration of collagen fibers. Notice, as well, the absence of inflammatory cells. Lastly, here is a chart showing characteristics of several brands of gadolinium contrast agents. Notice that Omniscan contains 48 times more excess chelate content than Prohance, and that Optimark has added nearly 120 times more excess chelate than Prohance.

Diagnostic bone scans (third through fifth pictures) have revealed that gadolinium accumulates predominately in the lower and distal upper extremities. Taking a further look using T1 and T2 axial tomography (last two pictures) shows NSF affecting both skeletal muscle and skin. There is a symmetric skin thickening and evidence of edema in the medial thighs. One can also detect edema in the subcutaneous fat, intramuscular fascia, and thigh muscles. Interestingly, there is some sparing of the posterior thigh muscles. For comparison, Here is an axial tomography of an otherwise normal thigh (except for a fractured femur).

The Chemistry behind Complexed Gadolinium Contrast Agent:

A paper entitled, Contrast Agents in Magnetic Resonance Imaging (Andrei Volkov 1997) provides a comprehensive look at gadolinium complexation and resulting stability. The Volkov paper also addresses among other phenomena, in vivo gadolinium toxicity and Transmetallation including its connection with toxicity.

Conclusion:

While all gadolinium contrast agents may contribute to the manifestation of NSF, some gadolinium agents may be less risky than others, due to the way in which the ligands (coating elements) are attached to the gadolinium itself.

Certain manufacturers seem to be aware that some more structurally stable chemical compositions of ligand treated gadolinium contrast agents are less risky than others. Knowledge of a range of stability for the different gadolinium contrast agent brands is evident because those manufacturers of the less stable coated agents have added free chelating agents to their particular brand of contrast solution.

GE Healthcare’s Omniscan brand of gadolinium contrast agent is a good example of a weaker linear-type bonded chelate (see the grand rounds presentation linked above). Because of the nature of the chelate bonding, the linear compounds are prone to breakdown and release of free and highly toxic gadolinium3+ from the safer chelated form, before elimination from the body. Omniscan contains unbonded chelating agent, which GE Healthcare has added to the solution in the hope of preventing early and toxic free gadolinium release.

Early release of free gadolinium from the chelated form, and perfusion of the free gadolinium into the body's tissues usually results in NSF.

Originally posted at InjuryBoard by Armand Rossetti

E-Cigarette…Anyone Else?

Armand Rossetti — Fri, 24 Jul 2009 10:00:17 GMT

The FDA has alleged that one of several E-cigarette distributors in the United States, Smoking Everywhere, Inc. (SE), has marketed a product that is both an unapproved drug (nicotine) and an unapproved medical device (synthetic cigarette body).

The FDA made this determination after examining the product, several claims made about the product, and information that SE, itself, provided to the FDA. For further information, please read E-cigarette Anyone?

While class I medical devices (gauze pads, throat sticks and the like) do not necessarily need FDA approval, class II or III medical devices do require FDA clearance before legal marketing can occur. The FDA has classified the E-cigarette as a class III medical device, and as such that device must undergo the strictest FDA scrutiny before it can reach the marketplace.

Depending on the manufacturer and type, the cost of entry to use E-cigarettes can vary from $14.99 for the “disposable” version all the way up to more than $200.00 for reusable deluxe models. Complete “starter kits” with cartridges and batteries included have been advertized at around $100. While the $200.00 price tag might discourage younger users, the chic of it all and the curiosity to try an E-cigarette at the price of about three packs of cigarettes ($14.99) might entice a younger demographic to give it a try.

Most people who use E-cigarettes do so with the intention of cutting down on smoking, or with the anticipation being able to get a nicotine high while working indoors (no smoke = no ban). Other consumers use the device to quit smoking altogether. Cessation is possible because the nicotine concentrations in the cartridges can range from 16 mg all the way down to zero mg. The choice remains with the consumer.

There can be no dispute that well designed and well regulated E-cigarettes have a potential to aid smokers in reducing or eliminating their habits. And several manufacturers are heading in the direction of making the E-cigarette device as safe as possible.

However, E-cigarettes might also provide an avenue for further addiction. A first time E-Cigarette user with the handle, “Utada” recently posted an after purchase review on Amazon.com. Although Utada was going to give the SE distributed E-cigarette five (5) stars, Utada only gave the product three (3) stars because he or she felt that the product was addictive since it had nicotine.

But here's the catch. When Utada was smoking real cigarettes, she smoked only 5 or 6 a day. However, with the E-cigarette, Utada wound up smoking two cartridges a day (each cartridge being equal to 20 regular cigarettes). Utada continued her review by advising the purchase of “e-cig juice” an after market nicotine cartridge rejuvenator, which comes in different flavors. With e-cig juice (or E.LIQUID, as one example), Utada expected to save a lot of money. In fact, using e-cig juice to extend the life of the device, reduces the cost of “smoking” significantly to far less than $5.00+ a pack for 20 smokes (see below). But there is a potential health hazard in using an E-cigarette beyond the number of cycles that the manufacturer has built into the device; an example follows.

