Advisers to the Food and Drug Administration met on December 8, 2011 to review the science behind Yaz and its class of birth control pills and voted that the drugs’ prescribing label should be changed to better reflect the blood clot risks to women who take the medications.

The advisers voted 21-5 that the information labels for the class of pills should be changed to more clearly reflect the potential for blood clots as a side effect of the medications.

The FDA does not have to follow the panels’ advice.

The clarity of the language and the way the label communicates the information formed part of the discussion about how the label should be updated to warn women who take the class of birth control medications.

Drospirenone is similar to the naturally occurring female hormone progesterone.

The FDA acknowledges that the newest generation birth control pills may raise the risks of blood clots.

Yas and Yasmin and similar medications combine drospirenone, a synthetic versions of the female hormone progesterone, with estradiol, a form of the female hormone estrogen.

Bayer faces thousands of lawsuits over injuries allegedly caused by the medications.

Lawyers have cited FDA reports on at least fifty deaths of those taking the medications between 2004 and 2008.

Some womens’ health advocates are so concerned by Yaz and Yasmin that they believe the medications should be taken off the market since there are safer options available.

We are actively evaluating omphalocele lawsuits / cases potentially originating from  all 50 states.

If you or somebody you know took an antidepressant while pregnant and your child was born with an omphalocele, you should contact our lawyers immediately.

We are actively seeking birth defects claims like these in order to represent the legal interests of children and families affected by the manufacturer’s failure to warn mothers of the potential for congenital birth defects as a result of taking their products.

What is Omphalocele?

An omphalocele is a congenital hernia in which the infant’s intestine and/or other abdominal organs protrude out of the navel.

Omphaloceles occur when the abdominal wall does not close properly during fetal development.

The extent and seriousness to which abdominal organs protrude through the base of the umbilical cord will vary with each individual case.

What SSRI Antidepressants Are Possibly Linked to Omphalocele?

The following antidepressants are the primary drugs potentially linked to the development of omphalocele in newborn infants and babies if their mothers took these drugs during pregnancy:

•Zoloft (Sertraline)
•Paxil (Paroxetine)
•Lexapro (Escitalopram)
•Celexa (Citalopram)
•Prozac (Fluoxetine)
•Symbyax (fluoxetine and olanzapine)
•Wellbutrin (Bupropion)
•Effexor (Venlafaxine)
•Generics and other types of this class of drugs (SSRI).

If you or a loved one have suffered an injury after taking any of these or other similar drugs, or their generics, please contact us immediately for a free potential claim evaluation.  Failure to act quickly may cause you to lose your potential legal rights if the statute of limitations period passes.

Please fill out any of the contact forms on this website or call us today so that we can mail you a free questionnaire.

THE MULLIGAN LAW FIRM IS CURRENTLY EVALUATING DEPUY ASR AND ASRXL HIP IMPLANT POTENTIAL CLAIMS

The ASR hip cup is a metal-on-metal ball and socket, large diameter hip resurfacing device.

DePuy, the company that manufactures the ASR hip cup (pronounced dee-pew), was acquired by Johnson & Johnson in 1998.

The cause of the DePuy ASR / ASRXL Cup hip implant problem / failure issue is under investigation.

Metal debris early in the placement of this implant may cause inflammation, leading to damaged muscles and soft tissue.

The result?  An expensive and painful surgery intended to last at least a decade often requires revision within two to three years.

If you or a loved one has been adversely affected / injured after surgical implantation of a DePuy Acetabular Cup, please contact us immediately for a free consultation.

False Claims Act “Whistleblower” litigation increased dramatically in 2010.
In the second half of 2010, the Department of Justice published settlements in many large cases against pharmaceutical companies.  Some examples:
• Abbot, Roxane, B. Braun Medical, and Dey Inc. – DOJ settled actions in 2010 against Abbot Laboratories, Inc., Roxane Laboratories Inc., B Braun Medical Inc., Dey Inc. and other related companies.  The settlements dealt with allegations that the companies illegally increased the reported “average wholesale price” of drugs.  This increased the reimbursement amount that the government paid for the drugs under  programs such as Medicare.    The companies paid $701.2 million dollars as part of the resolution of these claims.
• Elan Corp.  – DOJ settled actions in 2010 with Elan Corp., PLC and its related business Elan Pharmaceuticals Inc. related to the resolution of alleged illegal promotion of an epilepsy drug.  Elan agreed to pay approximately $100 million in criminal fines and about $102.9 million to resolve the FCA actions.
• A GlaxoSmithKline subsidiary settled actions in 2010, agreeing to plead guilty to criminal charges related to the distribution and manufacturing of adulterated drugs.  The company paid a criminal fine of $150 million and civil penalties of $600 million to resolve allegations that it caused the government to pay for adulterated drugs.  The whistleblower in this claim received approximately 96 million dollars.
• Novartis Pharmaceuticals Corp. settled claims in 2010 for $422.5 million to resolve criminal and civil liability that arose from alleged illegal marketing of various drugs. 
• Forest Laboratories subsidiary, Forest Pharmaceuticals Inc. came to resolution agreeing to pay $313 million to resolve claims that the company illegally distributed an unapproved drug known as Levothroid and also promoted “off label” uses for the drug Celexa.  It is also alleged to have caused false claims to be submitted to federal health care programs for Celexa, Lexapro, and Levothroid, in addition to paying kickbacks to doctors to prescribe Lexapro and Celexa. 
• Allergan Inc., agreed to pay a $600 million dollar settlement in 2010 to resolve claims that the company marketed Botox for “off label” uses.  The Food, Drug, and Cosmetics Act is alleged to have been violated in this instance. 

