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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

Problems abound with Eli Lilly’s Strattera

Armand Rossetti — Fri, 30 Jan 2009 11:27:33 GMT

Strattera is the first non-stimulant drug, which the FDA has approved for use in treating Attention Deficit Hyperactivity Disorder (ADHD), and at first glance, that might have been a good thing.

Because, for years, the FDA has ignored evidence that predecessor stimulant drugs used for treating ADHD have been problematic. During those years of seeming FDA complacence, pharmaceutical companies accumulated huge profits by pushing stimulant pills to kids, and for different reasons, to adults as well.

The term “pushing” is a bit sharp, but not totally unwarranted. Because, it is no secret that street side pill peddlers have been selling the same drugs for the past 50 years; i.e., those compounds found in stimulant pills called yellow jackets, uppers, black beauties, and bennies.

Those dangerous and often abused compounds were once the legal diet pills of the 1960s and 1970s. Truckers used them to stay awake. Party goers used them to remain alert to party for days. The same ingredients comprised the weekly “B-12” injections that wealthy patients received; that is, until those injections were banned.

Despite concern for safety, those once prescribed street abused pills did not disappear. Instead, they emerged as prescription stimulants with new identities, for treating millions of children in the United States with Attention Deficit Hyperactivity Disorder (ADHD).

Doctors have been prescribing the following drugs (identified by brand and generic names) for years to children for treating ADHD:

· Methylphenidate (generic Ritalin);

· Ritalin (brand name);

· Amphetamine/dextroamphetamine (generic Adderall);

· Adderall (brand name); and

· Concerta

Consumers taking any of these may suffer one or more of the side effects listed below:

· fast, pounding, or uneven heartbeats;

· feeling like you might pass out;

· fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

· aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);

· easy bruising, purple spots on your skin; or

· Dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Because Strattera is not a stimulant, the FDA may have been less critical in 2002, when it approved that drug as being a safe and effective drug for treating ADHD.

Leading up to approval and as part of the FDA approval process, Eli Lilly (Lilly) conducted six placebo-controlled clinical studies over two and one half years. Purportedly, Lilly demonstrated Strattera’s effectiveness in treating children, adolescents and adults with ADHD (stimulant drugs were not effective for treating adults suffering with ADHD). And the Lilly studies prompted the FDA to approve Strattera for use in treating ADHD

While Lilly did obtain FDA clearance to market Strattera in the United States, the pharmaceutical company did not have permission to distribute Strattera in Sweden. Therefore, Lilly had to conduct expensive studies before receiving the go ahead from Sweden to market Strattera.

According to one report, Lilly conducted a preliminary Swedish study and it failed miserably. Before the “disastrous” Swedish study began, the Medical Products Agency in Sweden (MPA) suggested that Lilly use a control group of 20 persons who would take a placebo. However, Lilly refused to include a control group and attempted to enroll 40 adults in the year long ADHD study.

Despite copious newspaper articles, Lilly was able to enroll only 20 persons for the trial. And curiously, 10 of the 20 recruits “disappeared” during the study. An additional 25% of the enrollees had to discontinue participating in the study due to harmful effects from taking Strattera. As a result, only one participant completed the study and there were four additional enrollees who “had still not fallen off,” according to a Lilly spokesperson.

Notwithstanding the poor study results, the MPA allowed Lilly’s Strattera study to continue, this time with 100 children, which included a placebo control group. According Swedish psychiatry investigating reporter, Janne Larsson, Lilly deliberately withheld important information from the children’s parents about disastrous side effects of Strattera. Lilly, however, did mention reports of liver injuries occurring in rare cases.

Nevertheless, Lilly reportedly failed to inform the parents about long known adverse psychiatric effects connected with Strattera that had occurred between November 2002 and June 2005. Ms. Larsson reported the following information about what Eli Lilly knew at the time:

“In that period Lilly had received 350 reports of psychosis or mania, 900 reports of aggression and violent behavior and 400 reports of suicidality. In a Preliminary Assessment Report from December 2005, written by the British medical regulatory agency MHRA, it is mentioned that Lilly from November 2002 to September 2005 had received 766 reports of heart disorders connected to the use of Strattera. (It should be noted that credible estimates of the percent of adverse reactions that are reported range from 1-10%).

