Last Updated December 7, 2020

Since the early days of e-cigarettes and vaping in the United States, manufacturers such as Juul and others, have made spurious claims that their devices are either “safe” or “safer than tobacco”. The practice of touting the ostensible “benefits” to vaping and Juul use went unchallenged for several years while those in the scientific and medical communities became increasingly concerned that not only are they not safer, they may in fact pose new and unique dangers to human health.

It’s helpful to remember that despite whatever beneficial claims manufacturers make, these devices are designed and built for the express purpose of delivering nicotine, a dangerous and addictive chemical, either just as or more efficiently than combustible cigarettes. Furthermore, the vapors created by vaping and Juul contain additives and ingredients which may be linked to severe lung damage in adults and teens.

The potential for adverse side effects from vaping and Juuling has become so pronounced that the U.S. Food and Drug Administration (FDA) extended regulatory power over e-cigarettes and Juul to its Center for Tobacco Products in 2016. Later, in 2018, the U.S. Surgeon General declared e-cigarette use “…an epidemic among our nation’s young people”.  Most recently, in April 2020, the FDA used its authority to ban the sale of flavored e-cigarette and Juul cartridges (except for menthol and tobacco flavors).

Now public health officials throughout the United States have started to document and publish studies into the association between vaping, addiction, and respiratory distress.

Commonly Associated Side Effects of Vaping

Vaping and Juul use have commonly understood side effects from their use. These side effects may be more noticeable among new users and may disappear over time once the use of vaping or Juul products have been discontinued:

• Coughing
• Dry or Sore Throat
• Dry Eyes
• Headaches
• Nausea
• Dizziness
• Dry Mouth
• Shortness of Breath

Nicotine Addiction and Withdrawal Side Effects

E-Cigarettes and Juul are nicotine delivery devices and contain nicotine just like combustible cigarettes. They may even be more potent at putting nicotine into the bloodstream given the high concentrations deposited by the vaping mechanism. Added to this potency is the fact that many vaping systems sell high concentration nicotine cartridges or allow voltage to be augmented to bump up the amount of nicotine.

It is well understood that nicotine is extremely addictive and is dangerous for adults and teens alike. Short term exposure to nicotine has been demonstrated to induce tremors and an increase in heart rate, blood pressure, and respiration. It is suspected to cause issues in early teen and fetal brain development. Furthermore, long-term exposure to nicotine is linked to tumor growth and promotion.

Nicotine addiction is insidious and difficult to overcome.  In adults and teens alike, nicotine triggers a dopamine “reward” effect which encourages the user to keep using nicotine over and over again. Consequently, when e-cigarette and Juul users attempt to quit vaping, they tend to suffer nicotine cravings and other side effects such as:

• Feeling irritable
• Headaches
• Increased sweating
• Anxiety
• Sadness
• Feeling tired
• Difficulty with concentration
• Insomnia or difficulty sleeping
• Increased hunger

Breathing Issues

Over several decades, the American public has been made well aware of the numerous hazards associated with smoking combustible cigarettes such as heart disease, emphysema, and lung cancer. Regrettably, because e-cigarettes and Juul remove the combustible element inherent in traditional cigarettes, many people believe that these devices pose no risk at all to lung health. However, the scientific and medical communities are now voicing new concerns about vaping compounds and lung health that introduce a range of new potential side effects.

Bronchiolitis Obliterans Organizing Pneumonia (BOOP)

Researchers recently published an article concerning the prevalence of Bronchiolitis Obliterans Organizing Pneumonia (also known as “BOOP”) in the American Thoracic Society (ATS) Journal. BOOP is a lung disease which causes inflammation in the small air tubes (bronchioles) and air sacs (alveoli). Ordinarily, BOOP symptoms include: shortness of breath, dry cough and fever. Some symptoms may be much more acute than others.   BOOP is typically treated with a drug regiment focused on corticosteroids such as prednisone.

E-Cigarette or Vaping Associated Lung Injury (EVALI)

EVALI was first recognized by the U.S. Centers for Disease Control (CDC) in August 2019 following the combined work of several public health officials across the United States to study cases of severe and sometimes fatal lung infections in several otherwise healthy people. The individuals who required hospitalization complained of symptoms such as shortness of breath and fever. The common factor among all of them was that they were recent users of e-cigarettes and vaping products. The CDC and the New England Journal of Medicine have conducted further research which suggests, Vitamin E Acetate, a thickening agent used in some vaping products, may be linked with EVALI.

Adam Hergenreder

Eighteen-year-old Adam Hergenreder was a steady e-cigarette user for over two years.  His favorite flavors were mint and mango. In September 2019, he was hospitalized complaining of acute lung issues and shortness of breath. After undergoing chest X-rays, his doctors told him he had the lungs of a 70-year old man and that his lungs may never truly heal.

Vaping-Related Acute Lung Injury

The December 2019 Mayo Clinic Proceedings examined the potential for breathing issues and vaping in its article: “Vaping-related Acute Lung Injury: A New Killer Around the Block.” Among the article’s highlights was the conclusion that the incidence of vaping-related acute lung injury is increasing and that electronic cigarette compounds present the potential for a range of detrimental effects on the human respiratory system.

Neurological Issues

Alleged Hemorrhagic Stroke

In 2017, 22-year old Syracuse University student Maxwell Berger suffered a severe hemorrhagic stroke which paralyzed the left side of his body and caused him to lose half of his vision in both eyes. Maxwell began vaping with Juul in 2015 and quickly developed a two-pod-per-day habit.  In a lawsuit he filed in 2019, Maxwell alleges that his use of Juul caused his stroke as well the cognitive brain impairment he has experienced as a consequence.

