Dallas-Fort Worth Drug Litigation Attorneys

Drug manufacturers have a duty to consumers to take every precaution to ensure the safety of people who will use the drugs they develop and market. When a defective drug is administered to a large portion of the population, there is a strong potential for widespread harm. The Dallas law firm of Frenkel & Frenkel offers free consultations to people regarding individual claims or class action lawsuits against pharmaceutical manufacturers.

We have handled past pharmaceutical cases involving the following drugs (and manufacturers): Albuteral (Proventil HFA); Fen Phen [recalled: fenfluramine and dexfenfluramine (Wyeth); Zyprexa (Eli Lilly and Company); Vioxx [recalled: rofecoxib] (Merck & Co.).; PPA [Phenylpropanolamine] (many different manufacturers).

We are currently accepting cases for injury and damages involving the following drugs or prescription pharmaceuticals:

Zyprexa (Eli Lilly and Company)

Zyprexa litigation has been targeted at a number of Zyprexa side-effect problems: After weight gain some developed the Zyprexa side-effect of diabetes or glucose abnormalities. Patients who already had the Zyprexa side-effect of their diabetes growing worse while taking Zyprexa. Worse yet -- patients died from developing diabetes. These patients were never treated for diabetes and didn’t know they had diabetes. Patients under 54 years old, face the highest risk of developing the Zyprexa side-effect of diabetes or having heart attacks and comas when taking Zyprexa. Have you, a family member, or dear friend been diagnosed with diabetes, diabetic ketoacidosis, hyperglycemia, pancreatitis, or diabetic-induced heart attack or coma following the use of Zyprexa? You may want to consider Zyprexa litigation and may want to consult with a lawyer familiar with Zyprexa litigation.
In November 2001, the Journal of the American Medical Association, the FDA's Center for Drug Evaluation and Research, and a Duke University Medical Center physician first possibly linked between the Zyprexa side-effect of hyperglycemia in adolescents with the drug. FDA staff members published a report in the December 2001 American Journal of Medicine linking Zyprexa to diabetes. Both Zyprexa reports used information from the FDA's adverse drug reaction database. Most recently, the FDA has identified at least 384 reports of diabetes linked to Zyprexa, with the majority of cases appearing within six months of starting Zyprexa treatment. This has been a major focus in the Zyprexa litigation. The failure to give adequate warnings is one of the core allegations in the Zyprexa litigation. Researchers have also found preliminary evidence that linked the Zyprexa side-effect and pancreatitis, a dangerous inflammation of the pancreas. Studies looked at patients using four antipsychotic drugs and examined all the pancreatitis cases reported to the FDA or written up in medical journals between January 1981 and February 2002. Researchers found more instances of pancreatitis in Clozaril, Zyprexa, and Risperdal patients. Of the 192 Zyprexa side-effect cases, people using Zyprexa alone had 62 instances within the four antipsychotic drugs. The pancreatitis occurrences resulted in 22 deaths. A definitive link between Zyprexa side-effect and pancreatitis has not yet been established though the findings have raised concern.

Duragesic Patch (Johnson & Johnson)

The Duragesic patch made by Johnson & Johnson subsidiary Alza Corporation was, for many years, the only approved fentanyl patch. However, there are now numerous generic versions of the fentanyl patch, including Sandoz (manufactured by Alza), Mylan, Watson and Actavis. The patches all come in dosage strengths of 12.5, 25, 50, 75 and 100 mcg/hr. Each patch is designed to deliver a steady dose of fentanyl for 3 days. However, the amount of fentanyl contained within the patch can cause death if it is delivered in an uncontrolled manner such as occurs when the patch leaks or when the patch is defective in some other manner.

The FDA has received hundreds of reports of fatalities linked to fentanyl patch use. The cause of these deaths can be due to seal breaches allowing fentanyl gel to leak from the patch, known as the "fold-over defect," malfunction of the rate control membrane or other defects. The FDA is currently investigating these deaths.

In 2004, Alza Corporation and Janssen Pharmaceutica (the Johnson & Johnson subsidiaries which manufactured and marketed Duragesic®) recalled 5 lots of patches because of "fold-over defects" leading to leakage of the fentanyl gel contained within the patches. Upon investigation by the FDA, numerous other defects were discovered including what is called a "stringer leaker" defect. Based on information from the FDA, it is clear that many other lots, of all sizes, that were not recalled suffered from leak defects.

Manufacturers of fentanyl patches continue to produce defective patches. In fact, on February, 12th, 2008, Johnson & Johnson recalled approximately 32 million patches because of possible leak defects. The recall includes Duragesic and Sandoz brands. Then, on Monday, February 18, 2008, Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group HF announced that 14 lots of fentanyl transdermal system CII patches sold in the United States are being voluntarily recalled from wholesalers and pharmacies because of leak defects. In each of these recalls, the manufacturers warned that exposure to the gel contained in the patch could lead to serious injury or death.

In addition to reports of leaking patches, the FDA has investigated deaths and life-threatening side effects in patients who never should have been prescribed the patch. In December, 2007, reports of improper prescribing of the patch prompted the FDA to issue its second Public Health Advisory regarding fentanyl pain patches, which stated that "reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed."

Fosamax (Merck & Co.)

Fosamax, also known by the generic name Alendronat, is a prescription drug manufactured by Merck & Co. It received Food and Drug Administration (FDA) approval in 1995 and became a blockbuster drug with 2005 sales in excess of $3 Billion Dollars generated by more than 22 million recorded prescriptions. Fosomax is a type of drug known as a bisphosphonate, which is prescribed to increase bone mass and reduce the likelihood of bone fractures. It is primarily used for the treatment of osteoporosis, a condition resulting in the loss of bone density, and Paget's Disease, where a break down in bone tissue occurs with resulting abnormal bone reformation. It can be administered either orally or intravenously. Despite the length of time on the market, an article published in the Journal of Oral and Maxillofacial Surgeons in March of 2004 revealed that Fosomax side effects include Osteonecrosis or ONJ, an irreversible and painful condition where the jawbone fails to heal and dies.

Ambien (Sanofi-Aventis)

Ambien has the generic name of zolpidem tartrateand is marketed by Sanofi-Aventis. Doctors prescribe Ambien to patients suffering from insomnia, which is a common sleep disorder causing difficulty falling asleep or problems staying asleep throughout the night. Ambien belongs to a class of drugs known as central nervous system depressants, which are designed to slow down the nervous system of the patient. Due in some part to a large advertising campaign, Ambien has become the top selling prescription sleeping pill in the nation, with 26.5 million prescriptions filled in 2005 in the United States. According to some reports, the 2005 sales of Ambien were approximately $2.2 billion. The FDA gave its approval for Ambien in 1993. Ambien linked to Strange Behavior: Recent reports in the media have highlighted many cases of "sleep-driving" or driving while sleep walking, in which patients taking Ambien get into their cars and drive while asleep. Some of these sleep drivers have been involved in car accidents during these episodes of sleep driving. According to the New York Times, a number of labs that test blood samples of impaired drivers have reported that Ambien is among the top ten drugs found in the samples. A sleep disorder expert has said that sleep driving occurs in a "twilight" state between sleep and wakefulness. Many of these Ambien patients have no history of sleepwalking and claim to have no recollection of these incidents when they later awaken.

These and other drugs have been subject to recalls and safety warnings. Were you harmed by a drug named in a drug recall? Frenkel & Frenkel handles drug litigation including class action suits on behalf of people who have suffered harm because of a prescription medication or over-the-counter drug.

We engage in drug litigation versus drug manufacturers and vendors of defective drugs. Call or e-mail us to schedule a free initial consultation.