Latest News

Allen Law Firm Teams Up With Preeminent Trial Lawyers in Yaz / Yasmin  and Reglan Litigation
October 23, 2009 - The dangerous drug lawyers at the Allen Law Firm are proud to announce their association with nationally prominent trial lawyers Lisa Blue Baron and Mike Kaeske to represent victims of serious injuries caused by the side effects of Yaz/Yasmin and Reglan.

Yaz and Yasmin Lawsuits Consolidated in MDL
October 1, 2009 - The Judicial Panel on Multidistrict Litigation ruled today that the lawsuits involving the birth control pills Yaz and Yasmin will be consolidated in the U.S. District Court for the Southern District of Illinois.  Pursuant to the order, pretrial proceedings for the cases and the first "bellwether" trials will be held in Illinois under Judge David Herndon.  Read more.

More Yaz Lawsuits filed
August 27, 2009 - Earlier this week a new lawsuit was filed in Illinois State Court against Bayer and related entities alleging that Yaz caused a pulmonary embolism. This is the latest in a flurry of lawsuits that have been filed against the makers and distributors of Yaz, Yasmin and Ocella for serious side effects including blood clots, pulmonary embolism, stroke, deep vein thrombosis, gallbladder removal and other organ failures.  Read more.

First Trial on Mentor OBTape Postponed
August 27, 2009 - Judge Clay Land has postponed the first trial in the Mentor OBTape MDL litigation until 2010. The delay is reportedly due to Plaintiffs request to have several cases heard at the same time.  The lawsuits involve Mentor OBTape, also known as a bladder hammock.  These devices provide support for the vaginal wall to help control the flow of urine.  The plaintiffs content that the slings were defectively designed and resulted in serious complications such as vaginal extrusions, urinary tract erosion and infection.  The first trial is now slated to begin June 1, 2010 in Columbus, Georgia.

Hearing on potential Yaz, Yasmin MDL to be held September 24, 2009
A hearing on the Petition to consolidate the Yaz, Yasmin and Ocella product liability litigation into an MDL is set for September 24, 2009 in Richmond, Virginia.  The hearing will be held before the Judicial Panel on Multi-District Litigation.  If the federal cases are consolidated, they will proceed in U.S. District Court for the Northern District of Ohio.

Documents confirm GSK's ghostwriting program for Paxil
August 20, 2009 - The lawyers representing Plaintiffs in law suits against GSK based on injuries from using Paxil uncovered documents from the so-called CASSPER program.  CASSPER was a ghost-writing program that was pitched to doctors as a way to help with anything from "developing a topic" to "submitting the manuscript for publication."  GSK is the fourth pharmaceutical company to be accused of using ghostwriting to promote their drugs.  AstraZeneca, the maker of Seroquel, was among the four large pharma companies with ghostwriting programs. 

Avandia has significantly higher risk of heart failure than Actos
August 19, 2009, 2009 - An article published yesterday concluded that Avandia is associated with a significantly higher risk of heart failure and death than Actos.  According to the authors, older patients with diabetes should not be prescribed Avandia because it lacks a distinct clinical advantage over Actos.  Read more about Avandia's serious side effects.

Petition to Consolidate Yaz/Yasmin Lawsuits Filed
July 24, 2009 - A petition was filed on July 24, 2009 to consolidate the Yasmin/Yaz lawsuits into an MDL in the United States District Court for the Northern District of Ohio. The motion was filed with the Judicial Panel on Multidistrict Litigation in Washington, D.C.  The Yasmin/Yaz lawsuits involve Plaintiffs who have suffered injuries, including deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, stroke, kidney failure, seizures, gall bladder injuries, and death after using the birth control pills.

Yamaha Rhino Wrongful Death Case to Proced to Trial in Texas
July 23, 2009 - A Texas appeals court has denied Yamaha's petition to force the case to arbitration.  Yamaha tried to force arbitration based on an arbitration clause in the financing agreement when the vehicle was first purchased.  A trial court denied Yamaha's motion to compel arbitration on June 30, 2009.  The case involving the death of a 13 year old boy will proceed to trial on August 17, 2009 in Orange County, Texas. Read more.

