Georgia Injury Lawyer Blog

Elderly nursing home patients have been routinely receiving costly antipsychotic drugs which increase their risk of death and are not approved for their treatment.

According to a report from the Health and Human Services Department’s inspector general, 88 percent of the antipsychotic drugs administered in nursing homes were prescribed for uses that the Food and Drug Administration hasn’t approved.

Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, the government audit found.

More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the study found, costing the program $116 million for those six months.

Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) want Medicare to explain why it wrongly paid millions of dollars in claims for drugs that were given to seniors for these unapproved uses.

Medicare provides coverage for some unapproved uses, but the senators suggested that the report’s findings might indicate a flawed decision-making system.

The Medicare agency said in its response to the inspector general’s report that it should have denied more than half the claims it paid for the use of antipsychotics in nursing homes.

The inspector general of the Department of Health and Human Services went so far as to state that “government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions.”

According to the audit, some of the drugs such as Risperdal, Zyprexa, Seroquel, Abilify and Geodon are potentially lethal to many of the patients getting them and that some drug manufacturers illegally marketed their medicines for these uses.

In response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers’ paying kickbacks to nursing homes to increase prescriptions for the medicines.

Omnicare Inc., a pharmacy chain for nursing homes, paid $98 million in November 2009 to settle accusations that it received kickbacks from Johnson & Johnson and other drug makers for antipsychotic prescriptions.

The government auditors found that of the 2.1 million elderly patients in nursing homes during the first six months of 2007, 304,983 had at least one Medicare claim for an antipsychotic medicine. Nursing home residents received 20 percent of the 8.5 million claims for antipsychotic medicines for all Medicare beneficiaries at a cost of $309 million during those six months.

Federal rules require that any drugs that are paid for by the government be given only for uses that are approved either by the government or one of three independent drug usage encyclopedias. Auditors found that 51 percent, or 726,000 of 1.4 million claims, for antipsychotic medicines did not meet this criterion and were thus paid for by the government improperly.

Johnson & Johnson, the maker of health care products, has recalled about four million packages of cherry and grape flavored Children’s Benadryl allergy tablets and about 800,000 bottles of junior-strength Motrin caplets.

According to the company, the recall was necessary because of "insufficiencies in the development of the manufacturing process.,The recalls are taking place at wholesale and retail locations.

The company issued a press release advising consumers that they can continue to use the products because the action “is not being taken on the basis of adverse events” or safety issues.

Johnson & Johnson’s McNeil unit withdrew more than 40 types of children’s over-the-counter liquid medicines in April, forcing a suspension of production at a manufacturing plant and reducing 2010 sales by about $600 million.

The United States House of Representatives Oversight and Government Reform Committee has been investigating the company’s handling of the recall and a separate incident involving Motrin tablets.

The products being recalled are Children’s Benadryl allergy Fastmelt tablets, in cherry and grape flavors, and junior-strength Motrin caplets, 24 count, according to the McNeil Web site.

A disturbing Inspector General report from the shows that medical errors are harming and killing our senior citizens at alarming rates.

An estimated 15,000 Medicare patients die each month, and many more are injured, because of usually preventable medical mistakes in hospitals and other facilities.

The report focused on “adverse events,” defined as "harm to a patient as a result of medical care, such as infection associated with use of a catheter," and “never events,” which are specific "serious events, such as surgery on the wrong patient, that the National Quality Forum (NQF) deemed 'should never occur in a health care setting.'”

The Inspector General of the Department of Health and Human Services found:

--An estimated 13.5 percent of hospitalized Medicare beneficiaries experienced adverse events during their hospital stays.

--An additional 13.5 percent of Medicare beneficiaries experienced events during their hospital stays that resulted in temporary harm.

--Physician reviewers determined that 44 percent of adverse and temporary harm events were clearly or likely preventable.

--Hospital care associated with adverse and temporary harm events cost Medicare an estimated $324 million in October 2008.

Significantly, the 2009 loss to taxpayers was "$4.4 billion spent on care associated with events"--which did not even include the cost of followup care.

The cost in lives, health, and taxpayer dollars of preventable medical errors is far too high. Respect for life of our senior citizens requires accountability when harm occurs, and preventive steps to ensure patient safety.