FDA Investigation Into Possible Link to Seizures

In a series of 2018 internal communications uncovered by Bloomberg News, the FDA took a hard look at three cases of seizures that occurred alongside Juul use. To be sure, the FDA did not detail any direct causal link between Juul and the seizures. However, they did believe that at a minimum, there was an “association” between the seizures and Juul. Over the next few months, the FDA uncovered an additional 32 reports of vaping and seizures and in April 2019, the agency announced a formal investigation into a linkage.

Juul Pod Contamination

A former Juul Labs executive filed a 2019 lawsuit in federal court in California alleging that at least one million contaminated Juul pods made it onto the market despite numerous warnings to the company’s leadership. In his lawsuit, Siddarth Breja alleged that Juul’s CEO Kevin Burns told him: “Half our customers are drunk and vaping like mo-fos, who the f**k is going to notice the quality of our pods?” Juul’s CEO has publicly denied the allegations.

Last Updated October 28, 2020

Talcum-based powder has been a staple in American bathrooms and medicine chests since global pharmaceutical and medical device conglomerate, Johnson & Johnson, first developed and sold its baby powder in 1893. Marketed as a convenient and comforting method to eliminate moisture for both babies and women, baby powder was, for years, touted as “safe” and leaving the skin “delicately soft and dry”. The success of Johnson & Johnson’s baby powder spawned a host of other entrants to the market including “Shower to Shower” (itself developed by Johnson & Johnson, then later sold to Valeant) and “Gold Bond” body powders, all of which continued telegraphing to consumers that their products are “safe” and appropriate tools for maintaining “freshness and cleanliness” for women and babies.

Despite manufacturer claims of health and safety, increasing evidence of the risks associated with talc began to mount in the 1960s, in particular with respect to risks from talc and asbestos exposure. Furthermore, since 1982, there have been at least 21 studies by doctors and scientists around the world which concluded that talc presents an elevated risk of ovarian cancer when applied to female genitals. This increasing awareness of the health concerns associated with talc has led tens of thousands of people to file lawsuits alleging that talcum powder manufacturers were aware of the potential for cancer caused by their products and still did nothing to warn consumers.

Talc Background

A naturally occurring mineral, Talc is composed of magnesium, oxygen, and hydrogen and is known chemically as a “hydrous magnesium silicate”.  In its natural form, talc appears as grey/green or white and typically has a somewhat greasy feel to it. Talc is the main substance within talcum powders such as Johnson & Johnson’s branded baby powder. Talc is usually mined in proximity to concentrated deposits of asbestos, a known deadly carcinogen. As a consequence, it has been understood for quite some time that, in its natural form, talc will contain asbestos and that exposure to natural asbestos from talc must be limited. 

Top-Selling Talc Products (Historically)

Since 2017, many manufacturers of talcum powder products have either withdrawn their brands from the U.S. market or switched to a safer alternative like cornstarch powder. Historically however, the following are/were the leading talcum powder brands on the market throughout the United States:

• Cashmere Bouquet (Colgate Palmolive)
• Gold Bond Powders and Sprays (Chattem)
• Johnson’s Baby Powder (Johnson & Johnson)
• Shower to Shower (Valeant/Johnson & Johnson)

Talc Exposure and Mesothelioma

Malignant mesothelioma is cancer that arises within the mesothelium – a very thin layer of tissue within the body that covers many internal human organs. Due to the presence of this important tissue throughout the body, a diagnosis of mesothelioma is usually a final one. There are not many available treatments and the cancer is very aggressive. There are different types of mesothelioma. However, the most common form is pleural mesothelioma which involves tissue around the lungs.

Asbestos exposure is considered to be one of the primary risks for developing mesothelioma. Airborne asbestos fibers can settle into the lungs or stomach when inhaled or ingested and then fester for years possibly leading to mesothelioma. In fact, it is believed that mesothelioma may develop as late as 20 to 60 years following initial asbestos exposure.

For years, talc product manufacturers, in particular Johnson & Johnson, asserted that their powder products were safe and did not contain asbestos. However, as the result of recent litigation, Johnson & Johnson was compelled to hand over thousands of pages of internal company documents for examination by plaintiffs. Some of these documents detail that going back to at least 1971, the company knew on multiple occasions that its talc-based powders were testing positive for small amounts of asbestos. It is worth noting that the World Health Organization (WHO) does not recognize any safe level of exposure to asbestos.

Worse yet, internal Johnson & Johnson documents also show that the company could have easily substituted corn starch in the place of talc in all of its products. Johnson & Johnson knew that cornstarch is absolutely free of asbestos yet refused to make the change.

In the belief that their mesothelioma was caused by exposure to asbestos from talc powder (as well as the powder itself), several victims have filed lawsuits and obtained critical verdicts supporting their claims.

• A Missouri jury ruled in favor of four plaintiffs in 2019, who each claimed that exposure to asbestos leaden talcum powder used on them as children caused their mesothelioma. The jury awarded $37.2 million in damages to the group.

• In 2018, a New Jersey jury found that Stephen Lanzo’s mesothelioma diagnosis was likely the result of his exposure to asbestos after years of regular use of Johnson’s Baby Powder. The jury awarded Mr. Lanzo $117 million, including punitive damages after finding that Johnson & Johnson “acted with deliberate indifference” to the rights of Mr. Lanzo.

• After a six-week trial in 2017, a California jury awarded a $22 million verdict to Richard Booker. Mr. Booker died at the age of 72 from mesothelioma and claimed that his diagnosis came after years of exposure to asbestos in paint and ceramics which used talc as a primary ingredient. The jury award included $4.6 million in punitive damages against one of the largest talc mining companies in the world, Imerys.

Talc Exposure and Ovarian Cancer

Going back decades, talc-based powder manufacturers touted their products as a safe and effective means for managing genital perspiration and as a genital deodorant. Products such as Johnson’s Baby Powder and Shower to Shower were aggressively promoted as non-irritating daily-use solutions for vaginal odor. The campaign was wildly successful and by the mid-2000s, adults accounted for 91% of Johnson’s Baby Powder use.  

