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Medical Device Injuries

Fairfax Injury Lawyer Brien Roche Addresses Medical Device Injuries

Brien Roche

Medical device injuries give rise to either a product defect claim or a medical malpractice claim.

Medical Device Injuries May Produce Two Claims

In the course of surgery doctors may install medical devices. Those medical devices are subject to the same rules as apply to any product. Therefore if a doctor installs a device in you and that device fails you may have a claim. The claim may be against the doctor or the maker of that device.

The FDA’s Medwatch Department collects info on medical devices. If you have questions about your device you may want to go to that website for info. Also 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. There the Court held that patients who are implanted with high risk devices that went through the pre-market approval process called “PMA” cannot sue for resulting injury. This is due to the so-called federal preemption doctrine.  When the U.S. engages in action then the states (including state courts) cannot step in. They are preempted. No one but the U.S. agencies can step in.

Classes Of Devices

The law divides these devices into three classes. Class I are low risk. Class II are medium risk. The Class III are high risk.  The higher the risk the greater the FDA screening. At least that is the theory. Therefore the greater the shield the maker has.

In the upside down world of medical devices they are presumed to be safe by the FDA until such time as there are adverse events. At that time there may be product recalls.  However the odd thing about the MAUDE reporting system is that Lenzer states that only about 1% of all serious adverse events ever make it into the FDA’s database. If you have been injured due to a medical device contact us.

Prior Approval

In addition there is a large loophole in the FDA approval process. Devices that have received FDA approval may be modified by the maker with minimal or no further review. The FDA 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. That was the case with the DePuy artificial hips. They have now been recalled by Johnson and Johnson. These hips were a change from an already approved product. In fact the first device was very different from the DePuy hip. This latter device was on the market without FDA approval. Likewise there was no prior patient testing.

Medical Device Injuries-Recalls

Medical device recalls are mostly of products that have not been tested on a human being.  This is from an article in the Archives of Internal Medicine. In a report published on February 14, 2011, researchers examined 113 devices that the FDA 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 any testing on human beings.  They were able to skirt around the testing because they were deemed to be similar to other products already being sold.  Hence only 19% of those products that were recalled had undergone the more stringent review process of being tested on humans.

Paucity Of Recalls

One-third of the recalled devices were for heart disease. These included the automatic external defibrillators which are seen in airports, office buildings and other public places. They are used to revive people who have undergone sudden cardiac arrest.  These devices have caused hundreds of patient deaths.

Although the report above is critical of the FDA, the FDA responds that the sample referenced is only 80 recalls which is a very small part of the total devices cleared through this program.

At this point, the FDA is contemplating stricter review procedures for so-called similar products.

Medical Device Injuries and Artificial Hips

Going back to the artificial hips manufactured by DePuy Orthopaedics, this device has failed at an very high rate.

The maker was allowed to make small changes to the original device to improve it. In addition they bundled parts from unapproved devices into the existing device and sold it with no patient testing.  The hip shed tiny metal particles. The metal was absorbed into the bloodstream.  DePuy was first informed of the problems in 2007 by a British doctor.  At first DePuy blamed the doctor’s surgical technique.  Over time this British doctor became more concerned. He saw increased levels of cobalt and chromium in the blood of his patients that had a DePuy implant.  However it was not until March of 2010 that DePuy finally issued a safety alert. Finally Depuy withdrew the product from the market after it had injured many people. If you have been injured due to a medical device contact us.

Medical Device Injuries-Surgical Mesh

The use of surgical mesh to deal with some gynecological problems is common. Surgical mesh is most often used where there is pelvic organ bulging or what is called prolapse into the vaginal area.  This is caused by stretched or weakened tissues or muscles in that area.  In addition the mesh is used to deal with urine leakage. In regards to the urine leakage problem, also called stress urinary incontinence, the mesh is used to support the urethra.
The mesh repairs these weakened tissues. Also it can be placed into the vaginal wall to reinforce it.  In addition it is used in other types of surgery. For instance hernia repairs and other tissue repair procedures.

FDA Warning

The FDA has issued a warning dealing with mesh. It states that the mesh has a tendency to shrink or to erode.  Mesh erosion or shrinking can cause a great deal of pain. In addition it  may require multiple surgeries to repair. If you have been injured due to a medical device contact us.