A portion of the Inpsector General's report is reprinted below:

Continue reading "Medical Errors Kill 15,000 Medicare Patients Each Month, According to Inspector General" »

Products should meet the ordinary expectations of consumers. If a product is defective and dangerous, then the designer, manufacturer and/or seller can be held accountable for any injuries or deaths that result. There are a number of different types of product liability cases.

Defective in Design: In a design-defect case, the dangerous product is in the condition intended by the manufacturer, but the design itself is unsafe.

Defects in Manufacturing: In a manufacturing defect case, the product’s design was safe, but the way the product was actually manufactured did not comply with those designs. The result is an unsafe product.

Defective Warnings: Some products are highly useful but “unavoidably unsafe: because there is no way to manufacture the product in a safer way while retaining its useful characteristics. In those cases the manufacturers are required to warn the consumers about the potential dangers of their products. For example, many medicines are “unavoidably unsafe” because even if they work properly they produce side effects. In these cases, the manufacturer is liable whenever it fails to attach proper warnings and instructions regarding those side-effects.

The Georgia injury lawyers at Finch McCranie, LLP are well known for our success in handling products liability claims. In the past, our cases have involved a wide array of products, including defective factory and construction equipment, harmful drugs, defective home appliances and hazardous chemicals . In addition, we have handled medical device products liability claims. For over 40 years, we have litigated complex automobile defect, seatbelt and tread separation cases against large corporations. If you or a loved one have been injured as a result of a dangerous and defective product of any type, call us to discuss your rights.

The Georgia injury lawyers at Finch McCranie, LLP have represented individuals in many different types of product liability cases. One type of case we are investigating involves individuals who have suffered bone problems as a side effect of Fosamax (Alendronate Sodium). Studies have shown that the popular osteoporosis drug could increase the risk of the painful and potentially disfiguring jaw injury, known as osteonecrosis of the jaw. Other studies have indicated that the medication could also lead to necrosis of the hip, knee and shoulder and a possible increased risk of femur fractures. Fosamax inhibits bone turn over, which could lead to permanent bone decay. Osteonecrosis of the jaw is a rare, but serious problem which may develop following dental procedures, such as tooth extractions. The gums fail to heal, leading to exposed jaw bone and infection. As a result, it is often necessary for dead or decayed portions of the jaw bone to be surgically removed. Symptoms of jaw Necrosis include: jaw pain, gum infection or swelling, loose teeth or toothaches, and exposed bone inside the mouth. Although Merck was aware of this serious risk, they have failed to adequately warn patients or notify the medical community of these Fosamax bone side effects.

Just this week, ABC News reported on two women who have been taking Fosamax for over 5 years. In both cases, both women sustained fractured femurs, notwithstanding that the femur is one of the strongest bones in the body. In one case, a woman was simply jumping rope with neighborhood children when she felt her thigh bone snap into.

If you or a family member have taken Fosamax over a period of years for osteoporosis and developed problems with the jaw, hip, shoulder, knee, or femur (particularly a fracture of your femur), it may be related to your use of this drug. If you have sustained injury as a result of taking Fosamax call the Georgia injury lawyers at Finch McCranie, LLP.

Georgia injury lawyers are well aware that just because a prescription drug is an FDA approved drug is , does not mean that it is safe. There was a time when the American public believed that to be the case but we have come to the realization that money talks. Yes, “it is always all about the money” when it comes to business relationships and the drug business is BIG business. It is common knowledge that many former FDA employees end up being hired by big pharmaceutical companies after leaving the agency that supposedly regulates them. In addition, the industry spends an enormous amount of money on lobbyist to influence politicians.

This week a Philadelphia jury awarded $9.45 million to an Alabama woman who claimed that Pfizer’s Wyeth unit hormone-replacement drug, Prempro caused her to develop breast cancer. $6 million dollars of the award was for punitive damages. More than six million women took the drug until a 2002 study indicated that the drug was linked to cancer. Including this verdict, Pfizer has lost seven of the ten cases that have gone to jury trials.