Please contact the attorneys of The Mulligan Law Firm at 866-529-0001 if you would like to discuss a qui tam whistleblower action.

Top 20 Largest Pharmaceutical Company Settlements, 1991-2010

Company;  Total Penalty;  Violation(s);  Year;  Major Drug Products Involved;  Laws Allegedly Violated (if applicable)
 

• GlaxoSmithKline; $3.4 billion; Financial Violation; 2006.
• Pfizer; $2.3 billion; Unlawful Promotion / Kickbacks; 2009; Bextra / Geodon / Zyvox / Lyrica; False Claims Act / Food, Drug, and Cosmetics Act.
• Eli Lilly; $1.4 billion; Unlawful Promotion; 2009; Zyprexa; False Claims Act / Food, Drug, and Cosmetics Act. 
• TAP Pharmaceutical Products; $875 million; Overcharging Govt Health Programs / Kickbacks; 2001; Lupron; False Claims Act / Prescription Drug Marketing Act.   
• GlaxoSmithKline; $750 million; Poor Manufacturing Practices; 2010; Kytril / Bactroban / Paxil CR / Avandamet; False Claims Act / Food, Drug, and Cosmetics Act.
• Serono; $704 million; Unlawful Promotion / Kickbacks / Monopoly Practices; 2005; Serostim; False Claims Act.     
• Merck; $650 million; Overcharging Govt Health Programs / Kickbacks; 2008; Zocor / Vioxx / Pepcid; False Claims Act / Medicaid Rebate Statute.     
• Purdue; $601 million; Unlawful Promotion; 2007; Oxycontin; False Claims Act.   
• Allergan; $600 million; Unlawful Promotion; 2010; Botox; False Claims Act / Food, Drug, and Cosmetics Act.    
• AstraZeneca; $520 million; Unlawful Promotion / Kickbacks; 2010; Seroquel; False Claims Act.    
• Bristol‐MyersSquibb; $515 million; Unlawful Promotion / Kickbacks / Overcharging Govt Health Programs; 2007; Abilify / Serzone; False Claims Act / Food, Drug, and Cosmetics Act.    
• Schering‐Plough; $500 million; Poor Manufacturing Practices; 2002; Claritin; FDA Current Good Manufacturing Practices.    
• Schering‐Plough; $435 million; Unlawful Promotion / Kickbacks / Overcharging Govt Health Programs; 2006; Temodar / Intron A / K‐Dur / Claritin RediTabs; False Claims Act / Food, Drug, and Cosmetics Act.    
• Pfizer; $430 million; Unlawful Promotion; 2004; Neurontin; False Claims Act / Food,Drug, and Cosmetics Act.      
• Cephalon; $425 million; Unlawful Promotion; 2008; Actiq / Gabatril / Provigil; False Claims Act / Food, Drug, and Cosmetics Act.    
• Novartis; $423 million; Unlawful Promotion / Kickbacks; 2010; Trileptal; False Claims Act / Food, Drug, and Cosmetics Act.    
• AstraZeneca; $355 million; Overcharging Govt Health Programs; 2003; Zoladex; Prescription Drug Marketing Act.    
• Schering‐Plough; $345 million; Overcharging Govt Health Programs / Kickbacks; 2004; Claritin; False Claims Act / Anti‐Kickback Statute.    
• Forest Laboratories; $313 million; Unlawful Promotion / Concealing Study Findings / Kickbacks / Illegal Distribution; 2010; Levothyroid /Celexa / Lexapro; False Claims Act / Food, Drugs, and Cosmetics Act.    
• Johnson & Johnson (State settlement); $258 million; Unlawful Promotion; 2010; Risperdal; Medical Assistance Program Integrity Law.

