Artificial hips offer a new lease on life to many thousands of people each year. They provide recipients the opportunity for independent living and mobility they might not otherwise have. Unfortunately, they also come with risks, one of the most prominent being metallosis. But there’s also another potential risk where the femur (thigh bone) could break.

The femur is the largest and strongest bone in the body. Yet the process of implanting an artificial hip, along with the older age of most patients who receive artificial hips, means there’s a greater risk of a thigh bone fracture. If this happens, artificial hip revision surgery may be needed.

The U.S. Food and Drug Administration (FDA) recently issued a safety communication alerting patients with the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper of an increased risk of thigh bone fracture. Let’s take a look at this safety communication and what you should do if you received this implant.

Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper Fracture Risks

Just to make things clear, practically all medical treatments come with some risks. So the question isn’t about whether there’s a risk, but the level of risk and whether a patient is properly told those risks so they can make an informed decision.

That being said, the primary issue here isn’t that there’s a bone fracture risk if you receive the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (Zimmer CPT Hip System). This is because most artificial hips have some risk of the thigh bone breaking after the surgery. The primary issue is instead whether you’re properly told about the risk of fracturing your femur should you receive this particular artificial hip, and whether this particular artificial hip carries a heightened risk of bone fracture.

The FDA cites a UK study that found that the Zimmer CPT Hip System had a risk of thigh bone fracture that was roughly 1.4%. This doesn’t sound like much, but it’s almost double the fracture rates of comparable artificial hip products. These other artificial hips had a fracture risk that ranged between 0.6% and 1.0%.

Based on this information, Zimmer Biomet initiated a voluntary recall of the Zimmer CPT Hip System to provide updated instructions that would include the risk of femur fracture. Zimmer Biomet also explained that they would stop selling this particular artificial hip by December 2024.

How Do I Know if I Received an Affected Artificial Hip from Zimmer Biomet?

The best way is to ask your doctor or other health care professional. If you’re curious about the specific models, you can find an affected product list in the FDA’s safety communication or on Zimmer Biomet’s website (it’ll be on Attachment 2).

What Should I Do If I Received an Affected Artificial Hip?

If you don’t have any unexpected problems walking, or pain around your hip, then you’re probably fine as long as you maintain the follow-up schedule with your doctor. The FDA doesn’t recommend surgery to remove the artificial hip if you aren’t experiencing any problems with it. However, it’s still a good idea to talk to your doctor to know if you have an affected device and confirm that there’s nothing additional you need to do or avoid doing.

If you’re having problems with your Zimmer CPT Hip System, then you should contact your doctor as soon as you can. They can review your situation and recommend your next course of action. You may also want to report your issue to MedWatch, which is administered by the FDA.

If you received a hip replacement surgery that used the Zimmer CPT Hip System and aren’t having any issues with it, that’s good news. But if you’re in pain, have trouble walking, or suffered a broken femur where the artificial hip was installed, legal action might be a possibility. If you want to learn more, call me at (919) 830-5602 or contact me online. In the meantime, you can talk to your doctor if you have any questions or concerns. Good luck.

Kratom (mitragyna speciosa) is a tropical leaf native to Southeast Asia. While the plant is indigenous to Asia, the use, and abuse, of the plant has become much more common in the United States over the last decade. Today, you can easily purchase products made from kratom leaf online as well as in brick-and-mortar stores. The substance is manufactured into various vehicles of consumption including concentrated powder capsules, chewable tablets and gummies, and liquids. The leaves can also be crushed and smoked, and also brewed into herbal tea. Common Uses of Kratom In low doses, the leaf has been known to produce a stimulant effect, with users reporting increased physical energy and alertness. When taken in higher doses, the opposite occurs: the substance produces sedative effects. Kratom is used to self-treat physical pain, coughing, and diarrhea. It is commonly used to aid in treating psychological disorders such as anxiety and depression. The substance is also used to aid individuals with opioid withdrawal, and opioid use disorder. Adverse Effects of Kratom Use The FDA has warned consumers of a myriad of physical and psychological side effects of using Kratom. The substance has a range of negative effects on the body, ranging from relatively mundane to extremely severe. Kratom has been reported to cause dry mouth, itching, and sweating. It also increases the likelihood of gastrointestinal problems including nausea and vomiting, constipation, increased urination, lack of appetite and extreme weight loss. It can additionally cause hepatotoxicity (chemical-induced liver damage), and can lead to liver toxicity. Use of the substance can cause serious cardiovascular problems, including tachycardia (irregular heartbeat). Usage has been known to provoke seizures, and in extreme cases, the substance use has been connected to death. Kratom, while marketed to aid users dealing with opioid withdrawal, can lead to addiction itself. There is a risk of substance abuse disorder (SUD) associated with Kratom usage. Users with SUD experienced cravings for the substance, increased tolerance, used the product for longer than intended, and experienced withdrawal symptoms after stopping usage. The substance can also cause psychotic symptoms including hallucinations, delusion and confusion, and psychosis. Regulation of Kratom

