Active Cases
The Lyon Firm is asked to review many cases and can only accept very few. Each case requires the review of medical records, consultation with treating physicians, and independent expert review.
The review process can be expensive and time consuming. Before a case is accepted for formal review, The Lyon Firm may request the client to provide some basic medical records and pharmacy records, where applicable.
If you or a loved one has suffered an injury and feel it may be due to any of the cases below, use the contact form to the left to reach Mr. Lyon directly.
Seroquel
The FDA approved a new drug application for Zeneca Pharmaceuticals and Astra Zeneca (“Zeneca’) in 1997. The medical community recognizes Seroquel as an effective treatment for patients suffering from schizophrenia; however, the risks of diabetes and increased levels of blood sugar outweigh its benefit for the vast majority of patients receiving the medication.
Clinical studies have demonstrated a connection between Seroquel and increased blood sugar and diabetes. However, the company has been slow to adopt a proper warning to reflect the risk of diabetes. In January, 2004, the FDA asked manufactures of this class of drugs to add a warnings statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications. The warning mentions a possible connection but downplays the data indicating that background rates and precise adverse event data complicate any conclusion or causal evidence. As a result, the warning has not affected growth, and in 2006, Seroquel's (change to Seroquel )earned $3.4 billion in sales.
Indeed, the Japanese Seroquel label includes a more prominent warning, specifically stating that there is a link between diabetes and the use of Seroquel. The United States label, however, does not unequivocally reflect this known problem, which is misleading and deceptive to consumers and physicians.
“Off Label Marketing”
When the FDA approves a drug it also approves the label, which lists the indications, adverse events, warnings, and patients for which the drug can be prescribed. Once a drug is approved to treat one condition, it is within a physician’s judgment whether to prescribe it for others if they think it will be effective. This provision is geared to not restrict prescribing drugs where it is clear that the risk of not giving the drug outweighs the use. Off label uses should be rare because there is insufficient safety data to support the use outside the approved class. By law, drug companies are not allowed to influence physicians to prescribe a drug for indications other than those listed on the label.
In this case, the Federal Government, State Attorney Generals, Patient Advocacy Groups and Medical Associations have all taken steps to discover information and prosecute the company for engaging in illegal “off label” marketing and promotion. Specifically, it has been alleged that Zeneca actively encouraged physicians to prescribe the medication to patients, with non severe psychiatric conditions, and conditions unapproved by the FDA in order to expand the market for higher revenue. As a result, many patients were put at an unreasonable risk and suffered injuries that should have been avoided.
If you or a loved one have suffered complications due to the prescription of Seroquel, please contact The Lyon Firm for help. We are handling these cases on a co-counsel arrangement with the prominent Miller Firm in Virginia.
NuvaRing
The Lyon Firm is currently evaluating cases arising from the use of the NuvaRing contraceptive.
“Convenience Over Safety”
The NuvaRing is a new contraceptive product that is designed and marketed to relieve a woman of the “inconvenience” and “responsibility” of taking the “pill” on a daily basis. The NuvaRing is about two inches in diameter and inserted into the vagina once a month. The package insert and promotional material presented to patients and healthcare providers indicate that during the three week period following insertion, the product will release a low, steady and consistent dose of hormones that will prevent pregnancy.
Similar to the pill, the NuvaRing is a dual hormonal product, i.e., it contains estrogen and progestin, that when released will prevent the ovaries from developing mature eggs. The Lyon Firm is currently evaluating two significant issues related to the defective design and marketing of this product:
- whether the type of progestin used raises the risk of blood clots as compared to alternative methods of birth control;
- whether the product is able to safely deliver the hormones in a consistent manner over the course of three weeks.
The litigation surrounding the ortho evra patch has discovered the risks associated with the inconsistent delivery of the patch. The NuvaRing by design may be susceptible to the same inconsistent mechanisms of dose delivery and dose response, which are more easily controlled with the pill.
“NuvaRing Warning”
The warning currently states as follows:
IMPORTANT SAFETY INFORMATION
NuvaRing® does not protect against HIV infection and other sexually transmitted diseases. The use of combination oral contraceptives is associated with increased risks of several serious side effects, including blood clots, which may lead to stroke or heart attack. The risk of getting blood clots may be greater with the type of progestin in NuvaRing® than with some other progestins in certain low-dose birth control pills. It is unknown if the risk of blood clots is different with NuvaRing® use than with the use of certain birth control pills. Cigarette smoking increases the risk of serious cardiovascular side effects; women who use combination hormonal contraceptives are strongly advised not to smoke. For additional important information, please see NuvaRing® Prescribing Information.
NuvaRing Injuries and Side Effects
If you or a family member or friend have suffered blood clots, pulmonary emboli, heart attack or stroke, while using this product. We would be happy to discuss these issues and review your case.
