GranuFlo & NaturaLyte: Dialysis Drugs Linked to Heart Attacks and Other Cardiopulmonary Complications

On June 25, 2012 the Food & Drug Administration issued a recall for two drugs commonly used in the dialysis treatment process. The drugs GranuFlo and NaturaLyte are used in the treatment of acute and chronic renal failure during hemodialysis. These drugs were manufactured and distributed by Fresenius Medical Care North America which also used the drugs in numerous dialysis clinics they own across the United States.

Serious and sometimes fatal heart attacks and other serious cardiopulmonary complications have been associated with the use of these drugs in dialysis patients. Most adverse reactions or heart attacks occurred either during the dialysis process or within 48 hours of receiving the now recalled drugs during the dialysis process. The recall for these drugs was listed as a Class 1 recall. These are the most serious type of recall reports issued by the FDA and involve situations in which there is a "reasonable probability that the use of the product in issue will cause serious adverse health consequences or death."

In 2010 Fresenius documented 941 incidents of cardiac arrest among GranuFlo patients at their dialysis facilities. An internal memorandum from Fresenius to its own dialysis clinics indicates the company knew that the drugs increased the risk of cardiopulmonary arrest and sudden death but the company did not "disclose" this information until 2012 after the internal memo was leaked to government sources.

There are currently a number of claims for victims and their families pending in State courts across the country but as of this posting no Federal District Court has been assigned to the Multi-District Litigation (MDL) of this matter.

If you or a loved one has suffered a heart attack or cardiopulmonary related complications such as low blood pressure, hypokalemia, hypoxemia, hypercapnia or cardiac arrythmia during dialysis or shortly thereafter, you may be entitled to compensation for your injuries. We can help. For more information, please contact Mark Wolfe of Boteler, Finley & Wolfe at 866 975-7766 or by e-mail at mark@bfw-lawyers.com

[please put GranuFlo claim in the subject line.]



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BP Oil Spill Settlement and Claim Information

SUMMARY OF BP CLASS ACTION CLAIM SETTLEMENT
This summary is the work product of Boteler, Finley & Wolfe
1 866 975-7766 or 251 433-7766

Knox Boteler of BF&W has been involved in the ongoing litigation concerning the BP Oil Spill since shortly after April 20, 2010. BP and the Plaintiffs have now settled an Economic and Property Damage Class Complaint ("Class Complaint") that was filed in the United States District Court for the Eastern District of Louisiana as a result of the April 20, 2010 Deepwater Horizon incident. The Class Complaint alleged several federal statutory and maritime claims on behalf of businesses, property owners, fisherman, and thousands more. On May 2, 2012, the Court preliminary approved this Settlement Agreement.

The 1,000+ page Settlement Agreement generally covers six (6) types of claims: 1) any individual or business that asserts an economic loss, 2) damage to waterfront property, 3) loss of value to anyone that sold a Gulf Coast waterfront residence during the time May 1, 2010 to December 31, 2010, 4) loss of subsistence use, 5) vessels of opportunity charter claims, and 6) seafood harvesting loss. In addition, there is a separate class settlement providing for medical claims. For specific questions about a potential business economic loss claim, please e-mail Knox Boteler of BF&W: knox@bfw-lawyers.com

Business Economic Loss Claims can be submitted by individuals and businesses that are eligible class members (banking, insurance, a few other industries are excluded). [See maps of geographic compensation zones for Alabama and Mississippi businesses to the right.] With the exception of the Seafood Program, Economic Loss Claims will be calculated on a number of factors including, but not limited to: type of business, geographic location, and the nature of the loss claimed. This class area is divided into four (4) zones. A very favorable aspect of the settlement for businesses in Zones A, B or C is that if your business meets certain financial criteria regarding income losses after the Oil Spill in April 2010, there is a presumption that the loss was caused (at least in part)  by the oil spill. Businesses outside of  Zones A, B and C can still make a claim under the settlement but face a more difficult causation test for the claimed losses.  Though not all of Alabama and Mississippi appear on the map, those areas not included are considered to be in Zone D. Important Note: It is not necessary to have already filed a claim to qualify and file a claim under the class action settlement.



Coastal Real Property Damage claimants include owners and lessees of real property and boat slips during the time period from April 20, 2010 through December 31, 2010. Qualified claimants can make claims for damage to property located in defined geographical areas. [Alabama’s Coastal Property compensation zones included in the settlement can be found in the maps to the left.] Under the proposed settlement, the property is categorized based on official reports as to the type of property and whether oil was detected on the property. Depending upon that category, the compensation is based upon a factor applied to the tax assessor appraised value of the property. In addition, owners and lessees of Coastal real or personal property that was physically damaged by the spill response cleanup operations can make claims for Response Operations Damages.

