FDA Medical Device Approval Process Flawed

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
According to a January 15, 2009 GAO (Government Accountability Office) report, the FDA’s process for reviewing and approving the sales of medical devices is severely flawed. In reviewing potential medical devices for market here in the US, the FDA uses an antiquated process that dates back to 1976, which categorized medical devices into three groups or tiers depending upon their risk level to consumers.
Between 2003 and 2007 228 medical devices were found to have passed through an insufficient medical review process including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers, according to the government report.
In spite of the flawed FDA system, the Supreme Court denied consumers the right to sue medical device manufacturers for faulty and dangerous medical devices, arguing that if the device received FDA approval, the device company was immune from product liability lawsuits in state courts.
Wyeth Pharmaceuticals, one of the country’s largest manufacturers of prescription and over-the-counter drugs, has brought suit in order to extend this same legal protection for drug manufacturers. Last November, the case was brought before the Supreme Court. If the Court extends this benefit to drug companies, it will prove to be another loss for consumers.

Priest Abuse Scandal: Why the Church Insists on Shooting the Messenger

In the last few weeks we’ve witnessed some extraordinary events in the long, tragic saga that is the Catholic Church’s priest abuse scandal. Thomas O’Brien, the US Attorney in Los Angeles is undertaking a federal probe of the Archdiocese of Los Angeles’ actions and lack thereof regarding its handling of priest abusers. Just this past week, the deceased founder of the Legionaries of Christ, Rev. Marcial Maciel, is reported to have fathered a child. The child, now in her early 20’s wants to write a book about her infamous father and her mother’s relationship with him. Even the Legionaries have stopped disputing the allegation as spurious.
Yet, we still have bishops attacking the media for reporting on the scandals. Bishop Jenky of Peoria Illinois claims that the media’s intense hatred for Catholics is fueling the stories. Jenky is distributing a letter to all parishes of the diocese this weekend complaining about the church’s unfair treatment in the courts and in the press. An excerpt of the letter reads as follows: ““Amid all the tensions of our nation’s culture wars and in the face of the media’s intense hatred for our Catholic faith, I am increasingly concerned that our Church in effect no longer enjoys equal justice under the law.” In his tirade, Jenky did not spare lawyers either.
“Attorneys representing some claimants and some “victims groups” obviously have a significant financial stake in trying to overturn our Diocesan policies.”
Jenky claims, abundant evidence to the contrary, that these “attacks” are an attack on the faith and not a matter of justice, truth, or protecting victims (whose credibility he questions by putting the words in quotation marks).
This defensive, reactive posture will not resolve the scandal nor will it restore credibility to the Church whose own members have suffered as a result of these scandals.

Chinese Drywall Found At Florida Lt. Governor’s House

It’s still not known how many homes in southwest Florida contain the defective and toxic Chinese drywall. One thing we do know at this point-Lt. Governor Jeff Kottkamp’s house is one of those homes containing the cheap, defective drywall. Kottkamp’s home was built by Aubuchon Homes owned by Gary Aubuchon who, ironically replaced Kottkamp in the State Legislature when Governor Crist named Kottkamp as his lieutenant governor.
The problem with the Chinese drywall is under investigation. We do know that the drywall emits sulfur compounds that could pose a health risk. Kottkamp who lives in North Ft. Myers, has called for the state Health Department to conduct tests on the home.
The potential area of affected Chinese drywall homes spans quite a large area on the west coast of Florida from St. Petersburg to Naples. There have already been lawsuits, including two class action suits, filed against manufacturers, suppliers, and builders who used the Chinese dry wall.

