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.

Massachusetts General Hospital’s Dr. Joseph Biederman has agreed to curb his interaction with pharmaceutical companies while the hospital investigates charges that Biederman’s dealings with the drug firms may be a conflict of interest. Biederman, known for his aggressive endorsement of Johnson & Johnson’s Risperdal and his $1.6 million undisclosed salary from drug companies, agreed to curb his involvement in drug trials and other entanglements with the pharmaceutical industry.
Late last year, a US Senate review of the pharmaceutical industry’s ties to doctors and researchers discovered the payments to Biederman and questioned his objectivity in promoting certain drugs for children. Embarrassed by the public disclosure, Mass General quickly took steps to begin an investigation of its own. Officials at the highly regarded New England hospital questioned Biederman’s objectivity in his research and openly criticized the financial arrangements. According to hospital officials, there are concerns that Biederman was more interested in promoting Risperdal on behalf of his benefactor than objective scientific research.
According to an article in the Wall St. Journal, “In its statement, Massachusetts General said Dr. Biederman would stop industry-funded activities at the hospital until its review was completed. Hospital spokeswoman Peggy Slasman said that would mean Dr. Biederman would discontinue his participation in several industry-funded clinical trials there. The hospital declined to describe the studies, which it said would continue under a different doctor.
Dr. Biederman also agreed not to participate in “any outside activities that are paid for or sponsored by industry, such as consulting activities or speaking engagements,” the hospital said.”
US Senator Charles Grassley has been particularly vigilant in investigating drug industry and medical device industry ties to researchers and doctors whose research the public and other physicians rely for prescribing medicines and medical devices for their patients. Senator Grassley correctly grasps that the integrity of the healthcare system is at stake when conflictual relationships exist between researchers and medical industries.

Citing dozens of eye problems, the FDA has issued a Class I recall of Advanced Medical Optics Inc.’s Healon D which is used in various types of eye surgeries including corneal transplants, cataract removal and other ophthalmic procedures. The FDA recalled the product after receiving numerous complaints and problems associated with the chemical agent.
The recalled product’s lot number is UD30654. The FDA’s determination that the product is Class I underscores the serious nature of the problems associated with Healon D which comes prepackaged in a syringe and is applied using a small tube.
Advanced Medical Optics, Inc. had issued a recall of the product in October but only recovered 964 of the 1,450 units that were distributed on the market.

Health officials are already calling it the worst environmental disaster of its kind in the United States. And that’s before earlier reports underestimated the scope of the spill and its far-reaching effects.
According to the NY Times, “Authority officials initially said that about 1.7 million cubic yards of wet coal ash had spilled when the earthen retaining wall of an ash pond at Kingston Fossil Plant, about 40 miles west of Knoxville, gave way on Monday. But on Thursday they released the results of an aerial survey that showed the actual amount was 5.4 million cubic yards, or enough to flood more than 3,000 acres one foot deep.
The amount now said to have been spilled is larger than the amount the Authority initially said was in the pond, 2.6 million cubic yards.”
The spillage contains such toxins as lead and thallium, known to cause cause birth defects and nervous and reproductive system disorders. The coal ash spill abuts a residential area and the Emory River. The coal ash spill can contain carcinogens and dangerous levels of heavy metals.
According to the Times article, the environmental spill has reawakened old arguments about whether coal ash should be federally regulated as hazardous material.

A few years ago, Merck’s Fosamax was linked to jaw necrosis. Now, the FDA is looking into Fosamax’s potential link to esophageal cancer. Fosamax has been linked to 23 cases of esophageal cancer since the drug’s inception in 1995. 23 cases is not statistically significant. However, the fact that the FDA is going to investigate the link is noteworthy and is another blow to Merck’s popular osteoporosis pharmaceutical.
Fosamax belongs to a family of drugs known as bisphosphonates. These drugs are known to be associated with esophagitis, which is an inflammation of the lining of the tube carrying food to the stomach.
Diane Wysowski, a member of the FDA’s drug risk assessment division has said that doctors should refrain from using Fosamax and other bisphosphonates in those patients who’ve been diagnosed with Barrett’s esophagus, which is a change in the lining that leads to the stomach. It is often found in people with acid reflux disease and itself increases the risk of cancer.

The Rev. Jean Ronald Joseph, a priest of the Diocese of Venice (Florida) is being investigated for sexual abuse that occurred 15 years ago when Fr. Joseph was assigned to St. Francis Xavier Catholic Church in Fort Myers. At the time of the abuse, the victim was a minor.
Bishop Dewane asked Joseph to remove himself from ministry and Joseph apparently complied with the Bishop’s request. At the time of the abuse, the Diocese of Venice was run by the Diocese’s first bishop John J. Nevins, a former priest of the Archdiocese of Miami. Nevins retired in 2007 when Bishop Dewane assumed leadership of the southwest Florida diocese.
Since its founding in 1984, bishopaccountability.org, an online database of priests accused of sexual abuse, lists 9 Venice priests accused of sexual misconduct including Edward McLoughlin, Jose Mena, William Romero, Neil Flemming, and Carl Bartholomew. The Diocese of Venice had received reports about McLoughlin for years, including some from doctors who warned Bishop Nevins that McLoughlin should not work around children. In spite of the warnings, McLoughlin continued working as a priest and abusing minors until a lawsuit was brought. Then, the Diocese of Venice arranged and paid for McLoughlin to move to Ireland.
This appears to be the first time Bishop Dewane has had to confront a new allegation of priest sexual abuse. In his news release, the Diocese speaks of the pain of the priest and the Church without acknowledging the pain of the victim, “These are very painful times for Father Joseph, the lay faithful as well as the clergy.”