Tennessee Injury Lawyer Blog

Many of us have seen commercials about the over the counter weight loss drug, Alli. Some of us have maybe even tried it or are still taking it. The Alli pill and program is supposed to change the way people think and feel about eating and dieting. It is has personalized plans and steps for each person and it is supposed to make burning calories even easier. Many of us across the country and even right here in Tennessee know about this pill, but many of us may not know the new problems it seems to be causing.

As of today, May 27, 2010, the Food and Drug Administration has revised the label for this drug so that includes new safety information about rare cases of severe liver injuries and damages. The FDA has not determined if Alli is actually causing the liver problems but wants the public to be aware because a condition like this is very serious.

This new warning is based on a complete review by the FDA of all data available from preclinical and clinical trials, as well as post marketing studies and the drug usage from April 1999 to August 7, 2009. The FDA has also identified thirteen post marketing cases of severe liver injury, twelve of them foreign cases involving another weight loss drug known as Xenical and one case involving Alli. In three of these cases, people needed liver transplants and two people died.

Even though cases like these are rare with this drug, it is unfortunate and sad when things like this happen, across the country and even right here in Tennessee. The FDA reported that about 40 million people worldwide use drugs like Xenical or Alli, which means that some of these cases could have been a friend or family member.

Continue reading "Popular Alli Weight Loss Pill Gets New FDA Warning Label" »

Recently, the risk of zinc poisoning and exposure to denture cream products has lead to many pending lawsuits in Tennessee and across the country. It has also lead the company GlaxoSmithKline who manufactures, markets, and advertises for three zinc containing denture creams to stop manufacturing them as of February 18, 2010. These products are: Super Poligrip Original, Ultra Fresh and Extra Care. The company is now working on new formulas for the products that will not contain zinc. These should be available by mid April 2010.

A healthy amount of zinc is needed for everyone, but doctors have found that too much exposure to zinc with products like these denture creams can cause problems such as:
• Numbness and tingling
• Lack of coordination for walking
• Unusual sensations in the hands, arms, and legs
• Weakness of arms and legs
• Copper deficiency problems
• Anemia
• Bone Marrow Failure
• Neuropathy (a condition that affects the nerves)

Some of these conditions are not that severe and when properly treated will not cause a person much more harm than some discomfort, but if zinc poisoning is misdiagnosed or untreated it can result in these more severe and life altering conditions and problems.

Many illnesses have some of these same symptoms, so it is important for doctors to test for zinc if you have taken a product containing zinc for a long period of time. Some of the conditions that have similar symptoms include:

• Demyelinating Syndrome
• Multiple Sclerosis
• Guillain-Barré Syndrome
• Chronic Inflammatory Demyelinating Polyneuropath

If you or a loved one has used one of these products or similar denture cream products containing zinc, it is very important that you stop using the product, contact your doctor, and use a product that does not contain zinc instead. It is also important that you keep whatever records, products, or other information indicating what you have used. This is important in all defective products cases.

Continue reading "Denture Creams with Zinc May Cause Neurological Problems for Tennessee Users" »

Stomach sickness and a strange smell forced Johnson and Johnson (J&J) division McNeil Consumer Healthcare to finally recall from market a total of 27 products, including Tylenol, Benadryl, Rolaids and Motrin, their second recall this month. The company claims the recalled medicines, manufactured in a Puerto Rico plant, became tainted by the wood storage pallets where it was stored. Pallet manufacturers have openly and aggressively challenged this claim that chemical treatment 2,4,6-tribromoanisole (TBA) could, as J&J claims, permeate the boxes, packaging, and bottles to taint the recalled medication.

Moldy-smelling, musty bottles of Tylenol Arthritis Relief caplets were first reported 20 months ago, and since people have complained of digestive problems, including nausea, vomiting and stomach pain. Apparently FDA officials knew about the odor in 2008, having received over 100 complaints by August 2009, but only took critical action recently.

Kickbacks were the cause of a False Claims lawsuit against nursing home pharmaceutical provider Omnicare for which J&J was implicated. The $98 million settlement was based on allegations that the nursing home pharmacists were unnecessarily, and dangerously, prescribing nursing home residents with dementia the antipsychotic drug Risperdal. Unfortunate for the nursing home resident, Risperdal isn't approved to treat agitated patients with dementia, but, according to the Justice Department (DOJ), this kickback scheme worked extremely well for J&J, tripling Omnicare’s sales of J&J drugs, from $100 million to $280 million with Risperdal making up $100 million of the latter sales figure.

Continue reading "Massive Drug Recall and Whistleblower (False Claims) Lawsuit Impact Pharmaceutical Giant Johnson & Johnson" »

Five months after discovery of a virus in one of its medical manufacturing plants, the Maine pharmaceutical company Genzyme faces another set of contamination problems and further potential injury for unsafe drug products on market.

Foreign particles including bits of steel, non-latex rubber, and fiber have been identified in five Genzyme drug products used to treat rare genetic disorders. Two affected drugs - Cerezyme and Fabrazyme - have had their production reduced after the viral contamination was detected in its Allston Landing plant this June.

FDA officials suggest potential serious drug contaminant injury could include blood vessel blockages and life-threatening allergic reactions, though no such adverse events have been reported.

Continue reading "FDA Contaminant Warning for Genzyme Drug Products " »

Pzifer’s off-label marketing of their anti-inflammatory drug Bextra will cost the pharmaceutical company a record-breaking $2.3 billion, $102 million of which will be split by five qui tam relators (whistleblowers). This most recent whistleblower lawsuit is the fourth illegal marketing lawsuit Pzifer’s settled since 2002. Of the $2.3B, $1B is in civil penalties with the remaining $1.195B as the largest criminal fine in U.S. history. This settlement is part of a four-year federal investigation into the business practices of the world’s largest pharmaceutical company.

At issue, this and previous lawsuits against the drug company allege marketing Bextra for “off-label,” or non FDA-approved, uses. In 1991, Bextra received FDA approval as a treatment for arthritis and menstrual cramps. In April 2005, Bextra was recalled after FDA officials received mounting evidence that the painkiller increased risks of heart attack, stroke, pulmonary embolism, and Stevens-Johnson Syndrome, a serious and sometimes fatal skin reaction.

During these nearly 14 years of distribution, Pfizer allegedly marketed the drug to doctors as a treatment for acute pain, a treatment the FDA never approved and one which required large doses of Bextra, an increase that would accordingly raise the health risks posed by Bextra. While it is not illegal for doctors to treat patients with drugs as they see fit, it is illegal for drug companies to market off-label uses.

