As I write this, the country is marking an historic occasion tomorrow. The first African-American is to be sworn in as President of the United States of America. The first Senator in 44 years is to be elected president of the United States. Perhaps, the most important milestone revolves around the perilous times this young president embarks on leading this country in a time where we’re fighting two wars, an economic collapse the likes of which we’ve never seen, and the domestic turmoil evidenced by the chaos in the FDA. Yet, there is hope. This President is seemingly capable of rousing the American people to hope and resolve. In spite of our political differences, he has summoned our “best angels” to support him and pray for his success. At this moment in history, we need a leader, a courageous leader to show us the way. We wish him all the success. Our hopes and our fortunes ride with him.

A prominent University of Wisconsin spine researcher, surgeon, and perhaps most significantly, Medtronic consultant, was paid more than $20 million by Medtronic which just happens to be one of the world’s foremost manufacturers of spinal medical devices.
The revelation is creating a tsunami of conflict of interest in the industry as well as on Capitol Hill. Thomas Zdeblick, the Wisconsin surgeon, was receiving the Medtronic payments for his work in promoting and developing the spinal products. The massive payments spanning the four years from 2003-2007 went far beyond what had been initially reported to the University of Wisconsin. The school, like all other schools receiving federal funding for research, is required by law to monitor its researchers’ potential conflicts of interest.
One of the more troubling aspects of this case involves the doctor’s duplicity. In each of the last five years he has told the University of Wisconsin that Medtronic payments were approximately $20,000. That’s a far, far cry from $20,000,000!
US Senator Charles Grassley has stated that Wisconsin’s disclosure rules are insufficient and need to be reformed. Robert Golden, dean of the University of Wisconsin’s medical school, agrees with Grassley and has noted that most states have similar disclosure laws.
What is clear and transparent is that each instance that such conflictual relationship is revealed to the public, the erosion of public trust in the healthcare system grows. It needs to be fixed sooner rather than later.

The new, expensive drugs such as Risperdal, Zyprexa, and Seroquel were supposed to be more effective than the old treatments for schizophrenia, autism, and dementia. At least that’s how they were marketed to patients and doctors alike. Yet a new study finds these new “wonder drugs” double the risk of death due to heart failure. Furthermore, they haven’t been found to be as effective as the older anti-psychotic drugs.
The most susceptible populations to the risks of rapid weight gain and heart failure are the young and elderly. Professor Wayne Ray of Vanderbilt University authored the study and concluded that the significance of risk compelled prescribing doctors to perform thorough cardiac evaluations prior to giving the drugs to their patients.
Zyprexa, manufactured by Eli Lilly, has been the target of lawsuits ever since it was found that the drug led to rapid weight gain as well as the onset of diabetes in some cases. Besides the civil lawsuits, Eli Lilly has just agreed to pay $1.4 billion to settle criminal and civil investigations into its marketing of the drug Zyprexa. Lilly will pay $615 million to settle the criminal probe and approximately $800 million for the civil investigation. The settlement comes in the midst of the cirminal probe targeting Lilly for promoting Zyprexa for uses for which it had not been approved.

A new study has found that the FDA does very little when it comes to monitoring doctors who may have financial conflicts with companies whose drugs and medical devices they are supposed to be testing. Perhaps the most damning finding was the revelation that agency officials didn’t believe it was “worth the effort” to try to protect patients from such conflicts of interest.
This latest study is just the latest in a myriad of bad press, resignations, and reports of mismanagement at the federal agency. This is especially bad since the courts have virtually left consumer safety in the hands of the FDA regarding the safety of medical devices.
According to the NY Times article, “Fewer than 1 percent of the doctors who helped oversee clinical trials registered with the agency and who filed the required financial disclosure forms reported that they had a significant conflict of interest. By contrast, studies have found that one-fifth to one-third of all doctors have such conflicts.”

We’ve been here before with salmonella tainted peanut butter. This time it’s King Nut Companies whose spokesman said in a statement that it asked customers to stop distributing all peanut butter under its King Nut and Parnell’s Pride brands with a lot code that begins with the numeral “8.”
According to the AP report, “The peanut butter was distributed only through food service providers in Ohio, Michigan, North Dakota, Minnesota, Arizona, Idaho, New Hampshire, Massachusetts and Florida. It was not sold directly to consumers.
Preliminary laboratory testing found salmonella bacteria in a 5-pound container of King Nut brand creamy peanut butter, the Minnesota Department of Health said Friday.”
The CDC said Friday that 399 cases had been confirmed nationally, with about one in five of victims hospitalized. California has reported the most cases, with 55, followed by Ohio with 53. All the illnesses began between Sept. 3 and Dec. 29, but most of the people grew sick after Oct. 1.

