Artificial hips offer many patients the opportunity to live active and full lives, but sometimes they don’t always work as intended. Thankfully, these are relatively rare situations. Unfortunately, if it’s your artificial hip that fails, there’s not much comfort in knowing the artificial hips in most other patients work as designed. Because an artificial hip failure can be such a serious problem, the U.S. Food and Drug Administration (FDA) takes steps to ensure artificial hip medical devices receive adequate review and scrutiny before being approved for use in patients. One such step is to confirm that if a company modifies an already approved product, those changes also receive appropriate FDA approval and oversight. Apparently, Synovo Production, Inc. (Synovo) failed to obtain these necessary FDA approvals after making changes to one of Synovo’s hip replacement products. Let’s take a look at what products are affected and what action the FDA has taken.

Affected Medical Devices

Synovo makes the Total Hip System (also known as the Total Hip Replacement System and the Preserve and Endotec BP), which the FDA cleared for medical use. However, the FDA claims that Synovo has made significant modifications to the following three components of this system: Femoral Resurfacing Cup, Acetabular Fixation Cup and Acetabular Bearing. Some of these components are also stand-alone products.

Because the FDA has not reviewed these modifications to ensure they’re safe and effective, the FDA issued a Safety Communication urging health care providers to stop using any of the three non-cleared components of the Synovo Total Hip System.

Potential Problems with the Synovo Total Hip System

Despite the FDA issuing this Safety Communication, there might not be anything wrong with the Total Hip System. Is it possible that the changes might actually make the product better? Maybe, maybe not. That being said, what changes were made?

The FDA’s Safety Communication doesn’t go into detail about what modifications Synovo made, but references a Warning Letter from March 2023 that discusses, among other things, Synovo’s changes to the Femoral Resurfacing Cup component.

Specifically, the letter outlined how the FDA cleared the Femoral Resurfacing Cup for use with cement to help attach it to the bone. However, the FDA notes that Synovo made changes to the product so that it received a different coating that would allow it to be attached to the bone without cement.

Attaching a hip replacement part to bone without cement may have some advantages, although this is apparently up for debate. Assuming for a moment that Synovo’s change to a cement-less hip implant is an improvement, they’d still need the FDA to confirm this is the case. After all, one of the reasons the FDA was created was in response to companies selling food and medical products that, at best, did not meet the marketing claims and at worst, harmed the consumer.

This isn’t to say Synovo is marketing and selling an unsafe product, but until the FDA can review the modification to the Femoral Resurfacing Cup and clear it as safe and effective, consumers and health care providers need to take notice.

What Patients Need to Do

The FDA recommends that patients who received any of the affected devices after 2019 should contact their health care provider if they experience problems with their hip implant. This includes:

• New or worsening pain
• Loosening of the hip
• Grinding or other noises coming from the hip
• Inability to put weight on the hip with the implant
• Any weakness in the hip or knee on the same side of the implant

If patients have no problems with the affected devices, the FDA doesn’t recommend surgery to remove the device. In other words, the FDA is suggesting a wait-and-see approach. However, the FDA asks patients with issues with their implants to notify the FDA through its MedWatch Voluntary Reporting Program.

FDA Recommendations for Health Care Professionals

The FDA asks that health care providers do several things, but the most notable include not buying or implanting the affected devices. These health care providers should also remove any affected products from their inventory. Finally, health care professionals should closely monitor their patients who have received the Total Hip System or any individual component affected by the Safety Communication.

If you received Synovo’s Total Hip System or one of its components after 2019, there’s no need for alarm just yet unless you’re having problems with your hip. Based on the information so far, if Synovo did anything wrong, it was not getting the necessary approval from the FDA for the changes to the components. But in an abundance of caution, pay close attention to your hip and discuss any concerns you have with your health care provider. Most likely you’ll be fine, but in case you aren’t, you want to be prepared.

I’ve written extensively about problems with some Philips CPAP and BiPAP machines, including alleged injuries, affected machines, recalls, and potential litigation. That litigation is ramping up, but a new concern has arisen over the FDA’s inadequate and delayed recall process.

Specifically, governmental safeguards designed to protect the public from faulty or dangerous medical devices may not be working properly. Using the Philips recall situation as a prime example, let’s examine what going on with the U.S. Food and Drug Administration (FDA) and why there might be room for improvement in how it handles potentially dangerous medical devices.

The FDA’s Role in Keeping Consumers and Patients Safe

The primary mission of the FDA is to regulate a large class of medical and consumer goods and products. Most of these include:

• Food (the regulation of certain foods is handled by another federal agency, the U.S. Department of Agriculture)
• Drugs (prescription and over-the-counter)
• Biologics (medical products that are biological, such as vaccines, gene therapy, and tissue products)
• Medical devices
• Devices that emit radiation
• Cosmetics
• Veterinary products
• Tobacco

The FDA’s primary goal in regulating these products is to make sure they’re safe and/or provide adequate warnings to the general public about their risks. This is especially true with medical devices and pharmaceutical drugs, which usually go through an extensive approval process that occurs before a device or medication gets sold to the general public.

Unfortunately, this approval process isn’t perfect. After a product hits the market, unexpected problems can arise. To deal with this, the FDA orders and/or oversees product recalls. The Philips BiPAP and CPAP machine recall has shed some light on how this recall process might not work as well as it should.

How the FDA Recall Process Should Work

The FDA requires certain entities (like medical device makers) to report problems with their devices to the FDA. Healthcare professionals and patients may also submit reports.

These reports go to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The FDA is then supposed to review each report and take appropriate action. Given how there could be thousands of medical devices in use, as well as the fact that a report may not be 100% complete (or truthful), the FDA won’t necessarily take immediate action if there’s just one negative report about a certain device.

But the FDA is supposed to analyze the data over time to identify any trends or patterns with a particular device or group of devices. One bad report may not mean anything. But several dozen bad reports when only a few hundred devices are in active use could be a sign of a problem. The FDA can then decide to order a recall themselves or suggest to the manufacturer that it should initiate a voluntary recall.

Why the FDA Recall Process May Be Broken

According to an investigative report by ProPublica, there are several problems with MAUDE in the recall process. First, mandatory reporters (like medical device companies) should submit reports in a timely fashion. This generally means filing a report within 30 days of a patient’s death or a device malfunction. However, these reports often get filed late.

How late? Well, ProPublica’s report found that Philips (and its related subsidiaries) filed at least 60,000 reports late since 2010. Many of these reports were late by several years. Of these 60,000 reports, at least 3,700 reports involved Philips breathing machines and ventilators.

Second, medical device makers often need to provide follow-up information to the FDA. During this follow up process, the FDA requires the companies to change the dates of when the companies first learned of the problem. This new date is usually later, meaning the records in MAUDE appear to show that the device company learned of the problem later than they actually did.

In addition to the ProPublica report, there was a 2011 report from the U.S. Government Accountability Office (GAO) that looked into how the FDA conducts its recalls. It found multiple problems within the recall oversight process, such as:

• The FDA often took more than a year to complete a recall (the FDA had a goal of completing them in 90 days).
• The FDA did not analyze the recall data to find systemic problems in the medical devices, such as common causes for problems leading to the recalls.
• The FDA did not always follow its own recall procedures, such as inspecting the manufacturing facility of a medical device maker.
• The FDA had inconsistent procedures that led to inconsistencies in recall effectiveness.
• The FDA did not have specific parameters in place to determine whether a medical device company properly completed its recall.

What’s Being Done About This Problem?

As of December 13, 2023, Senators Richard Durbin and Richard Blumenthal have sent a letter to the GAO asking them to update the 2011 report by investigating the FDA’s oversight of medical device recalls and identify ways the process could be improved.

