The makers of Roundup just lost another big case, this time involving a couple who used the weedkiller and were later diagnosed with non-Hodgkin lymphoma. This month, a jury in California awarded Alva and Alberta Pilliod more than two billion dollars. The jury found that Monsanto and Bayer acted negligently and failed to warn the plaintiffs of the dangers of using Roundup. The key active ingredient in Roundup, glyphosate, has been shown in studies to increase the risk of developing non-Hodgkin lymphoma (NHL). The jury then awarded Mr. Pilliod $18 million in “compensatory damages,” which is a money award for actual injuries suffered. The jury awarded Ms. Pilliod $37 million in compensatory damages, for a total of $55 million in compensatory damages. Finally, the jury awarded the Pilliods $1 billion each in punitive damages. The final jury award was $2,055,000,000. A truly astonishing number, and a major rebuke to the makers of Roundup.

The Pilliods testified that they used Roundup on their property for more than thirty years, from 1975 and 2011. They were diagnosed with NHL in 2011 and 2015.

Punitive damages play an important role in consumer protection. Punitives are awarded by a jury to punish or deter a bad-acting company, and similarly situated companies, from engaging in similarly awful conduct. Punitive damages are not common, and are usually awarded when a jury decides that the defendants had prior knowledge of a serious issue or problem and ignored this knowledge to the serious injury or detriment of other people.

Three years ago I wrote this column: My Challenge to Medical Device and Drug Companies: Put Me Out of Business! The point was straightforward: if companies would do the right thing, and properly test their medical devices, and carefully monitor the drugs they sell, and try to help patients instead of merely chasing profits, then I will stop being a product liability lawyer. Well, turns out my line of work may be safe for a long time. This week several executives from Insys Therapeutics were found guilty of racketeering. The jury found that these executives conspired to push sales of a deadly fentanyl drug, by increasing dosages and prescriptions. These guys are going to jail. And they should. The story that emerged from the two-month trial was hideous, and it proves yet again that without careful oversight companies will often harm public health in their pursuit of massive profits.

Before I bullet point some of the evidence developed at trial, start with this: the Centers for Disease Control estimates that well over 200,000 people have died from prescription opioids since 1996. Sit with that for a moment. More than 200,000 people have died from opioid overdoses. It is heart-wrenching. Now, add to this tragic statistic the narrative that several opioid companies, and not just Insys Therapeutics, pushed for more prescriptions and higher doses for decades, solely to increase sales and profits and employee bonuses.

Hearing loss is awful no matter how it happens. I’m sure it has been stellar to play guitar for The Who, as Pete Townshend has done for decades. Sadly though he now suffers from serious hearing loss and tinnitus. Townshend contracted noise-induced hearing loss (NIHL) after years standing too close to powerful amplifiers projecting extremely loud rock music. Eric Clapton has also suffered hearing loss because of his work as a blues guitarist and rock musician. Townshend and Clapton have had legendary careers, but their suffering today from hearing loss is very real and awful.

The reality is, anyone who works in loud environments can suffer NIHL. Musicians, engine mechanics, construction workers, miners, and farmers are all susceptible to hearing loss from the work they do in loud environments and with loud equipment. (I’ve even read that the squeal of a pig can reach decibels of 115, louder than a power tool!)

Perhaps the worst cruelty occurs when members of our armed services suffer hearing loss. These are people who volunteer to keep us safe. These are people who choose a career which may call for them to go to war and fight and possibly die to protect the rest of us. Of course you would expect that the least we would do as a nation is to send these men and women out to train and serve with the safest possible equipment. Sadly, though, news reports are emerging that military service members were issued defective earplugs that may have caused permanent hearing damage to hundreds of thousands of soldiers. These earplugs were developed by the Aearo family of companies, which was then bought out by 3M Company. The earplugs were called Dual-Ended Combat Arms Earplugs (CAEv2). And between 2003-2015, Aearo and 3M sold millions of pairs of these earplugs to the branches of the armed forces. If you served in the military during this period and were issued dual-sided earplugs (with a distinctive olive and yellow color), you got the Combat Arms Earplugs.

In my last post I introduced the 3M Earplugs and the (alleged) defects that caused hearing loss in thousands of military service personnel. I thought it would be helpful to bullet point some of the key allegations made by injured soldiers in lawsuits filed against 3M related to these earplugs.

First, I refer to this product simply as the 3M Earplugs. However, the product’s official name is the Dual-Ended Combat Arms Earplugs (CAEv2). So if in your reading you see 3M Earplugs or Combat Arms Earplugs, it is most likely the same product.