Dangerous drugs are prevalent in our country. Everyday we learn about others, including Yaz, Yasmin, Avandia and many others. If you have been injured as a result of taking a dangerous drug, call the Georgia injury lawyers at Finch McCranie, LLP for a free consultation

Recently, the Georgia injury lawyers at Finch McCranie, LLP got a call from a former client who advised us that her 21 year old daughter had been having gall bladder problems that led to her having her gall bladder removed. It turned out that she had been taking one of two related dangerous drugs that have become associated with such health problems, Yaz. Yasmin became a very popular seller for Bayer Corp. almost immediately upon release to the public in 2001 (Yaz was approved in 2006). Both are oral contraceptives that combine progestin with estrogen to prevent pregnancy. Bayer’s earlier commercials for Yaz claimed it was not only an effective birth control, but that it also provided relief from PMS and acne. Although the side effects were played down in the original commercials, the FDA demanded new spots be aired that were more forthcoming about potential risks. Yasmin and Yaz share an ingredient; drospirenone, which is a component of progestin. Drospirenone has been associated with health risks that are not present in other forms of progestin. It may increase potassium levels in the bloodstream which could result in serious health issues, such as cardiac arrhythmias. This becomes a serious problem for people who suffer from obesity, diabetes or high blood pressure. Symptoms to be noted are: a sudden numbness, confusion, vision problems, speech or balance difficulties, chest pain, nausea, migraine headaches, jaundice, insomnia, depression and behavioral changes, as well as changes in the woman’s menstrual cycle.

If you or a loved one have taken these drugs and been injured as a result, call the Georgia injury lawyers at Finch McCranie, LLP.

Dangerous products seem to be everywhere these days. This is particularly true when it comes to pharmaceuticals and over-the-counter drugs. This week the New York Daily News reported that a Manhattan man has filed suit against the manufacturer of Zicam Cold Remedy Nasal Spray that he used from 2006 to 2009. The man claims that as a result of using the product, he has lost both his dense of taste and smell. The lawsuit claims that the manufacturer knew or should have known that studies dating back to 1937 have shown that topical applications containing zinc ions can cause a loss of taste and smell. The lawsuit further claims that the manufacturers representations that the product was safe and effective were false. According to the article, the U.S. Food and Drug Administration issued a public health warning last summer warning consumers to stop using all Zicam nasal products that contained zinc because they had received over 130 reports from people who claimed to have lost their sense of smell and taste after using the product.

The Georgia injury lawyers at Finch McCranie, LLP have represent victims of dangerous products ranging from electrical appliances to deer stands for over 45 years. If you or a loved on have been seriously injured as a result of using or coming in contact with a dangerous product, call us today at (800) 228-9159.

Dangerous products seem to be everywhere these days. This is particularly true when it comes to pharmaceuticals and over-the-counter drugs. This week the New York Daily News reported that a Manhattan man has filed suit against the manufacturer of Zicam Cold Remedy Nasal Spray that he used from 2006 to 2009. The man claims that as a result of using the product, he has lost both his dense of taste and smell. The lawsuit claims that the manufacturer knew or should have known that studies dating back to 1937 have shown that topical applications containing zinc ions can cause a loss of taste and smell. The lawsuit further claims that the manufacturers representations that the product was safe and effective were false. According to the article, the U.S. Food and Drug Administration issued a public health warning last summer warning consumers to stop using all Zicam nasal products that contained zinc because they had received over 130 reports from people who claimed to have lost their sense of smell and taste after using the product.

The Georgia injury lawyers at Finch McCranie, LLP have represent victims of dangerous products ranging from electrical appliances to deer stands for over 45 years. If you or a loved on have been seriously injured as a result of using or coming in contact with a dangerous product, call us today at (800) 228-9159.

Georgia injury lawyers are very much aware of the number of dangerous drugs that make it to the market. Lobbying efforts by the powerful drug companies and the FDA’s failure in recent years to police the pharmaceutical industry has resulted in more than a few dangerous drugs coming on the market. We read last week that a Philadelphia jury recently awarded $75 million in punitive damages to an Illinois woman who developed cancer after taking one of Pfizer’s menopause drugs. The jury awarded $3.7 million awarded in actual damages. More than 6 million women have taken Prempro, a hormone replacement drug, used to treat symptoms such as hot flashes, night sweats and mood swings during menopause. A study in 2002 by the Women’s Health Initiative suggested women who used hormone replacement drugs are at higher risk for developing breast cancer. According to news reports, the Illinois woman took Prempro for 5 years before she developed breast cancer in 2002. So far, Pfizer’s Wyeth unit has lost 5 of the 8 cases tried with 33 more scheduled for trial.