Part of this illegal marketing included, according to the whistleblower lawsuit, kickbacks, perks, and incentives.

In addition to the fine, Pfizer must pledge to improve its corporate behavior, including marketing practices, as part of the settlement. This is the third such pledge Pfizer has made since 1999, signing such agreements in 2002 for Lipitor and in 2004 for Neurontin. The government has also accused Pfizer of illegally marketing the antipsychotic Geodon.

Because one of the parties defrauded by Bextra’s off-label marketing was the federal government, whistleblowers were eligible to take qui tam action and receive a portion of the funds from the government lawsuit. Qui tam lawsuits require a special knowledge of False Claims laws and should be pursued through an experienced whistleblower attorney, such as my colleagues at Higgins Firm.

For more information on qui tam lawsuits, explore my TN law firm’s employment law pages on False Claims Whistleblower / Qui Tam lawsuits.

Hospira, Inc., a Illinois medical device manufacturer, has initiated a product recall for medical devices with defective AC power cords. These cords are manufactured by Electri-Cord Manufacturing Corporation. Click for a defective power cord image courtesy of FDA Recall page.

This medical product recall was initiated in response to reports of these defective power cords’ sparking, charring, and catching fire. Yes, for the following medical products designed to ensure the health and longevity of U.S. citizens, a patient may find him or herself subject to electrical shock, immolated, or injured from total device failure:

Continue reading "FDA Dangerous Device Recall –
Hospira Medical Equipment Recall for Defective AC Cords" »

FDA issued a public health advisory on Tuesday warning consumers to immediate stop using and discard all American Cellular Labs supplements. Many of these dangerous steroid supplements were being labeled as dietary supplements, or as containing “steroid-like” ingredients, when in fact these supplements contain synthetic steroids.

FDA officials have accused the California company of misbranding its supplements and selling unapproved steroids through these dietary supplements. The dangerous supplements include:

• TREN-Xtreme
• MASS Xtreme
• ESTRO Xtreme
• AH-89-Xtreme
• HMG Xtreme
• MMA-3 Xtreme
• VNS-9 Xtreme
• TT-40-Xtreme

The FDA had received five reports of adverse side effects, including serious liver injury and pulmonary embolism (blockage of an artery in the lung), allegedly caused by American Cellular and similar manufacturers’ products. These products appear to be popular among high school athletes whose drug-testing isn’t as sensitive as professional athletes’. Because they’re cheap and can be bought locally, they are extremely popular, despite carrying the same risks as steroids.

Contrary to popular belief, FDA officials have little oversight over dietary supplements. Nor can they recall dangerous supplements from the market.

It is still within recent memory that a company called MuscleTech produced ephedra-containing dietary supplements that may have caused strokes, heart attacks and death, and the muscle-building supplement Teston-6 was found contaminated with steroids increasing and posing risks of aggressive prostate cancer. These dangerous supplement manufacturers target our competitive youth in their marketing for body building and increased muscle mass and have no qualms with causing serious injury with their outright lies and omissions.

If you have been injured by a body-building supplement and believe you have an injury claim, please contact our Tennessee Legal Office. You can also contact us toll free at 1-800-705-2121.

Georgia generic drug manufacturer Brookstone Pharmaceuticals issued a drug recall today after FDA officials discovered potential overdose dangers and corresponding dangers for drug-related injury, such as liver injury, from a manufacturing error.

Unlike earlier manufacturing-based drug recalls Tennessee Law Blog has reported, Brookstone Pharmaceuticals of Alpharetta, Georgia did not negligently dose its pills or provide an ineffective product. Rather, in this recent drug recall, 16-ounce bulk containers of the company’s generic concentrated acetaminophen drops were inappropriately labeled, according to FDA officials. Packing on these concentrated dose pills look very similar to the regular dosage but the pills inside have far more acetaminophen, the active ingredient in Tylenol.

Acetaminophen is also found in other pain killers and cold medicines, and significant dosages can cause liver damage, including permanent injury. Serious painkillers such as Percocet and Vicodin combine acetaminophen with other pain-killing ingredients for their synergetic effects, and an estimated 100 people died every year from overdose involving acetaminophen as at least one of the ingredients.

The Georgia company had shipped 344 bottles of the concentrated drops to U.S. customers and donated 5,301 bottles to charity for international distribution.

If you or a loved one has suffered injury from a defective drug or drug manufacturer's error and would like to pursue legal action with a Georgia, Kentucky, or Tennessee injury lawyer, call the Higgins Firm at (615) 353-0930 or fill out our drug injury initial response form for a free consultation with myself or my qualified staff of injury lawyers.

On December 31, 2008, a subsidiary of Johnson & Johnson recalled two lots of 50 mcg Duragesic pain patches due to potential tears in the product. If the product has a rip or tear, there is a potential for direct exposure to the powerful drug within the patch, fentanyl. Direct exposure to the fentanyl gel can result severe reactions up to and including a fatal overdose caused by the medication. Many patients throughout Tennessee and the United States received these potentially defective patches. Out Tennessee Law office has already received multiple calls with concerns.

As a result of the problems with fentanyl patches over recent years, there have been several multimillion dollars verdicts against the manufacturers in products liability cases. Products Liability law have developed to protect people from products that are flawed in either there design, development, or manufacture. Drug cases fall under the products liability umbrella because these case typically involve the defective manufacturing or defective design of the products or drugs that cause the injuries.

At the Higgins Firm, we handle cases and work with other nationally recognized firms across the country involving defective drugs and will fight for your rights. If you have been injured as a result of a leak or other problem with a duragesic pain patch, call Jim Higgins or speak to our staff.

Tennessee Law Blog is happy to report that, in a follow-up to an earlier TN law blog on defective product eye injuries caused by ReNu with MoistureLoc, the contact lens solution maker Bausch and Lomb has settle over 600 personal injury lawsuits to the tune of $250 million.

As discussed in another previous Tennessee Law Blog, injuries from the tainted contact lens solution were caused by a potentially blinding fungus present in the solution. The potential for fungal infection (Fusarium keratitis) was high, leading to a recall of the product. The CDC had confirmed 180 cases in 35 states as of September 2006. In Tennessee, one Tennessean had to have an eye removed, as did six other people in the U.S. To date, over 700 contact lens wearers have stepped forward with claims to have been exposed to the blinding fungal infection., some of whom have required corneal transplants to preserve vision in one or both eyes.

