DANGEROUS DRUGS, MEDICAL DEVICES AND BLOWING THE WHISTLE ON BIG PHARMA

Novartis' blood pressure medication Tekturna®, TekturnaHCT®, Valturna®, Tekamlo® and Amturnide® Linked to Cardiovascular and Renal Side-Effects, Including Stroke

2011-12-20T14:07:00.001-05:00

Bad news for Novartis' blood pressure medication Tekturna®, TekturnaHCT®, Valturna®, Tekamlo® and Amturnide®. Novartis has decided to end a trial evaluating the med in Type 2 diabetes patients with renal impairment who are also at high risk of cardiovascular and renal events after researchers saw an increased number of adverse events--including nonfatal stroke, renal complications, hyperkalemia and hypotension--in the Tekturna plus standard of care arm.

There are many treatments for high blood pressure, but Tekturna works differently versus other meds. The company was trying to establish with this and other studies whether Tekturna, if taken over a longer period of time could protect key organs, such as kidneys and the heart, Dow Jones notes.

The company says it is in ongoing talks with health authorities worldwide about the implications of the trial's findings. As a precautionary measure, Novartis will cease promotion of Tekturna-based products for use in combination with an ACE inhibitor or angiotensin receptor blocker (ARB).

Kepler's Martin Voegtli notes that the higher number of adverse events with the Novartis drug was a "major setback" and could lead to the drug being pulled from the market, according to a Bloomberg report. And it also could serve as bad news to members of Novartis' sales force. Some analysts are speculating that Novartis will now accelerate plans to reduce its sales force in the U.S. to cut costs. In fact, Deutsche Bank estimates that the Swiss drugmaker may reduce as many as 1,000 sales jobs as a direct result of the study results, according to Dow Jones. The drugmaker hasn't commented on this prediction.

"The finding comes very unexpected," says Vontobel's Andrew Weiss, who once saw Tekturna as generating peak sales of about $2.9 billion if it could be shown that the drug had additional benefits for key organs if taken over a long period of time. Now, however, he will reduce his sales estimates.

Novartis predicts in its statement that Tekturna sales "are likely to be negatively impacted by the study results going forward."

Call Claudine Homolash, Esq. at Sheller, P.C. at (215) 790-7379 or (215) 790-7359 for a free case evaluation.

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

2011-09-16T09:48:00.000-04:00

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 me at chomolash@sheller.com

Artelon CMC Spacer Failures

2011-06-02T11:41:00.002-04:00

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 and swelling. Other symptoms include:
- Shooting or burning pain
- Inflammation
- Swelling
- 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.

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CVS pays $17.5 Million to Settle Medicaid Fraud Lawsuit

2011-04-19T12:34:00.000-04:00

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

Claudine Homolash Presents LexisNexis Webinar on False Claims Act

2011-04-18T11:28:00.000-04:00

On April 5, 2011, Claudine Q. Homolash presented, with a panel of legal experts, a Webinar on the False Claims Act ("FCA"). The Webinar entitled, "Whistleblowers: Friend or Foe to Industry, Litigation and Society?" was a huge success, with over 160 attendees. Ms. Homolash's presentation focused on liability under the FCA, newly adopted provisions, and how plaintiffs build a case.

Ms. Homolash represents whistleblowers in a variety of cases, including cases involving off-label marketing, illegal kickbacks and "best price" against pharmaceutical companies. Ms. Homolash's experience litigating against pharmaceutical companies in the mass tort arena provides her with a legal edge in whistleblower cases against big pharma.

Contact Ms. Homolash at chomolash@sheller.com or (215) 790-7379 for a free consultation.

Johnson & Johnson . . .ANOTHER RECALL!

2011-04-14T14:21:00.000-04:00

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

J&J DIDN'T PROOFREAD!

2011-02-25T14:01:00.003-05:00

Johnson & Johnson just can’t seem to do anything right. On top of all the quality-control problems that have led to tens of millions of product recalls for over-the-counter meds, syringes, contact lenses and hip replacement devices, now J&J is recalling more than 660,000 Sudafed packages because the labeling has an extra ‘not’ in the instructions. FOR REAL!!

A notice on the J&J web site says the McNeil Consumer Healthcare initiated the recall at the wholesale level “due to a typographical error in the directions section on the label, which incorrectly repeated the word ‘not’ as follows: ‘do not not divide, crush, chew, or dissolve the tablet.’ To date there have been no reports of adverse events caused by this labeling error.”

Proofreading is a big pet peeve of mine but I do sympathize with whoever made the typo. I’ve made my fair share. And in the grand scheme of things, it’s not as bad as the faulty hips that leech cobalt and chromium particles causing tissue death, musty smelling tablets, cracked syringes or contact lenses that cause stinging eye pain!

J&J Accused of Fraud - Risperdal

2011-02-25T13:47:00.000-05:00

A former Johnson & Johnson sales manager accused the health care giant of concocting various schemes to defraud federal and state Medicaid programs in a lawsuit that was filed in 2005, but only recently unsealed amid a transfer of the litigation from a federal court in Pennsylvania to another in Massachusetts.

The lawsuit was filed by Scott Bartz, a New Jersey resident who worked as a sales compensation manager from 1999 until 2007, when he alleges he was terminated in retaliation for repeatedly complaining about illegal marketing practices. His lawsuit also names the Omnicare nursing home operator and McKesson, the pharmaceutical wholesaler.

In his Complaint, Bartz charged J&J manipulated sales data; reported false prices to various government health programs, and paid kickbacks, such as rebates, so its Risperdal Consta antipsychotic and Razadyne Alzheimer’s treatment would be more widely prescribed. He also alleged J&J practiced channel stuffing, an accounting gimmick used to boost sales to distributors at year’s end.

The lawsuit, which is one of many filed in federal court in Boston that accuse J&J of such practices, has been amended twice, but the latest version remains under seal. The feds, however, have not intervened, or joined, his lawsuit. For his trouble, Bartz suffered a heart attack at age 44, despite being in good health, due to the stress associated with filing on-the-job complaints and was unable to find work, prompting his lawyers to help arrange for loans, according to court documents.