It is certainly not so that Eli Lilly had received these reports in the period February - June 2005. Almost all of reports had been received in the foregoing 26-month period and only a minor part in the 5 month up to June 2005.”

This means that Eli Lilly deliberately withheld crucial decision making information from those children scheduled to participate in the study through their parents. It was undeniably evident to Lilly that patients taking Strattera might suffer psychosis and mania, exhibit aggressive and violent behavior, or might commit suicide or suffer heart disorders. And if the 1-10% reporting number is accurate, the 200+ reported adverse effects might have ranged instead from 20,000 to 200,000 affected.

There is evidence that Lilly’s marketing modus operandi included manipulating information for gain. It is evident from publicly available documents that Lilly has openly made a practice of manipulating important facts to suit its quest for profit.

For example, Lilly is on record with the FDA as having promulgated false or misleading information about Strattera’s efficacy and safety. Such was evident in 2005, when Lilly ran a television advertisement entitled “Videogame” for Strattera. According to the FDA, Lilly’s advertisement was false or misleading because it inadequately communicated the indication for Strattera and minimized its associated risk.

The FDA termed the advertisement misbranding, because the commercial suggested that doctors and patients could use Strattera for more than treating ADHD. The details of Lilly’s misbranding begin on page three of the FDA’s Warning Letter to Stacey Holdsworth.

Lilly’s approach to marketing and safety had often ignored the reality connected with consumer safety, while focusing sharply on squeezing every bit of profit out of specific drugs. With only a few new drugs in Lilly’s pipeline emerging from Phase III (many new Lilly drugs are in Phase I or II trials), Lilly has made it a practice to stretch claims for its existing drugs.

As an example, Lilly’s Zyprexa is used to treat bipolar disorder in adults. Nevertheless Lilly pushed Zyprexa to doctors for off label use to control the behavior of “disruptive kids.” It seems as if increased profit was Lilly’s sole motive for suggesting that doctors prescribe such a potent drug as Zyprexa to children who are not suffering from Schizophrenia. Here is an excerpt from Alex Berenson’s New York Times Article on the subject published on March 15, 2008:

“The Zyprexa news is telling because it is indicative of Lilly’s core marketing strategy right now: In the absence of actual new drugs Lilly is attempting to add indications and uses to its existing drugs.

In some cases, the company has stretched claims for its existing drugs so far that people have begun to notice. The FDA slapped the company’s wrists for its marketing of Strattera, saying it had falsely broadened the drug’s indication and wrongly implied that its side effects were transient when, the FDA said, it had failed to present evidence that was the case. Lechleiter himself was accused of this kind of stretching in 2003, when an email surfaced in court that implied he encouraged off-label promotion of Zyprexa.”

Although forty-one reported cases of raised liver enzymes have surfaced (see page 3), a recent search of ClinicalTrials.govfor “Strattera” or “atomoxetine” produced 108 listed trials as completed or in progress, none of which address liver toxicity. It is evident, however, that a majority of the 108 studies concentrate on the expansion of Strattera’s use for treating a host of conditions, such as: Schizophrenia, Autism, Traumatic Brain Injury, comorbid Dyslexia, cannabis abuse, comorbid alcohol abuse, Parkinson’s Disease and insomnia.

Why would any company want to sell, or any doctor want to prescribe, Strattera to children who already might have liver disease from using alcohol or cannabis, especially after the FDA has cautioned that the drug can cause liver damage?

Originally posted at InjuryBoard by Armand Rossetti

“The Heavy Weight Fight” – Extreme Dangers of Bodybuilding Supplements

Alyssa DiEdwardo — Mon, 03 Aug 2009 08:08:05 GMT

Bodybuilding has been known as an Extreme Sport, because it is associated with extreme diets, rigorous weight lifting and rigorous competitions. Famous names such as Arnold Schwarzenegger, Lou Ferrigno, and Charles Atlas come to mind. However with the aggressive marketing of dietary “natural” supplements to speed up results or create short cuts to the perfect physical condition, an unhealthy “opportunity” exists to market and sell dangerous supplements that have slipped under the radar of the FDA. As seen in the weight loss supplement industry, with the harmful effects of ephedra and related deaths, we are seeing the same with anabolic steroids. But like “The Night of the Living Zombies” these supplements get reformulated and remarketed and spun out again onto the shelves of health foods stores as “safe and natural.”

