Kentucky Injury Lawyer Blog

Ever since the New England Compounding Company's (NECC) tainted medicine led to the injuries and deaths of dozens, if not hundreds, the U.S. Food and Drug Administration (FDA) has stepped up its efforts at shining a light on a burgeoning problem. Compounding pharmacies are not regulated like other pharmacies.

Since the NECC issue arose, no fewer than six compounding pharmacies have issued recalls for similar problems. Just last week, Nora Apothecary & Alternative Therapies and Balanced Solutions Compounding Pharmacy recalled products due to sterility concerns. If you get any drugs from a compounding pharmacy, it is best to exercise caution.

Nora Apothecary & Alternative Therapies has announced a multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.

The recall includes sterile products that Nora Apothecary & Alternative Therapies supplied to patients and offices of licensed medical professionals. Specifically, the recall includes approximately 95 dosage units of sterile compounded products that the pharmacy supplied to offices of medical professionals located within Indiana. Though some patients that received products from those medical professionals may be live in states other than Indiana. The recall also includes approximately 400 prescriptions compounded for patients within Indiana and four other states: four prescriptions for patients in Illinois; and one prescription each for patients in Ohio, Florida and Tennessee.

The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013.

Affirm XL, Inc. has issued a recall of its Affirm XL "dietary supplement", becoming the most recent non-prescription male enhancement supplement to yield to recent scrutiny by the FDA for containing the same active ingredients as prescription impotence drugs, but without listing them on the label, the regulation that goes along with it and the warnings for potential trouble. The active ingredient is sildenafil, which is the same active ingredient in Viagra.

We recently posted about the Recall of Rock-It Man for the same reasons. An even earlier post describes some of the potential problems from these types of "supplements." More information about the recall can be found here.

The U.S. Food and Drug Administration issued a recall of ROCK-It Man Male Enhancement Capsules after finding it contains hydroxythiohomosildenafil. The FDA's tests found that this over-the-counter "supplement" has virtually the same active ingredient (sildenafil) in it as the FDA-approved prescription impotence drug, Viagra. Therefore, the expectation is that it will have some of the same side effects.

In an earlier post, the danger was explained: Many of the prescription impotence drugs warn men who also take nitrates for heart problems about the risk of a dangerous drop in blood pressure. No such warnings exist on these "supplements."

The recall covers capsules sold between October 2012 and April 2013.

The U.S. Food and Drug Administration (FDA) recently released warnings aimed at men who take so-called dietary supplements that purport to enhance sexual performance. Some of the brand names include Ninja Mojo, Love Rider, Affirm XL, Rocket-it Man and Kaboom Action Strips.

All of these products hold themselves out as dietary supplements and use words like natural and herbal to describe themselves. The problem is that the FDA's lab found tadalafil in Ninja Mojo, for example, which is the active ingredient in the impotence drug Cialis. Ninja Mojo fails to list it as an ingredient at all. Virtually all of the "supplements" have hidden chemicals or ingredients that are the same or very similar to the active ingredients in prescription impotence drugs.

The problem with that is that the prescription impotence drugs have side effects that can be harmful. For example, many of the prescription impotence drugs warn men who also take nitrates for heart problems about the risk of a dangerous drop in blood pressure. No such warnings exist on these "supplements."

The U.S. Consumer Product Safety Commission (CPSC) issued a massive recall of the popular Triaminic and Theraflu syrups, which are used for coughs, colds and fevers. Novartis Consumer Health, Inc. manufactures the drugs.

The recall covers 24 different products. The hazard presented is the failure of the child-resistant caps, which could lead to unintentional poisoning. More information, including specific lot numbers, can be found here.

Xyrem, a drug used to treat narcolepsy patients for muscle weakness and daytime sleepiness, can lead to unconsciousness, coma and even death when used in conjunction with alcohol or other depressant drugs warns the FDA. Specifically, the FDA warns that patients taking Xyrem should not drink alcohol or take insomnia drugs. Doing so can lead to breathing problems resulting in the loss of consciousness, coma or death. Also the following types of drugs should generally be avoided:

- opioid analgesics
- benzodiazepines
- sedating antidepressants or antipsychotics
- general anesthetics
- muscle relaxants

Other side effects of Xyrem, even at regular, recommended doses without the use of alcohol or other drugs, include depression, confusion and other neuropsychiatric events. More information is available here.

Transvaginal mesh, a medical product designed to help women with Pelvic Organ Prolapse or urinary incontinence. However, instead of helping women, TVM products have severly injured thousands of women, causing organ perforation, nerve damage, and even death.

In 2011, the FDA ordered the largest TVM manufacturer, Johnson & Johnson, to stop marketing its vaginal mesh product. However, records reveal that J&J continued to sell Gynecare Prolift, it's transvaginal mesh device, for at least another 9 months.

Unfortunately, the case is just one example of the FDA's inability to protect American's from faulty drugs and medical devices sold by powerful pharmaceutical and medical device corporations.

In April 2012, the U.S. Food and Drug Administration (FDA) approved safety labeling changes to packaging for Propecia, a very well-known drug taken by men for hair loss. The label now warns in the Adverse Reactions section that men taking Propecia have experienced numerous sexual dysfunction side effects, including erectile dysfunction, loss of sex drive, infertility and more.

Lawsuits have been filed, and I have begun accepting these cases. The problems we are seeing go beyond just the physical. Clinical depression associated with the physical problems are common. Moreover, the physical problems do not go away once the drug is discontinued.

Dangerous and defective drugs are responsible for many injuries and death nationwide. Our profession calls this area of law products liability. Consulting a lawyer experienced in handling these matters is usually easy. Most lawyers will provide a complimentary initial consultation to evaluate a claim or case and let the person know if they can help.

Here are some of the product recalls, news and warnings from this past week of note:

1. DuPont herbicide Imprelis. Imprelis causes the death of trees. DuPont pulled Imprelis and the Environmental Protection Agency banned it. A class action against Dupont has been filed and they expect the amount of the claims to potentially reach $575 million. More information can be found here.

2. Innovage Discovery Kids Animated Marine and Safari Lamps. Hazard is fire from electrical short-circuiting and sparking. More information here.

3. TBC Corporation Big Foot and Mirada tires. A manufacturing anomaly could cause a crack or separation in the lower sidewall. Brand names, lines and sizes can be found here.

4. Bedford Laboratories Leucovorin Calcium Injection. Hazard is the existence of particulate matter that can lead to adverse reactions including vein infection, tissue infarction, severe pulmonary issues, occlusion of capillaries and arteries, anaphylactic shock and death. Learn more here.

5. Buona Vita, Inc. frozen meat. Danger is potential Listeria contamination. Find more specifics, including brand names, description and case code numbers here.

6. Maquet Critical Care AB and MAQUET Medical Systems USA FLOW-i Anesthesia Systems. Danger is a software glitch and malfunction may prevent the device from switching to ventilation mode. More detailed information here.

7. Care Fusion 2200 Inc. Airlife Infant Breathing Circuit. Hazard is a spontaneous crack of the Y adapter, which could cause a leak in the ventilation system leading to a decrease in the tidal volume delivered. Adverse reactions include serious injury and death. Description, including lot numbers and manufacturing dates, found here.

Dangerous and defective products are responsible for many injuries and deaths nationwide. Our profession calls this area of law products liability. Consulting an attorney experienced in handling these matters is usually easy. Most lawyers will provide a complimentary initial consultation to evaluate a claim or case and let the person know if they can help.

This consumer protection information is provided by Louisville, Kentucky attorney Will Nefzger, a partner at Bahe Cook Cantley & Nefzger PLC.