Important Information for Patients, Doctors and Medical Device Company Workers
We depend on the FDA to keep us safe from dangerous drugs and malfunctioning medical devices. The FDA in turn depends on the drug companies, device manufacturers and healthcare providers for information about adverse patient outcomes tied to a particular medical device. The law also requires to the companies making these products to report adverse events.
The databases are searchable and free to the public. Unfortunately, they are also not very user friendly.
For example, the FDA medical device database page contains 25 different lists! That alone makes it hard for consumers to find important product safety information. But it isn’t just consumers who have problems. Shocking new information from the FDA indicates a secret hidden list, one not made available to the public or doctors.
Kaiser Health News tells the story of a Pittsburgh surgeon removing an appendix. That pretty much should be an everyday routine surgical procedure. It was until the surgical stapler used to seal tissue around the removed “locked up.” The patient survived but many do not.
When the doctor went online to see if there were other problems with the stapler, he found nothing. It turns out, however, that more than half of the surgeons who have used the device reported problems.
So where are those reports? They are on a hidden list!
It turns out that for many years, the FDA has allowed certain medical device makers the right to obtain a special exemption from public reporting. Mishaps and problems still must be reported to the FDA but they are shielded from public view. That means your doctor can’t see them either.
Can the FDA do this? I have been practicing law for over 30 years and can’t find any rulemaking or regulation allowing the FDA to do this. There was not even a public notice suggesting they were planning on doing this. It smacks of a cover up. A cover up with deadly consequences.
Kaiser’s story concentrated on surgical staplers but the FDA has allowed makers of all sorts of devices seek private exemptions from disclosure. And there is no good reason for it. (Protecting the makers of shoddy products doesn’t count as a good reason.)
Just looking at surgical staplers, the Kaiser investigation found that the results of hiding information can be deadly. According to their investigation, in one example a patient named Mark Levering nearly lost his life after a surgical stapler “misfired” during liver surgery.
Hospital staff performed CPR on Levering for 22 minutes while surgeons tried to fix a severed vein. Mark ultimately survived but now can’t walk and even has problems recognizing his own family.
When Mark’s wife found out that safety reporting data wasn’t available to doctors, she filed a lawsuit. “Why would this information not be made available to doctors? The true information — I mean the actual numbers … People’s lives are at stake. Mark’s life will never be the same.”
The exemption for staples is now gone. And suddenly in 2018 there were 11,000 reports of staple malfunctions or injuries for Covidien staples. Medtronic and its affiliate Covidien are the largest manufacturer of surgical staplers and staples.
Data on staples is now available again but consumers and doctors shouldn’t be cheering yet. Many manufacturers still have their secret exemption. How many? It’s hard to tell because the information is secret!
Kaiser says the FDA acknowledged 480,000 medical device malfunctions were hidden in 2017 alone. These products include staplers, balloon pumps, pacemaker electrodes, implantable defibrillators and mechanical breathing machines. Incredibly, the FDA won’t eve disclose the full list of who has been granted an exemption.
The industry argues that the information isn’t really secret. Anyone can file a Freedom of Information Act request with the FDA. That isn’t the same as a real time database for consumers and doctors who often need information instantly. (From our cases, we know that a so called FOIA request on the FDA can take 2 years or more rendering it useless for a surgeon who needs information before or during surgery.)
The hidden exemption program is so secret that many physicians don’t know about it. Kaiser reports that one former FDA commissioner was unaware of it.
The FDA also allows device makers to file a summary report if they are in litigation. Many readers have probably watched TV commercials seeking women who were injured by defective pelvic mesh.
Look at the database for one mesh manufacturer and you will find a single report. Since for privacy reasons the FDA doesn’t release many details, it would appear that just one person was injured by the mesh product. If you had two years to wait and did a Freedom of Information Act request, however, you would find that this “placeholder” report lists hundreds and hundreds of reports of injuries and product failures attributable to the mesh. Once again, it isn’t fully visible on the public database.
Says a former FDA manager, “The FDA is basically giving away its authority over device manufacturers. If they’ve given that up, they’ve handed over their ability to oversee the safety and effectiveness of these devices.”
What can be done? In certain instances, current and former employees of medical device companies may be eligible for large cash awards for reporting fraud. More on that later, first information for patients.
Help for Patients
No doubt the sudden publicity will force the FDA to become more transparent. At least for a little while. The FDA says it has already revoked the hidden reporting exemption from several device makers. Unfortunately, we don’t know who.
The promise of increased transparency is limited, however. There is still nothing to stop device makers from batching multiple reports into one so that a patient or doctor thinks the number of problems is much smaller than it actually is.
Few people complain to the government these days. It is almost as if we have become conditioned to believe that bad service is normal.