Johnson & Johnson’s marketing was even slickly targeted to emergent consumers – in particular “curvy” and “overweight” women. As the WHO began to scrutinize talc-based powders as being “possibly carcinogenic” in 2006, Johnson & Johnson shifted its marketing gears to target overweight and African American women who they considered as a viable consumer opportunity at the time.

The first suggestion of a linkage between ovarian cancer and talc usage emerged in the early 1960s. At that time, researchers felt that since some talc powders contain asbestos, and it was known that animal studies showed the potential for asbestos to migrate to the ovaries from the genitals – there was at least the possibility in humans. It wouldn’t be until 1982 when a case-control study first linked talc use with ovarian cancer.  Since that time, dozens of studies have followed confirming an association.

Despite the studies and evolving knowledge concerning the association between talc-based powders and ovarian cancer, Johnson & Johnson and other manufacturers continue to insist that their talc-based powders are asbestos-free and do not cause cancer. Nevertheless, in May 2020, Johnson & Johnson announced that it was discontinuing sales of talc-based powder products in North America. The company will allow existing bottles of baby powder to be sold by retailers until supplies run out.

Talc and Ovarian Cancer Lawsuits

At present, there are large lawsuits taking place in state courts in New Jersey, California, and Missouri involving claimants who believe that talc-based powder products caused their ovarian cancer. Beyond these state court claims, there is a massive multidistrict lawsuit pending in a federal court in New Jersey (MDL-2738) with nearly 18,000 plaintiffs cases consolidated. Several powder manufacturers are named in these lawsuits, however, Johnson & Johnson is named in the overwhelming lion’s share of cases.

In October 2020, Johnson & Johnson agreed to settle 1,000 of the MDL cases for $100 million dollars. Johnson & Johnson has also agreed in the past to settle some individual cases for undisclosed amounts. The rest of the MDL will likely proceed into the bellwether trial stage in 2021.

Notable Ovarian Cancer and Talc-Based Powder Verdicts

• A Missouri jury sided with ovarian cancer sufferers in 2018 who alleged that years of use of Johnson’s Baby Powder caused their cancer. The $4.7 billion award included $4.14 billion in punitive damages against Johnson & Johnson for the company’s “reprehensible conduct” concerning its longtime knowledge of the presence of asbestos in its talc-powder products.
• Eva Echevarria was awarded a verdict of $417 million by a Los Angeles, California, jury after it found that Johnson & Johnson failed to adequately warn her of the cancer risks associated with talc-based products.
• Jacqueline Fox used Johnson’s Baby Powder daily going back several decades and was shocked to learn that it was potentially the cause of her ovarian cancer diagnosis. In 2016, a jury in Missouri awarded her $72 million, $62 million of which were punitive damages on the basis of the conduct of Johnson & Johnson.

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73. “Talc, Asbestos, and Epidemiology: Corporate Influence and Scientific Incognizance” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6784763/

74. “Mesothelioma: A Review” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307510/

75. “Malignant mesothelioma” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905399/

Last Updated November 19, 2020

The association between talcum powder and increased risk for ovarian cancer and mesothelioma is one that simultaneously is the focus of much research and the object of extensive litigation. Industry leaders and researchers have spent a great deal of time and money bolstering their arguments concerning talc’s possible relationship to both ailments.

With that in mind, there is relatively little discussion elsewhere regarding some other potential illnesses associated with talcum powder products, as well as other possible cancer risks. Talc-based baby powder products can cause respiratory ailments for both babies and adults alike if inhaled. Additionally, some research has associated talc with other cancers such as lung cancer and uterine cancer.

Talc and Asbestos – A Key Distinction

Talc is a naturally occurring mineral that appears as almost grey or green with a greasy type of texture. When talc is processed, crushed, dried, and milled – it develops its signature soft, white powdery look and feel.  Historically, talc has been mined in close proximity to concentrated asbestos deposits. Asbestos is a well-known carcinogen. Therefore, it has been understood for some time that naturally occurring talc will contain some amounts of asbestos.

Over the years, talc’s properties for moisture absorption and friction reduction have made it a very popular ingredient in many household items such as baby powder and a range of cosmetic products. However, concerns about asbestos exposure led the Cosmetics, Toiletry and Fragrance Association (CFTA) to develop an internal “self-policing” standard within the United States wherein members agreed that their products should be free of “detectable amounts” of asbestos. The World Health Organization (WHO) does not believe that any amount of asbestos is safe, detectable, or not.

Accordingly, when thinking about talc and the risk for cancer and other diseases – it must be remembered that some manufacturers claim that their talc products are “asbestos-free”. It is an important distinction because the linkage between cancer and asbestos is clear. The link between talc-free asbestos and the risk for illness is not as well understood or researched.

Talc Inhalation and Pneumonia Risk

Infants and children may suffer from “acute talc inhalation” symptoms, although the condition is very rare in adults. When applied to the skin, talc is largely harmless. However, talc does not dissolve in water and when inhaled immediately sets to dry up mucous membranes in the windpipe and lungs. Coughing or sneezing symptoms ranging up to sometimes fatal severe respiratory distress can result.

Infants and children suffering from acute talc inhalation must receive immediate medical attention. Treatment will usually involve medication to stimulate the bronchial passageways in the lungs and chest x-rays to monitor for inflammation as well as the administration of antibiotics to counter any possible onset of bacterial pneumonia.  

Other Potential Cancer Risks from Talc

Stomach Cancers

A March 2019 article in the International Journal of Environmental Research and Public Health studied the potential for increased risk of stomach cancers from ingestion of asbestos-free talc. The study focused upon a population in Taiwan that had consumed Chinese herbal remedies that contained asbestos-free talc (commonly used as a diuretic and antacid). The study was conducted through Taiwan’s health insurance registry database and participants were followed to learn of any diagnosis of stomach cancer. At the conclusion of the study, researchers believed there is a “positive association” between increased stomach cancer risk and ingestion of asbestos-free talc.