Kratom has yet to be approved by the FDA for any personal or medical use. The agency warns against using the substance until further scientific studies can be conducted. The chemical compound is not controlled under the Controlled Substances Act. Additionally, the DEA has listed Kratom as a drug/chemical of concern. The substance is banned in a few states, including Georgia, Texas, and Alabama, with the latter having deemed Kratom a Schedule I controlled substance, banning it alongside Heroin and Marijuana. Kratom Litigation There have been several personal injury lawsuits filed against organizations with regards to Kratom. These claims have been filed against manufacturers and distributors for inadequate warnings about the risks of use. Plaintiffs have sought compensation for injuries, lost wages, pain and suffering, medical expenses, emotional distress, among other damages. The most common current litigation involves wrongful death, with plaintiffs in Washington, Oregon, Florida, receiving settlements in excess of one million dollars. Lawsuits have also been brought against distributors for allegedly getting users addicted to the substance. Additional litigation involves product contamination, with a salmonella outbreak being linked to Kratom products in 2018. If you or a loved one believe you have experienced health problems from Kratom use, first and foremost make sure to contact your doctor. If your physical or psychological reactions have been severe, it might be worth taking the time to assess your legal options. Feel free to contact Attorney Clay Hodges at (919) 830-5602.

Note: This post is not legal advice or medical advice.

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.

During the course of surgery, a doctor may need to find a way to connect sections of organs or close wounds. One way to do this is through the use of sutures, a special type of thread. Another way is with the use of surgical staples. The Ethicon surgical stapler is pictured at right.

Doctors commonly use staples over sutures during surgery because they offer several advantages, including:

• Lower risk of infection
• Speed of insertion
• Reduced adverse reaction to surrounding tissue

Two of the major manufacturers of surgical staplers in the United States include Covidien and Ethicon. This blog post will focus on Ethicon’s staplers, in particular those involved in its most recent recalls.

History of Problems with Surgical Staplers

Despite their advantages, widespread use and overall general safety, surgical staplers and staples do not have a perfect operational record. They have caused a variety of problems for patients, including:

• Tissue and organ tearing
• Postoperative connection leak
• Hemorrhaging
• Hemorrhagic shock
• Fistulas
• Sepsis
• Bleeding
• Death

These problems can be caused by surgical staplers can malfunctioning in several ways:

• Misfiring of the stapler
• The stapler failing to fire
• Improperly formed staples
• The staple line opening

Countdown to Recall

As a result of these problems, various stapler manufacturers have recalled their products and the U.S. Food and Drug Administration (FDA) has made several announcements regarding these issues. Here is a brief timeline of recent events:

March 8, 2019: The FDA issues a letter to health care providers describing the adverse events associated with surgical staplers and staples. The FDA mentions that from January 1, 2011 to March 31, 2018, the FDA received reports that included 366 deaths and more than 9,000 serious injuries.

April 11, 2019: Ethicon issues a recall for circular staplers because they do not fire properly and fail to correctly form staples when fired. The FDA classified this as a Class I recall, the most serious type, as they involve devices that could result in death. This recall applied to approximately 92,496 devices in the United States.

April 23, 2019: The FDA issues draft guidance. This is a proposal for new recommendations for surgical stapler and staple manufacturers requiring they include additional information on product labels.

April 24, 2019: The FDA issues a proposed order to change surgical staplers and staples for internal use from Class I medical devices to Class II medical devices. This change, if adopted, would allow the FDA to implement special controls to make the products safer.

May 30, 2019: The FDA holds an open meeting to discuss reclassifying internal surgical staplers and staples from Class I to Class II medical devices.

October 3, 2019: Ethicon issues a recall for Echelon Flex Endopath Staplers due to their failure to properly form staples. The FDA classified this as a Class I recall. More than 5,700 devices in the United States were subject to this recall.

Ethicon’s Most Recent Recall from October 3, 2019

Ethicon’s October 3, 2019 recall involved one product line, the Echelon Endopath staplers. Specifically, they involved the following products:

• Product code: EC60A – Echelon Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter
• Product code: PCEE60A – Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
• Product code: PLEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 44cm Shaft Length
• Product code: PSEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 34cm Shaft Length

The lot numbers, as well as additional information concerning the identification of the specific products being recalled, can be found on the FDA’s Medical Device Recall website.

These staplers are being recalled because the stapler may have a component that is out-of-specification. This could create malformed staples, causing problems in patients. As of the date of the recall, Ethicon publicly acknowledged that the recalled products had caused seven serious injuries and one death.

Litigation Involving Ethicon Staplers

Some litigation has begun and it is ongoing. Concerning the products recalled by Ethicon on April 11, 2019, some individual lawsuits have begun, but are currently in the pre-trial stages of litigation.