Medical Device Injuries-Conflict of Interest

Conflict of interest between doctors and medical device providers abound.  Doctors prescribe medicine from makers that the doctors have ties to. Also doctors implant medical devices from makers they have a relation with.

The Wall Street Journal, on October 8, 2011, noted that a Mississippi surgeon was a part owner of a company known as Spinal U. S. A. However that company was the maker of devices the surgeon was implanting in patients for back surgery.  In one reported case the patient passed away shortly after the surgery.

That surgery was spinal fusion. It involved fusing together vertebrae.  This was a 360 degree fusion. It involves cutting open the patient’s abdomen and also the back and fusing the vertebrae from front and rear.

Big Business and Kickbacks

Spinal fusion surgery now accounts for approximately $10 billion a year in U. S. spending according to the WSJ.

A U.S. anti kickback law bars medical device makers from paying surgeons to use their products. However both makers and surgeons have found a way to get around that law. They enter into partnerships. The maker pays the surgeon consulting fees or royalties. Or the surgeons form their own companies to make these devices.

The Kickbacks Come In Many Forms

The extent of the involvement of these makers in the medical profession is not fully known.   However it is known that Pharma and medical device makers go to great lengths to curry favor with doctors. The hope being the doctors will promote their products. This currying of favor may come in several different forms:

    Direct Payment

  • paying for doctors to serve on advisory boards that review clinical trials and marketing
  • providing grants to publish case studies and journal articles
  • paying doctors to sign their names to ghostwritten articles
  • paying doctors to enroll patients in clinical trials
  • covering costs for meetings at resorts
  • paying for travel, hotel expenses, car services and golf games
  • providing restaurant gift certificates and other forms of entertainment
  • providing research grants
  • covering costs for continuing medical education
  • paying doctors to speak at medical seminars
  • paying  doctors to attend medical seminars
  • Indirect Payment

  • paying for the operating cost of medical societies to which the doctors belong
  • operating what are called “preceptorships” wherein sales reps from the companies follow the doctors for as much as a full day of patient appointments

Journals and Experts

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 results.

The presence of the industry in the medical profession is also seen in terms of the use of expert witnesses.  Pharma and device makers hire expert witnesses who have received payment to either conduct trials or research.

Disclosure

ProPublica maintains a database on Pharma payments to doctors. In addition, some states have passed “sunshine” laws requiring that these payments be made public.  Also beginning in 2013, all drug and medical device makers must comply with the Affordable Care Act and report payments to doctors and teaching hospitals. If you have been injured due to a medical device contact us.

Medical Device Injuries Involving Sales Reps In OR

Medical device makers some times have their own reps in the OR. That is all part of the package that many of the makers sell to hospitals. These major players are Stryker, Johnson & Johnson and Medtronic.

Noteworthy is that in some instances the sales reps are the real experts on the product. Hence they become the “super assistant” to the surgeon.

The presence of these reps in the OR raises a questions about informed consent. Was the patient informed that the sales rep may be in the OR? In addition did the patient consent?

A November 15, 2016 article in The Washington Post cites Adriane Fugh-Berman, an Associate Professor of Pharmacology at Georgetown. She raised questions about whether surgeons rely too heavily on sales reps. They may rely on the reps for technical help sometimes to the detriment of the patient.

Attempts To Bar The Sales Rep

Over the years there have been many lawsuits about 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. The sales rep had assured the surgeon that a bone cement was suitable for sealing a hole in the patient’s skull. However it was not.

In 2003 there were both civil and criminal penalties against a device maker associated with 12 deaths. It was an abdominal device where the sales rep had devised a method for removing the device that had not been approved by the FDA.

Some hospitals bar sales reps from the OR. 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 do is to contract with the makers to provide the product and then to send their own in-house technical people to the maker for specific training. Overall that produces savings to hospitals and eliminates any conflict.

If you have been injured due to a medical device contact us.

Since medical device injuries can be tied in with medical malpractice see the related articles on this site and also see the pages on Wikipedia.