The culprit, keratitis, is so rare that doctors were at first puzzled by the seeming outbreak, which began in Hong Kong and reached Tennessee and other states by 2006. Eventually, the correlation was made between the potentially blinding infection and the new, multipurpose lens cleaner on the market, MoistureLoc, though the exact mechanics of why this one product caused this particular eye injury remain unclear.

Keratitis sufferers often complain of eye irritation that progresses to sudden searing pain. 2.3 million of our country’s 30 million soft contact lens wearers used MoistureLoc.

In the years since, Bausch & Lomb has marketed its older product, ReNu MultiPlus.

In Kentucky, Georgia, or Tennessee, if you have been injured by a defective consumer or medical product, contact the Higgins Firm for a fair, firm assessment of your legal situation. Contact our Nashville-based product liability lawyers online or toll-free at 800.705.2121.

Just a couple of years ago, a company called MuscleTech produced dietary supplements with ephedra that was believed to have caused strokes, heart attacks and death. That company went into bankruptcy and put new dietary supplements on the market under known as Hydroxycut. Now it appears that this new Hydroxcut product may be just as dangerous as the old product.

The FDA has received 23 incident reports of liver damage in users of Hydroxycut supplements. These injuries include jaundice, liver damage, and even liver transplant. One reported case involves a 19-year-old who died as a result of the associated liver damage. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine.

Currently the FDA has recalled the following products:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Capsules
Hydroxycut Max Liquid Capsules
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Even you have taken any of these products and believe you have a claim please feel free to contact our Tennessee Legal Office. You can also contact us toll free at 1-800-705-2121.

Deaths from defective Medtronic heart devices continue despite recall in 2007. When Medtronic first announced its recall of Sprint Fidelis leads, the company acknowledged five defective device-caused deaths. This month, Medtronic updated its defective Sprint Fidelis death count to thirteen, nine of which due directly to defibrillator failure from faulty Sprint Fidelis leads.

Despite the Medtronic recall, the device remains in use. Many patients with Medtronic's Sprint Fidelis leads face the difficult decision of to keep the prolific recalled device. One reason the medical device's danger is so widespread is the delay in recalling Sprint Fidelis leads from market. Medtronic waited until 2007 for issuing their Sprint Fidelis recall; this despite FDA officials receiving reports of the device’s defective equipment as early as 2004. By year-end 2005, FDA had received 30 complaints about the device. Whether Medtronic knew of that defects in the Sprint Fidelis posed safety problems remains open to question.

Continue reading "Medtronic Sprint Fidelis Deaths –
13 Admitted Fatalities from Defective Heart Device" »

Recalls, recalls, recalls--FDA officials were busy working with manufacturers of dangerous medical devices last week to inform the public of potentially injurious medical products it has decided must be removed from market. Included in these FDA recalls were Baxter International’s Colleague Volumetric Infusion Pumps and Covidien’s tracheostomy tubes for children. Excluded from these FDA recalls was immediate action to protect patient safety and health.

Serious injury and death have been reported caused by Baxter International’s defective Colleague infusion pumps. These medical devices are used to deliver regular, controlled amounts of medication or other fluids to patients.

Continue reading "FDA Recalls Two Defective Medical Devices
Baxter Infusion Pumps and Covidien Pediatric Trach Tubes" »

Tennessee drug injury liability lawsuits, drug injury lawyers, and those injured by prescription drug side-effects across the U.S. received surprising support with last week’s Supreme Court decision ruling against drug manufacturer Wyeth. The 6-3 decision in Wyeth v. Levine marks a sea change in the Court’s stance on liability law and has many pharmaceutical drug manufacturers sweating.

Since a 2006 executive order, pharmaceutical companies have been avoiding injury lawsuits for dangerous medical products by absurdly asserting that FDA approval means that a defective medical device or drug has been deemed safe. This, despite the public misconception that the FDA performs its own safety studies before approving prescription and OTC drugs; this, despite FDA officials admitting publicly that the agency lacks the resources to protect the public from dangerous drugs (and, I'm inferring, salmonella).

Continue reading "Drug-Injury Lawsuits Supported
in 6-3 Supreme Court Decision" »

The FDA website recently published names of potentially dangerous drugs under review. Among these potentially dangerous prescription medicine side effects are bleeding caused by a diet drug, suicidal ideationfrom an antipsychotic prescription medicine, and possible birth defects from popular antidepressant drugs.

Drugs on this updated investigation list include: antidepressants Prozac, Zoloft, Lexapro, and Celexa; schizophrenia drug Abilify; and diet drug Xenical.

After issuing warnings about these antidepressants' side effect of suicidal behavior, FDA officials are finally investigated SSRI and SNRI antidepressants for potential congenital disorder (birth defects) side effects. The form of these suspected antidepressant-caused birth defects was not disclosed, but both Selective Serotonin Reuptake Inhibitors (SSRI), such as Prozac and Zoloft and other popular antidepressants, and Selective Norepinephrine Reuptake Inhibitors (SNRI) antidepressants, such as Viloxazine (Vivalan) and Maprotiline (Ludiomil), are under evaluation. Both Atomoxetine (Attentin, Strattera), an ADHD medication with off-label uses as a antidepressant and the smoking cessation drug Bupropion (Wellbutrin), which also is prescribed as an antidepressant, are on this list.
(For more on antidepressants' negative affects on prenatal infants, check out Tennessee's Law Blog's coverage back in 2006 on this very issue in Does Paxil Put Unborn Babies at Risk?)

Additionally, Abilify, a prescription drug schizophrenia approved by the FDA in 2002 and one of pharmaceutical giant Bristol-Meyes Squibb’s fastest growing products, is being evaluated for possible the side effect of hepatotoxicity (drug-based liver damage). Xenical, an anti-obesity drug approved by the FDA in 1999, which may cause rectal bleeding.

All of these prescription drugs are presently on market. Being under investigation does not necessary indicate harmful side effects. These drugs have only been identified as having, in the words of the FDA, “a potential safety issue.” If FDA drug officials’ investigations determine these prescription medication pose severe side effect risks, label changes or development with the pharmaceutical company of a Risk Evaluation and Mitigation Strategy (REMS) may be initiated.

This dangerous prescription drugs list update was posted as part of the 2007 mandate from Congress that the FDA publish quarterly those dangerous prescription and OTC drugs whose potentially harmful side effects are under review. Click to open the full FDA potentially dangerous drugs list.

