FDA Takes Action Against Dangerous Eye Drops

Recently the Food and Drug Administration asked several retailers to stop selling several brands of eye drops, citing the risk of serious infection.

The Food and Drug Administration issued an alert for twenty-six products from the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma.

The federal regulatory agency said it asked the manufacturers to recall the subject products after investigators found bacterial contamination in critical drug production areas of a manufacturing facility.

Over ten different brands were linked to the infections, the most common being Ezri Care Artificial Tears from India-based Global Pharma Healthcare. The FDA said Global Pharma’s microbial testing of its eye product was inadequate and that the pharmaceutical provider failed to use adequate, tamper-resistant packaging and distributed the drugs without proper preservatives.

Eye Drop Infections

Bacterial infections often occur suddenly and without warning, particularly in the eyes and other vulnerable areas of the body. That’s especially true of Pseudomonas aeruginosa, an infection that’s normally associated with medical malpractice and unsanitary hospital conditions.

P. aeruginosa is one of the most powerful kinds of bacteria. It’s often used to break down petroleum following oil spills, and researchers believe this kind of bacteria could even break down municipal waste. 

In humans, however, it’s usually associated with sepsis (flesh-eating bacteria) infections. If P. aeruginosa spreads to the liver, it’s usually fatal, particularly if the victim is immunocompromised.

Standard antibiotics are ineffective against P. aeruginosa. Instead, doctors must rely on powerful drugs, such as Vancomycin, which may have powerful side-effects. Furthermore, the body quickly develops immunity to antibiotics. So, if the victim contracts another serious infection, doctors may be unable to help.

These infections spread so quickly that a slight diagnosis delay could have tragic consequences for a victim. Additionally, the diagnosis process takes some time. Only a gram stain test distinguishes P. aeruginosa from other garden-variety bacterial infections.

Doctors have a very high duty of care, and this extends to the hospital setting. P. aeruginosa usually lives on moist surfaces, such as surgical instruments. Usually, the medical team superheats instruments to kill P. aeruginosa bacteria and otherwise sterilize them. If the temperature is too low, P. aeruginosa survives. If the temperature is too high, the instrument burns the patient.

Sus opciones legales

Tainted products often injure or kill hundreds or thousands of people. So, collective actions are very common in these cases.

Once tainted products enter homes and injure several people, an attorney may determine that  a class action should be filed.

Judges usually grant class action status if several lawsuits have common facts and legal issues (e.g. one hundred people buy the same kind of eye drops at the same store and use them in the same way). Once judges consolidate these cases, they remain together until MDL, or multi-district litigation, is a hybrid between class actions and individual actions. If the number of cases makes individual actions inefficient but the claims aren’t similar enough to qualify as a class action, officials consolidate the cases for pretrial purposes. Then, if a case does not settle quickly, it returns to its home jurisdiction for further proceedings.

All three kinds of dangerous product mass tort actions usually involve one of three legal theories, which are:

• Defecto de manufactura: Unsanitary factory conditions often cause bacterial infections. A single dirty hand, machine, or warehouse could contaminate an entire lot. Usually, manufacturers are legally responsible for any defect that occurs before a retailer labels an item for sale.
• Falta de advertencia: Companies have a legal duty to adequately warn consumers about known product risks and side-effects. Frequently, however, companies suppress such information. A New York personal injury lawyer often partners with an outside professional to establish the standard of care in these cases.
• Defecto de diseño

Failure to warn is a negligence claim. A lawyer must establish negligence, or a lack of care. The other two claims are strict liability claims. An attorney must only establish cause.

Tainted product victims need and deserve substantial compensation. For a consulta gratis, contact Napoli Shkolnik. We have offices across the country to handle these matters on a nationwide basis.