All posts by Joseph H. Saunders

Drug Company Omnicare Fined for Paying Kickbacks

Omnicare, a large pharmaceutical dispensary that provides drugs to nursing homes, will have to pay $98 million in fines for soliciting and receiving kickbacks from the pharmaceutical company Johnson & Johnson, the parent company of Janssen Pharmaceutica, the maker of Risperdal.
In exchange for the kickbacks, Omnicare had to promote and encourage the use of Risperdal to its nursing home clients. It’s important to note that Risperdal comes with a specific warning about the use of Risperdal among the elderly population: ““Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.”
Risperdal isn’t approved for patients with dementia and yet the drug has been widely used in the past in nursing home settings in spite of the warning label.
In agreeing to pay the $98 million fine (a drop in the bucket for any big pharma company), Omnicare admits nothing and walks away from the sordid episode with no finding of any wrongdoing, including any criminal liability for any elderly patients who may have died after using Risperdal.
This is a perfect example of what’s wrong with our healthcare system, particularly the pharmaceutical drug industry. When the federal government undertakes an investigation into the possible bad behavior of a pharmaceutical company, the drug company avoids any penalty that would curb the bad behavior in the future. By the time the fine is paid, the drug company has made such a substantial profit on the drug that any financial gain they’ve made outweighs the loss incurred by the penalty.
Until the federal government makes it cost prohibitive for drug companies to circumvent the law and public safety concerns, big pharma will continue to act in its own best interests ie. the profit margin.

Chinese Drywall Class Action Lawsuit Defendant Agrees to Be Served in US

One of the defendants in the Chinese Drywall class action lawsuits has agreed to accept service of process of a class action complaint thus allowing those affected by the Chinese Drywall to consolidate their claims in one lawsuit against the defendant Knauf Plasterboard (Tianjin) Co., Ltd. (KPT).
The acceptance of service was announced in New Orleans by Judge Eldon E. Fallon. Prior to the agreement Knauf had insisted that it would have to be served through the Hague Convention, which is responsible for establishing procedures for US claims against international companies. In the past, this has proved difficult and expensive for those attempting to bring foreign companies to justice in US courts. The Hague Convention requires a payment of $15,000 for each lawsuit in order for it to be served on the foreign company.
This agreement is a major victory for those who’ve lost their homes or have been severely affected by the Chinese Drywall contamination problem.
According to a report in Reuters, “The court order provides that KPT will accept service of process and waive its
express rights under the Hague Convention only for homeowner plaintiffs who
are named in an omnibus class action complaint to be filed by December 9, 2009
in In re Chinese Drywall Products Liability Litigation, MDL No. 2047 (E.D.
La.).”
Knauf is one of several companies of manufacturing and importing the contaminated drywall into the United States. It’s estimated that between 60-100,000 US homes have been affected by the Chinese Drywall.

Byetta Gets Updated Warning Label Linked to Kidney Failure

Byetta, the Type-2 diabetes drug manufactured by Amylin Pharmaceuticals Inc., has received a stronger warning label from the FDA after the federal agency received updated information concerning the drug’s association with kidney problems relating to function and failure.
The side effects associated with Byetta include nausea, vomiting, and diarrhea. A loss or reduction in kidney function may result in a build-up of waste in the bloodstream which in turn can lead to serious infections and death.
The stronger warning label comes in the wake of 78 reports of kidney function issues in those taking Byetta.
Byetta (generic exenatide) is an injectable drug that is designed to help control blood sugar in patients with Type 2 diabetes. In 2008, the FDA said it planned to issue a stronger warning for Byetta after reports of 2 deaths and 4 hospitalizations linked to Byetta use.

US Supreme Court Rejects Diocese of Bridgeport Document Request

The Roman Catholic Diocese of Bridgeport has lost its final appeal in its attempt to keep sealed its priest abuse documents. The SCOTUS order amounted to a final refusal to hear the Catholic Church’s appeal concerning the sealed documents. The order was issued without any commentary from the Supreme Court justices.
The thousands of documents now under seal concern diocesan papers that were part of priest abuse lawsuits against the Diocese of Bridgeport. After the cases were settled, four major newspapers The Washington Post, The Boston Globe, The NY Times, and the Hartford Courant, sued for access to the church documents.
Barbara Dorris of SNAP issued the following statement: “We’re relieved that the public is one step closer to finally learning how much Cardinal Egan knew and how little he did to stop child sex crimes when he was in Bridgeport. We’re just sorry Bishop Lori has taken 7 years and probably spent at least $100,000 donated by parishioners to protect himself and his colleagues instead of protecting kids.
We believe these records will also reveal the names of others in the Catholic hierarchy who ignored or hid the devastating wrongdoing of pedophile priests.”

Seroquel Lawsuits Cost Astra Zeneca $520 Million

Seroquel, AstraZeneca’s top selling psychiatric drug, will cost the drug company $520 million to settle two federal inquiries as well as two whistle blower lawsuits. The settlement comes after the US Justice Department began investigating AstraZeneca for its marketing of the psychiatric drug to children and the elderly. In addition to the federal lawsuits, Seroquel’s maker is facing 14,444 civil suits on behalf of patients who developed diabetes and other health issues after taking the psychiatric drug.
Seroquel is the latest psychiatric drug to face stiff penalties for its marketing practices. Earlier this year, the maker of Zyprexa, Eli Lilly & Co. paid $1.4 billion.
The identities of the whistleblowers and other details surrounding the case against Seroquel remain sealed in federal court.

