Georgia Injury Lawyer Blog

Dangerous drugs seem to have been rushed to market with F.D.A .approval during the early part of this century. Now, this seems to be changing. This week, advisory committee recommended that the F.D.A. revoke approval of the drug Avastin as a treatment for breast cancer.

This recommendation is stunning as Avastin is the world’s best-selling cancer drug, with global sales of about $6 billion last year.

Avastin, which is sold by Roche’s Genentech unit, will remain on the market even if the F.D.A. follows the committee’s advice, as it usually does. That is because Avastin is also permitted as a treatment for colon, lung, kidney and brain cancers. So even if the F.D.A. does take the rare move of rescinding its approval, doctors would still be able to use Avastin off-label for treatment of breast cancer.

While drug manufacturers are prohibited by law from selling and promoting drugs for non-approved purposes, doctors are not restricted in their use of drugs. This has led to many drug companies devising schemes to illegally promote drugs for off-label use.
Avastin was given so-called accelerated approval in early 2008, a way for the F.D.A. to approve drugs for life-threatening diseases based on less than complete evidence of effectiveness. Manufacturers must then do further studies to confirm the benefit of the drug.

The two new trials sponsored by Roche for this purpose showed a much smaller effect of the drug. The two studies, in which different chemotherapy drugs were used with Avastin, showed few signs that it could prolong lives. Use of Avastin did not prolong the women’s lives by a statistically significant amount, the gold standard for cancer drugs. And the drug had serious side effects for some patients.

The panel voted 12 to 1 to recommend the revocation. The data discussed at the meeting that for advanced breast cancer, the initial data that led to approval was not borne out by subsequent studies.
Even though doctors can still use Avastin for treatment of breast cancer, some insurance companies might be reluctant to pay for an unapproved use.

Avastin, also known as bevacizumab, is Roche’s best-selling product. Market analysts predict Roche might now lose about $500 million of the estimated $700 million in Avastin sales.

Many Georgians have taken the drug Avandia which was heavily promoted as a treatment option for diabetes by its manufacturer, GlaxoSmithKline. Yesterday, a federal medical advisory panel recommended that Avandia should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.

First approved for sale in 1999, Avandia helps control blood sugar in diabetics by making patients more sensitive to their own insulin. It is one of a class of three drugs, the first of which, Rezulin, was withdrawn because it caused liver damage. The other drug in the class, Actos, made by Takeda, has appeared safe.

Avandia was once the biggest-selling diabetes medicine in the world. However, sales declined in 2007 after a study by Dr. Steven Nissen of the highly regarded Cleveland Clinic found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.
The panel voted to take this action after two days of intensive scientific hearings during which GlaxoSmithKline insisted that Avandia is safe and necessary for the treatment of diabetes.

The scientific panel members expressed concerns about the trustworthiness of GlaxoSmithKline after questions were raised about its clinical trials. Internal company documents showed that the company for years kept crucial safety information about Avandia from the public.

The panel consisted of 33 members. Twelve voted that Avandia should be withdrawn from the market; ten voted that its sales should be restricted and the warnings on its label enhanced; seven voted only to support enhanced warnings on the drug’s label; and three voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.

The Food and Drug Administration will have the final decision regarding the future of Avandia sales, as the panel serves in only an advisory role. The F.D.A. often takes the advice of its advisory panels, but experts say they cannot predict its action in this case due to the split nature of the vote.

Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug.

Dr. Nissen of the Cleveland Clinic commented that the committee’s vote was the best he could hope for. “Effectively, this drug is gone,” he said.

GlaxoSmithKline said it was in the midst of a clinical trial that would test definitively if Avandia caused heart attacks. Several panel members said the trial came too late.
In the 1990s, GlaxoSmithKline decided against just such a study because it feared that the results might hurt sales, according to recently revealed internal company documents.

A study of Medicare patients shows that doctors are increasingly performing costlier, more complex spinal fusion surgeries, sometimes unnecessarily, for stenosis, a common lower back condition caused by aging and arthritis.

Even more disturbing is that the findings suggest these more challenging operations are riskier, leading to more complications and even deaths.

