Matrix Initiatives Inc., the company that manufactures Zicam Intranasal Cold Remedy Products has recalled these products after it received a warning letter from the Food and Drug Administration. The FDA sent a warning letter stating that the products have been linked to anosmia, or loss of the sense of smell. The condition can be either temporary or permanent.

The FDA warning letter states that it has received 130 complaints from people who suffered loss of the sense of smell after using the products. In some of the complaints that the FDA received, persons also reported the loss of the sense of taste. The products included in the recall include Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs Kids Size. The FDA has asked consumers to stop using this product.

The company has received more than 800 complaints about anosmia from people who used these products, and the agency has asked for information about these complaints. Zicam was introduced in 1999, and has sold billions of units since then.

The FDA letter says that the agency has not received any data proving that Zicam Cold Remedy Intranasal products are safe and effective for the kind of uses that the labeling mentions. The labeling for these products claims that it reduces the “duration of the common cold” and reduces the “severity of symptoms” of cold.

Because they contain herbs and minerals, Zicam Cold Remedy products are identified as homeopathic drug products which fall under separate compliance guidelines of the agency. According to the letter, while the agency has received more that 130 reports of anosmia with Zicam use, it has received few reports of anosmia with the use of other intranasal products. The agency cited published scientific evidence that affirms that various salts of zinc can impact olfactory function in humans and animals. The FDA letter also says the products are misbranded, because their labeling does not adequately warn consumers about the risk of anosmia.

Since these are homeopathic category products, the agency has not asked for a complete recall, but has asked Matrix Initiative Inc to submit safety and effectiveness data about the Zicam products included in the recall. Anosmia is a condition in which there is a loss of sense of smell. It can be a dangerous condition because it prevents people from smelling gas or the smell of something burning.

Earlier this year, the agency announced a recall of Hydroxycut, a weight loss supplement that sells millions of units every year. As a nutritional supplement Hydroxycut did not require FDA approval before marketing. The agency does not require manufacturers of herbal and nutritional supplements to apply for approval before marketing their products.

The new Zicam recall has California personal injury lawyers very concerned. The market for homeopathic herbals and other alternative medicines is a billion dollar one. Consumers are exposed to health risks when these products are made available in the market without going through standard FDA approval processes. It’s time that the FDA revaluates its standards regarding alternative health products to protect consumers.

The Reeves Law Group is a law firm with offices throughout California dedicated exclusively to the representation of personal injury victims, including victims of dangerous drugs. Please visit our website at trlglaw.com. If you desire a free consultation on a personal injury matter, please call us at (800) 644-8000 or email us.

On the surface of it, it seems like it’s really not something to be overly concerned about. But add the possibility that it could be the harbinger of more serious dangers, and you begin to take the squeaking very seriously indeed. Many patients who have been fitted with ceramic hips are beginning to discover that their new hip squeaks as they walk, bend, or engage in otherwise routine behavior.

The squeaking is definitely an embarrassment, and patients who have been fitted with the hips complain that they feel humiliated, and have been subjected to strange looks and ridicule because of the noise that emanates from the hip.

The ceramic chip, at the time of its introduction, was touted a breakthrough in artificial hip technology. These chips, which tens of thousands of Americans are walking about now wearing, were hailed as being more durable that conventional steel hips.

Stryker, a medical products company, has been at the center of a growing storm that threatens to get louder by the day. While hips made of any kind of material can be prone to the occasional squeak, the number of instances of squeaking in these new ceramic hips by Stryker has been unusually large. Stryker itself denies that the problems are that huge. One researcher, James D. Antonio, who was involved in the clinical trials prior to the approval for the hips, says, that he has only every heard of 4 cases where the squeaking occurred. In other studies, the incidence of squeaking is far higher. In one study of 1500 patients with these ceramic hips, squeaking was seen in 49 cases.

The entire issue reeks of a hurry to get a less than perfect product approved by the FDA in light of the potential profits. When you consider that a patient pays $45,000 and upwards for a ceramic hip, you would assume that he or she would receive a hip that would squeak as minimally as possible! A rate of 3 percent of squeaking hips out of all the hips that are currently fitted is an alarming figure. Patients should be assured that when they have paid top dollar for a ceramic hip in this country, they can use them without having to undergo embarrassment because of the squeaking noise.

