The fact that Medtronic Inc., a leading medical device manufacturer, paid Dr. Timothy Kuklo $800,000 over the past three years is not as disturbing as the fact that Kuklo falsified and exaggerated the benefits of the company’s Infuse bone graft in scientific medical journals. Making matters worse, Kuklo stands accused of forging the signatures of medical co-authors.
The ethical quandary in this case has real life implications for the rest of us. This isn’t some ivory tower academic falsifying reports to justify a bloated consulting salary. Kuklo’s conclusions and writings promote a product that doctors around the country will rely upon to heal and restore health. The false claims can actually end up injuring patients. The scientific community that publishes these medical journals also suffers collateral damage from Kuklo’s behavior.
Presently, Congress is holding hearings regarding medical device safety. They’re trying to determine whether the FDA needs more regulatory power. While they’re investigating this issue, they also need to establish some basic groundrules concerning scientific research and the remuneration of the researchers. It seems to me that a researcher whose task it is to research a drug or medical device can’t be compensated by that same drug company or medical device company. There’s an inherent conflict of interest. The payment naturally predisposes the researcher to look favorably upon the drug or medical device.
If medical journals, doctors, and the community at large are to place their confidence in this research, the research itself must be beyond reproach. These conflictual relationships have to stop. Perhaps the establishment of an independent funding source that is operated apart from the companies would work.

Rep. Frank Pallone (D-NJ) who chairse a House Energy and Commerce subcommittee, characterized the country’s oversight of medical devices “broken”. Citing FDA inaction and lack of appropriate response in some instances, Pallone is trying to determine is new federal legislation or more FDA oversight is necessary to fix the problem.
Pallone cited what many industry analysts have been saying for quite some time. The safety measures and quality control presently in place is inadequate and is not protecting the public from defective or unsafe medical devices.
Examples of such recent defective medical devices are numerous. We’ve been involved in some of these matters including the Stryker hip, Kugel Mesh, Zimmer Durom Hip, and the Medtronic Sprint Fidelis defibrillator leads. These cases represent a danger to the general public who rely on these products for their safety and health.
According to a Reuters report, “Cardiologist William Maisel, who heads the nonprofit
Medical Devices Safety Institute, said recent recalls of
defibrillator wires and other devices raised questions about
the FDA’s ability to identify safety problems promptly. “Additional consumer safeguards are needed. Only bydemanding more thorough, scientific device evaluations can theFDA hope to reestablish consumer confidence in its ability to protect the public’s health,” Maisel told a House of Representatives Energy and Commerce subcommittee.

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
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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.