Medical Device Injuries
Medical device injuries may give rise to either a product liability claim or a medical malpractice claim.
In the course of surgery frequently physicians will install medical devices. Those medical devices are governed by the same criteria as applies to any product in terms of evaluation of a product liability claim. If a physician has installed a medical device into you and that medical device fails, then you may have a basis for making a claim either against the physician or the manufacturer of that medical device.
The FDA’s Medwatch Department collects information on medical devices. If you have questions about your medical device, you may want to go to that website for information. A program known as MAUDE (Manufacturer and User Facility Device Experience Database) is available on the FDA website. Jeanne Lenzer in 2017 published an interesting book entitled The Danger within Us. Her book deals with implanted medical devices. She recounts the 2008 U.S. Supreme Court decision of Riegel v. Medtronic where the Court held that patients who are implanted with high risk devices that went through the pre-market approval process called “PMA” are not allowed to sue under the so-called federal preemption doctrine. Devices are classified into three (3) different classes with Class I being low risk, Class II being medium risk and Class III being high risk. As to the high risk devices, the manufacturers are in the favorable position of only having to prove that their product is safe after it is on the market.
In the upside down world of medical device approval the medical devices are apparently presumed to be safe by the FDA until such time as there are adverse events and then there may be product recalls. The odd thing about the MAUDE reporting system referenced above is that Lenzer states that only about 1% of all serious adverse events ever make it into the FDA’s database.
Many medical devices are governed by FDA approval although there is a significant loophole in that approval process. Those medical devices that have received FDA approval may be modified by the manufacturer without further FDA approval. That is the case with the DePuy artificial hips that have been recalled by Johnson and Johnson,the manufacturer. These hips are a modification of a previously approved product, which is dramatically different than the DePuy hip. As a result they were put on the market without FDA approval and without any previous patient testing.
Medical Device Injuries-Recalls
Medical device recalls, according to an article in the Archives of Internal Medicine, overwhelmingly involve products that have not been tested on a human being. In the report published on February 14, 2011, researchers examined 113 devices that the Food and Drug Administration had recalled between 2005 and 2009. These devices were all ones that posed serious health risks. Seventy-one percent of those recalled devices had been approved without undergoing any testing on human beings. The reason that these products were able to skirt around the rigorous testing is because they were deemed to be similar to other products already being sold. Only 19% of those products that were recalled had actually undergone the more stringent review process of being tested on human beings.
One-third of the recalled devices were for heart disease, including the automatic external defibrillators which are seen frequently in airports, office buildings and other public places to revive people who have undergone sudden cardiac arrest. In fact, defective automatic external defibrillators have reportedly resulted in hundreds of patient deaths.
Although the report in question is critical of the FDA, the FDA responds that this only constitutes 80 recalls which constitute a very small number of the total devices that are cleared through this program.
At this point, the FDA is contemplating more stringent review procedures for so-called similar products.
Medical Device Injuries and Artificial Hips
According to product liability sources artificial hips manufactured by DePuy Orthopaedics have failed at an alarming rate. The product liability consequences are significant. Although most consumers think that medical devices like this are subject to FDA approval there is a loophole in the approval process. Unlike new drugs, which have to go through clinical trials before receiving FDA approval, certain implants and artificial devices such has hips can be sold without such testing if the device resembles an implant that has already been approved and used on patients.
Under this process manufacturers can make small changes to a device to improve it or they can bundle a component from an unapproved implant into an existing device and sell it with no patient testing. This is essentially what has happened to the DePuy artificial hip. The hip has shown not only an alarming failure rate but it has shown a tendency to shed tiny metallic particles which are absorbed into the bloodstream. DePuy was first informed of the problems in 2007 by a British doctor. Initially, DePuy blamed the problems on the doctor’s surgical technique. Over time that physician became more concerned and noticed increased levels of cobalt and chromium in the blood of his patients that had a DePuy implant. It was not until March of 2010 that DePuy finally issued a safety alert about this artificial hip and then eventually withdrew the product from the market.
Medical Device Injuries-Surgical Mesh
The insertion of surgical mesh to deal with certain gynecological problems has become more and more popular with surgeons. Surgical mesh is most often used in instances where there is pelvic organ bulging or what is called prolapse into the vaginal area. It is caused by stretched or weakened tissues or muscles in that area. The mesh is also used to deal with urine leakage during physical activities or even when laughing. The mesh is a medical device that is used to repair these weakened or damaged tissues and is implanted permanently into the vaginal wall to reinforce it. In regards to the urine leakage problem, also called stress urinary incontinence, the mesh is used to support the urethra.
The mesh is also used in other types of surgery such as hernia repairs and other types of tissue repair procedures. Like so many surgical products it has its upside and downside so to speak.
The U. S. Food and Drug Administration has issued a warning dealing with this mesh indicating that the mesh has a tendency to shrink or to actually erode. Mesh erosion or contraction can cause not only serious discomfort but may require multiple surgeries to repair the erosion or contraction.