There is also the fear of more dangerous defects in the hips that the squeak is only a symptom of. There is still much we don’t know about these artificial hips, and the possibility of a ceramic hip smashing into smithereens inside the body, and doctors being unable to find every last shred of smashed ceramic is not an unreal one. It makes sense that the squeaking would be a sign of wear and tear or some other such dangerous problem. And all the while, Stryker and their team of doctors insist that there is nothing to worry about, and that the hips are perfectly safe to use.

In the real world, things squeak when they are worn out, old or need to be repaired – a frightening thought when the thing that might need repair is fitted inside your hip. Stryker is currently fighting lawsuits filed by patients with ceramic hips.

If you have suffered the adverse side effects of a dangerous medical product, you need the help of an experienced California personal injury attorney. Contact a lawyer at The Reeves Law Group for a free consultation.

Hundreds of thousands of patients in the United States who have pacemakers implanted in their hearts might have a new danger to worry about, and it has nothing to do with the malfunctioning of their device. The new risk, as reported in the New York Times, comes from the potential for hacking of the pacemaker. It might seem like the plot of a sci-fi thriller, but although experts say there is no cause for concern, you have to wonder how much of a security risk this could pose.

The risk was proved by a group of computer security researchers who have claimed that they were able to gain access to a combination heart defibrillator and pacemaker. They were able to hack so successfully that they were able to program the pacemaker to shut down and to deliver jolts of electricity that could have been fatal if the test was being conducted on a human being.

Apparently, the researchers were able to access the signal from the wireless radio that is placed inside the Medtronic devices. This wireless radio lets doctors monitor the progress of the pacemaker in their patients without the need for surgery. As evident from this experiment, technology is not always foolproof and is not always used for the same reason it was intended for. In other words, regardless of the claim that this isn’t a serious risk, you can’t help but wonder, what such technology could do if it got into the wrong hands?

Experts say that the hacking experiment required $30,000 worth of sophisticated lab equipment and a team of specialists from the University of Washington and University of Massachusetts to succeed. Such specialized experiments are simply not possible for lay people to undertake. Or are they?

Increased risk could come from the fact that many of these pacemaker and defibrillator combo devices have begun to be connected to the internet, so doctors can monitor the state of their patient’s heart remotely without the need for the patient arriving at the clinic. It’s just one more example of the advances in medical technology, and like all advances has the potential to be misused.

After all, when computers first caught on, nobody had heard of hackers and the destruction they could wreak. Now, we all know enough to protect our systems from the threat of hackers, who constantly devise ever more ingenious ways to get to our data. What’s to guarantee that this sort of hacking will not carry over to the defibrillator device too?

Experts claim that in the millions of such devices that have been implanted worldwide there has never been a single instance of any security breach. Just because something has never happened in the past, is no guarantee that it will never happen in the future. For years, we believed that this country was safe from terror, and that we had an invisible wall that protected us. We all know what happened to that theory.

There might be no need for panic right now, but there is definitely cause for concern when you take into account how many people are walking around with pacemakers fitted into their hearts.

If you have been injured by a dangerous medical device, you need the help of an experienced team of personal injury attorneys in California. Contact a lawyer at The Reeves Law Group for a free consultation.

A jury has awarded a Washington resident a sum of $40 million in compensation for the damage his heart received during a surgery at the Providence Everett Medical Center in September 2004. The man, Paramjit Singh, checked into the hospital in October 2004 for cardiac bypass surgery. While the surgery was in progress, a monitor malfunctioned and caused the catheter that was in his heart to overheat and caused his heart to get burned. The damage was so severe that Singh needed a heart transplant. Since then, Singh has reportedly been on anti-rejection drugs and has suffered other health problems as a result of the injury.

The monitor in question was manufactured by Edwards Life Sciences Corp. of Irvine, California. This monitor seems to have contained a line of computer code that caused fail-safe devices to be shut off, leading to the overheating of the catheter. Singh’s heart was left practically useless after the injury. His attorneys had hoped for a settlement of $8 million and the jurors haven’t disappointed.