As for the products recalled on October 3, 2019, there are few, if any, current lawsuits against Ethicon and Johnson & Johnson, Ethicon’s parent company. If there are any changes, I’ll be sure to let you know in an updated blog post.

Note: The information and images contained in this post were derived from FDA content and news sources.

Many of us suffer from heartburn, and one of the most popular ways to treat it is by taking Zantac. Until recently, Zantac was considered a very safe medication and was available without a prescription.

Given how well it worked, along with its affordable price and the perception of safety, hundreds of thousands of people, if not millions, took Zantac. In the fall of last year, the US Food and Drug Administration (FDA) reported that this popular drug might contain N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance.

The past few months have resulted in mass voluntary recalls and a rush of FDA updates and reports about the possible dangers of taking Zantac and what it means for consumers. This blog post will attempt to summarize what’s going on and briefly discuss what happens next.

What Is Zantac?

Zantac is the brand name of a popular H2 histamine receptor antagonist called ranitidine. In plain English, Zantac is an antacid. It works by reducing the amount of stomach acid your body produces. Zantac is most commonly used to treat heartburn, ulcers and acid reflux.

What Is NDMA?

Before you ask, no, Zantac won’t get you high. Though the initials might seem similar, Zantac does not contain the active ingredient found in ecstasy. Ecstasy is 3,4-methyl​enedioxy​methamphetamine or MDMA. The possible carcinogen in Zantac is NDMA, not MDMA. Confusion is understandable given how an “N” not only looks like an “M,” but it sounds that way, too.

The FDA considers NDMA a “probable carcinogen” as it has caused cancer in laboratory animals. NDMA, in very small doses, is possibly not harmful as it’s often found in cured and grilled meats. But with enough exposure, NDMA may cause cancer in humans, such as in the bladder and stomach. NDMA can also be harmful to your liver.

How Much NDMA Is in Zantac?

One of the first publicized instances of NDMA causing cancer was the Citizen Petition sent by Valisure to the FDA on September 9, 2019. In this petition, Valisure explained that in its testing, it found alarming levels of NDMA in ranitidine.

Per the FDA, humans can acceptably consume up to 96 nanograms (ng) of NDMA per day. Valisure tested various types of over-the-counter 150 mg ranitidine medications found at stores like Walmart, Walgreens and CVS.

Valisure discovered that the amount of NDMA found in each 150mg dose ranged from 2.2 to 3.2 million ng. So by taking just one 150mg pill each day, a person was potentially consuming about 30,000 times the amount of NDMA the FDA says is acceptable.

Even when using modified testing methods that should better simulate the human body, Valisure found that each 150mg pill had between 23,600 and 304,500 ng of NDMA. This still vastly exceeds the FDA’s recommendation.

Things get complicated when you look at the FDA’s ranitidine testing results, which found far lower levels than Valisure did. The levels, while elevated, did not alarm the FDA enough to stop the sale of ranitidine.

What’s the FDA Doing About Zantac?

The FDA hasn’t done much besides issue Statements, Press Releases and Updates. However, they did complete their own testing of ranitidine and have asked ranitidine manufacturers to test for NDMA before their products hit store shelves. The following is a recent timeline of events:

September 13, 2019: the FDA publishes a Statement that announces it had become aware of possible problems with ranitidine. The FDA mentions that concerned consumers may ask for a different prescription or take an alternative over-the-counter antacid.

September 24, 2019: the FDA publishes a Press Release announcing the voluntary recall of prescription ranitidine capsules distributed by Sandoz, Inc.

September 26, 2019: the FDA alerts consumers and medical professionals that generic over-the-counter ranitidine made by Apotex Corp was being voluntarily recalled.

October 2, 2019: the FDA discusses more effective methods of ranitidine testing. Specifically, lower temperature testing methods should be used to avoid artificially raising NDMA levels.

October 23, 2019: the FDA further discusses NDMA testing procedures.

October 28, 2019: FDA announces more voluntary recalls.

November 1, 2019: the FDA publishes its ranitidine testing results for NDMA in an Update and issues a Statement. The overall conclusion is that NDMA levels were somewhat higher than what the FDA recommends, but not high enough to require all sales of the drug to stop. In fact, the FDA states that:

“FDA has determined that the levels of NDMA in ranitidine and nizatidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”

November 8, 2019: the FDA alerts the public about a voluntary recall for ranitidine medications manufactured by Aurobindo Pharma USA.

November 22, 2019: the FDA mentions more voluntary recalls for ranitidine medications.

December 4, 2019: the FDA asks manufacturers to test for ranitidine before shipping to retailers.

December 18, 2019: the FDA announces a voluntary recall for ranitidine medications manufactured by Glenmark Pharmaceutical Inc.

January 8, 2020: the FDA announces that Appco Pharma LLC and Northwind Pharmaceuticals (for tablets manufactured by Glenmark Pharmaceutical Inc.) were issuing voluntary recalls of ranitidine.