Uterine and Cervical Cancers

Over the years, a range of studies and research have discovered a positive association between “dusting” of the female genitalia with talcum powder and an increased risk of ovarian cancer. The International Association for the Research of Cancer (IARC), a unit of the World Health Organization (WHO) classified “perineal use” of talcum powder as a “Group 2B” human carcinogen in 2006. Specifically, the IARC found that between 16-52% of women in the world used talcum powder on their genitals and that among them there was an increased risk of ovarian cancer ranging from 30-60%.

While there has been a great deal of credible research on the linkage between ovarian cancer and talcum powder, not as much attention has been focused on a possible relationship to other female reproductive ailments. A 2011 article in the journal Cancer, Epidemiology, Biomarkers, and Prevention reported on a study of over 66,000 women with nearly 600 cases of uterine cancer diagnosed between 1982 and 2004. The study suggested that there was an association between talcum powder and uterine cancer, particularly among postmenopausal women.

Other studies have found no linkage between talc and uterine or cervical cancers. The American Cancer Society and other experts agree, however, that further research is needed to explore the potential risk.

Lung Cancer

The risk of lung cancer from exposure to inhaled asbestos is well established. Asbestos is one of the most well-documented carcinogens known to the medical profession. However, the cancer risk from asbestos-free talc is less understood, outside of an industrial or mining setting. A 2006 study of talc miners and millers did not observe any higher rate of lung cancer mortality rates, outside of other risk factors such as smoking. However, other studies have suggested a possible link between long-term industrial exposure without drawing any specific conclusions.  Experts agree though, that additional research is warranted.  

Last Updated November 11, 2020

As far back as the 1960s, medical researchers first suggested the possibility that talcum powder sprinkled on female genitalia could be linked with ovarian cancer. Their belief stemmed from the knowledge that talc naturally contains asbestos, a fibrous mineral with a well-established connection to increased cancer risk. Years later, in 1982, scientists conducted the first case-control study to link talcum powder and ovarian cancer. Since then, more and more studies have followed confirming an association with increased risk.

Talc is a naturally occurring mineral that can be crushed, dried, and milled to form a fine, soft, white powder that has a propensity to absorb moisture and reduce friction. Usually, talc is mined in close proximity to deposits of asbestos. Despite the potential for asbestos contamination, talc has been a very popular ingredient in personal care and cosmetic products in the United States for decades. In 1976, in an effort to beat federal and state regulators to the punch, an industry trade association, the Cosmetics, Toiletry and Fragrances Association (CTFA) proposed that the industry be allowed to self-regulate with voluntary standards requiring that all member companies market products which are “free of detectable amounts of asbestos”. “Detectable” is an important distinction as many research experts will contend that even small or virtually undetectable amounts of asbestos can potentially increase cancer risk substantially.

Products such as Johnson & Johnson Baby Powder were aggressively promoted to American consumers for over a century. Originally pitched as a drying and diaper friction solution to mothers for their babies, use of talcum based powder began to wane as parents, concerned with risks from inhalation, switched to other solutions such as corn starch. Accordingly, manufacturers of talcum powders began to switch their marketing focus toward women in general, promoting talcum powder as a solution for genital odors, perspiration, and moisture. Johnson & Johnson even specifically targeted “curvy” and overweight African-American women in its advertising as the use of baby powder underwent a demographic shift. These campaigns were wildly successful and by the mid-2000s, adults accounted for 91% of Johnson’s Baby Powder use.

Despite the studies and evolving knowledge concerning the association between talc-based powders and ovarian cancer, Johnson & Johnson and other manufacturers continue to insist that their talc-based powders are asbestos-free and do not cause cancer. And to be sure, there exists no definitive evidence that talcum powder causes ovarian cancer.  Nevertheless, in May 2020, Johnson & Johnson announced that it was discontinuing sales of talc-based powder products in North America. The company will allow existing bottles of baby powder to be sold by retailers until supplies run out.

Evolving Understanding of Ovarian Cancer Risk

The first epidemiologic study involving talcum powder use on female genitalia was performed in 1982 by Dr. Daniel Cramer and his team of researchers. Dr. Cramer’s study found a significantly increased risk of ovarian cancer in women who reported that they regularly used talcum powder in their genital area. According to Dr. Cramer, officials from Johnson & Johnson came to discuss his study.  At that time, Dr. Cramer recommended to Johnson & Johnson that they place a warning on its talcum powder about the risk of ovarian cancer. Since the Cramer study, there have been approximately 22 additional epidemiologic studies that have reported an elevated risk for ovarian cancer associated with talcum use on female genitalia. Among these studies and findings:

• In 1993, the U.S. National Toxicology Program (USNTP) published a study on the toxicity of non-asbestiform talc and, according to their statement, found clear evidence of “carcinogenic activity”.
• The International Association for the Research of Cancer (IARC), a unit of the World Health Organization (WHO) published a paper in 2006 wherein it classified perineal use (i.e. in the area of the female genitalia) of talcum based powder as a “Group 2B” human carcinogen. IARC is widely accepted as the international authority on cancer issues.
• The IARC found that between 16-52% of women in the world were using talcum powder to dust their genitals and found that among them there was an increased risk of ovarian cancer ranging from 30-60%.
• The Canadian government classified talc as a “D2A – Very Toxic” cancer-causing substance under its Hazardous Products Act. Notably, asbestos is similarly labeled as D2A.
• The journal “Epidemiology” published the article “The Association Between Talc Use and Ovarian Cancer” in May 2016 which examined the association in 2,041 cases of ovarian cancer and genital talcum powder use. The article concluded with the observation that the use of talcum on the genitals is associated with elevated ovarian cancer risk vs. no increased risk among women who did not use talcum powder on the genitals.
• A study headed up by Joellen M. Schildkraut, Ph.D., MPH, was published in the October 2016 journal “Cancer and Epidemiology, Biomarkers, Prevention”, which indicated that African American women had a substantially higher risk for ovarian cancer if they used talcum to powder their genitalia.