This list of Top 20 Largest Pharmaceutical Company Settlements is located in:  Sammy Almashat, M.D., M.P.H.,  Charles Preston, M.D., M.P.H., Timothy Waterman, B.S., Sidney Wolfe, M.D., Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry:  1991 – 2010, Public Citizen’s Health Research Group, December 16, 2010.

If you or a loved one have a whistleblower claim we would like to speak with you.   The Mulligan Law Firm is particularly interested in speaking to individuals with claims in Texas, Pennsylvania, California and Florida, but please call regardless of where you live in the United States or elsewhere if you believe you have a Qui Tam Whistleblower action to discuss with our attorneys. 

Any delay may cause you to lose your potential legal rights permanently.

If you have information about any of the following, please contact us immediately.  The Mulligan Law Firm is investigating potential Qui Tam Whistleblower claims, especially involving the pharmaceutical industry.

• Pharmaceutical Companies or sales representatives paying kickbacks and inducements to doctors / physicians, pharmacists, and/or hospitals to prescribe or in any manner favor their drugs.
• Off-label marketing of drugs / medications.
• Selling, manufacturing, or distributing adulterated pharmaceutical drugs;  i.e. where the required standards of safety, quality, correct strength, and/or purity of drugs have not been met. 
• Kickbacks or any other fraudulent activity by pharmaceutical companies.
• Providing false data to the FDA or withholding negative information / data from the Food and Drug Administration (FDA) concerning the efficacy of a drug and/or medical device during clinical research trials to get FDA approval to sell / market the medication, drug, or device. 
• Manufacturing, diverting, selling, etc., tainted or substandard drugs.
• Misrepresentation of the “federal ceiling price” or “best price” or other benchmark prices that pharmaceutical companies report to the Medicaid and Medicare programs.
• Overcharging on “340B” program drugs.
• Excessive markup on external vendor services and products resold to the government.
• Excessive and unnecessary products and services on goods / contracts sold to the government.
• Delivery of poor quality goods or services to the government.
• Non-conformance to government contract specifications.
• Fraudulently billing the government for work not performed.
• Overvaluing leases or rents that the government must pay.
• Passing incomplete work off as complete.
• Improper billing practices.
• Over pricing of any kind.
• Inappropriate travel grants.
• Wasteful University Studies.
• University Grant Fraud.
• Accounting not in compliance with GAAP.
• Deliberate delivery delay for government contracted services.
• Deliberate production delay for government contracted services
• False or overstated “padded” legal billing for government entities by major law firms.
• Non-conformance with federal wage and employment laws.
• Quality Control Failures on Government Contracted Services
• Double billing.
• Final billing on unfinished contracts.

Please fill out a form on this website or call us immediately at the number on our home page if you have information about any of the above.

The Zimmer NexGen® knee replacement implant has been found to have a high rate of failure, loosening, pain and other issues / complications.

A surgeon and consultant to Zimmer Holdings called for a Zimmer NexGen® knee recall to be issued. The reason this action was taken was as result of repeated observation of problems, later to be followed by a study confirming the initial findings.

The model at issue, the NexGen® CR-Flex, is designed to provide a greater range of motion than the standard NexGen.

The most commonly used method of implanting an artificial knee is by using an adhesive to bond the thigh bone to the portion of the device that bends, cementing the two together. Some specialists avoid adhesives because cement can break down, causing failure of the device. Because of this, Zimmer sells an uncemented version of the CR-Flex that relies on the bone naturally growing into the implant. This uncemented version is the source of the problems and complaints.

“…he gave the device, which is supposed to last about 15 years, to about 125 patients in 2005, the first full year he used it. But by early 2006, some X-rays showed lines where the implant met the thigh bone, an indication that the device was loose and had not fused completely. Patients could walk, but they were reporting pain, apparently a result of the loose joint.”  – New York Times article titled “Surgeon vs. Knee Maker:  Who’s Rejecting Whom?” 18 June 2010

Several prominent surgeons, one the former consultant for Zimmer mentioned above, first presented their study at a medical meeting in the fall of 2009 and again this year at a national meeting of the American Association of Orthopedic Surgeons.

The uncemented Zimmer knee was found to fail in 9 percent of 100 patients featured in the study. Furthermore, the knee was observed to be loose in approximately 50% of the patients, requiring additional surgeries in some of the patients.

The Zimmer NexGen® CR-Flex Porous Femoral components are replacement knee products that have been associated with a high number of reports of:

•Loosening of Replacement Knees (50% in study mentioned above)
•Knee replacement failure
•Surgery required to correct complications
•Other knee complications and pain
If you or a loved one has been seriously injured after surgical implantation with any of the Zimmer NexGen® CR femoral components, please contact us immediately for a free consultation.