Senator Blumenthal has also sent an October 10, 2023 letter to the FDA and U.S. Department of Justice (DOJ) asking them to “take immediate action” against Philips relating to allegations that it knew its ventilators and breathing devices were dangerous due to complaints it received, but withheld this information from the FDA. We’ll now have to wait and see how the FDA, DOJ and GAO respond to these letters.

If you’re using a Philips breathing machine that’s subject to a recall, please talk to your healthcare provider about whether you should continue using it. If you think you’ve been harmed by your machine, you might have some legal options. To discuss what these are, you can call me at (919) 830-5602 or contact my office.

In Part 1 I discussed the concept of the Master Complaint in product liability multi-district litigation, and we also set the table with the plaintiffs and the many defendant-companies involved in the Zantac litigation. Now let’s keep grinding through the Zantac Master Complaint. The story of Zantac, the presence of the carcinogen NDMA, and the links to cancer can be found in the Factual Allegations, beginning on page 39 of the Master Complaint. (Note that I use the brand-name Zantac and its actual name ranitidine mostly interchangeably in this post.)

These are the key elements of the story:

Inventing and Selling Ranitidine

• Ranitidine is a medication relieves heartburn and acid indigestion.
• According to the Master Complaint, it was developed by GlaxoSmithKline (GSK) predecessors to compete with other “histamine H2-receptor antagonists” on the market, particularly Tagamet (cimetidine).
• A scientist working for a Glaxo subsidiary discovered ranitidine in 1976.
• In 1983, the FDA granted approval for Glaxo to sell Zantac.
• The prescription drug was a smash hit for Glaxo, the first drug to make $1 billion in sales.
• GSK turned Zantac into a blockbuster in part by driving sales. It added 800 salespersons to Zantac’s U.S. sales force.
• In 1993, GSK introduced an OTC version of Zantac, which it began selling a few years later.
• Over the next twenty-five years, other Defendants acquired the rights to sell OTC Zantac, including Pfizer, Boehringer Ingelheim, and Sanofi.
• GSK retained control of prescription Zantac in the U.S., which it sold until 2017.
• On October 18, 2019, Defendant Sanofi recalled all brand-name OTC Zantac in the U.S.
• In 1997, the original Zantac patent expired, allowing other companies to sell generic ranitidine products. Seventy-five companies eventually sold generic versions of ranitidine over the next two decades.
• The Brand-Name Manufacturer Defendants continued to sell prescription and OTC ranitidine.
• OTC Zantac antacid tablets had sales totaling $128.9 million in 2018.

Dangers of NDMA

• N-Nitrosodimethylamine (“NDMA”) is a toxic chemical and a danger to human health.
• NDMA is a carcinogen. As the Master Complaint puts it ominously, “its only use today is to cause cancer in laboratory animals.”
• Since 1980, companies have pulled all kinds of products from stores that were found to contain high levels of NDMA.
• In 2018, there have been recalls of several generic drugs to treat high blood pressure, including Valsartan and Losartan, (which I wrote about here).
• Scientists believe any amount of NDMA can increase risk for cancer or other health problems.
• In studies, laboratory animals taking NDMA orally developed liver, lung, bladder, kidney, pancreas, and stomach cancers.
• NDMA is a small particle, which means it can pass easily through the body, including into the brain and into placenta.
• But, studies also show that small amounts of NDMA can be fully metabolized in the liver, while larger amounts move throughout the body.
• In 1995, several studies showed an increased risk in cancer for humans after ingesting small amounts of NDMA.
• Studies in 1999, 2000, 2011, and 2014 reconfirmed the findings that NDMA can cause several cancers in humans.

NDMA Found in Ranitidine Products

• 

  In September 2019, an independent lab found significant levels of NDMA in ranitidine products. Four days later the FDA issued a warning that ranitidine (Zantac) may contain NDMA.
• In the next days and weeks, companies began voluntarily recalling their Zantac and generic-ranitidine products.
• On November 1, 2019, the FDA announced unacceptable levels of NDMA in ranitidine products based on recent testing, and requested that drug makers recall the medication.
• On December 4, 2019, the FDA issued a statement warning consumers who still take ranitidine to limit intake of nitrite-containing foods, like processed meats.
• The Complaint then throws a haymaker, noting that this was the same advice as the advice given by an Italian scientist . . . in 1981. Had GSK listened to the Italian scientists decades earlier, the Complaint argues, then millions of people may not have been exposed to dangerous levels of NDMA over thirty-eight years.
• In 2020 studies showed that ranitidine products can develop NDMA when exposed to temperature changes over time. The conclusion was that ranitidine is time and temperature sensitive, meaning the longer it sits or the more often it is exposed to temperature fluctuations, the more NDMA it is likely to develop.
• On April 1, 2020, the FDA recommended the removal of all ranitidine products.

In Part 3, we will look at the science behind the way ranitidine becomes NDMA.

Remember: These allegations come from the Master Complaint in the Zantac MDL and have not yet been proven in court.

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.

I take her case. I file a lawsuit in the new “multidistrict litigation” organized to handle the hundreds of cases involving injuries from this new medical device. I move the case along, handle the discovery and make sure my client’s case complies with all Case Management Orders from the MDL judge. Eventually we secure a good settlement for my client.

Later, at a press conference, a spokesperson for the corporation breezily refers to lawyers as ambulance chasers.

So after that narrative of events, I am the ambulance chaser?

As John McEnroe might scream, “you cannot be serious!”

I understand in this age of constant spin, the primary defense to a bad act is to attack. We see it in business; we see it in politics. We see it so often on social media it seems social media was invented for the purpose. And it is very frustrating. But that’s why it is vitally important not to let agents of spin control how you understand any subject. If a corporation can manipulate you into considering whether I am an “ambulance chaser,” it does not have to defend itself for introducing a harmful medical device into the marketplace, seriously hurting thousands of people.

Fighting spin is necessary to appreciate the excellent work so many plaintiffs’ lawyers are doing for injured people across the country.

There is no doubt there are unscrupulous lawyers out there. Some are opportunistic. A few lawyers wade into a new area of law simply because it appears profitable. Some lawyers produce ridiculous and creepy television commercials. A few may even hand out business cards at hospitals like Danny DeVito did in The Rainmaker. I understand that. And I don’t like it. It hurts all lawyers when a few lawyers do incompetent work or play fast and loose with ethics rules.

But the large majority of plaintiffs’ lawyers are doing good work for their clients. And in a world where the 510(k) fast-track approval pathway exists, it is critically important that good plaintiffs’ lawyers keep holding companies accountable for selling flawed, defective medical devices. In fact, it is one of the only defenses a patient has against unscrupulous device manufacturers.

So if an “ambulance chaser” is considered this way, then count me as a proud ambulance chaser. Because taken in this context, ambulance chasers are consumer protection heroes.

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.

FDA Pressures Medical Device Manufacturers to Utilize Newer Technologies

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.

We don’t want our FDA approval programs to be so burdensome as to stunt meaningful growth and advancement in medical technologies. However, we must have safe medical devices on the market that are based on more recent predicates in order to encourage the incorporation of modern safety features. Currently, the FDA is considering whether to make information about devices and manufacturers using predicates older than a decade available to the public. The idea behind these notifications would be to place pressure on medical device manufacturers to utilize newer predicate devices. As some industry critics have noted, in many cases new medical devices are approved under 510(k) based on older “predicate devices” that have proven to be problematic and may no longer even be manufactured and marketed.

Would Publicizing Information on Older Predicate Devices Protect Consumers?

I don’t know. I have never been comfortable with the ease with which medical devices reach the market through the 510(k) process. While I welcome the effort to reform 510(k), these latest changes are just a modest start. The motivation behind the FDA’s efforts to bring the 510(k) Program up to speed with modern developments is well-intentioned. Public disclosure of those utilizing old predicates in order to expedite the release of medical devices allows patients and their doctors relying on the medical devices to make informed decisions about what medical devises they wish to incorporate into a treatment plan. But, will publication of this information, alone, put enough pressure on the medical device market to modernize medical devices? I doubt it. More aggressive methods, such as completely disallowing product approval short-cuts for devices based on predicates older than a decade, should be considered. In fact, in the interest of consumer safety, this country needs a robust debate on whether the 510(k) process should be eliminated altogether.