According to surgeons, a simpler and less risky operation could cost $20,000 and the more complex one $80,000 without any good evidence the expensive one is being used appropriately in the majority of cases.

The cost to Medicare, just for the hospital charges for the three types of back surgery reviewed is about $1.65 billion a year, according to the researchers.

All the patients in the study had stenosis in their lower backs, a painful squeezing in the spine that's most common in people over 50. The researchers compared the risks for three different types of surgery for the condition: decompression, simple fusion and complex fusion.

There's little agreement about the best way to treat chronic lower back pain, and much depends on what's causing the pain.

Many times steroid injections and physical therapy provide relief, and a simple decompression procedure is as helpful as a spinal fusion and with less risk.
In a decompression procedure, the simplest method in the Medicare study, a surgeon cuts away part of the bone that's painfully pressing on nerves. It can cost about $30,000 in hospital and surgeon fees.

For a fusion, a surgeon binds two or more vertebrae together using a bone graft, with or without plates and screws. The researchers defined a complex fusion as one involving three or more vertebrae or more than one side of the spine. Fusions cost $60,000 to $90,000.

The researchers analyzed data on more than 32,000 Medicare patients who had one of the three types of surgeries in 2007.

About 5 in 100 patients who had simple or complex fusions suffered major complications such as stroke compared to 2 in 100 with decompressions. The risk of death within 30 days after surgery was different too: 6 in 1,000 for complex fusions compared with 5 in 1,000 for simple fusions and 3 in 1,000 for decompressions.
More than half the patients who had complex fusions had a simple stenosis, which usually calls for decompression alone. They did not have curvature of the spine or a slipped vertebra which might suggest a fusion is needed.

Rates of complex fusions in Medicare patients rose 15-fold from 2002 to 2007, while decompressions and simple fusions declined, the study found. Although the overall procedure rate fell, hospital charges grew 40 percent.

Aggressive marketing of devices used in complex fusions is likely playing a role in the increase according to researchers. The marketing includes ads in medical journals and lectures by surgeons on the payroll of device manufacturers.

Allegations of kickbacks to spine surgeons for using products and questionable financial arrangements to doctors as consultants have abounded in the industry. One company, Medtronic Inc., reached a $40 million settlement with the U.S. Justice Department in a whistleblower case that included allegations the company paid doctors to use its spine surgery products. The company denied any wrongdoing.

A provision in the new health care law requires device makers and others to file annual reports to the government on their financial ties to doctors. Patients will be able to look up possible conflicts in a government database.

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.

Vaccines have caused serious injuries to children for many years. There are many legal hurdles and restrictions faced by parents and victims who seek legal redress from vaccine manufacturers for their losses. The United States Supreme Court has accepted a case in which it will determine whether drug makers can be sued by parents who claim their children suffered serious health problems from vaccines.

Last Monday the Supreme Court agreed to hear an appeal from parents who want to sue Wyeth over the serious side effects their daughter, six months old at the time, allegedly suffered as a result of the company's diphtheria, tetanus and pertussis vaccine.

According to the lawsuit, Hannah Bruesewitz was a healthy infant until she received the vaccine in April 1992. Within hours of getting the DPT shot, the third in a series of five, the baby suffered a series of debilitating seizures and continues to suffer from residual seizure disorder.

The U.S. Circuit Court of Appeals for the Third Circuit in Pennsylvania ruled against Robalee and Russell Bruesewitz, saying a 1986 federal law bars their claims. That law set up a special vaccine court to handle disputes as part of its aim of insuring a stable vaccine supply by shielding companies from most lawsuits.

The vaccine court earlier rejected the family's claims.

Drug maker Wyeth won in the appeals court but also joined in asking the court to hear the case, saying it presents an important legal issue that should be resolved. The Obama administration joined the parties in calling for high court review, although the government takes the side of the manufacturers.

The Georgia Supreme Court is the only state high court that has ruled that families can sue in a vaccine case. The vaccine industry has opposed the Georgia ruling in a case in which the parents of a child claim their son suffered neurological damage after receiving vaccine booster shots made by pharmaceutical companies Wyeth and GlaxoSmithKline that contained the preservative thimerosal.

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.