PHARMACY LIABILITY

On Monday, April 22, 2013, the Journal News reported “Pharmacy recall sterile drugs”. A Florida based compounding pharmacy recalled all its lots of sterile non-expired drug products sold nationwide. The reason given is that the products are not sterile and may contain bacteria. The Federal Food and Drug Administration became involved and warned providers who have received sterile products (including injectables from Balanced Solutions Compounding Pharmacy to check the products and quarantine the products for recall. The FDA inspection of the company revealed “poor practices and conditions which may have exposed the company’s sterile products to microbial contamination”. They sampled chromium chloride injections from Balanced Solutions and found gram negative bacteria in the product which can cause diseases and many types of infections.

If someone used one of these products and became ill, they have recourse under the law. They can sue the manufacturer (Balanced Solution Compounding Pharmacy) under Breach of Implied Warranty and Breach of Express Warranty under the Uniform Commercial Code (UCC). The legal theory is that a product put into the stream of commerce must be safe and if it causes injury or is unsafe, the manufacturer of the product has breached its warranty of merchantability. Most products have a written warranty setting forth the purpose of the drug and effect. If the product is unsafe and causes injury or illness, this is called a “Breach of Express Warranty”. Each legal course of action has a four year statute from discovery of the defect. Along the same legal theory, the manufacturer may also be liable under Theory of Strict Liability in tort. This means a product put into the stream of commerce is being used for the purpose for which it was intended and results in an injury or illness, the company is liable under Strict Liability in Tort. This theory has a three years statute of limitations.

All of these legal theories are for the benefits of the consumer.

Pharmacies have additional liability when filling prescriptions. They are liable for filling prescriptions with a wrong dosage. Our firm recently handled a case against CVS Pharmacy. My client picked up a three month supply of insulin pens. They were prepackaged from the manufacturer in certain dosages. With the three month supply, one box out of them was labeled like the rest of the boxes but, in fact, under the label (put on by the CVS Pharmacy) the correct dosage of the pens was different. They had a greater dosage of insulin in the pens than the label indicated. One morning at 5:00 AM, our client takes out a new set of injectable pens (5 in a box). The box is labeled like all the rest of the boxes (lower dosage of insulin) but in fact had a higher dosage. The client injected himself and then left to travel from Orange County to New York City. He got on his usual train and felt very dizzy and lightheaded. His friend leaned him against the wall to go get help. The client fainted and went down like a board onto his face fracturing his nose and eye orbits. He was rushed to a hospital and underwent facial surgery consisting of inserting a plate into his face to help the shattered bones. The end result was that the client had devastating injuries.

When the client returned home, he opened the box of the wrong labels insulin pens which was in his refrigerator. He looked at the side of the box and then the label and noticed the dosage was not the same. The label put on the box of pens by CVS was wrong. It had a lower dosage written on it. The box looked like all the rest of the boxes picked up from the pharmacy at the same time. When the client took the shot, the greater dosage made the client’s blood sugar go down sharply resulting in a hypoglycemic shock (lack of sugar) causing the client to faint and fall flat on his face.

The case proceeded against CVS and the pharmacist was examined under oath. He testified that he labeled the boxes of insulin pens and when labeling, did not notice that one box had a different dosage of insulin. Thus, he mislabeled the box. Of course CVS argued that the client should have not trusted the label and read the pen itself (which had the correct higher dosage marked on the side of the box). After 2 or so years of litigation, the case was settled just before trial with CVS paying a substantial sum to compensate my client for his injuries and pain and suffering.

If you or a family member has been injured or became ill from pharmacy medicines or mislabeled prescriptions, call the office of Dominick J. Robustelli & Associates, PLLC at (914) 288-0800.

On Monday, April 22, 2013, the Journal News reported “Pharmacy recall sterile drugs”. A Florida based compounding pharmacy recalled all its lots of sterile non-expired drug products sold nationwide. The reason given is that the products are not sterile and may contain bacteria. The Federal Food and Drug Administration became involved and warned providers who have received sterile products (including injectables from Balanced Solutions Compounding Pharmacy to check the products and quarantine the products for recall. The FDA inspection of the company revealed “poor practices and conditions which may have exposed the company’s sterile products to microbial contamination”. They sampled chromium chloride injections from Balanced Solutions and found gram negative bacteria in the product which can cause diseases and many types of infections.

If someone used one of these products and became ill, they have recourse under the law. They can sue the manufacturer (Balanced Solution Compounding Pharmacy) under Breach of Implied Warranty and Breach of Express Warranty under the Uniform Commercial Code (UCC). The legal theory is that a product put into the stream of commerce must be safe and if it causes injury or is unsafe, the manufacturer of the product has breached its warranty of merchantability. Most products have a written warranty setting forth the purpose of the drug and effect. If the product is unsafe and causes injury or illness, this is called a “Breach of Express Warranty”. Each legal course of action has a four year statute from discovery of the defect. Along the same legal theory, the manufacturer may also be liable under Theory of Strict Liability in tort. This means a product put into the stream of commerce is being used for the purpose for which it was intended and results in an injury or illness, the company is liable under Strict Liability in Tort. This theory has a three years statute of limitations.

All of these legal theories are for the benefits of the consumer.

Pharmacies have additional liability when filling prescriptions. They are liable for filling prescriptions with a wrong dosage. Our firm recently handled a case against CVS Pharmacy. My client picked up a three month supply of insulin pens. They were prepackaged from the manufacturer in certain dosages. With the three month supply, one box out of them was labeled like the rest of the boxes but, in fact, under the label (put on by the CVS Pharmacy) the correct dosage of the pens was different. They had a greater dosage of insulin in the pens than the label indicated. One morning at 5:00 AM, our client takes out a new set of injectable pens (5 in a box). The box is labeled like all the rest of the boxes (lower dosage of insulin) but in fact had a higher dosage. The client injected himself and then left to travel from Orange County to New York City. He got on his usual train and felt very dizzy and lightheaded. His friend leaned him against the wall to go get help. The client fainted and went down like a board onto his face fracturing his nose and eye orbits. He was rushed to a hospital and underwent facial surgery consisting of inserting a plate into his face to help the shattered bones. The end result was that the client had devastating injuries.

When the client returned home, he opened the box of the wrong labels insulin pens which was in his refrigerator. He looked at the side of the box and then the label and noticed the dosage was not the same. The label put on the box of pens by CVS was wrong. It had a lower dosage written on it. The box looked like all the rest of the boxes picked up from the pharmacy at the same time. When the client took the shot, the greater dosage made the client’s blood sugar go down sharply resulting in a hypoglycemic shock (lack of sugar) causing the client to faint and fall flat on his face.

The case proceeded against CVS and the pharmacist was examined under oath. He testified that he labeled the boxes of insulin pens and when labeling, did not notice that one box had a different dosage of insulin. Thus, he mislabeled the box. Of course CVS argued that the client should have not trusted the label and read the pen itself (which had the correct higher dosage marked on the side of the box). After 2 or so years of litigation, the case was settled just before trial with CVS paying a substantial sum to compensate my client for his injuries and pain and suffering.

If you or a family member has been injured or became ill from pharmacy medicines or mislabeled prescriptions, call the office of Dominick J. Robustelli & Associates, PLLC at (914) 288-0800.