The award includes $8.35 million in punitive damages. Edward Life Sciences Corporation, while they have said they regretted what happened to Mr. Singh and believed that he should be compensated for his injures, claimed that the punitive damages ruling was not called for. According to their attorneys, “This was the only reported injury relating to millions of uses of this device and the problem that caused the issue has been rectified.” Regardless of how many times a device had been used, a severe injury on the scale of the one that occurred in Paramjit’s case calls for a substantial award. Singh’s injuries were hardly the kind to warrant only “sympathy” – he will live out the rest of his life suffering from the effects of a transplant that he didn’t need, and was forced upon him by the faulty medical machinery manufactured by Edwards Life Sciences Corp. Singh suffers from a host of other health problems relating to the heart injury he received, and is on anti-rejection drugs as well. In the light of the seriousness of his injuries, he deserves a major settlement, and the jury seems to have agreed.

Both Edwards Life Sciences Corporation and Providence Hospital were engaged in a blame game before the verdict was announced. Edwards asserted that the injury was caused by a damaged cable supplied by the hospital, while the hospital claimed that the monitor was faulty. The settlement has gone overwhelmingly against Edwards – they will pay 99.9 percent of the amount while Providence hospital will be responsible for 0.1 percent. Edwards will now also have to pay Providence Hospital $310,000 in damages for breaking a contract and fraud.

While Singh may not completely recover from the trauma of what he has been through, this award should take care of his medical bills, which must be substantial at this point. It should also make Edwards pay more attention to their design mechanisms, so they can avoid such gruesome incidents in the future.

Even Merck’s proposed $4.85 billion settlement, which is to be endorsed by close to 44,000 plaintiffs, might not sound the end of all legal trouble for the company. It still finds itself facing a barrage of lawsuits from all directions, all of them related in some way to the Vioxx fiasco.

The legal troubles will cost Merck approximately $6.773 billion in legal fees alone, and the company has already earmarked this amount to be spent on lawyer’s fees, as well as on the 20 personal injury cases that went through trials before the settlement was proposed. But it’s hardly the end of financial headaches for the drug maker that has found itself embroiled in thousands of lawsuits related to Vioxx. The settlement for instance will only cover those who suffered heart attacks, strokes, or died after taking Vioxx. It does not cover patients who had other health ailments as a result of taking the drug like chest pain, irregular heart rhythms and other conditions caused by the drug that aren’t covered in the settlement.

Patients who have fallen ill after taking Vioxx aren’t the only plaintiffs Merck has to worry about. Patients in over 18 foreign countries are waiting for their turn in court with the drug maker, while consumer and health providers who paid for Vioxx, are also waiting in the sidelines. Then there are the shareholders who lost a cumulative total of $28 billion on the day that Merck withdrew Vioxx from the market - September 30, 2004. The share prices of the company crashed, leading many who had invested in mutual funds and pension plans as well as individual investors to lose personal savings and fortunes. These investors are suing to get Merck’s company executive and board members to pay stockholders’ money which was lost when the drug was pulled off the market. Attorneys for the investors say that Merck company executives falsely inflated the worth of the stock. When the truth about Vioxx was made known, the share prices dropped dramatically, they claim.

More trouble for Merck will come from union and health care plans in New Jersey, where health providers who paid for Vioxx want the company to pay for all the expenses incurred in providing Vioxx, an expensive painkiller, when cheaper and more effective ones were available in the market. The unions have had one class action lawsuit turned against them by the New Jersey Supreme Court, but attorneys are busy coordinating 100 such cases for individual unions. This blow could prove particularly painful for Merck, considering that New Jersey allows triple damages. Attorneys predict that awards could easily be in the hundreds of millions of dollars.

There’s also trouble brewing across the border. A judge in Canada has certified a class action personal injury lawsuit for residents of Quebec. At least 5000 people have already signed up. Quebec’s health service is also seeking to recoup the money to be spent on providing Vioxx to patients. Lawyers in Australia and Israel are already looking at the prospect of Vioxx related lawsuits.

Even with the proposed billion dollar settlement, Merck’s’ troubles are far from over.

If you have suffered the adverse side effects of a dangerous drug, you need the help of an experienced team of California personal injury lawyers. Contact an attorney at The Reeves Law Group for a free consultation.

