Recent Blog Posts

Holding Those Who Do Not Report Child Abuse Responsible

Ray Boucher — Thu, 10 Nov 2011 20:35:00 GMT

Penn State University has reacted swiftly to revelations that child molestation was not reported to law enforcement by those who knew. No one at the University claimed that there was a different awareness 9 years ago. No one at the University claimed that their internal policies trumped the law. No one at the University claimed that this was an attack on Educational Freedom.

The head of the University is gone. The Coach, who has done so much for the community, is gone. The Athletic Director is gone. The VP is gone.

Meantime, in Kansas City, Archdiocese leader Bishop Robert Finn refuses to resign despite acknowledging that he and the Catholic Diocese of Kansas City-St. Joseph knew of sexual child abuse by one of their priests, and failed to report it. Cardinal Mahony refused to resign even though he admitted to allowing a known pedophile priest to continue his sexual abuse of children.

What is wrong with this picture?

Catholic Church Still Protecting Child Abusers

Ray Boucher — Wed, 09 Nov 2011 21:45:00 GMT

Two grand juries have recently handed down indictments regarding the mishandling of Child Abuse by supervisors of the sexual predators. A Jackson County grand jury in Kansas City has indicted Bishop Robert Finn on a charge of failure to report child abuse. The Catholic Diocese of Kansas City-St. Joseph also was charged with failure to report. A Pennsylvania grand jury just indicted several Penn State University officials for on a charge of failure to report child abuse.

The response by the two indicted organizations says volumes. Two Penn State University principals resigned within 24 hours of the indictment and a third, Joe Paterno, announced his resignation this morning. The leader of Penn State University, president Graham Spanier is expected to resign today. Meantime, in Kansas City, Archdiocese leader Bishop Robert Finn refuses to resign despite acknowledging that he and the Catholic Diocese of Kansas City-St. Joseph knew of sexual child abuse by one of their priests, and failed to report it.

The Catholic Church claims that the welfare of children under their protection come first, but actions speak louder than words and Bishop Robert Finn is sending the wrong message.

Child Abuse at Penn State University

Ray Boucher — Tue, 08 Nov 2011 19:44:00 GMT

The victims of Jerry Sandusky and those at the Penn State University who allowed these horrific crimes to continue, are likely suffering in silence. All will be traumatized for life, and some will become suicidal. In the wake of the scandal we cannot lose sight of what is most important, namely that another group of vulnerable children lost their innocence through a program that offered hope.

One of the greatest criticisms of the Church is that despite all their resources and knowledge about sexual abuse they never reached out to help in treating the survivors until litigation started. The University has a department of psychology and a child study center, the university should be reaching out to the victims and their families to provide support at this traumatic time which will help mitigate the damages. The revelations and cover up are a painful reminder that Childhood Sexual abuse is a wide spread national concern that crosses all aspects of our lives and is a problem with Churches, Doctors, Coaches and in many other areas. This should be a shot across the bow that tells people in positions of authority and responsibility that their first duty is to the child and to the law.

Another Lawsuit Filed Against the Maker of "Yaz" Birth Control

KBLAdmin — Thu, 05 Nov 2009 20:05:00 GMT

From ChicagoNow:

A woman is suing the maker of Yaz birth control after the contraceptive allegedly caused her to develop gall stones.

Melissa Johnson is suing Bayer, the maker of the prescription birth control, because she says it caused her to develop gall stones necessitating the removal of her gall bladder.

According to the complaint, Yaz contains drospirenone, a type of progestin not contained in any other birth control and of which "there is insufficient data to support its safe use." The complaint states that, since Yaz first appeared in the U.S., "hundreds of reports of injury and death" have been submitted to the FDA.

The lawsuit also points out the maker's "over-promotion" of Yaz that led to the FDA requiring it to run new TV ads correcting some of the misleading information.

Click here to view the complaint.

Entertainer Impaled by Gate Operated by Indian Wells, Widow Sues City

KBLAdmin — Tue, 03 Nov 2009 20:05:00 GMT

From The Desert Sun:

A trial date for a case involving the death of a local entertainer is expected to be set by the end of the year, officials said.

Victor Leon, 63, of Palm Desert died Jan. 12 after he was impaled by a gate that pierced his car as he was driving through Indian Wells.

Leon was executive producer of Musical Chairs, a local tribute concert series featuring music by great American songwriters.

The incident occurred at the corner of Miles Avenue and Highway 111, near the construction site for the Indian Wells Crossing project.

