Are Your Sterile Implants Really Sterile?

Are Your Sterile Implants Really Sterile?

 

I have been on both sides of patient safety for over 13 years.

On the one side, I am a harmed patient who suffered a multitude of adverse events stemming from pharmaceuticals and medical devices, including contracting Methicillin-resistant Staphylococcus aureus (MRSA) and Sepsis. In addition, I have had over 3 dozen surgeries, some of them resulting in errors and infections.

On the other side, I am a Special Government Employee (SGE) at the U.S. Food and Drug Administration’s Center for Device and Radiological Health (CDRH). As the consumer representative on the Advisory Committee, my role is to analyze scientific data, understand research design, discuss benefits and risks, and evaluate the safety and efficacy of medical devices under review.

I was recently contacted via LinkedIn by Dr. Aakash Agarwal, Director of Research and Development for Spinal Balance Inc. at the University of Toledo to tell me about the growing problem of device contamination. After a brief phone call, Dr. Agarwal sent me research literature. I was alarmed by what I read and I feel that this matter needs to be brought to the public’s attention, including patients, physicians, and regulators. I agree with Dr. Agarwal that a public hearing needs to be held at the FDA to discuss the pedicle contamination. This is a matter that is not talked about and it should be.

Pedicle screws are used in spinal fusion surgeries to add extra support and strength to the fusion while it heals. The screws are placed above and below the vertebrae that were fused. A rod is used to connect the screws which prevents movement and allows the bone graft to heal. They can become contaminated and it is a growing problem in the United States; a fact that most people don’t know.

Bacterial infections following spinal surgery are estimated at 12.7% according to Dr. Agarwal.

The average hospital bill following such infections is $63,000, with hospitalization being necessary in 5.5% of those cases.

Pedicle screws are the most common implant used in spinal fusion surgery. A surgeon will typically have over a hundred screws available for use during surgery, but actually uses a small amount.

The pedicle screws’ low usage rate leads to these screws being repeatedly reprocessed—or “automated washing with contaminated instruments from theatre and then sterilized without prior inspection by hospital staff” by the sterilization processing department (SPD).

In essence, these “sterile” implants, alarmingly, have been found to contain contaminants.

Furthermore, unused pedicle screws are subject to contamination during surgery.

Pedicle screws are linked to MRSA infections during their handling during the procedure, and during the reprocessing before and after surgery. MRSA is a bacterium that causes infections in different parts of the body and it is tougher to treat than most strains because it is resistant to some commonly used antibiotics. Re-processed screws have been found to harbor corrosion, biofilm, endotoxins, fatty tissue, and soap residue mixed with fat, whereas exposed pedicle screws in “sterile-field” become contaminated. These infections were present in at least 10% to 30% of patients with chronic pain and were detected only during revision spine surgery. I have these screws following spinal surgery and suffered infections as a result.

In order to keep pedicle screws from becoming contaminated, researchers are suggesting providing the implant in an individual sterile pack (single-use and ready for implantation), and each implant should have a functional guard around it to protect from direct exposure during handling. Dr. Agarwal and his colleagues co-authored a study to determine the magnitude of the issue, and how to prevent surgical site contamination linked to pedicle screws in spine surgery.

Dr. Agarwal explains it like this:  “The single center study as well as our multicenter study, showed that all unguarded screws resulted in bacterial contamination inside the “sterile field” during live surgeries, whereas guarded screws had no such contamination. The key constituents that define the pathogenesis of SSI (Surgical Site Infection) are the virulence, host-site immunity, and dosage. We demonstrated the preventative method effective on reducing the dosage of bacteria.”

The guards used on the single-use pedicle screw are commercially available.

Dr. Agarwal has filed a Citizens Petition with the U.S. Food and Drug Administration calling for a ban on the reprocessing of pedicle screws in the U.S. It is currently under review, a process which could take a year or longer. Agarwal requests “the Commissioner of Food and Drugs to cease clearing 510(k)s and approving PMAs [pre-market approvals] for reprocessing of pedicle screws and other implantable orthopedic devices and cease clearing 510(k)s for re-usable implantable orthopedic device[s].”

In addition to asking for the cessation of approvals for reprocessed pedicle screws and interbody cages, the petition requests that every implantable orthopedic device should be provided “such that it is not touched or exposed before implantation, by the operating room staff, in the sterile field.”

