Corporate Court hears argument in food safety and railroad safety cases

Tomorrow the Supreme Court will hear argument in two cases in which corporate defendants are attempting to avoid liability by arguing that state safety laws are preempted by federal law. At stake in Kurns v. Railroad Friction Products Corp. is the ability of individuals to hold railroad manufacturers responsible for violating state safety regulations that are more protective than federal safety standards. At stake in National Meat Association v. Harris is the ability of states to enact laws designed to protect the food supply when federal regulations do not provide that protection.

$900 Million in Dividends, Nothing for the Injured

Last week, the FDA announced that it lacks critical powers of oversight over medical devices submitted using the “510(k)” or “Pre-Market Notification” (PMN) process, and that it may go to Congress to request additional regulatory authority.

For the last 35 years, the FDA has annually approved approximately 3,500 devices using a 35-year-old law from Section 510(k) of the Food, Drug and Cosmetic Act. 510(k) allows the FDA to determine whether a new medical device is substantially equivalent to a device previously approved, in which case it will be quickly cleared for release onto the market. The program is popular among medical device manufacturers because it is expedient: only 50 or so devices are approved annually under the more rigorous FDA approval system. According to the Government Accountability Office, 20 high risk devices later discovered to be dangerous to consumers were mistakenly passed through the FDA under the 510(k) system last year.

In related news, last week the FDA lifted restrictions on Medtronic external defibrillators, saying that the company had met quality control requirements and could again begin unrestricted shipment worldwide. Medtronic then announced a fourth quarter dividend of $0.205 per share. Medtronic shareholders are on pace to receive over $900 million in dividends this year, while the victims of its faulty devices find their legal claims against the company preempted by FDA approval, and have no legal recourse to recover damages for medicals bills, lost wages, or pain and suffering.

Consumers have faced multiple surgeries due to faulty orthopedic implants, or found themselves shocked by faulty defibrillator leads. However, upon bringing suit, consumers have then found their legal rights nullified by the device’s prior approval by an agency that concedes it lacks the authority necessary to ensure public safety. Circumstances demand speedy legislative action to correct these injustices: passage of the Medical Device Safety Act (MDSA). MDSA would protect consumers’ right to sue when they are harmed by certain defective medical products. As Dr. Larry Kessler, a 13-year veteran of the FDA device center, points out, “The device world codified by the Medical Device Amendments of 1976 is dramatically different than where we are today 35 years later. The pace of innovation has really ramped up and the 510(k) process has been used, and in some cases people would say misused, to clear very advanced technology.”

Help hold device manufacturers accountable: sign our petition urging Congress to pass the Medical Device Safety Act.

Protecting Patients from Defective Medical Devices

On August 4, patients from across the country who have been harmed by defective medical devices will travel to attend a hearing in front of the Senate Committee on Health, Education, Labor, and Pensions. The 2:30 PM hearing, entitled “Protecting Patients from Defective Medical Devices” will be preceded by a press conference from 12:00 - 1:00 PM in the Russell Senate building room 485.

Alliance for Justice President Nan Aron will open the press conference, with Senator Harkin (D-IA) and several medical device patients speaking about why Congress must quickly take action to pass the Medical Device Safety Act of 2009. The event will also feature a screening of AFJ's film “Hit and Run”. If you are interested in attending the press conference please contact Lisa Hayes at LHayes@afj.org or 202-822-6070.

AFJ continues to push Congress to pass the Medical Device Safety Act

This morning the Campaign to Stop Corporate Immunity held a conference call that included a campaign update, as well as a short presentation from Alliance for Justice on Judge Sotomayor’s record on preemption. Jennifer Meinig, Legislative Counsel for AFJ, shared data from AFJ’s recently released report focusing on Judge Sotomayor’s access to justice cases. Judge Sotomayor has ruled on only a few preemption cases, but has exhibited a characteristically measured approach in her rulings. The decisions reflect a rigorous analysis and Judge Sotomayor delves deep into the facts of cases reflecting the complex interplay between state and federal law. Ms. Meinig gave a few examples of cases that typify Judge Sotomayor’s rulings involving preemption including, Protection & Advocacy for Persons with Disabilities v. Kirk, 448 F.3d 119 (2d Cir. 2006), Patient Protection & Advocacy, Inc. v. Houstoun, 228 F.3d 423 (3d Cir. 2000), and Empire Healthchoice Assurance v. McVeigh, 396 F.3d 136 (2d Cir. 2005). These cases, and others, are explored in detail in the Access to Justice report.

