Tennessee Law Blog

FDA officials announced a nationwide recall of the heart drug Digitek (digoxin), last week. Nashville patients with heart problems were made safer by the recall of these generic heart drug tablets used to treat abnormal heart rhythms and heart failure.

Digitek is distributed by Mylan Pharmaceuticals, Inc. under the Bertek label.

On April 28, 2008, the corporation responsible for this dangerous heart drug, Actavis Totowa, LLC, announced along with FDA officials this nationwide Type I Drug Recall after tablets were found to have double the thickness in size. This increased heart pill size poses a significant health risk of poisoning the heart patient from Digitalis toxicity.

Poisoning by this recalled heart medicine causes various unpleasant reactions. Digitalis toxicity causes in heart patients taking the dangerous medicine:

• vomiting


• nausea


• dizziness


• low blood pressure


• cardiac instability

other dangerous and potentially fatal reactions.

The heart medication dangers were caused by irregular manufacturing practices (much like the imported and dangerous heparin drugs reported in this earlier Dangerous Drug Tennessee Law Blog). Digitek’s dangerous side effects pose the highest health dangers to heart patients with renal failure and low blood pressure.

Digitek is widely distributed through mail-order medication business and large retail pharmacies like those at Nashville-area Wal-Mart and Target. The Class I Drug Recall requires Digitek not be sold and requires heart drug patients return their remaining supplies of the dangerous drug tablet.

While only 11 persons have been reported as sick, many of the symptoms may have been hidden by doctors who attributed injuries to old age instead of the dangerous heart medication.

If you believe you or a loved one has suffered injury from this dangerous, recalled heart drug and believe you would like to pursue legal action against those responsible for this Digitek injury or death, call HHP at (615) 353-0930 or fill out our drug injury initial response form for a free consultation with myself or one of our other qualified, Nashville drug injury lawyers.

Baxter International Inc. has announced the recall of all remaining, potential lethal doses of its heparin products including its possibly defective:

• Sodium injection multi-dose


• Single-dose vials


• HEP-LOCK heparin flush

This completes the series of heparin recallsTennessee Law Blog has been covering.

The first Baxter heparin recall was made in January when it recalled nine lots of heparin sodium injection multi-dose vials. This came after a number of reports of patient reactions and side-effects.

FDA officials refused to take further action at the time out of fear a total recall would create product shortages of the blood thinner, which is need in operating rooms, dialysis centers, and other areas of critical care.

FDA officials and Baxter now consider the supply of safe heparin sufficient to remove possibly lethal Baxter heparin from market, including all remaining heparin sodium injection and heparin flush products.

Reported adverse reactions include stomach pain and discomfort, burning sensations, nausea, diarrhea, and faintness/shortness of breath. The defective heparin has also been known to to be entirely ineffective, causing serious side-effects. Confirmed cases also show that the defective Baxter heparin has caused death. Most Baxter heparin deaths have come from allergic reactions and occur within minutes of heparin-initiation.

Note: This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

If you or a loved one has been seriously injured by Baxter’s defective heparin, contact HHP today to begin the process of forcing Baxter to take responsibly for the injuries it has caused from its defective drugs.

Click for a free consultation with a Nashville dangerous drug attorney.

FDA recall of Baxter International’s drug heparin made the front page of yesterday’s Wall Street journal after FDA officials confirmed four deaths from the blood-thinner. The culprit appears to be a Chinese plant producing the active ingredient in heparin.

Four deaths and hundreds of allergic reactions and other adverse drug side effects have been reported, including vomiting and diarrhea. More serious injuries from the drug heparin include increased heartbeats, low blood pressure, and fainting. FDA officials state that 40% of patients taking Baxter’s heparin suffered serious adverse reactions.

Heparin, which has been available in the U.S. since the 1930s, is administered by injection to prevent blood clotting during apheresis, heart surgery, and kidney dialysis. Patients undergoing these three treatments suffer the most severe injuries from Baxter's defective heparin.

Baxter, which produces about half of all heparin used in the U.S., announced a temporary halt in production of its generic anti-clotting (blood-thinning) drug. This FDA recall and Baxter's halt is predicted to create a shortage of the heparin blood thinner to hospitals and was the reason this dangerous drug was not pulled from market earlier.

Despite last year’s recalls and public notifications of lead in children’s toys and tainted pet food, the People’s Republic of China remains the world’s largest producer of active ingredients in drug medications. Drug companies seeking cheap labor and questionable safety and work conditions produce their pills and medicines in China, which produces just over 10% of the world's drugs.