Bodybuilding, which once was for the chosen few, has become so mainstream that every young person is being told they not only can, but should, engage in this severe sport. Products designed to convince us that anyone can achieve a bodybuilder’s physique with “a “just add water” approach and the “magic” of modern pharmaceuticals..
This has not gone entirely unnoticed by the FDA and under the New Rule and current Obama administration the newly nominated commissioner Margaret Hamburg warnings are now being posted to alert the public that body building products marketed as containing steroids or steroid-like substances should be discontinued immediately.
In a recent Public Health Advisory (PHA), the FDA announced a warning to consumers to avoid using bodybuilding supplements claiming to contain steroids, steroid-like substances, steroid alternatives and hormone products.

However the FDA warning did not list specific product ingredients and the overly broad warning creates confusion and suspicion toward all “body building supplements”. These compounds are not regulated by the FDA and it is difficult to determine what products are safer than others or which manufactures are more trustworthy. In the release it is stated that all the products marketed for the claims of body enhancing, increasing muscle mass, alternatives to anabolic steroids for increasing muscle mass and strength and “promoted to athletes to improve sports performance and to aid in recovery from training and sporting events” are all included in the warning posts.

This appears to have been designed to dissuade the public to completely steer away from all products because the consumer can not determine the safety and efficacy of dietary supplements under DSHEA. Reading between the lines the FDA acknowledges that aside from sending out a “broad warning” there is nothing that they can do to recall or ban dangerous products timely and that more than ever the buyer should beware. No one will disagree that the FDA has failed miserably and allowed unscrupulous manufactures to market and sell dangerous products but the question remains what can be done about it now?

The FDA’s positions on these substances, containing synthetic steroids are frequently marketed as dietary supplements, but they are NOT dietary supplements. Instead they are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness. Systems most often associated with the use of these dietary supplements include: nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine precursors to liver injury, kidney failure, stroke, and hormone-associated adverse effects, such as blood clots, including pulmonary embolism and deep vein thrombosis.

In a recent warning the FDA set forth that “Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances.”

Originally posted at InjuryBoard by Alyssa DiEdwardo

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

Loser Pays -- Tort Reform Hypocrisy

Patrick Quinlan — Fri, 13 Nov 2009 15:06:08 GMT

I just read another anti-lawyer diatribe by John Stossel. Mr. Stossel is one of the great many Tort Reform Hypocrites: people who scream in public about evil trial lawyers filing frivolous lawsuits for pain and suffering damages, but then run to a trial lawyer the moment that they feel that their rights have been violated. Mr. Stossel has said:

“We all have pain and suffering in our lives. And if each time we hang onto it until we get some kind of compensation, society can’t work.”

Yet when a pro wrestler slapped him in 1986, what did Mr. Stossel do? He sued for -- you guessed it -- pain and suffering damages.

Mr. Stossel ends his latest attack on plaintiffs’ lawyers with this suggestion:

"America needs “loser pays." Lawyers marginalize "loser pays" by calling it “the English Rule," as if it’s some peculiar British rule. But it’s not. "Loser pays" is the "Rest-of-the-World Rule."

To Mr. Stossel and all of his tort reform warriors, I say “be careful what you wish for.” By no means do plaintiffs’ lawyers win every lawsuit. But, according to a Bureau of Justice Statistics report, plaintiffs won 59% of state court civil trials in 2005. Interestingly, that number is up from 55% in 2001, and plaintiffs won a higher percentage of bench trials than jury trials, but those are both subjects for another day. Moreover, the 59% figure does not account for the great many valid claims that get settled before trial. Suffice it to say that every plaintiffs’ lawyer I know would be thrilled to see a prevailing party fee provision (or, as Mr. Stossel puts it, “loser pays”) become the law of the land.

