Drug Side Effects
The Department of Environmental Protection has fined the Mount Nittany Medical Center $17,500 for violating state radiation protection regulations that are designed and enforced to protect the public’s health and safety. “These state regulations are in place to ensure that medical facilities follow proper procedures and take the appropriate steps to safeguard its employees and members of the public it serves,” said DEP Southcentral Regional Director Rusty Diamond.
Diamond said the violations occurred during a 12-month period and included radiation therapists inadvertently delivering a dose of radiation to the wrong patient and, on two occasions, to incorrect parts of patients’ bodies. Contract employees performing work on the roof of the center may also have been exposed to radiation levels greater than public dose limits.
The medical center, located in State College, paid its fines earlier this month and has taken corrective action. The center is in the process of hiring an additional management position to provide more oversight of the radiation therapists in the oncology department. DEP will continue to monitor the corrective actions and will increase the frequency of inspections to ensure no further radiological health and safety. If you believe that you were inadvertently delivered a dose of radiation, or delivered radiation to the wrong part of your body, or improperly exposed to doses of radiation, contact the Levensten Law Firm to protect your rights.
Discovery is proceeding at a brisk pace in the Gadolinium Based Contrast Agent (GBCA) federal litigation. Plaintiffs have served 104 interrogatories and 104 document request on GE Healthcare. To date, GE Healthcare has produced two million pages of documents and will produce at least another additional million pages by October. GE has produced the entire global adverse event database, which is every adverse event for the product, NSF or other adverse events, reported to the company since it’s been on the market. GE Healthcare has also produced 13 foreign custodial files. The custodial files comprise 13 witnesses or employees of GE Healthcare who are located in the UK or in another way, including the scientists involved in the development of the product. GE also produced all of their science-based documents, from the development of the drug back in the late 80’s and early 90’s to the clinical and preclinical trials and studies to date. All of the safety and efficacy studies that have been done are being produced to the Plaintiffs. Additionally, GE is producing the entire FDA regulatory file, which includes foreign matters the company is obligated to produce to the FDA. Plaintiffs have hundreds of thousands of pages of documents that relate to foreign issues of science-based regulatory labeling.
A lot of Nephrogenic Systemic Fibrosis (NSF) cases were first reported out of Denmark, and the Danish authorities asked GE and other companies to do an analysis of NSF cases in their databases. Plaintiffs are attempting to secure these analyses and reports. In Europe, experts write reports to submit to various agencies about the risks and benefits of a drug. For example, if GE sends a chemistry review about the stability of a scan, and the German authorities review it and say there is a problem with stability; this is something that plaintiffs are attempting to obtain because it is useful in our cases. Additionally, we know in some countries, they limited the ability of GBCAs to be marketed to renally-impaired patients. Plaintiffs are attempting to obtain the documents relating to the reasons for limited access of GBCAs in foreign countries.
Plaintiffs can establish that it has been well known and acknowledged by GE scientists since the late 1980s that these drugs had the ability to break down in the body and that the consequence of that is that you have free Gadolinium lodged in the tissues of people. The internal documents that we are receiving from the GBCA manufacturers will establish what the defendants knew about this fatal condition caused by their products and when they knew it.
Finally, plaintiffs are permitted to begin deposition one person per week starting September 15th. Plaintiffs contemplate deposing up to 65 GE employees. All of this work is building towards trials beginning in the Spring of 2009.
On July 8, 2008, the Court held its monthly Gadolinium Based Contrast Agents (GBCA) status conference with the gadolinium lawyers who represent Nephrogenic Systemic Fibrosis victims. Most significantly, Judge Polster shared his views on the scheduling of the test cases to go to trial.
Judge Polster set a deadline of August 29, 2008 for the domestic General Electric (Omniscan MRI Contrast) and Bayer (Magnevist MRI Contrast) entities to produce their documents to plaintiffs. The foreign General Electric and Bayer entities must produce their documents by October 15, 2008. Mallinckrodt (Optimark MRI Contrast) must produce its documents by September 30, 2008. Judge Polster believes that these deadlines will enable the gadolinium lawsuits to move quickly.
Judge Polster would like the defendants and plaintiffs to each propose 10 test cases by Friday, November 14, 2008. The Judge will allow five months for fact discovery and general expert discovery in the cases selected. By April 13, 2009, the plaintiffs and defendants are to each pick five of the other side’s cases, meet and confer, and agree on the first four cases to be tried. If the plaintiffs are living in the cases that are selected, the Court would like the ones who have experienced the greatest progression of nephrogenic systemic fibrosis to be tried first. The gadolinium trials will be scheduled after the selection process is completed in April, 2009.
