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.

So What’s the Difference?

Medical malpractice is the legal term for a doctor who has been negligent. This means that the doctor failed to perform the surgery with an expected degree of care and competence. In a phrase, the doctor simply screwed up the surgery. For a plaintiff to win a medical malpractice claim, he or she must show that the doctor failed to perform his duties with a normal “standard of care” typical of similarly situated doctors. This means that surgeons in small towns will be judged against similar doctors in similar towns, while doctors from major research hospitals in big cities will be judged against their similarly situated peers, and of course will be held to a higher standard. The bottom line is this: medical malpractice is the failure to provide competent medical care, causing the patient unexpected injury.

Please understand that medical malpractice is not limited to surgeons: hospitals, nurses, and other medical care providers can be liable for malpractice. For example, a nursing staff may fail to do the proper count of “sharps” in a surgery and leave a surgical needle inside the patient’s body. That’s a bad thing, potentially very harmful, and certainly malpractice.

Product liability is an area of tort law where a person is injured by a defective product. Virtually any kind of product can harm us: a car, a heating pad, an artificial hip. On this site I focus on two kinds of product failures: medical devices and prescription drugs, two products which can cause serious injury when they turn out to be defective.

A defective product is one that has a substantial flaw or imperfection. The defective characteristic could be a design flaw, or a manufacturing defect, or even a missing or inadequate warning (for example, “do not take this mix this medication with alcohol”). A defective product becomes a product liability case when the defect causes injury to the consumer. To use an example from this site, when a metal-on-metal (MoM) artificial hip causes metal shavings to leach into the body, and the blood metal levels become dangerously high, the product is defective and has caused injury, and the patient should have the right to bring a lawsuit against the manufacturer.

In many cases it is not always simple to sort out whether the injury was caused by the defective product or by negligent surgical technique.

And here’s another problem: in many of these cases, when the case is grinding forward, the separate defendants will point fingers at each other. The surgeon will insist he performed the surgery correctly, but that the defective product (a defect of which he was unaware) was the cause of the injury. The product manufacturer will state that the product is fine, but the surgeon was a hack and did not understand the correct implantation technique. (In fact, Smith & Nephew may be suggesting this defense in the Birmingham Hip Resurfacing (BHR) litigation, which you can read about here and here.) Still, a good lawyer can figure it out.

Can’t It Be Both?

Yes. You can certainly be the victim of a defective product and negligent medical care. But it’s often like threading a needle. To win such a case, you will need to prove that your injuries were caused by the failure of a defective product and by negligent surgical technique. So sticking with the MoM artificial hip example, let’s say you were injured following hip replacement surgery. In the months that followed your cobalt and chromium metal levels shot up, but you also developed a painful infection near the surgical site. An investigation revealed the hospital was flagged for inadequate sterilization practices, leading to an outbreak of dangerous infection. In that case, the plaintiff-patient can rightly bring claims both for the defective product and for medical malpractice.

Unfortunately, it is rarely simple to identify two separate injuries from two separately identifiable acts of negligence in a single surgery. In most cases, it is one or the other: the surgeon implanted a faulty device, or the surgeon implanted a non-defective medical device, but put it in upside down.

Either way, you need a good lawyer to help you find the answers.

This is the question I get most often from people who have hired a lawyer but are not happy with the legal representation. Above almost everything else, good communication is the key to a healthy attorney-client relationship. I try not to be the kind of lawyer who doesn’t return phone calls. I don’t want any of my clients talking to another lawyer about me. And I understand: every client deserves to be updated regularly on his or her case.

Let’s look at some reasons why your lawyer may not be returning your calls:

• Your lawyer is doing lawyer things.

Every professional is busy. I won’t tell you that lawyers are busier than doctors or stonemasons or accountants, but most lawyers are busy too. And sometimes very busy. When I am on a court deadline, it feels as if I go down in a hole. Everything else is blocked out. For example, when I am writing a legal brief for a client to support a motion for summary judgment, I have to do what Cal Newport calls “deep work.” The legal brief may be a thirty or forty-page legal analysis applying relevant law to the facts of my client’s case. It is complex. It is not easy. For me to do it right, I have to shut out everything else. On these days, I simply cannot pull another file and call another client with an update on her case. I just can’t get to it that day.

The good news is that when it comes time for me to prepare a complaint or a motion or a legal brief for the client whose call I could not return, I will do “deep work” for that client and shut out everything else. This is how the practice of law is supposed to work. So often when a lawyer does not return your call for a few days it may simply mean your lawyer is busy getting some important work done in your case or in another client’s case.

• There is nothing going on with your case.

The work of civil litigation comes in waves. There are weeks when I spend day after day preparing legal documents or engaged in depositions for one individual case, and then weeks can go by with no activity at all. I usually call a client during a week of intense activity (“Just wanted you to know we filed your lawsuit in the multi-district litigation yesterday. Everything went smoothly.”), but I may not call a client for some time if there has been no meaningful activity. Still, I understand that this practice may be a mistake, especially for some clients who need more frequent attorney contact. I try to perceive which clients need regular check-ins, even if there is nothing to report, and which clients can absorb a few weeks with no communication.

