Case Studies
FOSAMAX: Virtual Client Case
Below is a virtual case, similar to many Pharmaceutical Litigation-type cases that we are currently undertaking at Malcomson Law. This is not a real case and no real names are used in this article as we believe it will breach our client's confidentiality. In addition, we believe that the Law Society Regulations preclude us from mentioning the graphic and gruesome details of some of our cases.
Background Information
Name: Faye
Sex: Female
Age: 48
Marital Status: Married
Children: 1 son aged 10
Occupation: Advertising Executive
Hospital attended: Dublin Dental Hospital
Faye's Story
a) March 2001
Faye, then 42 years of age, fractured her leg after falling from a step ladder in her kitchen. Faye was taken to hospital where her leg was x-rayed, reset and placed in a cast. During the treatment for her fractured leg, Faye was diagnosed with osteoporosis (a disease of the bone, where the bone mineral density is reduced and leads to increased risk of fracture). Because Faye was menopausal and her mother had suffered from osteoporosis, it was recommended that she begin treatment with bisphosphonate therapy to reduce the risk of future fractures. Faye immediately began taking the prescription drug Fosamax, once a day, in an effort to prevent bone loss and future fractures.
b) June 2006
Faye began to notice her teeth feeling loose and extremely irritated gums including gum recession in some places in her mouth. By this time Faye had been taking Fosamax as directed by her doctor for just over 5 years.
Faye made an appointment to see her dentist; however, prior to the date of her appointment she woke up one morning with excruciating pain in her jaw. Faye attended her dentist on an emergency basis who examined her mouth and jaw. Her dentist sent Faye immediately to the Dental Hospital where it was determined that Faye was suffering from osteonecrosis of the jaw.
Osteonecrosis of the jaw is a disfiguring and disabling condition through which the jaw bones suffered literal bone death and which can lead to infection and rotting of the bone.
The Dentist and Oral Surgeons at the Dental Hospital began treating Faye with powerful antibiotics which failed to control the serious infection and rotting of her jaw.
After several days in the Dental Hospital it was determined that all of Faye's teeth had to be removed and that part of her jaw would have to be shaved off to remove the dead bone. The pain that Faye was suffering during this period was excruciating and she was unable to eat solid food.
c) Sept. 2006
Unfortunately, after all of the decay and infections which Faye suffered, she is now left with a permanent loss of sensation on the right side of her lip and face. She also had a scar on her face from the jaw surgery. She still has great difficulty chewing solid foods.
Osteonecrosis & Fosamax
Osteonecrosis of the jaw, also known as "dead jaw" or ONJ, is the destruction of bone tissue due to infection and/or rotting. Osteonecrosis of the jaw is rare but it has been linked with bisphosphonates which are a class of drugs used to treat osteoporosis as well as to prevent the metastasis (spread) of certain cancers in the bones. Biophosphonates lessen the body's ability to re-absorb bone, a process that naturally takes place in order to allow new bone cells to occupy the skeleton structure. Because the jaw has a greater blood supply than other bones and a faster turnover rate related to both their daily activity and the presence of teeth, it is more susceptible to the effects of bisphosphonates and therefore osteonecrosis.
Fosamax was approved in September, 1995 by the United States Food & Drug Administration and launched in Europe in the same year. Fosamax is marketed by Merck and is one of their biggest sellers, approximately 3.5 billion dollars per year in sales.
Since Fosamax was released there have been a significant number of reports of osteonecrosis of the jaw amongst users of Fosamax. The connection between Fosamax users and osteonecrosis of the jaw has been detailed in medical journals such as the Journal of Oral and Maxillofacial Surgery and the Journal for the American Dental Association. In addition, in August 2004, the U.S. Food & Drug Administration posted its ODS Post marketing Safety Review on biophosphonates, including Fosamax. In this review the FDA observed that there was a risk of ONJ in users of biphosphonates and that ONJ was a "class effect" disease associated with the use of biophosphonates containing drugs, including Fosamax.
Despite all this, Merck has not issued any warnings about Fosamax and the risk of osteonecrosis of the jaw to prescribing physicians.
Taking Legal Action
A pharmaceutical claim is a type of product liability case. A claim for product liability can be taken through many types of legal vehicles. For example, a claim may be brought under the Liability for Defective Products Act, 1991, the Sale of Goods and Supply of Services Act, 1980, and through common law causes of action for tort and/ or contract law. As with all claims, the facts and circumstances of each individual case will determine which legal avenue is most appropriate to pursue given their respective evidentiary and proof requirements.
The Experts
In order to litigate such a complex case, it is necessary to engage the knowledge and expertise of expert witnesses. As Malcomson Law have extensive experience in medical negligence litigation and healthcare scandals for well over a decade, we were able to draw on World-class experts in the areas of epidemiology, pharmacology, dental surgery, maxillofacial surgery, infectious disease and cosmetic surgery.
What type of compensation will she receive?
Given the severity of Faye's injuries it is also necessary to ascertain all elements of her damages, including|:
- Future medical care needs
- Past medical care expenses
- Past and future nursing/carer needs
- The necessity for aids and appliances to make her quality of life as best as possible
- Loss of earnings
- Affects of her loss of earnings on her husband and her minor child
- General damages for pain and suffering.
If you, or someone you care about, have been affected by Fosamax or any other drugs, it is important that you choose a legal team with the knowledge, expertise and skill in the area of healthcare and medical negligence litigation that Malcomson Law can offer. Medical Negligence litigation claims are extremely complex, which is why you should have the specialist legal team of Malcomson Law representing you.
Seeking Health Law Advice
For further information, please contact Malcomson Law by calling 01 8744422 or complete an Online Enquiry Form. A solicitor who specialises in this area will contact you to advise you of your legal rights and entitlements.
This news section contains stories of interest from publicly available news sources. Where we are representing the clients referred to in the news material we will say so. Where we do not represent individuals or bodies mentioned or quoted, the inclusion of the news story in our news section is not intended nor should it be taken to imply that we act for the individual or body concerned.