The Court stressed its main objective is to keep the cases moving forward. Lastly, the Court advised that it is always available to assist in mediations of gadolinium settlements when and if the parties are ready.
Our firm is heavily involved in Gadolinium litigation throughout the entire United States. If you or a loved one have been injured by a Gadolinium Based Contrast Agent, you should contact me immediately. You may be entitled to compensation for your injuries.
Do I Have a Gadolinium Based Contrast Agent or Nephrogenic Systemic Fibrosis Lawsuit?
Please use the form below to contact The Levensten Law Firm, P.C. for a free confidential case evaluation regarding your Gadolinium Based Contrast Agent or Nephrogenic Systemic Fibrosis lawsuit. You may also call toll free 24 hrs/day (866) 879-3040.
On November 5, 2007, The U.S. Food and Drug Administration (FDA) announced that, at the FDA’s request, Bayer Pharmaceuticals Corporation agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending a detailed review of results from a Canadian study that suggested an increased risk for death.
If you or a loved one have suffered an adverse event related to Trasylol, you should contact us immediately. You have rights and may be entitled to compensation for your injuries. Please click here to contact us for a free confidential case evaluation
Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals, the manufacturer of Trasylol (aprotinin), notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Future supplies of Trasylol are only available through the company as an investigational drug under a special treatment protocol.
The Trasylol lawyers at the Levensten Law Firm have filed several Complaints in Philadelphia County alleging wrongful death and other personal injuries. The common pattern we see in our cases involves patients undergoing bypass surgery and subsequently developing kidney failure, which leads to complete organ failure and death.
Close to forty (40) Trasylol personal injury cases and Trasylol wrongful death cases have been filed in Philadelphia County. On June 25, 2008, the Court convened the first status conference for all Trasylol lawyers handling Trasylol personal injury cases in Philadelphia County. It was confirmed at the conference that the cases will proceed in a uniform manner. The Court took under consideration Case Management Order No. 1 for Trasylol Personal Injury Cases, which governs, among other things, pleading issues (Master Complaints, Short Form Complaints, and Answers to Complaints), Service of Process, and Discovery of Plaintiffs and Defendants (Interrogatories, Request for Production of Documents, Fact Sheets and Expert Discovery). The Court was mindful of the federal court Trasylol litigation, which is discussed below, and it is anticipated that the federal and state Trasylol litigation will proceed at a similar pace.
There is also consolidated federal Trasylol litigation. Judge Donald Middlebrooks, judge for the United States District Court for the Southern District of Florida oversees the Trasylol Multi District Litigation (MDL). He served as General Counsel to the Governor of Florida from 1974 – 1977, and in 1997 was appointed by President Bill Clinton to serve as a United States District Judge. As schedule was set up in the Trasylol MDL, which anticipates most discovery being completed by February 27, 2009, generic experts being disclosed in March of 2009, and all discovery being completed by July 2009. It is contemplated that federal Trasylol trials will take place in early 2010.
Do I Have a Trasylol Lawsuit?
Our law firm is handling Trasylol lawsuits in all 50 states. If you or a loved one have suffered an adverse event related to Trasylol, you should contact us immediately by using the form below. You have rights and may be entitled to compensation for your injuries.
Since December 2006, FDA has continued to investigate reports of NSF in patients who received GBCAs. In addition, the FDA requested the manufacturers of all five GBCAs (Magnevist, MultiHance, Omniscan, OptiMARK and ProHance) to add a new boxed warning and a new Warnings section to their labels to describe the risk of developing NSF.
If you or a loved one have been diagnosed with Nephrogenic Systemic Fibrosis and you have recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your injuries. Please click here to contact us for a free confidential case evaluation.
Since December 2006, FDA has continued to investigate reports of NSF in patients who received GBCAs. In addition, the FDA requested the manufacturers of all five GBCAs (Magnevist, MultiHance, Omniscan, OptiMARK and ProHance) to add a new boxed warning and a new Warnings section to their labels to describe the risk of developing NSF.
Gadolinium is a paramagnetic metal ion. Paramagnetic ions, such as gadolinium, move differently within a magnetic field. This trait makes gadolinium useful for magnetic resonance imaging (MRI).
GBCAs are manufactured by a chelating process, a procedure in which large organic molecules form a stable complex around the gadolinium. The chelate reduces the chances of toxicity that could result from exposure to gadolinium. This stable complex is eliminated predominantly via the kidneys.
GBCAs are approved by FDA for use with MRI as a contrast agent to provide an improved image of body organs and tissues.
GBCAs are also used for magnetic resonance angiography (MRA), an imaging procedure used to evaluate blood vessels. FDA has not approved GBCAs for use in MRA.