Avandia linked to Death from Liver Failure
July 22, 2009 - Diabetes drug Avandia came under fire again--this time for its link to liver failure and death. The group Public Citizen wrote in the journal Pharmacoepidemiology and Drug Safety that 11 adverse events reported to the FDA from 1997-2006related to death caused by liver toxicity were associated with Avandia.  Read more.

"Black Box" Warning for Chantix, Zyban, Wellbutrin
July 1, 2009 - FDA alerted healthcare providers today that the manufacturers of varenicline (Chantix) and bupropion (Zyban, Wellbutrin and generics) must add new "Black Box" warnings highlighting the risk of serious neuropsychiatric symptoms in patients using these products. Symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.  Read more. 

Diabetes Drug Lantus Linked to Cancer Risk
June 29, 2009 - European studies released last weekend suggest a link between Sonofi-Aventis' diabetes drug Lantus and cancer. Two database analyses found an increase in cancer risk, especially breast cancer, amont Lantus patients compared to people using other forms of insulin. The data is not conclusive, but does arouse suspicion that should not be ignored when treating patients.

Allen Law Firm Representing Zicam Plaintiffs
June 23, 2009 - Allen Law Firm is currently representing numerous Plaintiffs in their claims against Matrixx Initiatives the makers of Zicam.  If you have lost your sense of smell after using Zicam Nasal Gel spray or Zicam Nasal Swabs, contact the Allen Law Firm for a Free Consultation.

Lawsuits filed agaisnt maker of Zicam
June 22, 2009 - Today more than 100 people filed lawsuits against the makers of Zicam. The lawsuits seek compensation for loss of smell after using Zicam Nasal Gel Sprays and Zicam Nasal swabs. The lawsuits were filed in Maricopa County, Arizona.

FDA notifies consumers that Zicam Nasal products linked to permanent loss of smell
June 16, 2009 - Today the FDA alerted consumers that Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kid Size have all been associated with long lasting or permanent loss of smell (anosmia).  These nasal cold remedies contain zinc.  These products have not been shown to be effective in the reduction of the duration and severity of cold symptoms.  FDA recommends that consumers stop using these products and throw them away.  Read more about Zicam and the loss of smell.

FDA notifies consumers of Class I Recall on Medtronic Pacemakers
June 11, 2009 - Today the FDA alerted patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers.  The recalled devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.  A Class I recall indicates reasonable probability that the use of the device will cause adverse health consequences or death.  Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.  Read more.

FDA warns doctors about risk of serious liver injury from use of PTU Thyroid drug
June 3, 2009 - Today the FDA warned doctors of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU).  The warning follows a letter written to the New England Journal of Medicine in April 2009 warning of liver damage from this drug, especially in children.  The FDA advised physicians that PTU should not be used in pediatric patients unless the patient is allergic to or does not tolerate MMI (methimazole) another drug approved to treat overactive thyroid and Graves' disease.

Heart Rhythm Societ Offers First Comprehensive Guidance on Lead Performance
May 13, 2009 - Today the Heart Rhythm Society has released the first comprehensive guidance document on defibrillator lead performance.  The Heart Rhythm Society's Task Force provides a wide range of recommendations on issues including communication of lead performance, pre-market evaluation of leads, post-market monitoring of lead performance, threshold for action and communication after abnormal lead performance is identified and clinical recommendations for physicians.  New clinician recommendations will help prevent misunderstandings, eliminate unwarranted patient anxiety and fear, and minimize inappropriate, unsafe responses to malfunctions that have low risks to patient safety.  The complete Guidance document will be published in the June issue of the HeartRythm Journal, the official journal of the Heart Rhythm Society.