For a complete list of FDA recall announcements involving ranitidine, please go to the FDA’s Recalls, Market Withdrawals, & Safety Alerts page.

Zantac Lawsuits Emerge

Given how popular Zantac has been and how long it’s been on the market in the US, we’re probably going to see a large wave of litigation against various ranitidine pharmaceutical companies. The lawsuits have already begun. A few of them include:

• Coggins v. Sanofi Case No. 3:19-cv-20060
• Rodriguez v. Sanofi, Case No. 1:19-cv-09527-AT
• Garza v. Sanofi, Case No. 5:19-cv-05772-NC
• Melillo v. Sanofi, Case No. 1:19-cv-06376

What’s important to note is that these lawsuits do not focus on cancer or other personal injuries due to the NDMA. These lawsuits were filed in late 2019 after news broke about the NDMA risks. Therefore, they are mostly suing on the basis of consumer fraud, breach of expressed and implied warranties and other unfair competition laws.

It’s only a matter of time before the personal injury class action lawsuits begin. One reason why they haven’t arrived yet is because they’re far more involved legal cases.

In most of the current cases in litigation now, plaintiffs are basically saying, “the defendant deceived me by not telling me of the health risks in taking ranitidine.” This is a lot easier to prove than saying, “ranitidine caused my cancer.”

Cancer is a complicated disease. Plaintiffs must figure out how much ranitidine was needed to cause cancer. This isn’t to say it’ll be impossible to prove ranitidine caused injuries in people, but it’ll take time to build a case.

What Does the Future Hold for Zantac?

These are still very new developments, so it’ll take some time to create a personal injury lawsuit against the makers and distributors of ranitidine. But there is huge potential for massive litigation. For instance, from 2007 to 2017, ranitidine was prescribed about 15 million times . . . per year . . . in just the US. And this doesn’t even count over-the-counter sales.

As more lawsuits get filed, it’s possible we can expect them to be placed into a multi-district litigation, or MDL. This will hopefully allow for more efficient litigation and maybe even a possible settlement that avoids decades of time in the courts.

Right now, it’s probably best to avoid taking anything containing ranitidine without at least talking to your doctor first. And as I get more information, I’ll post the updates in this blog. If you want to discuss Zantac, call me: (919) 830-5602.

Like many parents, vaping and e-cigarettes caught my wife and me by complete surprise. Two years ago we asked our oldest child how many kids he knew in his high school who were vaping. He said, “it will be much faster to list the kids who aren’t vaping.” We were stunned. We knew very little about vaping, and at the time I assumed it was some kind of fringe product used by adults already addicted to nicotine.

Unfortunately, studies indicate that one in five high school kids have tried vaping, but in my unscientific observation I believe the number is higher. Still, there are more than fifteen million kids in enrolled in public high schools in this country, so even if the number is “only” one in five, this means over three million public high school children have either tried or are currently using vaping products like JUUL.

What we do know is that e-cigarettes are extremely popular and profitable for the companies selling the devices. The primary manufacturer, marketer, and seller of these vaping devices is a company called JUUL Labs, Inc.

So What Is Vaping?

Vaping consists of using an electronic device called an “e-cigarette” to heat a liquid (“e-liquid”) which creates a vapor the user inhales. This vapor or aerosol contains nicotine, the same highly addictive drug found in cigarettes, cigars, and chewing tobacco. The e-liquid can come in many flavors, such as mango, menthol, bubble gum, cinnamon, cucumber, and tobacco.

The electronic device can resemble an actual cigarette, a USB flash drive, a handheld tank, or even an “e-pipe.”

JUUL states that its e-liquids contains just a few ingredients: nicotine, glycerol, propylene glycol, benzoic acid, and flavors.

Is Vaping Harmful?

In a word, yes. For starters, it is (apparently) an easy delivery system for nicotine, and because of that millions of Americans, including children, are now newly addicted to nicotine. Which is not good. Second, the use of nicotine elevates blood pressure, increases heart rate, and can increase the likelihood of having a heart attack. Third, a recent study from Stanford University concluded that e-cigarette flavorings can damage blood vessels even without the presence of nicotine. Cinnamon and menthol flavors were found to be most harmful. The Stanford Study ultimately concluded that vaping increases the risk of cardiovascular disease. Fourth, the science has simply not caught up with the massive popularity of the vaping devices. What are the long-term health effects of heating the flavor chemicals into a vapor, and then inhaling that vapor? We don’t yet know; but we do know that this aerosol is being inhaled into the lungs over and over again, and most scientists and doctors studying e-cigarettes and JUUL products agree that vaping is not safe and potentially very harmful.

Recently, news outlets have reported serious lung ailments in people using JUUL and other vaping devices. Adam Hergenreder is an eighteen-year-old in Illinois who was recently diagnosed with a lung illness after using vaping products for more than a year. Doctors told him he now had the lung condition of a seventy-year old. CNN reported that there are more than 450 cases of lung illness associated with e-cigarettes and vaping devices across the country.

