Georgia Injury Lawyer Blog

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.

Tylenol products have been recalled due to a moldy smell that has been reported to make users sick. Johnson&Johnson's McNeil Consumer Healthcare Products recalled batches of Tylenol Arthritis Caplets in November due to the smell, which caused nausea, stomach pain, vomiting and diarrhea. Approximately three weeks ago, the recall was expanded to include Tylenol Arthritis Caplets. Now, the company has broadened the recall to include batches of regular and extra-strength Tylenol children's Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph's aspirin. Caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji were recalled.

The Food and Drug Administration(FDA), has been very critical of the company’s handling of the problem. The FDA said about 70 people were either sickened by the odor, or noticed it.
The FDA says McNeil knew of the problem in early 2008 but made only a limited investigation. The FDA reports that McNeil did not act as swiftly as required in investigating and recalling the products.

The FDA sent McNeil a warning letter for violating manufacturing standards and failing to report and investigate the problem in a timely way. Johnson&Johnson has 15 days to respond. The FDA says it wants an explanation as to why the problem was not made public sooner.
Johnson&Johnson says the smell is caused by small amounts of a chemical associated with the treatment of wooden pallets. The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico.

Also on Friday, Federal prosecutors in Boston said Johnson&Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its schizophrenia drug, Risperdal. The company gave special rebates to Omnicare Inc., the country's biggest company providing pharmacy services to nursing homes, in return for recommendations from its pharmacists that patients use

The Georgia injury lawyers at Finch McCranie, LLP are investigating injury claims associated with the popular birth control drugs Yaz, Yasmin, & Ocella. Last month, we received a call from a 21 year old former client who had undergone surgery to remove her gall bladder. As it turned out, she had been taking Yaz. Recent reports suggest that these prescription medications could be putting millions of young women at risk of serious side effects, including stroke, heart attack, blood clots, deep vein thrombosis, pulmonary embolism, and even death. A recent study published by the British Medial Journal demonstrated that birth control products containing the active ingredient contained in Yaz, Yasmin and Ocella - Drospirenone - carried a risk of blood clots nearly double that of other birth control medications. Other reports have associated Drospirenone with an increased risk of gallbladder disease, resulting in removal. Yaz and Yasmin are manufactured by Bayer Healthcare Pharmaceuticals, Inc. Ocella is the generic equivalent of Yasmin, manufactured by Barr Laboratories. Bayer has previously received warnings from the Food and Drug Administration (FDA) for advertisements that overstated the benefits of Yaz and which minimized the potential safety risk associated with the drug. As a part of a subsequent agreement with the FDA and attorneys general in 27 states, Bayer began running a new ad campaign in February of 2009 to correct the information conveyed by deceptive Yaz commercials.

If you believe that you or a family member have been injured as a result of using the prescription contraceptives Yaz, Yasmin, or Ocella, contact the Georgia injury lawyers at Finch McCranie, LLP at 1 800-228-9159.

We just read of another incident in which an Atlanta area young man died as a result of an “overdose” of acetaminophen, the aspirin-free pain reliever found in Tylenol. Many people believe acetaminophen is one of the safest painkillers on the market. If used properly it is safe, but, it is also the leading cause of acute liver failure in the United States.

Taking just slightly more than the maximum recommended dose for a few days can be toxic, even deadly.

We have previously blogged on these dangers, but feel the warnings are worth repeating.
Overdoses are common because people mistakenly feel they can disregard the dosage recommendation; and, acetaminophen is included as an ingredient in many other products. Many people unknowingly ingest large doses when they treat multiple health problems with several products, each of which contains acetaminophen.

In June of this year, realizing the increasing dangers posed by this drug, the Food and Drug Administration advisory committee proposed lowering the maximum single adult dose for over-the-counter products from 1,000 to 650 milligrams and the maximum daily dose to less than 4,000 milligrams. The committee also recommended either eliminating prescription acetaminophen combination products that contain prescription acetaminophen or labeling them with a black-box warning about the risk of liver damage.

