$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.

Experts Come Together to Discuss the OPR Report on the “Torture Memos”

In anticipation of the Senate Judiciary Committee's hearing on the Office of Professional Responsibility's (OPR) investigation into the "torture memos," Alliance for Justice hosted a panel of experts who could speak about the findings of the OPR report.

During her introduction, moderator Nan Aron, president of Alliance for Justice stated, “regardless of OPR’s conclusion about the lawyers’ ethical conduct, the report adds to the mounting evidence that warrants a full-scale investigation of those who ordered, designed, and justified torture. The new findings must be independently investigated, and I am delighted that tomorrow the Senate Judiciary Committee will be taking the next step toward uncovering the truth.”

Panelists David Cole, Professor of Law, Georgetown University Law Center, Michael Frisch, Ethics Counsel & Adjunct Professor of Law, Georgetown University Law Center, Scott Horton, Adjunct Faculty, Columbia Law School and Contributing Editor, Harper's Magazine, and William Yeomans Fellow in Law and Government, American University Washington College of Law discussed the findings of the OPR report, and what next steps are possible.

Bill Yeomans pointed out a gaping hole in OPR's investigation, “we know that there was extensive contact between John Yoo and the White House, including the Office of the Vice President, but we don’t yet know what was said. This gap screams out for further investigation to determine whether DOJ’s legal views on torture were shaped by pressure from the Bush White House.”

Michael Frisch, spoke about the failure of the OPR report to consider whether the authors of the torture memos had knowingly counseled their client to engage in, or assisted in, criminal conduct. “This clear standard of ethical behavior was largely ignored in the DOJ process. Notwithstanding the conclusion that the matter not be referred to bar disciplinary authorities, those authorities remain obligated to investigate these serious allegations of professional misconduct.

David Cole, author of The Torture Memos, was disturbed by the evidence of "two tracks of law in this country, one for public consumption and one secret. At every step of the way the secret law was used to subvert the public law."

Finally, Scott Horton, was adamant that OPR did not ask the right question.

“The question is not only whether an ethical violation occurred but whether a crime occurred. The OPR report does not address whether there was a conspiracy to torture under Rule 2340A.”

Watch video of the event here:

OPR Report on “Torture Memos” Released By House Judiciary

In classic DC fashion, the report on the authors of the “torture memos” was released Friday night, buried under headlines about Tiger Woods. While the Department of Justice sent the Office of Professional Responsibility (OPR) report to Congress, it was the House Judiciary Committee Chair John Conyers (D-MI) who publicly released not only the final OPR report, but also the first and second drafts of the report and the responses from Yoo and Bybee.

In contrast to most peoples’ perception of Washington, Congress can move quickly when it wants to: by 6pm, less than an hour after the report’s release, Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.) announced that his panel will hold a hearing on the report next Friday morning. Leahy also called for Judge Bybee’s resignation.

“I have said before that if the Judiciary Committee, and the Senate, knew of
Judge Bybee’s role in creating these policies, he would have never been
confirmed to a lifetime appointment to the federal bench. The right thing to do
would be for him to resign from this lifetime appointment.”

The long-awaited report is the product of a five-year investigation by OPR, and the materials released by Conyers number more than 500 pages. We will be reading and analyzing the different drafts of the report and providing more in-depth analysis as we know more.

You can read the released documents here:
Memorandum for the Attorney General
OPR Final Report
OPR 1st Draft Report
OPR 2nd Draft Report
Yoo Response to OPR 2nd Draft
Yoo Response to OPR Final Draft
Bybee Response to OPR 2nd Draft
Bybee Response to OPR Final Draft

AFJ Filmmakers Nominated for an Oscar

Congratulations to filmmakers Jon Alpert and Matt O'Neill on the Oscar nomination for their HBO documentary Unnatural Disaster: The Tears of Sichuan Province!

Alliance for Justice is proud to have recently partnered with Jon and Matt to produce two short documentaries explaining why people harmed by prescription drugs or defective medical devices need to access justice through our courts. The films Hit and Run and Access Denied: the Fight for Corporate Accountability tell the story of Americans who trusted pharmaceutical and medical device manufacturers to sell safe products, were harmed as a result, and now have no ability to seek recourse for their damages. The films explain why Congress must pass the Medical Device Safety Act, which is desperately needed to end corporate immunity for manufacturers of faulty medical devices.