Last November, J&J disclosed talks were being held with the feds about settling charges of illegal marketing of its Risperdal antipsychotic after denying claims contained in a separate lawsuit that made claims similar to those alleged by Bartz. The lawsuit was disclosed by Omnicare in a filing with the Securities and Exchange Commission and first reported by Dow Jones.

SHELLER P.C. represents many people who have been injured by the drug Risperdal and its related version, Invega.

Court Ruling Allows Consumer Case to Proceed Against Cell Phone Manufacturers

2011-01-28T15:50:00.002-05:00

On January 10, 2011, the Superior Court of the District of Columbia in Dahlgren v. Audiovox, et al., No. 2002 CA 007884B, issued an opinion, upholding consumer claims under the D.C. Consumer Protection Procedures Act that cell phone manufacturers failed to disclose and misrepresented a variety of material information about their cell phones – including information about how to reduce exposure to potentially harmful radiofrequency waves, which cell phone accessories should be avoided and why, the potential for increased exposure to children using cell phones and that the cell phone manufacturers themselves (rather than the FCC) test and certify their cell phones. Plaintiff Dahlgren has also brought these claims on behalf of the General Public of the District of Columbia against these manufacturers as a private attorney general.

If you have any questions regarding this case or would like to discuss your rights and interests in this matter, please contact Claudine Q. Homolash of our Philadelphia, PA office toll-free at 800-223-2299 or by email at info@sheller.com.

Use Of Avastin or Sutent and I.V. Bisphosphonates May Increase Osteonecrosis of Jaw (ONJ) Risk

2010-12-07T22:49:00.005-05:00

MHRA Warns UK Doctors To Monitor Cancer Patients For ONJ Where There Is Concomitant Use Of These Drugs - Pfizer Sends "Dear Doctor" Letter in the UK but Not to Doctors in the U.S.

On November 30, 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) issued two new safety warnings to doctors and other healthcare providers in the UK concerning the cancer drugs Avastin and Sutent.

The first item, "Avastin (bevacizumab) Cases of osteonecrosis of the jaw in patients with cancer treated with bevacizumab and concomitant or previous use of bisphosphonates", simply identified the nature of this emerging drug safety issue:

Cases of osteonecrosis of the jaw (ONJ) have been reported in cancer patients in association with Avastin treatment, the majority of whom had received prior or concomitant treatment with i.v. bisphosphonates.

Avastin treatment may be an additional risk factor for the development of osteonecrosis of the jaw....

Avastin is from the drug company Roche.

The second item, "Sutent (sunitinib) Cases of osteonecrosis of the jaw in patients with cancer treated with sunitinib and concomitant or previous use of bisphosphonates", included a so-called "Dear Doctor" letter from Pfizer with some more information about the extent of this problem, at least as it regards Sutent:

From 26 January 2006 (International Birth Date [IBD]) through 31 January 2010, the worldwide estimated exposure to Sutent is 101400 including post-marketing and clinical trials worldwide.

Overall, a total of 27 cases of ONJ have been reported as of 31 January 2010....

To date, Pfizer has only issued a Dear Doctor Letter in the UK even though Sutent is also sold in the U.S.

If you have suffered an injury related to Avastin or Sutent and have questions regarding your legal rights, please call me.

Claudine Homolash, Esquire
(215) 790-7379
Sheller, P.C.

DePuy Hip Replacement - DePuy ASR and Corail Hip System

2010-09-28T14:33:00.003-04:00

Claudine Q. Homolash - Product Liability Attorney
(215) 790-7379
Advances in medicine now enable people with joint problems to replace their diseased cartilage and bone with artificial prostheses. One of the most common replacement surgeries is the hip implant, which allows patients to maintain reasonably active lifestyles without the pain that is often associated with a degenerative hip. Of the many companies that manufacture joint replacement components, Johnson and Johnson, parent company of DePuy Orthopaedics, Inc., has recently been in the news for a recall issued in July for its DePuy ASR system, and for marketing the Corail Hip System using illegal methods.

A DePuy ASR hip recall was issued in July, 2010 due to a high failure rate of the metal-on-metal hip implants. A number of lawsuits have been filed by individuals who have experienced problems and complications after receiving DePuy hip replacement products. Patients who had the system implanted may suffer when metal particles shed into the body from the metal-on-metal design. The particles can cause soft tissue damage, inflammatory reactions, and bone loss. Between 2007 and 2009, more than 500 patients reported problems with their hip replacement devices. To resolve the problem, patients may need to have the devices replaced, and treatment for additional surgeries, inflammation, bone loss and soft tissue damage can be extensive.

The FDA issued a warning letter to DePuy Orthopaedics, Inc. president David Floyd on August 19, 2010, ordering the company to halt marketing the Corail Hip System. The Corail system was approved under the FDA's premarket approval system, an expedited process that requires medical devices to be functionally equivalent to devices already on the market in order to fast-track the approval process. However, according to the warning letter, DePuy's brochure about the device lists a number of claims that were never approved by federal regulators.

If you have received a hip implant in the last few years, you should contact your doctor to determine the model of your implant. This should be done even if you are not presently experiencing any negative side effects because serious problems could arise at any time. If it turns out that you are in fact depending on a potentially defective hip implant, you should take action to protect your rights. Contact Claudine Homolash at (215) 790-7379 so I can help you pursue financial compensation for the pain, suffering, and medical costs that you have sustained as a result of these unsafe hip replacement devices.

While medical technology has helped relieve the suffering of many people, the Institute of Medicine estimates that almost 1.3 million Americans are injured or die as the result of faulty medical products. Claudine Homolash, Esq. represents the injured victims and families of those who have died because the makers and suppliers of medical devices failed in the design, marketing promises, or the manufacturing of their products. If you experienced any problems after receiving a DePuy hip replacement, it is important that you immediately contact a qualified personal injury attorney who is familiar with product liability claims and the tactics of corporations and insurance companies. Call the experienced lawyer, Claudine Homolash at (215) 790-7379.
If you hesitate to file suit within the specified time limit, you may lose your opportunity forever.