Leon's wife, Elizabeth Leon, filed a lawsuit June 15 against the city of Indian Wells, the Coachella Valley Water District and two Illinois-based companies — Miles Lodge LLC and Jerson Investments LLC, demanding a jury trial.

A court hearing for the case was scheduled Oct. 7, but was canceled.

The next hearing date is set for Dec. 14, where it is expected that the judge will set the trial date, said Paul R. Kiesel, the Los Angeles-based attorney representing Elizabeth Leon.

“The investigation is ongoing to determine why this tragedy happened,” Kiesel said.

Miles Lodge LLC and Jerson Investments LLC are listed as owners of the property where the gate was, Kiesel said Friday.

Indian Wells and CVWD, however, had a legal easement that allowed employees to have access to and control of the area as well, he added.

According to court documents, the listed defendants “negligently designed, installed, maintained, controlled and operated the gate” that subsequently swung out into Miles Avenue, impaling Victor Leon.

Yaz: Riskier than Other Birth Control Pills?

KBLAdmin — Thu, 22 Oct 2009 19:05:00 GMT

Here's another sad story about woman from the Bay Area that suffered from a stroke and, subsequently, was in a comma and then hospitalized for six months, after only taking Yaz for a month for menstrual pains, as prescribed by her doctor.

In 2007, Susan Galinis was the happy mother of 3-year-old twins. She wanted to have more children, so when her doctor said she could either have a hysterectomy or take the Yaz birth control pill to control her menstrual pain, she opted for the pill.

Four weeks and one day after starting it, she had a stroke. Surgeons removed part of her skull to accommodate the brain swelling. She lived, but she's not the same.

"My IQ has plummeted to 77, which I guess is borderline mentally retarded, from the stroke, from the brain damage, that's what they say it is," says Galinis.

Galinis was in the hospital for six months. She now has chronic pain and no short-term memory. She cannot drive. Her twins have had to adjust with the help of a counselor.

"She says basically to them their mom did die because she was there one day and the next day she was gone. I was gone for basically six months and then I came home with a different voice, a different personality," says Galinis.

Galinis says her doctors told her it was Yaz that caused the stroke. All birth control pills carry increased risk of stroke, but Galinis' lawyer Mike Danko says studies show it has twice the risk as other pills. On Monday, they filed suit against Yaz manufacturer Bayer.

Bayer's Legal Woes Continue...

KBLAdmin — Mon, 19 Oct 2009 19:05:00 GMT

From BNET:

Bayer faces more than 125 lawsuits over its Yaz contraceptive and new cases are being filed around the country at a rate of up to up to six a day, according to Courthouse News Service.

Download Seagraves v. Bayer here.

The cases all claim the same thing: That the new progesterone ingredient that Bayer used for Yaz causes more dangerous blood clots to form than previous formulations. BNET noted in July that drospirenone allegedly causes a buildup of potassium that slows down the heart rate, allowing clots to form.

A new White Plains, N.Y., case alleges a slightly more detailed theory of causation involving dehydration:

Drospirenone blocks the hormone aldosterone, and can cause dehydration from increased potassium secretion and increased absorption sodium and water.

Studies have reported that the resulting electrolyte imbalance can lead to potentially fatal hyperkalemia arrhythmia and deep-vein thrombosis …

Separately, even though Bayer removed anti-bleeding drug Trasylol from the market in 2007, new lawsuits keep arriving. Three were filed in Wisconsin recently. One alleges that Bayer failed to tell the FDA that a 67,000-patient study showed Trasylol increased the risks of renal failure, heart attack and stroke:

After a 19-member advisory panel studied the matter, it recommended to the FDA that Bayer’s warnings on Trasylol did not need to be strengthened, the complaints say.

But just days after the panel’s recommendation, a professor at Harvard’s School of Public Health contacted the FDA about a 67,000 patient study he helped to perform at Bayer’s request. The study confirmed that Trasylol increased the risk of renal failure, heart attack and stroke, the plaintiffs claim. In addition, it suggests that patients who receive Trasylol are at an increased risk of death, kidney failure and congestive heart failure.

Bayer knew of the study and its results, but failed to disclose the data to the FDA, according to the complaints.

FDA to Bayer: Quit Overstating the Efficacy of Yaz and Misleading Consumers

KBLAdmin — Wed, 14 Oct 2009 19:00:00 GMT

Below is the beginning of a letter, written in late-2008, to the President & Chief Executive Officer of Bayer, Reinhard Franzen, from the FDA. It warns Bayer that its TV ads for Yaz are misleading and misbrand the drug, which is in direct violation of the Federal Food, Drug, and Cosmetic Act, and that the ads undermine the FDA's ability to implement regulations. However, Bayer has chosen to ignore the FDA's warning, and, since this letter was written, many users of the drug maker's Yaz and similar birth control products have experienced serious-to-life threatening side effects.

