FDA Warns Drug Companies About Their Internet Ads

In what the Wall St. Journal has reported as a first for the FDA, the federal agency has warned 14 big pharma companies about their misleading advertisements on the Internet. The ads were typically found as a result of Google searches and the ads were usually sponsored links meaning the drug companies paid for the ads as part of their “pay per click” marketing campaigns. Sponsored links are one way of attracting Google search engine traffic by targeting certain key words that a person surfing the web may be trying to find.
The ads typically overpromoted their benefits while completely ignoring their risks and side effects. The Wall St. Journal article cites one ad by Biogen Idec Inc. for its drug Tysabri which boldly but inaccurately state, “”A Multiple Sclerosis Treatment That’s Different from the Others” or “Satisfied with your MS Medication or Looking for Something Different?”
This is a good sign that the FDA is not only reviewing big pharma’s traditional marketing practices to mainstream media but is branching out and investigating drug companies’ behavior on the Internet.
According to the Wall St. Journal, the companies that received the warning include: Pfizer, Biogen Idec Inc., Sanofi Aventis, Johnson & Johnson, GlaxoSmithKline PLC, Forest Laboratories Inc., Cephalon Inc., Bayer AG, Novartis AG, Merck & Co., Eli Lilly & Co., Roche Holding AG, Genentech Inc., and Boehringer Ingelheim Pharmaceuticals Inc. Genentech was recently acquired by Roche.

Rocket Fuel Chemical Found in Baby Formula

Scientists have discovered trace amounts of perchlorate in various brands of powdered baby formula. The chemical is mixed with water that also contains perchlorate can exceed what the CDC considers safe for adults. The chemical is usually associated with defense and aerospace facilities. The scientists didn’t disclose which baby formulas were tested. Perchlorate has been tied to problems with thyroid function. However, the health effects to babies and adults is still undetermined at this point. Various municipalities’ drinking water supplies have been tested and shown to have amounts of the chemical in the drinking water.
While some states have already set acceptable limits of perchlorate in drinking water, the EPA is reviewing the issue. It did state earlier this year that the chemical’s presence in drinking water may pose a serious health risk and a top priority for the EPA.
The tests that found the chemical in the baby formula were not health related so no determination as to the risks associated with the chemical can be made at this time.

Pope Speaks Out on Behalf of Economcially Poor

In light of the recent G-20 meeting in London, Pope Benedict XVI has called upon the world leaders to remember the poor when devising plans to aid the world economic situation. This is a laudable act considering a great many peoples still live below the poverty line.
However, poverty transcends the mere economic. Many live in poverty due to a lack of education, healthcare, and justice. In terms of the latter, many in this country are poor because they lack access to justice. I’m thinking in particular those who are poor because they lack access justice after they’ve experienced sexual abuse. This is a paralyzing poverty that often spills over into the educational, health, and economic spheres of life. Those who’ve been sexually abused and lack the proper recourse in a system of justice continue to suffer. The pope should’ve included those in his remarks as well. Very often, sexual abuse victims who’ve been abused by clergy are robbed of their relationship with God, a faith community, and their own human family. This is a justice issue and a life issue just as important as any other justice or life issues. When will we hear the church speak about that?

Priest Abuse Scandal: Bishops Knew Back in the 1950’s

Rev. Gerald Fitzgerald, founder of the Catholic order Servants of the Paraclete, dedicated his life and his priestly ministry to stopping the sexual abuse of children at the hands of Catholic priests. He did so by writing numerous letters to at least 12 Catholic bishops and one pope warning them of the dangers of sexually abusive priests. Fitzgerald even attempted to buy a Caribbean island where he would send the problem priests. The letters, unsealed a few years ago but now becoming public, show Fitzgerald as a priest who consistently warned bishops about the danger of transferring sexually abusive priests. In some letters, he called for their removal from the priesthood.
These revelations contradict the Catholic bishops consistent defense over the years that they didn’t know the nature or the extent of the problem. Fitzgerald had been working with priest abusers since the 1940’s and had spoken with Pope Paul VI in 1962 about the issue. Some of the most notorious priests were sent to Fitzgerald’s retreat in Jemez Springs New Mexico for treatment and counseling. The strongly worded letters mince no words in depicting the priests as “vipers” and “devils”. In a 1957 letter to a bishop in New Mexico, Fitzgerald wrote, “These men, Your Excellency, are devils, and the wrath of God is upon them, and if I were a bishop I would tremble when I failed to report them to Rome for involuntary layization (sic).”
Fr. Fitzgerald’s prescient warnings went unheeded until the scandal broke wide open in 2002 after the Boston Globe uncovered years of conspiracy and coverup by the Archdiocese of Boston. Fitzgerald died in 1969 and his successors changed the tone and manner in which priests with sexual abuse problems were treated. Often, the change resulted in the priests being returned to ministry in different dioceses. Fitzgerald himself was the object of scorn from some bishops who considered his methods and warnings bizarre and alarmist.
The Catholic bishops of the United States can no longer pretend they didn’t know about the issue. Nor can they feign ignorance of the magnitude of the abuse. As early as the 1940’s they received warnings from Fr. Fitzgerald. In the 1980’s Fr. Tom Doyle took up the mantle and warned the entire group of bishops assembled for their annual meeting. Just like Fitzgerald, Doyle was dismissed and ostracized by the bishops.