Residents of Tennessee, Kentucky, and Georgia who believe they or a loved one have been injured by a FDA investigated prescription drug should contact our Nashville law offices online to speak with ourdefective drug injury team or give us a call at 800-705-2121. As always, initial personal injury consultations are offered free of charge and in many cases, we only collect attorney’s fees after you’ve been compensated for your injury and future losses.

Atypical antipsychotic drug Zyprexa, after an 18-month drug injury investigation into manufacturer Eli Lilly's unsafe off-label marketing to vulnerable elderly and young patients, is expected pay a $1.42 billion settlement, $362M of which will go to 32 states, including Tennessee, and the District of Columbia.

Zyprexa was FDA approved in 1996 for treatment of bipolar disorder and schizophrenia in adults but the company has since marketed the drug for off-label (unapproved, often untested) uses. These include Zyprexa for treatment lesser psychological problems, such as behavioral problems, and prescription to children and the elderly patients. (More details on Zyprexa side effects and dangerous drugs at my law firm’s Defective and Potentially Dangerous Drugs site). An estimated 26 million patients worldwide have taken Eli Lilly's "wonder drug" Zyprexa.

Zyprexa was marketed as the next generation of anti-psychotic drugs called atypicals. Creators of atypicals claimed that severe psychological disorders like schizophrenia could be treated with drugs like Zyprexa with few, minor side-effects. Yet not all these new drugs developed accurate testing for long-term side effects, such as Zyprexa's side effect of rapid weight gain and diabetes in select populations. In one tragic case in Atlanta, Georgia (previously covered in Tennessee Law Blog’s “Southern Man’s Death Linked to Zyprexa”), a middle-aged bipolar man died after significant weight gain during his five years of taking Zyprexa. Eli Lilly has already spent $1.6 billion to settle over 30,000 product-liability lawsuits from people who developed diabetes or suffered from other unintended side effects of Zyprexa. And yet Zyprexa not only remains on the market but remains the company’s best selling drug.

The present Zyprexa settlement developed out of two qui tam whistleblower cases against Eli Lilly. As Medicare, Medicaid, and other government-funded hearth care programs were involved in the targeting of sales to the elderly, the federal government accepted the False Claims lawsuits against Zyprexa, which resulted in the then largest qui tam settlement in False Claims Act history.

Though the drug was not approved for geriatric patients, in at least one case, Eli Lilly urged medical staff to use Zyprexa to zonk unruly nursing home residents. According to court documents, Zyprexa's salespeople suggested doing so would reduce "nursing time and effort". Doctors were also urged to prescribe Zyprexa to patients with dementia, including Alzheimer’s, even though the drug is not FDA approved for such patients.

Zyprexa remains available to Medicaid patients, and most of Zyprexa’s sales are to the federal government. If the announced settlement does not go through, Eli Lilly may be barred from Medicaid and Medicare programs.

While Zyprexa has been subject of lawsuits, other drug makers such as Cephalon Inc. (read Tennessee Law Blog's entry on the Cephalon qui tam lawsuit settlement) have been subject to criminal and injury lawsuits and others such as AstraZeneca (Seroquel) and Johnson & Johnson (Risperdal) are under government investigations related to alleged off-label promotion of antipsychotics.

If you've suffered injury from a prescription drug, my drug injury attorneys and I can help. Initial contact can be made by completing our drug injury attorney form for Tennessee, Georgia, and Kentucky, or by calling our Nashville law offices toll-free at 800.705.2121.

FDA drug and medical device officials are continuing their efforts into 2009 with FDA recalls of two dangerous products: the pain patch Duragesic (fentanyl) and a Class I Recall of the ophthalmic medical device Healon D. In both cases, the FDA recall was limited to specific lots of affected, and dangerous, medical products.

The current Duragesic (fentanyl) pain patch recall is on a smaller scope than the previously issued in February 2008 Duragesic recall Tennessee Law Blog had reported. Johnson and Johnson, whose PriCara division’s ALZA Corp produces the fentanyl pain patch, recalled two lots of potentially dangerous Duragesic last week. These recalled dangerous drug patches may contain flaws in the patch that expose users to an immediate and full dosage of the active ingredients, potentially causing trouble breathing and opiate overdose.

Affected by the FDA recall are Duragesic 50 mcg/hr patches in lot number 0817239 as are Sandoz Inc. 50 mcg/hr patches in lot number 0816851.

Last year’s Duragesic recall of nearly 32 million fentanyl Duragesic Pain Patches with the potential to overdose its wearer was initiated not for tears but for excess dosage in the pain patch.

The other major FDA recall, Healon D, which is under a Class I recall (reserved for products that the FDA believes can "cause serious health problems or death"), is due to a chemical agent in the cornea transplant product already linked to optical patients’ eye problems. In addition to cornea transplants, Healon D, an ophthalmic viscosurgical device (OVD), is also used in cataract removal and other ophthalmic procedures.

Manufacturer Advanced Medical Optics has had a Healon recall on lot number UD 30654 in effect since November 2008, but only two-thirds of the recalled product have been returned. The manufacturer has received 66 reports of negative reactions from what appears to be elevated levels of endotoxin (toxins caused by decomposing bacteria) in the drug and of Toxic Anterior Segment Syndrome (TASS), a type of acute inflammation typically occurring within 12–24 hours of cataract surgery.

If you have been injured by a defective medical device or dangerous drug medicine in Tennessee, Georgia, or Kentucky, contact the medical injury lawyers at our Nashville, TN offices by phone (615.353.0930) or by completing a quick prescription drug/medical injury lawyer contact form.

In my years of writing Tennessee Law Blog and warning Tennesseans of dangerous products, I have avoided publicizing dietary supplement recalls, partly because dietary supplement recalls are so common, partly because I prefer to use this pace to warn readers of the far more dangerous and larger betrayal of trust found in Tennessee pharmaceutical drug injuries and recalls. This said, two recent weight loss supplements pose dangers beyond the pale that Tennessee Law Blog would be remiss not to mention.

Though no serious adverse effects or drug injuries have been reported in Tennessee, the two following recalled supplements can pose serious harm due to the undeclared drug substances they contain. Any consumer who has purchased either of the following two recalled appetite suppressants should immediately discontinue use.

