Faulty Retrievable Inferior Vena Cava Filters Cause Serious Physical Injuries

Cases involving faulty retrievable Inferior Vena Cava (IVC) filters are currently being litigated due to their propensity to fracture or migrate within the human body and/or perforating the IVC.  The failure of these devices often result in serious bodily injuries including: perforations of vessels and organs, hemorrhaging, cardiac/pericardial tamponade, cardiac arrhythmia, severe and persistent pain and death.  The FDA is currently conducting a review to evaluate the risk vs. benefit profile of IVC filters.  To date, the FDA has recommended that IVC filters be removed as soon as the risk of pulmonary embolism has subsided. 

The IVC filters are manufactured by C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.  IVC filters manufactured by Cook Medical are also at issue. 

The medical and scientific evidence demonstrates that Bard's retrievable IVC filters, in particular, are prone to an unreasonably high risk of failure and patient injury.  Multiple studies have reported that Bard's IVC filters have a fracture and migration rate ranging from 21% to 31.7%.  This far exceeds the reported fracture rates of comparable devices. 

FDA "Bad Ad" Initiative: Encouraging Health Care Professionals and the Public to Report MIsleading Drug Ads

Story from "The Pink Sheet" Daily, a Pharma Industry online news service, July 18, 2012

Martin Berman-Gorvine writes about the FDA continuing to publicize the program for health care professionals and the public.

In the past two months, FDA’s Office of Prescription Drug Promotion has been advertising its “Bad Ad” program in several medical journals, encouraging healthcare professionals to report potentially misleading drug promotion.

The ads have been running in the Journal of the American Medical Association, American Family Physician, the American Journal of Health-System Pharmacy and others. For more information, see information later in this post.

The FDA website also contains information on evaluating "direct to consumer" (DTC) advertising. Most people don't know that only one other country in the world, New Zealand, allows this type of advertising.

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Representing Whistleblowers, Beyond "Bad Ads"

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What may be critical to note here is some healthcare professionals, pharma industry employees, and others can have information far more than just a "bad ad"- there may be the possibility of criminal action on the part of the pharma company, for not just illegal marketing but fraud, failure to warn, and violations of the False Claims Act. 

My specialty is to represent whistleblowers who bring this information forward.

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Here's a little known fact, you can find this in the information on the "Bad Ad" program direct from the FDA's website:

The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as they do advertising to consumers, according to the Congressional Budget Office.

The webpage continues, describing the program. 

For more information on how to proceed as a whistleblower:

Call me at 215-790-7300 or write chomolash@sheller.com. Timing is important- our firm not only has the resources and track record representing whistleblowers, we bring a strategic perspective to how and when to file, optimizing the potential for both "first to file" and subsequent claims.

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

RAPTIVA, Psoriasis Drug, Causes Brain Infection Risks

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.

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

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.

PERSONAL INJURY LAWSUITS INITIATE CHANGE IN CHANTIX WARNINGS

(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.