"Warning Letter" to Bayer:

Dear Mr. Franzen,

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed two 60-second direct-to-consumer (DTC) broadcast television advertisements (TV Ads) entitled "Not Gonna Take It" and "Balloons" for Yaz (drospirenone and ethinyl estradiol) Tablets. The TV Ads are misleading because they broaden the drug's indication, overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug. Thus, the TV Ads misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), 352(f)(1) & 321(n), and FDA's implementing regulations. These violations are concerning from a public health prospective because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz [. . .]

Click here for the rest of the letter.

Bayer Misleading Consumers over Risks Associated with Popular Contraceptives

KBLAdmin — Thu, 08 Oct 2009 19:00:00 GMT

From The New York Times:

The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention.

Yaz, in particular, the top-selling birth control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a quality-of-life treatment to combat acne and severe premenstrual depression.

Yaz, a newer sister drug to Yasmin, contains less estrogen. The franchise had worldwide sales of about $1.8 billion last year, based on Bayer’s successful positioning of Yasmin and Yaz as the go-to drug brands for women under 35.

But recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do.

Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills.

But regulators are finding other faults with the Yaz franchise. The Food and Drug Administration early this year asked Bayer to correct misleading television commercials. Last month, the agency cited the company for not following proper quality control procedures at a plant that makes hormone ingredients.

In e-mail responses to a reporter’s queries, the American unit of the company said that its birth-control drugs had been and continued to be extensively studied and that the company stood behind their safety. The company also said it had responded to the F.D.A.’s questions about manufacturing practices, which it said it took very seriously.

But even if Bayer can adequately respond to the safety and other concerns, some industry analysts say that the avalanche of criticism could tarnish the Yaz line’s image. Other products by Bayer, like the erectile dysfunction drug Levitra and the intrauterine birth-control system Mirena, generate far less income than the Yaz product family.

“For Bayer, it is by far the highest margin and the fastest-growing brand,” Martin Brunninger, an analyst with the European investment bank Bryan, Garnier & Company, said in a phone interview from London on Wednesday. “Whether this turns out to be a serious issue or not, when a drug is stigmatized in public, people just withdraw from taking it.”

Bayer said that the company had been served with 74 lawsuits brought by women who charge that they developed health problems after taking Yaz or Yasmin. The company says it intends to defend itself vigorously against the suits.

The health questions and the lawsuits may rattle consumer confidence, but the warnings from federal health authorities about advertising and quality control raise larger questions about Bayer’s approach to complying with government rules, said Michael A. Santoro, an associate professor at the Rutgers Business School who has studied ethics in the pharmaceutical industry.

Birth control pills work by altering a woman’s hormone levels. Researchers have long known that taking a combination hormone birth control pill — which contains estrogen and a progestin hormone — can increase the risk of stroke and blood clots in the legs and lungs. That is because estrogen can play a role in blood coagulation. Indeed, since the introduction of oral contraceptives in the 1960s, drug companies have greatly reduced estrogen doses to decrease the risk of thrombosis, the medical term for blood clots.

With lower-dose estrogen pills now available, the safety debate, continuing for the last decade, has focused on whether the type of progestin in a formula may also play a role in the risk of cardiovascular problems.

FDA Warns Bayer Over Quality Control Issues, Drug Ingredients

KBLAdmin — Wed, 07 Oct 2009 18:55:00 GMT

WASHINGTON — U.S. health regulators have warned drugmaker Bayer over quality control issues at a plant that makes the key ingredient in Yaz and other popular birth control drugs.

In a warning letter posted online Tuesday, the Food and Drug Administration said its inspectors uncovered testing problems at the company's plant in Berghamen, Germany, during a March visit.

FDA inspectors said the company measured the quality of its drug ingredients based on an average of several samples, instead of reporting individual tests results.

Bayer shipped eight drug batches to the U.S. that were tested using the method, which the FDA does not accept.

The drug ingredients included drospirenone, which is used in the popular birth control pills Yaz and Yasmin. Those products were the company's top-selling pharmaceuticals last year, with global sales of $1.8 billion.

After reviewing all drug batches shipped to the U.S. between 2007 and 2009, Bayer responded to the FDA in an April 7 letter that concluded "the quality of these batches was not affected."