Second, I need to provide some clarification on the defendants involved in this expanding litigation. The 3M Earplugs were originally developed and manufactured by Aearo Holding Corporation (which became Aearo Holding LLC) along with the involvement of Aearo Technologies LLC, Aearo Intermediate LLC, and Aearo LLC. It may be a bit confusing, but it’s not uncommon for a company to have subsidiary companies handling research, or development, or the manufacture of a product. In any case, 3M Company bought Aearo Holding LLC in 2008 and with the purchase acquired the Combat Arms Earplugs. The Earplugs were thus placed under the 3M brand, and 3M became entitled to the profits flowing from the earplugs but also became responsible for the liabilities of the product. Thus, 3M Company is the primary defendant in this litigation.

We rely on safety equipment to do what it was meant to do: protect us. But this is precisely what 3M earplugs have failed to do for our troops. The specific product at issue? 3M’s now discontinued Combat Arms earplugs issued to U.S. military servicemen and women from 2002 until 2013. The fundamental flaw with the earplugs? They were too short and therefore could not adequately provide hearing protection to our troops while they were in combat situations or were involved in training activities. The result? Many members of our military now have to deal with irreparable, but completely avoidable, hearing damage from a defective product. Combat situations are dangerous enough as it is. Service members should have the peace of mind that basic safety equipment will be free of fundamental defects and will function properly.

These Combat Arms earplugs got the attention of the United States government. In 2016 the Justice Department accused 3M of knowingly providing defective earplugs after the government learned of 3M’s activities thanks to whistle-blower activities by another earplug maker, Moldex-Metric, Inc. In the summer of 2018, 3M paid approximately $9.1 million to settle the claims made by the government. Justice, however, is far from complete. There are countless veterans and current active duty military now dealing with the hearing damage from relying on these faulty products for hearing protection. These individuals, however, are not seeing a penny from the 2018 settlement. Individual lawsuits against 3M are therefore necessary for those damaged to obtain compensation for the preventable damage done to their bodies.

The Combat Arms earplugs at issue were originally developed by Aearo Technologies; 3M later acquired the company and its products. These earplugs had a two-sided design that was supposed to provide ear protection no matter which side was inserted into the ear. The yellow side was supposed to provide protection against high-level impulsive noise while still allowing the wearer to hear talking, commands and other lower level noises. The other side, the green side, was intended to block out all sounds. According to several lawsuits brought by injured service members, the earplugs did not work as designed, largely because they did not stay in place properly due to their length. Internal documents linked to 3M allegedly suggest that 3M was on notice of the defect and failed to take action. Now, our veterans are paying the price.

It’s a great question. And I’m glad I asked it for you. Now let me answer it. There are several ways to identify the specific medical device implanted in your body. (A medical device is any manufactured device–like an artificial hip–implanted in the body for the purpose of resolving an injury, curing disease, or improving a person’s health. Medical devices can be artificial joints like hips and knees and shoulders, heart stents and pacemakers, IVC filters, hernia mesh, and hundreds of other examples.) Some ways of identifying exact product components are better than others. Identifying the medical device several different ways is the best of all.

Product Stickers: The Gold Standard

It all sort of starts with “product stickers.” These are the identifying stickers that are attached to the box containing the medical device, and they can be peeled off and affixed to a nurse’s hospital note or to another page in the hospital or surgeon’s record for the implant surgery. It goes something like this: the representative for the device maker shows up with the artificial hip components (or other medical device). The surgical nurse or the surgeon will double check that the components are the precise ones needed for the surgery, scan them into the system and note them in the record. The nurse will then peel off the product stickers and attach them to the hospital record and include them with all the other pages of documents explaining details of the surgery. The image at right is an approximation of what the stickers will look like: a bar code, the name of the manufacturer, the specific product name, the Lot and Reference numbers, and other identifying information.

I have written about artificial hip litigation on this site more than any other area of product liability law, and for a very good reason: there is a lot to write about. Metal-on-metal hips have gravely injured tens of thousands of people, and new victims are undergoing revision surgeries each week to remove defective hips. One current active litigation involves Smith & Nephew “Birmingham” artificial hips. MDL 2775 is the multidistrict litigation court handling hundreds of lawsuits filed against medical device maker Smith & Nephew for these (allegedly) defective artificial hips. There are several artificial hip products involved in MDL 2775:

Birmingham Hip Resurfacing System (BHR). The multidistrict litigation court was first organized to handle these BHR lawsuits. The BHR system is a type of metal-on-metal artificial hip, but in resurfacing procedures the hip “ball” bone is shaped and resurfaced with a smooth metal covering and a metal shell is implanted into the hip socket, thus creating a metal-on-metal connection or “articulation.” As with most metal-on-metal artificial hips, Smith & Nephew uses cobalt and chromium to construct both of these resurfacing components. These metals have been shown to wear away and leach into the blood and tissue of the patient, causing all kinds of symptoms and problems, including metallosis.