We hope people will take action and join with the AARP, The New England Journal of Medicine, Public Citizen, Easter Seals, the National Conference for State Legislatures, and a number of other medical and consumer advocacy groups to pass the Medical Device Safety Act in 2010.

Thanks to Jon and Matt for helping Alliance for Justice bring attention to FDA preemption and the Medical Device Safety Act, and best of luck to you at this year’s Oscars!

Non-profits Divided Over Citizens United

Abby Levine, AFJ’s Deputy Director of Advocacy Programs, spoke at today’s Hudson Institute panel titled “Non-profits Divided Over Citizens United,” analyzing the impact of Citizens United v. Federal Election Commission on business corporations, unions, and nonprofit organizations.

The panel was broadcast live by CSPAN, and you can watch it in its entirety here.

As you can see in this broadcast, the Citizens United case in some ways encompasses the breadth and depth of AFJ’s work—it demonstrates the importance of who sits on the Court and the impact the Court has on our everyday activities; as well as the important role nonprofits play in our democratic society and the ways in which nonprofits can participate in our electoral process.

In speaking about the composition of the court, Levine commented that:

“Too often, the current Court has decided cases in favor of big business at the
expense of ordinary people. We expect to have a Supreme Court vacancy sometime
this year. It is critically important that our next justice understands how the
law affects ordinary people. We need justices and judges in all of our courts
who will keep faith with our core constitutional values and protect the rights
of all Americans, not a select few.”

As for the opportunities afforded to nonprofits, Levine pointed out that while much of the focus has been about increased spending by for-profit corporations, the Citizens United decision provides new opportunities for organizations that promote the social good. AFJ has developed a number of resources to ensure nonprofits have the information needed to navigate this new legal landscape. Nonprofit organizations interested in taking advantage of these new opportunities can visit our website for a plain-language discussion of the impact of Citizens United as well as updates on changes in the law as a result of Citizens United.

While it’s likely Congress and some state legislatures will pursue new mechanisms to counteract the high court’s decision, Levine pointed out it is doubtful these proposals will be in place before the fall election season. She recommended that nonprofits learn to seize the current opportunity to participate more fully in our democracy.

Other speakers included: Geri Mannion, Carnegie Corporation of New York, Allison Hayword, George Mason University, Larry Ottinger, Center for Lobbying in the Public Interest, and Cleta Mitchell of Foley & Lardner.
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Fox News calls out AFJ

Last night, Brett Baier of Fox News criticized Alliance for Justice president Nan Aron for hypocrisy, suggesting that her recent piece in Politico conveniently forgot her own role in defeating the nomination of Robert Bork and the filibusters of then-President Bush's most extreme judicial nominees.

Baier's analysis misrepresents vastly different political actions and states of the federal bench. We at Alliance for Justice are justifiably proud of our advocacy on behalf of blocking George W. Bush's most extreme nominees. We authored reports detailing the record of each nominee and Robert Bork, whose nomination was so extreme that 58 Senators voted against his confirmation.

The nominees filibustered during the Bush administration were outside the mainstream and had records detailing their extreme beliefs. In sharp contrast, those nominees who today see their prospects dwindle in the Senate are qualified nominees with bipartisan support who will adhere to the constitutional values entrusted to courts promising equal justice for all. Alliance for Justice is proud to have opposed nominees with extremist ideas, and will continue to fight against obstructionism in favor of qualified jurists.

Today's nominees deserve swift action on the Senate floor. Judge Greenaway was nominated on June 19th and has been waiting for 231 days, Justice Keenan was nominated on September 14th and has been waiting for 144 days, and Judge Chin was nominated on October 6th and has been waiting for 122 days. All three of these circuit court nominees have lingered on the Senate calendar for months, despite being reported out of committee unanimously. Given the broad support for these qualified jurists and the tremendous backlog of work in our federal courts, this is an unconscionable delay.

For thirty years, the community has relied on Alliance for Justice for thorough research and analysis regarding judicial nominations, and we plan to continue this important work.

