In response to the FDA warning letter concerning Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Swabs, the company has stubbornly refused to recall the products in spite of the fact that the products have been associated with anosmia-a loss of the sense of smell. In those who’ve been injured by Zicam products, the loss of smell may be permanent. The company, Matrixx Initiatives, Inc. has already faced hundreds of lawsuits with many more anticipated after Zicam was suspended yesterday.
In a company press release issued hours after the FDA warning letter, company officials complained that the FDA issued the public health advisory before contacting the company. Isn’t that the purpose of the FDA? Isn’t it the mission of the FDA to protect consumers not shield a healthcare company from lawsuits?
Even at this early stage, it appears that the manufacturers of Zicam were well aware of the potential dangers of their product. Yet, they continue to market it as a healthy, homeopathic remedy to lessen the severity and duration of the common cold. Zicam was a best selling product for Matrixx and its suspension is sure to cause financial woes.
Yet, the important issue here is consumer safety not a company’s bottom line. The new, aggressive approach of the FDA in suspending sales of Zicam is laudable and a move in the right direction.

Zicam Cold Remedy received a stern warning from the FDA after approximately 130 have lost their sense of smell. In the wake of the FDA warning letter, Matrix Initiatives, Inc. has voluntarily recalled the product.
Zicam Cold Remedy is an over the counter medicine that delivers medicine in nasal swabs. However, the swabs have been linked to nasal nerve damage resulting in the loss of the sense of smell.
Zicam Cold Remedy is considered by the FDA to belong to a small group of remedies knows as homeopathic.
The FDA issued a warning letter to Mattrix, the manufacturer of the zinc-based homeopathic Zicam Cold Remedy, but stopped short of issuing a recall of the product. However, due to the warning letter, the makers of Zicam will now have to submit safety and effectiveness data concerning Zicam to the FDA. Because of the dangers determined to be associated with Zicam, the manufacturer will now have to go through an FDA approval process.
Of course, a logical question to ask at this point is why does the designation “homeopathic” exempt Zicam and other similar products from FDA review and the approval process. As we’re seeing with so-called “natural” diet supplements, they can be as dangerous as defective prescription drugs. There is nothing about a homeopathic product that inherently makes them safe. They should be forced to undergo the same rigorous evaluation as other drug products PRIOR to coming to market.
The global market for homeopathic remedies is around $200 million but it’s growing. This market includes Nutraceutical International Corp. and Natural Health Supply.
On the Matrixx website, the company boasts that “no plaintiff has ever won a court case. . .” involving Zicam. The company has known for years about the potential harm caused by its homeopathic remedy Zicam and the loss of the sense of smell. Hundreds of lawsuits have been filed against the company. Yet, it takes an FDA warning letter to have the product removed from the market.

Zicam Recall Side Effetcs Lawsuit Attorney
Saunders & Walker P.A. will provide a free case evaluation Zicam users. The side effects of Zicam may be basis for a lawsuit.
If you have taken Zicam and would like to know if you have a zicam side effects lawsuit, contact us by visiting our main website http://saunderslawyers.com
Zicam FDA Recall Attorney

Zicam Cold Remedy received a stern warning from the FDA after approximately 130 have lost their sense of smell. In the wake of the FDA warning letter, Matrix Initiatives, Inc. has voluntarily recalled the product.
Zicam Cold Remedy is an over the counter medicine that delivers medicine in nasal swabs. However, the swabs have been linked to nasal nerve damage resulting in the loss of the sense of smell.
Zicam Cold Remedy is considered by the FDA to belong to a small group of remedies knows as homeopathic.
The FDA issued a warning letter to Mattrix, the manufacturer of the zinc-based homeopathic Zicam Cold Remedy, but stopped short of issuing a recall of the product. However, due to the warning letter, the makers of Zicam will now have to submit safety and effectiveness data concerning Zicam to the FDA. Because of the dangers determined to be associated with Zicam, the manufacturer will now have to go through an FDA approval process.
Of course, a logical question to ask at this point is why does the designation “homeopathic” exempt Zicam and other similar products from FDA review and the approval process. As we’re seeing with so-called “natural” diet supplements, they can be as dangerous as defective prescription drugs. There is nothing about a homeopathic product that inherently makes them safe. They should be forced to undergo the same rigorous evaluation as other drug products PRIOR to coming to market.
The global market for homeopathic remedies is around $200 million but it’s growing. This market includes Nutraceutical International Corp. and Natural Health Supply.
On the Matrixx website, the company boasts that “no plaintiff has ever won a court case. . .” involving Zicam. The company has known for years about the potential harm caused by its homeopathic remedy Zicam and the loss of the sense of smell. Hundreds of lawsuits have been filed against the company. Yet, it takes an FDA warning letter to have the product removed from the market.