As we have all seen, prescription drugs can have serious side effects. Other drugs which are thought to cause health problems include birth control drugs, Yaz and Yasmin which were manufactured by Bayer Healthcare Pharmaceuticals, Inc. The Georgia Injury lawyers at Finch McCranie, LLPhttp://www.georgiainjurylawyers.net/Dangerous-Drugs.cfm have pursued prescription drug injury cases and other personal injury lawsuits in Georgia for over 40 years. If you are somebody you care about has been injured or killed by an unsafe prescription drug, call us today at 1-800-228-9159 for a free evaluation of your case.

The Women’s Health Initiative has issued warnings in the past that certain hormone replacement medications have the ability to harm many women. For example, Prempro is a drug that has been taken by as many as 6 million women in just one year. Statistically, it did not seem that the increased risk of developing breast cancer from using this hormone replacement therapy was all that great. Statisticians stated that there would be a .08% additional case of breast cancer for every 10,000 women that did take Prempro as opposed to those that did not. Another .07% of women that take Prempro would have a heart attack. 0.8% additional women taking Prempro would have a stroke. Apparently, these numbers were based on a research into the number of additional cases reported and extrapolations therefrom.

Statistics do not sound all that harmful when taken in the abstract. .08% does not sound like a great risk. However, if 6 million women took Prempro in any one calendar year, that .08% would mean an additional 4,800 additional breast cancer cases. 4,200 more heart attacks and 4,800 more strokes. Moreover, there are many other side effects which are related to the use of hormone replacement therapy.

Despite the life threatening and significant health risks associated with hormone replacement therapy such as Prempro, countless women continue to use hormone replacement therapy. After all, it has been around for many years and has almost become accepted, some calling it a rite of menopause passage. Some women look to drugs now to deal with menopause as opposed to more healthy means of reducing the menopause symptoms without deadly side effects of some of the hormone replacement medications. While synthetic hormone replacement therapy such as Prempro may provide some relief from menopausal symptoms, based on research done to date, it does not appear that some of the synthetic replacement therapy is not worth the risk, particularly when safe alternatives exist for use by women.

We have noted recently in following the litigation associated with Prempro that some of these cases are now going to trial. Recently there was a huge verdict up in Philadelphia where a jury found that the manufacturer had failed to disclose its knowledge of the increased risks associated with the use of Prempro returning a large punitive damage award. While some medications might be more harmful than others, obviously, all women deserve the right to know the truth and particularly deserve the right to know what risks are

Continue reading "Hormone Replacement Therapy and Breast Cancer: " »

As Congress debates providing and paying for health care, another huge "cost" must not be forgotten: the cost of medical errors and medical negligence.

According to conservative estimates, 98,000 Americans annually die because of preventable medical negligence. Many more suffer life-changing injuries.

A terrific website, 98,000 Reasons, describes many of these stories of preventable injuries and deaths. Please visit it, as reducing medical errors saves innocent lives, and reduces costs of health care.

As Georgia injury lawyers, we are well aware that citizens can no longer rely on the Federal Drug Administration (FDA) to be the guardian of public safety when it comes to new drugs that come to market. Every year, the cash rich pharmaceutical companies, with their high powered lobbyist market and sell dangerous drugs and medical devices to the public. The Coalition Against Bayer Dangers, a consumer watchdog group, has demanded an ban of “third generation” contraceptive pills with increased rates of side effects. Studies recently published in the British Medical Journal found that pills which contained the hormones Drospirenone or Desogestrel carry twice the risk of potentially fatal injuries than the second generation medication first used in the 1970's. The study showed that contraceptive pills such as Yaz and Yasmin, manufactured by Bayer, caused a 6-fold increase in the risk of blood clots, which cause serious injuries such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). These pills may also cause gallbladder disease requiring surgical removal. Bayer is the world market leader in hormonal contraceptives. Sales of Yaz and Yasmin were more than one billion dollars last year.

If you or a loved one has been injured as a result of taking Yaz or Yasmin, manufactured by Bayer, contact the Georgia Injury Lawyers at Finch McCranie, LLP for a free consultation.