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Contact Us For A Free Consultation

Medical Device Injuries

Fairfax Injury Lawyer Brien Roche Addresses Medical Device Injuries

Brien Roche

Medical device injuries give rise to either a product defect claim or a medical malpractice claim.

Medical Device Injuries May Produce Two Claims

In the course of surgery doctors may install medical devices. Those medical devices are subject to the same rules as apply to any product. Therefore if a doctor installs a device in you and that device fails you may have a claim. The claim may be against the doctor or the maker of that device.

The FDA’s Medwatch Department collects info on medical devices. If you have questions about your device you may want to go to that website for info. Also 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. There the Court held that patients who are implanted with high risk devices that went through the pre-market approval process called “PMA” cannot sue for resulting injury. This is due to the so-called federal preemption doctrine.  When the U.S. engages in action then the states (including state courts) cannot step in. They are preempted. No one but the U.S. agencies can step in.

Classes Of Devices

The law divides these devices into three classes. Class I are low risk. Class II are medium risk. The Class III are high risk.  The higher the risk the greater the FDA screening. At least that is the theory. Therefore the greater the shield the maker has.

In the upside down world of medical devices they are presumed to be safe by the FDA until such time as there are adverse events. At that time there may be product recalls.  However the odd thing about the MAUDE reporting system is that Lenzer states that only about 1% of all serious adverse events ever make it into the FDA’s database. If you have been injured due to a medical device contact us.

Prior Approval

In addition there is a large loophole in the FDA approval process. Devices that have received FDA approval may be modified by the maker with minimal or no further review. The FDA 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. That was the case with the DePuy artificial hips. They have now been recalled by Johnson and Johnson. These hips were a change from an already approved product. In fact the first device was very different from the DePuy hip. This latter device was on the market without FDA approval. Likewise there was no prior patient testing.

Medical Device Injuries-Recalls

Medical device recalls are mostly of products that have not been tested on a human being.  This is from an article in the Archives of Internal Medicine. In a report published on February 14, 2011, researchers examined 113 devices that the FDA 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 any testing on human beings.  They were able to skirt around the testing because they were deemed to be similar to other products already being sold.  Hence only 19% of those products that were recalled had undergone the more stringent review process of being tested on humans.

Paucity Of Recalls

One-third of the recalled devices were for heart disease. These included the automatic external defibrillators which are seen in airports, office buildings and other public places. They are used to revive people who have undergone sudden cardiac arrest.  These devices have caused hundreds of patient deaths.

Although the report above is critical of the FDA, the FDA responds that the sample referenced is only 80 recalls which is a very small part of the total devices cleared through this program.

At this point, the FDA is contemplating stricter review procedures for so-called similar products.

Medical Device Injuries and Artificial Hips

Going back to the artificial hips manufactured by DePuy Orthopaedics, this device has failed at an very high rate.

The maker was allowed to make small changes to the original device to improve it. In addition they bundled parts from unapproved devices into the existing device and sold it with no patient testing.  The hip shed tiny metal particles. The metal was absorbed into the bloodstream.  DePuy was first informed of the problems in 2007 by a British doctor.  At first DePuy blamed the doctor’s surgical technique.  Over time this British doctor became more concerned. He saw increased levels of cobalt and chromium in the blood of his patients that had a DePuy implant.  However it was not until March of 2010 that DePuy finally issued a safety alert. Finally Depuy withdrew the product from the market after it had injured many people. If you have been injured due to a medical device contact us.

Medical Device Injuries-Surgical Mesh

The use of surgical mesh to deal with some gynecological problems is common. Surgical mesh is most often used where there is pelvic organ bulging or what is called prolapse into the vaginal area.  This is caused by stretched or weakened tissues or muscles in that area.  In addition the mesh is used to deal with urine leakage. In regards to the urine leakage problem, also called stress urinary incontinence, the mesh is used to support the urethra.
The mesh repairs these weakened tissues. Also it can be placed into the vaginal wall to reinforce it.  In addition it is used in other types of surgery. For instance hernia repairs and other tissue repair procedures.

FDA Warning

The FDA has issued a warning dealing with mesh. It states that the mesh has a tendency to shrink or to erode.  Mesh erosion or shrinking can cause a great deal of pain. In addition it  may require multiple surgeries to repair. If you have been injured due to a medical device contact us.