I am a patient who has undergone dozens of surgeries and have several medical implants. This is all information I wish I had known prior to my surgeries. Contamination is preventable and reprocessing needs to be banned.

Your life could depend on it.

About The Author

Rachel Brummert is a Special Government Employee at the U.S. Department of Health and Human Services and the Patient Safety Director at ION Medical Safety. She is also CEO of Patient Safety Impact, headquartered in Charlotte, North Carolina.

Media Inquiries: rachel@rachelbrummert.com

 

FDA Internal Surgical Staples and Absorbable Collagen-Based Hemostatic Device Hearings: Consumer Representative Perspective

Disclaimer: Views in this post are my own and does not represent the views of the FDA.

On May 30, 2019, the FDA Advisory Panel committee discussed and made recommendations regarding the reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls).

On May 31, 2019, the committee discussed and made recommendations regarding the reclassification of certain Absorbable Hemostatic Agents from Class III to Class II (special controls).

I served as Consumer Representative for both hearings.

Internal Surgical Staples

The advisory committee met to discuss the April 2019 proposed reclassification order after the following risks to health were discovered:

  • Complications associated with device failure/malfunction. Device failures or malfunctions may result in prolonged surgical procedures, unplanned surgical interventions, and other complications such as bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.
  • Complications associated with use error/improper device selection and use. Use error may result from a device design that is difficult to operate and/or labeling that is difficult to understand. For example, user difficulty in firing the stapler may result in staples not being fully deployed, and misfiring may result in staples being applied to the wrong tissue. Inadequate instructions for use may result in selection of incorrectly sized staples for the target tissue. When staples are applied to the wrong tissue or when incorrectly sized staples are applied, staples are unable to properly approximate the underlying tissue, resulting in tissue damage, anastomic leakage, and bleeding. This in turn may lead to more severe complications, such as abscess, sepsis, peritonitis, hemorrhage, or death.
  • Adverse tissue reaction. If the patient-contacting materials of the device are not biocompatible, local tissue irritation and sensitization, cytotoxicity, or systemic toxicity may occur when the device contacts sterile tissue.
  • Infection. If the device is not adequately reprocessed or sterilized, the device may introduce pathogenic organisms into sterile tissue and may cause an infection in a patient.

Surgical staplers are currently classified as Class I devices. Class I are “low risk” devices. Low risk devices are not tested. These include items such as band-aids, tongue depressors, crutches, and are subject to General Controls. The proposal would reclassify surgical staplers to Class II. Class II devices are considered “moderate risk”, and subject to Special Controls.

In the proposed reclassification order, FDA proposed that the following special controls would mitigate the risks to health and provide reasonable assurance of safety and effectiveness for surgical staplers for internal use:

  • Performance testing must demonstrate that the stapler, when use with compatible staples, performed as intended under anticipated conditions for use. Performance testing must include evaluation of staple formation characteristics in the maximum and minimum tissue thickness for each staple type; measurement of the worst-case deployment pressures on stapler firing force; measurement of staple line strength; confirmation of staple line integrity; and in vivo confirmation of staple line hemostasis.
  • Usability testing and labeling comprehension study must demonstrate that the clinician can correctly select and use the device, as identified in the labeling, based on reading the directions for use.
  • The elements of the device that may contact the patient must be demonstrated to be biocompatible.
  • Performance data must demonstrate the sterility of the device.
  • Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
  • Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.

Labeling the device must include that unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of necrotic or ischemic tissues and tissues outside of the labeled limits of tissue thickness; unless available information indicates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazrads associated with the device including:

  • Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures
  • Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage
  • Avoidance of use of the stapler on large blood vessels, such as the aorta
  • Establishing and maintaining proximal control of the blood vessels prior to stapling
  • Appropriate measures to take if a stapler malfunction occurs while applying staples across a blood vessel, such as clamping or ligating the vessel before releasing the the stapler, while the stapler is still closed on the tissue
  • Ensuring stapler compatibility with staples

Reported adverse events are 412 deaths and 11,000+ injuries. Seventy-two percent are from linear stapler and 17% were from circular stapler. Thirty percent was during the procedure and 52 occurred post operative.