DePuy ASR Hip Replacement Recall - CALL ME AT 215-790-7379 or EMAIL ME AT chomolash@sheller.com

2010-09-23T16:57:00.001-04:00

DePuy has issued a recall for its ASR hip implants that will affect thousands of patients. If you've been harmed by the DePuy ASR hip replacement recall, filing a hip replacement lawsuit to seek compensation for your injuries is your right.
ASR hip replacement systems are the subject of a recall by manufacturer DePuy Orthopedics. DePuy ASR hip replacements have had an unusually high failure rate, and many people who have received DePuy hip replacements have had to undergo multiple, painful surgeries to replace the defective hip implant. If you've been harmed by a DePuy ASR hip replacement, it's your right to file a hip replacement recall lawsuit against DePuy and seek compensation for your injuries.

Do I Have Grounds for a Hip Replacement Lawsuit?
If you have received a DePuy ASR hip replacement since 2003 you may have grounds for a lawsuit against DePuy. The ASR hip replacements have an unusually high failure rate and can become loose and fracture the bone around the implant, the implant's ball and socket can become dislocated, and metal from the implant can even flake off and enter the bloodstream. Orthopedic specialists have been calling attention to the high failure rate of ASR hip replacements for years, and both DePuy and its parent company Johnson & Johnson have been warned by the FDA numerous times about defective products.

If you or a loved one received a hip replacement anytime after 2003 and has had any pain or complications resulting therefrom, please email or call Claudine Homolash at chomolash@sheller.com or 215-790-7379 for a free consultation.

SCOTUS Restricts Whistleblower Suits

2010-03-31T15:04:00.002-04:00

The Supreme Court ruled 7-2 Tuesday to limit the grounds for some lawsuits brought by whistle-blowers claiming fraud in US health care, defense and other programs. USA Today notes that the "overall effect of the decision is likely to be narrow because Congress amended the disputed provision as part of the health care overhaul that became law March 23." At issue, according to USA, "was the scope of the False Claims Act, first enacted during the Civil War to elicit help from ordinary citizens against contracting fraud. The new case and the recently passed legislation put a spotlight on whistle-blowers who uncover fraud through the help of state or local audits that normally would not come to the federal government's attention."

The National Law Journal (3/31, Coyle) reports, "In Graham County Soil and Water Conservation District v. US ex rel. Wilson, Justice John Paul Stevens, writing for a 7-2 majority, held that whistleblowers whose allegations are based on publicly disclosed information in state or local reports and investigations are barred from filing so-called qui tam lawsuits. The Court's decision -- which also drew the first dissenting opinion by Justice Sonia Sotomayor -- said the act's public disclosure bar was not limited to federal sources of information" but "as Stevens noted, both in his opinion and his summary on the bench, the Patient Protection and Affordable Care Act, signed by President Barack Obama on March 23, limits the public disclosure bar to federal sources of information. The new act, however, is not retroactive, so the Court's decision will apply to claims filed before its effective date."

Bloomberg News (3/30, Stohr) reported, "Business trade groups had urged the Supreme Court not to expand the False Claims Act, saying the upshot would be new burdens on companies. Lawsuits under the False Claims Act have recovered more than $24 billion since Congress strengthened the law in 1986." The AP (3/30) also covered the story.

Eighth Circuit Sets New Date for Oral Argument on Appeal of Federal Case Dismissal

2010-03-31T15:00:00.001-04:00

The Eighth Circuit Court of Appeals has notified the parties of a new date for oral argument in plaintiffs’ appeal of the dismissal of complaints against Medtronic for its faulty heart devices. The appeal will now be heard on April 12, 2010, in St. Louis, Missouri. Oral argument had originally been set for January 2010. The state court appeal date has not yet been scheduled. The parties are still briefing their sides of the case.

REGLAN LITIGATION DESIGNATED A MASS TORT IN PHILADELPHIA COUNTY

2010-02-03T10:49:00.009-05:00

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

2009-08-03T10:48:00.001-04:00

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. •

Medical Device Safety Act Hearing before the Senate HELP Committee

2009-08-03T10:38:00.004-04:00

Tomorrow we will hear from the following people regarding the Medical Device Safety Act, at at hearing before the Senate HELP Committee entitled, "Protecting Patients from Defective Medical Devices,":
- William H. Maisel, MD, MPH, Director, Medical Device Safety Institute,Beth Israel, Deaconess Medical Center, Harvard Medical School, Boston, MA
- Professor Thomas O. McGarity, Joe R. and Teresa Lozano Long Endowed Chair in Administrative Law, University of Texas School of Law, Austin, TX
- Michael Mulvihill, Patient, Bettendorf, IA
- Peter Barton Hutt, Esq., Senior Counsel in Food and Drug Law, Covington & Burling, Washington, DC
- Michael Roman, Patient, Kirkwood, MO

For those who are not aware, the Medical Device Safety Act of 2009 will restore patients rights to sue a manufacturer of a faulty / defective medical device when they have been injured. The current state of the law provides a 'Get out of jail for free' card to device manufacturers so long as their device is FDA-approved. Without this law, patients will have no recourse for their injuries, and the cost will be shifted to taxpayers for medical bills, among other things. Medical device manufacturers should be accountable for their products, and allowing lawsuits will ensure that device manufacturers put the safest products on the market. We've learned from many other product liability lawsuits that large companies many time put profits over people. A Lawsuit is just one of the many mechanisms that will provide adequate checks and balances.

The hearing will begin at 2:30 p.m. on August 4, 2009 in SD-430.

Medtronic Paid $800,000 to a Surgeon Accused of Falsifying Study

2009-06-18T21:41:00.003-04:00

Meditronic, the well-known medical device maker, is in the headlines once again. This time, Medtronic says it paid approximately $800,000 over the past 3 years to a former Army surgeon accused of fabricating a study that reported positive results for one of the company's key spine products. This type of pay isn't too shabby for writing falsities!

