Monthly Archives: January 2012

Adverse Effect Drug Data and Failed Medical Device Information Online

Two start-up companies have taken on the important task of compiling and publicizing data that has been maintained by the Food and Drug Administration for years. The data concerns adverse effect reports concerning pharmaceutical drugs and medical devices. The latter is especially important for consumers since the United States still has no medical device registry system in place that tracks the history and performance of medical devices. This type of data is most useful in tracking medical devices such as failed artificial hip devices such as the DePuy ASR XL, the DePuy Pinnacle, and the Zimmer Durom Cup hip devices.
According to the Wall St. Journal, “A start-up company, AdverseEvents Inc., has streamlined the FDA’s often impenetrable database and made it easy to search the adverse-event reports for more than 4,500 drugs, free and online.
Another start-up, Clarimed LLC, has done the same for reports filed with the FDA on 130,000 medical devices, a far more complex group that runs the gamut from syringes to stents to tanning beds and diagnostic machines that could impact tens of thousands of lives.
Both companies, which launched in September, see their services as empowering patients, many of whom now comb Internet discussion boards for medical information. “If your doctor tells you to take a drug and it’s three times more likely to give you a heart attack than another drug, not having that information seems foolish,” says AdverseEvents President and co-founder Brian Overstreet.
While basic searches will remain free, AdverseEvents plans to charge consumers $10 a month for access to full drug reports starting Wednesday, and will offer health-care professionals and businesses more detailed information for additional fees. Clarimed may follow suit. Both websites offer a way to file reports to the FDA, but few visitors have done so.”

Convicted Pedophile Priest Jailed Again in Ireland

Notorious serial pedophile priest Oliver O’Grady is going back to prison, this time for three years after an Irish court found him guilty of possession of thousands of computer images of child pornography.
O’Grady had been a Catholic priest in California until he was sent to prison and was the subject of a myriad of sexual abuse lawsuits for molesting children during his 30 year tenure as a Catholic priest.
According to one media source, “The 66-year-old returned to live in Ireland and was flying from Amsterdam to Dublin in 2010 when he left a laptop on his flight containing graphic images of children.
Gardai traced him to a hostel in Dublin where they found thousands more photos, videos and audio of child porn stored on hard drives and USB keys.
The judge at Dublin District Court jailed O’Grady for 3 years saying the former priest – described as socially isolated – seemed to have a serious problem and his time in American prison had not rehabilitated him.”
Pedophiles like O’Grady will continue to prey on children unless they are permanently removed from society. Just because he was defrocked as a Catholic priest, he remains a pedophile and a danger to children. It’s surprising to me that he received only a 3 year sentence, given that he has already spent considerable time in prison for numerous child sex offenses.

Mesothelioma and Asbestos-Related Lawsuits

Civil lawsuits involving asbestos and its signature injury mesothelioma have been ongoing for more than three decades and there is no foreseeable end in sight. This is so because unlike many other injuries, mesothelioma may take up to 50 years before its symptoms begin to show in someone who has been exposed to asbestos.
Unfortunately, the Environmental Protection Agency did not ban the use of asbestos in the United States until 1989 in spite of the fact that asbestos lawsuits have been filed since 1929. The dangers associated with asbestos and their relation to the contraction of mesothelioma have been known for decades. That’s primarily how legal theories of negligence have been articulated so that those who’ve been injured by asbestos exposure are able to sue the manufacturers of asbestos.
While asbestos-related products are ubiquitous, many people were exposed as a result of their work in the US shipyards, especially after World War II.
EPA asbestos regulations fall primarily under the authority of two different federal laws and
their resulting implementations:
- the Clean Air Act (CAA) (e.g., Asbestos National Emission Standards for Hazardous
Air Pollutants, or NESHAP) rules, and
- the Toxic Substances Control Act (TSCA) (e.g.,Asbestos Ban and Phaseout) Asbestos
rules.

FDA Orders Vaginal Mesh Manufacturers to Study Safety Issues

With vaginal mesh lawsuits mounting, the FDA has ordered 33 vaginal mesh device manufacturers to undertake a 3 year study to determine their effectiveness as well as their safety in treating two approved uses-pelvic organ prolapse and female urinary incontinence.
In recent years, the transvaginal mesh makers have been receiving complaints about mesh failures and their ineffectiveness in treating either of the two conditions for which the device was originally approved under the government’s 510(k) system, which allows products to reach the market without human testing if the agency decides they’re similar to devices already for sale. In October, Bloomberg News reported many implants can trace their approvals back to a Boston Scientific Corp. mesh recalled for safety concerns in 1999.
According to Bloomberg, “Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices’ alleged failures have spurred more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing. The letters ask each manufacturer to collect data on the results and potential complications of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina. The FDA said in July that it wasn’t clear from available studies whether the devices provided a benefit over older methods in certain cases.”

Actos Recalled In France and Germany, Why not the US?

Germany and France have both recalled the popular but controversial diabetes drug Actos because of its well-documented link to bladder cancer. While these European countries have taken decisive steps to protect their citizens, the US, through its federal agency the FDA has not taken such steps. Rather, the FDA has increased the drug’s black box warnings and called for further studies.
Yet, the evidence connecting Actos and bladder cancer as well as an increased risk of heart attack and stroke has led to numerous Actos lawsuits across the country. In fact, the number of Actos lawsuits has grown to such an extent, Actos litigation has been consolidated in a multidistrict litigation in the Federal District Court in the Western District of Louisiana.
The lawsuits allege that Takeda Pharmaceutical and Eli Lilly, the manufacturers of Actos, failed to provide appropriate warnings of the dangers of Actos despite knowledge of those dangers. It has been determined that Actos can increase the risk of bladder cancer by up to 40%. Those taking Actos for more than one year are at the greatest risk. The risks increase with longer usage and greater dosages.
It seems apparent that further action should be taken by the FDA to protect consumers.

