The first Paxil lawsuit has finally gone to trial and the jury has awarded a suburban Philadelphia family $2.5 million. GlaxoSmithKline has been ordered to pay the monetary damages for birth defects suffered by a young child whose mother took the anti-depressant drug. The jury awarded the family double the amount they sought because they found that GlaxoSmithKline failed to warn doctors of the potentially serious birth defects associated with Paxil.
Paxil belongs to a family of drugs known as selective serotonin reuptake inhibitors (SSRI) and GlaxoSmithKline was warned about the drug’s link to serious birth defects in 2005. Yet, the company chose to minimize the association and decided to downplay the risks when discussing the drug with doctors.
As in many of our lawsuits, the company’s own internal documents provided the damning evidence of misbehavior and mischaracterization of the drug’s real dangers.
While GlaxoSmithKline says it will appeal the jury verdict, it faces 600 similar Paxil birth defect lawsuits.
The FDA has called for a post-market safety review of certain dynamic-stabilization devices used in spine surgeries. The review concerns questions about their safety and their effectiveness in the device’s fusion rate compared to more traditional procedures. The study will try to determine the rate at which these dynamic-stabilization devices fail to fuse, break, or loosen over time. Problems with the medical devices could require further surgery and spinal complications for the patient. The devices in question are manufactured by Johnson & Johnson (JNJ) and Zimmer Holdings Inc.
The newer spine stabilization systems which were first introduced 12 years ago provide some flexibility while the older systems are more rigid. The FDA, in calling for the post market safety review, wants to determine the safety records of such devices now that they are being used by healthcare professionals. Of course, this process would be much easier if the FDA had some sort of medical device registry in place. However, Congress is working on such legislation in collaboration with the federal agency.
The FDA has released a list of drugs that are being monitored by the federal agency for possible safety issues. The list is compiled from the Adverse Event Reporting System and names those drugs who made the adverse event list after a safety issue was raised with the particular drug. The list is published quarterly and includes drugs such as:
Ceftriaxone (Rocephin) – Hemolytic anemia was added to the Warnings section of labeling in June 2009
Diclofenac epolamine patch (Flector) – Hypersensitivity reactions
Didanosine (Videx) – Portal hypertension
Entacapone (Comtan) – Colitis
Gadolinium-based contrast agents – Anaphylaxis
Alpha interferon products – Pulmonary Hypertension
Mecasermin products (Increlex, Iplex) – Hypersensitivity reactions
Methylnaltrexone (Relistor) – Gastrointestinal perforation
Minocycline (Solodyn) – Autoimmune disorders in pediatric patients
Promethazine injection – In September 2009 FDA informed manufacturers of promethazine injection to include a Boxed Warning in the labeling to highlight the risk of serious tissue injury when this drug is administered incorrectly.
Sunitinib (Sutent) – Liver failure
Tenofovir (Viread) – Safety during pregnancy
Zoledronic acid (Reclast) – Renal impairment was added to the Warnings and Precautions section of labeling in March 2009.
Other than making the list and being monitored by the FDA, no further information is provided. The FDA is careful to point out that a drug’s listing does not necessarily mean there are safety issues with the drug or that doctors should not prescribe the drug.
Bay Pines Florida residents are the second group of Tampa Bay residents hit with bad news concerning a toxic plume of environmental contamination in their neighborhood. Just last year, the residents of the Azalea neighborhood learned that the Raytheon plant in the area had been leaking hazardous chemicals into their groundwater. As in the Raytheon case, Bay Pines residents only found out two weeks ago that a toxic mix of dangerous chemicals such as 1,4-dioxane, TCE and vinyl chloride and metals such as arsenic, cadmium and lead were forming a migratory plume in their neighborhood.
State and federal environmental officials have known for many years about the problem but inexplicably chose not to inform residents of the potential dangers.
Those are the words of private environmental investigator Becky Sharp when she called the Pinellas County Sheriff’s Department on February 3, 1992 concerning the environmental contamination located at an industrial park in Bay Pines. When she inspected the industrial plant at the former APF Industries, she found open acid containers and other chemicals that were so powerful they disintegrated concrete. She feared they would catch fire or explode. Yet, 17 years later, local residents are only now discovering the environmental hazard that surrounds their neighborhood. According to a WFLA report filed by Mark Douglas, “Some chemicals are found in concentrations as much as 1,400 times the level at which the state targets an area for cleanup.”
The EPA deemed the site hazardous noting in its records, “the release or threat of release of hazardous substances at the site may present an imminent and substantial endangerment to the public health or welfare or the environment.”
Earlier this year, Senator Charlie Justice proposed legislation that would make it mandatory for residents to be notified of such a toxic health hazard in their neighborhood. The bill failed and received no support from the Environmental Protection Agency. Justice, undeterred by last year’s failure, has re-submitted another bill for consideration in this year’s legislative sesssion.
As in the Raytheon toxic plume in the nearby Azalea neighborhood, residents weren’t notified about the danger. Now officials from the Pinellas County Health Department want to inspect some of the wells in the area but not in the area where the plume is thought to be migrating-south and east toward Harbor Lights.