Some of the consulting payments were made when the surgeon, Timothy R. Kuklo, was shopping his favorable study of Medtronic's Infuse bone-graft product to medical journals. The paper, ultimately published last August in the Journal of Bone and Joint Surgery, reported advantages in healing the legs of injured soldiers when Infuse was used.

The Army has said that the study is based on "falsified information" and that Dr. Kuklo forged the signatures of purported co-authors. Dr. Kuklo listed his affiliation with Walter Reed Army Medical Center in the journal. He left the Army hospital in August 2006 and joined the faculty of Washington University in St. Louis.

Medtronic disclosed the payments to The Wall Street Journal Wednesday. Of course, Medtronic says the payments were compensation for Dr. Kuklo's work developing products for the company, training doctors and speaking at company events and that they weren't connected to the study or journal article in any way.

Bone and Joint Surgery withdrew the paper after the Army contacted it about the fraud allegations. Dr. Kuklo, who has taken a leave from the university, hasn't commented publicly on the matter and didn't return a message left at his home Wednesday. The university declined to say whether it was investigating Dr. Kuklo.

In 2007, Dr. Kuklo offered the study to at least two medical journals, according to the publications. Medtronic says it paid him $356,242 that year for consulting, speaking, travel and training services. In 2008, the year the study was published, Medtronic says it paid Dr. Kuklo $249,772. While Medtronic says that its consulting arrangements with surgeons are critical to the development of new products, its payments to surgeons who use its spine products are under investigation by the Justice Department following accusations by several former employees that the doctors were being induced to use the products -- allegations the company denies.

Medtronic last year provided Congress with a list of 22 consultants who worked specifically on Infuse-related matters. The payments to those doctors ranged from $100 a year to $67,600. Surgeons with more general consulting arrangements, such as Dr. Kuklo, can earn a lot more. Jeffrey Wang, chief of spine surgery at the University of California, Los Angeles, reported receiving $186,700 in product development, royalty and teaching payments from Medtronic from 2004 through 2007.
Medtronic placed its consulting relationship with Dr. Kuklo on "inactive status" in May, when the Army disclosed it had found problems with the study. In the first few months of 2009, it paid him $132,453. Medtronic also says it paid Dr. Kuklo smaller amounts, including $42,627 in 2006, and picked up his expenses while he worked for the Army. The latter payments, which total $42,295 from 2001 through 2005, were primarily tied to travel to medical conferences and speeches at Medtronic events.

Hearing on the Medical Device Safety Act of 2009

2009-05-13T12:51:00.005-04:00

Yesterday, my client Bridget Robb testified before the Health Subcommittee of the House Energy and Commerce Committee at a Hearing, Chaired by Congressman Frank Pallone, on the Medical Device Safety Act of 2009. Also in attendance were witnesses:
· David Vladeck, J.D., Professor of Law, Georgetown University Law Center;
· William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute,
Department of Medicine, Beth Israel Deaconess Medical Center, Boston;
· Gregory Curfman, M.D., Editor, New England Journal of Medicine;
· Richard Cooper, Partner, Williams & Connolly LLP; and
· Michael Kinsley, Seattle, Washington

Ms. Robb’s testimony detailed the events of her tragic experience of being shocked by a defective medical device 31 times in front of her then five-year-old daughter. Since the event, Ms. Robb’s health has significantly declined and, she and her daughter suffer extreme anxiety related to the events of that day.

Professor Vladeck articulately summarized the current state of the law, its development over the years, and the Congressional intent behind the Medical Device Act – that preemption of state tort law claims was never meant to occur.

Dr. Maisel, who works with the FDA on a number of projects, supports the act and believes that it will assist in the development of safer products. Dr. Maisel testified that the FDA does not have the resources to be the sole gatekeeper of medical device safety. Dr. Curfman of the New England Journal of Medicine expressed the view that without litigation, the dangers of many drugs would never have been brought to light but for litigation and that he supports the act. Mr. Cooper and Mr. Kinsley too positions in favor of the device companies. Mr. Cooper frequently testifies in favor of device manufacturers. Mr. Cooper works for a firm that represents big business and was former counsel for the FDA. Mr. Kinsley, a political journalist who suffers from Parkinson’s and has a device implanted to relieve his symptoms, testified against litigation. Mr. Kinsley has taken an anti-litigation position for years being in the journalism industry. Mr. Kinsley did state that if a company knowingly withholds information from the FDA, they should be held accountable. He offered no opinion on whether the Seventh Amendment (the right to a jury trial) should be protected. His testimony turned into more of a sideshow at the hearing.

The recent decision rendered in Riegel v. Medtronic, gives medical device manufacturers complete immunity when it knowingly places and/or keeps on the market dangerous products. According to the current state of the law, so long as a device complies with FDA standards (even after significant adverse events have been reported) a company cannot be held accountable when their product fails and injures someone. Companies argue that innovation will be stifled; however, only for a short period of time has preemption been applied in medical device cases and for the time it was not applied, innovation was in no way protected.

Currently, consumers of medical devices are not protected when things go wrong and there is no accountability for manufacturers or incentive for manufacturers to make their products safer. Manufacturers keep faulty products on hospital shelves to save costs at the expense of peoples’ lives. Why should drug companies be held accountable and device companies not?

The companies unsuccessfully argue that this is an insurance issue – it’s not. Exorbitant medical bills are only one part of the damages this patients have. In cases like Ms. Robb’s, their lives are forever changed, with increased surgeries, medications and loss of ability to do things in live they were once able to do.

Please reach out to your Congressmen and Congresswomen and express your support for the passing of this law. You might be surprised that many of your representatives support big business over your constitutional right to a trial by jury and patient safety.

Hydroxycut Product Recall

2009-05-04T13:23:00.003-04:00

HYDROXYCUT PRODUCT RECALL

May 1, 2009 - the Food and Drug Administration (FDA) advised people to immediately stop using the dietary supplement (weight loss supplement), Hydroxycut, linking it to serious liver injuries and death. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss. Hydroxycut is available in most grocery stores, health food stores and local pharmacies.