Every year Georgia citizens purchase and take millions of dollars worth of prescription medication, thinking that it is safe to do so. Georgia injury lawyers know that unfortunately, many of these medications are dangerous drugs, notwithstanding the fact that the Federal Drug Administration (FDA) has “approved” them. As we have seen, many of these dangerous drugs cause serious injuries and sometimes result in the wrongful death of the consumer. An example of such a drug is Vioxx. Fortunately, some victims and their families are getting justice. The Philadelphia Inquirer just reported that New Jersey’s highest court has upheld $4.5 million in Vioxx-related damages against drug maker Merck & Co. The lawsuit was filed by the widow of John McDarby who developed heart problems after taking the drug and ultimately died of a heart attack. The original $13.9 million award in the case was later reduced to $4.5 million. Read Article: Philadelphia Inquirer

If you or a loved one has been seriously injured as a result of taking a dangerous drug, call the Georgia injury lawyers at Finch McCranie, LLP for a free consultation. We have been representing victims of serious injuries and wrongful death for over 40 years.

Georgia injury lawyers know that the Food and Drug Administration (FDA) is hardly the consumer safety “watchdog” that it was in prior years. In fact, just because a product has been approved by the FDA does not mean that it is a safe product! The influence drug manufacturers have over regulators, politicians and Congress is enormous. The Washington Post recently reported in an article (The Washington Post) that the FDA approved a controversial knee-surgery device after receiving pressure from lawmakers and lobbyists. According to a report released last week by the FDA, regulators seem to have buckled under political pressure from four New Jersey lawmakers with financial ties to ReGen Biologics. The report noted that FDA staff had previously opposed approval of the device.

The Georgia injury lawyers at Finch McCranie, LLP have been representing the victims of dangerous drugs and medical devices and other dangerous products for many years. If you or a loved one have been injured as a result of a dangerous products, call us for a free consultation at (800) 228-9159.

Many Georgians were affected by the recent salmonella outbreak related to peanut butter. Some were sickened by the defective product and others lost jobs in the peanut processing plant that became ground zero for the recall. Now, the Food and Drug Administration has announced it is moving towards stronger, more aggressive and much faster responses to enforcing the laws and regulations that govern the safety of drugs, medical devices and much of the U.S. food supply,

New FDA commissioner Margaret Hamburg has been in office only 8 weeks but has made positive moves to protect citizens. During the past several years, the FDA has faced a number of high profile food recalls, including pistachios, peanuts, spinach, tomatoes, hot peppers, cookie dough, pet food and various meats, as well as problems with medical devices and drugs. The agency has also been rightly criticized for not acting quickly or strongly enough when it encounters violations of the law.

The new Commissioner admitted that in some cases, serious violations have gone unaddressed for far too long. These include violations involving product quality and safety, adulteration and misbranding. false, misleading, or otherwise unlawful labeling; and misleading advertising.

But now, she has announced that the FDA is streamlining its internal processes to speed and strengthen enforcement. The new guidelines being implemented are:

• When FDA inspectors find significant problems at a food, drug or medical device firm, the company will generally have no more than 15 days to respond.

•FDA warning letters will go out much more quickly with review by its lawyers limited to only significant legal issues.

•FDA will work more closely with local, state and international officials, who often have more authority to take action more quickly than FDA.

•FDA will prioritize enforcement follow-up after warning letters are sent or a product is recalled.

• FDA will no longer issue multiple enforcement letters before taking action.

• Finally, FDA will create a "close-out" process and issue a "close-out letter" indicating violations corrected.

FDA recently received an increase in funding from Congress, which will aid in this overhaul. In addition, last Thursday the House passed major food safety legislation, which among other things would give FDA mandatory recall authority. The Senate is expected to vote on the legislation in the fall.

A bone growth agent used in thousands of spinal fusion surgeries for neck pain has been linked to complications and higher cost, according to the first nationwide study of the product. Spinal fusion is one option for people with back and neck pain, although some researchers have questioned how well it works.

In a spinal fusion, a surgeon removes the disc between two vertebrae and replaces it with the patient’s own bone, BMP or another product. If successful, new bone grows and fuses the vertebrae into one piece, stabilizing the spine.

Safety questions arose last year about the protein product, BMP, when used in fusion surgeries in the neck region, a use not approved by federal regulators. Doctors are allowed to use products such as this for purposes for which they have not been approved. The lead author of the study which appears in the latest issue of the Journal of the American Medical Association reported that some of these complications are life-threatening because the neck is such a sensitive area.