American Idle: Dawn Johnsen committee vote delayed

On February 4, the Senate Judiciary Committee had scheduled a vote on Dawn Johnsen, nominee to head the Office of Legal Counsel, but the vote never happened. After spending more than an hour considering other nominees also scheduled for votes, the committee ended its meeting because a number of senators had to leave to attend to other business, causing the committee to lose the quorum necessary to hold votes.

Johnsen is supremely well-qualified. Before a distinguished career as a Constitutional law professor, Johnsen served as acting head of the OLC for a full year during the Clinton administration. Her performance in this role was so exemplary that it was lauded by Republican-appointed Doug Kmiec, head of the OLC under presidents Reagan and Bush senior. Kmiec praised Johnsen’s independent judgment, saying that she “repeatedly separated policy preference from rendered opinion.” Johnsen also has the support of her Republican home state senator. Despite outstanding qualifications and recommendations, Johnsen’s nomination has sat idle in the Senate, requiring a second nomination by President Obama. Hopefully, with the support of Richard Lugar (R-IN) and Arlen Spector (D-PA), Johnsen’s confirmation vote will be able to successfully move past a legislative quagmire.

It is past time that Republicans in the Senate stopped reducing judicial and executive nominations into a partisan, ideological battlefield. The American people deserve a fully functional government that can ensure adherence to the rule of law. A proper OLC director with integrity and good judgment is crucial to that end. The office is routinely called upon to draw fine distinctions in the potential legality of proposed policies and executive orders, to ensure that the President follows established law. After gross misconduct of OLC attorneys in recent years, the OLC would be well served by a director with the experience, integrity, and intellect of Dawn Johnsen.

DOJ Whitewashes “Torture Memo” Ethics Report

News leaked this weekend that the five-year old Office of Professional Responsibility report about the “torture memo” authors has been downgraded to clear John Yoo, Jay Bybee, and Steven Bradbury of any wrongdoing. An earlier draft of the report concluded that Yoo and Bybee violated their professional responsibilities in drafting the most infamous 2002 “torture memo,” but, as Newsweek first reported, Associate Deputy Attorney General David Margolis has softened the report to conclude only that they showed “poor judgment.”

Under DOJ rules, “poor judgment” does not amount to professional misconduct – and therefore does not trigger a referral to state bar associations for disciplinary review or, in the case of Judge Bybee, a recommendation for an impeachment inquiry. This news confirms suspicions that the Obama DOJ has not spent the last year simply processing the OPR report draft through the normal channels of declassification review but has been modifying the report to let the “torture memo” authors off the hook.

Newsweek also reported that the report contains new facts that will raise further questions about what led the OLC lawyers to write the “torture memos” and whether the White House unduly interfered with their legal decisions. According to Newsweek:

The report, which is still going through declassification, will provide many new
details about how waterboarding was adopted and the role that top White House
officials played in the process, say two sources who have read the report but
asked for anonymity to describe a sensitive document. Two of the most
controversial sections of the 2002 memo—including one contending that the
president, as commander in chief, can override a federal law banning
torture—were not in the original draft of the memo, say the sources. But when
Michael Chertoff, then-chief of Justice’s criminal division, refused the CIA’s
request for a blanket pledge not to prosecute its officers for torture, Yoo met
at the White House with David Addington, Dick Cheney’s chief counsel, and
then–White House counsel Alberto Gonzales. After that, Yoo inserted a section
about the commander in chief’s wartime powers and another saying that agency
officers accused of torturing Qaeda suspects could claim they were acting in
“self-defense” to prevent future terror attacks, the sources say. Both
legal claims have long since been rejected by Justice officials as overly broad
and unsupported by legal precedent.

The OPR report will therefore add to the mounting evidence that calls for a full-scale investigation into what led our country to torture. For years, DOJ has hidden behind the phantom OPR report as a means of accountability for Yoo, Bybee, and Bradbury. Yet, regardless of the degree of their professional misconduct, our laws require Attorney General Holder to investigate all allegations of torture and enforce our laws to the fullest extent possible. If OPR lets the “torture memo” authors off the hook, it has proven itself to be as ineffective as its critics have claimed it to be – and provides all the more reason why AG Holder should appoint a special prosecutor, who is independent from the institutional interests of DOJ, to investigate allegations of torture.