But the FDA responded in its own letter last month, disagreeing with Bayer's "rationale and conclusion."

Metrolink Still Struggling with Saftey Improvements

KBLAdmin — Tue, 08 Sep 2009 18:55:00 GMT

From the Los Angeles Times:

As the anniversary of the Sept. 12 Chatsworth train disaster approaches, officials with Southern California's sprawling commuter rail service are facing a vexing array of technical, financial and potential legal challenges as they struggle to deliver on pledges of trailblazing safety reforms.

A burst of energy to remake the region's Metrolink train operation was unleashed by the deadliest rail collision in modern California history, a watershed event that killed 25, injured 130 and prompted landmark federal mandates to modernize the nation's rail safety systems.

Today, the rush to reform Metrolink -- a thinly staffed hybrid transportation agency once derided as the political stepchild of the five counties that created it -- is becoming increasingly costly, time-consuming and complicated.

Labor leaders are digging in to fight an unprecedented push by agency officials to place locomotive train crews under continuous video surveillance.

Technical and financial challenges loom over an ambitious schedule to a deploy a $200-million collision-avoidance network for all commuter, freight and intercity trains moving across hundreds of miles of track.

Meanwhile, Metrolink officials have reversed course on an effort to assume direct control over hiring, training and supervising rail crews, a move prompted partly by disclosures that in Chatsworth, an engineer employed by a contractor apparently ran a red light while sending a text message on his cellphone just before colliding head-on with a freight train.

Fearing that trying to manage on-board train crews could overtax staff and trigger thorny labor issues, Metrolink's board of directors opted to farm out the critical function again, this time to Amtrak.

Compounding financial strains, ridership has been sliding since the crash, largely because of lower gas prices and the recession. Fare revenues dropped $1.4 million below estimates in the last quarter alone.

And operating insurance premiums recently surged $1 million above estimates because of Metrolink's accident history over the last decade, averaging one potentially catastrophic liability payout every two years, records show.

Although no major wrecks have occurred since Chatsworth, smaller accidents involving cars and pedestrians are running about the same this year as last -- 3.25 and 3.4 per month, respectively, the agency says.

But a rash of incidents leading up to this week's memorial observances has served as a reminder of the risks Metrolink confronts in its heavily urban mixed-rail environment.

Will the FDA Recall Birth Control Products Yasmin & Ocella?

KBLAdmin — Tue, 25 Aug 2009 18:55:00 GMT

From The Record:Will the FDA Recall Birth Control Products Yasmin & Ocella?

After a birth control pill spent months in the spotlight during commercials aimed at correcting misrepresentations about it, the pill is now at the center of a St. Clair County lawsuit.

Kerry Sims filed a lawsuit Aug. 18 against Bayer and Walgreens, alleging her ingestion of the birth control pill Yasmin, which is also known as Yaz, caused her to experience a blood clot in her lung and infection surrounding the clot.

The suit comes after a commercial warning of some fallacies about the pill repeatedly ran on television for months.

"You may have seen some Yaz commercials recently that were not clear," the ad says. "The FDA wants us to correct a few points in those ads."

It goes on to say Yaz is used to treat the less serious premenstrual dysphoric disorder and moderate acne, not the more serious premenstrual syndrome or mild acne as Bayer once advertised.

But the $20 million Bayer spent on the commercial is not enough for Sims, who says the company failed to warn her about the pill's dangers before she started taking it.

"Plaintiff Kerry Sims reasonably relied upon Defendants' representations to her and/or her healthcare providers that Yaz/Yasmin was safer than other types of oral contraceptives for human consumption and/or use and that Defendants' labeling, advertisements and promotions fully described all known risks of the product," Sims's suit states.

However, such representations were misleading, Sims claims.

In fact, from 2004 through 2008, Yaz has reportedly caused more than 50 deaths, which occurred in some women as young as 17, the complaint says.

"These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke in women in their child bearing years," the suit states.

The pill's danger possibly stems from Bayer's use of drospirenone, a new type of progestin only used in Yaz and its generic counterpart, Ocella, according to the complaint. The drospierenone causes increased levels of potassium in the blood, which can lead to a condition called hyperkalemia if potassium levels become too high, Sims claims.

In turn, hyperkalemia can cause heart rhythm disturbances, which can then cause the slowing of blood to the heart, allowing for the formation of blood clots. Those clots can lead to heart attacks or can break off and travel to the lungs, causing pulmonary embolism, which is the condition Sims suffered from. In another scenario, the blood clot can travel to the brain where it can cause a stroke, according to the complaint.