Belgian Law Enforcement Raid Catholic Bishops’ Offices

In a second time in the span of a year and a half, Belgian civil law enforcement authorities conducted raids on three Catholic Church headquarters in Antwerp, the eastern city of Hasselt, and Mechelen. The investigators were looking for physical evidence of the cover-up of thousands of sexual abuse allegations made in the last few years against Catholic clergy.
The first such raid occurred in 2010 and was followed by an unprecedented and shocking admission by former bishop of Bruges, Roger Vangheluwe who admitted he had sexually abused two of his nephews.
The Belgian Catholic Church, like those in most of Europe, have been plunged into the scandalous priest sex abuse scandal that has shocked the United States Catholic Church for the last decade.
According to the NY Times, “A spokeswoman for the Federal Prosecution Service, Lieve Pellens, said that the investigation, known as Operation Chalice, was an important phase in which officials were trying to establish whether there were grounds to prosecute priests on charges of negligence and failing to aid abuse victims.
“We have had around 200 statements from victims,” she said, “and based on these, and 87 civil claims, we wanted to look at the individual personal records of priests made by their superiors to see if, in these records that were kept by archbishops or bishops, there is anything useful.”

Actos Bladder Cancer Lawsuits

Actos bladder cancer lawsuits filed in California state court will be consolidated for purposes of pretrial discovery and motion proceedings under Los Angeles Superior Court Judge Carl West. Also, federal Actos bladder cancer lawsuits were similarly consolidated in a multidistrict litigation in the U.S. District Court for the Western District of Louisiana.
Actos, manufactured by Takeda Pharmaceutical, was approved by the FDA in 1999 to treat Type 2 diabetes. However, since that time, Actos has been linked to an increased risk of bladder cancer, especially those patients who’ve taken Actos for an extended period of time.
In June 2011, the FDA issued an Actos warning about the bladder cancer link and noted, “”results from two, three-year controlled clinical studies of Actos (the PROactive study and a liver safety study) demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators,” the FDA wrote in its announcement of the safety review.”
According to MedPage, “The FDA is investigating a possible link between pioglitazone (Actos) and bladder cancer, and, as a result, both of the available thiazolidinediones — pioglitazone and rosiglitazone (Avandia) — are undergoing safety reviews.
The FDA said it initiated the pioglitazone review after it received preliminary data from a 10-year epidemiological study sponsored by Takeda.”

Catholic League President Attacks Survivors Advocates

Catholic League for Religious and Civil Rights President Bill Donohue has once again lashed out against those trying to help the survivors of sexual abuse. Donohue wrote a column published on the League’s website calling them a “pitiful bunch of malcontents” with a caption of a baby crying next to the article.
While these types of verbal attacks are not new from Donohue, it’s high time the bishops stand up and tell him to stop speaking as if he was speaking on their behalf. Anyone who has had the privilege of working with sexual abuse survivors knows full well the psychic damage caused by sexual abuse, especially at the hands of a religious figure such as a priest. It’s completely unwarranted and reprehensible to attack the victims and act as if all of us should just “move on” or “get over it”.
One wonders how Donohue would react if one of his children had been the victim of sexual abuse.

Risperdal Trial Opens in Texas

A trial wherein the plaintiff seeks a billion dollars in damages against the manufacturer of the drug Risperdal has opened in Texas. Johnson & Johnson, the beleaguered pharmaceutical giant has already lost more than $600 million over the marketing of its anti-psychotic drug, faces a potentially huge losses in the trial.
Texas is seeking damages of more than $1 billion.
State Attorney General Greg Abbott accused J&J of paying officials to get Risperdal on approved drug lists, marketing it for unapproved uses to children and the elderly, and lying about its effects. The case in state court in Austin was filed by a whistle-blower and joined by the state, which is seeking repayment of Medicaid payments.
Texas is asking for reimbursement of $579 million, said Tom Melsheimer, a lawyer for the whistle-blower. The amount could be tripled by jurors under state law. In addition, jurors will decide the number of violations and set a penalty of up to $10,000 apiece, if the state wins.

Catholic Church Lawyers Will Depose SNAP Official

David Clohessy, the national director of Survivors of Those Abused by Priests, will have to appear for a deposition concerning a lawsuit brought against the Diocese of Kansas City-St. Joseph regarding sexual abuse allegations lodged against Rev. Michael Tierney.
The unprecedented move by Catholic Church defense lawyers requires the deposition be taken duces tecumwhich means Clohessy must appear with documents relating to abuse matters. The specifics concerning the document production is very broad and asks for items that are tangentially (if at all) related to the particular lawsuit in question.
Advocates for survivors of abuse have criticized the move stating that it’s heavy-handed and designed to intimidate survivors. Marci Hamilton, a professor at the Cardozo School of Law at New York’s Yeshiva University, told the National Catholic Reporter that the subpoena is “one of the uglier moves I’ve seen by any organization in these cases so far.”