FDA Approves new labeling for antiepileptic drugs warning of suicide risk
May 5, 2009 - The FDA notified healthcare professionals that it has approved new labeling for antiepileptic drugs that warns of the suicide risks when taking these drugs.  Since issuing safety alerts in January and December 2008, the FDA has been working with the manufacturers of the antiepileptic drugs to better understand the suicidality risk.  The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs in this class.  The observation suggests that the risk applies to all antiepileptic drugs used for any indication.   The drugs include Pfizers Lyrica, which is approved for treating pain associated with diabetes and fibromyalgia; Johnson & Johnsons Topamax, which is also approved to treat migraines; and Glaxos Lamictal.

Recall of all Hydroxycut Products due to Reports of Serious Liver Injuries
May 1, 2009 - The FDA is warning consumers to immediately stop using all Hydroxycut products by Iovate Health Sciences, Inc. of Oakville, Ontario and distributed by Iovate Health Sciences USA, Inc. of Blasdell, N.Y.  Some of the Hydroxycut products have been linked with a number of serious liver injuries.  The FDA has received 23 reports of serious health problems ranging from jaundice to liver damage requiring liver transplant.  The FDA has also received one report of a death related to liver failure caused by Hydroxycut.  Other health problems related to Hydroxycut include seizures, cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems.  Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with the Hydroxycut products. Read more about potential legal claims against the makers of Hydroxycut products.

Black box warning for Botox
April 30, 2009 - The FDA announced today that the labels for Botox and similar products will carry its strictest safety warning, known as a "black box" warning.  The warning will include information on the risks when a botulinum toxin injection spreads beyond the injection site.  Today's announcement comes after a year of FDA review of Botox.  The FDA had received reports of serious adverse events after the use of Botox and similar drug injections.  The worst outcomes included hospitalization and death.  These most serious cases happened most frequently in children with cerebral palsy who used the drug to treat limb spastisity.  The FDA is also requiring the drug makers to develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers.

Denture Cream lawsuits filed
April 22, 2009 - The first lawsuits related to high levels of zinc in denture creams has been filed naming the makers of Fixodent as the Defendants.  Recent studies have shown that the high levels of zinc in denture creams like Fixodent and Poligrip can cause serious neurological problems.  Patients absorb the zinc through their gums and the resulting zinc poisoning causes a decreased level of copper in the body.  This combination can cause neurological problems including neuropathy.  Read more. 

Thyroid drug can cause fatal liver failure
April 8, 2009 - In a letter published in the New England Journal of Medicine, two Yale University School of Medicine doctors warn that propylthiouracil should not be used to treat children due to the high risk of fatal liver failure.  Propylthiouracil (PTU), is a treatment for Graves' disease, the most common cause of an overactive thyroid.  The doctors estimate that five to ten children die each year from complications of using this drug.

Psoriasis drug Raptiva removed from the market
April 8, 2009 - Raptiva made by Genetech is being withdrawn from the U.S. market.  Raptiva is an injectable drug used to treat moderate to severe plaque psoriasis.  The drug is being removed from the market due to a link between Raptiva and progressive multifocal leukoencephalopathy (PML).  PML is a serious and usually fatal brain infection caused by a virus.  Symptoms include vision problems, loss of coordination, and memory loss. For more information, read the FDA notice here.

Caraco brand Digoxin Tablets Recalled
March 31, 2009 - Caraco Pharmaceutical Laboratories, Ltd., recalled potentially defective digoxin tablets today.  The tablets may contain either too much or too little digoxin.  A higher than labeled dose could lead to digitalis toxicity while a lower than labeled dose poses a risk of lack of efficacy.  For more information including the specific lot numbers recalled, read the FDA Recall Notice here.

Yamaha Rhino Vehicles Sales Suspended Pending Repair to Address Safety Issues
March 31, 2009 - The U.S. Consumer Product Safety Commission (CPSC) announced a free repair program to address safety issues with all Rhino 450 and 660 model off-road recreational vehicles. Yamaha has agreed to voluntarily suspend sales of the Rhino vehicles until repaired by dealers.  The CPSC advises consumers to immediately stop using these vehicles until the repair is installed by a dealer. The repair to the Yamaha vehicles corrects the Rhino's tendency to rollover. The announcement comes on the heels of an an investigation into more than 50 incidents involving 46 deaths related to the Yamaha Rhino models at issue.  Read more.

