Lawsuit funding is NO LONGER AVAILABLE on Lipitor
While it is difficult for plaintiffs of the lawsuits to prove that the drug actually caused the development of type-2 diabetes, studies have shown that there really is a link between the drug and the increased risk of triggering type-2 diabetes. These studies may be used to support the claims of the individuals who filed these lawsuits. Studies also show that women taking the drug have an increased risk of heart attacks as compared to those who do not.
Lipitor has severe side effects that can cause serious diseases. One of the most common lawsuits filed were due to the fact that patients who took the drug developed type-2 diabetes. This matter is not taken lightly as diabetes is one of many diseases that cannot be fully treated. Patients suffering from diabetes have to go through maintenance treatments and drugs, as well as maintenance tests for blood sugar levels for the rest of their lives. In a span of five months, lawsuits have shot up to more than a thousand from just 56. A multidistrict litigation is set for trial in July to be held in South Carolina. The drug manufacturer claims to have no liability and plans to fight all lawsuits and litigations, unlike most drug lawsuits wherein the drug manufacturers opt to settle with plaintiffs instead of going through a trial.
Lipitor Lawsuits and Litigation
Pfizer had failed to inform consumers of the drug’s association with high blood sugar and elevated risk for diabetes. It was only in February of 2012 when the company informed the market of these risks, in spite of its approval in 1996. Pfizer agreed to update the labeling of Lipitor almost six months prior to February 2012 at the request of the FDA’s Division on Metabolism and Endocrinology products.
Numerous patients who used Lipitor and developed typed 2 diabetes filed lawsuits against the pharmaceutical company. The claims allege that the development of type-2 diabetes was caused by the drug and that Pfizer knew about these side effects or should have further investigated the risk of diabetes before marketing the drug. The individuals that filed these lawsuits claim that the company neglected to properly inform and warn patients and doctors alike about the health threats of Lipitor.
It was in April 2013 when three plaintiffs filed lawsuits against Pfizer regarding Lipitor; they had petitioned the U.S. Judicial Panel on Multidistrict Litigation to transfer all ongoing and future lawsuits regarding diabetes claims to a sole court in the District of South Carolina for a more efficient process. Even though the panel agreed to consolidate the lawsuits in South Carolina on February 2014, Pfizer attempted to oppose the motion to consolidate said lawsuits into a multidistrict litigation. The company claimed that consolidating these lawsuits would surface even more lawsuits that would have not been filed in the first place. The MDL will be presided over by Honorable Judge Richard M. Gergel.
Of the various lawsuits Pfizer has faced due to Lipitor, the most common claims are ignored risks, engagement in negligent conducts, failed to monitor, misled consumers through marketing campaigns, and inadequate labeling. These claims are due to the fact that the company marketed Lipitor as safe and effective even when it was not; the company had the responsibility to know about the risks of high blood sugar and diabetes and failed to disclose these before marketing the product. Pfizer also ignored to screen Lipitor safety issues as well as negligent presentation conduct in terms of marketing or packaging of the product, including mislabeling. Aggressive and misleading marketing is also one of the claims – without informing patients or doctors about injury prevention.
As of August 2014, lawsuits of U.S. women who claim to have gotten type-2 diabetes from the use of Lipitor have significantly increased from 56 to almost 1,000 within five months. Lawsuits were filed shortly after the FDA warning of 2012 regarding Lipitor and other statins being associated with memory loss and increased liability for diabetes. Pfizer, in a public statement, said that it denies liability and will fight the lawsuits against them, unlike most lawsuits wherein pharmaceutical companies opt to make settlements with plaintiffs. The MDL, on the other hand, will begin this coming July.
What is Lipitor?
Lipitor, with generic name atorvastatin, is manufactured by Pfizer and is used to regulate high cholesterol levels. Lipitor is designed to prevent blockages in blood flow by reducing triglycerides in the blood stream and bad cholesterol, particularly, low-density lipoprotein. It also increases the levels of high-density lipoprotein or good cholesterol. This lowers the risk of heart attacks, other heart complications in people with type-2 diabetes, coronary heart disease and strokes in patients taking the drug. Lipitor is a kind of HMG CoA reductase inhibitor or more commonly called as a statin.
Statins are the most prescribed class of drugs in the United States. Lipitor is the most popular of all statins in the market and was approved by the FDA in December 1996, racking up more than $130 billion in global sales since it was launched. Although the drug has attained the title of the world’s top selling prescription drug of all time, severe side effects like type-2 diabetes have surfaced post-marketing of the product. It has been proven that Lipitor substantially reduces potentially life-threatening risks related with cardiovascular diseases.
The researchers from the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) studied the ability of Lipitor to prevent heart disease in over 10,000 patients who are at risk. Results from the clinical trial showed that the drug reduced the risk of fatal or non-fatal cardiac occurrences by 36% as compared to patients who took placebos.
Lipitor has also shown to be successful as a preventative treatment option for patients with type-2 diabetes as well as risk factors for heart disease and stroke, particularly hypertension, history of smoking, retinopathy and albuminuria with the latter two raising serious concerns as they are diabetes-related diseases. Lipitor can help reduce the risk of heart attack, stroke and chest pain for patients recognized to have coronary heart disease. It can also lower the threat of heart failure surgeries and hospitalization from congestive heart failure in patients with the same diagnosis.