1. Zhen De Shou Fat Loss Capsules. Distributed through the U.S. and sold online, FDA officials found undeclared sibutramine (trade name Meridia) in these OTC appetite suppressant (“fat loss”) pills. While the appetite suppressant sibutramine is approved by FDA (despite claims of the drug being far more dangerous than the conditions it “cures”), sibutramine can significantly increase blood pressure and pulse in some consumers and studies are underway investigating reports of sudden death, heart failure, kidney failure, and other problems caused by this drug. Particularly at risk are patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Zhen De Shou Fat Loss Capsules are sold in 10 light and dark green capsules in blister packs. Consumers should immediately discontinue use and responsibly dispose of any unused product.

2. StarCaps Diet System Dietary Supplement. At first voluntarily recalled by Balanced Health Products, now subject of a FDA immediate recall, these supplements were recalled upon discovering unlisted bumetanide as an ingredient. Bumetanide is a diuretic that requires a prescription and can cause dehydration and low blood pressure. Also, consumers allergic to bumetanide may experience adverse reactions from the drug, as can consumers using other prescription drugs, especially digoxin and lithium. FDA officials urge takers of StarCaps experiencing any symptoms to immediately call their health care provider.

StarCaps are marketed as an all-natural product from Peru that combines papaya enzyme and garlic to reduce appetite. A plastic bottle of 30 tablets costs about $100.

Neither dietary supplements’ packaging or labeling indicated that these products were anything other than completely harmless.

If you have suffered injury from undeclared substances in a dietary supplement and are a resident of Tennessee, Kentucky, or Georgia, our drug injury attorneys at our Nashville law offices would like to help. Contact our TN defective drug injury team online or give us a call at 800-705-2121. As always, initial consultations are free of any charge and, in many cases, we only charge attorney’s fees when you’re fairly compensated.

FDA officials were busy in the final days of last week as U.S. Marshals under FDA orders seized tainted heparin from Celus Labs in Cincinnati on Thursday. Meanwhile, after three months on market, FDA officials stepped in to help healthcare device manufacturer Covidien recall dangerously mislabeled insulin, a potentially lethal packaging error that has already led to at least one injury.

After the heparin scares earlier this year from FDA-recalled tainted Baxter heparin, I thought Tennessee Law Blog would be finished warning our readers of potential heparin injuries and tainted lots of heparin. Unfortunately, this was not the case as 11 lots of heparin were seized Thursday.

U.S. Food and Drug Administration (FDA) seized 5 lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and 6 lots of Heparin Lithium from Celsus Laboratories Inc. in Cincinnati. These 11 lots were manufactured from Chinese over-sulfated chondroitin sulfate (OSCS), a crude substance that imitates heparin’s blood thinning activity but whose over-sulfated qualities make the injected anticoagulant dangerous to the patient.

To-date, there have been over 13 recalls of tainted Chinese heparin and over 200 deaths connected to the contaminated heparin. (Click for FDA’s complete list of potentially Chinese heparin tainted medical devices.) In April, FDA inspectors found over 30 pounds of contaminated heparin at Celsus Labs used for two of its medical products. Thursday’s raid represents a more aggressive strategy for the FDA.

Meanwhile, FDA officials alerted patients and doctors of an insulin recall of 4,710 boxes of ReliOn Insulin Syringes (each box containing 100 insulin syringes). Insulin syringes labeled for use with U-40 insulin instead were packaged with syringes for U-100 insulin, or 2.5 times the stated dosage. These mislabeled ReliOn Insulin Syringes pose a danger of “hypoglycemia, serious health consequences, and even death,” according to the FDA.

Recalled boxes of syringes applies to ReliOn Insulin Syringes (31 gauge 1 cc) from lot number 813900 having product identification number 38396-0403-02. ID numbers can be found in upper right-hand corner of the syringe box. These syringes were sold through Wal-Mart stores and Sam’s Clubs.

One adverse report related to one of these recalled insulin syringes has been reported to the FDA.

If your ReliOn syringes bear the affected lot number (lot #813900), please take one of the following actions:

* Call ReliOn 866-780-5436 for replacement instructions on recalled insulin syringe.
* Read for replacement instructions at www.relion.com/recall.
* Return the recalled syringes to the pharmacy where purchased for replacements.

If you have been injured by defective drugs, tainted medicines, or a medical error in Tennessee or surrounding states, our personal injury law team at our Nashville law offices would like to help. Contact our TN personal injury team or give us a call at 800-705-2121.

A little over a week has passed since the medical device manufacturer Medtronic issued its Class 1 Recall for its automated external defibrillators (AEDs), this AED recall following a number of dangerous Medtronic medical device recalls Tennessee Law Blog has reported. Now news has broken of yet another dangerous medical device Medtronic manufactured and the FDA considers life-threatening: Sutureless Intrathecal Catheters.

These sutureless connector intrathecal catheters (also called SC catheters) are part of implantable drug infusion systems for administering drugs to the spine, and their defectiveness makes these Medtronic infusion systems unsafe and dangerous medical devices. The affected Medtronic models are

INDURA 1P Intrathecal Catheter, Model 8709SC

Intrathecal Catheter, Model 8731SC

Sutureless Pump Connector Revision Kit, Model 8578

Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC

Over 25,000 of these SC catheter pumps are being used by patients since the came on market in May 2007. Most patients who use the SC catheter pumps have constant spasms from traumatic brain injury, multiple sclerosis, or other causes and need the steady supply of heavy medication these SC infusion pumps deliver.

In June, Medtronic told FDA and doctors worldwide that it had reports of problems with its infusion pumps--83 reports to be exact. The Medtronic SC catheters subject to recall clogged or came loose from the pump, which in both cases makes it difficult to deliver the necessary, sometimes vital, medications these defective medical devices were designed to deliver.

Symptoms of the defective Medtronic medical device include overdose and withdrawal symptoms in the patient. For those patients receiving intrathecal baclofen therapy, symptoms can include death, as baclofen withdrawal leads to life-threatening conditions if not cared for properly. This was the case for the one confirmed death attributed to a defective SC catheter pump.

The recalled Medtronic intrathecal drug delivery systems use pump implanted in the intrathecal space in the spine, which is the area around the spinal cord. Powerful drugs (e.g. baclofen, morphine, and ziconotide) are administered here to make them even more power as they can enter the spinal fluid without crossing the blood-brain barrier and go directly to the brain.

If your Tennessee loved one was injured by a malfunctioning Medtronic Intrathecal Catheter Pump, the Nashville law offices of Higgins, Himmelberg & Piliponis wants to help. Call (615) 353-0930 or fill out our Tennessee medical device injury attorney form for a free initial consultation with a defective medical device lawyer.