In its warning, the FDA identified 23 reports of Hydroxycut causing liver damage.

The maker of Hydroxycut has agreed to the recall of all fourteen (14) of its products. The recalled products are:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Hydroxycut products are manufactured by Iovate Health Sciences, Inc. of Ontario, Canada and distributed in the U.S. by Iovate Health Sciences USA Inc., near Buffalo, New York.

SHELLER, P.C. is investigating Hydroxycut claims. We are reviewing cases in which a person taking Hydroxycut has suffered liver failure, a liver transplant or death from liver failure.

Please email me at chomolash@sheller.com or call me at (215) 790-7379 with any questions regarding your potential case.

Reglan Linked to Serious Side-Effects

2009-04-17T09:59:00.004-04:00

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.

RAPTIVA, Psoriasis Drug, Causes Brain Infection Risks

2009-04-09T09:30:00.006-04:00

April 8, 2009: Genentech and FDA announced a voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML).

PML is a brain disease that gets worse over time and can attack many parts of the brain at once. The brain infection is caused by a loss of white matter, a substance that protects nerve fibers in the brain. Without this white matter or myelin, nerve signals don't compute from the brain to the rest of the body. PML is caused by the reactivation of a common virus in the central nervous system of immune-compromised persons. The JC virus is carried by a majority of people and is considered harmless except for persons with lowered immune defenses. PML is most common among people with acquired immune deficiency syndrome (AIDS).

Symptoms vary but include clumsiness, gradual but progressive weakness, and a change in visual acuity, speech, and personality. These symptoms lead to a life threatening disability and can decline leading to death.

By June 8, 2009, Raptiva will no longer be available in the United States. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis.

History
On February 19, 2009, the FDA announced that people who take Raptiva are at risk for developing the rare fatal condition known as PML. The FDA issued a public health advisory concerning three confirmed, and one possible report of PML, a rare brain infection, in patients using the psoriasis drug Raptiva. Three of those patients have died. All four patients were treated with Raptiva for more than three years. None of the patients were receiving other treatments that suppress the immune system.

On October 16, 2008, the FDA issued a black-boxed warning to highlight the risks of life-threatening infections from Raptiva, including PML.

The EMEA ("European Medicines Agency"), Europe's version of the FDA announced that the risks of Raptiva outweigh the benefits and should no longer be prescribed.

Please contact me to discuss your case at (215) 790-7379.

Zimmer Durom Hip Implant Recall

2008-07-29T09:35:00.000-04:00

On July 24, 2008, Zimmer Holdings, the nation's largest producer of orthopedic devices, announced the suspension of sales of an artificial hip implant component due to a high failure rate. The medical device, a hip socket known as the Durom cup, was first sold in the U.S. in 2006 and has been implanted in 12,000 patients.

Physicians have complained that device is faulty with possibly hundreds of patients needing replacement surgery in the coming years. Zimmer has denied that the Durom hip implant is defective. Instead, Zimmer claims surgeons have failed to implant the device properly and was suspending its sale to provide doctors specialized training for the implant surgery.

Not all physicians have agreed with Zimmer's assessment. In April 2008, Dr. Lawrence Dorr, an orthopedic surgeon in Los Angeles, California, publicly warned other orthopedists about cup failures his patients were experiencing. When questioned on Zimmer's announcement, Dr. Dorr told the New York Times that he did not plan to start reusing it. "It is a bad design," he said.

The law in most states provides individuals with legal claims and the right to compensation for injuries they suffer as a result of a medical device that is defective or fails to perform as advertised. Patients may file a personal injury lawsuit seeking compensation for their pain and suffering, medical expenses including the cost of replacement surgery, lost past and future wages and punitive damages.

Claudine Homolash of Sheller, P.C. represents persons across America injured by defective and dangerous medical devices. Ms. Homolash can be reached at (215) 790-7300, or chomolash@sheller.com

Critics blast feds' legal shields for manufacturers

2008-06-30T09:16:00.003-04:00

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.

Minnesota News Channel Airs Bridget Robb's Story

2008-06-17T09:17:00.005-04:00

In Minnesota, where Medtronic is located, listeners heard the horrific events of Bridget Robb retold before the Senate Judiciary Committee. I can tell you firsthand that Ms. Robb is one of the bravest people I know. Invited to testify before the Senate Judiciary Committee by Senator Leahy, her main goal is to help others and to make sure that the terrible events of the morning of December 31, do not happen to others. During her testimony, Ms. Robb recounted the terror she experienced after being shocked 31 times due to a fractured Sprint Fidelis lead manufactured by Medtronic.

Ms. Robb's story is just one of many stories told where individuals have been severely harmed by dangerous products placed into the stream of commerce by big businesses that are more focused on profits than safety.

If you click on the title above, you will view a clip of Bridget testifying on June 11. We hope to continue this fight in an effort to make serious change. The law, as it stands, is not consumer friendly and flies in the face of people's fundamental rights to have their case heard in court.

BRIDGET ROBB TESTIFIES BEFORE THE SENATE JUDICIARY COMMITTEE ABOUT INJURIES FROM DEFECTIVE MEDTRONIC SPRINT FIDELIS LEAD

2008-06-16T16:42:00.010-04:00

On June 11, 2008, I had the pleasure of accompanying Bridget Robb, one of my clients, to Washington, D.C. to testify before the Senate Judiciary Committee, at a hearing entitled “Short-change for Consumers and Short-Shrift for Congress? The Supreme Court’s Treatment of Laws that Protect Americans’ Health, Safety, Jobs and Retirement.” Senator Patrick Leahy (D, Vt.) presided over the hearing. Witness testimony and the live hearing can be viewed at http://judiciary.senate.gov/hearing.cfm?id=3404

Ms. Robb courageously spoke about her harrowing experience with a Medtronic Sprint Fidelis lead in late 2007. Ms. Robb was shocked 31 times due to the defective cardiac lead, which had been recalled two months before her tragic incident. She never received notice of the recall. She described each shock as “if a cannon was being repeatedly shot at [her] chest at close range.” The event was made all the more terrible because our client’s telephone call to 911 was captured on tape, and the pain and agony of the numerous shocks is evident throughout the 7-minute call, which took place in the presence of her young child. Her experience was featured in a Good Morning America segment that ran on Wednesday morning before the hearing, which can also be viewed on the web at http://abcnews.go.com/GMA/OnCall/story?id=5044693&page=1

The hearing focused on how several recent decisions by the U.S. Supreme Court affected consumers’ health and safety, including preemption and ERISA.