Madris Tomes, CEO of Device Events and former FDA employee, reported even higher numbers. She also presented information regarding materials in staples- most specificially nickel- which can cause allergy and autoimmune issues.

Immediately following, the Panel Chairman ruled that we as a panel cannot discuss the staples; only the staplers. My opinion, and that of other panel members, is that you cannot discuss staplers without also discussing staples but the Chairman harshly shut down the discussion. It still makes no sense to me since Medtronic, a maker of surgical staplers (and the only surgical stapler manufacturer to show up for the hearing) wanted to discuss biocompatibility and the FDA themselves proposed biocompatibility testing of the staples in the special controls.

Both Medtronic and the FDA admit that adverse events are underreported. When I attemped to ask the FDA what they plan to do to improve their reporting system and be transparent about adverse events,  I was cut off by the Chairman. This highlights the concern about whether FDA truly values the patient and consumer perspective when all other panel members were permitted to ask multiple questions, but the Consumer Representative was not.

At the end of that hearing, the advisory panel voted unanimously to up-class internal surgical staplers from Class I to Class II with special controls.

The staples themselves, unfortunately, will have to be a separate discussion due to the subject being shot down at this one. I encourage all readers to do research about surgical staples prior to sugery. It is a discussion that needs to be had and patients have the right to know what is going into their bodies.

 

Absorbable Collagen-Based Hemostatic Agents

On Day 2, the panel discussed reclassifying absorbable collagen-based hemostatic agents from the current Class III classification to Class II with Special Controls. We were instructed to not consider added biologics.

FDA identified several risks to health for absorbable collagen based hemostatic devices:

  • Uncontrolled bleeding. Failure to completely control bleeding can lead to death or severe injury.
  • Hematoma. If small amounts of bleeding persists following application of an absorbable collagen-based hemostatic device, the accumulation of blood behind the device will form a hematoma. A hematoma may press on soft tissue and cause soft tissue or nerve damage. It also has a high mortality rate.
  • Infection. An absorbable collagen-based hemostatic device may serve as a nidus for infection and abscess formation. They are manufactured from materials derived from animal sources such as collagen and gelatin and bacteria can grow on device materials.
  • Wound dehiscence. Devices near the sites of incision closures has interfered with the healing of the incision. This interference is due to mechanical interposition of the device and is not due to intrinisic interference with the wound healing process.
  • Foreign body reactions. These devices have been associated with foreign body reactions involving fluid accumulation due to encapsulation of the device. This has resulted in granuloma formation, inflammation, and edema, which may require surgical removal. Encapsulated devices can also present as an image artifact mimicking residual or recurrent tumor or abscess resulting in additional diagnostic studies and surgical procedures.
  • Immunological reactions. These devices are made of products rerived from porcine and bovine gelatin or collagen. Some patients are allergic (emphasis is mine) to these animal-derived materials.
  • Adhesion formation. These devices, in the presence of coagulated blood and tissue fluid, can often lead to scarring and adhesion formation in the weeks and months (emphasis is mine) following the surgical procedure. The procedure itself can result in additional scarring and adhesion formation.
  • Failure to be absorbed. These devices are readily degraded by emzymatic and hydrolytic action. They may be implanted in an area with low emzymatic and hydrolytic activity. In such instances, it may not be efficiently absorbed. Subsequently, it may become incapsulated and exert pressure or create a chronic granulomatus inflammatory reaction on surrounding soft tissue to cause necrosis or injury, requiring surgical intervention.
  • Interference with Methylmethacrylate Adhesives. Some types of these devices have been reported to reduce the strength of methylmethacrylate adhesives used to fixate orthopedic prosthetic devices to bone.
  • Aspiration into Blood Salvage System Filters. Fragments of these devices may pass through blood salvage system filters and occlude the systems or patient’s vasculature.
  • Embolization. These devices used near moderate to large blood vessels may result in embolization of the blood vessel (which has a high mortality rate).Embolization has been associated with severe adverse effects, including fever, duodenal and pancreatic infarc, embolization of lower extremity vessels, pulmonary embolization, splenic abscess, necrosis, asterixis, and death.
  • Paralysis/Nerve Damage/ Tissue Necrosis.These devices absorb fluids and swell to varying degrees, up to 40 times their weight in volume. The device swelling can encroach on surrounding nervous tissue to cause paralysis or tissue necrosis.
  • Disease Transmission. These devices are composed of animal-derived collagen-based materials, which may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured.
  • Adverse Tissue Reaction. These devices may result in local or systemic adverse tissue reaction due to material composition or interaction of the material with the body.
  • Toxicity. These devices may contain materials or ingredients that result in local or systemic toxicity.

