FDA Adverse Event Cases

Pharmaceutical and medical device companies are some of the world’s largest and most profitable corporations.  While these industries set out to help and heal the sick, a few do quite the opposite.  

Unfortunately, there are drug and medical device companies that produce and sell defective products to hospitals, causing harm to consumers.  What’s worse, some conceal this harm to avoid scrutiny from the Food and Drug Administration.  When that happens, doctors are kept in the dark, ignorant to the risk posed by a dangerous product.  Doctors continue to offer the products to their patients, unbeknownst that it may harm them in the process.

Of course, when this behavior is discovered, companies are punished for it. In extreme circumstances, a criminal prosecution may even follow.  In 2018, Olympus Medical Systems Corporation was fined $80 million dollars for failing to report serious infection associated with its product.  Its former quality control manager faced criminal charges and received a year of probation for his part in the scandal.

This is a unique example.  For the most part, even bad actors and repeat offenders rarely face criminal prosecution.  Given some companies conceal the data to begin with, the FDA is never notified, and the manufacturer escapes scrutiny, unscathed by sales drops, lost profits and potential recalls.

Under-Reporting  

When a patient’s injury or death is caused by a drug or medical device, it’s important to ask whether the manufacturer reported similar instances of like-harm to the FDA.  If a doctor was notified of these similar events, it may have changed the doctor’s decision to use the product in the first place, in which case the patient’s life may have ultimately been spared.

Reporting duties are found in Federal Law via the Federal Food, Drug, and Cosmetic Act.  Drug and medical device companies must report what are called Adverse Events to the FDA.  When they don’t, they face reprimand (like Olympus Medical Systems).  Adverse Events are defined by the FDA as an undesirable experience associated with the use of a medical product in a patient.  The event is serious and should be reported to the FDA when the patient outcome is:

  • Death
  • Required intervention (product must be removed) 
  • Life-threatening harm
  • Hospitalization
  • Disability
  • Permanent Damage
  • Birth Defect

If a manufacturer gets notice of negative experiences like these, it must report them to the FDA.  The incident is then made public on the FDA’s Adverse Event Database known as MAUDE.  

Using the MAUDE, competitor companies can point out to doctors and hospitals certain Adverse Events that may affect their patients.  Respected medical journals may even cite to this public database to investigate troubling trends.  The FDA itself may investigate incidents once it’s known there are similar ones or cluster patterns.  

Sadly, devious action can stem from the MAUDE as well.  Manufacturers may hide Adverse Events from the FDA, and then cite to the MAUDE in its claims of low-incident rates.  By controlling the number of reports to the MAUDE, it can make dubious claims about its product success rates.  

Reporting Adverse Events is critical to assist doctors and the medical community at large understand the risks a product may pose to certain individuals. 

How can Combies Hanson, P.C. help?

We know that drug and medical device companies have an obligation to the Food and Drug Administration.  That obligation requires they report adverse events involving their product. If they don’t, fines and even recalls may follow.  More importantly, concealing this information puts doctors at a disadvantage when assessing the risk profile of a product or drug. We undertake an extensive investigation to determine whether doctors’ decisions were made without accurate information, all because product manufacturers hid the truth.

Our investigations span the globe.  We investigate whether a product manufacturer has been caught under-reporting in the past, or if its company is plagued with recalled products having unforeseen side effects.  We dig deep to determine whether a product manufacturer or drug company hid the truth from the FDA so it could sell more and increase profits, at the expense of patient health.

If a friend or family member you know experienced a catastrophic tragedy from a drug or medical device, contact our office to learn if there’s something we can do to help. 

Product cases we are currently investigating:

Sorin Mitroflow Heart Valves

Becton Dickinson Alaris System Infusion Pump

  • On March 6, 2020, the U.S. Food and Drug Administration announced that it had recalled the Becton Dickinson Alaris System infusion pump due to it causing serious injury and premature death.  
  • https://www.drugwatch.com/fda/recalls/

Kratom

Livanova

  • LivaNova VNS Therapy SenTiva Generator System, model 1000 used for vagus nerve stimulation therapy has “unintended reset errors.”  This may lead to reintervention or removal.

The FDA has classified this as a Class I recall because use of the device may cause serious injury or death.