MRA is a special type of MRI used to study blood vessels. MRA aids the detection of heart disorders, stroke, and vascular diseases.
An MRI or MRA can be performed without contrast. MRI with GBCAs provides additional diagnostic information as compared to MRI without contrast. Although GBCAs are not FDA-approved for MRA, some radiologists believe that these agents help provide detailed images of blood vessels. There are no FDA approved MRA contrast agents.
Patients with acute or chronic renal kidney insufficiency, or renal dysfunction due to hepato-renal syndrome or in the perioperative liver transplantation period, are at an increased risk for developing NSF when administered GBCAs. Many studies and publications support the association between NSF and GBCAs. Researchers have found gadolinium in the tissue of patients with NSF. Accumulating data indicate that GBCAs increase the risk for the development of NSF among patients with severe renal insufficiency or renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplant period.
NSF was first described in the medical literature in 2000. The first case of NSF was purportedly identified in 1997. NSF is reported only in patients with kidney disease. NSF causes fibrosis of the skin and connective tissues throughout the body. Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility in joints. NSF usually starts in the lower extremities. Fibrosis can also develop in the diaphragm, muscles in the thigh and lower abdomen, and lung vessels. Over time, NSF becomes worse and can cause death.
There is no known treatment for NSF.
The reports FDA has received, the published report of gadolinium deposits in the skin of patients with NSF/NFD, and other published reports suggest that GBCAs play a role in the development of NSF in patients with acute or chronic severe kidney insufficiency or kidney dysfunction due to the hepato-renal syndrome in the perioperative liver transplantation period.
FDA has requested that the manufacturers of the 5 GBCAs include a new Boxed Warning and new Warnings section in the labels that describe the risks of developing NSF. Additionally, FDA has requested that all manufacturers prospectively collect data on patients with varying degrees of renal insufficiency who are exposed to GBCA to more accurately estimate the magnitude of the risk for NSF for patients with kidney disease.
If you have severe renal insufficiency (severe kidney disease) and a physician has requested an MRI or MRA study with a contrast agent, ask if the use of the contrast agent is essential. There are situations where an acceptable study can be obtained without the use of contrast.
NSF litigation at a national level is quickly maturing. Unique procedures apply to cases like this where multiple people from around the country suffer injuries from the same source, such as a pharmaceutical drug, medical device, Ford Explorer rollovers…etc. These cases are called “mass torts.”
Generally, as happened in this litigation, cases start by being filed in various federal courts around the country. Appropriate forums could be your hometown federal court, New York federal court as gadolinium manufacturer General Electric is located there, Pennsylvania in some instances because gadolinium manufacturer Bayer is located there, and other courts.
After a handful of cases are filed, the lawyers file a motion before the Judicial Panel of Multidistrict Litigation (a group of federal judges referred to as the J.P.M.L.) to have all federal cases consolidated on one Court’s docket, assigned to one judge for pre-trial proceedings. The pre-trial proceedings that occur on the docket include obtaining all of the defendant’s corporate documents, taking the depositions of the heads of their key departments, such as regulatory matters, marketing, pre-clinical and clinical testing, and adverse event surveillance. This is also the time when we give the defendants the critical information about your case.
The JPML met on January 31, 2008, and issued its order assigning the litigation to the docket of the Honorable Daniel Polster of the United States District Court for the Northern District of Ohio.
Our firm has filed many cases, which are now pending before Judge Polster. It is our intent to steadily file all of our cases, and vigorously pursue them until they are successfully resolved. The pre-trial proceedings are going very well at this stage of the litigation. A protocol for presentation of all tissue samples was established. We wrote to all doctors involved with biopsies of our clients and provided them with the Court order that sets forth their obligations with respect to tissue samples. Additionally, a process was put in place by the Court to facilitate product identification. This protocol will assist Plaintiffs in the difficult task of identifying all GBCA’s to which they were exposed. Additionally, the Court requested that the parties submit scientific and technical information concerning GBCA’s and Nephrogenic Systemic Fibrosis. This submission enables the Court to fully understand NSF and the suffering of the victims.
Plaintiffs anticipate receiving all relevant internal documents from the Defendant manufacturers very soon. This will enable plaintiffs to prove what the Defendants knew, when they knew it, and what steps they should have taken to avoid the public health crises that they caused. Additionally, depositions of all pertinent depositions are being taken.
I will continue to provide updates on NSF litigation as it develops. However, if you would like additional information, please do not hesitate to contact me.
Additionaly, our firm is accepting new Nephrogenic Systemic Fibrosis cases in all 50 states. If you or a loved one have recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your injuries. Please click here to contact us for a free confidential case evaluation.
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