Still, because it shines a light on the flawed 510(k) process, the new proposed measure by the FDA is a small step in the right direction.

So What is Valsartan?

Valsartan is a drug used to treat hypertension, high blood pressure, congestive heart failure, and other conditions. It also improves health outcomes in people who have suffered a heart attack. Valsartan is part of a group of drugs called angiotensin receptor blockers (ARBs). The drug works in part by relaxing blood vessels to permit easier blood flow, which leads to lower blood pressure. Lower blood pressure leads to fewer strokes, heart attacks, and kidney problems.

Valsartan was originally sold under the brand name Diovan. The patent expired in 2012, after which the drug could be sold as a generic medication.

In 2011, prior to the expiration of the patent, the Diovan family of drugs generated $5.7 billion in sales worldwide.

What is NDEA and NDMA?

The carcinogens identified in these drugs are NDEA and NDMA.

NDEA , which is the acronym for N-nitrosodiethylamine, is formed in the lab through a series of manufacturing steps and chemical reactions. The FDA reports that NDEA is “a known animal and suspected human carcinogen.” It has been detected in tobacco smoke, among other places.

NDMA is the acronym for N-nitrosodimethylamine, a chemical that has been used to make lubricants and softeners and even liquid rocket fuel. According to news reports, it can also be produced as an unintended byproduct in chemical reactions. Exposure to NDMA can cause several health problems, including tumors of the liver and kidneys, and certain other cancers.

These chemicals allegedly were added to certain valsartan medications through manufacturing processes in China.

Obviously, humans should avoid all exposure to NDEA and NDMA.

What Products Are Involved in the Valsartan Recall?

Several valsartan drugs have been recalled in 2018. With the latest recall Teva Pharmaceuticals has now recalled all their unexpired valsartan-containing products from the United States market. The FDA has announced that Teva is recalling “all lots of amlodipine and valsartan combination tablets and amlodipine, valsartan, and hydrochlorothiazide (HCTZ) combination tablets” because of the presence of NDEA. Further, in prior months Teva and other manufacturers have recalled other valsartan drugs because of the presence of NDMA.

The recall involves products from the following drug makers:

• Teva Pharmaceuticals (Major Pharmaceuticals)
• Prinston Pharmaceutical Inc. (Solco Healthcare LLC)
• Teva Pharmaceuticals USA (Actavis)
• AvKARE (Teva/Actavis)
• RemedyRepack Inc. (Prinston/Solco)
• A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco)
• Bryant Ranch Prepack Inc. (Teva/Actavis)
• H.J. Harkins Company Inc. d/b/a Pharma Pac (Prinston/Solco)
• Northwind Pharmaceuticals (Teva/Actavis)
• Hetero Labs, Inc. (Camber Pharmaceuticals, Inc.)
• NuCare Pharmaceuticals Inc. (Prinston/Solco)
• RemedyRepack, Inc. (Hetero/Camber)
• AvKARE (Hetero/Camber)
• Preferred Pharmaceuticals, Inc. (Hetero/Camber)
• Torrent Pharmaceuticals Limited
• RemedyRepack, Inc. (Torrent)

The FDA has provided a complete list of all recalled medications, which you can check out here. It’s important to realize that not all valsartan products contain the carcinogens NDEA or NDMA. You should not panic, but you should educate yourself on the medications you are taking. My suggestion would be, if you are taking any hypertension or blood pressure medication, check the label for active ingredients and contact your doctor about whether you should discontinue taking the drug, particularly if valsartan is listed as an ingredient.

Not surprisingly, lawsuits are being filed against the makers of valsartan drugs. Plaintiffs are suing based on their potential exposure to these carcinogens and allege fraud, breach of warranty, negligence, and other claims. These lawsuits will multiply, as thousands of people may have been exposed unwittingly to these carcinogens. In October Plaintiffs asked the Judicial Panel on Multidistrict Litigation (JPML) to consider formation of a multi-district litigation (MDL) court to handle valsartan-related lawsuits. If you have taken drugs containing valsartan and believe you may have been harmed by exposure to cancer-causing chemicals, give me a call ((919) 830-5602) to discuss your options.

As always, good luck.

Note: This post should not be considered medical or legal advice.

The Bleeding Edge

is a remarkable film investigating the public health crisis caused by our current medical device industry. It examines the two main causes permitting the manufacture and sale of defective medical devices: corporate greed and inadequate FDA oversight. It is a tragic story, particularly when the film takes a close look at many of the actual victims of these harmful medical devices. It’s one thing to hear that the Essure birth control device has injured thousands of women; it’s quite another when you see a woman on screen explain how she has given up on her hope to find love because she can no longer have intercourse due to permanent internal injuries. It is deeply sad to hear these stories. And it may have you writing your member of congress. Which you should.

I urge you to check out the film. Here are a few key takeaways:

Medical Device Regulation and the FDA

The 1976 Medical Device Amendments Act (“MDA”) was a positive step forward for regulating medical devices and for protecting human health. However, over the years certain loopholes in the MDA have allowed medical device companies to run amuck. The worst of these loopholes is the 510(k) process, which I have written about extensively on this site. Under 510(k), a medical device company may avoid clinical testing and the “Pre-Market Approval” process if the company can show that the new device is “substantially equivalent” to a similar device already approved and on the market. This may sound benign–after all the products are equivalent–but it has allowed many inadequately tested and dangerous devices to hit the market. One of the best examples of this 510(k) failure is the metal-on-metal (MoM) artificial hip. Because the MoM hip was “substantially equivalent” to previous artificial hip systems, the FDA permitted several device companies to manufacture and sell MoM artificial hips. Turns out, in many cases the MoM construction allowed metals to grind and be released into the blood and tissue of patients, causing all kinds of problems, from severe leg pain to neurological symptoms. Check out this site for many articles on the MoM artificial hip.

According to The Bleeding Edge, in some cases a new medical device is approved under 510(k) because of its substantial equivalence to an existing product that has been recalled because of health concerns. The FDA has explained that, under 510(k), it does not look at the safety of the underlying medical device; rather, it simply examines whether the new product is “substantially equivalent” to the predicate product. If this sounds loony, then you are paying attention. As a former FDA commissioner noted in the documentary, “we built a system that doesn’t work.”

Dr. Stephen Tower and Metal-on-Metal Artificial Hips

If you have had a metal-on-metal artificial hip implanted, you should know the name Stephen Tower. Dr. Tower is an orthopedic surgeon who figures prominently in The Bleeding Edge. And he deserves the screen time. I first wrote about Dr. Tower in 2017 after I discovered a lecture he had given on the potential for neurological problems associated with increased cobalt levels caused by metal-on-metal artificial hips. Dr. Tower is in a unique position as a hip surgeon but also as a victim of a MoM hip replacement, the DePuy ASR MoM hip. After his hip replacement surgery, he suffered memory loss, ringing in his ears, tremors, and mood swings. He even trashed a hotel room. Dr. Tower discovered that the metal levels in his blood were causing these neurological symptoms. After revision surgery, his metal levels dropped and his symptoms disappeared.

The documentary looks at several of these harmful medical devices, from artificial hips to hernia mesh to the Essure birth control device. More importantly, it takes a long look at several of the victims of these devices. The human suffering is intense and hard to watch, but it is vitally important to see it.

What Should You Do If Facing a Medical Device Implant Surgery?