In fact, the FDA and even the White House are getting involved. Reports this week state that flavored vaping “pods,” which are most popular with children, may soon be banned in the United States.

Is JUUL to blame?

JUUL Labs is now working feverishly to distance itself from the epidemic of children newly addicted to nicotine. Nevertheless, many consumer groups have reported that JUUL and other e-cigarette makers actively targeted children through its marketing campaigns promoting flavored vape products such as mango and bubble gum.

What is not in dispute is that thousands of children and young adults are now addicted to nicotine solely because of vaping products. That is a shameful and unacceptable result. And JUUL Labs, maker of the most popular vape product, deserves plenty of blame for this unnecessary wave of nicotine addiction.

Do I Have a Lawsuit Against the Vaping Companies?

Quite possibly. Cases have already been filed against JUUL and other e-cigarette manufacturers involving individuals who were injured and hospitalized after using vape products. A multi-district litigation (MDL) site to handle the wave of vaping product lawsuits is inevitable. If you or your child used JUUL or other vaping devices over several months and were later diagnosed with cardiovascular disease, seizure, lung illnesses, breathing problems, stroke, nicotine poisoning, or other health problems, call me to discuss your options: (919) 830-5602.

And for your own good health, try your best to stop vaping today.

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.

I’ve been representing people injured by defective medical devices and harm drugs for many years. Because I study these types of products on a daily basis, I have become leery about putting anything inside my body, whether it is an artificial joint like a hip or knee, or a prescription medication. As I often tell people–mostly joking but not completely–these days I am uncomfortable taking a baby aspirin.

Of course that’s not rational. Please hear me: there are important, helpful drugs and medical devices which improve lives, extend lives, and save lives. Paranoia is not your friend when you are facing a serious health issue. That said, it is always prudent to double check anything put into your body when a medical procedure is performed. Read about the product, get a second or third opinion.

In the past few years studies have identified troubling health problems in patients following the administration of gadolinium-based contrast agents (GBCAs) used during MRIs. Some people have gotten debilitating symptoms from these GBCAs. Let’s take a look:

What is an MRI?

MRI is the acronym for magnetic resonance imaging. It is an advanced medical imaging system used to produce detailed images of the inside of a person’s body. MRIs use powerful magnets and radio waves to generate specific images of organs and other parts of the body. MRIs are very effective at producing detailed images, which greatly assist radiologists and physicians in diagnosing illness or injury. For example, an MRI of the heart can detect heart disease or a blockage, and an MRI of the brain can diagnose brain injury, multiple sclerosis, cancer, and other conditions. Unlike X-rays, an MRI does not use radiation. The MRI has been a revolutionary diagnostic tool in medicine.

In some MRIs, your doctor may order a “contrast agent” to be injected into your body to produce more detailed images.

What is a GBCA?

GBCA is gadolinium-based contrast agent. Gadolinium is a chemical agent that is injected through a vein into the body in some MRIs. It serves as a kind of dye which enhances the quality of the images obtained from the MRI. These GBCAs allow radiologists to see more clearly the tumor in the lung, or the brain for signs of concussion, or many other health issues. Once the MRI images are obtained utilizing GBCAs, the gadolinium is supposed to exit the body through the kidneys. Initially radiologists stated that over 90% of gadolinium is released through the urine in the first 24 hours after injection.

So What is the Problem with GBCAs?

This is the concern: research has shown that gadolinium can be retained in tissue, bone, and the brain. In fact, it is now understood that significant amounts of gadolinium can remain in the body and tissue of patients for months or even years. This doesn’t always happen, but when it does it can cause hurt a person’s health. Let’s look at two diseases caused by GBCA retention:

• Nephrogenic systemic fibrosis (NSF). This disease occurs in individuals with reduced kidney function who have retained gadolinium in their bodies. NSF is a serious condition that causes skin thickening, muscle and tendon shortening, organ damage, and other symptoms. Unfortunately, NSF can even be fatal.
• Gadolinium Deposition Disease (GDD). Gadolinium Deposition Disease occurs in patients with retained gadolinium who had normal kidney function. Symptoms of GDD can include: headaches, severe pain in the joints, bones, arms and legs, thickening of tendons, tissue, and ligaments, burning sensation, numbness, nausea, sleeplessness, cognitive decline, and other symptoms. In one publicized case, Gena Norris, wife of actor Chuck Norris, alleges that she suffers from GDD and has sued the manufacturer of the gadolinium product injected in her through several contrast MRIs. Other lawsuits have been filed against manufacturers for harm caused by gadolinium.