I always tell clients: you call me whenever you need to talk to me, but if I don’t call you it’s because we are between deadlines and there is nothing going on at the moment with your case. But I am always watching over your case, even in periods of inactivity.

• You call twice a day.

Not really. OK, rarely, but it happens. Most clients understand there are times when big events are occurring and communication is essential (“we reached a settlement!” or “you won your appeal!”), and times when nothing is going on and no communication is acceptable. As I have written in this blog many times, product liability litigation is a slow moving train, particularly with mass torts such as artificial hips or prescription drugs. These cases take years to resolve. And for much of that time, no meaningful activity is occurring in your case.

I would likely lose my law license if I called every one of my clients every day. Even though I make a point not to represent too many clients at any one time, I have enough active cases that if I called each client every day I would simply not be able to complete the legal work required to move each case forward. There simply would not be enough time each day.

If you need weekly or daily check-ins about your case, let your attorney know up front (“I expect to hear from you twice each week . . . “). If the attorney cannot meet that standard he or she should let you know up front. And maybe you can work out a call schedule that works for both of you: “Unless I am in court, I will call you each Thursday with an update.”

• You hired an attorney from a national marketing firm.

These guys get to you before the rest of us. You see them in afternoon television commercials, in online ads, in your local newspaper. (It is hard for me to compete with them.) When you call that 800 number you get an intake phone person who is often not a member of the firm but a separate paid contractor. The intake person will write up your story, confirm it is a promising “lead,” and if viable will send it to a more thorough review person at the marketing “firm.” Once the medical records “check out,” the marketing firm may refer the case to one of many participating law firms across the country who will take on the case and pay a referral fee to the marketing firm who took your original call. That will likely be the last time you hear from the “firm” who caught your eye in a late-night advertisement.

I don’t mean to disparage this crowd of marketing firms, but I caution you to be careful in choosing your law firm. The advertising group may not be your best fit.

• Your lawyer doesn’t want to talk to you. Or maybe doesn’t even know who you are.

This is the worst reason. Let’s say a firm pays referral fees to obtain dozens or even hundreds of product failure cases. This firm is employing many paralegals and attorneys to move cases forward as quickly as possible. Returning a client’s phone call is not an efficient use of their time. Often, if you get a return call at all it is a paralegal assigned to the case, and often this paralegal cannot answer many of the legal questions you may have. Try not to become just another number in a law firm’s “inventory.” Slow down and choose a law firm and your lawyer carefully.

And if it gets really bad, you may be forced to fire your attorney and hire another one. This is a delicate subject, and I would say be careful and deliberate when hiring or firing a law firm.

If you want to talk to an actual product liability lawyer, give me a call any time: (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 a serious condition that affects the way the body metabolizes sugar. Over 29 million Americans currently suffer from the disease. Of the newly diagnosed cases of diabetes in adults, around 95% are for Type 2 diabetes. Type 2 diabetes occurs when the body produces enough insulin but cannot use insulin properly. Type 2 diabetes results in high blood sugar levels which can cause long-term health problems. So what does all this mean? From the perspective of pharmaceutical companies, it means there is a massive market for Type 2 diabetes drugs. Enter the latest diabetes “wonder drug,” Invokana. more Invokana

Invokana is the trade name for the medication canagliflozin. Canagliflozin is a diabetes medication sold by Janssen Pharmaceuticals and Johnson & Johnson. Invokana works to lower the body’s blood sugar levels by preventing the kidneys from reabsorbing blood glucose. The blood glucose is removed with the body’s urine. Unfortunately, many patients who took Invokana suffered side effects 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, stroke, renal failure and other kidney injuries, urinary tract infections, and leg and foot amputations.

After its approval and release in the United States, canagliflozin was the subject of several safety announcements and warning label updates. In May 2017 there was another FDA Drug Safety Communication which confirmed an increased risk of leg and food amputations for those patients taking medications containing canagliflozin. The FDA also required medications containing canagliflozin to have updated warning labels to reflect this risk.

So what should you do if you suffered an injury while taking Invokana? Here are six helpful steps:

1. Don’t Stop Taking Invokana Until You Speak with Your Doctor.

The FDA currently recommends that patients taking Invokana to contact their doctor if they’re experiencing problems with the medication. The FDA has also recommended that patients should not stop taking Invokana until they meet with their doctor first.

I would go a step further and recommend that even if you have no injuries or symptoms, you should ask your doctor if Invokana poses an unnecessary risk to your health. There may be safer medication options for you.

2. See Your Doctor Immediately.

This is the most important thing to do if you are suffering injuries or side effects while taking Invokana. Your health issues must come first. Ask your doctor if Invokana is simply too risky to continue taking. If your doctor insists that you should continue taking Invokana, ask your doctor why (and write down the answers). Also ask your doctor if there are safer alternative medications. Gather as much information as you can. If your doctor does not give the issue the attention you think it deserves, seek a second opinion.