Irony’s real politick

It’s ubiquitous in the public square. We’re seeing it with our new President and his Cabinet appointments. We’ve witnessed it in the Catholic Church for a number of years now. It’s the irony of one’s words and statements when matched up against actions. Presently, the most poignant example of it is Cardinal Mahony of Los Angeles who for years was a staunch defender of the church’s moral positions. He’s even publicly criticized past Administrations on such moral issues as war, poverty, disease, and immigration. Yet, his actions belie another reality. This is a public leader, a Cardinal in the Catholic Church who’s been dogged by the priest abuse scandal. While the epicenter of the scandal in the east was Cardinal Law of Boston, few would argue that that distinction belongs to Cardinal Mahony of Los Angeles. He is now faced with a federal investigation, that unlike other inquiries, which should prove to challenge even Mahony’s formidable skills of evasion and covering-up. However, we have to sound a word of caution here. The man hasn’t been known as Roger the Dodger for nothing. He’s survived this scandal pretty much unscathed. He’s had to make some financial payments to abuse survivors but he kept himself out of the courtroom. Thus far, he’s been able to escape the fate of others who haven’t escaped the irony of real politick.

Lennar Files Lawsuit Against Chinese Drywall Manufacturers

Lennar Corporation, a major builder in southwest Florida, has filed a lawsuit against manufacturers, installers, and suppliers of a toxic drywall that has affected numerous Florida homes.
The Chinese drywall emits gas that corrodes the walls of the homes, according to the complaint filed in Miami-Dade Circuit Court. Two class action lawsuits have been filed separately as a result of the defective Chinese drywall. The class action lawsuits allege that the defective drywall has adversely affected the health of those residing in the homes containing the Chinese drywall. The companies being sued for using the drywall dispute those claims. One target of the class action lawsuit is Knauf Plasterboard Tianjin Co. Ltd., a Chinese subsidiary of German-based manufacturer Knauf. Another company that will have to answer the suit is Knauf Tianjin and its German parent, along with a second manufacturer, Taishan Gypsum.
According to a published report in the Sarasota Herald Tribune, the companies have shipped millions of pounds of the defective Chinese drywall into Florida since 2006.

LA Cardinal Mahony Target of Federal Probe

US Attorney Thomas P. O’Brien is looking into whether Roger Cardinal Mahony of Los Angeles can be charged with honest services fraud in connection with the priest sexual abuse cases in the Archdiocese. However, O’Brien has declined comment and has refused to acknowledge such an investigation exists.
The “honest services” fraud charge concerns parishioners and others who relied on such Catholic leaders as Mahony to keep their children safe from predatory priests who abused numerous children in the Archdiocese for many, many years.
Allegations of mishandling and covering-up sexual abuse matters have dogged Cardinal Mahony for years. A few years ago, Mahony and the Archdiocese of Los Angeles setted more than 500 claims by paying $660 million.

Los Alamos and Beryllium Exposure

Los Alamos National Laboratory has warned that as many as 2,000 employees and visitors to the lab may have been exposed to beryllium. According to OSHA, exposure to beryllium by inhalation of beryllium dust or fumes can cause serious damage to the lungs, lung cancer, and may be fatal.
Berylliums is a natural metal found in beryl and bertrandite rock. It is very lightweight and hard. It serves as a good conductor of electricity and heat.
According to OSHA, “Chronic beryllium disease (CBD) primarily affects the lungs. CBD may occur among people who are exposed to the dust or fumes from beryllium metal, metal oxides, alloys, ceramics or salts. It occurs when people inhale beryllium in these forms. CBD usually has a very slow onset, and even very small amounts of exposure to beryllium can cause the disease in some people. In some cases, CBD develops while workers are still on the job, but in others it may not develop until many years after a person has stopped working in the beryllium industry, or has been transferred to a job that does not involve beryllium exposure. The amount or length of exposure to beryllium necessary to cause a specific individual to develop CBD is not known, but recent information suggests that exposure below OSHA’s 2 micrograms/m3 TWA PEL over a very short time (weeks or months) can lead to CBD in some workers.”
Symptoms may include: unexplained cough, shortness of breath, especially with activity; fatigue, weight loss or loss of appetite, fever, or night sweats. The disease may develop slowly over a period of years and many of those affected may be carrying it without their knowledge.
The Los Alamos beryllium exposure concern first surfaced in November when a box containing beryllium was delivered to the Los Alamos plant. The box appeared damaged so officials at the lab tested the area for contamination. The area was found to have beryllium contamination but the source of the contamination was not the box. The lab had not been tested for beryllium exposure since 2001 so Los Alamos officials have sent warning letters to anyone who worked there since or visited the lab since 2001.