A group of FDA scientists have written a blunt letter to President-elect Obama’s transition team about corruption and mismanagement at the federal agency’s medical device inspection division. The letter was written on Center for Devices and Radiological Health letterhead. The division is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. Interestingly, the concerns outlined in the letter are similar to those voiced by members of the FDA’s drug review division during the Vioxx investigation.
The letter, released to the Associated Press by a Congressional official, states, “Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”
With the Supreme Court’s ruling concerning pre-emption in Riegel v. Medtronic, this letter’s importance can not be overvalued. Congress will be considering a measure to overturn the Court’s decision and given the reports of problems with the FDA, the legislation appears to have a good chance at passing.

Last month’s coal ash dump in Tennessee was one of the worst environmental disasters of that kind in US history. Yet, according to a report today in the NY Times, the Tennessee coal ash incident is not isolated. There are more than 1,300 similar coal ash dumps around the country and they contain hazardous chemicals such as arsenic, lead, mercury, and selenium. These toxins are a serious threat to human health and local drinking water supplies.
More importantly, none of these dumps are monitored or regulated. Without such regulation, the probability of another toxic spill like the one in Tennessee is fairly high.
The environmental problem has been growing with the increasing demand of electricity coupled with efforts in the last few decades to curb air pollutants. What once spewed through the air near coal plants has now been transformed into solid waste stored at these coal ash dumps. The dumps are not just the problem of the coal mining regions either. Coal ash dumps can be found near such unlikely cities as Tampa, St. Louis and even the Mississippi River.
According to the NY Times article, “as the E.P.A. has studied whether to regulate coal ash waste, the cases of drinking wells and surface water contaminated by leaching from the dumps or the use of the ash has swelled. In 2007, an E.P.A. report identified 63 sites in 26 states where the water was contaminated by heavy metals from such dumps, including three other Tennessee Valley Authority dumps. Environmental advocacy groups have submitted at least 17 additional cases that they say should be added to that list.”
This past week a judge approved a class-action lawsuit settlement concerning such toxic coal ash dumping against Constellation Power Generation in Maryland.
In spite of the fact that the EPA has been studying the issue for 28 years, nothing has been done to address the problem. The EPA’s inertia has led to chaos and a growing problem that threatens to seriously impact our groundwater supply and public health. States are not much better at tackling the issue in their own backyards. Alabama doesn’t regulate or monitor the situation at all. Texas deals with the problem by denying it. They don’t view coal ash as solid waste and don’t have any type of monitoring or engineering requirements for utilities that dump the ash in their state.
As with most large federal agencies, part of the problem is political. The Times article notes, “In 2000, the agency came close to designating coal ash a hazardous waste, but backpedaled in the face of an industry campaign that argued that tighter controls would cost it $5 billion a year. (In 2007, the Department of Energy estimated that it would cost $11 billion a year.)” Once again, lobbying and influence peddling in Washington puts our public health in jeopardy.
In spite of the growing public health concern and 28 years of inactivity, the director of the office of solid waste at the EPA had this to say to the NY Times, “We’re still working on coming up with those standards. We don’t have a schedule at this point.” Perhaps his firing should be scheduled.

The Catholic Diocese of Vermont or the Diocese of Burlington has asked a judge to dismiss the jury’s verdict which awarded a priest sex abuse victim $3.6 million last month. Lawyers for the plaintiff have countered that their client is willing to use the money for the Catholic education of children but that offer has been ignored by the Diocese.
This is an interesting case especially the church’s stance after the verdict. We live in a country whose civil justice system is ultimately based upon the judgment of one’s peers in the jury box. After all the legal hurdles have been overcome, a civil trial comes down to the judgment of the jury. In some instances, the judge may overrule a jury’s verdict if it is illegal or grossly unfair. However, most judges hesitate to do this because they understand the importance of the jury system. As a trial lawyer, I’ve always felt comfortable with leaving the verdict and the amount of compensation in the hands of a jury. The outcomes have not always been in my favor but the system works.
Another aspect of this post-case wrangling concerns the survivor of abuse. Is the Diocese of Burlington saying his life isn’t worth what the jury awarded? Is the Diocese saying what he suffered really wasn’t all that bad? The priest who abused the plaintiff in this case was a well-known pedophile, Fr. Edward Paquette and the Diocese of Burling knew about his sex abuse history before they brought him to work with children in Vermont.
One final thought-how can the Catholic Church in Vermont have any moral credibility when it denies responsibility for its own actions? It’s part of Catholic teaching that bad behavior has consequences. Isn’t that what the jury verdict tells us? Responsibility and accountability are important qualities in moral leadership. If Vermont’s Catholic Church shirks such, how can it claim moral leadership?

