Claudine Homolash Featured on "Legally Speaking" WMPV 1440 on April 4

I was featured on Radio Show, "Legally Speaking," on WMPV 1440 on Wednesday, April 4, 2012. www.wnpv1440.com Click on the image below to listen to the program.

Topics included pharmaceutical whistleblower cases, cash payments made to doctors by pharma co.'s and general discussion about pharmaceutical injury cases.

Fosamax, Actonel and Boniva May Cause Femur Fractures and Esophageal Cancer

Two FDA committees on Sept. 9 recommended that labels for bisphosphonate drugs be changed due to the risk of fractures.

In a 17-6 vote, the committees said the FDA should clarify how long patients should take the drugs, which are prescribed to treat osteoporosis.  The committees were the Reproductive Health and the Drug Safety and Management advisory committees.
The drugs, sold as Fosamax, Actonel and Boniva, have previously been linked to osteonecrosis of the jaw (ONJ), a condition in which new jaw bone fails to grow and the jaw "dies." More recently, studies have linked the drugs to fractures of the femur and to esophageal cancer.

Litigation of claims for ONJ has been ongoing in a multidistrict litigation in the U.S. District Court for the Southern District of New York and in the Atlantic City Superior Court in New Jersey. An MDL for cases alleging femur fractures was recently created in the District of New Jersey.

If you or someone you know took either Fosamax, Actonel and Boniva and either suffered a femur fracture or have been diagnosed with esophageal cancer, please call Claudine Homolash at (215) 790-7379 or email chomolash@sheller.com

Artelon CMC Spacer Failures

On April 12, 2011, Pennsylvania Court of Common Pleas Judge Sandra Mazer Moss decided that all cases involving faulty Artelon Spacer implants should be treated as a mass tort. Complaints will be handled as one unified program and managed by Pennsylvania’s Complex Litigation Center.

The Artelon CMC Spacer

The Artelon CMC Spacer was developed by Artimplant AB and marketed by Small Bone Innovations, Inc. In 2007, the Food and Drug Administration approved the device for use in the United States.

The device was intended to treat early and mid-stage osteoarthritis that occurs in the carpometacarpal thumb joint. Osteoarthritis causes the cartilage to breakdown until the thumb joint can no longer provide cushioning for the bones. The Artelon CMC Spacer is supposed to provide a substitute cushion.

The implant only requires outpatient surgery. Doctors place a T-shaped plastic gauze near the base of the thumb at the wrist joint, where the first carpometacarpal joint is located. The spacer is “interpositional,” meaning that it goes between the trapezium bone and the first metacarpal bone.

Artelon CMC Spacer Failures

Artimplant AB and Small Bone Innovations, Inc., claim that the spacer is biocompatible and degradable. They contend that the device offers joint stability, faster recovery, and less pain.

Unfortunately, the manufacturer’s claims have not been born out over the last few years. The FDA has received numerous adverse event reports related to defective Artelon CMC Spacers. Moreover, recent medical studies have shown that the Artelon CMC Spacer is failing at a high rate.

On many occasions, patients have had to undergo painful revision surgeries to have the defective Artelon implant removed. Patients complain of:

• inflammation
• swelling

Other symptoms include:

• Shooting or burning pain
• Limited range of motion with hand
• Thumb has become misshapen

Some patients have even reported that the Artelon Spacer breaks apart while in the hand, requiring immediate secondary surgery. In many cases, these additional procedures require the surgeon to remove tendons from other areas of the body in order to repair the thumb joint. Still other patients have experienced permanently misshapen thumbs as a result of the faulty Artelon Spacer.

If you or a loved one has been injured by a faulty Artelon Spacer, please call attorney Claudine Q. Homolash at (215) 790-7379 for a free consultation.

Free Text Link

CVS pays $17.5 Million to Settle Medicaid Fraud Lawsuit

Stephani LeFlore, as Relator for the United States v. CVS Pharmacy, Inc. -
CVS, the giant retail pharmacy chain, has agreed to pay $17.5 Million to settle a whistleblower lawsuit accusing it of Medicaid fraud.  According to her False Claims Acts lawsuit, CVS pharmacist Stephani LeFlore of Minnesota brought evidence to the government that CVS used a billing system for years that was designed to overbill Medicaid on prescription charges.  The billing was done in relation to dual-eligible customers - those legitimately on Medicaid who also maintained their private health insurance coverage. The insurance coverages required CVS to charge the insurance company a smaller amount for prescriptions, and limited co-pay from the customer. When a person is allowed Medicaid coverage, the government always obtains an assignment of the person's rights under their private health insurance coverage. The government essentially takes over the citizen's rights under the coverage. This includes the common right to pay a smaller co-pay amount on prescriptions.

