Tennessee Injury Lawyer Blog

The Food and Drug Administration regulates almost every aspect of prescription drugs in the United States, including manufacturing, labeling, and marketing. To obtain FDA approval for a drug, the manufacturer must demonstrate to the FDA that the drug is safe and effective for its intended use. If the company can demonstrate that the drug is safe for a particular use, the FDA will approve the drug to be advertised and promoted for that intended use. However, once a drug hits the market, it will often be discovered that the drug can be used in ways not contemplated by the manufacturer or submitted to the FDA for approval. Such use is called “off-label” use and accounts for approximately twenty percent of all drug prescriptions in the United States. Off-label use of drugs is not illegal in the U.S., but drug makers are not supposed to advertise off-label uses or attempt to persuade physicians to prescribe their drugs for such uses, as it can be a crime.

Allergen, Inc., the maker of Botox and its sister drug Botox Cosmetic, recently filed a lawsuit against the United States seeking to enjoin the government from preventing drug companies from providing information on off-label uses to the medical community. Allergen contends that it is protected by the First Amendment of the United States Constitution from being prevented from disseminating truthful information to the medical community about effective uses of its drugs, even if they are considered off-label uses. Botox is FDA approved to treat certain types of spasms involving the eye but has other medically accepted, but non-approved, uses such as relieving certain types of spasticity in adults and children. Botox contends that since such “off-label” uses are legal, they should be able to work with the medical community in evaluating the risks and benefits of off-label uses.

Continue reading "Off-Label Advertising Ban Sparks Lawsuit" »

Earlier this year, the pharmaceutical industry suffered a crushing defeat at the hands of the Federal Supreme Court. In a 6-3 decision, the Supreme Court upheld a Vermont court’s decision awarding 6.7 million in damages to Ms. Levine for the defendant pharmaceutical company’s (Wyeth’s) failure to provide sufficient warnings for its promethazine hydrochloride injections. The narrow issue for the court to decide was whether federal drug labeling laws “preempt” or prevent an injured plaintiff from suing a drug firm in state court. The court held that it does not.

In Wyeth v. Levine, a Vermont court found the pharmaceutical giant, Wyeth, responsible for the loss of Ms. Levine’s arm caused by an intravenous injection of Phenergan using the IV-drip method. Phenergan is the brand name for promethazine hydrochloride, which is an antihistamine often used to treat nausea. It can be administered either intramuscularly or intravenously using either the IV-push or IV-drip method.

Apparently, the IV-drip method presents a danger of gangrene because Phenergan is corrosive to arterial walls, and the IV-drip method presents greater risk of accidental arterial injection. This is what happened to Ms. Levine.

Counsel for Ms. Levine argued that Phenergen’s labeling lacked sufficient warnings and, due to the lack of sufficient warning, the clinician administering the drug wasn’t aware of the risks of using the IV-push. In fact, nothing in the labeling contained any specific warning connecting the IV-push method with the increased risk of gangrene to extremities. As such, Wyeth should have contraindicated intravenous use even though the FDA had not required the drug maker to indicate as such.

Continue reading "Promethazine Hydrochloride Injection" »

In our ongoing efforts to keep you informed about the risks associated with prescription and over-the-counter medications and dietary supplements, the Knoxville personal injury attorneys at Baker Associates today wish to provide you with information regarding a recent FDA warning. On June 4, 2009, the FDA warned health care professionals about the risk of serious liver injury associated with Propylthiouracil treatment.

Propylthiouracil is an anti-thyroid medication administered for the treatment of Graves' disease. Graves' disease is an autoimmune disorder that leads to over activity of the thyroid gland. The thyroid gland is located in the front of the neck just below the Adam’s Apple. It releases hormones that regulate the rate of the body’s metabolism and is critical for body temperature control, energy, weight, mood, and blood calcium levels.

The FDA issued the warning after analyzing adverse event reports, which showed that a number of individuals with Grave’s disease had sustained serious liver injury while taking the Propylthiouracil treatment.

A standard of care for physicians administering Propylthiouracil therapy seems to be developing. According to Amy Egan, M.D., "health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If Propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy." Failure to follow this standard of care, could give rise to a cause of action for medical malpractice in Tennessee if it is also the standard of care adopted by Tennessee’s medical community.

According to medicinenet.com, patients with serious liver disease develop symptoms that include:

• fatigue,


• weakness,


• vague abdominal pain,


• loss of appetite,


• yellowing of the skin (jaundice)


• itching, and


• easy bruising.

You should consult a physician immediately if you are experiencing any of the above-listed symptoms. If upon diagnosis you learn that you have sustained a serious liver injury, you may be able to recover money damages for your medical bills, loss of income, and pain and suffering. For an experienced medical malpractice attorney in Knoxville, call Baker Associates at 866-853-2888.

Last month, we reported that certain manufacturers of over 70 dietary supplements had committed health fraud against consumers by slipping undeclared, active pharmaceutical ingredients into defective products in Tennessee marketed as “dietary supplements.” A listing of the tainted supplements along with the chemicals and associated health risks are still available at the FDA’s website.

If you’re wondering how these dietary supplements have entered the market without detection of unapproved pharmaceuticals and steroids, here’s a brief synopsis. After intense lobbying by the manufacturers of dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under the DSHEA, the FDA regulates dietary supplements as foods—not as drugs. Consequently, dietary supplements, like food, do not require pre-approval by the FDA prior to entering the market.