Obviously, we encourage everyone disturbed by the hidden lists to write or call their federal elected officials and express their concern and anger over faulty and secret reporting. You have a legal right to know and the FDA shouldn’t make you wait 2 years and a FOIA request to find out information about devices used or implanted in your body.
You can find your elected officials through Common Cause by just entering your address. (You don’t need to join their mailing list to do so.) You should also contact the FDA Commissioner’s Office at U.S. Food and Drug Administration 10903 New Hampshire Avenue, Silver Spring, MD 20993. 1-888-INFO-FDA (1-888-463-6332).
Having worked in state and federal service, elected officials and agency heads do keep track of how many calls or letters come in on a given subject. Those calls and letters do make a difference.
Next, if you have question about a specific medical device, you can search the FDA’s public database, MAUDE. It is free although a bit clunky. Even on devices that have been granted a hidden exemption, there is often some information on MAUDE. Just remember that merely because there are problems reported doesn’t mean the device or product is defective. Use the information to have an intelligent, informed discussion with your physician.
Are You a Victim of Defective Medical Device?
If you are the victim of a defective medical device or product, you may be entitled to monetary damages. Under U.S. law, device manufacturers can often be held strictly liable for injuries caused by their products.
All inquiries are kept confidential and there is never a fee for a consultation.
Call for Medical Device Manufacturer Whistleblowers
Mahany Law is a nationally recognized whistleblower law firm. That is where we got our start. In the last five years we have helped our whistleblower clients recover over $100,000,000.00 in cash rewards. You could be next.
If a medical device is reimbursable by Medicare, Medicaid or Tricare, inside information about fraud becomes eligible for an award.
In 2018, medical device manufacturer Alere Inc paid $33.2 million to settle claims that they were “knowingly selling materially unreliable point-of-care diagnostic testing devices” to hospitals.
In announcing the Alere settlement, a Justice Department spokesperson said, “The United States is fortunate that innovative healthcare companies regularly develop medical devices that improve patients’ lives, often in remarkable ways. But the Department will hold medical device manufacturers accountable if they knowingly sell defective products that waste taxpayer dollars and adversely impact patient care.”
According to prosecutors, Alere sold unreliable point-of-care testing devices marketed under the trade name Triage®. The Triage® devices aided in the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious conditions. The device was used in ERs across the country where split second decisions must be made regarding a patient’s care.
According to the settlement documents, Alere received customer complaints that put it on notice that certain devices it sold produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making.
The “customers” in this case weren’t patients. Instead they were hospital emergency departments. Obviously, complaints are important in determining whether there is a problem with a particular device. Doctors can’t do much, however, if the complaint data is hidden.
The Alere case represents an important victory for medical device whistleblowers. The person filing the initial complaint in this case wasn’t an FDA official. It was Amanda Wu, a former senior quality control analyst that worked for Alere. For her actions in alerting the FDA and filing a False Claims Act complaint, she was awarded $5.6 million.
Physicians can file False Claims Act cases too if they have inside information. Dr. Steven Higgins filed a whistleblower complaint against Boston Scientific Corporation. He says that the company’s cardiac defibrillators are supposed to be lifesaving devices. Instead, he says they were defective.
Manufacturing or selling a defective medical device may make the company liable to patients who are harmed or die because of the product. But a defective product alone isn’t enough for a False Claims Act whistleblower reward. That law is geared towards fraud.
Dr. Higgins says there is fraud because while the company was going through the FDA registration process in the United States, it knew its products already launched in Europe were experiencing catastrophic failures. He says the company knew its defibrillators “were known to deliver inappropriate shocks to patients, and to fail to deliver shocks to patients when necessary to prevent possible cardiac arrest and death.”
Instead of reporting these problems to the FDA, Higgins says Boston Scientific did the opposite and tried to downplay any reports of problems.
According to Higgins, as many as 30,000 problem devices were sold and paid through Medicare and Medicaid. At an average cost of $35,000, the government suffered as much as a $1 billion loss. (The False Claims Act also allows for triple damages and penalties of up to $20,000 per occurrence making the total potential fine in the billions of dollars.)
Dr. Higgins, the whistleblower who reported the company, was both an active cardiologist and an outside advisor to Boston Scientific.
Under the False Claims Act, whistleblowers with inside information about fraud involving federal healthcare dollars are eligible for an award of between 15% and 30% of what the government collects from the wrongdoers.
Not every medical device whistleblower is eligible for an award. Reporting these events, however, is still important for patient care and safety. None of us wants to see a loved one killed or injured because of a defective medical device. These injuries and deaths are largely preventable.
If you have inside information about a defective medical device, give us a call. Even if you have signed a nondisclosure agreement, we can still help. (Courts routinely find that nondisclosure agreements do not prevent reporting safety concerns to authorities.)
All inquiries are protected by the attorney – client privilege and kept confidential. Our services are handled on a contingent fee basis meaning no fees unless we are successful recovering money for you.