Ms. LeFlore claimed in her federal and state lawsuits that CVS should only have billed the Medicaid program the same limited co-pay on prescriptions that it would have normally billed the customer under the insurance plan.  She alleged that CVS designed a billing software program for its pharmacies that consistently overcharged Medicaid on these co-pays.  She claimed that these overcharges occurred on hundreds of thousands of prescription sales for well over five years.

The $17.5 Million settlement covers over-billings by CVS in the states of Minnesota,California, Massachusetts, Michigan, Florida, Indiana, Alabama, Nevada, New Hampshire and Rhode Island.

Ms. LeFlore first complained internally, but she was told by a supervisor that “corporate took care of the billing” and that she need not be concerned.
The lawsuit stayed under seal (non-public), according to the False Claims Acts and court orders, until the announcement of this settlement. The civil reward totaled $2,595,460.00.

This case is just another example of the way in which Medicaid fraud occurs.  In my professional experience, usually whistleblowers try to report the fraud internally and hope that the company will "do the right thing" before they actually bring information to the government.  In this case, Ms. LeFlore reported it to CVS and she was told that corporate took care of the billing.  This is another lesson for companies to better their internal reporting structures. 

Claudine Q. Homolash, Esq. is an attorney who represents whistleblowers in a variety of lawsuits, including pharmaceutical fraud and billing.  She can be reached at (215) 790-7379 or chomolash@sheller.com

Johnson & Johnson . . .ANOTHER RECALL!

Johnson & Johnson is yanking two lots, or about 57,000 bottles, of its Topamax epilepsy drug (100 mg tablets). These were distributed in the U.S. last fall and winter, but J&J’s Ortho-McNeil Neurologics unit believes only about 6,000 are still circulating. Topamax has recently been in the news because on March 4, 2011, the FDA informed OB/GYN doctors and neurologists about new data demonstrating that infants born to women treated with Topamax during pregnancy have an increased risk for developing cleft palate or cleft lip.

Interestingly, Topamax is also widely prescribed “off-label” for weight management, or night eating. The drug has an appetite suppressant effect.

Why are the lots being pulled? There were four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a chemical used in wooden pallets that transport and store packaging materials.

J&J maintains no adverse events have been reported. In any event, this latest recall adds to a long and impressive list of products that J&J has pulled over the past year due to assorted manufacturing gaffes - tens of millions of over-the-counter meds, including Tylenol, Motrin and Benadryl; contact lenses, syringes and hip replacement devices.

Makes you wonder who’s in charge of manufacturing these drugs and whether J&J is properly overseeing their manufacture? This could potentially become a big issue for J&J -- let’s not forget the recent whistleblower, Cheryl Eckard, who was the catalyst for an investigation into GlaxoSmithKline’s plant in Cidra that ultimately led to GSK receiving a $750 million fine for manufacturing adulterated medicines.  The whistleblower received $96 million for reporting the misconduct. Watch out J&J ... you could be next!

Claudine Q. Homolash, Esq. is a partner at Sheller, P.C. who represents pharmaceutical whistleblowers, as well those injured by dangerous pharmaceutical products and medical devices. She can be contacted at (215) 790-7379 or at chomolash@sheller.com

REGLAN LITIGATION DESIGNATED A MASS TORT IN PHILADELPHIA COUNTY

The Honorable Judge Sandra Moss of the Philadelphia Court of Common Pleas has designated the Reglan® litigation a "mass tort." I recently had the pleasure of interviewing Judge Moss concerning the mass tort system. My article was published in The Verdict, a publication of the Philadelphia Trial Lawyers Association. http://sheller.com/uploads/Homolash_PTLA_article_on_Judge_Moss.pdf
I serve on the association's Future Leaders' Committee, a small group of attorneys thought to be the future leaders of the organization.

The anti-nausea medication Reglan®, or metoclopramide, is prescribed to treat gastrointestinal disorders such as acid reflux, diabetic gastroperesis and nausea. Reglan® increases stomach and small intestine contractions and can be prescribed to children, adults and pregnant women.

The Food and Drug Administration has only approved Reglan® for short term use, however, a third of its users are on the drug for a year or longer and are classified as long-term users. A number of serious side effects have been associated with continuous use of Reglan® including dangerous neurological conditions.

Patients taking Reglan® can develop the condition known as tardive dyskinesia. Tardive dyskinesia is a neurological condition that causes the patient to suffer from jerky and involuntary movement in the face, lips, tongue, mouth, and sometimes other parts of the body. Tardive dyskinesia is often incurable and can permanently debilitate the patient.

I have experience representing individuals suffering from tardive dyskinesia in other drug injury litigations which will benefit you greatly in the Reglan litigation.

If you or someone you know have taken Reglan® and are now suffering from severe neurological conditions such as tardive dyskinesia please contact me at chomolash@sheller.com or 215-790-7379 today.

