Tag Archive for FDA

From Hallucinations to Heart Problems: The Effects of Concerta and Its Generic Equivalents

259502894_f3e435ebd8_zOn October 18, 2016, the United States Food and Drug Administration (FDA) proposed withdrawing two generic versions of Concerta. The FDA ran tests on both drugs and it was determined they had insufficient effects on patients. The drug, Concerta, is alleged to have a number of side effects on people who take it including suicide, agitation, convulsions, disturbed sleep, hallucinations, hostility, stroke, anxiety, depression, drug addiction/abuse, heart issues, mania, and psychosis. The two drug manufacturers are Kremers Urban (subsidiary of the Lannett Company), and Mallinckrodt Pharmaceuticals, which were both given opportunities to request a hearing by the FDA to show why their drugs shouldn’t be withdrawn. Ordinarily, a move like this from the FDA would lead to a flurry of lawsuits.

Patients cannot sue the manufacturers relating to efficacy or labeling of the drug. Also, because they are generic manufacturers, the companies cannot change the formula or labels on their own even if new information about safety and side effects are discovered. The United States Supreme Court upheld this idea in a 5 to 4 decision that overturned a New Hampshire jury verdict; the verdict awarded over $20 million to a woman who took a generic version of a drug. Generic drugs exist to help consumers save money on buying drugs they need to treat illnesses. According to the Congressional Budget Office, generic drugs help consumers save an estimated $8 to $10 billion at retail pharmacies. Institutions like hospitals and clinics save billions when they use generic drugs.

According to the FDA, a generic drug is developed under patent protection when it is first created. This gives the company the sole right to sell the drug while the patent is in effect, essentially giving it a monopoly on the market. Once the patent wears off, generics can enter the market submitting their new drug application for approval. The Orange Book provides a way to look up generic versions of brand name drugs. Concerta is manufactured by Janssen (subsidiary of Johnson & Johnson). It is used to treat Attention Deficit Hyperactive Disorder (ADHD).

 

Photo credit: Michael Chen, photo

First Transvaginal Mesh Lawsuit Settles for $3.35 Million

scales of justiceLast week marked a huge win for plaintiffs involved in the transvaginal mesh litigation, as a New Jersey jury announced a $3.35 million decision against Johnson & Johnson and its subsidiary Ethicon. According to Bloomberg, the punitive damages as a result of the $3.35 million verdict could exceed $16 million.

The plaintiff in this case got the implant without knowing all the associated risks and needed 18 operations after it was implanted. Years later, the United States Food and Drug Administration investigated vaginal mesh complications and organ damage. They discovered that the mesh caused pain and harm to women. In addition, in September of 2011, an FDA advisory panel recommended the reclassification of vaginal meshes as high risk.

Meningitis Outbreak Responsible for at Least 5 Deaths

meningitis outbreakCBS News reported a story about the Meningitis outbreak that has been spreading across the country. According to different news reports, at least five people have died with over 30 people sick because of contaminated steroid shots for back pain.

The steroid shots were reportedly mixed in compounding laboratories that supply doctors, hospitals, and clinics. They have the possibility of becoming contaminated if the compounding process isn’t completely sterile. In addition, their products do not require approval from the Food and Drug Administration.

If the causes of the meningitis outbreak are true, then there could be huge liability issues for all the clinics, doctors, and hospitals that might have used the shots.


Written by Lulaine Compere

Listeria Lawsuits Close to Settling

A settlement is close to being made in regards to the listeria outbreaks on a Colorado farm. The amount has not been determined, but some estimates put it at $4 million, which would be supplied by the farms’ insurer as well as the insurer of the equipment company. The Jensen farm is at the heart of this lawsuit because it has been discovered as the source of the outbreak.

Listeria is a bacterial disease that is potentially fatal to humans. It is susceptible through eating exposed food such as cantaloupes and has symptoms that include nausea, diarrhea, fever and muscle aches. Some of the plaintiffs have suffered food poisoning, and there are reports of about 30 people dying because of the outbreak.

According to the Food and Drug administration, the outbreak might have happened because of dirty water and because the equipment is old and hard to clean. According to many news reports, cantaloupes from the Jensen farm are the cause of the outbreaks. The Center for Disease control says there are 28 states that have listeria outbreak cases.

 

The Jensen farm has filed for bankruptcy because of the lawsuits, but the judge has not allowed the bankruptcy proceedings to continue until the lawsuits are dealt with. There are at least seven other lawsuits apart from this one led by attorney Bill Marler, who represents 39 plaintiffs. Some of the plaintiffs have said a $4 million settlement is not enough to compensate their claims.


Written by Lulaine Compere.

Vaginal Mesh Lawsuits

The plaintiffs in lawsuits against four vaginal mesh manufacturers continue to grow as they try and seek damages for their pain and suffering. The product was found to have problems after being examined by a medical journal. The Federal Drug Administration also came out and said vaginal mesh was marketed without FDA approval.

Vaginal mesh is a product inserted through the vagina, and it is used to treat abdominal hernias and other ailments that affect the pelvic area. The doctors who perform this surgery have to use a sling procedure when dealing with mesh.

Among the list of problems that mesh has caused include bleeding, infection, erosion of vaginal epithelium, and bladder perforation. There is also the possibility of additional surgery to fix the problem. The FDA has issued a statement on their website about complications associated with vaginal mesh products.

Manufacturers of transvaginal mesh and sling devices include Boston Scientific, CR Bard, Johnson & Johnson, and American Medical Systems. Some of the brands under investigation include Elevate, Apogee, Avaulta, Pelvitext, Gynecare, and Gynemesh.


Written by Lulaine Compere.