At the end of the film the producers list a few smart moves you should make if your doctor has advised you to have a medical device implanted:

1. Do your research on the device. Distrust the “newest innovation.” As Dr. Tower said, innovation is not always a good thing.
2. Get a second opinion. Trust me, this is a good idea. And you may be surprised how different is the opinion of the surgeon a mile up the street from your treating surgeon.
3. Ask your surgeon how many times he or she had done the surgery. In some surgeries, like the Smith & Nephew hip resurfacing technique, the surgeon is expected to practice the procedure hundreds of times before he or she performs the surgery on patients. Often doctors begin these procedures after just a few practice sessions. Which is scary.
4. Take a friend or family member with you to the hospital. Have them pay attention and advocate for you.
5. Find out whether your doctor was ever paid directly by a medical device company at openpaymentdata.cms.gov.

Disclaimer (However Mild)

The Bleeding Edge presents the medical device industry in a sharply critical light. The documentary “takes a position,” and the position is that for-profit corporations who develop and manufacture medical devices often push these devices into the market without adequate testing and guided too often by a profit motive. I happen to agree with this position. However, it’s no surprise that medical device companies have been pushing back on the film’s allegations. Bayer, for example, maker of Essure, “fact checks” The Bleeding Edge on its website. I encourage you to check it out it if you would like to read the company’s response to the documentary.

If you want to discuss The Bleeding Edge, or if you have a medical device that has caused you problems, give me call: (919) 830-5602.

Most of you have heard reports about the devastating effects of opioids. Millions of people have become addicted, and many of those people have overdosed and died while taking the addictive pain medication. Even in cases when death does not occur, addiction has caused job losses, ravaged families, and cost billions of dollars in treatment for victims.

Up to this point, most of the recent litigation involving opioids has involved lawsuits against the makers of opioids on behalf of states and local governments. The essential complaint is this: [Blank] State has incurred millions of dollars in losses because citizens in the state became addicted to opioids and required government assistance in the form of hospitalization, treatment programs, unemployment, welfare, and other governmental expenditures.

But what about individuals? It is plain to see how a state or county can articulate damages from the direct and indirect costs of widespread opioid addiction, but individuals have been injured as well. In 2018, do these individuals have valid claims? Increasingly, it appears the answer is yes. And if so, this litigation will eventually be massive.

Let’s take a look.

Individual Claims for Injuries Caused by Opioids

So when the opioid litigation shifts from states and counties to individuals, what kinds of injuries could these injured plaintiffs base their claims for compensation?

1. Opioid Addiction. It starts here. This claim must be established through the medical records, but it should not be difficult to prove. Doctors (and families of the victim) know addiction when they see it. It is estimated that over 2 million people suffer from opioid addiction in the United States.
2. Opioid Overdose. Opioid overdose can permanently injure the victim and cause years of required health care.
3. Opioid Overdose Causing Death. This tragic result is the most obvious and most painful of the potential injuries caused by opioids. The wrongful death claim would be brought by estate for the deceased victim and the victim’s family.
4. Neonatal Abstinence Syndrome (NAS). This condition occurs when a baby is born addicted to opioids. The newborn becomes addicted when the pregnant mother abuses the medication while pregnant. Some symptoms a newborn may experience when suffering from NAS include diarrhea, fever, sleep problems, seizures, trembling, birth defects, and many others.
5. Lost earnings and other financial losses. For this claim, the plaintiff must show the financial losses were directly caused by the opioid addiction, leading to lost jobs, lost savings, etc.

But What About the Learned Intermediary Defense?

Make no mistake, the manufacturers of opioids will present every defense they can find. Check out my post on Opioid Drug Company Defenses.

One of the more insidious of these potential defenses is the learned intermediary doctrine. I’ve written about this defense often on this site, but it essentially goes like this: if the drug company crafts a drug label detailing the risks of taking a medication, the company may rely on the patient’s doctor–the learned intermediary–to explain to the patient the risks and benefits of taking the drug. In this scenario, the doctor is expected to know (often in granular detail) the contents of the warning label and be able to give precise medical advice on whether the patient should take the medication. It’s a lot to ask of a general practitioner or a surgeon, but the defense has been used often by drug companies to escape liability for harm caused by dangerous medications.

But here is the reason the learned intermediary doctrine may not be the get-out-jail-free-card for drug companies in the new emerging opioid litigation:

1. The FDA and the medical community have learned much more about the devastating effects of opioids in recent years. This means that the medical community simply was not sufficiently informed (“learned”) about the serious risks until very recently, and so could not have been expected to give precise and proper caution to a patient taking the drug;
2. The FDA has recently added new “black box warnings” on opioid labels. The warnings have gotten stronger and more comprehensive. This means that individuals who were harmed by opioids prior to the latest warnings may not have to contend with the learned intermediary defense;
3. State medical boards have issued new guidelines for doctors who may prescribe opioids;
4. Doctors and their patients may overcome the learned intermediary defense by arguing that the drug companies informed doctors for years that opioids were not addictive. We now know that opioids are highly addictive and can be destructive to a person’s health. The drug companies’ representations in the past may eliminate or severely weaken the learned intermediary defense.

All that said, I believe many new individual claims for injuries caused by opioids will emerge over the next few years. In fact, the litigation could become huge over the next decade. You can read more about opioid litigation on this site. And you can always call me to discuss your potential opioid case at any time (919.830.5602). Good luck.

Smith & Nephew Artificial Hip Replacement

By way of background, the hip is a ball-and-socket joint, moving not just forward and back (like a knee joint) but also sideways. In a total hip replacement, part of the upper thigh bone and the ball portion of the hip joint are replaced with metal components. Part of the replacement includes a liner between the ball and the socket that allows the hip to rotate freely. Some patients have hip resurfacing surgery instead, where only the interface between the hip joint’s ball and its socket is replaced with a new surface.

The plaintiff in this case, Walter Shuker, received a total hip replacement using Smith & Nephew’s R3 Acetabular System. Although Smith & Nephew holds itself out as a “world leader in joint replacement systems,” the R3 hip replacement that Shuker received didn’t use a typical plastic liner.

Instead, the liner in Shuker’s replaced hip was an R3 metal liner designed for use in Smith & Nephew’s Birmingham Hip Resurfacing System. The R3 metal liner was neither designed nor approved for total hip replacement. In fact, its label states that it “must be replaced with an R3 poly[ethylene] liner” if used in a total hip replacement. Despite that label, Smith & Nephew marketed the R3 metal liner as an “option for its R3 Acetabular System” in its promotional materials.

Less than two years after having his hip replaced, Shuker developed hip pain that was severe enough to limit his activities. When his surgeon investigated, he found “metallic debris” indicating that the metal-on-metal joint in his hip was wearing away and had to be replaced. Shuker ended up needing multiple revision surgeries to correct the defective replaced hip.

Walter Shuker’s Case Against Smith & Nephew

Shuker brought three types of state law claims against Smith & Nephew: for its failure to warn patients about the dangers of the R3 metal liner, he claimed negligence, strict liability, and breach of implied warranty. Based on Smith & Nephew’s off-label promotion of the R3 metal liner, Shuker also claimed negligence, while his wife claimed loss of consortium. Finally, Shuker argued that Smith & Nephew engaged in fraud.

The trial court dismissed Shuker’s claims, finding that they were preempted by federal law.

Shuker appealed to the Third Circuit Court of Appeals, which recently issued its opinion. The appeals court agreed that the failure to warn claims should be dismissed due to federal preemption. However, it allowed Shuker’s off-label promotion claims to proceed.

So what does federal preemption actually mean, and how did it apply here?

Federal Preemption and Medical Device Lawsuits

The U.S. Constitution declares federal law to be the “supreme law of the land.” Therefore, when a state law conflicts with a federal law, the federal law controls and the state law is essentially voided. This concept is called preemption. Preemption may be express—where a federal law specifically says that it controls and that state laws can’t interfere—or it may be implied.

Medical devices are regulated under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. That law expressly states that it preempts any state “safety or effectiveness” claims. Here, Shuker tried to claim that Smith & Nephew was negligent under state law even though it had passed the Food and Drug Administration’s safety regulations for medical devices. The Third Circuit held that Shuker’s state law negligence claim was preempted by federal law.