By the way, there are two types of GBCAS: linear GBCAs and macrocyclic GBCAs. This gets really scientific and complex, but these distinctions are based on the molecular structure of the GBCAs. Linear GBCAs have elongated molecular “ligand” (an ion bonded to a metal atom), while macrocyclic agents have a structure resembling a cage. The reason I mention this is because the FDA has reported that linear GBCAs may produce more gadolinium retention in the body than do macrocyclic GBCAs. But I don’t think the science has resolved this issue, and in any event this does not mean that macrocyclic GBCAs are safe or even safer than linear GBCAs. If you are heading toward a contrast MRI, do your homework.

There are several brand-name gadolinium products on the market, including:

• Dotarem
• Eovist
• Gadavist
• Magnevist
• Multihance
• Omniscan
• OptiMARK
• ProHance

The FDA has issued an order requiring that all gadolinium-based contrast agents (GBCAs) include a warning that gadolinium can be retained in the body after contrast MRIs. For more information, check out the FDA website on GBCAs. The bottom line: be aware of data showing gadolinium retention in the body from GBCAs. Retained gadolinium in the body is not a good thing. And for many people, the suffering is very real and very serious.

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.

Bayer’s Essure birth control device is coming off the market, thanks to a public campaign aimed at raising awareness about its dangers. After years of silence, in which women were told that their pain wasn’t real, and years of incident reports that went unheeded, the U.S. Food and Drug Administration (FDA) finally agreed that Bayer needed to do more to warn patients about the risks of the birth control device.

Now that women are making informed decisions, use of the birth control device has dropped off so precipitously that Bayer is ending its production. Let’s look at what Essure is and why it’s so dangerous.

The Essure Birth Control Implant

The Essure birth control implant is actually two implants, each a narrow coil of metal and fiber that must be inserted in the fallopian tubes. For three months or so after the implants are inserted, scar tissue grows around the devices, permanently closing the fallopian tubes and—at least in theory—preventing sperm from reaching the eggs.

Essure is a permanent form of birth control that cannot be removed. The coils essentially become part of the patient’s body, encased in her own scar tissue. As Bayer describes it, Essure results in irreversible female sterilization.

The FDA approved the device in 2002. At first, all seemed to be well. Essure doesn’t involve any drugs or artificial hormones. The procedure requires no incision or, usually, anesthesia. It’s a walk-in, walk-out appointment that takes about 30 minutes. Sounds great, right?

Wrong.

Problems With the Birth Control Implant

In the last few years, the FDA finally noticed “the growing number of adverse event reports” from women with Essure implants. Those reports included serious, life-threatening symptoms:

• persistent and significant pain;
• punctures to the uterus and fallopian tubes;
• movement of the implant into other areas of the body, including the abdomen and pelvis;
• bleeding;
• allergic reactions; and
• deaths.

Women seeking removal of their Essure devices have needed painful surgery—whether the devices were still where they were placed or had migrated elsewhere.

In addition, a few women with the implants nonetheless became pregnant, sometimes with catastrophic results. The FDA states that it received 26,773 medical device reports related to Essure between its approval in November 2002 and the end of 2017. In that time, there were 40 reported deaths. While eight of those deaths were of adults, the majority were infants who died during pregnancy.

The FDA assembled an expert panel to evaluate these safety concerns and the extent of the warnings that doctors were giving to potential patients. In October 2016, it required a new warning on the device label and created a “Patient Decision Checklist” to help women considering Essure implants make informed decisions about the risks.

These efforts to counsel patients about the risks had a huge impact: since the increased warnings, Bayer has seen a 70 percent decline in Essure sales in the U.S.

But in April 2018, the FDA realized that “some women were not being adequately informed of Essure’s risks … despite previous significant efforts.” Clearly, while more women were rejecting the devices, women were still getting this permanent implant without ever hearing about its risks. Therefore, the FDA imposed a restriction limiting Essure sales to facilities that agreed to counsel patients and use a signed acknowledgment form.

Shortly after that, things got even worse for Bayer’s attempts to promote this dangerous device.

The Public Campaign About Essure’s Dangers

Essure isn’t, of course, the only dangerous implant; medical devices of all types are often under-regulated and risky. Fortunately, the word is getting out about those dangers. In July 2018, Netflix released a documentary called The Bleeding Edge that discussed five medical devices, including Essure, and the often unmentioned risks associated with them.

Just before the release date for The Bleeding Edge, Bayer announced that it was taking Essure off the market at the end of 2018—but not because it was causing harm to patients. Rather, Bayer pulled the device as a “business decision” because it is no longer generating enough profit. In its announcement, Bayer blamed, in part, “inaccurate and misleading publicity about the device” for those declining sales. Bayer firmly stated that it “continue[s] to stand behind” the safety of the birth control device.

But with a device that literally becomes part of the patient’s body, ending sales doesn’t do anything to help women who already have the permanent implants. The FDA was careful to announce that “postmarket safety … will continue to be a top priority.”

As of now, around 16,800 lawsuits have been filed against Bayer for problems related to Essure implants. Bayer reports that “additional lawsuits are anticipated.”

Have you had problems with an Essure implant or another medical device? Let’s discuss your options. Call me at (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.