Originally posted at InjuryBoard by Patrick Quinlan

Medtronic...Beleaguered Consumers and Yet Another Recall

Brenda Fulmer — Tue, 29 Sep 2009 15:31:58 GMT

On August 27, 2009, the Food & Drug Administration issued yet another recall for a device manufactured by Minnesota-based Medtronic (who also has experienced recalls of its pain medication infusion pumps, defibrillators, defibrillator leads, and insulin pumps recently). This Class I recall, the most serious level of recall of an FDA-approved medical device, involved the Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit. These devices are used in connection with the popular Medtronic SynchroMed II and SynchroMed EL infusion pumps; these pumps deliver pain medications such as baclofen and other drugs directly into the spine. Chronic pain patients have been led to believe that implanted pain pumps such as the Medtronic devices would provide a panacea and avoid all of the pitfalls of chronic use of narcotic pain medication, including the stigma and potential addiction associated with such drugs, their side effects, and recent safety concerns (including manufacturing defects in Fentanyl pain patches that leach toxic levels of the drug due to improper sealing techniques and Ethex morphine pills manufactured at double strength).

The latest recall for Medtronic and its pain pump line stems from design defects that prevent the catheter from properly connecting to the infusion pump, which could lead to disconnection of the pump or a blockage. The inability of the device to properly administer a steady stream of pain medications to a patient creates the potential for an inadvertent overdose or unnecessary suffering for the patient who receives an inadequate level of pain medication. The SynchroMed II line of infusion pumps has been in the news a great deal over the past couple of years with numerous advisories of potential safety problems. These are located on the Medtronic site and can be accessed by clicking on "Medical Device Safety Alerts". They include:

July 2009 -- Premature Battery Removal
August 2008 -- Potential Effects of MRI Imaging on Pump Performance
June 2008 -- Potential Disconnection of Sutureless Connector Catheters
May 2008 -- Pump Malfunction Due to Missing Propellant
January 2008 -- Formation of Inflammatory Mass at Catheter Tip Leading to Serious Injuries
August 2007 --Notification of Malfunction of Synchromed El Pump with Stalling Due to Gear Shaft Wear
November 2006 -- Educational Brief to Physicians on proper monitoring of patients to reduce risk of death or serious injury during initiation of intrathecal opioid therapy for pain
July 2006 -- Voluntary Worldwide Medical Device Recall for Model 8731 Intrathecal Catheter and Model 8958 Intrathecal Catheter Distal Revision Kit (due to platinum-iridium tip becoming dislodged by guide wire during implantation)
May 2006 -- Medical Device Recall of Model 8627 SynchroMed EL Due to Pump Reliability Concerns
January 2006 -- Education Brief for Patients regarding drug formulations using preservatives that may be neurotoxic or compromise the safe use of the Medtronic infusion pumps

Patients who have received these devices should contact their physician for more information regarding the impact of these various recalls on the functioning and safety of their implanted infusion pumps. Medtronic has a sales force that regularly calls upon physicians and should be able to provide current safety data to healthcare providers and their patients. There are also tools available on Medtronic’s web site that enable physicians and patients to input the serial number for a particular infusion pump device to determine whether it is impacted by the various safety alerts and recalls.

It appears from the documents published on Medtronic’s web site that it has also enhanced its warranty coverage to include some of the out of pocket expenses incurred by patients. A review of these warranty supplements, however, indicates that patients are only being reimbursed up to $1,000 for out of pocket expenses associated with surgery and medical care necessitated by the defective product and that health insurers are left without recourse for the tens of thousands of dollars that they might be required to pay for medical care necessitated by the litany of defects associated with these pain pumps. This is an excellent example as to why federal preemption for FDA-approved medical devices (as outlined in the Medtronic v. Riegel decision) is a travesty for patients, physicians, and health insurers, all of whom are shouldering the burdens created by poorly designed and manufactured medical devices. It is for this reason that the Medical Device Safety Act, which would once again hold device manufacturers such as Medtronic responsible for their defective products, is gaining significant, bi-partisan support in Congress. More information about federal preemption and how it unfairly shields manufacturers of defective products can be found on our firm’s web site. We urge you to contact members of Congress to voice your support for this very important safety legislation.