Why did Shuker attempt this argument? His lawyer argued that only the component that failed—the R3 metal liner—was regulated and governed by federal law. The system as a whole, the argument went, was not subject to the same strict federal regulation. It’s true that only the R3 metal liner was subject to a comprehensive testing and approval process. However, the appeals court held that a medical device is defined as any component within the device, not the entire system as a whole, preempting these claims.

Federal preemption is one of several powerful defenses available to negligent medical device manufacturers. Often people injured by the clear negligence of companies do not have a right to compensation because of the legal concept of preemption. (This is one reason it is critically important for federal agencies like the FDA to “get it right” when allowing products into the market.)

Fortunately for the Shukers, the appeals court also ruled that their off-label promotion claims—arguing that Smith & Nephew negligently marketed the R3 metal liner for an unsafe off-label use—were not expressly preempted by federal law. Those claims are still pending in the trial court.

What Does This Mean for Your Case?

As you’ve probably figured out, these cases can be complicated! Federal preemption often lurks to destroy what may seem to be a valid claim against a negligent manufacturer. If you’re having a problem with a medical device, you don’t have to try to fight the manufacturer alone. Give me a call today to discuss your specific injuries and your specific claims against the manufacturer (919.830.5602).

Invokana is a drug prescribed to treat people with Type 2 diabetes. The medication lowers blood sugar levels by preventing the kidneys from reabsorbing blood glucose. I’ve written often about Invokana and the studies that have identified problems with the drug, which you can read about here. I thought it may be useful to give you a history of key dates in the life-cycle of the drug, from its market release through the latest developments in the multidistrict litigation, where currently 1,000 lawsuits have been filed.

May 31, 2012. On this date Janssen Pharmaceuticals, a drug company owned by Johnson & Johnson, submitted an application to the FDA for approval of Invokana.

March 29, 2013. The FDA approves Invokana for sale. Janssen and J&J begin selling the drug.

May 15, 2015. The FDA issues its first warning about possible injury from taking Invokana. The FDA announces that the drug can cause ketoacidosis, which occurs when a person’s body produces high levels of acids called ketones. Ketoacidosis can cause extreme thirst, nausea, pain, weakness, and other conditions. It is considered a serious condition.

September 10, 2015. The FDA issues new warnings regarding Invokana. In this warning, the FDA states that decreased bone density and bone fractures have been reported by some patients taking the medication.

October 2015. The first lawsuit against Janssen and J&J is filed over injuries caused by taking Invokana. The plaintiff alleges that the drug caused her to develop ketoacidosis. The case is filed in California. Many lawsuits will follow.

December 14, 2015. Yet another safety communication is announced by the FDA. This time, the FDA warns about the public the potential for elevated blood acid levels and urinary tract infections in patients who take Invokana.

June 29, 2016. The FDA announces that patients taking Invokana have an increased risk of bone fractures, particularly with patients who use the medication for longer periods of time. Which is to say, the longer you take Invokana, the higher your the risk of bone fractures.

December 7, 2016. The JPML designates a multidistrict litigation (MDL) site for plaintiffs suing the makers of Invokana. The venue is the federal court in New Jersey, with Judge Brian Martinotti presiding. I have written quite a lot about MDLs on this site, but for now, just know that MDLs permit hundreds or thousands of plaintiffs to have their cases managed in one court through the initial stages of litigation. If a settlement is not reached, eventually each individual case is transferred to the district court in the state where it should have originally been filed. Please note: multidistrict litigation is not a class action lawsuit. Each MDL case is ultimately handled individually, on its own merits. The MDL is used simply to consolidate litigation work on discovery and certain key motions before the cases are returned to their home districts for trial.

January-December 2016. Janssen and J&J earn approximately one billion dollars on the sale of Invokana in 2016.

May 16, 2017. The FDA warns about a higher risk for leg and foot and toe amputations associated with the use of Invokana. The FDA orders that Invokana’s “boxed warning,” which is the highly visible warning on the label inside a black box or border, should include language about the increased risk for amputations.

August 31, 2017. On this date the FDA releases its latest assessment of injuries from patients taking Invokana. On its “FAERS” website, which stands for FDA Adverse Events Reporting System, the FDA notes that 14,072 “adverse events” have been reported since the drug was first sold in 2013. Of these, 1,988 were cases of diabetic ketoacidosis, 714 were incidents of urinary tract infections, 641 were kidney injuries, 594 were kidney failure, 58 were toe amputations, and 17 were leg amputations. There have been 169 reported deaths associated with taking Invokana. Keep in mind that the FAERS will not have every adverse event associated with any drug. Some injuries are not reported to the FDA. Still, this site gives you an overview of the kinds of injuries being reported in patients taking Invokana (or any other drug).

Let me say that I think the FDA “FAERS” website is very useful for consumers. If you have concerns about a certain drug, the FAERS site will provide a ton of collected information. I would educate yourself on the prescription drug you may be taking, and then ask your doctor about all the risks in taking the medication. You can access FAERS here.

November 7, 2017. In a Case Management Order in the Invokana MDL, it is reported that 943 cases have been filed through this date.

September 2018. The first Invokana bellwether trial is scheduled. I will keep you posted on on this bellwether case and in MDL 2750.

If you are currently taking Invokana, I would suggest you have a conversation with your doctor about the risks in taking the drug. And if you have been injured by the drug, perhaps in one of the ways discussed above, give me a call to discuss your legal options.

Diabetes is an awful disease. It is a chronic condition that affects the way the body metabolizes sugar. Diabetes is also a growing health problem in the United States, with over 29 million Americans currently suffering from the disease. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type 2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes.

Type 1 diabetes occurs when the human body doesn’t produce enough insulin, a hormone used to help the body absorb glucose. Type 2 diabetes occurs when the human body produces enough insulin, but cannot use insulin properly. Both types of diabetes result in high blood sugar levels which can cause long-term health problems.

What does all this mean? From the perspective of pharmaceutical companies, it means there is a huge market for Type 2 diabetes drugs.

Invokana: Diabetes Drug

Invokana is the trade name for the medication canagliflozin. Canagliflozin is a subtype 2 sodium-glucose transport inhibitor marketed by Janssen, a subsidiary of Johnson & Johnson. Invokana works to lower the body’s blood sugar levels by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

Problems and Side Effects of Invokana

All drugs have side effects and Invokana is no different. However, many patients who took Invokana suffered many side effects that they did not anticipate because Janssen allegedly did not warn users adequately of these side effects. Injuries claimed as a result of Invokana include:

• Diabetic ketoacidosis
• Renal failure and acute kidney injuries, even in those without a history of kidney problems
• Stroke
• Urinary tract infections, resulting in either blood or kidney infections
• Increased risk of leg and foot amputations

After its approval and release in the United States, drugs containing canagliflozin, including Invokana, were the subject of several safety announcements and warning label updates.

For example, in May 2015, the FDA issued a Drug Safety Communication telling the general public that there was a risk of diabetic ketoacidosis.

In September 2015, the FDA issued another Drug Safety Communication declaring increased safety warnings concerning the risk of bone fractures due to decreased bone density.

In December 2015, the FDA released yet another Drug Safety Communication requiring that drugs containing canagliflozin have warning labels that listed diabetic ketoacidosis and urinary tract infections.

And in May 2017 there was another Drug Safety Communication released by the FDA confirming an increased risk of leg and food amputations in those taking medications containing canagliflozin. The FDA also required medications containing canagliflozin to have updated warning labels to reflect this risk. The FDA’s decision was based on two clinical studies which found that individuals taking medications containing canagliflozin had twice the risk of having a foot or leg amputated.

With all these newly discovered problems with a popular medication, it’s no wonder there is currently a flurry of lawsuits pending in the courts.