Two recent clinical trials studying Invokana (canagliflozin) shed light on the diabetes drug’s alarming side effects. Canagliflozin is a type 2 sodium-glucose transport inhibitor (SGLT2 inhibitor) marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The medication works to lower blood sugar levels in the body 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.

The clinical trials were named CANVAS and CANVAS-R, based on long scientific acronyms. The studies examined the effects of canagliflozin on patients with Type-2 diabetes. The trials discovered that leg and foot amputations occurred twice as often in patients taking canagliflozin as those treated with a placebo.

The risk for amputations broke down like this: 5.9 out of every 1,000 patients treated with canagliflozin suffered amputation, as compared to 2.8 out of every 1,000 patients treated with a placebo. Over a year’s time, the risk of amputation was 7.5 out of every 1,000 patients treated with canagliflozin, compared to 4.2 out of every 1,000 patients treated with a placebo. These are statistically significant results, meaning the risk of amputation for those people taking Invokana was large enough to cause alarm in the medical community.

In the clinical trials, amputations of the toe and middle of the foot were the most common; however, amputations of the leg, below and above the knee, also occurred. Some patients had more than one amputation.

Based on this new data, the FDA ordered new warnings, including a prominent boxed warning, to be added to the canagliflozin drug labels to explain and describe this risk. more Black Box Warnings

A boxed warning is serious business. A “boxed warning” or “black box warning” is a warning that appears on the package insert for certain prescription drugs. It is given this name because the FDA requires that the warning be presented with a box or notable border around the text. The boxed warning is designed to call attention to serious or life-threatening risks that are possible when using the prescription drug.

In July 2017, the FDA required a boxed warning for the diabetes drug Invokana, which included these bullet points:

“Warning: Lower Limb Amputation”

• A 2-fold increased risk of lower limb amputations was observed in two studies of patients taking Invokana.
• Amputations of the toe and midfoot were most frequent; amputations of the leg were also observed. Some patients had multiple amputations.
• Before taking Invokana, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving Invokana for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

See FDA Website for the complete boxed warning.

The bottom line: if you are taking Invokana for treatment of Type-2 diabetes, talk to your doctor about the risks and whether you should remain on the medication. For more information, consult the FDA website.

Over the past few years, an opioid epidemic has caused horrific problems for many regions of the country. In 2015 alone, the US Department of Health and Human Services estimated that 12.5 million people misused prescription opioids, causing over 33,000 overdose deaths. In 2013, the opioid epidemic resulted in $78.5 billion in economic losses. In response to this tragic loss of life and the economic strain placed on many state and local governments, several lawsuits have begun.

What Exactly Are Opioids?

Opioids are synthetic or semi-synthetic forms of opiates (like morphine). Opiates are derived directly from the poppy plant while opioids are manufactured chemicals that are very similar to opiates.

Opioids are used as painkillers and prescribed to patients to treat a variety of medical conditions where moderate to severe pain is a concern. Commonly prescribed opioids include:

• Oxycodone (OxyContin)
• Hydrocodone (Vicodin)
• Fentanyl

Opioids are effective at relieving pain, but unfortunately, they are extremely addictive and often lead to overdoses and the use of stronger (and more dangerous) illicit drugs. The causes of the opioid epidemic are complex, but one approach to combating it is to seek relief in the courts by going directly after the opioid makers.

The Basis for Opioid Lawsuits

Both individuals and local governments have sued the pharmaceutical companies under a variety of legal theories, although they are often based on the idea that the makers of opioids downplayed the risks of opioids while exaggerating their benefits.

These lawsuits are in new legal territory, but parallel some of the earlier lawsuits where states sued Big Tobacco and firearms manufacturers for the number of deaths and the financial toll their products were taking on the general population and state budgets.

If the opioid lawsuits have the same ending as the lawsuits against cigarette companies, states and municipalities may be able to help pay for fighting and treating the opioid crisis. For example, when the lawsuit against Big Tobacco settled, it resulted in the largest civil settlement in history, amounting to tens of billions of dollars. Continued payments are made by cigarette companies forever to help states treat their sick citizens suffering from tobacco-related illness and disease.

However, the opioid lawsuits face potential challenges that may not guarantee victory. For example, the opioid crisis has many causes, not just the pharmaceutical companies allegedly marketing their opioid products incorrectly.

For example, opioid abuse is the result of doctors who are overprescribing opioids and (questionable) scientific studies incorrectly concluding opioids were non-addictive. In addition, many of the abused opioids are obtained illegally by users and prescription medication distributors often don’t halt suspicious orders for opioids. Despite these challenges, there have been early successes in the opioid litigation.

For example, in 2004, the state of West Virginia settled its lawsuit against Purdue Pharma, the makers of OxyContin, for $10 million. And in 2007, Purdue Pharma agreed to pay $130 million for future civil lawsuit settlements brought by private parties, such as patients who were prescribed OxyContin.