Smaller studies have shown BMP promotes better healing of the bone and fewer repeat surgeries to fix failed spinal fusions. The product also makes it unnecessary to surgically harvest the patient’s own bone from the shin or hip for a graft. However, the powerful protein can make bone grow in unwanted places if it’s incorrectly used. There are no official guidelines for its use.

For the new study, researchers looked at records of more than 325,000 spinal fusions from 2002 to 2006. When BMP was used in the front of the neck region of the spine, there were complications in 7 percent of patients before they left the hospital, a 50 percent higher rate compared to when the product wasn’t used.

Elsewhere in the spine, however, BMP led to no more complications than other spinal fusion treatments.

Surgeons have rapidly adopted BMP since the Food and Drug Administration approved it in 2002 for back surgeries. Doctors used it in 17,623 spinal fusions in 2006, nearly 1 in 4 cases, the researchers found.

Last year, the FDA warned doctors about 38 reports of complications when the treatment was used in the neck region of the spine. For unknown reasons, some patients had swelling after surgery, and that caused problems with breathing and swallowing.

Federal officials are warning consumers to stop using Zicam, a popular cold remedy because they say that it could damage or destroy the users’ sense of smell. The Food and Drug Administration (FDA) has received 130 reports of people who lost their sense of smell after using Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs.

The products were introduced by Matrixx Initiatives of Scottsdale, Arizona in 1999. In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell. Hundreds of other lawsuits have been filed. The Georgia Injury Lawyers at Finch McCranie, LLP have served injured Georgians since 1965. We have won millions for our clients and are committed to protecting consumers from dangerous products. If you have been injured by Zicam or any other dangerous products, call us for a free consultation.

The Georgia injury lawyers at Finch McCranie, LLP have represented many victims of dangerous products. The type and nature of these dangerous products runs the gambit. Products liability in Georgia has arisen primarily as a negligence concept and even today remains the most viable theory of products liability in terms of jury comprehension. It was announced this week that a federal judge in Atlanta is permitting dozens of product liability suits against Home Depot and the makers of a tile grout cleaner to proceed to trial on negligence claims; however, he has dismissed other claims that sought damages for violating federal consumer product safety laws. The product at issue, Stand ‘N Seal Spray-On Grout Cleaner, was produced exclusively for Home Depot according to court filings in the case. It is alleged in the case before the Court that the manufacturer of the grout sealer had been on notice, for more than a month before the victim purchased the product, about the potentially devastating health problems associated with its use. It was also alleged that the manufacturer delayed notification to the Product Safety Commission of the growing health complaints associated with the product’s use and that they withheld critical information that delayed a mandatory recall of the product. According to documents filed in the case, at least 2 people died and dozens were hospitalized after breathing vapors from the aerosol chemical spray product.

If you are a loved one has been injured as a result of using a dangerous product, contact the Georgia injury lawyers at Finch McCranie, LLP for a free consultation.

Yesterday, the Food and Drug Administration (FDA) warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell, a condition called anosmia.
The Food and Drug Administration received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, Ariz., first introduced the products.

The FDA issued its consumer alert even though Matrixx refused to recall its products. In a news release, Matrixx said it had suspended shipments of Zicam and would reimburse customers who wanted a refund.

Matrixx had $101 million in sales last year, of which $40 million came from Zicam products. Because Matrixx has called Zicam a homeopathic product, the company was not required to seek agency approval before selling it.

Under current law, the FDA. does not have the authority to order product recalls but must rely on manufacturers to do so voluntarily. Bills have been introduced in Congress would give the agency recall power.

This action by the FDA is hopefully a signal that the Obama administration will take the public safety seriously and not bow to desires of large companies who have no concern for the safety of their products. Bush administration appointees said the FDA. did not need mandatory recall authority because companies always withdrew unsafe products when asked.

Matrixx issued a statement saying it believes there is no causal link between its products and anosmia.

Matrixx has received more than 800 reports of Zicam users losing their sense of smell but did not provide those reports to the FDA. The law requires producers of approved drugs to forward to the FDA all reports of product-related injuries.

In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell. Hundreds more such suits have since been filed.