Senator Leahy stated that he “called this hearing today to shine a light on how the Supreme Court’s decisions affect Americans’ everyday lives. Often, the Court’s rulings come into focus when they involve divisive cultural issues. Lately, however, many Court observers have noticed that business interests have been the big winners, over workers and consumers. In this worsening economy, mothers and fathers are struggling with health care coverage, the uncertainty of retirement, credit card payments and mortgages. Congress has passed laws to protect Americans in these areas, but in many cases, the Supreme Court has ignored the intent of Congress in passing these measures, oftentimes turning these laws on their heads, and making them protections for big business rather than for ordinary citizens.” During the hearing, Sen. Arlen Specter (R., Pa.) also spoke out forcefully on the failings of the FDA, calling the FDA "a joke."

Also testifying was Maureen Kurtek, a Harrisburg, Pennsylvania, resident, who offered personal testimony about how a recent ruling by the Supreme Court relating to ERISA preemption limited her right as a consumer to seek recovery for harmful practices by an HMO. Other witnesses include Andy Anderson, a lawyer with the law firm of Morgan, Lewis & Bockius LLP; Thomas O. McGarity, a law professor at the University of Texas School of Law; Richard M. Cooper, a partner with the law firm of Williams & Connolly LLP; and Robert Lawless, a law professor at the University of Illinois College of Law.

This hearing helped shed light on the profound effect that the failures of the Food & Drug Administration have on consumers, like Ms. Robb.

I am happy to answer any questions regarding the hearing or the recalled Medtronic Sprint Fidelis lead. Please contact me at (215) 790-7379 with any questions or to discuss your potential case. It is important that the horrible tragedy Ms. Robb experienced does not happen to others.

Tysabri Linked to Liver Injury, Including Death

2008-02-28T13:02:00.000-05:00

Drugmakers Biogen Idec Inc. and Elan Corp. Plc. have warned doctors of significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, after taking the multiple sclerosis drug Tysabri. These adverse effects occurred as early as six days after the first dose of the drug. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in people with jaundice or other evidence of significant liver injury.

The companies co-market the drug, with Biogen taking the lead in the U.S. The drug Tysabri is also used to treat people with Crohn's disease.

Claudine Homolash is a personal injury attorney in Philadelphia, PA, who focuses her practice representing individuals who have been injured by dangerous drugs and medical devices. Ms. Homolash was recently nominated for the National Multiple Sclerosis Society's 2008 MS Leadership Class and is familiar with the physical harm Tysabri may cause to certain individuals.

Riegel v. Medtronic -- Have You Lost the Right to Sue?

2008-02-07T15:26:00.001-05:00

We represent multiple clients who have experienced unnecessary shocking due to Medtronic's faulty lead. One client, in particular, was shocked over thirty times.

What is more frightening is the fact that the Supreme Court recently held oral argument on whether federally approved medical devices are broadly shielded from product-liability lawsuits. If the Supreme Court agrees with this big business position, many people who are injured due to faulty medical devices will be left with no recourse. It seems that big business has bought the FDA since it recently admitted that it cannot keep up with advances in science! The report, from a subcommittee of the FDA's outside Science Board that included members and advisers from industry as well as academia, said the agency "cannot even keep up with the advances in science." An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities -- including food, drugs and medical devices -- in 2006.

In Riegel v. Medtronic. The Riegel case was brought by a New York man, Charles Riegel, who was injured when a Medtronic catheter burst during a 1996 angioplasty procedure. Riegel, who died in 2004, asserted the catheter had design flaws and that labeling instructions for the device were misleading.

Allison Zieve, a Washington-based attorney representing Riegel, labored to convince the justices that federal law allowed Riegel to sue Medtronic over the device, which had received so-called premarket approval from the Food and Drug Administration.

"It is clear that Congress didn't want any additional requirements", Justice Antonin Scalia said, indicating he thinks Congress wanted the FDA to regulate medical devices without interference from state regulators or courts.

A majority of the Supreme Court appeared to support this view.

The BIGGER QUESTIONS - if the FDA has admitted that it can't protect the people and companies can avoid liability by having its products FDA-approved, what protections are afforded to the users of these products? What incentives do medical device companies have to protect the end user?

February 7, 2008 12:25 PM

PERSONAL INJURY LAWSUITS INITIATE CHANGE IN CHANTIX WARNINGS

2008-02-07T14:45:00.000-05:00

(Feb. 1, 2008) The FDA announced a public health advisory about abnormal behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior with Pfizer’s anti-smoking drug, Chantix. The FDA provided updated calculations reflecting the following:
- 491 cases of suicidal thinking or behavior, including 420 in the US. And of those, there were 39 suicides, including 34 in the US.

“We’ve become increasingly concerned as we see a number of cases that truly look like exposure to the drug and not other causes,” says Bob Rappaport, director of the FDA’s division of anesthesia, analgesia and rheumatology products, in a briefing this afternoon with reporters. As of now, he adds, “there’s no definitive evidence there’s a causal relationship” between Pfizer and the abnormal and suicidal behaviors. Although, the agency notes that “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”

The FDA started reviewing cases last November after national attention grew as a result of the case of Carter Albrecht. Albrecht was a guitarist and keyboardist with the band Edie Brickell & the New Bohemians. He died September 3, 2007 after being shot in the head by a neighbor as he tried to kick in his door.