Claims and Payments via the Gulf Coast Claims Facility (GCCF). In the next few weeks, a "Court Supervised Settlement Program" or "Settlement Program" will be established to receive, evaluate, and pay claims made by members of the Business Economic Class. Mr. Kenneth Feinberg will not be involved with the Settlement Program. During the interim, victims of the oil spill claims may still accept 60% of their proven loss under the old GCCF guidelines. The remaining 40% will be calculated once the Settlement Program has reviewed the claim. You will be paid, upon executing a full and final release, the greater of the remaining 40% of your GCCF offer or your Settlement Payment. If a business has already accepted a final payment, and not just a partial payment, from the GCCF and executed a full and final release then no claim can be made under the proposed class settlement.

Vessels of Opportunity (VOO) Claims. The recently announced class action settlement in the BP Oil Spill litigation includes claims for owners of vessels registered with the Vessels of Opportunity (VOO) program. The VOO program was initiated by BP after the oil spill and was intended to allow local vessel owners an opportunity to participate in the oil spill clean up operations. The registered vessels were required to be on "stand-by" and the owners had to complete extensive training

in advance of receiving a VOO contract. However, many vessels that were registered with the program were either never called into service or used sparingly. Also, some vessels suffered damages in the clean-up operation. In the lawsuit VOO owners claimed that their contract with BP called for payment whether the vessel was put into operation or not and required payment for a specified "usage" period. They also claimed that BP had agreed to compensate vessel owners for any damges to the vessels incurred during the clean-up operations. Under the proposed settlement, all vessel owners who executed VOO Master Vessel Charter Agreements and completed the initial VOO training program are entitled to compensation under the terms of the BP Settlement Agreement. The fact a vessel owner has previously executed a release of liability against BP or other responsible parties for other claims does not matter. Compensation is determined based on whether the vessel was placed “on-hire” and participated in the program or "on-standby". All VOO vessel owners will get a specified standard charter rate for a set number of days. If you are a vessel owner and you signed up for the VOO program, you may have a claim for damages under the new class action settlement. For more information, call Knox Boteler at Boteler, Finley & Wolfe, 251 433-7766 or toll free at 1 866 975-7766 or e-mail Knox at knox@bfw-lawyers.com

NOTE: This summary is the work product of the law firm of Boteler, Finley & Wolfe and has been digitally encrypted as such. It is protected by all applicable State and Federal copyright laws. This summary is not to be considered as legal advice or counsel for a specific and/or particular claim arising from the BP Oil Spill of April 20, 2010. It is offered to the public via the internet for educational and marketing purposes only.

Pradaxa warning! FDA investigating excess bleeding and death claims.

Pradaxa (Dabigatran): Dabigatran is used to help prevent strokes or serious blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly, increasing the chance of clots forming in the body, and possibly causing strokes) without heart valve disease. Dabigatran is in a class of anticoagulant (''blood thinner'') medications called direct thrombin inhibitors.

According to a CBSnews.com report of January 11, 2012, Patients taking the new anti-clotting drug Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease than do patients taking warfarin. The finding, from Cleveland Clinic researchers Ken Uchino, MD, and Adrian V. Hernandez, MD, PhD, is based on data from seven clinical trials that enrolled 30,514 patients. "The risk of [heart attack] or acute coronary syndrome is increased with [Pradaxa] compared with various control treatments, which include adjusted-dose warfarin, [Lovenox], or placebo," Uchino and Hernandez conclude. Acute coronary syndrome -- acute symptoms of serious heart disease -- is usually caused by the rupture of a plaque in a heart artery. In an editorial accompanying the study in the Jan. 9 issue of Archives of Internal Medicine, journal editor Rita Redberg, MD, notes that this isn't the first safety warning issued for Pradaxa. The FDA is investigating an unusually large number of reports of serious bleeding linked to the drug. Japan and Australia already have issued a safety warning. The European Medicines Agency advises doctors to check patients' kidney function before prescribing Pradaxa. And last year the FDA warned patients that the drug breaks down quickly when removed from its original container. "These additional concerns deserve serious consideration in weighing the risks and benefits of [Pradaxa]," Redberg concludes. Despite the apparent increase in heart attack risk, Uchino and Hernandez note that the benefits of Pradaxa -- particularly its ability to prevent stroke in patients with atrial fibrillation -- outweigh its risks. And they note that while the risk of heart attack or acute coronary syndrome is higher in patients on Pradaxa than in those on warfarin, the actual risk of these events is increased by only 0.25% per year. That's still an important added risk for patients who may already be piling up risk factors for heart disease, says Kirk Garratt, MD, clinical director of interventional cardiology research at New York's Lenox Hill Hospital. While absolute risk may not be bad, when added on top of measurable risk it becomes worth noting. "If I have a patient on this drug for 10 years, I'd expect a 5% increased lifetime risk of heart attack," Garratt tells WebMD. "The most important aspect of this study is that it allows us to see a consistent risk across studies and types of patients. That speaks to the conclusion that this study is well done and that the risk is real." By Daniel J. DeNoon Reviewed by Laura J. Martin, MD