Medical Device Injuries Involving Conflict of Interest
Conflict of interest between physicians and medical device providers abound in the medical field. Not only is it seen in terms of doctors prescribing medication that may work to their financial interest but also it is seen in terms of implanting medical devices that may benefit the surgeon financially.
In a case reported by The Wall Street Journal, on October 8, 2011, it was noted that a Mississippi surgeon was a part owner of a company known as Spinal U. S. A. which also happened to be the manufacturer of devices that the surgeon was implanting in patients who were having back surgery. In the reported case the patient passed away shortly after the surgery.
The surgery that was being performed was spinal fusion surgery which involves fusing together vertebrae. This particular surgery was a 360 degree fusion which involves cutting open the patient’s abdomen and also the back and fusing the vertebrae from both the front and the rear.
Spinal fusion surgery now accounts for approximately $10 billion a year in U. S. spending according to the WSJ.
There is a federal anti-kickback law that prohibits medical device manufacturers from paying surgeons to use their products. Both device manufacturers and surgeons have, however, found a way to get around that law in terms of either entering into partnerships and then paying the surgeon consulting fees or royalties or, in the alternative, the surgeons simply forming their own companies to manufacture these devices.
The U. S. Food and Drug Administration has a very relaxed approval process for medical devices that are substantially equivalent to existing ones. It typically only takes the FDA 90 days to approve such devices.
The pervasiveness of the drug and medical device industry in the medical profession is probably not fully known or fully appreciated. It is known, however, that the pharmaceutical industry and medical device manufacturing industry go to great lengths to curry favor with physicians in order to promote their particular product thereby producing physician conflict interest. This currying of favor may come in several different forms:
- paying for the operating cost of various medical societies to which the doctors belong
- paying for physicians to serve as consultants on advisory boards that review clinical trials and marketing
- providing grants to publish case studies and journal articles
- paying physicians to sign their names to ghostwritten articles
- paying physicians to enroll patients in clinical trials
- operating what are called “preceptorships” wherein sales representatives from the companies follow the doctors for as much as a full day of patient appointments
- paying for meetings at resorts
- paying for travel and hotel expenses and car services and golf games
- providing restaurant gift certificates and other forms of entertainment
- providing research grants
- paying for continuing medical education
- paying physicians to speak at medical seminars
- paying physicians to simply attend medical seminars
The obvious purpose of these types of payments and remunerations, either directly or indirectly, is to influence the physician in terms of utilizing drugs that are manufactured by the pharmaceutical company or utilizing devices that are manufactured by the device manufacturing company.
Of the four most respected medical journals almost three-fourths of the clinical trials that are published therein are commercially funded. That alone undermines the credibility of the result.
The pervasiveness of the industry in dealing with the medical profession is also seen in terms of the use of expert witnesses. In cases against pharmaceutical companies or device manufacturing companies frequently their expert witnesses have received payment in some form to either fund trials or to conduct research or to engage in any of the activities referenced above.
ProPublica maintains a database on pharmaceutical industry payments to physicians that may be a source of information on this issue. In addition, some states have passed “sunshine” laws requiring that this disclosure of payments be made public. In addition, beginning in 2013, all drug and medical device manufacturers must comply with the Affordable Care Act and report payments to physicians and teaching hospitals.
Medical Device Injuries Involving Sales Reps In OR
It’s not uncommon that medical device manufacturers have their own representatives available for surgeries. Many times these sales reps are actually in the Operating Room with the surgeon. That is all part of the package that many of the major manufacturers sell to hospitals. These major manufacturers are Stryker, Johnson & Johnson and Medtronic.
Unfortunately in some instances the sales reps are the real experts on the product. They become the “super assistant” to the surgeon.
The presence of these sales reps in the Operating Room raises a question about informed consent. In particular was the patient informed of the fact that the sales rep may be in the Operating Room and did the patient consent?
A November 15, 2016 article in The Washington Post cites Adriane Fugh-Berman, an Associate Professor of Pharmacology at Georgetown University as being a person who has written on this topic and raised questions about whether surgeons rely too heavily on sales reps for technical expertise and assistance, sometimes to the detriment of the patient.
Over the years there has been substantial litigation relating to the involvement of sales reps. In a 2006 Ohio case a surgeon and the sales rep were ordered to pay $1.75 Million after a botched brain surgery wherein the sales rep had assured the surgeon that a bone cement was suitable for sealing a hole in the patient’s skull.
In 2003 there were both civil and criminal penalties against a manufacturer associated with 12 deaths dealing with an abdominal device wherein the sales representatives had devised a method for removing the device that had not been approved by the FDA.
Some hospitals have gone to the extent of actually eliminating sales reps from the Operating Room for orthopaedic procedures. The Code of Ethics of AdvaMed, the device industry trade association, states that sales reps are to refrain from medical decision-making and participation in any surgery. What some hospitals have done is to enter into contracts with the manufacturers to provide the product but not the representative and then to send their own in-house technical people to the manufacturer for specific training in how to utilize the device. Overall that has resulted in savings to hospitals that have implemented this procedure and likewise eliminated any potential conflict of interest by having the sales rep in the Operating Room without the actual knowledge of the patient.
If you have been injured due to a medical device contact us.