Ruling in favor of drug makers, the Supreme Court has closed the doors of appeal in civil courts on the attorneys parents seeking claims from vaccine manufacturers for producing vaccines that result in autism and other health-related disorders in their kids. The court ruling is a great disappointment for the attorneys of those parents who look for legal help for the suffering of their kids due to vaccination related injury and infection. The Supreme Court ruling clearly protects vaccine manufacturers from “legal liability” and asks parents to approach the special no-fault federal vaccine court to address their grievances.
The United States Food and Drug Administration ( FDA ) has issued an official warning letter on / to California based Invisalign Braces maker Align Technology for failure to report life threatening side effects caused by the Invisalign braces.
The FDA warning was issued after Align Technology failed to respond to FDA inquiries requesting more information regarding documented instances of Invisalign side effects causing a variety of injuries in patients including oral ulcerations, life threatening allergic reactions and the possibility of death for Invisalign braces users who experience recurring side effects.
A class-action lawsuit has been filed against Merck & Co., Inc. for failing to fully disclose the serious side effects of the prescription drug Propecia prescribed for male pattern hair loss or baldness. The lawsuit seeks compensation on behalf of all the men who have taken Propecia and suffered from severe side effects in the form of sexual dysfunction and mental impairment. The lawsuit claims that the pharmaceutical company failed to fully disclose the side effects of the drug, which resulted in immense suffering and permanent loss of sexual desire for the plaintiffs.
The Connecticut law firm, filing the lawsuit against the pharmaceutical manufacturer, asserts that the prescription drug claimed to combat hair loss has resulted in severe side effects for the plaintiffs. The lawsuit claims that the defendant pharmaceutical company failed to fully disclose the severe side effects of Propecia on the drug label. The plaintiffs claim that if the company had put a stronger warning label on the drug, they would not have taken the risk of testing that. The lawsuit asserts that despite receiving warnings from European regulators, the company did not adjust the warning labels in the American market. The suit claims that the company failed to abide by its moral duty to ensure the safety of Propecia and Proscar for all kinds of patients.
The recent recall of DePuy ASR hip replacement systems raises a few questions on the efficacy of Metal On Metal hip implants used in total hip arthroplasty, which were claimed to be more durable than other forms of hip replacements. However, this so-called durability has come to be questioned as a result of numerous cases of severe tissue and bone damage in many of the patients who had undergone Metal On Metal hip replacement surgery. Most of the patients were required to undergo revision surgery within five years of the first one, thus raising questions about the effectiveness and durability of these hip implants.
This abnormaly high failure rate has prompted the FDA to review all the Metal On Metal hip implants. This also raises questions about the FDA’s 510 (k) review process.
In recent years, Metal On Metal implants have been used in one-third of the250,000 hip implant surgeries performed annually in the United States. Metal On Metal implants are used in conventional hip replacements and resurfacing, a popular alternative procedure.Primarily used to treat osteoarthritis and joint pain, Metal On Metal implants are made of cobalt and chromium and thus touted to wear less with a reduced risk of a dislocated hip. The implant device consists of a cup, which is implanted into the hip with a ball joint connecting the leg. Several health product manufacturers have entered the market with Metal On Metal hip implants.
As the recent DePuy hip replacement recall shows, there are numerous side effects associated with using some Metal On Metal hip devices. The metallic devices can quickly flake off, generating a large quantity of metallic ions in the patients body, which causes inflammation, pain, tissue death, loss of surrounding bone, and even metal toxicity. The wear and tear occurs as a reult of both the acetabular cup and femoral head being made of metal. While the acetabular cup rests on the femoral head, it rubs directly against the latter when the leg moves, which causes metal to wear off slowly and diffuse into the bloodstream, leading to metal sensitivity and cobalt poisoning in some patients. When these metallic ions relocate, they can disperse in the nearby body organs, produce irritation, pain, inflammation, and even create cysts and tumors. Many surgeons have even reported