Medical Device Injuries-Conflict of Interest

Conflict of interest between doctors and medical device providers abound.  Doctors prescribe medicine from makers that the doctors have ties to. Also doctors implant medical devices from makers they have a relation with.

The Wall Street Journal, on October 8, 2011, noted that a Mississippi surgeon was a part owner of a company known as Spinal U. S. A. However that company was the maker of devices the surgeon was implanting in patients for back surgery.  In one reported case the patient passed away shortly after the surgery.

That surgery was spinal fusion. It involved fusing together vertebrae.  This was a 360 degree fusion. It involves cutting open the patient’s abdomen and also the back and fusing the vertebrae from front and rear.

Big Business and Kickbacks

Spinal fusion surgery now accounts for approximately $10 billion a year in U. S. spending according to the WSJ.

A U.S. anti kickback law bars medical device makers from paying surgeons to use their products. However both makers and surgeons have found a way to get around that law. They enter into partnerships. The maker pays the surgeon consulting fees or royalties. Or the surgeons form their own companies to make these devices.

The Kickbacks Come In Many Forms

The extent of the involvement of these makers in the medical profession is not fully known.   However it is known that Pharma and medical device makers go to great lengths to curry favor with doctors. The hope being the doctors will promote their products. This currying of favor may come in several different forms:

    Direct Payment

  • paying for doctors to serve on advisory boards that review clinical trials and marketing
  • providing grants to publish case studies and journal articles
  • paying doctors to sign their names to ghostwritten articles
  • paying doctors to enroll patients in clinical trials
  • covering costs for meetings at resorts
  • paying for travel, hotel expenses, car services and golf games
  • providing restaurant gift certificates and other forms of entertainment
  • providing research grants
  • covering costs for continuing medical education
  • paying doctors to speak at medical seminars
  • paying  doctors to attend medical seminars
  • Indirect Payment

  • paying for the operating cost of medical societies to which the doctors belong
  • operating what are called “preceptorships” wherein sales reps from the companies follow the doctors for as much as a full day of patient appointments

Journals and Experts

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 results.

The presence of the industry in the medical profession is also seen in terms of the use of expert witnesses.  Pharma and device makers hire expert witnesses who have received payment to either conduct trials or research.

Disclosure

ProPublica maintains a database on Pharma payments to doctors. In addition, some states have passed “sunshine” laws requiring that these payments be made public.  Also beginning in 2013, all drug and medical device makers must comply with the Affordable Care Act and report payments to doctors and teaching hospitals. If you have been injured due to a medical device contact us.

Medical Device Injuries Involving Sales Reps In OR

Medical device makers some times have their own reps in the OR. That is all part of the package that many of the makers sell to hospitals. These major players are Stryker, Johnson & Johnson and Medtronic.

Noteworthy is that in some instances the sales reps are the real experts on the product. Hence they become the “super assistant” to the surgeon.

The presence of these reps in the OR raises a questions about informed consent. Was the patient informed that the sales rep may be in the OR? In addition did the patient consent?

A November 15, 2016 article in The Washington Post cites Adriane Fugh-Berman, an Associate Professor of Pharmacology at Georgetown. She raised questions about whether surgeons rely too heavily on sales reps. They may rely on the reps for technical help sometimes to the detriment of the patient.

Attempts To Bar The Sales Rep

Over the years there have been many lawsuits about 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. The sales rep had assured the surgeon that a bone cement was suitable for sealing a hole in the patient’s skull. However it was not.

In 2003 there were both civil and criminal penalties against a device maker associated with 12 deaths. It was an abdominal device where the sales rep had devised a method for removing the device that had not been approved by the FDA.

Some hospitals bar sales reps from the OR. 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 do is to contract with the makers to provide the product and then to send their own in-house technical people to the maker for specific training. Overall that produces savings to hospitals and eliminates any conflict.

If you have been injured due to a medical device contact us.

Since medical device injuries can be tied in with medical malpractice see the related articles on this site and also see the pages on Wikipedia.

Contact Us For A Free Consultation

Contact Us For A Free Consultation