The Science Board of the U.S. Food and Drug Administration (FDA), which oversees prescription drugs, issued a report highlighting the fact that the FDA has failed to do the job required of the agency in an adequate manner. Despite the fact that the world looks to the FDA as a leader in medicine and science, the FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability. As an unfortunate result, many dangerous prescription drugs and over-the-counter medications are approved for market each year, placing American lives at risk.
Engstrom, Lipscomb & Lack has successfully represented people who have been victims of dangerous drugs. Our pharmaceutical team of lawyers have successfully litigated individual and mass tort lawsuits against many of the largest drug manufacturing corporations in the world. In 2011, due to the hard work of Engstrom, Lipscomb & Lack and their partner attorneys across the nation, Merck agreed to settle tens of thousands of Vioxx cases for $4.85 billion. This was one of the largest pharmaceutical settlements in history, and it represents a major victory for our clients.
Risperdal and Invega are antipsychotic drugs. The active ingredient in Risperdal and Invega is risperidone. Risperidone affects levels of dopamine and serotonin, which are neurotransmitters that affect mood and behavior in the brain. Risperdal is used to treat schizophrenia and symptoms of bipolar disorder in adults. In children, Risperdal is also used to treat irritability associated with autism.
Risperdal and Invega are products of Johnson & Johnson’s subsidiary Janssen Pharmaceuticals, Inc. Risperdal and Riperdal M-Tab are brand names for the drug, both of which have the generic name risperidone.\n\nRisperdal and Invega have been linked to the development of gynecomastia in young males, a condition marked by the excess development of male breast tissue. According to risperidone lawsuits, as noted below, symptoms of male breast growth associated with Risperdal may include swollen breast tissue, tenderness in the breast, pain in the breast, and nipple discharge from one or both breasts.
Facts about Risperdal:
Risperdal was first approved by the U.S. Food & Drug Administration (FDA) in the United States in 1993, specifically for the short-term treatment of schizophrenia in adults. In 2003, the FDA approved Risperdal for the short-term treatment of adults with acute manic or mixed episodes associated with extreme mood swings. In 2006, the FDA approved Risperdal for the symptomatic treatment of irritability in autistic children and adolescents. Therefore, Risperdal was not approved for use in children until 2006.
Risperdal may also be used as a treatment for ADHD (Attention Deficit Hyperactivity Disorder); however, this is an off-label use that has not been approved by the FDA.\n\nIn 2006, the Journal of Clinical Psychopharmacology published a study finding that the use of risperidone in children was associated with excessive levels of the hormone prolactin, which can be tied to breast development and lactation. In 2009, the Journal of Child and Adolescent Psychopharmacology found that high levels of prolactin could persist for as many as two years while on risperidone.
Mirena is an intrauterine device manufactured by Bayer Healthcare Pharmaceuticals, Inc. This small, T-shaped device releases small amounts of a synthetic progestin hormone called levonorgestrel, a prescription medication used as a contraceptive. It is made of flexible plastic and inserted by a healthcare provider for the purpose of contraception. Mirena may be used for up to 5 years before it must be removed or replaced by a healthcare provider.
Facts about Mirena IUD:
The FDA (Food and Drug Administration) approved Mirena as an IUD and recommended for women who have had at least one child. In 2009, the FDA additionally approved Mirena for women with heavy menstrual bleeding. Today, more than 2 million women in the United States use Mirena.
Bayer has been given several warnings by government agencies, including DDMAC (Division of Drug Marketing, Advertising and Communications within the FDA) in December 2009 regarding the company’s advertisements that minimized the risks associated with Mirena.
Lawsuits alleging that after insertion, their Mirena perforated their uterus have been filed by hundreds of women. Once outside the uterus, serious internal complications, such as intestinal perforation or obstruction, can occur. The migration of the Mirena typically results in surgical removal.
Over 350 million patients worldwide suffer from Type 2 Diabetes Mellitus. Type 2 Diabetes is the most common form of diabetes and is the most frequent cause of blindness, amputations, and dialysis worldwide. It truly is one of the major health challenges of the 21st century. Incretins, including Januvia, Janumet, Byetta, Victoza, and others, were designed to prevent these diabetic complications. However, the use of Incretins has been associated with a significant risk of developing pancreatic cancer and thyroid cancer. If you or a loved one has used or is using an Incretin, read on for facts about these drugs and the litigation surrounding them.
Facts about Incretins:
Januvia, manufactured by Merck, was first approved by the FDA in 2006 to help diabetes patients improve glycemic control. In 2007, the FDA approved Merck’s successor to Januvia, Janumet. Since that time, Januvia has become the most successful drug to be launched since 2006. In 2012, global sales of Januvia reached $5.7 billion.
