MahanyLaw Investigating Biosense Webster for Defective Cardiac Catheter Systems
Biosense Webster is one of the leading manufacturers of cardiac ablation systems. For those not familiar with a cardiac ablation, doctors thread a catheter through your blood vessels until it reaches the heart. Using energy, the physician scars or destroys tissue in your heart that allows incorrect electrical signals to cause an abnormal heart rhythm (arrythmia).
For atrial fibrillation it is often successful on the first try. Problems can occur if the heart doesn’t establish a normal rhythm after several tries. Depending on the type of arrythmia (abnormal heart beat), some patients may need a heart transplant.
To avoid drastic heart transplant surgery, some doctors have been experimenting with a procedure called bipolar cardiac ablations. Like any new procedure, there are no devices yet on the market that have been FDA approved for this procedure.
In the traditional cardiac ablation, the physician threads a catheter through a blood vessel until it reaches the heart. Doctors usually begin by making an incision near the groin and threading the catheter through a large vessel. (Sometimes the procedure is performed as an open heart procedure although that is rare.)
A dispersive set of electrodes, also called a dispersive pad, is placed somewhere else on the patient’s body. It is used to complete the circuit.
Cardiac catherization is very effective but the devices used are limited in how much energy they can deliver.
Some physicians have been experimenting with bipolar ablations. Just like it sounds, the doctor places two catheters into the area of the heart. That allows more electricity to be concentrated in an area. Generally, this procedure is only used when traditional measures fail and is quite controversial.
We are investigating reports that Biosense Webster, a Johnson & Johnson company, is allowing sales reps to reconfigure existing catheter systems to make them into a bipolar system. We have learned that patients have suffered serious injury because of these modifications.
Do you remember those Holiday Inn Express commercials which claim that staying at a Holiday Inn Express will make you feel smarter? Our favorite is the random person performing heart surgery. At the end of the commercial, the operating room staff realizes the “surgeon” isn’t a surgeon at all. The mystery man admits that he is not Dr. Stewart but he did stay at a Holiday Inn Express the previous night.
The commercials are comedy but sales reps modifying sensitive cardiac devices and promoting their use in unintended ways isn’t the funny.
Fast forward to the present and we have sales reps making homemade black boxes or modifying existing cardiac systems to support two catheters inserted into the heart.
Do you know what happens when two wires get close to one another? They can arc. And in these homemade systems, there is no real way of measuring the electricity flowing to the heart tissue.
Ordinary cardiac ablations are not overly dangerous but allowing untrained, unlicensed sales representatives to tamper with highly sophisticated medical devices is dangerous. In the words of our medical expert, “insanely dangerous.”
It is also illegal.
The FDA requires all medical devices to be preapproved. Biosense Webster’s catheter systems are preapproved but only when used as designed and without modification.
The FDA allows exceptions for certain copycat devices that have no risks to the patient such as a stethoscope or a wheelchair. If you follow an existing design, you don’t need preapproval. Cardiac catheters, however, are considered Class III devices involving safety risks to patients. FDA approval is always required for any modification or use.
Currently we are aware of NO FDA approved bipolar cardiac ablation devices. Biosense Webster did get approval for some investigational testing but scrapped those tests after there were too many “adverse events”. [An adverse event is a death or injury.]
According to one article from the Heart Rhythm Society, “An investigational device exemption (IDE) trial (ClinicalTrials.gov Identifier: NCT02374476), in which Bi-RF is specifically configured within CARTO (Biosense Webster, Diamond Bar, CA), is underway to assess safety and efficacy, and through which both active and ground catheters can be simultaneously visualized, with inter-catheter distances and active catheter force registered. However, this technology is not available to institutions not participating in the IDE trial.”
As noted above, that test was later scrapped because of adverse events to patients.
Our source tells us that bipolar or “Bi-RF” systems being used were not part of that trial and were not a specifically configured Carto system. In other words, the sales reps are still building their own black boxes and the company continues to turn a blind eye.
Despite cancelling the test, we are aware of Biosense Webster sales reps making homemade devices simply so they don’t lose sales. While we question the sanity of the doctors using such a device, Johnson & Johnson / Biosense Webster is squarely liable for injuries caused by these homemade black box modifications.
The practice is so widespread that we even read a reference in a medical abstract that thanked the Biosense Webster employee for his “engineering” skills in connection with a bipolar catheter.
Using an untested, unapproved bipolar cardiac ablation device involves extreme risk to the patient’s safety. Our experts tell us the risks of bipolar cardiac ablation include:
- Stroke or heart attack
- Severe scarring or burning of the heart tissue
- Permanent damage to the heart’s electric system
- Damage to heart valves
- “Steam pops” A steam pop occurs when too much heat from the catheter causes water in surrounding tissue to turn to steam and explode or “pop” like a popcorn kernel. The resulting tissue damage can be fatal.
It is a problem we see all too often with big pharmaceutical companies and medical device makers. Profits over patients.
Do we believe that J&J is instructing sales reps how to make homemade modifications to catheter systems using Radio Shack parts? No.
But we do believe that the company knows the practice is going on and turns a blind eye to sales reps that modify products in order to keep the orders coming in.
Were You Hurt During a Bipolar Cardiac Ablation?
Chances are the average cardiac patient doesn’t know what type ablation he or she received. After all, patients are sedated during the procedure. We know there have been injuries and probably deaths caused by bipolar ablations. And someone had to make the device used in the procedure. (Remember, there are no FDA approved devices for bipolar use.)
If you or a loved suffered from complications or death because of a bipolar cardiac ablation, you may be eligible for monetary damages.
“How Much Are My Bipolar Cardiac Ablation Injuries Worth?”
Every case is unique. Death cases are different from injuries and we recognize that everyone needing this procedure was already quite ill. That doesn’t mean anyone should suffer because a company allowed sales reps to manufacture or modify medical devices in their garage, however.
We welcome the opportunity to evaluate your case. In general, we can usually secure compensation for your:
- Medical bills
- Future and anticipated medical needs
- Lost earnings (past and future)
- Pain and suffering
- Reduced life expectancy
- Out of pocket expenses
In cases where death occurs, we can also help families secure additional compensation including for funeral expenses and lost earnings.
Sometimes punitive damages are available and sales reps modifying complex devices in their basement certainly cries out for punitive damage awards
For general information about dangerous product lawsuits, we invite you to visit our defective device lawsuit claims page. Ready to see if you have a case? Contact us online, by email at or by phone 202-800-9791. Cases considered nationwide.
[In case you wanted to see the “Holiday Inn Express Surgeon”…