Several other products under the Tylenol brand name contain acetaminophen. These include:

Backaid Maximum Strength Back Relief
Benadryl Severe Allergy Plus Headache Caplets
Benadryl Allergy Plus Cold Kapgels
Benadryl Allergy Plus Sinus Headache Kapgels
Contac Cold & Flu Day & Night Dual Formula Pack Caplets
DayQuil Cold & Flu Relief LiquiCaps
Excedrin (all products)
Midol Menstrual Complete and Midol Teen Formula
NyQuil Cold & Flu Relief and NyQuil Sinus
Pamprin Multi-Symptom and Pamprin Max
Sudafed (assorted products)
Theraflu Nighttime Severe Cold & Cough Packets
Theraflu Daytime Severe Cold & Cough Packets
Triaminic Multi-Symptom Fever
Triaminic Cough & Sore Throat

We urge you to carefully read the ingredients list of all over-the-counter drug products to see if they contain acetaminophen. If they do, restrict intake to the recommended doses. Avoid acetaminophen if you have liver disease or drink alcohol heavily. If you regularly take the drug, watch for signs of liver damage: dark urine, pale stool, right-upper abdominal pain and a yellowish tinge in the whites of eyes.

These simple precautions may save your life or the life of a loved one.

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: " »

Our Georgia product liability lawyers have filed many lawsuits against foreign manufacturers for dangerous products introduced into commerce in the United States. In these actions it is sometimes very difficult to find and serve the manufacturer in a foreign country.

This problem has now come into the spotlight as the result of the Chinese wallboard epidemic facing many unsuspecting consumers across the United States. The problem is enormous. By some accounts as many as 100,000 homes across the United States, built between 2004 and 2008, may contain defective and potentially dangerous Chinese drywall.

The wallboard has been determined to contain excessively high levels of sulfur. Homeowners have reported that the fumes from the wallboard cause illness and corrode the copper in home wiring, fixtures and appliances.

Until several years ago, most drywall used in the United States was made in this country. But when the housing boom increased demand, many sellers turned to China to meet the demand and due to lower costs.

Many insurance companies are refusing claims from homeowners to remediate the wallboard problem. While some owners have been forced to move from their toxic homes, many simply cannot afford to do so and the houses are not saleable.

While many lawsuits have been filed and undoubtedly many more are to come, it will be very difficult and expensive to identify the Chinese manufacturers and serve them with legal papers in China. Some attorneys are reporting that it is costing approximately $25,000 per case just to serve legal papers on one company. In many cases more than one Chinese manufacturer may be involved.

A bill now before Congress would place these foreign manufacturers in the same position as domestic companies. The Foreign Manufacturers Legal Accountability Act now before the United States Senate would require foreign manufacturers that export to the U.S. to agree to abide by U.S. law and be held accountable in state and federal courts; and, to appoint an agent in at least one state where the company does business to accept the service of legal papers for any lawsuits or regulatory claims.

The bill’s sponsor, Sen. Sheldon Whitehouse (D-RI) points out that the list of recent examples of Americans injured by defective foreign products is shocking.

That list includes deadly blood thinner, children’s jewelry made from lead, a variety of food products contaminated with dangerous chemicals, 60 million packages of contaminated pet food and substandard tires that failed and killed people.

Two major consumer groups, Consumers Union and the Consumer Federation of America (CFA) support the proposed legislation.

Potentially dangerous and ineffective drugs have been allowed to stay on the market by the Food and Drug Administration even when follow-up studies showed they didn't perform as advertised.

In a report released yesterday, the Government Accountability Office shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits, even when such information is more than a decade overdue.

The GAO says the FDA should do more to track whether drugs approved based on preliminary results actually have lived up to their promise. The FDA responded that the report paints an overly negative picture of its so-called "accelerated approval" program, which is only used to approve drugs for the most serious diseases, and said they have no plans to get more aggressive.

In 1992, the FDA began speeding up the approval of novel drugs based on so-called surrogate endpoints, or laboratory measures that suggest the drug will make real improvements in patient health. HIV drugs, for example, are cleared based on their virus-lowering power, a predictor of increased survival.