Current Status of Opioid Lawsuits

Recently, many of the opioid lawsuits have been brought by government plaintiffs, such as states, counties and cities. Several of these plaintiffs include:

• The state of Ohio
• Cherokee Nation
• The city of Everett, Washington
• Santa Clara and Orange counties in California
• Orange, Nassau, Broome, Erie and Suffolk counties in New York
• The city of Chicago, Illinois

Most of these lawsuits have been brought within the past few months, so we need more time to see the direction they will take. Regardless of the outcome of these cases, the mounting pressures from the opioid crisis is starting to make a difference in other ways.

For example, in June 2017, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to voluntarily pull one of its opioids, Opana ER (oxymorphone hydrochloride) from the market. The FDA made this recommendation on the basis that Opana ER was being abused in ways where the benefits from having the drug available in the market were outweighed by its risks. For example, Opana ER was being manipulated so that it could be injected. Besides the obvious addiction and overdose risks, this new method of abusing the drug created outbreaks of diseases, such as HIV and hepatitis C.

I suspect opioid lawsuits will increase dramatically over the next few years. With opioid litigation having only just begun, stay tuned to this blog for any additional updates.

According to the American Society of Plastic Surgeons almost 280,000 breast augmentation procedures took place in the United States in 2015. Given the popularity of breast implants, a wide range of breast implant products have been released in the United States and the rest of the world. One such product is the textured breast implant.

Why Are Breast Implants Textured?

The purpose of adding texturing to the breast implant surface is to help the body keep the implant in place and avoid it from shifting. Another reason is to prevent a complication called capsular contracture, which occurs when the scar tissue that forms around the implant become painful and hard.

Despite these logical reasons for using textured breast implants, the Food and Drug Administration (FDA) has concluded there is a clear link between textured breast implants and Anaplastic Large Cell Lymphoma.

What is Anaplastic Large Cell Lymphoma?

Anaplastic Large Cell Lymphoma, or ALCL, is a rare type of non-Hodgkin’s lymphoma, or cancer of the blood. In ALCL, the white blood cells grow uncontrollably and can spread to the lymph nodes and skin, in addition to the breast itself. ALCL is not breast cancer and if found early it can be effectively treated, although it can be fatal if not treated soon enough.

One of the common forms of treatment involves removing the breast implant along with the scar tissue capsule surrounding it in a procedure called capsulectomy. About 70% of the time, this is the only treatment needed to be cured of ALCL, although radiation and chemotherapy may also be required.

Common symptoms of ALCL include:

• Ongoing pain in the area surrounding the breast implant (this is the most common symptom)
• Fluid buildup, lumps or hardening masses surrounding the breast implant
• Fever
• Backache
• Fatigue
• Swelling of the lymph nodes

The Connection Between Textured Breast Implants and ALCL

In 2011, the FDA noted a possible connection between textured breast implants and ALCL. However, in March of this year, the FDA officially recognized the link between textured breast implants and ALCL.

Of the 231 medical device reports the FDA received where individuals who had ALCL also indicated the type of breast implant they received, 203 of the ALCL patients had textured breast implants while only 28 had smooth surface breast implants. This is a troubling statistic, and more study is needed.

Ideally, more data would be available for analysis, but unfortunately, it’s been somewhat sparse. For example, even though there were 231 ALCL medical device reports the FDA received identifying the breast implant type, 128 of the reports made no mention of the breast implant surface type. Currently, there is no comprehensive database of breast implant recipients and ALCL sufferers although efforts are being made to create one. It is critical that we get more information.

How Does the Textured Surface Cause ALCL?

This is likely the multi-billion dollar question because right now, no one seems to know for sure why textured breast implants result in a much higher rate of ALCL.

One reason for this lack of clarity is that multiple companies offer textured breast implants and the implants have different types of texturing and there are different ways of manufacturing the textured surface. However, there is one predominant theory to explain the link between a textured surface and ALCL.

This explanation is that ALCL is caused by a bacterial infection in the textured surface that starts an inflammatory response in the body. It has been established that certain types of lymphoma can be caused by chronic infections.

Does This Mean I Can Sue if I Have a Textured Breast Implant?

We are still early in the process. The FDA recognized the link just a few months ago. But if you suffer from ALCL after getting textured breast implants, it’s important (1) to get medical treatment immediately and (2) to keep detailed records of your pain, your medical care, medical bills, and any other vital information relating to your ALCL.

These companies manufacture textured breast implants, and it is important for them to study the issue immediately and thoroughly as we move forward:

• Allergan
• Sientra
• Mentor
• Ideal Implant, Inc.

So What Now?

Basically, we wait-and-see. The FDA does not recommend patients have their breast implants removed unless they have symptoms of ALCL or other adverse reactions to the textured breast implants. If you suffer any problems with your textured breast implants, you should see your doctor as soon as you can.

I will update this information as I receive more news, so keep checking back with me.

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.