Tallahassee Legislative Update

State Rep. Rick Kriseman (D-53) is a lawyer with Saunders & Walker PA
Nancy Shopper heads to her favorite grocery store to purchase her groceries for the week. While walking down the aisle in the produce section, Nancy steps on a banana peel, slips and falls down, and injures her right shoulder. She contacts a lawyer to learn what her rights are in this type of case.
Had Nancy fallen in this store prior to the case of OWENS vs. PUBLIX SUPERMARKETS, INC. , (802 So.2d 315(Fla. 2001), she would have been obligated to prove that the store had actual or constructive knowledge of the dangerous condition and that the condition existed for such a length of time that in the “exercise of ordinary care, the premises owner should have known of it and taken action to remedy it”. Constructive knowledge can be established by circumstantial evidence. Under this factual scenario, if the banana Nancy slipped on was black, circumstantial evidence would have suggested that it had been on the floor for a long enough period of time to conclude that the store could have or should have known of its existence and taken action to remedy the condition.
In this instance, Nancy slipped AFTER the Owens decision was rendered. Because of the Court ruling in Owens, Nancy was not required to prove the store had actual or constructive knowledge of the condition. Instead, the burden was shifted to the grocery store, with the Court in Owens holding that the premises owner or operator “had to establish that it exercised reasonable care under the circumstances, eliminating the specific requirement that the customer establish that the store had constructive knowledge of its existence in order for the case to be presented to the jury.” (Owens at 331). The Owens case created a new standard, finding that “the existence of a foreign substance on the floor of a business premises that causes a customer to fall and be injured is not a safe condition, and the existence of that unsafe condition creates a rebuttable presumption that the premises owner did not maintain the premises in a reasonably safe condition”. (Owens at 331).
Because Nancy fell after the Owens decision, the store was presumed to be negligent in allowing the banana to be on its floor, and to rebut that presumption, had to prove that it exercised reasonable care in maintaining its floor under normal circumstances of running its business.
Because of the Owens case, in 2002, the Legislature adopted Florida Statute 768.0710. This statute shifted the burden of proof back to the claimant, but, changed the elements necessary to prove negligence. Under this statute, the claimant was required to prove that the business owed a duty to the claimant, that the business acted negligently by failing to exercise reasonable care, and that the failure to exercise reasonable care was the cause of the loss, injury or damage suffered by the claimant. In showing that the business acted negligently by failing to exercise reasonable care, the claimant does not have to show the business had actual or constructive notice of the object. So while this new statute shifted the burden of proof back to the claimant, doing away with the presumption of negligence, it lessened that burden on the claimant. Had Nancy fallen after the enactment of the 2002 statute, she would have had to prove that the store owed a duty of care to her, that the store failed to exercise reasonable care in maintaining its floors, and that she was injured because of the failure by the store.
Just when you thought the law could not get any more confusing, wait, there’s more. This year, Rep. Dave Murzin has filed HB 495. The effect of this bill is to change the law once again, this time bringing the law BACK to what was in 2001, before the decision of the Florida Supreme Court in Owen.
Whether this bill passes the full house and senate and get’s signed into law by the Governor remains to be seen. For now, the bill has passed its first committee stop, on a vote of 8 to 2. It has 2 more committee/council stops before reaching the floor of the house.

New New York Sex Abuse Bill Not Helpful to Victims

Vito Lopez (D-Brooklyn) says his alternative bill to help victims of sexual abuse levels the playing field by allowing sexual abuse victims to seek justice from both public and private institutions that allowed the abuse to occur. In fact, so does the much better legislation proposed by Rep. Margaret Markey (D-Maspeth). The crucial difference between the two bills is that Markey’s bill would provide a one year window during which sexual abuse victims could pursue justice irrespective of when they were abused. This is important because most of those who’ve been abused aren’t able to come forward about their abuse until many years later, if at all. The Markey legislation takes into account the particular circumstances of the constituency her bill is aimed to serve. It is an undisputed fact that victims of sexual abuse crimes are not able to go public at the time the abuse occurred due to the traumatic nature of the abuse as well as the position of authority the abuser holds. Lopez’ bill doesn’t take this important factor into account. By the way, the Catholic dioceses of New York are vigorously supporting the Lopez version. That should tell you all you need to know.