The world’s largest drug maker, Pfizer, has suffered a setback as a deadlocked Supreme Court tied in its decision to reinstate a lower court ruling that would allow Michigan residents to sue the company.

The case related to Pfizer’s troublesome Rezulin Type 2 Diabetes drug, which was pulled off the market in 2000 after reports of liver failures and deaths among patients who took the drug.

The suit was field by 27 Michigan residents and their spouses who had either suffered severe liver injuries or had died as result of taking the drug. What is really at issue is if drug companies can actually be sued for any effects from the drug, even if it’s is proven that the company made use of fraud to achieve approval for its drugs, or if it withheld information, which if the FDA had at its disposal, it would not have approved the drug.

Michigan is one among a handful of states that allows people to file lawsuits against drug companies if it can be proven that fraud was used before gaining approval for the drug from the FDA.

A verdict in favor of Pfizer would have impacted this state of affairs and made it impossible for patients suing companies for injuries from pharmaceutical products if that product is FDA approved.

Rezulin was produced by the drug company Warren Lambert Company, which sold the drug until it was withdrawn from the market in 2000. Pfizer later bought the company, and the suit names both Pfizer and Warner Lambert. In the aftermath of the Rezulin injuries, Pfizer has fought thousands of cases filed by patients who claimed the company failed to warn them about the toxic effects of the drug.

One reason for the hung verdict was that Chief Justice John Roberts, who owns stock in Pfizer, abstained from voting.

This is obviously bad news for Pfizer, and only the coming weeks will tell exactly how bad the is for the company. With the Supreme Court essentially allowing lawsuits to be filed against a drug company for injurious sustained after ingesting an FDA approved drug, more lawsuits can be expected to crop up in coming weeks and months, and not just against Pfizer.

The decision might have come as a whimper – one Justice withholding his vote isn’t exactly a thumping, resounding slap in the face of pharmaceutical companies - but that doesn’t really matter now. The scope for drug companies being made to be accountable for the drugs that they sell – even the ones approved by the FDA has been dramatically increased. It might be bad news for the pharmaceutical industry, but it is definitely good news for patients’ rights.

If you have suffered adversely from a dangerous pharmaceutical product, you need the help of a top California personal injury attorney. Contact a lawyer at The Reeves Law Group for a free consultation.

Wyeth has had their first loss in a series of lawsuits over its hormonal replacement therapy drugs Premarin and Prempro. A jury has awarded a woman in Little Rock, Arkansas a sum of $2.75 million.

The woman, Donna Scroggin, accused Wyeth of inadequately warning patients that their hormone-replacement drugs could actually increase the risk of breast cancer. Wyeth wasn’t the only one named in the suit. Upjohn, maker of Provera, was also named.

Scroggin had taken the hormone-replacement drug for over 10 years before contracting breast cancer. Her cancer was severe enough to necessitate a mastectomy.

The cases over the hormone replacement therapy began going to trial in 2006, and since then Wyeth has lost four out of the seven trials that have taken place thus far. Two earlier cases were won by the company, and its still faces over 5300 lawsuits over its hormone-replacement drug.

The company has managed to evade greater monetary damage thus far. Another Little Rock women lost her case against Wyeth, while an Ohio woman who was awarded $3 million had her decision overturned.

The biggest verdict against the company came in Reno, Nevada where a jury awarded $123 million to a group of three women who alleged that the company’s hormone-replacement drugs had been instrumental in giving them cancer. But that amount was cut down to $58 million. Although the amount had been dramatically reduced, it’s still a substantial settlement and lawyers who’ve been involved in the lawsuits against Wyeth say the company could begin to see more verdicts not going their way.

Making a drug that’s being proven to cause cancer in women has not left Wyeth unaffected. The company closed down its plant in New York where it manufactured the drug and over 10 percent of the workforce has been cut.

The Food and Drug Administration too seems to be adopting a cautious policy approving drugs from a company that many in the pharmaceutical business say puts health under profits. A number of recent Wyeth applications have been turned down in recent months by the FDA. Their osteoporosis drug Bazedoxifene was rejected because it was found to lead to strokes and blood clot issues, its menopause drug was rejected because it was found connected to heart and liver complications. Its schizophrenia drug bifepronox was reportedly not found to be as effective as other drugs already on the market.