Regulators and the Industry

Manufacturers of talcum powder products are not required to provide safety information in the United States. The U.S. Food and Drug Administration (FDA) has opined in the past that it does not believe it has the authority to require any sort of warning on talcum powder. However, in 2016, the FDA’s Office of Women’s Health (OWH) did announce its funding of additional research into the potential for a relationship between talcum powder and ovarian cancer, acknowledging that its effects on female genitalia have not been adequately investigated. The OWH research is aimed at filling in “data gaps” in the association of talcum powder and the onset of cancerous conditions.

Johnson & Johnson and other talcum-based product manufacturers uniformly continue to insist that their products are both asbestos-free and do not cause cancer. In May 2020, Johnson & Johnson announced that it would discontinue sales of baby powder in North America.

Last Updated December 3, 2020

As with any surgical procedure, implantation with an IVC filter presents a number of risks and benefits to patients. It is important that patients discuss the facts about IVC filters with their physicians and learn as much as possible about the risks and potential complications from these devices. Below are some of the more commonly asked questions about IVC filters which can form the basis for a broader conversation with your physician about DVT treatments and a comprehensive IVC filter strategy.

What is an Inferior Vena Cava (IVC) Filter?

IVC filters are small mechanical devices that surgeons place into the vein in order to prevent DVT and other types of blood clots from using the IVC as a highway back to the heart and lungs. They are spindly devices that look and act like a sifter – allowing clear blood components to pass through it while intercepting and catching clots.

Which Patients Typically Receive IVC Filters?

IVC filters are generally recommended for patients who suffer from chronic DVT and who cannot take blood-thinning medication. Sometimes, an IVC filter will be recommended to patients who are about to undergo surgery and have to suspend taking blood thinners temporarily.

Is an IVC Filter Implanted Permanently?

There are two general types of IVC filters on the market in the United States: permanent and optional (also known as “retrievable”). Permanent filters have been utilized in patients since the 1970s and are placed in patients with long-term needs to filter against PE or other issues with blood clotting.  Retrievable filters are newer and as the name suggests, are designed to be retrieved from the patient (or sometimes left in place) after a temporary risk of PE or clotting has passed or been resolved.

How are IVC Filters Implanted?

The procedure for implanting an IVC filter typically involves a smaller incision made by an implanting physician in either the groin or neck. The doctor will then insert a flexible tube or “catheter” with a collapsed filter into a vein and route into the Inferior Vena Cava. Once it reaches the IVC, the filter is then triggered to expand and attach itself to the walls of the vein. In some cases, the filter becomes a permanent fixture in the IVC, although others are implanted with the understanding they will be removed after some period of time.

How Should I Prepare for IVC Insertion Procedure?

Prior to the procedure, your physician will likely order a series of blood tests to examine kidney function and blood clotting patterns. You should be very open and tell your physician about all medications – as well as herbal supplements that you take on a regular basis. Also, ensure that your physician is well aware of any recent illnesses or other medical conditions. Your physician will advise you as to which medications you can take either in advance or the day of the procedure as well as whether or not to eat or drink anything after midnight beforehand.

What is the Procedure Like?

IVC insertion is usually performed on an outpatient basis either in an operating room or in an interventional radiology suite. Patients are typically positioned on their back and are connected to a heart monitor. Usually, the procedure does not require general anesthesia and patients can be administered a solution intravenously which induces a sedated state. The physician will numb the insertion site and make a very small incision for catheter insertion. When the procedure is finished, the catheter is removed and pressure is applied to stop bleeding. Stitches are not usually required and a small dressing is applied to the small incision.

When Can Patients Go Home After the IVC Filter Insertion?

The insertion procedure is usually completed within an hour. Patients will remain at the medical center for up to 3-4 hours and then can return home. In some cases, your physician will order you to remain overnight at the hospital for observation.

What Should You Do When You Get Home?

Patients should avoid strenuous activities for at least a day or two. They can resume a normal diet and should consume fluids to avoid dehydration. A bandage should be kept over the incision site for at least a day or as long as your physician recommends. An ice pack can be placed on the site for 10-20 minutes at a time to help alleviate soreness and swelling.

What About Medications?

You should speak at length with your physician about all medications and supplements you are taking. She will let you know when to stop and restart any medication consistent with the procedure. Be safe with your medications and take them precisely as directed by your physician. If you think your medication is making you sick, advise your doctor immediately and discuss options for possible substitution.

Can Things Go Wrong with IVC Filters?

IVC filters have enjoyed widespread adoption and use – in particular following the introduction of optional or retrievable filters in the 1990s. However, with the increased use of the filter, has come a growing recognition that there are a number of safety complications associated with these devices. Some risks and complications associated with IVC filters include:

• IVC Filter Fracture
• IVC Filter Penetration
• IVC Filter Migration
• Excessive Tilting

Patients should have a frank and open discussion with their physicians about the type of device with which they are going to be implanted as well as the risks associated with that particular device.

If I Have a Removable Filter – When Should It Be Removed?

The U.S. Food and Drug Administration (FDA) has issued a recommendation concerning removable IVC filters. Specifically, the FDA believes that removable filters should be removed as soon as the risk of PE has subsided. Guidelines further state that removal should take place within 29-54 days following insertion (if possible).