Originally posted at InjuryBoard by Brenda Fulmer

How much stress can a Suzuki GSX-R1000 motorcycle frame take? (Part II)

Armand Rossetti — Tue, 17 Feb 2009 17:14:43 GMT

According to Total Motorcycle Website, the entire 2006 Suzuki GSX-R1000 (gixer) motorcycle weighs only 365 lbs.; that's only twice the weight of the average gixer rider. When Suzuki introduced the GSX-R1000 in 2001 Suzuki engineers had increased the thickness of the frame by 0.5 mm (a dime at 1.40 mm is almost three times the added frame thickness). After adding to the GSX-R1000’s frame thickness, Suzuki reportedly gained a 10% increase in frame rigidity over the GSX-R750.

Suzuki then took about 31 pounds off the engine by replacing the GSX-R1300 high performance engine with a modified GSX-R750 engine. The new engine had a bigger bore, longer stroke, pistons with lower crowns, and a gear driven counter balancer, all weighing 130 lbs. The new GSX engine was about a third of the total weight of the motorcycle.

The replacement engine was capable of delivering a whopping 143 horse power to the motorcycle’s rear wheel with a capability of 80 ft lbs. of torque. Combining all that power with only 365 pounds of bike weight, a rider could reach a top speed of about 180 mph. Likewise from a standing stop, the GSX-R1000 was capable of running a quarter mile in 10.1 seconds and finishing at a speed of about 142 mph. If a rider tromped on the throttle and counted to three the GSX-R1000 would be storming down the road at 62 mph and readying itself to be at 100 mph a few seconds later.

Suzuki seemed to have created a really light and rigid 180 mph thoroughbred racing bike for streets that weren't safe to ride on at 90 mph. For example, Suzuki trimmed four pounds off the exhaust system by using Titanium, a lighter, tougher and stronger metal, and it manufactured the front fork using low weight Titanium. With these engineering changes, Suzuki topped the performance of the closest competitor in the GSX's class, the Yamaha YZF-R1 .

To keep the GSX-R1000 feather weight and speedy, Suzuki had to choose light weight metals for different parts of the bike. However, it seems curious that Suzuki did not use a Titanium alloy instead of Aluminum to make the GSX frame, especially when higher tensile strength would be necessary to counterbalance obvious frame stress factors.

Tensile strength is the stress at which a material (like Aluminum or Titanium) breaks or permanently deforms. There are three definitions of tensile strength:

Yield strength, which is stress at which material strain changes from elastic deformation to plastic deformation, causing it to deform permanently;

Ultimate strength , which is the maximum stress a material can withstand when subjected to tension, compression or shearing. It is the maximum stress on the stress-strain curve; and

Breaking strength, which is the stress coordinate on the stress-strain curve at the point of rupture.

For example, a certain Titanium alloy (Titanium + 6% Aluminum, 4% Vanadium) has yield strength of 800 MPa, while Aluminum has yield strength of less than half that number (400 MPa). The 6%Al, 4%V Titanium alloy has a much higher ultimate strength of 900 MPa versus 455 MPa for Aluminum. Why Suzuki chose Aluminum over Titanium alloy for manufacturing the frame while choosing Titanium alloy to manufacture the exhaust system baffles the mind.

To better understand why Aluminum might not have been the best choice for the GSX frame, we turn to the Suzuki Service Bulletin entitled Voluntary Safety Recall Campaign #2A08 2005 and 2006 GSX-R1000 Motorcycles Frame Reinforcement Brace Installation/Frame Replacement. That publication illustrates where the Aluminum K5 and K6 GSX-R1000 frames have been fracturing. The Service Bulletin also outlines reimbursement, and dealership/manufacturer responsibilities. The Bulletin also reveals VIN ranges for recalled GSX-R1000 motorcycles, the parts needed, and it establishes which motorcycles will not qualify for bracing. And it continues by providing frame inspection and reinforcement installation directions.

Suzuki's publication contais lots of graphics and pictures that reveal fractures on the underside of the frame and to the right and left of the steering neck. Accordingly, Suzuki has supplied a brace for the frame that is designed to span between and hold the two fracture sites together. And a mechanic has to either remove or detach several components from the frame, inspect the frame for cracks using a special, manufacturer supplied dye kit, and then use an epoxy adhesive to cement the brace to the frame before re-bolting the components.