Earlier that day, Albrecht had been having drinks with his girlfriend Ryann Rathbone at a local Dallas bar. After he become intoxicated, Rathbone drove Albrecht to their home where they both took their dose of Chantix. After that, Albrecht became incoherent and violent, breaking a glass and hitting Rathbone. When Rathbone left the house, Albrecht followed and she locked him out. He pounded on the door then went next door and began pounding on the neighbor’s door. The neighbor warned Albrecht to stop and fired a warning shot through the door, which hit Albrecht. Family and friends say that this type of violent behavior was atypical of Albrecht and believe that the use of Chantix caused the events.

Albrecht’s case is not so uncommon when compared to other normally calm people who have taken Chantix. Suits like Albrecht's initiate change and assist in protecting individuals who may have otherwise ingested this dangerous drug.

Benzene Related Leukemia

2007-12-10T11:17:00.000-05:00

Benzene leukemia has been associated with long-term exposure to the hazardous chemical benzene. Benzene, a carcinogen, is found in rubbers, plastics, synthetic fabrics, and resins. It is a clear, colorless and flammable liquid. This dangerous chemical has been strictly regulated by the federal government’s Environmental Protection Agency, but it is still a risk for many people in industrial professions.

Benzene Exposure in the Work Place

With exposures from less than 5 years to more than 30 years, individuals have developed, and died from, leukemia. Long-term benzene exposure can affect bone marrow and blood production. Short-term exposure to high levels of benzene can cause drowsiness, dizziness, unconsciousness, and death.

Individuals employed in industries that make or use benzene may be exposed to the highest levels of benzene. These industries include benzene production (petrochemicals, petroleum refining and coke and coal chemical manufacturing), rubber tire manufacturing and storage or transport of benzene and petroleum products containing benzene. Other workers who may be exposed to benzene because of their occupations include: laboratory technicians, mechanics, chemical plant workers, steel workers, paper and wood pulp workers, printers, rubber workers, shoe makers, firefighters, gasoline truck drivers, pipe fitters, refinery workers, maritime workers and gas station employees.

Benzene exposure has been associated particularly with myelogenous leukemia. Myelogenous leukemia is a cancer that forms within the body’s white blood cells. White blood cells destroy foreign bacteria and cells in the body that could cause infection or illness. Myelogenous leukemia causes the body’s production of white and red blood cells to be disturbed, substantially weakening the body’s immune system and causing anemia in many cases. Patients suffering from myelogenous benzene leukemia have impaired strength and are much more susceptible to infection.

If you or a loved one have been diagnosed with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), myelodysplastic syndrome (MDS), or non-Hodgkin's lymphoma (NHL), please call Claudine Q. Homolash for a free confidential benzene lawsuit evaluation.

Chantix Update: FDA Evaluating Reports of Suicidal Thoughts In Chantix Users

2007-12-07T09:15:00.000-05:00

On November 20, 2007, the Food and Drug Administration ("FDA") reported that it is evaluating post-marketing adverse event reports about Pfizer Inc.'s smoking cessation drug Chantix upon receiving company submitted reports about Chantix users having suicidal thoughts.

The FDA asked Pfizer for the reports. The FDA said that while it analyzed data, it recommends that health care providers monitor Chantix patients for behavior and mood changes. The FDA said patients should report behavior and mood changes to their doctors.

Claudine Q. Homolash, Esq. represents consumers who have been injured as a result of dangerous drugs and other products.

Serious Side-Effects Linked to the Smoking Cessation Drug Chantix

2007-12-04T16:04:00.000-05:00

The smoking cessation drug, Chantix, is manufactured and distributed by Pfizer, a pharmaceutical titan in terms of profits and influence. Chantix was marketed as a promising drug which was designed to work in conjunction with behavior modification therapy to help people work towards leaving their smoking habit behind for good.

Initially, minor side-effects were reported, such as nausea and dizziness, but as time progressed, the known side-effects became more serious. Reported side-effects include chronic feelings of extreme anxiety and depression, up to and including thoughts of suicide and acts of abuse.

Discovery remains ongoing in regards to Chantix, but if you're using it, seek medical attention immediately, especially if you're feeling any potential side-effects. If you have experienced side-effects regarding this drug, contact me directly so I can assist in investigating a potential claim on your behalf.

Claudine Q. Homolash is a personal injury attorney representing individuals injured by dangerous drugs and other products. Ms. Homolash represents injured individuals in litigations involving, but not limited to, the drugs Vioxx, Bextra, and Gadolinium. Ms. Homolash also represents plaintiffs in against Boston Scientific (formerly Guidant) and Medtronic.

Plaintiffs Obtain $240 Million Revised Settlement In Guidant Defibrillators Product Liability Litigation

2007-12-03T18:28:00.000-05:00

On November 19, 2007, it was announced that an amended settlement agreement has been obtained on behalf of 8,550 patient plaintiffs who asserted claims against Guidant Corporation, Boston Scientific Corporation and other entities (hereinafter collectively referred to as, the "Defendants"). The plaintiffs had claimed that Defendants knowingly sold them inherently defective defibrillator devices with potential life-threatening defects over a period of three years. The amended settlement expands a prior agreement obtained in July 2007, which had provided for a recovery of $195 million to settle over 5,600 claims. After additional injured patients stepped forward, the agreement was amended to provide up to $240 million in compensation. The settlement hopes to encompass most of the pending claims.

Claudine Q. Homolash heads her firm's heart device litigation representing clients who have suffered physical and emotional injuries as a result of the implantation of a recalled Guidant defibrillator and/or pacemakers.

Avandia Diabetes Drug Linked to Heart Attacks and Congestive Heart Failure

2007-12-03T17:43:00.000-05:00

A study recently released by the New England Journal of Medicine has linked one of the most commonly prescribed diabetes drugs, GlaxoSmithKline’s Avandia, to a significant increase in the risk of heart attack. The study reflects data involving 15,560 patients who took the drug and 12,283 patients who were given other medications or a placebo. Patients getting Avandia, known chemically as rosiglitazone, were 43 percent more likely to have a heart attack. The study strongly suggests a trend toward higher cardiac death rates in the Avandia study group.