FDA Classifies Medtronic Voluntary February Recall For BioGlide Ventricular Snap Shunt Catheters
March 27, 2009 - Medtronic's recall of its BioGlide Ventricular Snap Shunt Catheter (Cat. #s 27782, 27708 and 27802) has been classified as a Class I recall according to the FDA. A Class I recall indicates a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The recalled device is a cerebral ventricular catheter component of a shunt for the treatment of hydrocephalus.  Approximately 3,000 catheters have been distributed between 2002 and 2009.

Supreme Court Upholds Consumers' Rights to Sue for Drug Injuries
March 4, 2009 - By a 6-3 vote, the U.S. Supreme Court upheld a ruling awarding $6.7 million to a Vermont woman who lost her arm after an injection of the anti-nausea drug Phenergan.  Wyeth Pharmaceutical, the maker of Phenergan, argued that FDA approval of the drug protected drug makers from consumer lawsuits.  Consumer groups argued that the FDA does not always catch safety problems with drugs and therefore, it is vital that a consumer's right to sue over a defective drug be upheld. The Supreme Court agreed with consumers, stating that FDA approval of a drug does not pre-empt the filing of state law tort claims.

Unfavorable Seroquel Studies "Buried", Papers Show
February 27, 2009 - According to recently released documents, AstraZeneca failed to publicize results of at least three clinical trials of Seroquel that had unfavorable results. Corporate emails indicate that AstraZeneca officials were "highlighting only the good stuff" about certain studies when the overall results showed that Seroquel was "less effective than haloperidol and our competitors". The documents also revealed that AstraZeneca knew as early as 2001 that researchers had found links between diabetes and Seroquel.  Read more.

Reglan linked to Tardive Dyskinesia
February 26, 2009 - FDA requires Reglan, a drug used to treat gastrointestinal disorders, to include black box warning of Tardive Dyskinesia as a potential serious side effect of the drug.  Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment.  Reglan is a metoclopramide-containing product.  Over two million Americans use products that include metoclopramide like Reglan.  Read more.

Medtronic Sprint Fidelis Lead danger increases over time.
February 23, 2009 - A recent article by Robert G. Hauser, M.D. and David L. Hayes, M.D. in the medical journal, Heart Rhythm, found that the risk of a lead fracture increases as Sprint Fidelis devices age.  According to the authors who looked at a total of 3,037 defibrillator leads of varying models, a total of 94 leads failed.  Seventy-two of the failures were Medtronic Sprint Fidelis leads.  The study saw a Sprint Fidelis failure rate of 3.75% a year, compared with 0.58% among other models.  At three years after implant, 87.9% of the Sprint Fidelis leads were working, compared with 98.5% for other models studied.  The authors concluded that "[t]he hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable." 

HRT Linked to Breast Cancer By Additional Evidence
February 5, 2009 - Studies have long been pointing to the link between Hormone Replacement Therapy (HRT) drugs like Prempro and an increase in some cancers.  Today, the BBC reported on a study that found that the risk of breast cancer dropped significantly when HRT was stopped, according to New England Journal of Medicine research.  Also, an expert in the United Kingdom concluded that a 50 percent drop in HRT use likely prevented about 1,000 annual cases of breast cancer, said the BBC.

ETHEX Recalls Certain Lots of Five Generic Products
November 7, 2008 - ETHEX Corporation has voluntarily recalled specific lots of five generic/non-branded products that it markets due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.  This is the third recall by ETHEX since June of this year.  Read more information on the recalled products.

FDA Seizes Contaminated Heparin from Cincinnati Manufacturer
November 6, 2008 - As part of the FDA's ongoing efforts to ensure heparin remains safe for patients, the government seized 11 lots of heparin from Celsus Laboratories, Inc. in Cincinnati, Ohio. The lots were seized at the FDA's request by U.S. Marshals. The products, which were manufactured from material imported from China, were found to be contaminated with over-sulfated chondroitin sulfate, a substance that mimics heparin's anticoagulant activity. Read more.