FDA has issued a Class I recall for LIFEPAK CR Plus automated external defibrillators (AEDs) produced by Medtronic’s subsidiary Physio-Control, Inc. This urgent medical device recall was issued for 249 LIFEPAK CR Plus units manufactured between 4/2004 and 8/2007 and distributed until the end of 2007.

Class I FDA recalls of medical devices are the most serious form of recall reserved for medical equipment that can cause catastrophic injury. As the FDA states:

Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death. Examples of products that could fall into this category are a food found to contain botulinal toxin, food with undeclared allergens, a label mix-up on a life saving drug, or a defective artificial heart valve.

The Medtronic LIFEPAK CR Plus defibrillators, by design, is a fully automated medical device. In actuality, the Medtronic device was programmed with software intended for a semi-automated device that includes voice prompts to push buttons that are not accessible to emergency personnel. These battery-powered units are located in public places for potable emergency usage.

It is reported Medtronic has received at least one case of a problem associated with this defective medical device.

Replacements LIFEPAK defibrillator devices were shipped at the beginning of September with a warning from the Medtronic subsidy that the defective CR Plus devices should not be used or have the covering over the shock buttons be removed. There is no report of how many defective LIFEPAK AED devices are still in use.

If you or a loved one in Tennessee has suffered injury from this recalled Medtronic device or personal injury from another defective medical device, the law offices of Higgins, Himmelberg & Piliponis would like to help. Contact our downtown Nashville law office at (615) 353-0930 or fill out our Tennessee personal injury attorney form for a free initial consultation with a defective medical device lawyer.

Medtronic, the medical device giant best known for its heart and diabetes technologies, has recently released a flurry of press releases regarding the FDA’s approval of its software to detect cracks in potential defective Medtronic defibrillator leads. These defective components in their Medtronic's medical devices the company had manufactured were subject to an October 2007 recall. While the risk for serious injury from system failure persists for some patients with the Sprint Fidelis lead in their implanted defibrillator, what these Medtronic press releases have effectively done is bury reports of serious injury caused by off-label use of Medtronic’s Infuse Bone Graft system.

Continue reading "Spinal Injuries from Off-Label Use of Medtronic's Infuse Bone Graft Drowned by Medtronic's Recent Defibrillator Coverage" »

FDA officials and manufacturer Boston Scientific are recalling three types of Boston Scientific's carotid artery stents and delivery systems

NexStent Monorail,

NexStent Carotid Stent, and

Monorail Delivery System

A coronary stent is a slender device placed in a coronary artery to treat coronary heart disease; specifically, these stents prop open arteries. Coronary stents are used in a procedure called percutaneous coronary intervention (PCI), more commonly known as oronary angioplasty or just plain old angioplasty. NexStent is specifically used for clogged arteries in the neck that carry blood from the heart to the brain.

The problem with Boston Scientific’s defective (and now thankfully FDA recalled) defective carotid artery stents was that the tip had a great likelihood of coming off during angioplasty, which can cause a punctured artery, stroke, even more invasive emergency surgery to retrieve the stent tip, and other dangers.

FDA officials have stated there is no danger of broken stent tips for those who already have a stent in place; this defective medical device danger exists during the initial application of Boston Scientific carotid artery stents. The tip of the stent deliver system for these three recalled products detaches while it is run through the midsection up to the patient's neck.

Patients with upcoming heart surgeries involving a carotid artery stent procedure should consult with their heart surgeon to make sure that none of these recalled, defective Boston Scientific stents will be used.

I encourage any Tennessee resident injured by any of these defective medical devices to give HHP’s Nashville law offices a call or complete our dangerous medical device injury response form. There are time limits to successful defective device lawsuits and settlements in Tennessee; the more quickly you act, the greater your chance for fair compensation for your medical injury caused by Boston Scientific's defective and dangerous artery stents.

Sixty-five different potentially dangerous generic drugs manufactured by Actavis Totowa, LLC, one of the world’s largest generic drug manufacturers, were recalled from market last week. Regulators found that the company’s Little Falls, NJ plant didn't meet safe manufacturing standards for pills. Suppliers (pharmacists and hospitals) of the generic drugs have been asked to return all pharmaceuticals subject to Actavis’ recall.

These drugs include:

Continue reading "Pill Manufacturing Oversight Recalls Actavis Generic Drugs" »

I’ve been covering the tainted, dangerous Baxter-Chinese heparin recall, in our Tennessee Law Blog since the story broke in February. While dangerous heparin remains, its circulation is finally diminishing. From 1 January to 31 March, 93 heparin-related deaths were reported to the FDA, and yesterday FDA officials stated that they’ve completed their review. And reporting on these heparin-injuries and deaths, the FDA played it conservative.

Three heparin related deaths were undoubtedly caused by tainted heparin; what the FDA reported on the remaining 90 is an unsettling reminder of how our Food and Drug Administration is not a proactive testing regulatory agency with our nation’s health at its foremost but a political regulatory agency that drags its feet whenever they must be moved.

This is the first time since the Baxter recall that the FDA has allowed themselves to state conclusively that any deaths were caused by the tainted heparin. These three persons each had an infusion of the blood thinner which led to an adverse allergic reaction and the loss of life.

The three deaths were among ten patients who had an allergic reaction to heparin, specifically its contaminant (oversulfated chondroitin sulfate) that tainted the recalled Chinese heparin, but FDA officials were unable to say whether or not the other seven deaths were from the heparin lots that were known to be tainted. They only know that reaction to the contaminant caused the deaths--so these were not counted as caused by Baxter's contaminated Chinese heparin. This is similar to detectives stating that they know the homicide victim died of massive blood loss from a bullet wound, but because no bullet was found in the body, they cannot state with certainty the man with the smoking gun was responsible.

Of the remaining 83 tainted heparin deaths reported in those three months, FDA officials dismissed 25, leaving 58 losses of life attributed to heparin but not from allergic reaction. Because heparin may have contributed to factors leading to a loss of life but heparin did not alone cause the death, FDA officials didn't count them conclusive.

So when the FDA reports three deaths due to tainted heparin, what is meant is that these three deaths cannot possibly be from another cause that could cast doubt. It does not mean Baxter’s questionable business practice of buying heparin from unregulated Chinese villages led only to three deaths.

If you were one of the over 1,000 people on dialysis, undergoing heart surgery, or other medical procedure and injured by tainted heparin, I’d like to know about it. Give our Nashville law offices a call at (615) 353-0930 or fill out our quick heparin injury attorney question form.