In addition, some of the hardware had to be changed, and depending on temperature and conditions, the epoxy that glues the bracket to the frame has to cure anywhere from one to 24 hours before the dealership can return the GSX-R1000 to its owner. The dealership then has to submit a claim for each frame repair (labor taking three hours) or frame replacement (labor taking 11 hours). The dealership then has 10 days to return replaced frames for credit.

Suzuki service centers also received a copy of its January 21, 2009 recall letter, which outlines the reasons for the recall, and explains reimbursement. Lastly, the Service Bulletin contains a request worksheet and Fax form.

After reading all of the above information, it seems reasonable that Suzuki should have engineered the frame to better withstand ordinary forces that occur during daily use. Once again, those ordinary forces might include a 160 lb (average) rider sitting over a 130 lb. engine, and other accoutrements, all located smack dab in the middle of the GSX-R1000’s 55.3 inch wheelbase.

It is also interesting to note that the GSX-R1000 comes equipped with a front suspension that has a fully adjustable piggy-back shock absorber having a linear rate linkage system. The adjustable shock is attached to that rigid, lightweight Aluminum frame, having a combination cast and extruded spar construction for "precisely calculated rigidity."

Lets recapitulate. The GSX-R1000 is light, it's lightening fast, and the rider can adjust its front suspension to make the bike even stiffer while going over bumps in the road. Everything that has any weight; the engine, exhaust and rider...are sitting in the middle of the motorcycle, supplying a massive vector force downward. That downward force multiplies: as the GSX-R1000 takes ordinary bumps in the pavement; as its engine brings the bike to warp speed; and as the bike banks, turns and brakes while riding on uneven pavement. With all of this in mind, the centerpiece that is managing and supporting all of this "normal" activity is a thin, lightweight Aluminum frame. And to make that frame stronger and more rigid, Suzuki has tacked on what amounts to a third of the thickness of a dime's more worth of the metal.

For some reason, however, using high tensile strength Titanium to manufacture the frame was not in the cards, back then, as a Suzuki design option.

Lastly, on September 22, 2006, Suzuki updated the GSX-R1000 for 2007. The new GSX gained 14 lbs. over the 2006 model, and the engine and chassis were updated (http://en.wikipedia.org/wiki/Suzuki_GSX-R1000).

Originally posted at InjuryBoard by Armand Rossetti

Is Intellectual Property Management a Missing Piece of the FDA’s Regulatory Puzzle?

Armand Rossetti — Wed, 05 Nov 2008 11:04:53 GMT

Should the FDA establish an Intellectual Property Committee (IPC) to oversee licensing and distribution of pharmaceutical and medical device intellectual property?

The following discussion outlines some reasons why the FDA should step in and require intellectual property pooling as a requirement for those manufacturers that are seeking FDA approval for commercial distribution of pharmaceuticals and medical devices, and how the FDA might go about managing intellectual property pooling.

It is obvious that US manufacturers operate within the umbrella of a free enterprise system. While free enterprise in a health care setting might produce patient safety concerns from time to time, it would not be wise to stifle innovation by prohibiting manufacturers from operating under the free enterprise system. However, it might be beneficial to change free enterprise operating policies to enhance patient safety. The FDA might accomplish this by imbedding intellectual property management within the FDA’s regulatory scheme.

Under the current patent system, manufacturers conduct research and invent new pharmaceutical substances and medical devices. Thereafter, those manufacturers usually seek utility patents on those products that provide product manufacturing and distribution exclusivity for up to 21 years.

Manufacturers holding patents can prevent other manufacturers or entities from making, using or selling a same or substantially similar product. The limited patent “monopoly” provides a manufacturer with a means to accumulate wealth for the corporation and to fund future research and development. This is and has always been highly beneficial to the public.

However, when other manufacturers interested in developing alternatives to a blockbuster drug or medical device find themselves with their backs up against the technological wall, attempting at all costs to reverse engineer a same or similar drug or device, frustration could spell and sometimes has spelled trouble for patient safety. Here is an example.

By now, we are all aware of problems that plagued the contact lens solution industry. During the past decade, contact lens solution manufacturers, such as Alcon, Bausch & Lomb (B&L) and Advanced Medical Optics (AMO) were in stiff competition with each other to remain on the cutting edge of contact lens care solution technology. The first to develop the right contact lens solution active ingredients would win, and the others would either reverse engineer that effort or lose.