Recall of ReliOn Insulin Syringes
November 5, 2008 - The Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoclycemia, serious health consequences, and even death. The recall applies to Lot No. 813900, ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin.  The ReliOn syringes were sold only by Wal-Mart and Sam's Club stores.  Read more.

November 5, 2008 A new version of Byetta, a diabetes drug, is facing obstacles in obtaining approval from the FDA. The drug made by Amylin Pharmaceuticals, Inc. and Eli Lilly said that study data did not satisfy the FDA's standards.  The likely approval delay is just the latest problem surrounding Byetta.  In August of this year, the FDA stated that several patients taking Byetta had developed serious, and sometimes fatal, pancreatitis.

Pleasanton, CA, October 24, 2008 Thoratec Corporation initiated a worldwide medical device recall for its HeartMate II implantable heart pumps. Wear and tear on the leads connecting the Left Ventricular Assist Systems to the System Controller may lead to damage that could interrupt pump function. Thoratec is urging patients to contact their doctors to assess the device. Read more.

October 22, 2008 -- The Institute for Safe Medication Practices (ISMP) released a report today stating that 1001 serious adverse events were reported for Chantix. According to the report, the side effects reports included 50 deaths, 52 cases of blackouts and 15 events that were related to road traffic accidents. In response to the report, the FDA will review the reports of blackouts and traffic accidents to determine whether the warning lable should be updated. Read more.

St. Louis, MO, October 15, 2008--ETHEX Corporation announced a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets due to the possibility of oversized tablets. The recalled lots were distributed between January 2007 and May 2008. The adverse effects associated with higher doses of Dextroamphetamine Sulfate include tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth. Ethex issued a similar recall this year of its Morphine Sulfate Tablets.  Read more.

September 4, 2008--Today the FDA ordered stronger warnings about the risk of potentially deadly fungal infections, especially histoplasmosis, in people taking the drugs Enbrel, Cimzia, Humira and Remicade.  Read more.

August 18, 2008 -- The FDA plans to strengthen warnings about serious and potentially life-threatening pancreas problems linked to Byetta, a type 2 diabetes drug. The action by the FDA was spurred by reports of two deaths and four other hospitalizations by Byetta users. Byetta is produced collaboratively by Eli Lilly and company and Amylin. Read more.

Morristown, NJ, August 1, 2008 -- Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.  Actavis also manufactures Digitek, an oral tablet used in treating heart problems, that was the subject of a Class I recall in April of this year.  Read more

July 22, 2008 – Sales of Zimmer Durom Cup hip implants suspended.  The Durom Cup has been implanted in more than 12,000 U.S. patients since its introduction to the market in 2006.  The implant, designed for us in young, active patients who are likely to outlive a conventional hip prostheses, has come under fire for months.  In April 2008, a prominent surgeon went public with his concerns about the Durom Cup.  Shortly thereafter, Zimmer began an investigation leading to the suspension of sales of Durom cups in July 2008.  Read more

June 2008 - In response to the reports of side effects, the FDA required Merck to update Gardasil’s label to include the more minor side effects that have been conclusively tied to the vaccine including: nausea, joint and muscle pain, fatigue, physical weakness and general malaise.  Read more

Morphine Sulfate Recall
St. Louis, MO - June 13, 2008 - ETHEX Corporation announced a voluntary recall for certain lots of morphine sulfate 60 mg and 30 mg extended release tablets. The tablets were recalled because they may contain as much as two times the labeled level of active morphine sulfate. Read More

March 14, 2008--Today the makers added a "black box" warning to the prescribing information for Enbrel.  The warning alerts doctors and patients to an increased risk of tuberculosis (TB) infection among the users of Enbrel.  Read more.

Digitek Recall
Morristown, NJ - April 25, 2008 – Actavis Totowa, LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use.  The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label.  Read more

Ortho Evra Label Changes Again
January 18, 2008 - The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.  Read more

Trasylol pulled from World Wide Market
MONDAY, Nov. 5, 2007 - Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons. Read more