If you have been injured by a FDA recalled drug medication or other dangerous prescription drug and would like to recover your losses from hospital bills, doctors’ bills, lost wages, and for your pain and suffering caused by shady business practices of big pharm companies, HHP would like to help. To speak with Attorney Jim Higgins or another one of our local, Nashville, TN dangerous drug medication attorneys, give us a call at (615) 353-0930 or fill our drug injury legal consultation forms.

Ortho Evra contraceptive patch users should be aware of injuries caused by the transdermal (skin) birth control patch. FDA investigations have revealed Ortha Evra contraceptive users have a significantly higher risk of developing serious blood clots (aka “venous thromboembolism” or VTE) than women taking oral contraceptives. Ortha Evra patch-caused VTE can lead to serious injury or sudden death from pulmonary embolism.
FDA has modified the prescription information for Ortho Evra after the release of the independent study of women ages 15-44. This drug safety study confirmed earlier safety studies showing the VTE dangerous side effect of Ortho Evra contraceptive patches.
Ortho Evra contraceptive patches have been under safety investigation for VTE and other side effects since the patch’s approval in 2001. Previous studies have shown women taking the contraceptive patch have twice the risk of developing VTE than women using birth control pills. This dangerous side effect appears to be caused by the patch’s birth control hormones which expose patch users to about 60 percent more estrogen than those who take oral birth control pills.
FDA officials have taken no other action than this label change announcing the results of this study.
If you or a loved one has suffered an Ortho Evra side effect injury, contact Nashville’s esteemed drug injury attorney Jim Higgins for a free consultation. Call toll free 1.800.705.2121 or fill out HHP's contraceptive patch injury form.

Children’s OTC cold medication was the subject of the FDA’s public warning issued yesterday, a subject that has been awaiting strong censure for many years. The FDA report states

“Over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use.”

That serious side effects can occur from nonprescription medications given to young children has been known for years. Unfortunately, the FDA has been dragging its feet, despite reported toddler and infant deaths from drug medications readily available over-the-counter.

FDA officials are remain undecided on an issue that first gained momentum last year when it announced it would review the drug safety (whether dangerous drug side effects outweighed drug efficacy) data for children ages 2-11.

October 2006, many children’s OTC drug companies quit selling their medicines marketing specifically to infants after FDA reports showed that the drugs are ineffectivein children under age 6 and are unnecessarily dangerous.

Yesterday’s advisory is the first time the U.S. government has released a direct statement on the drug dangers posed to children with a strong recommendation that parents not give children under 2 these drugs.

If your child or loved one has suffered a dangerous drug injury, contact HHP today for a free consultation with me or another Tennessee drug injury attorney.

The Duragesic pain patch and other, generic pain patches similar to Duragesic have received a second safety warning from FDA regulators.

FDA officials have issued this second warning to doctors and patients using the Duragesic pain patch due to many injuries and deaths reportedly caused by the drug fentanyl. This most recent warning about dangerous effects of Duragestic pain patches comes after the patch was put on high alert in July 2005 when 120 patients who had used the pain patch had died.

Fentanyl is a narcotic most often used to assuage patients suffering from terminal forms of cancer. In Duragestic pain patches, this painkiller (opoid) is administered through the skin (transdermal delivery).

When this pain drug is incorrectly prescribed by medical professionals, deaths can result. Almost all deaths related to Duragestic pain patches are preventable, according to FDA officials.

Duragestic and other fentanyl pain patches required a second warning, according to FDA officials, because they have been inappropriately prescribed for surgery pain and head aches. These are not the intended and FDA approved uses for the Duragestic pain patch. Additionally, this dangerous drug medication can be abused by patients who may develop an addition to the drug or may incorrectly administer the patch; fentatnyl, estimated to be 80 times more potent than morphine, is highly addictive. Fentanyl patches should only be used and prescribed for constant, severe pain in patients.

Duragestics deaths can result from any number of dangerous side effects but most commonly occur because fentanyl in even moderate doses can cause difficulty breathing.

The Duragesic pain patch is marketed by Johnson & Johnson and is considered a Class II substance.

Since June 2005, survivors of relatives who have died from fentanyl overdose caused by Duragesic pain patches have been awarded compensation.

If you or a Tennessee loved one has suffered serious side effects of a Duragesic pain patch, you may be eligible to file a Tennessee Duragesic lawsuit. I and the other qualified, personal injury attorney at HHP offer free case evaluations in dangerous and recalled drug medication matters.