During its contact lens solution research and development phase, Alcon discovered an active called polyquaternium-1 (PQ-1), a polymer that provided a unique combination of lubrication and disinfection capabilities in a single ingredient, and a unique polymer that was relatively cornea friendly. Although Alcon did not hold a patent for this substance, the company quickly realized the uniqueness of PQ-1 and it negotiated with PQ-1's manufacturer and patent holder to enter an exclusive contract. These types of contracts are not uncommon. An exclusive contract acts like a patent because no other entity can obtain the particular ingredient from the supplier or manufacturer. Thereafter, Alcon successfully incorporated PQ-1 into its Opti-Free line of multipurpose disinfecting solutions, and produced a line that was unparalleled in safety and effectiveness. What were the competitors to do?

With the advent of PQ-1 and Alcon's exclusive contract, B&L was faced with a dilemma. B&L was faced with reverse engineering a similar active or losing its competitive edge. For the next three years, B&L searched its R&D files in an attempt to arrive at a solution. In addition, B&L looked at Alcon’s PQ-1, and at the family of PQ chemicals to try to come up with an alternative active with the same beneficial properties.

Needless to say, the task was not that easy, because all of the other PQ substances were either too harsh, did not disinfect effectively, or presented other problems that disqualified them as possibilities.

After a comprehensive review, B&L’s investigators felt that PQ-10 came closest to Alcon’s PQ-1. However, PQ-10 had little or no disinfecting capability. As a result, B&L had to find a complimentary active ingredient to provide adequate disinfection. The first choice for added disinfection was PHMB (which B&L was already using as an ingredient in its MultiPlus multipurpose disinfecting solution).

Nevertheless, B&L’s first choice proved not to be ideal because it was unstable in combination with PQ-10 and certain buffers. As a result, B&L reached into its file cabinet of experimental disinfecting actives and came up with another substance that was closely related to PHMB, Alexidine. That ingredient had a lower molecular weight, it was from the same family and Alexidine was quite effective as a disinfectant. The only problem was that B&L had tried to use Alexidine in the 1990’s without success, because it was harsh. Yes, Alexidine was more stable in combination with PQ-10, but it was hard on corneas.

What could B&L do to alleviate this problem? The answer was to develop combinations of actives and buffers in solution to dampen Alexidine’s harshness, and that was not an easy task. In fact, B&L attempted to do just that for three years, with limited success.

B&L used every combination of substances it could muster to alleviate the Alexidine problem, and it was almost impossible to arrive at a "tame" solution. Then the deadline fell upon B&L to produce a solution or lose market, and B&L decided to chose the best of the worst, then to seek FDA approval, and proceed to market ASAP.

We all know what resulted.

The question remains: How might the FDA have preserved Alcon’s right to enter an exclusive contract with the sole PQ-1 manufacturer and intellectual property rights holder, yet have promoted consumer safety?

There is no easy answer except to suggest the following as a starting point:

The FDA should establish an intellectual property committee (IPC);
The IPC should have authority to require manufacturers to attach to all PMAs and 510(k) submissions, copies of all patents, exclusive contracts, agreements and, if applicable, affidavits that one or more actives are a trade secret;
Subsequently, the IPC should review the intellectual property submissions and decide on a public safety basis, whether the applicant should be required to provide non-exclusive licenses, or the substance itself, to competitors for profit to allow them to use a particular unique active;
The FDA should suggest fair compensation for the manufacturer holding exclusive rights to the intellectual property under review, in the form of royalties, perhaps as a percentage of sales; and
If the manufacturer does not agree to license its competitors that FDA may refuse to grant approval to the manufacturer to market the drug or device.

Here is the reason why the FDA would not be overstepping its authority. Where pharmaceuticals and medical devices are concerned, ublic safety is imperative. While manufacturers have a right to prevent others from making using, selling, distributing or contracting with another to obtain certain useful substances or technology, intellectual property rights do not give manufacturers the right to produce, distribute or to sell a substance or a technology. Manufacturers are free to place that technology on the shelf. Likewise, the FDA is well within its granting rights to manage intellectual property in a quest for consumer safety.