The Sotomayor Record: Access to Justice

Today Alliance for Justice unveiled the first in a series of in-depth reports analyzing Supreme Court nominee Judge Sonia Sotomayor’s record.

This first report focuses on the issue of Access to Justice, which encompasses a variety of legal issues including justiciability, preemption, stripping courts of their jurisdiction to hear certain claims, sovereign immunity, recovering attorneys’ fees, interpretations of statutes of limitations, and certifying classes for class-action litigation. These issues illustrate the important role courts play in ensuring equal justice for all. The report analyzes Judge Sotomayor’s record in each of these areas and finds that…

“Judge Sonia Sotomayor has a careful, cautious, and reasoned approach to access
to justice issues. Her rulings are well within the legal mainstream.
She closely follows precedent, and analyzes facts with meticulous detail.
Judge Sotomayor shows no bias for or against plaintiffs. She shows
sensitivity toward persons bringing claims, but always grounds her decision
making on the law and binding authority.”

Visit our Supreme Court Watch page for more information and to read the report in its entirety.

We Need Medical Device Safety Now

The announcement on May 20 from Medtronic comes as a timely reminder of why we need the Medical Device Safety Act.

Medtronic’s announcement warns doctors that 37,000 of their pacemakers may be defective. This announcement comes after last week’s House Subcommittee Energy and Commerce hearing on "H.R. 1346, the Medical Device Safety Act of 2009." The 2008 Supreme Court decision Riegel v. Medtronic took away the rights of injured consumers to hold negligent medical device manufacturers accountable when their products cause injury and death. The Medical Device Safety Act will restore those rights allowing consumers such as Bill Storms, of Delaware, Ohio, to hold device manufacturers accountable.

From the Cleveland Plain Dealer
Two summers ago, Bill Storms of Delaware, Ohio, says he got 138 electrical jolts over a five-hour period when the wires to his pacemaker went haywire. The 38-year-old truck driver had to visit several emergency rooms before the device could be turned off.

"It felt like having a horse inside you trying to kick its way out of your chest," said Storms, whose lawsuit against the maker of his Sprint Fidelis pacemaker wires was thrown out of court this year along with hundreds of similar cases by a judge who cited a 2008 Supreme Court precedent.

Storms and others who say they were injured by faulty medical devices want Congress to pass legislation that would override the Supreme Court decision in Riegel v. Medtronic, which found that consumers can't sue medical device companies over medical devices that have been approved by the Food and Drug Administration.

You can help people like Bill Storms receive justice by urging Congress to pass the Medical Device Safety Act. Sign our petition to Protect our Health and Safety and Restore Corporate Accountability. You can learn more about the Medtronic case and other recent decisions on our Supreme Court Watch page.

@NanAron Tweeting Live from House Subcommittee Hearing

The House Subcommittee on Energy and Commerce is holding a hearing on "H.R. 1346, the Medical Device Safety Act of 2009." The hearing today at 2:00 p.m. features 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
• Bridget Robb, Gwynedd, Pennsylvania
• Richard Cooper, Partner, Williams & Connolly LLP
• Michael Kinsley, Seattle, Washington
  

We will be giving live updates from the hearing via Twitter, so follow @NanAron for the latest news and information.

The Medical Device Safety Act, H.R. 1346, would overturn a 2008 Supreme Court decision that, for the first time, denied patients injured by certain medical devices the right to seek compensation through state product liability lawsuits.

Learn more about the Medical Device Safety Act and how you can help.