Last Updated November 6, 2020

Alongside the important role that it plays in maintaining life, the IVC can also develop issues that threaten life as well. Veins like the IVC can develop clumps of thickened blood which form clots. When clots form below the heart, and in particular in the thigh or lower leg, they are referred to as “Deep Vein Thrombosis” (DVT). If a DVT clot breaks free and makes its way back to the heart or lungs, it can become a deadly “Pulmonary Embolism” (PE). Once lodged in the chest cavity, a PE can block the flow of blood to the heart and lungs, significantly disrupting cardiopulmonary function.

Symptoms of Pulmonary Embolism

Symptoms of PE can vary dramatically from patient to patient. The size of the clot and its location in the lungs, as well as the underlying heart condition of the patient, can all play a large impact on the magnitude and duration of symptoms. Common signs of PE include:

• Shortness of Breath
• Chest Pain
• Coughing
• Rapid or Irregular Heartbeat
• Lightheadedness or Dizziness
• Excessive Sweating
• Fever
• Leg Pain or Swelling
• Clammy or Discolored Skin

PE can be life-threatening. If you experience unexplained shortness of breath, chest pain, or a cough that produces bloody fluid – you should seek immediate medical attention.

Inferior Vena Cava Filters

IVC filters are small mechanical devices that surgeons place into the vein in order to prevent DVT and other types of blood clots from using the IVC as a highway back to the heart and lungs. They are spindly devices that look and act like a sifter – allowing clear blood components to pass through it while intercepting and catching clots.

IVC filters are generally recommended for patients who suffer from chronic DVT and who cannot take blood-thinning medication. Sometimes, an IVC filter will be recommended to patients who are about to undergo surgery and have to suspend taking blood thinners temporarily.

To implant an IVC filter, a physician or surgeon will make a small incision in either the groin or neck and then position the filter using a small catheter maneuvered through the incision. Once in place, the filter is “triggered” to expand and attach itself to the walls of the vein. Some IVF filters are permanently left in the vein while others are implanted with the understanding they will be removed later.

Issues with IVC Filters

IVC filters are not necessarily “new” technology. They were first cleared for use by the U.S. Food and Drug Administration (FDA) through the abbreviated 510(k) Clearance process in the late 1970s. However, their use expanded dramatically in a very short span of time between 1999 and 2008.

In 2010, the FDA, after noticing a spike of “adverse event reports” through the previous years, issued a warning about IVC filters and the potential for such issues as filter migration; embolization; perforation of the Vena Cava; and mechanical fracturing of the filter itself. The FDA’s warning was followed in 2014 with a “safety communication” concerning the filters and the agency instituted a new postmarket surveillance study to evaluate the growing use of IVC filters and to make additional recommendations.

IVC Filters and Migration

Experts have grown concerned that too many retrievable (temporary) IVC filters have been implanted into patients – and then never removed. IVC filters which are inserted on a temporary basis, but then left for a longer duration in the body can begin to shift inside of the vein. This is known as IVC filter migration – and it is a serious problem. There are three main types of IVC filter migration:

• Mechanical: Typically, this involves the failure of the device itself.  Surgeons will usually identify mechanical issues during surgical implantation.

• Iatrogenic: Each IVC filter is measured and approved to fit specific measurements within the IVC itself. Iatrogenic migration occurs where the device doesn’t fit the placement properly due to guide wire entanglement.

• Physiological: Bending, coughing, or straining while lifting could cause an IVC filter to dislodge and migrate.

Embolization (Migration into Heart and Lungs)

If the IVC filter migrates far enough away and into the functioning apparatus of the heart and lungs in the chest cavity, it can create life-threatening conditions that require urgent medical treatment.

Perforation of the Inferior Vena Cava

An implanted IVC filter is designed to attach and grapple onto the walls of the vein to remain in place. However, this same technique can sometimes also result in a tiny perforation of the vein causing damage to the IVC itself as well as to surrounding tissue and organs. Symptoms of a perforated IVC include:

• Swelling
• Pain
• Pulmonary Embolism Symptoms (see above)

Some patients suffering from a perforated IVC also report progressively worsening abdominal or back pain over several weeks, later accompanied by bouts of nausea and vomiting. In any event, IVC implantees suffering from these symptoms should seek immediate medical attention and the care of a physician.

Filter Fracturing

When viewed in their operational position, IVC filters tend to resemble umbrellas in their design and function. Like an umbrella, the spindly legs which open inside of the vein are key to its function and to keep the filter in place. Some filters were designed to be implanted and stay in the body permanently. Others were designed to be implanted and then removed at a later date. Unfortunately, for patients with these “temporary” filters, the follow-up procedure to remove them is often forgotten or disregarded.  

Temporary IVC filters that are left in the body can begin to degrade due to excessive wear and tear from the pressures exerted within the vascular system of the human body. Eventually, the spindly legs on the filter can break off or fracture – traveling through the body.  Remember – all blood in the IVC travels toward the heart and lungs. Accordingly, a fractured filter can present a multitude of dire medical consequences for the patient including DVT, heart attacks, and internal bleeding.

The FDA and IVC Filters

To date, the FDA has yet to issue any formal recalls for any IVC filter device.  Nonetheless, between 2005 and 2019, at least eight types of IVF filters have been voluntarily withdrawn from the market by their manufacturers.  In its first warning letter concerning IVC filters in 2010, the FDA detailed over 921 injuries from IVC filters spanning: migration through the body; migration into the heart and lungs (embolization); perforation of the vena cava; and filter fracturing. Since 2014, filter manufacturers have been given the option of either participating in the FDA’s 522 Postmarket Surveillance Studies program or an independent clinical study known as “Predicting the Safety and Effectiveness of Inferior Vena Cava Filters” (PRESERVE).

Furthermore, filter manufacturer C.R. Bard was recently party to a now-settled case in multidistrict litigation over its filter products (MDL-2641).  Cook Medical is currently a party to ongoing multidistrict litigation in federal court in Indiana (MDL-2570) over its IVC filter products.