Today may be the day that the NY State Legislature finally votes on the Child Victim Act-a measure sponsored by Rep. Margaret Markey. The bill, if passed, would allow the victims of childhood sexual abuse to seek justice from the predators and the institutions that covered up for them. In spite of the aggressive protestations of the NY State Catholic Conference, there’s no reason for the bill to fail. The necessary compromises such as adding public institutions to the measure have been made. The only argument left in the Catholic Church arsenal is tired and worn-out. “It’ll cost a lot of money.”
But what about the children whose lives have turned into a hellish nightmare as a result of the abuse. What about the adults who still live with these gaping wounds inflicted on them when they were innocent children.
It’s time NY state sends a message: We’re not Ireland. We’ll deal with criminal behavior in a court of law. We’ll allow those victimized by the wrongful actions of authorities and institutions to be held accountable in a court of law. It’s time to deal with this!

The FDA has issued a Class I recall of Medtronic’s Kappa and Sigma pacemakers due to a separation in the electronic medical device. The 21,000 pacemakers recalled are the Kappa Series 600/700/900 and Sigma Series 100/200/300. According to the FDA, the recalled devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery
The Class I recall designation means that the FDA considers the defective medical device has a reasonable probability to cause serious injury or death.
The defect in the pacemaker may cause pacemaker patients to experience an irregular heartbeat and shortness of breath. Patients who are concerned about the pacemaker defect should contact their physician.

The US Senate overwhelmingly approved a bill that would regulate and control the tobacco industry by a vote of 79-17. The vote would give the FDA new powers to regulate and restrict tobacco companies in the manufacturing and marketing of their products.
Not since 1971 when television ads for cigarettes were banned has the government been able to step in and impose strict new controls on the powerful industry. The measure will now move to the US House of Representatives where it is expected to easily pass. President Obama has promised to sign the bill as soon as it reaches the Oval Office.
The bill would give the FDA new powers to ban harmful chemical additives in cigarettes. The bill also gives the regulatory agency the power to limit nicotine in cigarettes as well as ban flavored cigarettes.
The marketing of tobacco products will also face stricter controls. Any outdoor tobacco advertising within 1,000 feet of a school or playground will be banned. Additionally, visual marketing displays will only appear in black and white. Perhaps most importantly, cigarette makers will have to stop using the terms “light” or “low tar” in their labeling and marketing campaigns. In their place will be larger, more visible health warnings about the dangers of tobacco.
This is the first real step in the right direction since the Surgeon General declared 40 years ago that smoking posed a serious health hazard.

I happened to catch XM 175’s Power Alley with Seth Everett and Jim Duquette as I was driving yesterday. They were interviewing the Philadelphia Phillies’ J.C. Romero about his 50 game suspension from Major League Baseball for violating the league’s substance policy.
If you’re a basball fan like I am, you’ll already know Romero’s case is not the typical A-Rod, Manny, Roger Clemens steroids case. Romero was found negligent by an arbitrator primarily because he failed to call the league hot-line regarding a dietary supplement he purchased at a GNC store in Cherry Hill, NJ.
Now, this is where the Romero story becomes interesting. Romero, a native of Puerto Rico, complied with baseball’s admonition to purchase diet supplements only from stores in the mainland. He complied with baseball by having his trainer check out the supplement prior to using it. He himself has stated that he read the supplement’s label and found nothing that would indicate the product contained banned ingredients.
Yet, when Major League Baseball tested him he came up positive. To Romero’s astonishment, he was fined $1.25 million and suspended for 50 games! Most baseball insiders admit Romero’s only error was not calling the baseball hot-line prior to ingesting the supplement, a supplement purchased at a well-known establishment.
This brings up a larger, more troubling point that goes beyond Romero and baseball. What’s actually in those supplements so many of us purchase at GNC stores or other health food outlets? The casual observer might think the answer’s simple-just read the label. However, it’s not that simple since the FDA has found some of these dietary supplements contain ingredients not listed on the bottle’s label. In some instances, the FDA has found that the quantities of ingredients listed on the label is erroneous.
Can we trust these diet supplements? Does anyone actually know how they’re manufactured and the ingredients in them? The answer is no, we don’t. And we don’t know because the dietary supplement industry is unregulated. Take for instance, the wildly popular Hydroxycut. It’s been removed from the market after some users have shown signs of liver damage, rhabdomyolysis, and cardiac problems.
The Dietary Supplement Health and Education Act of 1994 required supplement manufacturers to ensure product safety but the manufacturers have never been required to register with the FDA or gain FDA approval prior to marketing their products.
While the J.C. Romero case is sad and perhaps unfair, many consumers will suffer far greater fates if these products are not regulated.

