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.

Minnesota News Channel Airs Bridget Robb's Story

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

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.