Yet again, the regulatory gap created by DSHEA has exposed consumers to unapproved substances with risk of personal injury. On May 11, the U.S. District Court for the Eastern District of Michigan entered a consent decree condemning for destruction about $1.3 million worth of dietary supplements because the products do not contain the adequate information necessary to assure consumers that the supplements are not harmful.

The products are distributed by LG Sciences LLC, of Brighton, Michigan and were marketed for use by body builders. They were distributed on the Internet and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.” The products contain unapproved steroids that inhibit the activity of the enzyme aromatase. It is not yet known what adverse health effects are associated with the steroids found in these dietary supplements.

Obviously, the de-regulation of the food-supplement industry has proven a disaster—both for the FDA and for consumers across the United States. Widespread public concern, in fact, has resulted in the FDA issuing a final rule, effective 2010, that will change the way food supplement manufacturers do business in the United States.

Until then, we should continue to hold negligent dietary supplement manufacturers and their distributors accountable when personal injuries result. If you have experienced adverse health consequences and believe that they may have been caused by the ingestion of dietary supplements, please contact the knowledgeable and experienced food and drug Knoxville products liability attorneys at Baker Associates today.

The FDA has issued a warning to consumers to immediately stop using Hydroxycut products because they have been associated with liver damage requiring liver transplant. One death has been reported.

Hydroxycut products are dietary supplements marketed for weight-loss and energy enhancement. They are made by Iovate Health Sciences Inc., of Oakville, Ontario, and distributed by Iovate Health Sciences USA Inc. of Blasdell, New York. They are marketed under the brand names Iovate and MuscleTech.

Defective products in Tennessee recalled under the FDA warning include:
• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)

Symptoms of liver injury associated with the use of Hydroxycut products include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

You should consult a medical doctor if you have taken a Hydroxycut product and experienced any of the symptoms described above. If you are diagnosed with liver damage, call 866-853-2888 to speak with an experienced Knoxville personal injury attorney at Baker Associates.

Product Liability Update: Unlawful Distribution of Pain Narcotics and Defective BioGlide Shunts Expose Tennesseans to Risks of Serious Personal Injury

The following nine companies have manufactured and distributed unapproved prescription pain narcotics containing morphine sulfate, hydromorphone, and oxycodone, thus posing severe concern for product liability in Tennessee.

• Boehringer Ingelheim Roxane, Inc., Columbus, Ohio
• Cody Laboratories, Inc., Cody, Wyoming
• Glenmark Pharmaceuticals Inc., Mahwah, N.J.
• Lannett Company, Inc., Philadelphia
• Lehigh Valley Technologies, Inc., Allentown, Pa.
• Mallinckrodt Inc. Pharmaceuticals Group, St. Louis
• Physicians Total Care Inc., Tulsa, Okla.
• Roxane Laboratories Inc., Columbus, Ohio
• Xanodyne Pharmaceuticals Inc., Newport, Ky.

By law, narcotics must be subjected to the FDA’s safety and effectiveness standards before going to market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality. Consequently, the above-listed companies have acted unlawfully and exposed people to risks of serious personal injury in Tennessee.

Another product creating potential Tennessee personal injury liability is the BioGlide Ventricular Snap Shunt Catheter (shunt) manufactured by Medtronic, Inc. The shunt has recently been bumped up to Class I status, which means there is a reasonable probability that the use of the shunt will cause serious adverse health consequences or death.

The BioGlide shunt is a component of a ventricular catheter used for the treatment of hydrocephalus (build up of fluid around the brain). This shunt has been found defective and potentially compromises the ventricular catheter.

Consequences for a patient with failure of a ventricular catheter may include: nausea, vomiting, headache, lethargy, change in mental status, seizures, visual disturbance, and other more serious conditions. Patients who have a ventricular catheter and have experienced any of these symptoms should call their physician.

If you or a loved one has experienced serious personal injury as a result of any of the products described in this update of Tennessee product liability, call the top personal injury attorneys at Baker Associates at 866-853-2888 for a free consultation.

Certain manufacturers of over 70 dietary supplements have committed health fraud against Tennessee consumers by slipping undeclared, active pharmaceutical ingredients into products marketed as “dietary supplements.” The reason these manufacturers have been able to do this is because the FDA does not require approval of dietary supplements prior to marketing.

These tainted weight loss products pose grave risks of personal injury in Tennessee and even death to consumers because there are no warnings or chemical listings on these products. In some cases, the products contain prescription drugs in amounts that greatly exceed the maximum recommended dosages.

A listing of these tainted dietary supplements along with the chemicals and associated health risks are available on the FDA website.

Some notable health risks are:
• Toxic reactions with other drugs
• Fecal incontinence, rectal discharge, and defecation urgency
• Skin and subcutaneous tissue disorders
• Development of gallstones and kidney stones
• Arrhythmia
• Changes in mental status, including suicidal thoughts and aggressive tendencies
• Nausea, diarrhea, headache, insomnia and anxiety
• Dehydration
• Seizures
• Kidney damage
• Coma
• Death

Manufacturers and sellers of these “dietary supplements” may be held responsible for Tennessee personal injury and Tennessee wrongful death, even if there is a product recall or the danger was unknown. In many cases, the failure to foresee potential risks or dangers posed by a product is enough to create liability for both the seller and manufacturer.

Don't make the false assumption that your injury was caused by bad luck. If you feel you have been injured by ingesting tainted dietary supplements, contact the skilled and experienced product liability attorneys in Tennessee at Baker Associates for a free consultation.