People Injured by Invokana Filing Suit

As of April 27, 2017, there were 295 Invokana product liability lawsuits in federal court. By the time you read this, that number is very likely to be higher.

Because of the varied side effects and problems with taking Invokana, the lawsuits set forth a variety of physical injuries, including stroke, diabetic ketoacidosis, urinary tract infections, kidney failure and death.

The most significant legal argument of the plaintiffs is that Janssen did not adequately warn them or their doctors of these and other risks associated with taking Invokana. Had they been warned about these risks, they could have chosen an alternative method of treating their Type 2 diabetes.

Invokana Litigation Status

The Invokana federal lawsuits have been placed into a multi-district litigation, or MDL. The purpose of this consolidation is to allow for a more efficient pre-trial litigation process and facilitate a potential settlement.

The cases are currently in the discovery phase, which will take many months to complete. The Judge overseeing the Invokana MDL hopes to have three bellwether trial cases selected by January 2018, with the first bellwether trial beginning in September of 2018.

What Happens Next?

The pretrial activities, such as discovery, will need to run their course and that can take a while. The discovery process occurs when both sides share information that may be used at trial. In large cases involving corporate defendants, the discovery process can be the most time consuming and expensive part of the lawsuit.

The FDA currently recommends patients taking Invokana and other medications containing canagliflozin to contact their doctor immediately if they’re experiencing any problems with the medication. The FDA has also told patients not to stop taking Invokana until they speak with their doctor first.

When there are additional updates to the Invokana litigation, I will post them on this blog.

Osteoporosis is a disease where the human body’s bones become weaker. It is a common issue with women who have gone through menopause. The drug company Merck developed a drug called Fosamax (alendronate) hoping to prevent and treat osteoporosis in postmenopausal women.

As with all other drugs, Fosamax had side effects, one of which was actually increasing the risk of femoral (thigh) bone fractures. Thousands of users of Fosamax suffered this side effect and sued Merck.

Even though there were a lot of plaintiffs suing, many of their cases became consolidated into a multi-district litigation, or MDL, in New Jersey.

Initially, things didn’t go well for the injured plaintiffs, with Merck winning the first bellwether trial. Then things got worse for the plaintiffs when the trial court granted Merck’s motion for summary judgment to dismiss all the MDL lawsuits. However, this week plaintiffs won a big decision on appeal, restoring hundreds of cases.

But let’s back up.

The Fosamax Litigation

The crux of the plaintiffs’ argument against Merck was that under state law, Merck failed to issue revised drug warnings that would properly warn potential Fosamax users of the risk of femoral fractures. Merck’s primary defense was that the Food and Drug Administration (FDA) would not have approved the required revised warnings and therefore, Merck should not be liable for violating any state “failure-to-warn” laws.

Before we go any further, we’ll need to explain why the FDA would need to approve any revised drug warnings. It sounds odd, but drug companies are not allowed to add notice of possible problems with their drug unless the FDA approves the revised warnings.

There are two reasons for this. First, if a possible risk for using a drug is not supported by evidence, it may discourage the use of a useful drug. Second, by adding certain risks and side effects that are not supported by proper scientific evidence to a drug’s warning label, users of the drug may not recognize the more important and scientifically proven drug risk information. In other words, if there are too many meritless or marginal warnings for a particular drug, users of the drug will either ignore all the warnings or not properly consider the more serious ones.

What Happened at the Trial Court?

Before trial, Merck filed a motion for summary judgment. Merck’s primary argument was that plaintiffs’ lawsuits should be dismissed because their failure-to-warn claim was preempted by the FDA’s federal regulations. Preemption refers to the legal concept that where when a state law and federal law conflict, or where it’s impossible to comply with both laws, the federal law will apply and the state law will not.

The applicable FDA regulation had to do with approving a revised warning for Fosamax. Merck argued that it had discussed the risk of femoral fractures with the FDA and whether a revised warning was required. Merck claimed that the FDA told Merck during those discussions that a revised warning to reflect the risk of femoral fractures would not be approved.

Merck claimed that based on this discussion with the FDA, Merck believed that had they asked the FDA to approve a revised warning label warning users of the risk of femoral fractures, the FDA would never have approved it. Since FDA regulations overrode state laws thanks to preemption, and the FDA regulations would not have allowed a revised warning label about femoral fractures, Merck could not be in violation of state failure-to-warn laws.

Essentially, Merck’s position was: “We asked the FDA to let us revise the Fosamax warning label, but the FDA wouldn’t allow it. So we can’t be responsible.”

The trial court agreed with Merck and granted its motion for summary judgment, effectively dismissing every single Fosamax MDL lawsuit against Merck. Hundreds of people with severe femur fractures, many caused by low-stress activities like walking or getting into a car, were now, temporarily, dismissed from court.

What Happened on Appeal?

The appeals court acknowledged that the trial court was correct in that an FDA regulation could preempt a state law. However, in order for preemption to apply in this case, Merck had to prove it would be “highly probable” that the FDA would not have approved a change to Fosamax’s warnings.

According to the appeals court, Merck could not meet this high evidence standard and that such a decision was for a jury to decide, not a judge, who usually rules solely on issues of law, not fact. The appeals court concluded that plaintiffs had:

“…produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures…[this] is enough for Plaintiffs to defeat summary judgment and proceed to trial.”

Needless to say, this is a huge win for Fosamax plaintiffs. After years of delay, they may finally get their day before a jury.

What’s Next?

With Merck’s motion for summary judgment now dismissed, plaintiffs’ lawsuits can move forward to trial. There are also many other Fosamax lawsuits in New Jersey and California state courts. This federal appeals decision does not directly affect those state court cases, although it will surely influence the outcomes.

Note: Photos for illustration purposes only.

Let me state the obvious: companies sell you stuff with one purpose in mind, to make money. McDonald’s doesn’t sell you quarter pounders because the company believes what you need to live a better life is to eat more quarter pounders. The NRA doesn’t advocate gun ownership because it believes you need to own five Glock 9s (you don’t), but rather so the gun makers can sell more guns. Mercedes doesn’t make expensive cars because its board of directors hope to improve the world by selling you cars with heated leather seats. Every company sets out first to last to make money. And the more money the better.

So it goes with pharmaceutical companies. The general public may sleepwalk through the concept and lazily presume that the primary motivation for drug companies is to develop medications which cure diseases or which minimize the suffering from diseases. But in fact the motivation for pharmaceutical companies is to make money, and a lot of it. This is rather obvious and not a controversial point, and I’d like to believe that every “BigPharma” corporate board would agree with me. But it helps to keep this profit motive in mind when doing research on drugs you have been prescribed or which you are currently taking. And to be hyper-vigilant about assessing any new “wonder drugs” which hit the market.

“Off-Label” Drug Promotion

Recently, the pharmaceutical industry strenuously objected to new regulations implemented by the U.S. Food and Drug Administration (FDA) on off-label drug uses. Essentially, several advocacy groups supporting the pharmaceutical industry filed petitions opposing heightened restrictions on the marketing and sale of drugs for unapproved or “off-label” uses.

Let’s back up.

There are approved and unapproved uses for prescription drugs. For approved uses, the drug has been thoroughly tested and evaluated. The FDA has determined that the benefits and risks are acceptable and that this determination is backed by “strong scientific data.” Finally, for approved uses, the drugs have labels which set out clearly how to use the drug and for what specific purposes.

Then there are unapproved uses. Once the FDA approves any drug, your doctor is then allowed to prescribe the drug to treat another condition which is not listed as an approved use. Basically, once the FDA green-lights a drug, it relies on competent, unbiased physicians to make the best decisions for their patients in prescribing the drug, for whatever purpose.

Doctors may prescribe a drug for an unapproved use when the doctor believes the drug will help the patient in some way and there is no other drug available to help the patient. The FDA uses the example of a cancer drug approved for one type of cancer, but the oncologist prescribes it to treat a different form of cancer that does not have a similar medication available for treatment.