Byetta, manufactured by both Amylin Pharmaceuticals and Eli Lilly, was first approved by the FDA in 2005 to help prevent diabetic complications. Worldwide sales of Byetta are predicted to reach $1.00 billion by 2015.
In as early as February, 2010, publications noted concerns over a linkage between the use of Incretins and the development of pancreatic cancer. Researchers warned that individuals treated with Incretins could develop pancreatic cancer. In February, 2011, a journal article was published regarding the link between Incretins and the development of both pancreatic and thyroid cancers. This research was based off of FDA Adverse Event Reports and reported that the event rate for pancreatic cancer was 2.9-fold greater and for thyroid cancer was 4.73-fold greater in patients treated with Byetta compared to other therapies. Pancreatic cancer is an aggressive and deadly cancer, affording patients just a 1.8% chance of survival for longer than five years after the cancer spreads.
Lawsuits alleging that the Incretin manufacturers failed to adequately warn about the increased risks of developing both pancreatic cancer and thyroid cancer from using their drugs. In addition, the risks posed by these drugs severely outweigh any benefit received from ingesting them. Rather than responding to the serious risks posed by their products, the Incretin manufacturers continued to place Americans at risk of developing deadly cancers by putting profits over safety.
Vioxx has been linked to an increased risk in heart attacks and strokes. Vioxx has been prescribed to relieve the symptoms of osteoarthritis, rheumatoid arthritis, acute pain, painful menstrual cycles and more. After it was uncovered that Merck had failed to disclose the serious risks associated with Vioxx, it was pulled from the market. Unfortunately, Vioxx was taken off the shelves too late for thousands of innocent Americans.
Engstrom, Lipscomb & Lack represents dozens of injured individuals in Vioxx lawsuits in California and in the Federal Courts. Engstrom, Lipscomb & Lack was selected, based on its experience and expertise, to serve on the Plaintiffs' Liaison Committee for the California Coordinated Vioxx Litigation.
Due to the hard work of Engstrom, Lipscomb & Lack and their partner attorneys across the nation, Merck recently agreed to settle tens of thousands of Vioxx cases for $4.85 billion. This is one of the largest pharmaceutical settlements in history, and it represents a major victory for our clients.
Rezulin (generically called troglitazone) is a prescription medication created by Warner Lamberts Parke-Davis division. It is designed to treat Type-2 diabetes, that is, a condition typically found in adults where the body becomes resistant to its own insulin. Even before its public release in 1997, Rezulin was known to pose a serious health risk to its users, causing side effects ranging from mild liver damage to complete liver failure. Because of this, on March 22, 2000, the sale and distribution of Rezulin was voluntarily discontinued at the request of the federal Food and Drug Administration.
Rezulin had been designed to help diabetes patients respond better to insulin. While other sugar (glucose) lowering pills stimulate the pancreas into producing more insulin, Rezulin instead helped the body use its existing insulin more efficiently. As a result, blood glucose control could be improved in people taking Rezulin, while episodes of low blood glucose (hypoglycemia) levels could be reduced.
While there were benefits to the use of Rezulin, the FDA directly attributes numerous liver failure deaths and many additional cases of liver damage to the product.
Avandia is a popular prescription diabetes drug marketed by GlaxoSmithKline. Avandia has recently been associated with serious cardiovascular side-effects, including heart attacks. Although doctors and patients taking Avandia should have been warned of these risks, they were not. Also, Avandia has been aggressively marketed despite the fact that there are other safer, and cheaper, drugs which can be used to treat Type-2 diabetes with substantially longer safety records than Avandia.
Engstrom, Lipscomb & Lack currently represents individuals harmed by the use of Reglan (metoclopramide). Reglan (generically called metoclopramide) is prescription medication designed to treat patients suffering from vomiting and nausea due to various causes including chemotherapy. Reglan is also prescribed to treat heartburn due to gastroesophaphageal reflux disease (GERD). There are many generic manufacturers of Reglan. Use of Reglan is proven to cause movement disorders such as tardive dyskinesia and dystonia.
Currently, Engstrom, Lipscomb & Lack represents clients injured by the following products: Accutane; Byetta; Mirena IUD; Reglan; Rezulin; Yaz or Yasmin; DePuy Hip Replacement Products; Wright Medical Hip Replacement Products and Zimmer Hip Replacement Products.
If you have been injured because you used a dangerous medication or defective medical device, or have lost a loved one as a result of an unsafe medication, we may be able to help you recover fair compensation.