It’s good to see the FDA taking a harder stand against companies like Wyeth who seem to teat patients who take their drugs as some kind of laboratory rats. We can expect more verdicts as each of the 5300 suits reached a conclusion, one way or another.

If you have suffered adverse side effects from a dangerous drug, don’t hesitate to look for an aggressive California personal injury law firm to fight for you. Contact a lawyer at The Reeves Law Group for a free consultation.

It’s a sad state of affairs that we’ve come to expect ineptitude from the FDA, a body that is entrusted with making sure that Americans have access to safe drugs. Once too often, we’ve see the agency fall flat on its face, like the scandal recently where the FDA approved drugs manufactured by a Chinese plant that it hadn’t seen the inside of in years.

We don’t expect such actions from the people who grill our burgers, let alone condoning such behavior from the body funded by our tax dollars that seems to have such scant disregard for public health. To add to an already lengthy list of FDA scandals comes the Bayer episode.

Last year, the FDA voted to keep Bayer’s anti-bleeding cardiac drug Trasylol on the market. This was even after studies conducted by Dennis Mangano, the founder of the Ischemia Research and Education Organization, a non-profit body, showed that patients who took Trasylol were more prone to heart attacks, strokes and renal failure. There is no indication of the reason, which prompted this action by the FDA. But a few days later, the FDA was contacted by a Harvard School of Public Health official who said that he had been hired by Bayer to review the effects of Trasylol as compared ot other anti-bleeding drugs. His conclusion? The exact same as Dr Mangano. Trysalol seemed to expose patients to greater risks of renal failure and heart attacks. When confronted with this research – and here’s where you begin to get a little frightened at the extent of deceit prevalent in the pharmaceutical industry – Bayer said it had “mistakenly” neglected to furnish details about the study.

Neglected? How can you neglect to mention that you had conducted a study that evaluated data from a grand total of 67,000 bypass patients?

Even more shockingly, the FDA let Bayer get away with nothing but a slap on the wrist. An episode which should have logically led to the drug maker being banned from applying for new drug applications was all but ignored.

Finally now, new studies have shown that patients who take Trasylol are 27 times more likely to suffer serious heart ailments and strokes than those on a rival drug.

Bayer isn’t budging from its position. The company maintains that there have been discrepancies in the findings and claims that the risk benefit analysis weighs in Trasylol’s favor.

Bayer suspended sales of Trasylol last November, after the most recent study showed evidence of a connection between use of the drug and unexplainable deaths, but there is every indication that the company doesn’t intend to withdraw the drug from the market altogether. Besides causing heart attacks and strokes, Trasylol is many times costlier than other choices. The difference in cost is enough to save as much as $250 million a year for healthcare, and a billion dollars on dialyses very year.

Ultimately, it’s the patients who suffer when the FDA so blatantly ignores evidence against a drug. The healthcare system suffers because of the huge costs of this drug. The FDA risks looking like a paper tiger.

The only one who benefits is Bayer.

If you have suffered adverse side effects or a loved-one has been killed due to a dangerous drug, you need the help of an experienced California personal injury lawyer. Contact an attorney at The Reeves Law Group for a free consultation.

There seem to be a whole other set of rules where drug companies are concerned. If you were caught speeding five times, you could expect to have your license suspended. If you were caught DUI and had not caused any injuries or deaths due to your drunken driving, you could have your license suspended indefinitely (and rightfully so). If you’re Johnson & Johnson on the other hand, and you have a product out on the market that has been recalled a total of five times, you could actually get away with nothing more than a slap on the wrist.

That’s what seems to be happening with Johnson & Johnson’s latest recall involving its Duragesic patch. A defect in the patch could lead to the contents of the patch leaking and causing accidental overdoses. The drug that’s contained in the patch is Fentanyl, a highly addictive opiate that is up to 80 times more potent than morphine. The patch, it is now believed, could have a cut along the drug reservoir, exposing users to the possibility of an overdose. The defective patch has already claimed victims, and their families have filed million dollar lawsuits against Johnson & Johnson.