United States District Judge Richard H. Kyle has dismissed all lawsuits against Medtronic for faulty design or manufacture of its Sprint Fidelis cardiac defibrillator leads. Citing the Supreme Court’s ruling in Riegel v. Medtronic, Inc., Judge Kyle opined that the consumers have no legal basis for pursuing consumer justice lawsuits against large medical device manufacturers for FDA approved Class III devices, even if the medical device causes significant injury. The reason given is the same one proffered in the Riegel decision-if the FDA gave the device pre-market approval the device is immune from lawsuits and consumers have no recourse.
This decision, which is actually broader and more sweeping than the Riegel verdict, is wrong on many levels. 1) it is a clear case of federal encroachment on states’ rights. 2) it slams the door of consumer justice on those wrongfully injured by faulty medical devices, 3) it protects the large and financially well-heeled medical device corporations from any responsibility to the consumer. Given the FDA’s recent history of inadequacy and the frequent reports of the federal agency being unduly influenced by the pharmaceutical and medical device industries, this reliance on the FDA for consumer safety isn’t warranted. Consumer justice lawsuits are an integral component of protecting the public health.
Consumer justice lawyers all around the country, including me, will vigorously appeal this ruling. As part of the party platform, the Republican Party has a particular disdain for consumer justice and lawyers who fight for the ordinary citizens. Just look at the party platform,
“America’s litigation system is broken. Junk and frivolous lawsuits are driving up the cost of doing business in America by forcing companies to pay excessive legal expenses to fight off or settle often baseless lawsuits….And the bulk of jury awards to plaintiffs don’t even go to the people who deserve it…. Trial lawyers get rich from the misfortune of others. They cost hundreds of thousands of good jobs, drive honest employers out of business, deprive women of critical medical care – then skip out with fat wallets and nary a thought for the economic havoc and human misery they leave in their wake.”
A bill has already been introduced into Congress which we blogged about yesterday. The bill, if passed and signed into law by President Obama, would nullify this decision. Change has come to the White House and I hope with this change a new dawn of corporate accountability and responsiblity is on the horizon.

Last year, the US Supreme Court ruled that consumers who’ve been injured by faulty or defective medical devices are barred from suing the manufacturers if the device was marketed in a fashion that received premarket approval from the FDA. The FDA stamp of approval barred consumer justice lawsuits regarding medical devices and prevented a time honored system of checks and balances for the medical device industry. Prior to the Supreme Court decision in Riegel, medical device manufacturers claimed consumer and product safety in their best financial interest. The specter of lawsuits kept the medical device industry honesty and at least striving to provide quality, effective, and safe products for the consumer. Riegel tore at the very fabric of that system of checks and balances.
Of course, Congress can preempt state laws in areas of national concern by expressly providing in the language of a bill that state regulations are preempted or superseded by the federal law. That is called express preemption. Until the Bush administration the FDA had always taken the position that state consumer tort suits were a consumer protection that complemented the federal FDA regulation.
Congress recognized the basic inequity in the Riegel decision and began immediately crafting legislation to make the court decision moot. The Medical Device Safety Act of 2008, H.R. 6381-S.3398-is a proposed amendment to the Medical Device Amendment to the Food Drug and Cosmetic Act.
The proposed bill reads as such,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘Medical Device Safety Act of 2008’.
SEC. 2. LIABILITY UNDER STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES.
(a) Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act
(21
U.S.C. 360k) is amended by adding at the end the following:
‘(c) No Effect on Liability Under State Law- Nothing in this section
shall
be construed to modify or otherwise affect any action for damages or the
liability of any person under the law of any State.’.
(b) Effective Date; Applicability- The amendment made by subsection (a)
shall–
(1) take effect as if included in the enactment of the Medical Device
Amendments of 1976 (Public Law 94-295); and
(2) apply to any civil action pending or filed on or after the date of
enactment of this Act.
Significantly, there are some Congressional heavyweights who’ve either sponsored the legislation or have already voiced their support. The legislation will be reviewed in the House Energy and Commerce Committee chaired by John Dingell, a supporter. The primary sponsor in the Senate is the healthcare giant, Senator Ted Kennedy and the bill will be considered in the Senate Health, Education, Labor and Pensions Committee. Interestingly, one of the Senate sponsors is none other than former US Senator and current President-elect Barack Obama.
Prospects for bill passage look good either some time later this year or early next year.