FDA claims that the following Special Controls would mitigate the risks to health and provide reasonable assurance of safety and effectiveness for absorbable collagen-based hemostatic devices.

  • Material source information must be sufficient to demonstrate that the likelihood of the risk that the device is transmitting infectious diseases is minimized.
  • Material processing information must detail all reagents used in the manufactur of the device, and residual amounts must be quantified.
  • For crosslinked devices, the density of crosslinks must be provided.
  • Device related particulates must be characterized.
  • Collagen characterization information, including elemental analysis and decellularization efficiency determination, must demonstrate the identity, purity, and quality of the collagen.

FDA was unable to provide any evidence or science in the Executive Summary- or when pressed by the panel- on why they proposed down-classing absorbable collagen-based hemostatic agents from Class III High Risk classification, down to Class II with Special Controls. Class III devices are considered “life sustaining” or “life saving” and have the highest amount of FDA oversight. The panel was not provided any evidence as to their reasoning and when the panel questioned this, we were told that information is “confidential”. FDA put us in a bad position because we can’t make a recommendation on something we were not shown and essentially, FDA was asking us to just take their word for it. The discussion got heated about that. We as a panel cannot- and neither should the FDA- use anecdotal evidence over scientific evidence. The only evidence provided to us were two premarket approvals which stated that there is no difference between the device and the control. It should also be noted that absorbable hemostatic agents have remained in Class III for 42 years.

FDA also stumbled on their answers to panel questions and were visibly uncomfortable that they couldn’t.

Absorbable collagen-based hemostatic devices come in powder, paste, sheets, and sponges and are made from porcine or bovine byproducts. This raised a concern from another panel member about those who cannot consume those products due to religious or cultural reasons, as well as for diabetics who often switch from porcine to bovine insulin (and vice versa). It was suggested by the panel member to include the ingredients on the labeling as part of the Special Controls.

Because FDA provided no evidence and no reasoning for down-classing the devices, we adjourned 4 1/2 hours earlier than planned. Most of the morning was spent discussing the lack of evidence and that we are put in a bad position by making a decision on so little information.

Points we could unanimously agree  upon is:

  1. Whether FDA should consider a validated bleeding scale to be used to demonstrate effectiveness of hemostasis. We felt that there needs to be some objectivity and standardization and we unanimously voted yes.
  2. Whether the panel agreed with FDA that absorbable collagen-based devices are not life supporting or life sustaining. We unanimously voted no– that the panel disagrees with FDA on that question.

That said, in a surprising vote about whether to keep these devices at Class III (life saving or life sustaining) or whether to down-class them to Class II following a heated discussion, I was the only panel member to vote no on down-classifying the devices and remaining firm that these devices should remain Class III.  The patient representative abstained from the vote stating that he will deflect to “the experts on this”. All other panel members voted to down-class to Class II. I was shocked considering that we unanimously agreed that these device are, in fact, life saving and life sustaining, that the vote was markedly different than the discussions leading up to it.

In a nutshell, the rest of the panel decided to just take the word of the FDA that they’ll do the right thing with the information that was not presented to us by reason that it’s “confidential” or that FDA “just didn’t think to bring that information and in hindsight, should have”

I’m extremely uncomfortable with that.

 

 

 

Improved Medicare For All: It’s Time to Change Healthcare to a Single-Payer System

If you’ve never heard of Health Care Justice North Carolina, you’re about to hear a whole lot about it.

I’ve been active in healthcare issues for a little over a decade, one of which is Medicare For All; single-payer national health insurance. As of January 17, I’m the newest member of the Legislative Committee.

It’s the perfect marriage for me. I am a harmed patient with high medical bills, I do national advocacy, and I’ve worked with local, state, and Federal government agencies to affect change.

Health Care Justice NC is the Charlotte, North Carolina branch of Physicians for a National Health Program. PNHP is a non-profit research and education organization of over 21,000 medical professionals and members of the general public who support single-payer national health insurance. If you also support this, please consider signing the Chapter Resolution.