The Duragesic patches have been riddled with problems right from the beginning. In 2004, several 75 microgram-per-hour patches were recalled after they were found to accidentally leak. The FDA issued a warning pointing out the dangers of an overdose to those who used the patch. The FDA at that point chose to put the blame on the users, rather than on the company. The argument was that the patch had not been placed properly, and this caused the leak. They even ordered all patch makers to create medication guides to help users make use of the patch properly.

By 2005, at least 120 deaths were reported, both from Johnson & Johnson’s brand of patches as well as other generic brands. The FDA issued another warning that death was a possibility because of these accidental overdoses. Now, comes this new recall.

Johnson & Johnson says it currently faces 72 lawsuits over the patches. Two lawsuits have already been settled. In one, a Texas state court ordered the company to pay a family $772,000, while in another the company paid a family $5.5 million.

Johnson & Johnson can’t be too concerned about the lawsuit and their monetary effect on the company. Duragesic patches are the company’s eighth-highest-selling product with sales last year exceeding $1.16 billion.

Many victims’ families are calling for a complete recall of all versions of the patch currently out in the market. A pharmaceutical company shouldn’t be able to get away with so many recalls of the same product. What it amounts to is using consumers as guinea pigs to test its patches. Until Johnson & Johnson can perfect its patch technology and guarantee that no accidental overdoses will occur, the FDA should step in and call for a complete recall of the product. One more strike, and Johnson & Johnson should be out.

If you or a loved-one have been injured or killed by a defective medical product, you need help from an experienced California personal injury attorney. Don’t wait until it is too late, contact a lawyer at The Reeves Law Group immediately for a free consultation.

You would think that with China’s “excellent” record in product safety, we would have learned to put better checks on all products coming from that country. In the recent past, Chinese imports have left FDA officials red faced as they have been caught with one food scandal after another –tainted Chinese pet food and fish among them.

Now we hear that the FDA effectively broke its own rules by failing to inspect a Chinese plant that manufactures a drug widely used in the US. The drug in question is the blood thinning medication, heparin, and the drug was approved for sale without the mandatory inspection of the Chinese plant’s facility.

This failure to inspect Chinese plants that export drugs to the US has already claimed its first victims. Baxter International has announced that it’s suspending sale of its brand of heparin after 4 patients died and 350 people suffered complications. Some of the complications are reported to be serious. Baxter says they sourced the active ingredient from a company called Scientific Protein, which has plants in Wisconsin and China. A spokeswoman for Baxter said that there had been slight differences in the shipment that Scientific Protein sent to them, but reiterated that Scientific Protein had been a good supplier in the past. This trust in their suppliers is very touching, but when 4 people are dead and hundreds have fallen ill after having heparin injections, someone has to take responsibility. For now, both Baxter and the FDA are pleading that they don’t really know for sure that the contaminated ingredient came from China. In fact, they’re not sure where it came from at all. Reassuring.

All responsibility, of course, rests on the FDA. The agency has been found guilty by the Government Accountability Office of neglecting oversight at foreign drug manufacturing plants. The rules say that the FDA must inspect domestic facilities every two years. In practice, the FDA has in inspected foreign drug plants only once in thirteen years. That’s more than a decade of allowing a plant to manufacture drugs and ship them across to the US, without ever knowing what was going on out there.

When it comes to China, the record is even worse. A total of 700 Chinese drug plants have been approved by the FDA but its only able to inspect 10 to 20 of them a year. The FDA calculates that it will take 40 to 50 years to inspect them all. The possibilities of what could happen in these 50 years are too frightening to contemplate.

To make matters worse, the FDA, it is now apparent, has varying accounts of the number of Chinese plants that it imports drug ingredients from.

A house investigative subcommittee investigating the matter has expressed its concern about the fact that the FDA had so little information available on the Chinese plants in question in the early days of the Baxter incident.

The FDA is at this moment scrambling to close the barn door after the horse has escaped – it’s preparing to send its inspection officers to the Chinese plant. There is a pattern here – of inferior Chinese production methods and the FDA’s corresponding negligence in inspecting products that arrive from that country- and it has terrifying implications for our nation’s health.

If you have suffered adverse side effects from dangerous drugs, you need the help of an experienced California personal injury law firm. Contact the lawyers at The Reeves Law Group for a free consultation.