Heparin deaths have now reached at least 149 Americans from dangerous, recalled Chinese heparin with many more injured. The tainted heparin blood thinner causes allergic reactions leading to serious injury and death.

Baxter International, which once provided half all heparin in the US, issued a total recall of its heparin in January after reports of the blood thinner’s contamination. Made from pig intestines, heparin as a blood thinner is used to flush out IVs, used in oxygenators and medical devices during bypass surgery, and will be injected in some standard medical procedures. The tainted heparin contains an adulterate (that is, Baxter bought heparin that had a cheaper ingredient substituted for pure heparin). Many believe the relaxed manufacturing standards of China where Baxter outsourced production of its heparin responsible for the defective heparin. Tainted heparin has also been recalled in Germany, Italy, France, and Japan.

While FDA officials have direct evidence for 149 death caused by tainted heparin, over 250 heparin-related deaths have been reported. Nevertheless, any sudden or untimely death of a loved one that might be heparin-related should be investigated by a qualified drug injury attorney.

Allergy-type reactions caused by tainted heparin include troubled breathing, nausea, vomiting, and loss of blood pressure. This is due to the substitution of oversulfated chondroitin sulfate (OSCS), a cheaper and illegal substitute for pure heparin. Despite the dangers, FDA officials report that some hospital and health care providers have not complied with heparin recall instructions. From laziness or negligent oversight, dangerous heparin still remains in storage, emergency kits, and dialysis machines, according to FDA reports.

If you believe you or a loved one has been injured by an adverse heparin reaction, contact me, Tennessee personal injury attorney Jim Higgins, by phone at (615) 353-0930 or fill out our online form for a free legal consultation with our Nashville law firm. Higgins, Himmelberg & Piliponis is a Nashville-based law firm with offices in downtown Nashville and offers legal services to clients throughout Tennessee.

St. Louis-based ETHEX Corp. issued a recall this weekend of its morphine sulfate pillstoday after discovering some tablets have as much as double their safe size. This unsafe size can be responsible opiate overdose from the life-threatening excess of morphine.

(NOTE: This should not be confused with the earlier digitek recall for similar unsafe manufacturing errors.)

The specific tablet lots subject to the ETHEX recall were of the 30 and the 60 milligram (mg) varities of the morphine sulfate tablets. These defective tablets have been on the market from for just under two years, June 2006 and May 2008. The 30 mg ETHEX morphine sulfate tablet is oval-shaped and pink with “30” on its front and “E” on its back. The 60 mg ETHEX morphine sulfate tablet is also oval-shaped and has an “E” on its back but is white with “60” on its front.

Potential drug injuries from morphine overdose include difficulty breathing, low blood pressure, and hypotension. Many of these side-effect injuries can be life-threatening.

FDA officials are helping the ETHEX Corporation with this recall of these potentially dangerous morphine sulfate pills from market.

Morphine sulfate tablets are a Schedule II narcotic of the opiate family used to relieve extreme pain.

If you believe you or a loved one has suffered injury from this dangerous morphine pill and would like to pursue legal action against those responsible for ETHEX morphine sulphate 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.

It is estimate that hundreds of contact lens wearers and dozens of Tennesseans injured by ReNu with MoistureLoc and Complete MoisturePlus contact lens solutions remain unaware of the recall of these 1-step lens cleaning solutions and the serious injuries these solutions caused. Class action and individual lawsuits by Tennesseans are still being filed against Baush & Lomb and AMO, the respective lens solution makers, to compensate injured contact lens wearers for the dangerous operations, their pain, and loss of vision caused by defective lens solutions.

AMO’s Complete MoisturePlus injuries were caused by Acanthamoeba keratitis (AK), a water-borne parasite that can lead to serious debilitating eye infections. ReNu with MoistureLoc (manufactured by Bausch & Lomb) no-rub solutions were recalled because the fungal infection Fusarium keratitis. Eyes of sufferers of these severe eye infections become irritated, sometimes with very sharp, stinging pains like grains of sand in one’s eye. The infected eye may ooze or become red and swollen. Many injured Tennesseans who suffered were dismissed by their doctors who suggested the patient might have swum in dirty pools or had unclean eye habits.

Both these contact lens products were subject to Class 1 recalls after demonstrating a reasonable chance of serious adverse health consequences. While FDA administrators have alerted health care professionals and some users of soft contact lenses about the recall, recent court findings have suggested these manufacturers chose to not act responsibly in notifying consumers and retailers about the dangers of their contact lens care products. Additionally, the South Carolina plant manufacturing ReNu with MoistureLoc had been cited by FDA inspectors a number of times for failing to maintain health compliance.

Now, after years of 1-step, no-rub contact lens cleaners causing injuries, necessitating injury lawsuits and recalls, FDA officials have decided to review contact lens cleaners in June. While the culprit remains the failure of AMO and Bausch & Lomb to check the quality of their contact lens solutions, FDA investigators are also looking at improving labeling to have customers to "rub and rinse" lenses before storage to remove germs. Studies suggest the older, peroxide-based cleaners with a two-step cleaning process are better at cleaning and removing dangerous parasites. But it’s hard for the manufacturers of Complete MoisturePlus and ReNu with MoistureLoc to turn a profit on the tried, tested, and true; a faster buck’s made by advertising what’s new and easy to use--even if easy and new leaves you with a glass eye and hospital bills.

CAUTION ALL CONTACT LENS USERS: You should never reuse old lens solution or mix new lens solution with old. Nor should you rinse your contact case with anything other than solution. This step should be taken by all contact lens wearers; rinsing with water instead of solution may be related to the Complete MoisturePlus lens solution recall as the parasite’s spreads in the presence of water.

Working with our Nashville personal injury lawyers can help you recovery wages from missed work, hospital bills, and loss of quality of life that eye injuries and that Renu’s and MoisturePlus’ bacteria caused. HHP has the expertise to take on the big company lawyers. Call me, attorney Jim Higgins, at (615) 353-0930 for a free initial consultation or contact us through the Tennessee personal injury form.

FDA officials ate crow last week as actor Dennis Quaid spoke before the House Oversight panel. Quaid, whose newborn twins nearly died after being given unsafe heparin, spoke passionately against FDA officials' claims that FDA-approval was the ultimate, end-all proof that a drug’s safe. Quaid supported personal injury lawyers of dangerous drug lawsuits, stating:

"I used to think lawsuits were frivolous. Now I know the courts are the only path."