History and Background of Cook Medical

The story of Cook Medical began when company founder, Bill Cook, and his wife started making catheters in a spare bedroom of their apartment in Bloomington, Indiana, during the early 1960s. Aside from catheters, the duo also manufactured needles and wire guides. Despite its humble start, Cook Medical rapidly grew in sales and expanded internationally throughout the 1970s. By the 1990s, Cook Medical had diversified into intravascular coronary stents, programmable pumps, and infusion devices. Cook describes its approach to medical device manufacturing as “Minimally Invasive Medicine”.

Cook Medical’s IVC Filter Products

The Gunther Tulip

The Gunther Tulip is an IVC filter that has been marketed in the United States since 2003. It was designed as a retrievable filter, meaning it is only supposed to be implanted for short periods of time. If it is left in the vein for a long period of time (3-4 months), the Gunther Tulip increases in its risk of fracture or migration, which can lead to Pulmonary Embolism (PE) and possibly death.

Celect IVC

Similar in shape and design to the Gunther Tulip, the Celect line of IVC filter is a retrievable, umbrella-shaped filter made of a cobalt-chromium alloy.  The Celect was approved through the 510(k) Clearance process (like the Gunther Tulip).  And similar to other IVC filters, the Celect has the potential for fracture and migration the longer it is left inside of the human body.

Issues with Cook Medical Technologies and Product Lines

In re: Cook Medical, Inc. IVC Filters (MDL-2570)

Lawsuits revolving around the Gunther Tulip and Celect lines of IVC filters manufactured by Cook Medical began to make their way into courtrooms around the country in 2013 and 2014. These cases were then consolidated into multidistrict litigation in Indiana. The implantees in this MDL complained of alleged design and manufacturing defects such as tilt, migration, and fracturing. Specifically, some claimants referenced a study published in Cardiovascular Interventional Radiology in 2012 which assessed that the Gunther Tulip and Celect lines failed at a rate of 100% up to 71 days following implant and caused some degree of perforation of the wall of the vena cava. The same study reported that tilt was witnessed in 40% of the Gunther Tulip and Celect filter lines.

The outcomes of the various bellwether trials in this MDL have been a mixed-bag:

• In November 2017, a jury sided with Cook Medical and failed to find the company liable.
• A second bellwether case was dismissed in April 2018 due to statute of limitation issues.
• A Houston firefighter was awarded $1.2 million by a Texas jury in May 2018 (not actually a bellwether case and not part of the MDL).
• In December 2018, the presiding judge in the MDL granted summary judgment to Cook Medical in a Georgia case brought by Tonya Brand.
• Most recently, in February 2019, an Indiana jury awarded $3 million to a woman who suffered a range of injuries from one of its IVC filter lines.

Last Updated November 18, 2020

Proton Pump Inhibitors (PPIs) are drugs that limit the production of digestive acid in the stomach wall. They work by disrupting key enzymes which in turn prevent certain cells in the stomach lining from pumping acid. PPIs are available both by prescription and in over-the-counter (OTC) formats.

While PPIs have proven very useful for the treatment of chronic maladies such as Gastroesophageal Reflux Disease (GERD), patients should be aware that they also have the potential to interact with certain other common medications. Accordingly, PPI users should consult with their physician about what other types of medication or supplements they take in order to reduce the possibility of adverse reactions.

PPIs and Common Drug Interactions

Omeprazole, perhaps one of the most commonly prescribed and purchased PPIs on the market is believed to interact with at least 194 drugs on the market today. Of these interactions, at least 16 are believed to be serious, 132 are thought to be moderate and 46 are minor.

Omeprazole (Prilosec) and Esomeprazole (Nexium) Interaction with Clopidogrel

Clopidogrel (brand names: Ceruvin, Clopilet, and Plavix) is an anti-clotting medication that is commonly prescribed for patients suffering from heart disease or who are at increased risk for heart attack and stroke.  

Clopidogrel’s effectiveness as an anti-clotting agent is frequently accompanied by one very common side effect: it causes significant disruption of the lining of the stomach and intestines. Sometimes this disruption can also increase the risk of gastrointestinal bleeding. Furthermore, doctors may also prescribe an aspirin regimen alongside clopidogrel, especially after placement of an arterial stent. Since clopidogrel and aspirin both have issues with excess stomach acid, physicians would commonly prescribe PPIs such as omeprazole and esomeprazole to patients to help ease this side effect.

Unfortunately, most PPIs, and in particular omeprazole and esomeprazole, stall the production of an enzyme known as “CYP2C19” that is critical to the body’s ability to metabolize clopidogrel. Consequently, the U.S. Food and Drug Administration (FDA) issued a warning in 2009 asking patients taking clopidogrel to avoid omeprazole and esomeprazole.

PPIs and Alcohol Consumption

Alcohol, in particular red wine and distilled spirits such as tequila, rum, and whiskey, are frequent culprits that trigger heartburn or other symptoms associated with GERD. The effect of alcohol on heartburn can be doubled or worse by combining alcohol with caffeine-boosted beverages.

People who suffer from heartburn or GERD frequently turn to OTC medications such as antacids, H2 blockers (Pepcid, Tagamet, Zantac, and Axid), and PPIs. Although there are no clear drug interactions between PPIs and alcohol use, it should be noted that the impact of PPIs can be lessened by excessive alcohol consumption. Furthermore, PPIs can mask other conditions such as gastric ulcers which can be exacerbated by excessive alcohol consumption.

Last Updated November 8, 2020

Onglyza is the brand name of the well-known anti-diabetic medication saxagliptin. Kombiglyze XR is the brand name of another anti-diabetic drug that combines saxagliptin and metformin HCL into one medication. Both drugs are prescribed to help sufferers of Type 2 Diabetes Mellitus (T2DM) better manage blood sugar levels. They are meant to be used in conjunction with diet, exercise, and other medications as part of a larger treatment strategy combating T2DM.