BHR Hip Components Used in Total Hip Arthroplasty (THA). These hip implants are constructed with Smith & Nephew BHR components and non-BHR components, but instead of resurfacing the “ball-bone” with a metal covering the bone is removed and a metal ball component is implanted. MDL 2775 added these Total Hip Arthroplasty (THA) cases to the litigation shortly after the MDL launched.

Herbicides have become a way of life. For some, like farmers and ground maintenance men, herbicide application is part of making a living. For homeowners, herbicides are used to grow the perfect weed-free lawn. For all of us, herbicide usage is closely linked to the production of our food. The most common herbicide? Glyphosate-based herbicides. The most well-known brand? Roundup. The alarming part? Glyphosate exposure has been alleged to increase the risk of cancer. More particularly, glyphosate is allegedly related to the increased risk for non-Hodgkin’s lymphoma and other blood cancers. Glyphosate-based herbicides are still widely used in our country.

Glyphosate discovered in the 1970s

In 1970, a chemist working at Monsanto within the herbicide screening program named John Franz discovered glyphosate, an organophosphate compound which would become the active ingredient in Monsanto’s Roundup herbicide. By 1972, Roundup was marketed to the public as an environmentally friendly herbicide that is safe for both human and wildlife alike. Roundup was produced commercially starting in 1974. It would quickly become one of the most popular herbicides of all time.

Let me see if I have this straight: There is a huge medical device manufacturer that earns over $75 billion dollars each year. This corporation decides to market and sell a new medical device. The corporation refuses to do extensive testing on the device because that would take too long and cost too much money. In fact, preliminary studies showed problems with the device, and the company believes extensive clinical testing may reveal more problems, further slowing its path to the market (and to big profits). Instead, the company seeks fast-track approval of the device. The company argues that because the device looks similar to a device already on the market, it should be allowed to sell the new device without extensive testing. This process is known as the 510(k) pathway, and I’ve written about it a ton on this site, including last week. In the application the company reassures the FDA: “and don’t worry, we will keep an eye on the device and the patients who receive the device and if problems arise down the road we will let you know.”

So the FDA gives the multi-billion dollar corporation 510(k) approval to sell the device. In the first year the company sells one billion dollars’ worth of the device. In the second year it sells $1.5 billion in new devices, but it also begins to receive an alarming number of “adverse event” reports. This means patients are reporting problems and injuries after receiving the device. The company undertakes an internal study but does not report its findings to the FDA. In the third year it sells even more devices, but by now hundreds of adverse reports are rolling in. The injuries finally get the attention of the FDA, and the company reluctantly hands over its data on the many serious injuries caused by the new device.

In the fourth year a woman with the implanted device is forced to undergo “revision surgery” to remove the device, and her recovery is lengthy and painful. She calls me and tells me her story. It is awful. She was once a competitive tennis player, but now she walks with a cane. She hasn’t played tennis in two years. She had to take time away from her job. Even with decent health insurance she has thousands of dollars in out-of-pocket medical bills related to the failure of the device.

At some point in your life, a medical device will likely become a necessary part of your medical care. You may need external items such as hearing aids, blood glucose meters, insulin pumps, or feeding tubes. You may also need the help of surgically implanted medical devices like artificial hips, heart pacemakers, breast implants, spine screws, rods, artificial discs, intrauterine devices, metal screws, pins, plates and rods, artificial knees, or coronary stents. No matter what type of medical device you need, you deserve safe devices of only the best quality that are responsive to technological updates. As a patient, you should have the right to make a fully informed decision about whether you want to use a newer or older version of a particular medical device. The FDA is now considering making changes to its (infamous) 510(k) medical device approval process.

You only have to look at the evolution of cell phone technology to appreciate the abundance of technological changes that have occurred over the past decade. So, why should you be provided with the medical device equivalents of flip phones? That’s one of the key focuses of the proposed new changes to the 510(k) Approval Program the U.S. Food and Drug Administration (FDA) which would be incorporated in 2019. The 510(k) Approval Program, put in place originally in 1976, has provided an approval “short-cut” for medical devices which are based on medical devices currently on the market. I have written about the 510(k) process often on this site. The medical device currently on the market, upon which the new product is based, is known as a “predicate device.” Historically, there have been no restrictions concerning the age of the predicate device. This is about to change.