Two House Democrats Bill Pascrell, Jr. (D-NJ) and Lloyd Doggett (D-TX) have introduced important legislation that would create a national database for medical devices including artitificial hips and knees. The database would allow industry analysts as well as government oversight groups to analyze the medical devices’ effectiveness as well as compaints concerning faulty devices.
There’s been considerable talk and little action for the last decade concerning the establishment of such a registry. The development of a privately-run and industry financed registry has never progressed due in large part to the medical device industry’s unwillingness to finance the project.
The government-run registry will provide the necessary independent oversight as well as play a crucial role in President Obama’s overhaul of healthcare. The “comparative effectiveness” reviews will allow an important analysis of which medical products and procedures are working and most cost effective.
Other countries have oupaced the US in such use of medical device databases where patients receiving artificial medical devices such as hips and knees are registered so that their progress can be determined.
The urgent need for the device database was highlighted last year when Zimmer Holdings, Inc., the country’s most prolific manufacturer of artificial hips and knees, came under scrutiny after doctors had complained to Zimmer that its product, the Zimmer Durom cup was failing at a higher than acceptable rate. In spite of the doctors’ complaints, Zimmer continued to market and sell the Durom cup. While Zimmer was reviewing their data concerning the cup complaints, it’s estimated an additional 1,300 patients received the Durom cup. In response to the NY Times article concerning the device registry, Zimmer officials declined comment on how many patients need revision surgery as a result of the failed Durom cup.
An advocate of the medical device registry, Dr. Henrik Malchau, an orthopedist at Massachusetts General Hospital, told the NY Times that such a device registry could save many patients the pain and suffering of undergoing a revision surgery due to a faulty medical device. Malchau estimated that in countries with no such registry, patients face double the risk of undergoing such risky revision procedures.
In Malchau’s comment’s concerning the Zimmer Durom cup issue, Malchau noted that if the country had had a medical device registry in place at the time doctors were complaining about the Durom cup, the issue could have been resolved far more quickly resulting in fewer patient problems and a decreased number of instances of hip revision surgery.
It’s estimated that the current House proposal would take up to three years to complete and would fall under the control of the Agency for Health Care Research and Control, a division of the Division of Health and Human Services.

I stopped in a health food store in St. Petersburg the other day with an attorney friend of mine. We wanted a quick protein shake after a strenuous workout. While the person behind the counter was preparing our shakes, my friend pointed to a bottle of NOX. He told me that he had heard from friends how this mixture increased the benefits of a workout while simultaneously maximizing energy and concentration throughout the day. The bottle’s ingredients were a veritable plethora of “natural” ingredients including nitrous oxide. The small bottle’s price was $59.99
His enthusiasm for the product and desire to buy it made me think about the many clients I represent who’ve been injured by other “natural” products.
The diet supplement sector is a multi-billion dollar a year industry whose growth potential is infinitely larger than any of the regulated pharmaceuticals manufactured to fight disease, cure illness, or stave off any of a number of ailments that afflict human beings.
The industry’s marketing campaigns are slick and disciplined in honing in on their target audience. Today, one can’t go into a smoothie shop, vitamin store, or health food outlet without noticing the multitude of products promising weight loss, weight gain, increased muscle, better performance, and better health.
Yet, these claims are for the most part untested and completely unregulated by the government. The FDA has no regulatory influence over the industry. It’s literally a “wild west” scenario where any one with entrepreneurial skills and access to “natural” ingredients can produce a product that promises results with very little to no scientific evidence to support the claims.
Recently, the FDA has intervened in cases concerning diet supplements where the ingredients are mixed with a regulated prescription ingredient. That’s clearly illegal and the FDA has rightly stepped in to halt the sale of such products.
However, the majority of these “natural” products remains on the market and enthusiastically purchased by those seeking the results promised in the marketing campaigns.
The products are not only found in health stores and smoothie shops. They can be purchased online. They are advertised in health magazines, muscle and fitness publications, and on television.
It’s not only those who are interested in fitness who are buying these products. Such “natural” products are marketed to those desiring more energy, better concentration, better sexual performance, healthier skin, and stronger bones.
The fact that the industry is unregulated is a boon for those with no scruples and a dearth of scientific evidence. The labeling on such products has been demonstrated to be vague at best. At times, the labeling of ingredients is actually false. Even the stated amount of the ingredients can be inaccurate. Many of these so-called “energy boosters” can contain harmful amounts of caffeine and/or sugar.
Perhaps more importantly, certain combinations of “natural” ingredients can be harmful if not fatal. Take for instance kava kava or hydroxycut. These so-called products haven’t been tested for safety and evaluations of these products have never been performed.
Until the FDA can gain regulatory control over this burgeoning industry, it’s a wild west scenario and “buyer beware” can take on morbid overtones. If you’re taking one of these products, you may be playing a dangerous game with your health.