Hearing on the Medical Device Safety Act of 2009

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.

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.