Lipitor is prescribed to adults and children with at least ten years of age.
Lipitor Symptoms and Side Effects
The main side effects of Lipitor and other statins include an increased risk of type-2 diabetes, Muscle Disease, Liver Complications, and Kidney Complications. Because many of the severe side effects are linked to occur with all statins, it has been deduced that the drug class as a whole have grave safety issues. Several clinical studies are being administered to determine the link of Lipitor and other statins with the increased risk for the aforementioned side effects.
Symptoms linked to Lipitor liver injury include fatigue, loss of appetite, pain in the upper right abdomen, dark urine and yellowing of the skin or eyes. Liver complications associated with Lipitor can range between Jaundice, to Hepatitis, to Cirrhosis, to fatty changes in the liver. The FDA advises doctors to accomplish liver enzyme tests before prescribing any kind of statin treatment to patients so as to figure out if the patient can tolerate the drug.
After almost 20 years after the FDA approval of Lipitor, data first surfaced regarding diabetes risk from statins. The data was collected from 91,000 patients that were treated with a statin or a placebo. Results from the data showed that 0.4% of statin users developed diabetes. However, the percentage was later found to be erroneous. More studies showed that statins prescribed in higher dosages, like Lipitor, Zocor and Crestor pose higher risk for diabetes.
Another research revealed that the drug class is associated with a 10 to 22% increased threat for type-2 diabetes. This occurred in almost 500,000 patients. Lipitor and Crestor had the highest diabetes risk with a figure of 22% and 18% respectively. More studies point to a higher diabetes risk in the elderly, in women, and in Asians.
Women have lower risk for heart attacks than men; however, women who take statins show an abrupt incline in the risks. Benefits of Lipitor and other statins still surpass the potential health liabilities for women at great risk of heart disease, as confirmed by medical experts. Nevertheless, researchers still cannot fully determine if the benefits of the drug class make up for the diabetes risk in women taking statins who have not been previously diagnosed with heart disease.
Lipitor also carries a number of side effects that were reported in clinical trials and by patients. These side effects involve abdominal discomfort, blurred vision, cognitive impairment, confusion, musculoskeletal pain, memory loss, hyperglycemia, tinnitus, fever, malaise and even hepatitis.
Patients who now suffer from diabetes due to the use of Lipitor consistently have to go through maintenance treatments and testing for blood sugar levels, comply with stringent diets, and take lifetime maintenance medication. They are also at high liability for kidney disease, blindness, heart disease and other diabetes-related complications.
FDA Warnings, Recalls and Reports
In the FDA consumer update of February 2012, said institution relayed information regarding new found complications linked to use of Lipitor. These complications include increased risk for hyperglycemia or high blood sugar and can trigger type-2 diabetes.
Also in February of 2012, the FDA issued additional warnings and precautions in their Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research. These include rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria, endocrine function – specifically affecting adrenal or gonadal steroid production, and anomalies of liver function.
The Archives of Internal Medicine had published outcomes of a 2012 study that Lipitor, among other statins, have considerably increased risk of diabetes in post-menopausal women. This study was drawn from 12 years’ worth of clinical data which included more than 150,000 women aged within the range of 50 to 79. The researchers concluded that elderly women taking statin are confronted with a 48% increased risk for diabetes as compared to those who did not take statin.
The FDA had issued a warning letter to Pfizer regarding Lipitor. The warning letter stated that the pharmaceutical company had published journal advertisements for the public with false or misleading information, thereby violating the Federal Food, Drug and Cosmetic Act and its regulations. These journal advertisements imply the use of Lipitor for unapproved uses. As explained in the letter, the advertisements suggest that Lipitor can diminish the risk of developing coronary heart disease; however, no studies have been recognized with regard to the effectivity of Lipitor on cardiovascular morbidity and mortality. Therefore, Pfizer has been deemed to use false information for marketing purposes. Important information was strategically downplayed in the advertisements.
The same journal advertisements also neglect to show information about the risks correlated to Lipitor use. Risks were underemphasized while alleged efficacies were overemphasized. Information in the ads were manipulated in such a way that it would highlight benefits and minimize attention on risks through the use of copywriting, layouts and other editing techniques.
The British Medical Journal published a 2013 clinical study regarding Canadian researchers’ diabetes risk comparison of five popular statins and Prayachol, which is a statin that substantially lowers the probability of diabetes development, in a prior study.
The FDA, in Patient Safety News: Show # 17 in July of 2003, notified healthcare providers about counterfeit Lipitor being recalled in numerous lots, which was purchased by Albers Medical Distributors, Inc. “Repackaged by: MED-PRO, INC., Lexington, NE 68850” can be seen on the label to help consumers identify if the drug they attained was counterfeit or not. Hence, the FDA had issued warnings to meticulously check the packaging before taking the drug. Patients who have managed to get a hold of the counterfeits are advised not to take it and return it to their respective pharmacies. It was in June 2012 when three bottles of Lipitor were also recalled for complaints regarding an uncharacteristic odor due to chemical contamination.