Call us at (615) 353-0930 or fill out our dangerous medication and recalls attorney contact form.

A few weeks ago I reported on a dangerous medical device FDA recall involving infusion pumps. In that Tennessee Law Blog, I wanted to include more information on FDA recalls but didn’t have the luxury of space or time. As a Nashville plaintiff’s attorney, I feel it is my place to make the public aware of FDA recalls and other dangerous products so that I might offer my services to the injured, just as I do whenever a Tennessee client suffers physical damage from a workplace injury or defective products or financially from workplace discrimination or denied social security. And I want to start this new year off right.

Fortunately, the FDA (despite rushing too many dangerous drugs like Vioxx and Ketek to market) also wants to start 2008 by raising public awareness about the recall process. They've published a downloadable document that has saved me the explanation. They’ve even included illustrations (well, clip art) in a handy PDF you can access by clicking FDA 101: Product Recalls (products include dangerous drugs, medical devices, food, cosmetics, and a number of other dangerous products for which HHP attorneys help injured clients win compensation).

The two-page document details the processes of FDA recall, reasons why drug medications or other products might be recalled by the FDA, and the three (3) levels of hazard associated with FDA recall.

It is important to realize that publicized FDA recalls such as tainted foods (remember the tainted spinach scares and peanut butter salmonella?) are only a small portion of FDA recall actions against pharmaceutical, medical device, and food and cosmetic companies. Most FDA interventions and warnings go unreported except for minor mention on the FDA website or press releases hosted by the producers of the dangerous, recalled product.

Don’t assume your dangerous product injuries are insignificant or not worth pursuing. Most recalls are voluntary and come only after the company has evaluated the costs of leaving dangerous products on the market versus paying settlement costs for the injuries the cause and lives they negatively affect. Working with an attorney can help make sure that you are compensated for your or a loved one’s injuries and that companies producing dangerous or harmful products take responsibility for their products. It's one of the checks our free market system has and serves to protect Tennesseans.

From all of us at HHP, we wish you, our Tennessee Law Blog readers, a happy and safe 2008.

Last week the FDA issued a warning letter to the owner of Melanocorp, Inc. based in Hendersonville, Tennessee for its illegal marketing and sale of Melanotan II.
Melanotan II has never received FDA approval. The company alleges in its illegal marketing claims that Melanotan II can prevent skin cancer.

Melanotan II is an injectable drug that is supposed to tan skin, according to its website that both markets and sells the drug (“drug” defined by the Federal Food, Drug, and Cosmetic Act). As a drug, its safety and claims to effectiveness have not been analyzed by FDA scientists. Because it hasn’t been tested, it is illegal to sell online. FDA officials have also cautioned consumers about injecting any substance, especially those without FDA approval, unless under the advice of a certified physician.

As of this writing, available information about Melanotan II appears to be from the company itself, including the article on Melanotan II on Wikipedia (the online, open-source encyclopedia resource). Melanocorp, Inc.’s official site has for the time being removed its website advertising Melanotan II, though FDA spokespeople believe other sites might still sell the potentially dangerous product. Wikipedia editors plan to soon remove the misleading information (considered advertising) about this skin tanning product.

If Melanocorp’s shady marketing schemes and misleading advertisement have led to your or a loved one’s injury, we’d like to help get you the recoveries you deserve. Check out HHP’s dangerous drug law page or contact us immediately at 615.353.0930 or toll free at 800.705.2121.

Washington Post’s front page is running an article today about how different top dogs at the Food and Drug Administration receive substantial bonuses for, well, not doing their jobs (and for making sure they don’t not do them elsewhere).

Of course, they probably picked the most egregious case to focus on: an employee with the strong credentials of an English major who’d joined the FDA in 2003 as Assistant Commissioner for Counterterrorism Policy and received $44,614 in bonuses (not salary, bonuses) last year, or about 20 times what the FDA investigator who won the agency's top national award last year received. Truth is, the top dogs are giving themselves up to 25% of their salaries in bonuses and throwing scraps to the researchers who protect us. (The kicker is they are still free to leave the agency even if they get these kickbacks.) And herein lies the real story the Washington Post mentions only in passing: safety.

Here’s the single paragraph in the article addressing the bonuses.
“The bonuses were paid during a rough patch at the FDA, encompassing a shortage of flu vaccine and embarrassing recalls of the pain-relieving drug Vioxx and malfunctioning heart defibrillators. Throughout, the agency repeatedly insisted that it lacked the resources to conduct adequate food and drug inspections.”