This sounds reasonably benign, even helpful, but drug companies can be aggressive in promoting off-label use. I have written about troubling off-label uses on this site. One off-label drug use nightmare occurred when doctors prescribed Risperdal for adolescent boys with certain behavior issues. Risperdal was originally approved solely to treat adult patients with schizophrenia. But Johnson & Johnson pressed for FDA permission to market the drug to treat other conditions, such as bipolar disorder and autism, and eventually to permit use in children. It was then expanded further to treat adults and children suffering from attention deficit disorder, anxiety and depression. As it turned out, Risperdal can promote the growth of female breast tissue (“gynecomastia”). Female breasts on adolescent boys is a terrible and traumatic disfigurement. And thousands of lawsuits have resulted from these injuries.

Thus, it is critically important that off-label drug use and off-label drug promotion are monitored carefully. You would think that the pharmaceutical industry would wholeheartedly agree, but . . .

BigPharma Objects to New FDA Off-Label Regulations

The FDA recently published its latest guidelines on regulating off-label drug use. The guidelines give the FDA new authority to police the selling of prescription drugs for unapproved uses. Specifically, the FDA focused on “intended use,” which is “the objective intent of the persons legally responsible for the labeling of drugs.” The goal is to make sure the companies promoting a drug are not pushing for it to be used in an unintended way. Intended use analysis is helpful to the FDA as it “helps the FDA gauge whether companies are intentionally marketing products for unapproved uses.” See FDA Website. The new rule was supposed to give more power to the FDA to hold manufacturers liable for promotion of off-label, unapproved uses of drugs.

The drug industry has objected, calling the new rule a “vague standard” with “no support in existing law.” At the end of the day, the drug companies simply do not want to be held liable for getting caught promoting drugs for off-label use. The industry’s position seems to be “get out of our way and let us make as much money as possible.”

They may get their wish. Recently, President Donald Trump has issued a “regulatory freeze” on all FDA rules and regulations. From what I’ve seen coming out of Washington lately, regulations on BigPharma are likely to get weakened, not strengthened, over the next four years. If you do not do your own research, you may be vulnerable to prescription drugs with unwelcome and harmful side effects.

What to Ask Your Doctor:

If your doctor prescribes a drug for an unapproved use, you should ask:

• What was the drug originally approved for?
• Why am I getting it for my condition?
• Are other drugs available that have been approved to treat my medical condition?
• Do studies support the use of this drug to treat my condition?
• Will this drug work better to treat my medical condition than using an approved treatment?
• What are the benefits and risks of treating my medical condition with this drug?

As always, be careful out there.

If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21^st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right?

21^st Century Cures Act: The Good

The 21^st Century Cures Act has the potential to save lives. For instance, it will provide funding for cancer research, fight painkiller drug abuse, advance Alzheimer’s research and improve mental health treatments.

Specifically, the new law provides $4.8 billion in funding for the National Institutes of Health, $1.6 billion for brain disease research and $1 billion in grants to help states tackle opioid abuse.

Another touted benefit of this new law are provisions requiring the Food and Drug Administration (FDA) to speed up the approval process for medical treatments so patients can get them sooner.

21^st Century Cures Act: The Bad

The biggest potential problem with the 21^st Century Cures Act is that new medical treatments might receive FDA approval on an expedited schedule. While this sounds great in theory, patients should be extremely wary because drugs and medical devices available for treatment may not have been thoroughly tested for safety and effectiveness. To explain why this may be the case, let’s give a brief background of the FDA and how clinical trials work.

The FDA and Clinical Trials

Before the FDA, companies could sell products with almost any claim they wanted, without having to prove their product actually worked or was safe. Today, one of the FDA’s jobs is to ensure that medical treatments work as claimed and do so in a safe manner. In order to do this, clinical trials are necessary.

Clinical trials usually exist in three phases, with the first phase involving a small number of test subjects to figure out dosing and make sure there aren’t any really bad side effects.

Phase two includes more test subjects and the medical treatment is actually tested to see if it works. Assuming it works with manageable complications, the clinical trial advances to phase three.

Phase three includes an even larger number of test subjects, usually numbering in the thousands. At this stage, the medical treatment is further tested to make sure it works, especially in comparison to similar treatments already available on the market. Most importantly, phase three trials look for complications and side effects.

Occasionally a fourth phase will be run to examine a medical treatment’s long-term effects and see if the medical treatment can be used in high-risk patients, such as children.

Phases two and three are the most important because they ensure the effectiveness and safety of a medical treatment. Because of their importance, special testing procedures must be followed for a multitude of reasons, including looking out for the placebo effect.

The placebo effect refers to the phenomenon where a patient will believe a treatment they are receiving is making them better, even though they are receiving no real treatment at all. An example of the placebo effect is when someone takes a sugar pill, but still believes the pill is doing more than just giving them a dose of sugar.

Monitoring the placebo effect is very important for determining if a medical treatment works or not. When using a placebo, researchers can make sure test subjects who feel better are feeling better because the treatment actually works, not because they think it works.

The 21^st Century Cures Act is designed to bypass some of these special testing procedures and clinical trial phases. The legislation directs the F.D.A. to consider the “least burdensome” means of demonstrating their safety. For example, under the new rules, clinical trials don’t have to have as many test subjects. Additionally, when determining if a medical treatment works or has any side effects, the FDA can rely on “real world evidence” instead of strictly controlled clinical test results. In some instances, this “real world evidence” will basically amount to patient testimonials. This is not the scientific process necessary to make sure medical treatments work and are safe.

What Does This All Mean?

To put things simply, it means medical treatments will become available more quickly, but without proper testing. Some might think speeding up the approval process is a good thing, since all those clinical trials and studies aren’t really necessary. You would be wrong.

Ever heard of Essure? It is a contraceptive device for women that is now known to have serious complications, such as severe pelvic pain, device disintegration and puncturing of Fallopian tubes. And it turns out that it was approved by the FDA using a special fast-track review process. You can look through my site to find many flawed medical devices that were approved pursuant to the fast-track 510(k) process.

Perhaps the benefits of getting medical treatments to market faster will outweigh the reduced testing and oversight by the FDA. I hope so. But additional injuries are very possible, so patients need to be extra cautious with these new lower testing standards.

Communications between pharmaceutical companies and medical device manufacturers and physicians are highly regulated by the federal Food and Drug Administration (FDA), but the agency, as much as it may want to be, does not have the final say in all regulation. These companies have First Amendment commercial free speech rights (though they’re not as broad as the free speech rights individuals have) and there’s a tension between what the FDA wants companies to say, what these companies want to say, and what the courts say the companies can say.

The agency in late August published a notice of public hearing and request for comments concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016 in Silver Spring, Maryland, and in case you want to present information you must register by October 19. You could also send in written comments by January 9.

more Off-Label Drug Use

These are very hot button topics. Manufacturers can’t market their products for purposes that are not approved by the FDA (such as if a drug is approved to treat lung cancer only it can’t be marketed to treat malaria), but once approved by the FDA a physician can prescribe it for off label uses. There have been court rulings stating manufacturers can talk truthfully about unapproved uses of their products to physicians. It’s a fine line, and it can easily be abused.

To be approved for a particular use a drug manufacturer must go through a long and expensive process to show the FDA the drug is safe and effective. The danger to patients is that if they take a drug for an unapproved use it may not be safe or effective. It may be a waste of money, it may harm them directly, or the time wasted taking this ineffective drug may allow the disease or condition to worsen, possibly making treatment more difficult or impossible.

On the flip side patients may be suffering from a disease or condition that may be very difficult to treat or is untreatable. A drug approved for one purpose may show promise in clinical trials to battle this hard-to-treat or impossible-to-treat disease. Instead of potentially waiting years for formal approval, these patients may be able to benefit in the present instead of waiting to use it in the future (if they live that long).