Here is a quick rundown to put single-payer health insurance in perspective:

  • Problem: The United States spends twice as much per capita on health care as other industrialized
    nations, yet we rank near the bottom in nearly all health indicators. Additionally, each year, one trillion of our healthcare dollars go to administrative costs (31%).
    Medicare For All: Having a single payer system– like Medicare– can cut administrative costs in half,
    saving $500 billion dollars annually.
  • Problem: Thirty million Americans have no health insurance. Forty million are underinsured..
    Medicare For All: The savings alone are more than enough to cover all Americans’ healthcare with no co-pays or deductibles.
  • Problem: Most U.S. household bankruptcies are due to medical bills; most households had insurance.
    Medicare For All: Funding for Improved Medicare for All will be less than current healthcare costs for 95% of U.S.households.

Why this is personal: I have several illnesses that require a lifetime of monitoring, tests, and expensive prescriptions. Hospital stay and surgery costs cut into our savings, like many Americans.

 

I remember one surgery in particular… The hospital was covered by my insurance and my surgeon was covered; my anesthesiologist wasn’t. I got a huge bill that I was expected to pay out of pocket. When I called the insurane company to appeal it, I said, “Was I supposed to bring my own anesthesiologist??”

Another example is a blood test I need to monitor my blood disorder. This test explained why my blood counts were so low and how my doctors can treat my condition. The insurance company called the test “experimental” (it’s not. It’s a standard test that is well known) and refuses to cover it. My primary doctor and hematologist were furious when I brought it to ther attention. They both submitted paperwork explaining why it is medically necessary. I’m still battling the insurance company over this.

My medications are costly. I’ve had to decide between paying mortgage and utility bills or paying for medications. I’ve had to either ration medicine or decide not to fill it out of fear of running out of money.

And remember, I am insured. I fall into the category of underinsured.

There are a lot of people like me who can’t pay medical bills under the current system. Improved Medicare for All warrants a lot more discussion and finding ways to fix a broken system.

This is something I’m passionate about and you’ll be seeing a lot more of me as I lend my voice to affect change.

 

 

 

 

The Bleeding Edge Documentary on Netflix

I met The Bleeding Edge documentary film makers Kirby Dick and Amy Herdy in February 2016 in Washington, DC. They were making a film about medical harm.

Their film The Bleeding Edge debuted today, July 27, 2018 on Netflix. It exposes the horrors of the medical device industry. Click on the image below to watch it.

(I make a brief cameo in the film)

I’ve been a patient advocate since approximately 2012. This happened accidentally because I was harmed in 2006 by Cipro and Levaquin, both fluoroquinolone antibiotics made by Bayer and Johnson & Johnson respectively. In the last twelve years I’ve had over two dozen surgeries to repair the damage caused by a medication that was supposed to help me. Antibiotics that carry extreme risks, that the risks outweigh the benefits, and that I was never warned about. The information regarding risks were hidden until advocates across the globe came forward to expose them, including myself.

It was advocacy that led to several changes in the warning labels. We were on  mission to hold Bayer and Johnson & Johnson, as well as the FDA, accountable. Although they still maintain that these drugs are safe and effective and they stand by their products, they did make changes because it became clear that their own data proved what advocates knew all along, and they could not deny the risks any longer.

The more I got involved in advocacy, I was invited to workshops and conferences. There I met advocates from the medical device side of advocacy. I saw that it isn’t just a flawed system in the approval and marketing of pharmaceutical drugs, it was also flawed in the approval and use of medical devices. It is an entire system that is designed to fail.

One workshop that I attended was in Washington, DC where I attended a training session led by the National Center for Health Research. This workshop changed the trajectory of my advocacy. I learned about the approval process, how drug companies use smoke and mirrors to market drug commercials, and how loopholes are created that make it hard to navigate. While there, I had the honor of being on a panel to discuss how advocacy leads to changes at the FDA. On that same panel is Angela Desa, who is featured in The Bleeding Edge documentary.

 

The training proved to be invaluable. Not only did I receive training that helps me in my job and in my advocacy, but I met medical device advocates who breathed new life into my own advocacy. Breast implant awareness advocates, mesh injury awareness advocates, and the incomparable E-sisters who raise awareness about the Essure medical devices, and who fight to create legislation to make medical devices safer.