These problems could include:

•Unexplained pain following knee replacement
•Loosening of replacement knee
•Revision knee surgery to correct problems 

Who We Are
The Mulligan Law Firm, a national law firm located in Dallas, Texas, provides legal information and resources for injured individuals and their families. The firm has successfully resolved over $600,000,000 in claims for its clients. Formed in 1995, it has been helping people for almost 15 years, with the strength and experience to represent plaintiffs in all 50 states.

The Mulligan Law Firm is currently investigating injury claims involving Zimmer NexGen® Knee Replacements. 

If you or a loved one has been seriously injured after surgical implantation of a Zimmer NexGen® Knee Replacement, it is important that you consult with a legal professional immediately. The Mulligan Law Firm has experienced lawyers standing by to help you.

You may be entitled to compensation for your injuries. We take all cases on a contingency-fee basis, which means you do not pay for our services unless you receive an award or compensation.

Do not delay, as your rights and compensation may be lost forever if you wait.  Call us now at 866 529 0001, Extension 245, or simply fill a form out on this website.

Banned in the United Kingdom since 2005 and then the European Union in January 2009, an estimated 10 million patients have used these common painkillers.

On November 19, 2010 the FDA asked manufacturers of propoxyphene (Darvon®, Darvocet®) for a product recall. 

Propoxyphene is an opioid used to treat mild to moderate pain.  Approved by the FDA and available since 1957, propoxyphene is manufactured by Xanodyne Pharmaceuticals Inc., which markets the drug as Darvon® and Darvocet®. The difference between the two painkillers is that while Darvon® is composed entirely of propoxyphene, Darvocet® combines propoxyphene and acetaminophen.

Some of the other limitations of propoxyphene-containing medicines include:
·         As weak painkillers, they provide minimal benefits.
·         The combination of propoxyphene and acetaminophen (Darvocet®) is no more effective than acetaminophen on its own.
·         The difference between the dose needed for treatment and a harmful dose is too small, increasing the potential for overdose.
·         As an opioid, it is also addictive.

“The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.” – FDA News Release, November 19, 2010.

Severe and even fatal responses to Darvon® and other pain medications containing propoxyphene have been reported, such as:
Death
Heart Attack
Heart Arrhythmia
Suicide
Overdose

If you or a loved one have experienced any side effects such as these from taking these medications, please contact us as soon as possible for a free potential claim evaluation.  Please fill a form out on this website or call our toll free number for additional information.   Always consult carefully with your doctor prior to stopping any medication.

Side-Effects of Januvia® and Janumet® currently being investigated by The Mulligan Law Firm:

Severe and even fatal responses to Januvia® and Janumet® have been reported, such as:

•Death, Acute Pancreatitis, Necrotizing Pancreatitis, Hemorrhagic Pancreatitis

and

•Cutaneous Vasculitis

If you or a loved one have been prescribed Januvia or Janumet and have experienced any of these side-effects, please contact us immediately for a free consultation.

Always see your physician before you stop taking any medications, including Januvia® or Janumet®. 

If you have taken Januvia and have questions, please do not hesitate to contact us immediately.

The DePuy Articular Surface Replacement Hip Implant is a hip replacement cup manufactured by DePuy, a division of Johnson & Johnson.  DePuy Orthopaedics withdrew the hip device after more than two years of reports that the hip implant, called an ASR, failed in patients only a few years after implant.  This failure required costly and painful replacement operations. 

The device was first used in the United States in 2005.

Withdrawn from the Australian Market in December 2009, it is under scrutiny in the U.S. and has been withdrawn from the domestic market.

The FDA has received, beginning in 2008, about 300 complaints about the early failure of the implanted device.

On March 9, 2010, DePuy announced that the DePuy ASR Hip Replacement would be discontinued in the U.S. market because it was failing and requiring remedial surgeries.

The same release mentions a higher failure rate in smaller-boned patients and those with certain bone weaknesses.

There is no FDA recall at this time.  Please check back at this website for updates from time to time.

The ASR hip cup is a metal-on-metal ball and socket, large diameter hip resurfacing device.

The cause of the DePuy ASR Cup hip implant failures is still not known. 
 
Metal debris early in the life of this implant can cause inflammation, leading to damaged muscles and soft tissue.

Among the primary and most serious side-effects mentioned in the ASR hip cup revision reports:

>Implanted cup loosening or failing to bond
>Pseudotumour: a soft tissue mass that may be the result of a toxic reaction to an excess of particulate metal wear debris.
>ALVAL (Aseptic Lymphocyte Dominated Vasculitis Associated Lesion): an adverse tissue reaction to metal particles and ions.
>Metallosis: condition of excessive metal debris.

If you or a loved one has been seriously injured after surgical implantation of a DePuy Acetabular Cup, please contact us immediately for a free consultation as soon as possible.