Beware of Generic Birth Control Pill Ocella

KBLAdmin — Tue, 18 Aug 2009 18:55:00 GMT

A 22-year-old woman who was taking Ocella, a generic version of the birth control pill Yasmin, recently suffered a stroke due to taking the drug. More information on this developing case will be available soon.

Since most women who take this drug tend to be on the younger side, it's difficult for many of them to ascertain if they're likely to fall prey to a stroke. It's important for anyone taking this drug, and for those who also choose to continue taking it, to make sure they let their doctors know of any changes in health, whether one considers the change small or significant.

If you or anyone you know has recently switched from Yasmin to Ocella or has just been prescribed Ocella, and you've experienced any type of side effects, contact the doctor who prescribed the drug to you and/or get in touch with an attorney, in order to protect your rights as a consumer.

The Catholic Church Still Doesn't Want You to Know Its Secrets

KBLAdmin — Thu, 23 Jul 2009 18:50:00 GMT

From the Associated Press:

NEW HAVEN, Conn. — A Roman Catholic diocese in Connecticut sought Friday to appeal to the U.S. Supreme Court to keep under wraps sex abuse documents that could shed light on how a prominent retired cardinal handled the allegations.

Bridgeport Diocese officials asked the state Supreme Court to continue a stay on releasing the documents while it asks the nation's highest court to review the case.

The state court has ruled that more than 12,000 pages of documents from more than 20 lawsuits against priests should be released. Those documents have been sealed from public view since the diocese settled the cases in 2001.

The records could reveal details on how retired New York Cardinal Edward Egan handled the allegations when he was Bridgeport bishop from 1988 to 2000. Egan's deposition should be in the file, according to an attorney for the newspapers seeking the documents.

In Boston, Cardinal Bernard Law resigned after church records were released detailing his role in handling sexual abuse claims.

The Bridgeport Diocese faced a Monday deadline to appeal before the records were disclosed.

"The diocese believes there are important constitutional issues," said Ralph Johnson III, attorney for the church. "These are issues important to all citizens."

Johnson acknowledged that the nation's highest court takes up only a small percentage of cases it is asked to review.

The New York Times, The Boston Globe, The Washington Post and The Hartford Courant have been seeking the documents. Jonathan Albano, attorney for some of the papers, said that he would object to continuing the stay and that the case really involves state law that has been resolved.

"It's somewhat disappointing that the diocese continues to approach the litigation in a way that delays the public's right to see these documents," Albano said. "There's been seven years of litigation."

An advocacy group for victims of church sexual abuse condemned the latest appeal.

"We're disappointed that the complicity of top Catholic officials continues to remain hidden," said David Clohessy, national director of the Survivors Network of Those Abused by Priests. "This is not what Connecticut Catholics or citizens deserve. It's one more painful reminder that bishops will do everything possible to protect themselves and their colleagues instead of children."

Church officials said that the media have reported on the cases extensively and that attorneys and victims had access to the sealed documents.

Court officials declined to comment.

In California, state courts ordered Los Angeles Cardinal Roger Mahony to turn over to prosecutors private personnel files of two former priests accused of sexual molestation. In 2006, the U.S. Supreme Court declined to hear the archdiocese's appeal.

Matrixx Stocks Fall After Zicam Lawsuits Announced

KBLAdmin — Fri, 17 Jul 2009 18:50:00 GMT

From the Associated Press:

NEW YORK (AP) — Shares of Matrixx Initiatives Inc. fell Monday after the company disclosed several class action lawsuits related to its withdrawn cold treatment Zicam.

After the markets closed on Thursday ahead of the long holiday weekend, the Scottsdale, Ariz.-based company said it is aware of six class action lawsuits connected to Zicam. The company also has disclosed a personal injury lawsuit involving 117 plaintiffs.

The Food and Drug Administration advised consumers to stop using Zicam products in mid-June, because the zinc in Zicam swabs and gel may damage the sense of smell. Matrixx started a voluntary recall on June 24.

"The company intends to vigorously defend each of the recently filed lawsuits," Matrixx said in a filing with the Securities and Exchange Commission. It said it expects more lawsuits.

Matrixx disclosed lawsuits involving residents of Arizona, Illinois, California, Florida, Texas, Minnesota, Wisconsin and Missouri. It said the California suit "alleges, among other things, that the company concealed or omitted material information regarding the safety of the nasal gel products."