Meeting them solidified my decision to advocate for all patients harmed by pharmaceutical drugs and medical devices. It gave me a complete picture about the flawed system as a whole and I felt compelled to be part of the solution by being on the policy end.

In 2016, I became a Special Government Employee (SGE) for the Center for Devices and Radiologic Health (CDRH) at the Food and Drug Administration.

I was chosen for two device panels, but under CDRH policy, I can be borrowed and called to serve on any panel under the CDRH umbrella.

Recently, I served as Consumer Representative on an advisory panel to discuss the safety and effectiveness of a cardiac device, and the risk vs benefit profile. My job is to represent consumers and raise concerns about how the particular device can affect patients. I analyze data that I must keep confidential, I ask questions to the device makers and to FDA investigators, listen to testimony from the public hearing portion of the hearing, and express input from a patient safety perspective. At the end of the hearing, before the panel vote, I can sum up what I brought up during deliberations and make recommendations to the FDA and device makers on how to incorportate patient safety. The panel then votes on whether to advise on further steps. In this case, some of the advisory committee recommendations made me happy because the risks did prove to be alarming and steps will be taken to make vital changes. Other parts infuriated me, such as when it was agreed by the majority of the panel that it should be left up to surgeon discretion as to whether the device should be used. With the exception of me, the Patient Representative and the Industry Representative, the voting panel was made up of all surgeons who use the device.

That all said, I watched the Bleeding Edge today and as a harmed patient, a patient advocate, and an SGE with the U.S. Department of Health and Human Services, I have some thoughts on it.

While I know a lot about the approval process of medical devices, and I know people harmed by the devices, the film is shocking. The depth of profits over patients is stunning. And the collective voices of the patients who bravely told their story is inspiring. This film is necessary and helps viewers understand how it came to be that this is allowed to happen, and why the voice of harmed patients and advocates can be a powerful force for change.

The film should serve as a wake-up call to everyone: patients, physicians, device manufacturers, and the FDA.

As an advocate, I’ve experienced push back by the industry, and it can be overwhelming. It can make you feel crazy because no one is listening to you, or they are dismissing your symptoms and pain calling it “rare” or “just part of the illness, not the device/medicine”. You become conditioned to think it’s all in your head. The thing is, can it be all in your head when so many people are coming forward with horrific stories of harm? That’s hard to ignore when people around the world are experiencing harm that they were never told about, and in the name of so-called “innovation”. Even harder when all the adverse events that have been reported are only 4 to 5 % of the total amount so the rest of the 95 to 96% are people suffering in silence. Adverse events are “voluntary reporting” by patients. Doctors who become aware of the adverse events are not required to report it. Only industry is required. Except that there is no incentive to do so when they have a stake in its usage and sales. When patients do report adverse events, they are dismissed with phrases like ” You’re not a doctor so what do you know?”. Actually harmed patients know a lot more than anyone. Just saying.

I was at Johnson & Johnson a few years ago to talk about my story and how I am now disabled from Levaquin. Before I was even allowed up to the microphone, I had to be approved by the “mic keepers”. I was given 3 minutes to speak to CEO Alex Gorsky and the shareholders in attendance.

My microphone was cut off and Mr. Gorsky went into a monologue about how safe Levaquin is and how the company stands by their product. How Johnson and Johnson stands by their Credo, which, honestly, is a crock of sh**.

As someone who held a ticket to attend, My. Mike. Was. Cut. Off. And I was not quiet about that.

The year after, I met with Johnson & Johnson for the second time, where again, Alex Gorsky was in attendance. This time, I was thrown out by security. Twice. My dad was with me and he still thinks it’s equal parts hilarious and ridiculous. And it’s all on tape. These meetings are recorded. I wasn’t quiet about that either.

I’ve also been on both sides of the FDA process. I’ve testified at hearings as a harmed patient, and I’ve also sat on advisory panel meetings.

My advocacy and my work at the FDA gives me a complete picture of the approval process, and how Black Box warnings work. The combination of all of that experience came together when I watched the Bleeding Edge documentary.

The things that pharmaceutical drug and device companies get away with should be criminal. But it’s not. The film delves into how the exception became the rule and how loopholes were created by industry, the FDA, and Congress that allows this level of harm come to patients.