If you or a friend or family member has experienced excessive bleeding or a heart attack while taking Pradaxa, you may have important legal rights for damages. Contact Knox Boteler @ Boteler, Finley & Wolfe for more information: 251 433-7766 or knox@bfw-lawyers.com

Polygrip Denture Cream

Polygrip Denture Cream’s manufacturer, GlaxoSmithKline, is under investigation for failing to inform users of this product’s potential safety risks. Polygrip Denture Cream contains 38 milligrams of zinc per ounce. Health experts recommend 8 milligrams of zinc per day for women and 11 milligrams for men. Medical studies have found excessive zinc may purge the body of copper, a chemical needed for normal brain and nervous system function. GlaxoSmithKline has announced that it will stop making Polygrip formulas containing zinc. Common side effects related to this product’s health risk include: loss of balance, loss of sensation in hands and feet and anemia. If you have any questions regarding your or a family member’s health and the use of Polygrip, please contact Knox Boteler at 866-975-7766 or email him at knox@bfw-lawyers.com for additional information. To learn more about this situation, click here.

Surgical Mesh Dangers for Transvaginal Pelvic Organ Prolapse Surgery Patients

Surgical Mesh: Manufactured by numerous companies including, Johnson & Johnson and Boston Scientific Corp.

Used for: Surgical repairs for Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI) surgery. Used in place of stitches surgical mesh is designed to be a permanent implant and has been commonly used in transvaginal POP and SUI surgeries for many years. In POP procedures the mesh is commonly called a “bladder sling.”

Symptoms or Consequences: In July 2011, the FDA announced that a multi-year study of surgical mesh implants found serious complications associated with surgical mesh for POP and SUI procedures. The FDA report also noted, “[f]urthermore it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” Erosion of the mesh through the vagina is the most common and consistently reported complication. Mesh contraction is also a risk. Both mesh erosion and mesh contraction can cause severe pelvic pain, painful sexual intercourse. Other symptoms may include: Bladder, bowel, or blood vessel bleeding or perforation, bone and hip infections and/or the recurrence of the POP and/or SUI condition.

Additional Information: For more information visit Providence Health Plan

Contact: If you believe you or a loved one may have a claim related to the use of surgical mesh in a POP and/or SUI procedure, please contact Knox at Boteler, Finley & Wolfe (knox@bfw-lawyers.com) for more information and help locating the law firm leading these Mass Tort cases.

Actos linked to Bladder Cancer

Actos: Manufactured by: Takeda

Prescribed for: Actos (pioglitazone) is used in the treatment of diabetes. Actos is used to control blood sugar levels in patients with Type 2 diabetes, which keeps the body from producing enough insulin to properly use the sugar in the blood stream. Type 2 diabetes can also cause the patient to become resistant to insulin. Actos remedies this problem by making cells more sensitive to insulin, thereby making it easier for sugar to pass through the body.

Symptoms or Consequence: May cause bladder cancer. The Food and Drug Administration (FDA) mandated a warning be added to Actos packaging in 2007. A second FDA warning in June 2011 contained specific details of the risk of bladder cancer associated with Actos. A recent study of 193,099 patients over a five-year period found that people who took Actos for at least 12 months or longer were 40 percent more likely to develop bladder cancer. A subsequent FDA Adverse Event report found that Actos was involved in one-fifth of all reported diagnoses of bladder cancer in diabetes drug users.
Additional Information: Read more on this matter at Web MD, and the June 15, 2011 FDA report.

Contact: If you believe you or a loved one may have a claim related to the use of Actos and a diagnosis of bladder cancer, please contact Knox at Boteler, Finley & Wolfe (knox@bfw-lawyers.com) for more information and help locating the law firm leading these Mass Tort cases.