Consumer Product Safety

“We reject as false the choice between our safety and our ideals.” Those words you very well may recognize as delivered by President Barack Obama on the day of his Inauguration. However, they are equally appropriate in response to an article in the Contra Costa Times this morning which bemoaned a federal law scheduled to take effect in a few weeks. The law is called Consumer Product Safety Improvement Act. The news article is entitled, “Product Safety Law Casts Gloom Over Businesses” hardly an unbiased title. The premise of the article is that businesses will be hurt by this overly restrictive law. Very little mention is made of those whom it is designed to protect-our children. The law is targeting lead in products used by those 12 years of age and under. Lead is a known as a potent neurotoxin. The law is also regulating and for the most part eliminating phthalates from children’s products and toys. Phthalates, used to make hard plastics, is particularly dangerous to reproductive systems.
Any bill designed to protect children, especially when the offending agents are known and proven to be dangerous, is a good consumer protection. I’m surprised the Contra Costa Times or any media outlet would side with big business over and above consumer product safety.

This Time It’s the Chinese and DryWall

The past year has not been very good for commercial US-China relations. We’ve witnessed the heparin contamination scandal, the tainted milk debacle, and counterfeit drugs manufactured in China. Now, it’s Chinese drywall. The problem stems from the building boom five years ago. Houses, especially in southwest Florida, were being constructed in record numbers. To cut costs, builders such as Lennar Homes and Aubuchon contracted with Chinese companies to purchase dirt cheap drywall. That’s when the old adage, “you get what you paid for” comes into play. The problem is the drywall was made with waste materials from scrubbers on coal-fired power plants. According to Dan Reid of Intuitive Environmental Solutions in Fort Myers, “Those materials leak into the air as gases and combine with the moisture on an air conditioning coil to create sulfuric acid, which appears to be dissolving solder joints and copper tubing — creating leaks, blackening the coils and even causing the system to fail.”
The problem doesn’t just involve private residences. Three Cape Coral Florida charter schools are being investigated to determine whether Chinese drywall was used in the construction of the schools. According to a News-Press article, “Cape Coral Mayor Jim Burch’s call for an investigation into the construction of all city buildings during years the drywall was imported to the U.S.”
“I have growing concern that the Chinese drywall problem could present serious economic and health challenges to Lee County,” Burch wrote in a Monday memo to City Manager Terry Stewart.
The health effects of exposure to the sulfur compound is unknown at this point.
According to the South Florida Business Journal, at least 80 Lennar Homes have been built with the controversial and potentially dangerous Chinese drywall. A spokesperson for Lennar Homes has said that the homes in question were built during the building boom in southwest Florida during 2005-06.
The drywall causes unpleasant, noxious odors, electrical problems, and potential health problems yet undetermined by health officials tasked with investigating the latest Chinese scandal.

Six States Join EPA in Ohio River Cleanup Study

Six states including Kentucky, Illinois,Indiana, Ohio, Pennsylvania, and West Virginia have joined forces with the Environmental Protection Agency to study bacteria and other pathogens that pollute the Ohio River.
While the task is enormous the symbolic effect of state involvement in the bacteria study is significant. A similar effort led to the restoration of healthy oxygen levels in the Middle Cuyahoga River.
The study which is scheduled to be completed next year will determine how much bacteria sewage treatment plants, factories, and other sources of pollutants can discharge into the river without exceeding the standards of safety. Presently, there are 49 cities and towns in the area which release untreated sewage directly into the river during heavy storms. An expensive upgrade is needed in order to stem the tide of bacterial flow into the river.
This is a good first step in identifying, treating, and restoring the Ohio River to its environmentally healthy place. It’s a good thing to have states cooperate with the federal government on an issue as important as environmental clean-up and restoration.