Although Onglyza and Kombiglyze present a novel treatment option that offers hope to a range of T2DM sufferers, they also carry with them a list of possible undesirable side effects that vary from less serious to potentially life-altering. According to the U.S. Food and Drug Administration (FDA) and the manufacturers of Onglyza and Kombiglyze, the following are some of the side effects noted during development and testing:

Risk of Heart Failure

In 2015, researchers and physicians collected information as part of a comprehensive effort to study any potential association between saxagliptin and increased risk for heart failure. The study, known as “Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus” (SAVOR), found that saxagliptin may increase the risk of hospitalization for heart failure by about 27%.

These results, in combination with other research findings, prompted the FDA to convene an advisory panel in April 2015 which concluded that saxagliptin may indeed increase the risk of heart failure in individuals taking the medication. On the heels of the advisory panel recommendations, the FDA issued a Drug Safety Communication in April 2016 warning of the increased risk. These warnings were also added to the drug labels for Onglyza and Kombiglyze.

To put the risk into perspective, the SAVOR trial examined patients taking saxagliptin for two years and noted the following:

• 3.5% of patients taking Onglyza were hospitalized for heart failure, compared to 2.8% for those who received a placebo. Put another way – if 1,000 people suffering from T2DM took Onglyza, 35 of them may theoretically be hospitalized for heart failure as opposed to 28 sufferers not taking the drug.
• Overall, those taking Onglyza had no increased risk of heart attack, stroke, or death from heart disease than those on placebo during the study.

People with preexisting heart disease history or kidney disease would have an increased risk of heart failure on Onglyza. The FDA recommends that prescribing physicians consider discontinuing the use of saxagliptin in patients who develop heart failure during treatment.

Pancreatitis and Pancreatic Cancer Risk

The British Medical Journal (BMJ) published an article in 2013 which shed light on growing safety concerns surrounding incretin mimetics. The article suggested that risks for developing pancreatitis and pancreatic cancer associated with these drugs were being downplayed. However, a follow-up investigation by the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDIK) suggested that there was likely no increased risk of either ailment associated with incretin mimetics.

The FDA has issued a public warning about pancreatitis and pancreatic cancer associations with incretin mimetics. Furthermore, the agency announced that it would investigate ongoing post-market reports concerning pancreatic ailments, including pancreatic duct metaplasia in patients.

Joint Pain

In August 2015, the FDA issued a warning statement that saxagliptin may cause severe and disabling joint pain in patients. The warning followed an analysis of reports within the FDA’s own Adverse Event Reporting System (FAERS) database which noted that patients started having symptoms from one day to years after starting to take saxagliptin. After the patients stopped taking saxagliptin, their symptoms were relieved and tended to restart if they went back on the medication.

The FDA warning noted that patients should not stop taking saxagliptin but should contact their physician right away if they experience severe and persistent joint pain. Furthermore, health care professionals should consider saxagliptin (and similar drugs) as a possible cause of joint pain and discontinue the drug if appropriate.

Last Updated November 15, 2020

Depending upon the nature of the metal-alloys present (and other factors), corrosion and leaching can develop into metallosis and more potentially painful joint symptoms as well as dermatologic conditions, depression, dementia, renal failure, cardiovascular issues, and pseudotumors.  

Metallosis has been found to occur as a side effect of hip joints composed of the metallic femoral stem and head combinations – also known as “metal-on-metal” (MoM). In years past, titanium and stainless steel were prevalent in many lines of implantable hip joints. However, in recent years cobalt-chromium combinations emerged as the most desirable for metal-on-metal (MoM) hip implants.

Metal-on-Metal Hip Implants

Beginning in the early 2000s, manufacturers like DePuy, Zimmer, Stryker, and Smith & Nephew all aggressively brought MoM hip joint lines to market through the U.S. Food and Drug Administration’s (FDA) abbreviated 510(k) clearance process. This “fast-track” review allowed manufacturers to bring new MoM hip joints to the market rapidly without having to engage in clinical trials or extensive testing.

MoM hip implants are characterized by a metallic ball and cup pairing which slide against each other when the joint functions (i.e. activities such as walking or running). When the two metal couplings rub each other, metal can begin to shed from the device causing particles to embed in surrounding tissue as well as metallic ions to enter the bloodstream and disperse throughout the body. These particles and ions can progress to metallosis.

As far back as the 1970s, surgeons have recognized the heightened association between MoM and metallosis. Dr. George McKee, a surgeon in the United Kingdom, first reported metallosis in patients who developed painful symptoms 3-4 years following hip replacement with a MoM joint. Dr. McKee’s patients reported progressive pain and instability and upon examination, showed soft tissue that appeared stained green with a grey paste accompanied by bone loss. Large amounts of joint fluid were also reported – either rust, green, cloudy yellow, or grey-colored in appearance.

In May 2016, the FDA shifted its approach to MoM hip joints, requiring all manufacturers to immediately cease and desist from marketing MoM devices until their safety and efficacy could be demonstrably proven with valid supporting scientific evidence. Since that time, no MOM hip replacement devices have been approved for the market in the United States.

Cobalt-Chromium Hip Implants

Cobalt chromium was first used for hip arthroplasty in 1938 by Dr. Marion Smith-Peterson. Dr. Smith-Peterson found that the cobalt-chromium alloy was preferable to others due to its relatively inert nature. As a general rule, any metal alloy implanted into the human body will undergo ionization and start the process of corrosion. However, cobalt-chromium showed itself to be more corrosion-resistant than others.

The same wear and tear associated with other MoM devices can also be a source of cobalt poisoning or acute cobalt toxicity. In addition to other symptoms associated with metallosis, cobalt toxicity can also cause patients to suffer from fevers, inflammation, low thyroid levels, loss of hearing and vision, organ damage, and even heart failure.