Related Documents
Gadolimium (MRI/CT Contrast Dye)
Many patients who undergo common diagnostics procedures such as MRIs and CT scans are unknowingly exposed to a dangerous metal, gadolinium, which is present in the dye that is injected to improve the imagery.
For patients without compromised kidney function, the dye and metal are moved through the body within 24 hours and has no effect. However, for patients with kidneys which are compromised to any degree, the dye and metal can linger in the body and the metal can become lodged in the tissues and organs.
MRI Injuries and Side Effects
Exposure to gadolinium for high risk patients can lead to a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). Patients with NSF develop a thickening of the skin, connective tissues, and organs, which restricts their ability to move and properly function. At this time, NSF is only caused by expose to gadolinium, and there is no current cure.
FDA Requests Boxed Warning for MRI/CT Contrast Agents
In May, 2007, the FDA updated its previous warning from December 2006, and requested manufacturers to include a new black box warning of all gadolinium based constrast agents.
The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.
Manufacturers Identified for MRI Injuries
The five manufactures in the United States are :
- Magnevist (gadopentetate dimeglumine),
- Ominiscan (gadodiamide); OptiMARK (gadoversetamide);
- MultiHance;(gadobenate dimeglumine);and
- Prohance (gadoteridol).
Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK.
Diagnosing NSF
If you suspect that you have been exposed to gadolinium and have suffered the skin rash, thickening discussed above, please contact our office immediately. Our office is working diligently with other firms and reputable experts around the country to properly evaluate each case. In order to determine whether you have NSF, it is necessary to obtain a “punch biopsy”. Mr. Lyon will personally discuss these issues with you and work with you and your health care providers to have the biopsy reviewed by one of the country’s foremost experts on this disease. For more information see the attached documents.
Related Documents
- Letter To Doctor
- Healthcare Provider Letter
- FDA Information (link)
- Additional FDA Information (link)
Bard Kugel Hernia Mesh Patch
The Lyon Firm is actively representing patients who have undergone subsequent removal of failed Bard Kugel Mesh hernia patches.
FDA RECALL OF HERNIA PATCH
The Bard Composit Kugel Mesh Patch is used to repair ventral (incisional) hernias. The FDA, along with the cooperation of Davol , Inc, has issued several Class 1 recalls, which are the most serious recalls indicating serious risk of bodily harm. The reason for the recall is that the “memory recoil ring”, is prone to break and can cause bowel perforation, intestinal fistulae (abnormal connections with the intestines or other organs).
The recall was first initiated in December, 2005, but has been expanded, most recently in January, 2007. For more information, including the list of recalled products, see the attached FDA documents.
Related Documents & Links
- Bard Distribution Letter
- Bard Distribution Letter
- FDA Information (link)
- Additional FDA Information (link)
Trasylol (Aprotinin) Litigation
Many patients are unaware they have received this drug because it is administered during the course of coronary by-pass surgery.
The Lyon Firm is actively investigating and accepting cases related to the use of Trasylol (Aprotinin) during coronary by-pass surgeries.
Trasylol is manufactured by Bayer Ag and has been found to significantly increase a cardiac patient's chance of cardiac death, kidney damage, and stroke. Moreover, it is also be found that the cheaper alternatives are as effective and safer.
Plavix Litigation
The case against Plavix is centered on the misrepresentation that Plavix is more effective than Aspirin. This is simply not the case. Moreover, more than half of the patients on Plavix were prescribed the drug because physicians were under the impression that Plavix is safer on the stomach than aspirin.
We now know this is not the case. In January of 2005, the New England Journal of Medicine published data that demonstrated that patients on Plavix experience 13 times as many ulcers as those on Aspirin.
Adverse events associated with Plavix include hemorrhage (gastrointestinal, cerebral), gastrointestinal bleeding, stomach ulcers, stroke, myocardial infarction, and thrombotic thrombocytopenic purpura.
Depo Provera Litigation
The Lyon Firm is actively investigating and accepting cases related to the long term use of the Depo Provera shot.
The Depo Provera shot has been linked to irreversible osteoporosis following use of more than two years. For more information, please see the Practice Areas or contact us.
Toxic Lead Litigation
The Lyon Firm is actively investigating and accepting cases of lead poisoning in the Cincinnati area.
Recent government reports suggest that the Board of Health and other agencies are failing in their efforts to force landlords to remove toxic lead and bring buildings up to health code, which is resulting in exposing thousands of inner city children a year to toxic lead paint.
Exposure to lead paint is strongly linked to developmental disorders and early childhood brain injury.
Third Party Payer Claims
The Lyon Firm jointly with Firms Lopez McHugh, Cook Portune are investigating third party payer claims on behalf of labor and employment health funds. The third-party payor cases involve claims brought on behalf of labor and employment health plans against the manufactures of defective products that have driven up unnecessary health care costs that have burdened health plans and individual members.