The entire premise of the bonuses is to retain talent that would otherwise work on the other side of the legal fence, i.e. the pharmaceutical companies where significant profits are made. I’m indifferent about whether or not these bonuses should not simply be part of the researchers’ pay. What chaps my hide is when self-dealing kickbacks keep regulatory agencies and their employees from being able do their jobs. The competition with mega-drug firms isn’t about salaries; it’s about your, my, and our loved ones’ safety.

Click for a list of Defective and Potentially Dangerous Drugs.

After three years of litigation, a $64 million class-action settlement
reimburses parents who were misled about the effectiveness and dangers of
Paxil.

These parents will receive full compensation from GlaxoSmithKline for what
they paid for the drug (out-of-pocket expenses), a rarity in these kinds of
dangerous drug medication cases in which victims usually can only receive a
percentage of what they lost.

Paxil was promoted as a drug to fix teenage depression. It leads to suicidal
thoughts. GlaxoSmithKline, the company who produces Paxil, made over $500
million in just its sells to minors.

The Paxil settlement allows anyone with a personal injury claim, such as
parents of a child who took his or her own life, to still sue.

To bring things home, Tennessee is no stranger to suicide and
antidepressents. As I've blogged about previously, more Tennesseans die
every year from suicide than from drunk-driving, homicide, or AIDS-an
estimated 750 people take their own life every year in The Volunteer State.
Even more live plagued by depression and suicidal thoughts.

Earlier this month FDA urged antidepressant pharmaceutical companies that
warnings on their drugs (including Paxil) should expand to include adults
ages 18 to 24 for the risks of suicidal thoughts and behavior. It is
interesting an extra six years have been added-and interesting that's the
extent.

The deadline to file claims for reimbursement is Aug. 31. Information for
submitting a claim can be found at www.paxilpediatricsettlement.com or by
calling the toll-free hot line, 1-866-494-8404.

Occasionally I am asked to do weekly legal updates for the Tennessee Mornings Show on Fox 17 in Nashville. Sometimes the topics are suggested by the show but often they would just like for me to give some recent legal news. Although it sounds easy it is often difficult to think of a topic. It never fails, however, that a client calls with some concern that is probably shared by many.

Today a client called who had been taking the drug fosamax. The call starts like most: "I have been taking a prescription drug that was recalled, so what should I Do?"They are concerned because this drug has been linked to Osteonecrosis of the Jaw (ONJ), also known as "dead jaw" and "fossy jaw". It is definitely a scary feeling when you find out that a drug that you take for your health may actually be harming you. These are concerns from clients in Nashville, Tennessee and throughout the Country.

Here is some quick advice. Call your doctor immediately. Some drug risk are low and there may be little to fear. Don't quit taking the drug until you talk to your doctor. Gather your drug records to show how long you have been taking the drug and in what dosage. If you fear you have been harmed talk to a lawyer. Research the drug on the Internet. There are a tremendous amount of sources available now than can let you know where you stand.

The American College of Obstetricians and Gynecologists will announce in the December issue of Obstetrics and Gynecology their opinion that pregnant women and those who plan to become pregnant should avoid taking Paxil, a common anti-depressant, because of the risk the drug poses to a developing fetus’ heart.

Paxil drug manufacturer GlaxoSmithKline found in a 2006 study that babies born to women who took Paxil during the first three months of their pregnancy were significantly more likely to have heart problems at birth than those born to women taking other anti-depressants or none at all. The drug has been reclassified to reflect the risk it poses to fetuses, and a warning has been put on the label. If you or a woman you care about is taking Paxil or another SSRI, such as Zoloft or Prozac, urge her to discuss the potential risks of this drug with her doctor and to seek alternative depression treatments.

In Tennessee, more people die every year from suicide than from drunk driving, homicide, or AIDS. The estimated 750 lives that suicidal depression takes every year in this state barely hints at the number of people living with depression in Tennessee and across the country. It is thus highly likely that you or someone you know is taking Paxil or a similar drug. If this, or any other prescription medication, has had a harmful effect on you or your baby, you may be able to file a claim against the manufacturer. Save your prescription bottle and contact an attorney as soon as possible.

It is up to all of us to make sure that drug manufacturers and healthcare providers are aware of these recent findings and take them into account when developing treatments for us and those we love. After all, the future of Tennessee depends on it.