FDA Gives Medtronic Brain Catheter Recall Highest Priority

Medtronic Corporation had voluntarily recalled its BioGlide Ventricular Snap Shunt Catheter in February. However, the FDA has now classified the recall as Class I which means that the defective medical device has a reasonable probability to cause serious injury or death.
The Medtronic device is a brain catheter which is supposed to drain excess fluid away from the brain. However, the catheter tends to disconnect necessitating a revision medical procedure.
The specific models recalled were manufactured from October 2002 through December 2008 and concern the following lot numbers: 27782 (Innervision), 27708, and 27802.
The catheters are used to treat hydrocephalus-a condition where excess fluid builds up in the brain. The pressure caused by the excess fluid can cause brain damage and death, if left untreated.
For those who’ve had the Medtronic brain catheter inserted, symptoms of hydrocephalus include but are not limited to the following: a rapid increase in head size, a large soft spot on the top of the head, dizziness, blurry vision, vomiting, seizures, nausea, and sluggishness.
Symptoms vary due to age. It is imperative to contact your physician if you or a loved one show any such symptoms or signs.

Sex Abuse Survivors and the Church’s Consistent Ethic of Life

As I read reports over various Catholic bishops and church organizations fomenting protest over President Obama’s invitation to the give the commencement address at Notre Dame University, I couldn’t help but think of the late Cardinal Joseph Bernardin’s plea for a consistent ethic of life ie. a “seamless garment” as he called it. The protests over the Notre Dame invitation concern President Obama’s stance on abortion and stem cell research.
This post has no intention of delving into the abortion/stem cell debate or President Obama’s postitions on either issue. However, I would like to take a moment and reflect on why the Catholic Church has been so vocal on these issues when another “life” issue ie. the treatment of those who’ve suffered sexual abuse continues to receive scant attention from the Church and the bishops. Some will say that the bishops have “fixed” the problem that resulted in the sexual abuse scandal. Others will say the church has made great strides to address the issue.
Yet, the manner in which these life issues, including the sexual abuse of children, is qualitatively different. However, if you re-examine Cardinal Bernardin’s theory of a consistent ethic of life, the sexual abuse of children should be no less worthy of church attention and action than say abortion or stem cells. How is it pro-life to protect a fetus while not doing the same for a young child? How is it pro-life to deny justice to those who’ve suffered due to the sexual abuse of a priest?
It seems to me that an aggressive implementation of this consistent ethic of life teaching would go a long way in restoring credibility to the bishops as well as the teaching authority of the church.

NY Catholic PR Machine Humming Along

As I predicted earlier, the NY Catholic Conference’s public relations apparatus is firing on all cylinders. Just today, I’ve read op-ed pieces about how the NY Child Victims Act if signed into law, will bankrupt the dioceses of NY State as well as the Archdiocese of NY. In another editorial, I read that the Catholic Church in New York is already handling the priest abuse crisis and has been doing so since the scandal in Boston erupted in 2002. Both slanted pieces are not aimed at the truth but rather a call to arms for the Catholic faithful who are asked once again to defend Holy Mother Church from the onslaughts of the lawyers and Catholic bashers. While this is unspoken and hyperbolic, it is the underlying message behind the Catholic lobbyists PR onslaught designed from allowing the Child Victims Act from being signed into law.
A thoughtful reader of the New York scene might have noticed that the welfare of children receives nary a mention. That’s because for those would seek to destroy the Child Victims Act, it’s not about the children. It’s about power and the institution. For the NY State legislators and NY voters, it’s time for you to decide. Who will you support: the children or the powerful institution that has neglected their welfare for the past 50 years?