Recently, several complaints have surfaced about a burning taste that consumers experience after cycling the E-cigarette through a number of puffs. This phenomenon may or may not involve SE’s version of the E-cigarette, but it would be prudent to obtain more information from the manufacturer.

As one blogger illustrated, most E-cigarette devices contain a wick inside a filament that soaks up the liquid in the cylinder that contains nicotine. A battery powered filament then heats the liquid that finds its way to the wick to form a vapor. After a while, the wick dries out fairly easily and starts to burn forming “burnt e-liquid”). Thereafter, the residual E-liquid has a propensity to turn into a solid and begin to burn. That sequence is what creates an unwelcome taste, and a possible, device-related health hazard. With little regulation, the possibilities for serious health risks seem as endless as human creativity will permit.

For example, some ardent E-cigarette consumers have expressed concern that manufacturers may be using a cheap polyester material to make the filter portion of the cigarette. Polyester filters could turn out to be dangerous when burned and inhaled.

Moreover, E-cig liquid is sold in 15 milliliter bottles in several flavors and nicotine strengths for $14.99. According to one distributor, only 2 or 3 drops of the liquid will regenerate a cartridge. Since there are 20 drops per milliliter, that means that one 15 milliliter bottle contains from 100 to 150 cartridge refills, and one cartridge equals 20 cigarettes. Doing some simple math, like many young people are able to do, a cigarette equivalent could cost as little as $14.99 divided by 3000, or about half a cent (or 10 cents a pack). It’s a great way to beat the cigarette tax.

To reiterate, the E-cigarette is a device, nicotine is a drug, and the FDA will be regulating both. Therefore it is within the purview of the FDA to ensure the safety of the E-cigarette device and its delivery of a drug. Otherwise, problems associated with misuse and/or device alteration might abound

Bottom line: In the interest of consumer safety, the FDA should require all E-cigarette manufacturers list materials used in respective devices. In addition, the FDA should require E-cigarette manufacturers to conduct studies to determine whether any materials subject to heat during cycling, including polyester, might produce toxins. Smart manufacturers should be forthcoming with appropriate warnings and, lastly, all forms of nicotine, including E-cig juice should be FDA regulated.

Originally posted at InjuryBoard by Armand Rossetti

E-cigarette Anyone?

Armand Rossetti — Thu, 23 Jul 2009 10:28:44 GMT

That’s right. The quest to deliver controlled nicotine doses to people of all ages never ends. Cigarettes are now on the technological cutting edge. There’s no secondhand smoke to worry about, but do worries about personal health still exist? The truth is that those health concerns are still apparent.

E-cigarettes, also know as electronic cigarettes are battery operated devices consisting of cartridges filled with nicotine, flavor and other chemicals. The consumer switches on the device, inhales the vapor and receives a dose of flavored, highly addictive nicotine. Young consumers who favor cover up flavors like chocolate and mint will definitely enjoy the high.

According to an FDA news release, e-cigarettes are available online and companies market those cigarettes to the young consumer. However, electronic cigarettes could increase nicotine addiction and tobacco use in young people. Margaret Hamburg, MD, commissioner of food and drugs indicated that “the FDA is concerned about the safety of these products and how they are marketed to the public.

So far, the FDA has not had the opportunity to evaluate the safety of or to approve marketing of e-cigarettes, and the agency has conducted only limited testing, concerning the levels of chemicals and nicotine that various brands of the devices will deliver to the consumer.

In one tested sample, the FDA detected diethylene glycol (a toxic chemical used in antifreeze), and in several other samples, the FDA detected cancer causing chemicals, including nitrosamines.

Evidently, e-cigarettes are reaching our borders from foreign sources. The FDA has intercepted and examined shipments of e-cigarettes at the border and has determined that those devices meet the definition of being a combination drug-device under the Federal Food, Drug and Cosmetic Act.

A concern called Smoking Everywhere is challenging the FDA’s jurisdiction and the case is pending in federal district court, District of Columbia. Healthcare providers and consumers may report serious adverse events (side effects) that concern the use of e-cigarettes to the FDA’s MedWatch Adverse Event Reporting Program (please scroll to the bottom of the page).

Originally posted at InjuryBoard by Armand Rossetti

Yamaha Rhinos are popular but dangerous vehicles

Armand Rossetti — Sat, 21 Feb 2009 11:34:20 GMT

If Ashlyn Vargas were still alive, she would be telling us about her experience driving a Rhino. Reportedly, Ashlyn was operating a Rhino in her home town in Paso Robles, California on Thanksgiving Day, and she was traveling slowly when her Rhino just rolled over, pinning her underneath the vehicle.

Why would a Rhino, traveling at a slow rate of speed just turn over suddenly? Well, Yamaha produced the Rhino with a short distance between the driver and passenger front and rear wheels (called the “track”), and a short distance between the front and rear sets of wheels (called the “wheelbase”), and then combined those two dangerous dimensions with a high center of gravity (making the Rhino top heavy) and fitted the Rhino with small wheels. In addition, Yamaha installed a very powerful engine in the Rhino and sold the vehicle with a wide door entry way, and without any doors.