While Bay Pines residents found out about the environmental hazard in their neighborhood, state environmental agencies have known for 13 years that the area was environmentally contaminated and posed a significant risk to area residents. According to a TBO story, the Florida Department of Environmental Protection sent a letter to the owner of the industrial site 11 years ago, calling it “an extremely hazardous environmental situation”.
Two weeks ago, workers from the Pinellas County Health Department began placing door hangers on the homes of residents just west of the former APF Industries plant located at 4800 95th St. North. The Health Department also referred 15 wells the Department of Environmental Protection for testing.
The Bay Pines environmental contamination news comes a little over a year after we filed a class action lawsuit against Raytheon Corporation for a toxic plume in the Azalea neighborhood in St. Petersburg. Like the Raytheon matter, residents weren’t notified even though state Department of Environmental Protection and other state and federal agencies knew about the toxic environment.
Bay Pines Pollution Lawsuit Information
A new study published in the New England Journal of Medicine has revealed that orthopedists failed to disclose $4,000,000 in payments from companies that manufacture artificial hips and knees. The discrepancy in payment disclosure was found after a new study compared what medical device companies disclosed in relation to the doctors’ disclosures at the March 2008 annual meeting of the American Academy of Orthopaedic Surgeons.
In 2007, medical device companies agreed to disclose such financial information as part of a US Justice Department investigation in which the federal government accused device companies of violating anti-kick back laws by remunerating doctors for using their products. Companies involved in the Justice Department probe included Zimmer Holdings Inc. and Biomet Inc. of Warsaw, Ind.; Stryker Corp. of Kalamazoo, Mich.; Smith & Nephew PLC of London; and the DePuy Orthopaedics unit of Johnson & Johnson, New Brunswick, N.J.
According to the research, 344 payments were made to orthopedists while only 245 doctors revealed the payments.
Medical devices such as artificial hip implants, knee implants, and other implantable medical devices have experienced a huge growth in use and popularity in the last decade. More patients are receiving some form of implantable medical device than ever before. Yet, in spite of the surge in usage, there is no protocol for tracking or monitoring these devices.
“There is no system for being informed of what the problems are with the products you have in your body. Even your physician may not know,” said Terry Fadem, president of the Biomedical Research and Education Foundation in Philadelphia.
If a problem arises with a particular medical device such as an artificial hip or knee, doctors and industry professionals have know way of knowing who received the devices. This is not an insignificant issue since 2,500 medical devices were recalled in 2008 alone. In 2006, surgeons implanted a million artificial knees and hips. That number is expected to quadruple by 2030.
In the first seven months of 2009, over 1,000 recall notices have been issued for medical devices such as pacemakers, artificial hips, tracheal tubes, and pain pumps. Without a centralized data system like the medical registry, industry officials admit it is very difficult to track the faulty devices and ensure consumer safety.
The new FDA chief, Margaret Hamburg, recognizes the problem and has vowed to make post-market safety a priority during her tenure. Hopefully, that will include a national medical registry for all medical devices so that doctors and industry officials can more easily monitor the devices they implant in patients.
The United States Supreme Court has rejected the Diocese of Bridgeport’s appeal to keep their church documents sealed. The 12,000 pages of documents are related to priest sex abuse lawsuits resolved in the 1990’s. Eight years ago, the NY Times, the Boston Globe, the Washington Post, and the Hartford Courant filed suit to unseal the documents and make them public. A Connecticut lower court ruling approved the unsealing which led to the diocese’s appeal to the Supreme Court.
According to a story in the Hartford Courant, “Late Monday, attorneys for the diocese filed motions at Superior Court in Waterbury seeking a status conference to determine which documents will be made public and to ensure that the few documents the state Supreme Court ruled should be sealed remain so.”
The Diocese of Bridgeport has one last attempt pending before the US Supreme Court concerning its appeal of the Connecticut Supreme Court’s concerning public disclosure of the documents.
Allergan, the maker of Botox, has filed a lawsuit against the FDA and the Justice Department for restricting their marketing efforts and violating their First Amendment rights to free speech. At issue in the lawsuit is a pharmaceutical company’s ability to market their products for so-called off-label uses, something which is currently prohibited by FDA regulations.
While other pharmaceutical companies have not joined the lawsuit, they are watching it closely. The outcome will likely affect the manner in which they conduct their marketing efforts for years to come. Botox is currently approved by the FDA to treat crossed eyes, eyelid spasms, excessive sweating, and wrinkles. Doctors are free to prescribe Botox for any off-label use they deem appropriate. The FDA restriction only prohibits pharmaceutical companies such as Allergan from marketing their products such as Botox for off-label uses.
In their lawsuit, Allergan contends that this restriction unfairly limits them from educating healthcare professionals on other uses of Botox. The FDA has not allowed such off-label marketing because the so-called off-label uses have not been subject to the same scrutiny as for those for which the drug has been approved. This is really a consumer protection issue. If drug companies are allowed to market their products for unapproved uses, it makes the FDA’s regulatory powers irrelevant and places the average consumer at risk.
Botox has received stricter labeling requirements from the FDA after dangerous side effects had been reported. Such adverse effects include difficulty swallowing and breathing problems. To date, sixteen people who had received Botox injections have died as a result of the side effects as a result of dosage and prescription errors.