Claudine Homolash Named Lawyer on the Fast Track 2009

Following are the names of the 30 Pennsylvania attorneys who have been selected as this year's "Lawyers on the Fast Track." Claudine Homolash is one of these attorneys.

With the help of editorial staff of The Legal Intelligencer and the Pennsylvania Law Weekly , a panel of judges has selected from your nominations these individuals as the future leaders of the state's legal community:

Michael Berry, Levine Sullivan Koch & Schulz

Todd A. Borow, Johnson Matthey

Shanon J. Carson, Berger & Montague

Frank A. Dante, Blank Rome

Michael Drossner, Drossner Law

Megan J. Duryea, Fox Rothschild Amy C. Foerster, Saul Ewing

Anthony L. Gallia, Duane Morris

Paulyne A. Gardner-Smith, Nelson Levine de Luca & Horst

John R. Gotaskie Jr., Fox Rothschild

Michael B. Hayes, Montgomery McCracken Walker & Rhoads

Claudine Q. Homolash, Sheller

Nikki Johnson-Huston, City of Philadelphia Law Department

Jennifer Lin, Philadelphia District Attorney's Office

John D. Martini, Reed Smith

Mary C. McGinley, Meyer Unkovic & Scott

Stephanie J. Mensing, Wisniewski & Mensing

Susan V. Metcalfe, McNees Wallace & Nurick

Joe Nguyen, Reed Smith

Michael D. O'Mara, Stradley Ronon Stevens & Young

Paul Thomas Oven, Dougherty Leventhal & Price

Gregory T. Parks, Morgan Lewis & Bockius

Riley H. Ross III, Drinker Biddle & Reath

Rachel Castillo Rosser, Eckert Seamans Cherin & Mellott

Matthew M. Ryan, Duane Morris

David G. Shapiro, Dechert

Shari Shapiro, Obermayer Rebmann Maxwell & Hippel

Erica Smith-Klocek, McCarter & English

Tracy L. Steele, Morgan Lewis & Bockius

Mark D. Villanueva, McCarter & English

Full profiles of this year's honorees will be included in a supplement to be published in the Legal on Monday, Sept. 28. The winners will also be honored at a dinner at the Doubletree Hotel in Philadelphia Thursday, Oct. 22. For information on purchasing tickets, contact Lana Ehrlich at 215-557-2392. •

Reglan Linked to Serious Side-Effects

Reglan (metoclopramide) is a prescription drug used to treat certain gastrointestinal conditions such as diabetic gastric stasis and gastric reflux, or heartburn. Reglan is a dopamine antagonist that increases lower esophageal sphincter pressure and improves gastrointestinal emptying.

Reglan, manufactured by Baxter Healthcare Corporation, was FDA-approved for short-term treatment only after other methods of treatment have failed. However, evidence shows that one-third of patients are prescribed Reglan for longer than 12 weeks, which is against FDA recommendations.

Some of the more serious Reglan side effects are:

- Tardive dyskinesia - involuntary muscle movements, usually in the face and tongue, but sometimes in the trunk or extremities or Neuroleptic Malignant Syndrome (NMS)
- Parkinson's-like symptoms - slow movements, rigidity, and tremors
- Akathesia - a severe anxiety and inability to sit still
- Suicidal Tendencies and other mental depressions
- Seizures and convulsions

Some of these side effects progressively worsen and may eventually become irreversible. The label on Reglan does advise of these side effects but states that the incidence is rare. Yet studies have shown that the use of Reglan can cause Tardive dyskinesia in as many as 27% of its long-term users.

I am currently evaluating Reglan cases. If you or someone you know has experienced adverse side-effects from the use of Reglan similar to those listed above, please call me at (215) 790-7379. Evaluation of your case is free. Waiting too long may compromise your legal rights.

Critics blast feds' legal shields for manufacturers

On June 29, 2008, the Chicago Tribune published an article recapping Bridget Robb's horrific tale of being shocked 31 times in 13 minutes due to a faulty, Medtronic Sprint Fidelis Lead. The article is one of many discussing how injured people, like Ms. Robb, are many times are precluded from recovering for their injuries due to a legal doctrine called "preemption." In effect, injured individuals are precluded from recovering against a company for defects in a product's design and labeling.

Proponents of preemption argue that manufacturers are not insurers and the FDA always has the option of holding a product from the market. During the June 11, 2008 Senate Judiciary Committee hearing at which Ms. Robb testified, Senator Specter called the FDA a joke and said that it is ludicrous to have preemption by an agency that is dysfunctional.

Before the hearing abruptly came to a halt because of a 2-hour rule invoked by a certain Republican Senator, Senator Whitehouse discussed "Regulatory Capture" -- which is when an agency that purports to be a public agency is taken over by the groups it was meant to regulate. Senator Whitehouse believes that the FDA falls within this definition.