If Yamaha was not thinking about the Rhino being prone to rolling over and killing and maiming drivers, some after market Rhino parts distributors were doing the thinking for Yamaha. One such after market distributor stated the following:

“The stock Rhino is very easy to get in and out of, but it is not built with a rollover in mind. The first problem is the door opening is wide open. During a roll, your first instinct is to try and stop the roll. Bad idea. No matter how strong that you think you are, your leg will not stop UTV from tipping over.

The solution is to add a barrier that will not allow you leg to get out of the vehicle. Lots of options to solve this are available from nets to aluminum leg minders, to steel tubing and full doors with aluminum.

The second problem with the stock Rhino is the "roll cage". Yamaha doesn't even call it a roll cage for liability reasons, and either do most of the aftermarket guys. In our sue happy society, calling it a roll cage would then somehow mean that you would be safe in a roll-over accident. For simplicity, we are going to call them roll cages - just try not to roll because that isn't what they were designed for. Silly, huh?

The stock cage is probably just fine for the most likely intended use of cruising around the farm doing odd jobs, but in the dunes, a bit more strength and cross bracing would be nice. New cages also add a bar behind the seats where harnesses (seat restraints) should be attached.”

Then the distributor advised the consumer what to look for:

· Material selection - Chromoly, mild steel or aluminum and thickness. Each material & thickness has pros and cons - cost, strength, weight, etc. Make sure you ask questions.

· Cage Design - Gussets and triangulation increase the strength without adding much more weight.

· Removable? - Most aftermarket cages are bolt-on. This eases the installation and also allows the customer to get their Rhino into their toy haulers. Besides mounting to stock lower bars, does the cage add any mounting locations? A custom made cage that is bolted or welded to the frame is stronger than one that bolts to the factory cage location, but cost will increase and you won't be able to get the cage off as easily or at all.

· Restraint Mounts - Make sure the cage includes a bar behind the front seats for attaching shoulder harnesses. Shoulder harnesses should be attached slightly below your shoulder level. If the cage does not allow for this, find another cage. Restraints should be as short as possible, and mounting them down on the floor seriously affects their effectiveness.

· Head Clearance - Make sure that all parts of the cage are sufficiently away from all passenger heads.

The reason why there is a market for such safety and performance add-ons is evident from viewing the linked graph. Since 2003, consumers have purchased about 140,000 Rhinos, approximately 86% of which were sold between 2006 and 2008.

However, it seems strange that an after market distributor would have more engineering sense than Yamaha's engineers. Since 2003, not only were there no doors on the Rhino, but the Yamaha provided little or no warning about roll-overs. In 2007, after Rhinos had been being sold for three years, Yamaha issued a new product label warning. Nevertheless, Yamaha chose to ignore the Rhino’s safety deficits and the manufacturer did not issue a voluntary Rhino UTV recall.

On August 28, 2008, Heidi Crow wrote a paper about the story of the death of her nine year old boy, Jeremy, during his last ride on a Yamaha Rhino. Heidi submitted that story, together with her comprehensive opinion, outlining the reasons why the Rhino is unreasonably unsafe, to The United States Consumer Protection and Safety Commission (CPSC).

It is interesting to note that because the Rhino is classified as a utility terrain vehicle (UTV), that government agency does not regulate the Rhino as it does all terrain vehicles (ATVs). ATVs and UTVs are largely similar except that an ATV has handle bars, and a UTV has a steering wheel.

Surprisingly, in her communication with the CPSC, Heidi mentioned that consumers were not the only Rhino victims. On page 5 of her submission, Heidi wrote the following about Yamaha employees who have driven the Rhino:

“Rhino tipovers and injuries have often involved Yamaha Motor test drivers and employees, including tipover and/or tipover injuries to Yamaha France employee Jean Claude Olivier, Engineering Vice President Mr. Ike Miyachi, President Casey Yoshida, test engineer Caleb Chesser, product tester Phillip McRae, and test rider Patrick Biolsi. Despite such knowledge, Yamaha has yet to modify the Rhino’s design to correct its stability problems.”

Out of grief for her own child's tragedy and a concern for the safety of others, Heidi has posted pictures on her website of some children and young adults who have died while driving or riding in a Rhino. They are: J.T Crow (9), Ellie Sand (10), Dusty Lockaby (14), Abbey West (13), Ashlyn Vargas (12), Kirsten Lake (11), Dani Bernard (18), Sydney Anderson (10), Richie Masse (14), Wyatt Bauer (13), Emily King (20), Eddie Ray (13), Lauren Dilworth (11), Emily Bates (11), Lane McCloud (8), Andrew Bahl (3),

If you have any further questions or concerns, you are welcome to visit our Rhino All Terrain Vehicle website. While there, you will find more information on ATVs and safety; including topics concerning what parents should know; operation of a Rhino on rough terrain; and the effects of speed while driving a Rhino.

Originally posted at InjuryBoard by Armand Rossetti