The hearing, called "Should FDA Drug and Medical Device Regulation Bar State Liability Claims?", heard medical and drug injury figures, such as the Institute of Medicine’s estimate that 1.5 million U.S. citizens suffer injury from medication mistakes every year. In the case of Quaid’s 14-day old children, the unsafe dosage was given because Baxter, the heparin manufacturers, had not changed the labels to clearly identify the heparin dosage levels--a measure the drug company drug its feet on until it faced lawsuits for the deaths of three infants in an Indiana hospital.

The House hearing was in response to a Bush Administration initiative that would eliminate the ability to sue for recoveries in drug injury lawsuits. The Administration has argued (and recent Supreme Court decision suggests) that drug and medical device companies should not be held liable for injuries caused by their drugs or medical products if they are FDA approved. The House hearing was to evaluate this insane proposal. But perhaps even more maddening that the FDA’s own statement that any product that meets its standards for approval should not subject to state liability laws.

This is not merely a matter of big pharmaceutical companies being in bed with the FDA or simply more rhetoric of tort reforms that distort the purpose of personal injury law (i.e. making those found liable in court for injuring innocent people pay for the real cost of those injuries), but represents a larger and graver matter: the rights of individual American citizens over those of powerful corporations.

Readers of the Tennessee Law Blog do not need to be reminded of the various failings of the FDA over the decades to see why denying the right to sue for medical device, food, or drug injury damages is just darn ludicrous. That these discussions can even be thought reasonable to occur is insulting to those who in the past three years have been fatally injured by defective infusion pumps, permanently blinded by fungal infections from recalled ReNu contact lenses, or potentially fatal fentanyl overdose from duragesic pain patches. And what of Vioxx and the slew of other FDA-approved drugs that have killed or injured Tennesseans because of their negligence?

Even David Kessler, ex-FDA commissioner (1990-97), testified that the FDA does not have the resources to detect emerging risks from approved (but dangerous) drugs or medical devices and that states should not be told that their citizens cannot sue drug and medical manufacturers for recoveries.

If you or a Tennessee loved one has suffered a medical device or prescription drug injury, you deserve compensation from those responsible for your injury. Contact HHP today to speak with a TN prescription drug/medical device injury attorney.

Expensive, uncomfortable, and potentially debilitating. That’s the cure. The cause is the blinding infection Fusarium keratitis and the culprit is ReNu with MoistureLoc, a contact lens causing eye injury in Tennessee and the other 49 states.

FDA and ReNu recalled all ReNu with MoistureLoc products over a year ago, but cases of eye injury continue to arise and Tennesseans in Nashville and throughout Tennessee continue to seek legal aid and representation to recover moneys for corneal transplant surgery (also known as corneal grafting or penetrating keratoplasty).

As the FDA wrote in its initial release of the contact lens recall:

This is to update you on the rare but serious eye infection in people who wear soft contact lenses. There has been a recent increase of reports in the U.S. of this infection. The infection is fungal keratitis, caused by the Fusarium fungus. It can cause a permanent loss of vision. Several patients with this infection have needed corneal transplants to save their vision.

In a corneal transplant, a dead but otherwise healthy cadaver’s cornea is cut out and grafted onto a living but infected person’s eye. This surgery has become more common as eye surgeons rush to prevent permanent blindness caused by the fungal infection (fusarium keratitis) found in the unsafely manufactured ReNu with MoistureLoc contact lenses. These defective contact lenses are believed to have cause loss of vision quality, blindness, and corneal ulcers.

If you have one of these symptoms, do not allow ReNu to get away with causing severe infections with their MoistureLoc brand of contact lenses. Though the company has stopped shipment, if you use Renu MoistureLoc Contact Lenses, stop immediately.

(Following this recall and for customer safety, FDA officials and optometrists advise all contact lens wearers rub and rinse their lenses even when “no-rub” contact lens solution is used.)

If you believe you or your Tennessee loved one are among the hundreds who have suffered from wearing defective ReNu MoistureLoc contact lenses, give me, Nashville Attorney Jim Higgins, a call at (615) 353-0930. You can also fill out our online form for a free legal consultation with our Nashville law firm about how you can be part of the ongoing ReNu MoistureLoc lawsuits and settlements in Tennessee.

Follow-up to Tennessee Law Blog’s 02-05-08 Heparin Recall Article.

Concerned that not all health care providers have recalled their medical products containing unsafe Chinese heparin, FDA officials again notify health care professionals about the FDA heparin recall. FDA has sent notices to various clinics and doctors about the recall of injectable heparin medicines. The cause for the FDA recall was dangerous contamination of heparin by oversulfated chondroitin sulfate.

Ordered earlier in February of this year after at least 81 people died from what are suspected to be defective heparin-related deaths, the FDA believes that quantities of this unsafe blood thinner used in heart surgeries and dialysis. FDA regulators suspect there is still contaminated, recalled heparin in storage areas, emergency kits, and dialysis units.

Despite this recall of China-produced heparin, FDA officials prefer to keep their orders private, having signed confidentiality agreements with the drug companies. These agreements make it illegal for the FDA, the highest U.S. authority in regulating drugs and charged with providing protection from dangerous drugs, to reveal the names of companies who purchased potentially tainted supplies of Chinese heparin and who are not adhering to the heparin recall.

Meanwhile, the price of heparin goes up. USA Today reports that the price of the blood thinner has doubled since last month, according to dialysis centers throughout the U.S. This is due not only to recalls in the U.S. but throughout the world where the dangerous Chinese heparin was sold.

APP Pharmaceuticals became the U.S.’s only supplier of heparin for surgeries and dialysis after the FDA heparin recall. While APP Pharmaceuticals also purchases heparin from China, its heparin appears to not contain the potentially fatal contamination found in the heparin cut by Chinese suppliers with a cheap counterfeit ingredient.

While demand for the limited heparin supply is part of driving heparin costs up 100%, the Chinese suppliers also raise their prices to meet and ensure basic safety standards, according to the USA Today article. In other words, or in my words, the cheap heparin upon which Baxter made its profits at the cost of providing its American customers an unsafe product is only now coming to cost its real market value for cheap labor and lack of oversight.

If you believe you might have a heparin injury lawsuit resulting from dangerous, FDA recalled heparin, contact me, Nashville attorney Jim Higgins, at (615) 353-0930 or fill our drug injury legal consultation forms for our legal services spanning Tennessee.

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

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

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.

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.