Tallahassee Update

Rep. Rick Kriseman (D-53) is a member of the Florida House of Representatives and an attorney with Saunders & Walker PA
The worker’s comp law in Florida was last changed in 2003. Prior to the change, Florida’s workers’ compensation insurance rates consistently ranked as the most expensive or second most expensive in the country. The changes in the 2003 legislation made several changes, the most controversial of which was the change to the provision governing attorney’s fees in workers’ compensation. The 2003 legislation retained a contingency fee schedule for attorney’s fees, but removed a listing of factors a judge of compensation claims (JCC) was required to consider, thus allowing the judge to increase or decrease the amount of the award. Some of the most important factors removed were the time and labor required, the difficulty of the case, customary charges, and the lawyer’s experience, reputation, and ability.
In October 2008, the Florida Supreme Court heard the case of Murray v. Mariner Health and ACE USA. The Murray case involved a claim for benefits that had been denied by the insurance company. At the conclusion of the trial, the Court ruled in favor of the claimant, Ms. Murray, finding that the carrier had denied Ms. Murray benefits she was legally entitled to receive.
Because the carrier had wrongfully denied benefits, the carrier was responsible for paying Ms. Murray’s attorney’s fees. Although Florida law at the time called for payment of a “reasonable fee”, the judge applied a statutory percentage formula, which resulted in the attorney receiving a fee of $648.84 for more than 80 hours of work (which breaks down to $8.11 per hour). The judge also commented that had he been allowed to use what was the reasonable local hourly rate in calculating a fee, the total would have been in excess of $16,000.00.
On appeal, the Florida Supreme Court ruled that the attorney’s fee schedule (which caused the award of $648.80 to Ms. Murray’s attorney), when read together with a provision that awards “a reasonable attorney’s fee” to the prevailing party, creates an ambiguity as to whether the fee schedule is the sole basis for determining a reasonable attorney’s fee. As such, the Supreme Court struck down that provision of the statute regarding “reasonable fees”.
House Bill 903, filed by Rep. Anitere Flores, attempts to address the impact of the Murray decision on workers Compensation by clarifying that awards of attorney’s fees, except in certain medical only cases, are to be calculated based solely on the fee schedule, not on any of the other factor’s previously described. The bill further states that an attorney who attempts to negotiate a rate different from that provided under law is subject to criminal prosecution.
Those supporting this change state that without this change, worker’s comp rates will once again begin to rise, placing a large financial burden on both small and large businesses. In support of this argument, they point to the decreases in rates which occurred after the 2003 legislation went into effect.
Those opposed to HB 903 state that rates were high in Florida prior to the 2003 legislation, not because of attorney’s fees, which, they point out, are only awarded when a carrier is found to have unlawfully refused to pay benefits due, but instead because carriers are allowed to include in their base rate attorney’s fees that they paid to both their own attorneys and to the Claimant’s attorneys. Neither medical malpractice carriers, property and casualty carriers or automobile insurance carriers are permitted to charge back attorney’s fees to their insureds. Only workers comp carriers are currently permitted to do this.
A second, and more important reason cited for high workers comp rates is because of the recommendations of the organization that submits requests for rate increases to the State on behalf of carriers, NCCI. NCCI, the National Council on Compensation Insurance, in their own words, is “the largest provider of workers compensation and employee injury data and statistics in the nation. NCCI analyzes industry trends, prepares workers compensation insurance rate recommendations, determines the cost of proposed legislation, and provides a variety of services and tools to maintain a healthy workers compensation system. ”
This organization helps the Florida Office of Insurance Regulation determine what rates are appropriate for workers comp carriers.
It should be noted that most of NCCI’s Board of Directors all work for insurance companies, many of whom sell workers comp insurance (including John T. Leonard, Maine Employers’ Mutual Insurance Company, Robert A. Lindemann, Zurich North America, Gary J. Thompson, The Hartford, Susan Doyle, Liberty Mutual Group, Bruce G. Kelley, EMC Insurance Companies, Craig L. Nodtvedt, Alaska National Insurance Company, and James C. Roberts, American International Group (AIG).
According to Steven Alexander, head of the State’s Office of Consumer Advocate, NCCI has recommended rates which overcharge businesses in the State of Florida by more than 25% over the past 10 years. He has recommended that NCCI be banned from filing rate increase requests on behalf of individual carriers, as he believes a conflict of interest exists in this current arrangement.
Yesterday, this bill was heard on second reading on the floor of the house. At the time it was heard, an amendment to the bill was offered by Rep. J.C. Plana. The primary changes offered in the amendment were that 1) it returned the attorney fee scale to the same level as it was prior to 2003 or a fee equal to fee paid by the carrier to it’s own attorney, which was greater; 2) it permitted claimants the opportunity to contract with their own attorney a fee in excess of the sliding scale provided under law; and 3) it denied carriers the opportunity to include fees paid to claimant’s attorneys and defense attorneys in their rate base calculations.
The sponsor of the amendment asserted that his amendment would best protect the rights of injured employees while helping to keep worker comp rates lower. Unfortunately, only 44 other members of the legislature (including me) agreed with Rep. Planas, and as such, his amendment failed.
Those of us who supported this amendment fear that should HB 903 pass the full legislature and be signed into law, access to the Court will be denied injured workers as they will face difficulty finding attorney’s willing to handle their claim if the amount in question is minimal. Additionally, many of us fear that there will be no incentive for a workers comp carrier to settle minor claims, as they know the claimant will have a difficult time retaining an attorney to represent their interests. As I expect this bill to pas the House next week, unless something in this bill changes prior to our next vote, for the sake of all workers in this State, I hope either the Senate or Governor do not let this bill become law.