The large pharmaceutical company and medical device maker, Johnson & Johnson, has been issued a subpoena by the Justice Department concering its sale of bile duct stents used to treat liver obstructions. The investigation and subpoena revolve around allegations the company many have sold the bile duct stents for unapproved uses, a violation of federal law. Doctors may prescribe medicines and use devices for unapproved uses but the manufacturing companies are prohibited from marketing a drug or device for uses that have not been specifically approved by the FDA. This is an obvious precaution designed to protect the consumer.
Biliary stents are approved to treat obstructions in tubes that carry bile, a digestive fluid, to the intestines, but reports to the F.D.A. indicate that they are often inserted to prop open blood vessels in the legs. The reports also stated that unapproved uses may be injuring patients.

Fr. Tom Doyle is a Catholic priest who belongs to the religious Order of Preachers, or more commonly known Dominicans. Depending on your perspective he is either a disgruntled, reviled priest or a John the Baptist-like hero who has dared to take on the hierarchy of the Catholic Church for their complicity in the Catholic priest sex abuse scandal. Those who revile him usually belong to the group who aided and abetted the sexual abuse cover-up plaguing the Catholic Church. I know Tom Doyle, consider him a friend and an advocate for survivors of sexual abuse. Doyle has been a “thorn in the side” of the Catholic Church for more than two decades now. He’s not a thorn because he’s simply a priest. He’s a problem for the hierarchy (the bishops and cardinals) because besides being a priest he is also a noted scholar. He knows canon law (church law) as well as church history.
Doyle gave the keynote address in July 2008 to the Survivors Network of Those Abused by Priests. The address was entitled “The Survival of the Spirit While Mired in the Toxic Wastes of the Ecclesiastical Swamp”. The address is both a rousing call to arms for advocacy and change as well as a thoughtful and scholarly analysis of the abuse crisis.
Doyle points out that the 2002 scandal in Boston was not unique in the history of the Catholic Church. The modern scandal was unique in the cover-up of the abuse and the bungling fashion in which the Church authorities, bishops primarily, handled the abuse crisis.
Perhaps more importantly, is Doyle’s assertion of the devastating effects on the victims of sexual abuse. As Doyle correctly points out, this is not something “gets over with and moves on.” The effects of abuse damage the psyche to the point that there remain wounds long after the abuse has ended. Because the abuse is perpetrated by so-called men of God, the abuse takes on a spritual character not easily diagnosed or “fixed”. As a lawyer, I’ve had numerous experiences where church lawyers ask for an accounting of the victims’ suffering as if it’s as easy as composing a grocery list. While these lawyers intentions may be neutral, they fail to realize that a facile categorization of injuries is nearly impossible and only adds to the suffering of the victim. Many times, the victims that has the tremendous courage to come forward is not able to verbalize the pain, alienation from God, and psychic trauma they’ve suffered. It’s as if they now live in an altered state.
One of the more subtle but vitally important aspect of Doyle’s address is how the Church has molded its victims to think of heaven, hell, sin, and redemption. In the Catholic belief system, a priest holds the power of forgiveness. Many survivors, victimized by a priest, must now turn to a priest for forgiveness and assurance that they are “right with God” even though they were victims of a crime! Doyle describes it accurately when he calls the entire situation “toxic”. According to Doyle, “forgiveness” is manipulated into something that it is not. It incorrectly requires a forgetting of the abuse with no consequences to the perpetrator of the institution that it covered it up.
Doyle’s piece is a must read not only for survivors but bishops who want to “move forward” without the accountability associated with real reform and progress. It’s a shame that in all likelihood the bishops will view the address as another attack on them and the institutional Catholic Church.

Beef has been recalled from stores due to findings of the E. coli bacteria present in beef sold at Whole Foods Market. Unlike the tomato contamination scare earlier this summer, the source this time appears to be known. Whole Foods supplier, Coleman Natural Beef, whose meat is processed by Nebraska Beef Ltd., which was also involved in the Kroger contamination, is the likely culprit in the beef E.coli contamination. Thus far, seven people in Massachusetts have fallen ill after eating the contaminated beef. There appear to be two more victims of E.coli linked to this beef in Pennsylvania. E.coli contamination can cause bloody diarrhea, dehydration, and in the worst cases kidney failure and death. Those who’ve been sickened by the tainted beef may be higher than the ones reported since not all E.coli victims report the sickness to a health official.
This particular recall involves beef sold between June 2nd and August 6th.

Earlier this year Vytorin’s effectiveness was called into question, producing a marketing problem for its manufacturer, Merck and Schering-Plough. This time the allegations are more serious. The FDA warned the public about muscle injuries linked to simvastatin, which is used in the controversial cholesterol drug Vytorin, and the heart-rhythm medication amiodarone. The FDA issued a warning to those taking simvastatin to watch out for symptoms of cramps, pain, tenderness, stiffness or spasm in their muscles. Simvastatin is marketed as Zocor and is known as a statin.