As a result of establishing an IPC, the FDA would learn more about new and esoteric drugs and devices, and it would be able to use that information to promote public safety.

Let’s take a look at what might be looming in our future if the FDA does not become proactive in intellectual property management.

Global pharmaceutical and device enterprises are rapidly emerging. For example, global companies are partnering with corporations like Ranbaxy in India to provide affordable medicines, in some cases to acquire older products that are off patent. Although substances are off patent, nothing prevents a manufacturer from enhancing those substances and keeping the technology as a trade secret. Likewise, nothing prevents a global manufacturer from contracting exclusively with a primary producer of an active ingredient that has sole proprietary large scale production capabilities.

Given the profit involved, other players such as China will be in a quest to compete with India. For example, Chinese manufacturers are posing a serious threat to their Indian counterparts by reverse engineering similar drugs and manufacturing alternatives at prices that are cheaper than Indian drugs. With all of this in mind, India is beginning to realize that Intellectual property management might play a major role in encouraging R&D and proper regulation.

In conclusion, the FDA should consider becoming more involved in reviewing and managing the intellectual property behind pharmaceuticals and medical devices. There will be a day when a competitive global, technological tsunami occurs, and the time for the FDA to prepare for that eventual tsunami is the present.

Originally posted at InjuryBoard by Armand Rossetti

Thoughts about a Possible Common Thread Running Through Drugs that Cause Devastating Skin Disease

Armand Rossetti — Thu, 02 Oct 2008 10:58:04 GMT

REVLIMID (lenalidomide)is an analogue of Thalidomide that that doctors prescribe to many patients with multiple myeloma. Lenalidomide works within the bone marrow to stop or slow the growth of cancerous myeloma cells. Revlimid is used in combination with Dexamethasone, a synthetic steroid with powerful anti-inflammatory effects.

Between 1957 and 1969, physicians in almost 50 countries prescribed Thalidomide to pregnant women as a sleep aid. However Thalidomide reached market without prior adequate testing to assess its safety. As a result, approximately 10,000 children were born with severe abnormalities.

In 1964, Israeli physician Jacob Sheskin used a left over bottle of Thalidomide to treat a critically ill patient suffering with leprosy. In Dr. Sheskin's attempt to help his patient to sleep, he observed that the patient began to make progress. That observation led to a successful clinical trial. In 1991, Dr. Gills Kaplan determined that Thalidomide inhibited tumor necrosis factor, and she partnered with Celgene Corporation to seek further development for Thalidomide. Later, Celgene developed Revlimid, a substantially more powerful analogue, having fewer side effects.

Revlimid gained FDA approval as a new drug application (NDA) on December 27, 2005. Later, the FDA further cleared Revlimid on June 29, 2006 for use in combination with Dexamethasone in patients with multiple myeloma who have received at least one prior therapy. While laboratory tests have suggested that Revlimid is not tetratogenic, Revlimid is categorized as such because it has structural similarities to Thalidomide. Given the uncertainty of this danger, the FDA requires restricted distribution through the RevAssistSM program, which requires that prescribers register with RevAssist, pharmacies contract with RevAssist, and that Patients enroll in RevAssist.

Despite special distribution requirements, the FDA has recently included Revlimid on a list of 20 prescription drugs under investigation for potential safety problems. In addition, the FDA has shed light on a postmarket safety review, linking serious skin reactions, including reports of Stevens Johnson syndrome (SJS) and similar skin conditions.

Revlimid, however, is not alone in this respect. The FDA has warned consumers that carbamazepine (an anti-epileptic drug also known as Tegretol) can also cause SJS. The drug-related skin disease is more prevalent among patients of Asian ancestry. However, it is important to note that patients afflicted with skin diseases as a result of using carbamazepine will show signs of the disease within 90 days of first taking the drug. If skin reactions do not appear within ninety days, there is minimal risk that those diseases will appear thereafter.

The FDA has found the same to be true for Provigil, Trileptal, Dilantin (phenytoin) Injection, and a few other similar drugs.

Just out of curiosity, I took a look at the chemical structures for the drugs under discussion:

lenalidomide; and

Does a reactive commonality exist, somewhere?

Originally posted at InjuryBoard by Armand Rossetti