Introduction
The drug Valsartan has encountered several legal hurdles owing to the inclusion of a carcinogen named NDMA in its formulation. Valsartan seems to prefer obtaining litigation paralleled with NCR rather than engaging in opposition as the situation has extinguished and nearly all cases in the US have been congregated into an MDL by December 2024. This write-up aims to give all pending lawyers an overall picture of valsartan litigation, the place of medical records formation in those lawsuits as well as several pieces of advice to improve their legal practice somehow.
What is Valsartan?
Overview of Valsartan
- Approval and Use: Valsartan gained the approval of the United States Food and Drug Administration in the year 1996. Valsartan brand names include Diovan.
- Mechanism of Action: It is identified as an angiotensin II receptor blocker (ARB), which assists in expansion of blood vessels thereby decreasing blood pressure.
Indications for Use
- Primary Uses:
• The treatment of high blood pressure (hypertension)
• Treatment of cardiac insufficiency
• Reduction in risk of hospitalization for patients of heart failure
• Improving chances of survival after a heart attack
• Management of the chronic kidney disease associated with diabetes.
The Valsartan Contamination Crisis
NDMA Contamination
- What is NDMA?: N-Nitrosodimethylamine (NDMA) is a chemical compound classified as a probable human carcinogen.
- Discovery and Recalls: The contamination of Valsartan was discovered in 2018, leading to widespread recalls by the FDA and other health authorities.
Impact on Patients
- Health Risks: Patients exposed to NDMA-contaminated Valsartan may face an increased risk of various cancers, including:
• Cancer of the colonial region
• Cancer of the stomach
• Cancer of the liver
• Cancers of blood tissues (such as non-hodgkin lymphoma and multiple myeloma)
Current Status of Valsartan Lawsuits (2024)
Overview of On-going Litigation
Multidistrict Litigation (MDL): As of December 2024, over 1,200 lawsuits have been consolidated in an MDL in New Jersey, with claims ranging from personal injury to economic loss.
Recent Developments:
- Bellwether Trials: This bellwether trial will commence in early November 2024 with jury selection announced to take place in late October.
- Expert Testimony: Daubert hearings are currently being held to determine if an expert’s evidence related to the pollution should be included in the proceedings.
Key Statistics
- Lawsuit Growth: The number of litigations has consistently increased and there has been a marked growth since 2023.
- Compensation Trends: Average compensation often ranges due in some cases a settlement of over $500,000 is reached.
The Role of Medical Records Review in Valsartan Lawsuits
Importance of Medical Records
• Establishing Causation: Medical records play a key role in establishing the relationship between the use of Valsartan and subsequent health issues.
• Documentation of Side Effects: Traceable records facilitate showing the treatment ordered, and the side effects the patient suffered, along with the date they were experienced.
How We Assist Attorneys
We provide specialized medical records review services tailored for attorneys handling Valsartan lawsuits. Our services include:
- Thorough Record Collection: We set to collect all medical records which may include prescriptions, treatment notes, and lab results.
- Qualified Review: Our medical personnel peruse through the records and pick vital details that are needed in the case.
- Expert Testimony: We can supply expert witnesses who can speak on the health risks Valsartan and its derivatives are associated with.
Case Studies
Case Study 1: Overview of the Case
Overview: A 58 year old female patient diagnosed with liver cancer three years after commencing treatment with Valsartan. This was discovered during normal checkups and later, she made a claim against the drug manufacturer for not providing sufficient information on this specific form of cancer.
Challenges: Absolutely the most fundamental challenge was to establish that Valsartan was the drug responsible for the liver cancer as there is a family history of liver problems.
Solutions: Our medical records review team worked tirelessly to locate the required information since the majority of the procedures were performed overseas. We noted that there was no earlier issue with the liver and collected expert opinions relating NDMA to Liver cancer.
Case Study 2: Overview of the Case
Overview: A 65 year old male patient was diagnosed with Non-Hodgkin’s lymphoma five years after he started taking Valsartan. He has since sued the pharmaceutical company arguing that they didn’t make efforts to ensure that their products are safe.
Challenges: They maintained that other risk factors such as old age and environmental exposure were the causes of the patient’s lymphoma.
Solutions: Based on the patients’ history obtained during the interview, it was noted that before the use of Valsartan there were no such risks of interest. Also we prepared a whole range of studies which discuss NDMA and the higher risk of cancer.
Conclusion
The tides of Valsartan lawsuits may change but as of now it is important to appreciate the intricacies of the case for the lawyers. There are several patients who have critical medical records and the reviewers are important in this case since they provide the information needed to substantiate a claim. Medical records evaluation is terribly important for the correct preparation of a case and proper representation of the patient before the court. Indeed, there is a lot of effort that should go into Valsartan litigation for positive outcomes to be realized in the practice.