Stryker Biotech Indicted for Illegal Marketing Practices

Stryker Biotech, a medical device company based in Hopkinton MA whose parent company is Stryker Corporation, has been indicted by a federal grand jury for marketing two medical devices which had not received FDA approval. The devices were designed for spinal and long bone surgeries. The indictment also accuses the company of trying to conceal their illegal marketing of the unapproved medical devices.
Prosecutors argue that company representatives aggressively marketed these products to doctors which resulted in several medical complications. According to the Boston Globe, “Former company president Mark Philip, who lives in Massachusetts, is also facing charges of wire fraud, conspiracy, and making false statements to the FDA. Three current sales managers were also charged in the case. Four other Stryker employees have already pleaded guilty to charges related to the case, according to the US Department of Justice.”
A spokesperson for the parent company, Stryker Corp. expressed disappointment in the indictment. Stryker Corp. is facing civil lawsuits from faulty artificial hips known as Trident PSL and Trident Hemispherical Acetabular Cups.

Antipsychotic Drugs and Significant Weight Gain in Children

Antipsychotic drugs such as Zyprexa, Abilify, Seroquel, and Risperdal have been shown to cause dramatic weight gain in children and adolescents. The new study to be published in the October 28 edition of the Journal of the American Medical Association is the largest study of the relationship between childhood weight gain and the antipsychotic drugs known as atypical antipsychotics.
While the study focuses on adolescents and children, concern with these types of drugs used to treat schizophrenia, bipolar disorder, and autism has been associated with weight gain in adults for quite some time. In 2003, the FDA ordered manufacturers of these drugs to add a warning label concerning their association with hyperglycemia and diabetes. These adverse side effects now appear to be prevalent in adolescents who take the atypical antipsychotic drugs as well.
The Atlanta Journal Constitution notes that “After nearly 11 weeks, the treated kids gained an average of 18.7 pounds on Zyprexa, 13.4 pounds on Seroquel, 11.7 pounds on Risperdal and 9.7 pounds on Abilify, while the control group gained less than half a pound. Between 10 percent and 36 percent became overweight or obese during the treatment period, according to the study.”

Stryker Hip Lawsuits Continue to Mount as Company Works to Address FDA Warning Letters

Stryker Corporation continues to work to address issues raised in four recent FDA warning letters as the company faces more lawsuits concerning its Stryker Trident artifical hip medical device. The Stryker hip was the subject of a recall in January 2008 after the FDA found quality control issues at its manufacturing plants in Ireland and New Jersey. The recalled hip received numerous complaints from patients who continued to experience pain and discomfort from the implanted artificial hip. Other patients reported squeaking from improper wear of the Stryker devices. Both issues concerning the Stryker hip have resulted in lawsuits against the medical device company.
Stryker Trident hips are not the only company device that’s been the subject of a recall. In December 2008, Stryker issued a recall of its cranial implant kits citing a risk for infection due to a lack of proper sterilization.
Stryker has pledged to spend $150 million over the next few years to address quality control problems as well as a monitoring system that will better track adverse event reports so that device defects can be spotted earlier.
Many Stryker hip patients have had to undergo one or more revision surgeries to correct the defective hip originally implanted.

New Sex Abuse Charges For Scranton Priest

A 43 year-old priest from the Diocese of Scranton has been arrested and charged with 16 counts, Sexual Abuse of Children (F2); 1 count, Sexual Abuse of Children (F3); 1 count, Criminal Use of Communication Facility (F3); and 1 count, Tampering with/or Fabricating Physical Evidence. The priest probe began in September 2008 when law enforcement officials received a letter from the Diocese of Scranton concerning an anonymous letter they had received. The letter contained information concerning an email address that contained explicit photographs of young boys.
The police traced the email address back to Rev. Robert Timchak, an active priest serving in the Diocese of Scranton Pennsylvania. The arrest of Timchak comes approximately one month after a Canadian bishop was arrested and charged with similar offenses. Bishop Raymond Lahey, formerly of the Nova Scotian Diocese of Antigonish, resigned his position as bishop immediately before turning himself in to Canadian law enforcement authorities.

Tysabri and Brain Infections

Tysabri, a highly touted multiple sclerosis drug marketed by Biogen Idec Inc. and Elan Plc, is drawing renewed scrutiny from European drug regulators who’ve witnessed an increase in cases where Tysabri users are contracting a rare but serious brain infection known as progressive multifocal leukoencephalopathy, or PML. The regulators are concerned about potential higher instances of brain infection corresponding to longer use of Tysabri in multiple sclerosis patients.
According to the Wall St. Journal, European regulators are in discussions with the FDA in the United States about the problem. Last month, the FDA updated the warning on Tysabri noting that PML risk appears to be commensurate with longer term use of the drug. Tysabri had been temporarily suspended in 2005 after 3 cases of PML were reported. The drug re-entered the market after 18 months. Thus far, 13 cases of PML have been reported by the company in patients who’ve used Tysabri to treat MS. At this point, Tysabri appears more problematic in patients who take the drug in prolonged fashion.