Drugmakers favor the program because it helps them get products to market sooner, without conducting long-term patient studies that can take years and cost hundreds of millions of dollars. A condition of quicker approvals is that drugmakers conduct follow-up studies to show the drug's benefits actually panned out.

But the GAO report identified several drugs still on the market that never lived up to their initial promise. And in the 16 years that the FDA has used accelerated approval, it has never once pulled a drug off the market due to missing or unimpressive follow-up data.

According to the report, of the 144 studies the FDA has required under the program since 1992, 64 percent have been completed and more than one-third are still pending.

The GAO report cites the case of Shire Laboratories' low blood pressure treatment ProAmatine The GAO found that ProAmatine has generated more than $257 million in sales, even though "the clinical benefit of the drug has never been established." Yet, the the required study has gone incomplete for more than 13 years. The GAO found numerous other instances in which the FDA has failed to act even when company’s own studies show drugs did not improve patient outcomes.

For example, the FDA approved AstraZeneca's lung cancer drug Iressa in 2003 based on early results showing it reduced the size of tumors. But later studies showed the drug did not significantly extend patient lives. The FDA has left the drug on the market, despite hundreds of reports of a sometimes fatal pneumonia.

The GAO concluded that the FDA has no policy for pulling drugs off the market that were approved using surrogate endpoints. When GAO investigators confronted FDA officials about this lack of enforcement, they reportedly said it would be difficult, if not impossible to draft a standard policy for withdrawals, given the unique circumstances of individual drugs.

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.

Big drug makers and medical device makers spend millions of dollars every year promoting their products to doctors and healthcare providers. Less known is the fact that they also spend millions lobbying Congress and agencies to push approval of their products. This was especially true in the last administration which had a reputation of bowing to the requests of big business, many times at the expense of patients.

The FDA released a report last Thursday that said four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees.

FDA reviewers had determined that ReGen Biologics Inc.'s Menaflex device was "unsafe" because it often failed, forcing patients to get another operation. Still, in response to 'extreme' 'unusual' and persistent pressure," agency managers approved the device for sale, the report indicated.

Joshua Sharfstein, the agency's principal deputy commissioner, said the report shows there were 'definite threats' to the integrity of the FDA's medical-device review process, and as a result, the agency is now reconsidering its decision on the device.

The report offered several recommendations to insulate FDA staff from outside pressures, all of which," Sharfstein said will be adopted.

In fact, the report said that after the FDA twice rejected the company's request for fast-track approval, ReGen enlisted the support of New Jersey lawmakers, who called then-FDA Commissioner Andrew von Eschenbach on the company's behalf. Eschenbach then "became involved in the case and pressed reviewers to issue a decision quickly

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.

U.S. Senator Charles Grassley, R-Iowa is continuing his probe of improper relationships between big pharmaceutical manufacturers and physicians. He is now investigating the financial ties between the head of spine surgery at the University of Minnesota and device giant Medtronic Inc.

Sen. Grassley sent letters Tuesday to the chief executive of Minnesota’s Fairview Health Services, and the director of Team Spine-Minnesota Inc., requesting information regarding their relationship with Dr. David Polly of the University of Minnesota's Medical School.

An internationally known spine surgeon, Polly has been a Medtronic consultant since leaving the military in 2003. Between 2003 and 2007, Medtronic paid him $1.2 million for consulting, expenses and honoraria -- details that were unearthed in Grassley's ongoing investigation of conflicts of interest in medicine.

Grassley also sent letters to University of Minnesota President Robert Bruininks requesting communications sent or received by Polly. Citing state laws on privacy, the University said it will release those documents only if Polly consents.

Consulting relationships are not uncommon in medical technology, but critics allege that the monetary nature of these relationships could skew doctors' preferences and create conflicts of interest in the types of devices they use on patients. Many such instances have been recently revealed by Grassley, leading many medical institutions to revise their policies.

Grassley's letter to Fairview's Eustis asks for a monthly accounting of all devices used by Polly in surgery since January 2008, as well as an explanation regarding Polly's role in Fairview's choice of devices used in spine procedures. The senator also asked whether Polly disclosed his relationship with Medtronic to Fairview.

