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, 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 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 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.
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, 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.
While the US Marine Corps publicly stated that it closed its drinking wells once it discovered the wells were contaminated with toxic chemicals, its internal documents show otherwise. Now, Marines and other residents of the famous Marine base are discovering that they’ve contracted cancer. 146,000 people have signed up to a Marine health registry designed to locate and document those who’ve fallen ill after living at Camp Lejeune. It’s estimated that between 400,000 and 1 million people may have been exposed to the toxic drinking water during a 30 year period from 1957 to 1987.
While Marine officials began receiving warnings from chemists about the toxic water in 1980, nothing was done about the problem for 4 years. Environmental regulators received reports from the Marine base but any mention of the toxic water problem was not included in those reports. Perhaps, more disturbing, Marine officials failed to notify regulators of a chemical spill that was leaking fuel at a rate of 1,500 gallons per month. The fuel and other toxic chemicals seeped into the groundwater and contaminated the camp’s drinking water.
The environmental problem at the camp was so bad that the location was designated as a Superfund site in 1989. Thousands of state and federal documents concerning the problem reveal a multiplicity of sources of contamination including the dumping of oil, industrial waste water, as well industrial waste from a nearby dry cleaning business.
Besides the document issue, Marine officials at the camp have continued to deny any responsibility for the contaminated drinking water in spite of clear federal regulations to the contrary.
Now, some of those who lived at the base are fighting back. One former Marine from Wisconsin who lived at Camp Lejeune received a 30% disability from the Marine Corps due to illnesses contracted because of the toxic water contamination. It seems certain that more will follow suit as news of the groundwater contamination at Camp Lejeune is publicized and the former residents respond.
A New York jury has found Exxon-Mobil Corporation liable for contaminating the groundwater by using a gasoline additive methyl tertiary butyl ether (MTBE). Exxon will have to pay the city $104,700.
In its lawsuit against Exxon-Mobil, the city of New York alleged that the oil company had ignored its own scientists when they warned the company not to use MTBE in areas where the groundwater also serves as drinking water. The groundwater contamination case involved six wells in Queens that provide the city with drinking water. MTBE has been banned by 20 states, including New York.
Reacting to the jury award the mayor of New York warned other polluters, “Our water supply is one of our most vital resources–and we will work to protect it and go after those who damage it,” Mayor Michael Bloomberg said in a statement.
On the eve of a sex abuse trial, the Catholic Diocese of Wilmington has filed for Chapter 11 bankruptcy protection in federal court in Wilmington Delaware. The Diocese of Wilmington is the seventh diocese in the United States and first on the east coast to file for bankruptcy protection. The Diocese faces liability for sexual abuse claims filed in Delaware courts after passage of the state’s 2007 Child Vicitms Act allowing survivors of child sexual abuse, who had been barred from filing suit against their abusers under the statute of limitations, to bring civil cases in Delaware Superior Court during a two-year window that expired in July. More than 175 cases involving at least 190 plaintiffs have been filed with Superior Court, according to court documents.
In announcing the bankruptcy filing, Wilmington Bishop Francis Malooly stated, “after careful consideration and after consultation with my close advisers and counselors, I believe we have no other choice, and that filing for Chapter 11 offers the best opportunity, given finite resources, to provide the fairest possible treatment of all victims of sexual abuse by priests of our Diocese.”
The founder of the advocacy group Survivors of Those Abused by Priests (SNAP), Barbara Blaine characterized the bankruptcy filing in another fashion. “The bottom line is that the bishop doesn’t want the truth to be exposed,” Blaine said.
The sex abuse trial that had been scheduled to begin Monday involved former Catholic priest Francis DeLuca who had worked in the Diocese of Wilmington for more than 35 years and is now the target of multiple lawsuits for sexually abusing minors.
Chinese drywall has now affected more than just the buildings built with the contaminated material. Two insurance companies, Citizens and Universal North America, have dropped property insurance coverage for some homes affected by the Chinese drywall. In some instances, homeowners have been told that they have six months to fix the Chinese drywall problem or their property insurance won’t be renewed. This poses a difficulty for the homeowner since no remediation plan has been formulated in spite of the fact that some builders have already started remediation efforts.
While homeowners suffer, the Consumer Products Safety Commission is investigating the problem which is estimated to affect at least 100,000 homes in the US.