Did you know that if a device is recalled because it’s dangerous, that a device company can still get their version of that risky device approved because of the 501K pathway created by Congress? Ninety eight percent of devices are approved based on the 510K process, and based on previously recalled devices that are proven risky. Only in the pharmaceutical, medical device, and regulatory agency industries can this be allowed to happen.

Did you know that most physicians are not aware of the risks involved in the device they are implanting? They figure that the FDA takes care of that part of it. It does not.

Did you know that a representative from the device company is present during your surgery to implant the device and that you don’t have to be told that an unqualified, non medical professional salesman is watching your surgery? I have several medical devices implanted as a result of the pharmaceutical harm I’ve suffered over 12 years. Not once was I told about this. Or what the devices are made of. Or that it was untested. Or that I could have an allergy to the materials the device is made of.

I wasn’t told anything when I was going through medical harm. But thanks to the Bleeding Edge documentary, you can be.

It is vital- even life saving- to have ALL the information so that you can make an INFORMED decision about your health.

Thank you to Kirby Dick, Amy Ziering, Amy Herdy, for exposing the dangers of medical devices and to the brave advocates who shared their stories. Y’all saved lives and you are my personal heroes.

 

 

FDA fails to finalize proposed rule about generic medications- Still

On March 27, 2015 – three years ago today – I testified at the Food and Drug Administration about proposed labeling changes on generic medications.

Finalizing this rule would open the door for patients who are harmed by generic medication the right to sue the generic drug manufacturer. This is because of a 2011 Supreme Court decision called Pliva v. Mensing.

Gladys Mensing and Julie Demahy were prescribed Reglan in 2001 and 2002 respectively. Instead of receiving Reglan, they were given its generic version metoclopramide.

They both developed tardive dyskinesia, a serious, non-reversable neurological disorder. As evidence mounted, the drug’s warning label was altered in 1985, 2004, and 2009. The 2009 label instructed that use of the drug beyond 12 weeks “be avoided in all but rare cases.”

Mensing and Demahy sued the manufacturers of the generic drugs they had taken. They alleged that the manufacturers were liable under state tort law for failing to provide adequate warnings. The manufacturers pleaded preemption as an affirmative defense, contending that because federal law required them to use the same label as Reglan, it was impossible to comply with a state-law duty requiring a different label.

The generic manufacturers moved to dismiss on implied pre-emption grounds arguing that:

1) FDA regulations require the warnings on generic pharmaceuticals to be the same as those of the brand-name product.

 2) They had no ability to unilaterally add or strengthen warnings without FDA approval. As a result, the manufacturers argued that plaintiffs’ failure to warn claims were pre-empted because it was impossible for them to unilaterally add the plaintiffs’ proposed warnings without violating FDA regulations.

The U.S. Supreme Court decision represents a landmark victory for generic drug makers on the issue of federal pre-emption. By a 5-4 majority, the Supreme Court held that state law failure to warn claims against generic pharmaceutical manufacturers are impliedly pre-empted by federal law. In reaching this decision, the court accepted the Food and Drug Administration’s interpretation of its own regulations that generic manufacturers are legally prohibited from unilaterally changing or strengthening their product labeling without prior FDA approval. This deference to the FDA paved the way for the court’s holding. The court held that because it was impossible for a generic manufacturer to unilaterally add or strengthen warnings without violating FDA regulations, all state law failure to warn claims are pre-empted.

A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. And they are significantly less expensive than its brand name counterpart.

Eighty percent of medications dispensed are generic. And if you are harmed by a generic medication, you cannot sue the manufacturer. There is no justice for those patients.

The Food and Drug Administration proposed a rule to change warning labels, which would open the door to those patients to receive justice.

I testifed at the FDA to urge them to finalize that proposed rule.

 

Those injured by generic drugs have suffered the same injuries and disabilities as those who took brand name medications and justice has been denied because of the current generic drug safety loophole.

The FDA has the power and responsibility to ensure patients are warned and to promote safety by making sure generic drug makers are accountable for their products just as brand name-drug makers are. By not finalizing the proposed rule, it is only adding injury to injury and leaving patients at risk.

An FDA decision has been postponed several times.

It has been three years and the FDA continues to fail to finalize the proposed rule.

Three. Years.