In Tuesday's letter, Grassley highlights several comments Polly made during an interview with Minnesota Public Radio and to a university conflict-of-interest committee in 2006 regarding his government-funded research on a Medtronic bone-growth product.
The comments "appear to be false or misleading both to your review committee back in 2006 and in a recent radio interview," Grassley wrote.

In 2006, Polly agreed to a conflict-management plan after a university committee determined that his relationship with Medtronic represented a potential conflict of interest.

Our Georgia attorneys frequently receive calls about dangerous drugs which seem to be routinely marketed to unsuspecting consumers and health care professionals. Recently, weight-loss drugs made by mega-manufacturers GlaxoSmithKline Plc and Roche Holding AG were linked to at least 32 reports of serious liver injury from 1999 to October 2008.

The Food and Drug Administration has posted a notice on its web site advising consumers taking Glaxo’s over-the-counter drug Alli or Roche’s prescription Xenical to consult a doctor if they experience weakness, fever, jaundice or other symptoms of liver injury. The FDA did not recommend that patients or doctors stop using these medicines.

Both medicines contain orlistat, a chemical that blocks the intestines from absorbing fat when taken as many as three times a day with meals. The FDA approved Xenical in 1999 for weight loss and weight management in conjunction with a reduced-calorie diet. Alli, half the dose of Xenical, was cleared for non- prescription use in 2007.

Thirty of the 32 reports reviewed by FDA occurred outside the U.S., according to the notice. Six of the cases involved liver failure.

Drug manufacturer GlaxoSmithKline has apparently been caught using a ghostwriting program to promote its antidepressant Paxil. The program allowed doctors to take credit for medical journal articles mainly written by company consultants.

Documents obtained through discovery in a civil lawsuit exposed the program. In one document, an internal company memo, salespeople were instructed to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug. The document explains how the company can help physicians with everything from ''developing a topic,'' to ''submitting the manuscript for publication.'' The program was code named CASSPER by the company.

The document was discovered , by Plaintiff lawyers representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.

According to the document, which dates from April 2000, the CASPPER program was designed to ''strengthen the product positioning and overcome competitive issues.'' At the time, Paxil was competing with rival antidepressant like Eli Lilly's Prozac and Pfizer's Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.

The use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry's influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.

Articles from the company's program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.

Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.

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.

Adverse prescription drug reactions are more common than most consumer are aware, and can have serious consequences, including death. Seeking to address these problems, a Food and Drug Administration panel has recommended new limits on acetaminophen, the main ingredient in Tylenol. Acetaminophen is the most commonly prescribed drug in the U.S., and commonly used in other drugs and remedies such as cough and cold medicines.

Acetaminophen overdoses are the main cause of liver failure in the U.S. Accidental acetaminophen overdoses kill about 100 people and send some 56,000 people to emergency rooms annually. The FDA said that while the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines means patients don't realize they are ingesting far more than they should. One study found that 19% of adults in the U.S. take the drug in a given week.

The FDA advisory panel consisting of 37 doctors, pharmacists and researchers voted on the recommendations yesterday after spending two days discussing steps the FDA should take to reduce the number of acetaminophen overdoses.

The FDA panel recommended a series of measures, including banning a number of well known and commonly prescribed prescription pain relief products, such as Vicodin, Ultracet and Percocet. These pain relievers combine acetaminophen with narcotic painkillers.
That recommendation could also affect 240 pending drug applications.

The panel recommended that prescription products containing acetaminophen should include strong warnings about potential liver damage. And they also strongly advised that only one concentration of over-the-counter cold medicines should be available, citing concerns about liver damage in children. That could affect products such as Theraflu and NyQuil.

The panel did not recommend banning over-the-counter cough and cold medicines and other products that combine acetaminophen with other ingredients. The panel cited data showing liver damage occurs most frequently in patients using prescription products.

If accepted by the FDA, which generally follows suggestions of its expert panels, the recommendations could result in major changes in labeling and packaging.

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.