In a move to bolster the public’s confidence in the FDA as well as lessen the conflicts between drug and medical device advisory boards and the doctors who serve them, the FDA has placed a $50,000 cap on payments a doctor can receive from a pharmaceutical company and/or a medical device maker and still serve as an expert consultant on the FDA advisory panel. The problem has led to many raised eyebrows and serious questions concerning conflicts of interests when doctors who are at times receiving six figure salaries from these companies also serve on the FDA advisory panels. Their judgment is suspect at best and the public’s confidence in their ability to be impartial is hampered.
The new rules bar the participation of an expert, if that person, their spouse or minor child has conflicting financial interests of more than $50,000. Under the new rules, there generally won’t be waivers for conflicts above $50,000, and waivers for smaller conflicts will be allowed only if the FDA determines “there is an essential need for the adviser’s particular expertise.”

Rev. Daniel A. Gomez has been arrested and charged lewd or lascivious battery — eight months after facing similar charges in Tampa. Gomez was pastor of the Center of Unction Church of the Nazarene in Brandon. He has been placed on unpaid leave by Nazarene Church officials. The victim, 12 years old at the time of the sexual molestation, let Gomez into her home because she knew him as a minister. That’s when Gomez attempted to have sex with the minor.
Unfortunately, many of these clergy abusers, whether they are Catholic priests, Protestant ministers, youth ministers, or Jewish rabbis gain access to their victims because of their role as religious leaders in the community. There is an unquestioned trust that accompanies the spiritual role they play in the lives of people, especially the young. When that trust is subverted for criminal sexual behavior as in this case, the public has a right to know about the sexual predator and the predator deserves to be removed and go to jail.

The NY Times is running today a front page, above the fold story about the growing clamor for a national registry for artificial limb patients so that their progress or lack thereof can be tracked via a national database. Other countries have adopted the system, yet the United States stubbornly refuses to do so. After the recent problems with Zimmer hips, proponents of such a registry have a more vocal ally. Dr. Lawrence Dorr, a well-respected orthopaedic surgeon of more than 30 years has lent his voice for the database. Dorr, if you recall, was the orthopaedic surgeon who sounded the alarm on Sulzer hip implants eight years ago. Sulzer withdrew the device six months later and 3,000 revision surgeries were performed due to the Sulzer hip implace defects.
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So when Dr. Lawrence Dorr, a highly paid consultant of Zimmer Holdings, began hearing complaints from his hip replacement patients of excruciating pain and difficulty with the artificial hip he had just implanted, Dorr began looking into the root of the problem. What he found was that in each of the patients who had complained, a Zimmer Durom cup had been implanted. It so concerned Dr. Dorr that he told Zimmer officials about his findings. Yet nothing was done to address the issue. So, Dr. Dorr spoke about it to one of his professional associations and discovered he wasn’t the only orthopaedic surgeon to encounter such problems with the Zimmer Durom cup.
A national database of artificial limb implants would give surgeons an opportunity to share information, experience, diffuculties, and possible solutions. It would also provide consumers with the information they need to make proper decisions in consultation with their surgeon. The database seems like a no-brainer to me but thus far it hasn’t happened.
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A collision on the Mississippi River last week involving a tanker and a barge resulted in 420,000 gallons of industrial fuel being spilled into the nation’s busiest waterway. The spill involved has affected 98 miles of the river. American Commercial Lines, Inc. has said it’s not responsible for the oil spill but has taken responsibility for the cleanup. The Coast Guard and the National Transportation Safety Board are investigating the incident and will eventually determine who was at fault. It is known that The tug Mel Oliver, which had been hired to push the barge upriver, had no properly licensed crew on board, Coast Guard officials said. The tugboat pilot had only an apprentice mate’s license instead of the required master’s license.

The NY Times article a few days ago concerning problems with Zimmer Holdings’ artificial hip device was not the first time news of issues with the hip had grabbed the media’s attention. A Reuters article in May of 2008 detailed complaints from a prominent orthopaedic surgeon about the Zimmer hips. At the same time, Zimmer phased out the position of chief marketing officer as shares of Zimmer stock took a tumble. A financial analyst who spoke with Reuters linked the stock tumble to problems with the hip device Durom. According to the report, there was speculation that the Durom hip device may be subject to a recall due to problems. Reuters reported at the time that even Zimmer acknowledged the possibility of a possibility of a Zimmer Durom hip recall.
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The Durom hip had been sold and marketed to younger, more active patients but may be prone to premature failure leading to revision surgery.

The federal government has charged a Hong Kong based shipping company with falsifying documents relating to the investigation of an oil spill in San Francisco Bay last year. Accoring to an Associated Press report, “Unidentified “senior ship officers and shore-based supervisory officials concealed and covered up documents with an intent to impede, obstruct and influence the investigation of the spill,” according to a Department of Justice summary of the indictment. The indictment also charges Fleet Management with two counts of misdemeanor crimes under the Clean Water Act and the Migratory Bird Treaty Act for negligently causing the crash, which dumped 53,000 gallons of toxic bunker fuel into the bay. The spill killed and injured thousands of birds and fouled beaches throughout Northern California.