FDA Public Hearing

The FDA poses a number of questions on which it would like input from a number of interested parties including manufacturers, health care providers, patient advocates, payors, academics and public interest groups. The topics generally cover:

• How off-label communications impact public health,
• How changes in the health care system result in data on new uses of approved products,
• How to preserve incentives for manufacturers to seek approval for new uses,
• Standards for truthful and non-misleading information provided by manufacturers,
• What the FDA should consider when it monitors and enforces the law on off-label communications by manufacturers, and
• Changes FDA should consider to regulations covering manufacturers’ communications about their products.

Can Congress Help?

Add Congress to the mix. In May the House Committee on Energy and Commerce sent a letter to Health and Human Services Secretary Sylvia Burwell:

• Showing concern that FDA hadn’t clarified its position on permissible manufacturer communications about uses of drugs and devices beyond their approved labeling; and
• Voicing displeasure that HHS apparently was stopping the FDA from issuing guidance or new regulations after a number of court victories for companies and individuals prosecuted for off-label communications about drug and medical devices.

First Amendment commercial speech protections have been interpreted by the courts to allow manufacturers’ truthful and non-misleading speech concerning their products even if that speech includes uses of their products that have not been approved by the FDA. Companies and groups impacted by the issue have encouraged FDA to issue new guidance or change its regulations so its oversight and enforcement actions reflect these court decisions. This announcement and these public hearings are a possible step in that direction.

Boston Scientific is facing more than 36,000 product liability cases because of injuries the mesh has caused, including infections and erosion of surrounding tissue, according to the Minneapolis Star Tribune. Transvaginal slings are used as treatment for incontinence and surgical meshes are surgically implanted to strengthen tissue in women suffering from pelvic organ prolapse.

more New Warnings

The warnings include additional language to existing warnings concerning:

• “Erosion” and “ongoing pain” as possible side effects, and
• The company’s meshes and slings should be considered permanent implants because taking them out can be complicated or impossible but the new warnings also state treatment for erosion caused by the mesh may require at least an attempt at surgical removal of the device.

The company announced the warnings in June as part of “urgent” advisory letters sent in May to physicians worldwide. Those letters were followed by announcements from European regulators that publicized warning label changes. The changed warnings apply to:

• Five brands of transvaginal slings (Advantage, Lynx, Obtryx, Obtryx II and Solyx), and
• Three types of mesh (Uphold LITE, Pinnacle LITE, and Upsylon Y).

Boston Scientific states the changes to the warning label are a result of a review of data by company officials and Australian medical device regulators.

The patients harmed by Boston Scientific’s products make a number of legal claims including that its transvaginal mesh’s design and manufacturing are flawed, that it failed to warn of known dangers in the past, and that the company breached warranties and violated consumer protection laws.

Securities filings by Boston Scientific state it has settled about 11,000 of these cases without admitting liability or wrongdoing. One source estimates there are about 100,000 lawsuits by those harmed by vaginal mesh and more than 135,000 worldwide.

Counterfeit Raw Material

In addition to all the issues that arise when transvaginal mesh is manufactured to Boston Scientific’s specifications, the company may have used the wrong raw material in making some of its products, adding yet another complication for patients. The federal Food and Drug Administration (FDA) issued its own warning to physicians in April that it was investigating allegations Boston Scientific used counterfeit raw material for its transvaginal mesh, according to the Boston Globe.

FDA stated the company will conduct new tests on the safety and effectiveness of the product and the agency will review the results. Boston Scientific has denied that has used “‘counterfeit’ or ‘adulterated’ materials” in its medical devices.

The Takeaway

Warnings are a step in the right direction so patients can have a better idea as to the risks involved with TVM, but if the products are used anyway warnings won’t prevent harm to patients. Eliminating all risk of injury will occur only when transvaginal mesh is no longer used. That will only happen if:

• Manufacturers decide to step selling it,
• Doctors decide to stop implanting it,
• Patients refuse to use it, or
• The FDA decides to ban it.

Until then patients will continue to be injured by transvaginal mesh and lawsuits against manufacturers such as Boston Scientific will continue to be filed. These lawsuits not only compensate plaintiffs for the injuries they’ve suffered but they also increase the cost of doing business as usual for companies like Boston Scientific. They may eventually decide profits from selling transvaginal mesh aren’t worth the costs and stop selling these products.

In every lawsuit the court issues key rulings which will impact the outcome of the case. By “court” I mean the presiding judge. Some court decisions end the lawsuit (e.g., a judge granting a defendant’s summary judgment motion). Some decisions kick a leg of the stool out from under one party (granting a motion to exclude one side’s key expert witness). As I have written about in this blog, a judge has great power and influence over every court case. One decision has the power to make or break the lawsuit.

Recently, in the Cook IVC filter multidistrict litigation, a federal judge has refused to bar discovery involving an allegation that Cook failed to report to the FDA bad results with the Cook IVC filters.

What Is Discovery?

After a lawsuit is filed, the defendants have the chance to “answer” the complaint (“yes, we admit that happened” or “no, we deny the truth of that statement”). After these “pleadings” are filed, the parties engage in formal discovery. In civil litigation, discovery is the exchange of documents and information between the parties. It is required by the Rules of Civil Procedure. It goes like this: one side will write out questions (Interrogatories) or requests for documents (Requests for Production of Documents). Unless there is a compelling reason to withhold the information, the other side must then prepare written answers and make all requested documents available to the requesting party. From there, the parties can build their cases for trial.

more Cook Medical’s Request for Protective Order

In the Cook IVC filter litigation, the plaintiffs requested discovery relating to the information Cook Medical delivered to the Food and Drug Administration about the outcomes of patients implanted with the Cook IVC filters. The plaintiffs’ group believes that Cook underreported IVC filter device problems to the FDA, and now plaintiffs want all information surrounding what Cook did or did not report to the FDA.

In response, Cook Medical filed a motion for “protective order.” This was a motion to bar discovery of the reports Cook made to the FDA. The argument did not appear strong, but Cook essentially said that it did not have any duty to produce this information to the plaintiffs based on a few recent court decisions.

Magistrate Judge Tim Baker disagreed. He ruled that this information requested by plaintiffs is potentially relevant to the claims in the case and that Cook has an obligation under the Rules of Civil Procedure to produce this information. Judge Baker denied Cook’s motion for protective order. In a few weeks, Cook will have to produce this FDA reporting information to the team of lawyers representing the plaintiffs in the MDL.

Why Is This Discovery Decision Important?

The court’s decision is important because it allows the plaintiffs to “discover” information Cook sent to the FDA. If the Cook reports to the FDA turn out to be false, or misleading, or incomplete, it could support plaintiffs claim that Cook misrepresented the risks of the device and that Cook failed to warn adequately of the risks involved in the use of the medical device.

Perhaps more importantly, if it turns out that Cook underreported problems with the Cook IVC filter, the defense of the learned intermediary doctrine could be stripped from the case. I have written about the learned intermediary doctrine in this blog, but essentially it goes like this: a medical device manufacturer cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (such as the implanting surgeon), who then must communicate with the patient about the benefits and risks of using the medical device. The manufacturer basically tells the court: we notified the doctor and the patient about the risks involved, so it’s the doctor’s responsibility to explain those risks to the patient. But if the manufacturer underreported problems to the FDA, the learned intermediary doctrine becomes meaningless. How can a physician give an accurate picture of the risks involved to a patient if Cook Medical is underreporting the risks to the FDA and the medical community?

Cook Medical received approval from the FDA to market the Cook IVC filters under Section 510(k) of the Medical Device Amendment, which I wrote about here. The 510(k) process has allowed many flawed medical devices to hit the market without adequate testing.

If you had a Cook IVC filter implanted and now have medical or health problems, give me a call to discuss further: (919) 830-5602.