The lead author of the study, Steven Nissen, who is the chairman of cardiology at the Cleveland Clinic in Ohio, stated that the results of this analysis raise serious concerns about the cardiovascular safety of Avandia. Furthermore, he continued, [u]nfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease.

In the wake of this study, on November 14th, it was announced that the FDA now requires Avandia’s manufacturer to include what is known as a “black box” warning on the drug’s label to warn patients of the increased risk of heart attacks. Patients who took the drug prior to this time, did not have the benefit of such a warning and, as such, may have legal claims against the drug manufacturer in the event of a cardiac event.

Avandia was first approved by the Food and Drug Administration in 1999 to treat type II diabetes. This condition, commonly called adult-onset diabetes, affects millions of people across the world. The American Diabetes Association reports that almost 21 million people in the U.S. have diabetes, a disease in which the body doesn’t properly make or use the hormone insulin to convert blood sugar to energy. Avandia acts by lowering the body’s blood sugar levels, which can cause complications - including kidney and eye damage - by increasing the body’s sensitivity to insulin. There have been tens of millions of prescriptions for Avandia written since it was approved in 1999.

Avandia has now been linked to heart failure and hypoglycemia (or extremely low blood sugar). Heart failure symptoms include:

• Chest pain
• Swelling of the extremities
• Weight fluctuations
• Difficulty breathing/Shortness of breath

Hypoglycemia symptoms include:

• Dizziness • Headaches
• Accelerated heart rate • Weakness
• Sweating • Fatigue

If you or a loved one has suffered a heart attack or congestive heart failure while taking Avandia, please contact me directly.

Claudine Q. Homolash litigates pharmaceutical injury and product liability cases across the country. Ms. Homolash heads her firm's Vioxx, Bextra and Gadolinium litigations, as well as other product liability matters.

Recall of Medtronic Sprint Fidelis Lead Wires Exceed 250,000 Worldwide

2007-12-03T16:24:00.000-05:00

On October 15, 2007, Medtronic issued a recall of its Sprint Fidelis defibrillator leads as a result of at least five patient deaths in which a lead fracture may have been a contributing cause. Sprint Fidelis Leads are certain models of cardiac electrodes (thin wires) that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. The recalled leads have been implanted in over 200,000 patients since 2004. Most patients with Medtronic defibrillators since 2004, and most patients who received Medtronic defibrillators since then have these leads. A small number of Sprint Fidelis leads are also used with defibrillators made by manufacturers other than Medtronic.

Medtronic estimates a 2.3 percent failure rate in patients with the Sprint Fidelis lead, or 4000 to 5000 people, will experience a lead fracture within 30 months of the device implantation. Replacement of the lead is a serious and delicate procedure which is far more dangerous than replacing the device itself because the lead wires are thread into the interior chamber of the heart.

Generally, patients with heart devices are issued device identification cards that will contain information about their heart device and leads. Patients can check this wallet card for the model number to see if their leads are under recall. The recalled leads are Sprint Fidelis Lead Model Nos. 6930, 6931, 6948 and 6949. These numbers may be shown at the beginning of a longer set of numbers on a patient's identification card.

Complaints against the company allege that a design defect is responsible for the lead fractures. The complaints also allege that Medtronic failed to act timely in recalling the lead as it has known of a large number of failures of the device since at least the end of 2006.

If you would like additional information regarding the aforementioned recall, or would like to speak to an attorney regarding bringing a potential case against Medtronic associated with the implantation of a Sprint Fidelis lead, please contact me directly.

Claudine Q. Homolash has successfully represented hundreds of patients across America who received faulty or recalled medical devices, including implantable cardiac defibrillators and pacemakers.

Injuries From Gadolinium Injectable Dye

2007-08-12T13:00:00.000-04:00

Gadolinium is a non-radioactive, water-like liquid injected into the veins of patients undergoing MRIs and MRAs “with contrast.” Contrast markers bond with damaged or diseased tissues, giving doctors a clearer picture of potential problems, many times resulting in an easier and more accurate diagnosis.

Normally, gadolinium is expelled from a person’s body within hours, with no damage or little risk. Unlike others, people with kidney problems have difficulty expelling the agent from their system. Maintaining this chemical agent in one’s system for too long a period of time can lead to a condition known as Nephrogenic Systemic Fibrosis (NSF), which is also known as Nephrogenic Fibrosing Dermopathy (NFD). This condition leads to severely restricted joint movement, possible confinement to a wheelchair and even death.

There are currently five FDA-approved gadolinium-based contrast agents, Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. These agents are approved for use during an MRI scan, but not for MRA. The FDA is asking health care professionals and patients to report possible cases of NSF/NFD through FDA's MedWatch program.

On May 29, 2006 the Danish Medicines Agency reported severe reactions to the common MRI contrast agent gadolinium. The agency reported 25 cases between Denmark and Austria of the extremely dangerous condition called Nephrogenic Systemic Fibrosis, sometimes called Nephrogenic Fibrosing Dermopathy. NSF or NFD is characterized by a number of diverse side effects including:

* Tightening and swelling of the skin, usually in the extremities

* Symmetrical skin lesions, commonly on the ankles and thighs

* Hypertension usually precedes skin lesions

* Reddened patches on the skin

* Calcification of muscle, skin, tendons

* Muscle weakness

* Thickening of the skin around the joints, which restricts movement

* Skin texture changes one not dissimilar to an orange peel

* Bone pain in the hips and ribs

* Yellow plaques near the eyes

* Burning, itching, sharp pains in affected areas

On May 23, 2007, the FDA notified healthcare professionals of the Agency's request for the addition of a boxed warning and new warnings about the risk of NSF to the full prescribing information for all gadolinium-based contrast agents (GBCAs). The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging.

If you suffer any of the symptoms described above or have been diagnosed with NSF after having received an MRI / MRA with Gadolinium contrast dye, Claudine Homolash can help you. Please contact Claudine Homolash at (215) 790-7300, for a free consultation.