3. Keep a “Symptoms Journal.”

It is simple enough: when you first begin to notice symptoms which seem abnormal or unexpected or troubling, jot down these sensations on a piece of paper or a notes “app” on your smart phone. The more detail the better. This journal may well provide critically important information for your doctors but also for your attorney as he or she prepares a settlement package or a lawsuit. A person who has been injured by a harmful drug can recover money “damages” in a category known as pain and suffering. A symptoms/pain/well-being journal can provide extremely valuable information to an attorney putting together the best case for you in the event you have a viable claim against a pharmaceutical company for a potentially dangerous drug like Invokana.

4. Keep Careful Record of Medical Bills, Out-of-Pocket Expenses, and Time Missed from Work.

Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your medical care related to injuries suffered from Invokana, including inpatient treatment, surgeries, recovery, rehabilitation, other medications, etc. In some cases, drug companies will pay the out-of-pocket expenses of a victim of a failed prescription medication. Finally, keep detailed records of all time missed from your employment, including sick days you were forced to spend, and days out of work for which you lost compensation.

5. Find an Attorney You Trust.

This step is very important and not easy. Do your research on the attorney and take your time with this important decision. If the first lawyer you call is not a good fit, you can easily move on to the next lawyer. Of course, you can always call me (919.830.5602).

6. File a Lawsuit Against the Makers of Invokana.

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

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 pretrial litigation process and perhaps facilitate a potential settlement. The cases are currently in the “discovery phase,” which will take several months to complete. The pretrial work must run its 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 like Janssen and J&J, the discovery process can be the most time consuming and expensive part of the lawsuit.

In the Invokana MDL, the judge intends to have three bellwether trial cases chosen by January 2018, with the first bellwether trial beginning in September 2018.

Note: I am not a doctor. As a product liability lawyer, I can’t diagnose your health issues and cannot connect any injury you may have suffered to Invokana or to any other drug. Please see your doctor immediately if you suffer any negative health issue (related to Invokana or another drug).

I blogged previously about the United States opioid crisis and how many local and state governments were looking to the courts to help deal with it. Specifically, these governments have brought lawsuits against manufacturers and distributors of opioids.

When we last wrote about the opioid crisis, I explained how these lawsuits had only just begun. The following post is an update on how these lawsuits are progressing. But before we get to that, let’s discuss why opioids are generating these lawsuits.

The Legal Basis for Suing Opioid Manufacturers and Distributors

The opioid crisis imposes a heavy price on states and municipalities. This figure is in the billions of dollars for healthcare costs, law enforcement costs, lost economic productivity and increased strain on the legal system and social services. State and local governments are looking to make the companies that had a large part in the opioid epidemic help pay to deal with these problems.

State and local governments argue that opioid manufacturers and distributors engaged in the following illegal behavior in order to profit from the opioid crisis:

• Purposely ignored suspicious orders (these were unusually large orders for opioids that could not be for any legitimate medical purpose) for opioids and refused to detect, report and stop these suspicious orders as required by state and federal law.
• Distributing questionable medical literature that proclaimed opioids had very little risk for addiction.

State and local governments have then used the following legal theories to allege the opioid manufacturers and distributors are liable for the opioid epidemic:

• Misrepresentation
• Negligence
• Public nuisance
• Federal Racketeer Influenced and Corrupt Practices Act (also known as RICO)
• State corrupt practices laws
• State trade practices laws

However, because of the similarity in their legal arguments and the common factual basis for their legal claims, these governments have requested that the 66 or so opioid lawsuits currently in federal courts be consolidated and coordinated under one multidistrict litigation, or MDL.

What Is Multidistrict Litigation?

MDL is a special procedure in federal courts for streamlining similar lawsuits that are currently pending in many different districts. If the lawsuits involve at least one “common question of fact” and can be more efficiently and conveniently handled when consolidated, they are eligible for MDL.

If a group of cases is consolidated into an MDL, a single judge and court will decide pretrial issues, such as discovery disagreements. This judge will also try to foster a settlement among the parties. Assuming there is no settlement, the actual trial will be held in each case’s original court.

Why Create an Opioid MDL?

There are two important reasons for creating an MDL. First, handling all the pretrial issues with one judge creates consistent pretrial rulings. For example, let’s say the plaintiffs want a copy of a certain document during discovery. The defendant objects to producing the document. Without the MDL, a judge in one case might rule for the plaintiffs and order the production of the document while another judge in a different case could make the complete opposite decision. This can create confusion and inconsistent court decisions.

Second, the parties can save time and money by litigating their case in a single court that’s most convenient for the parties, especially the defendants.

How to Create an Opioid MDL

The local and state governments have requested an opioid MDL based on the following arguments:

First, the local and state governments contend that opioid manufacturers and distributors breached their duty to identify, stop and report suspicious opioid orders. This presents a common question of fact, one of the requirements for creating an MDL.

Second, creating an MDL would allow for a more efficient pretrial process. As of the time of the opioid MDL request, there were 66 federal lawsuits in 11 federal districts, spanning nine states. And any similar cases that are later filed can be sent to the MDL, further increasing the need for consolidation.

The local and state governments have suggested the Southern District of Ohio host the MDL due to its centralized geographic location and being home to offices or distribution centers for the major defendants.

JPML Establishes Opioid MDL

On September 29, 2017, the Judicial Panel on Multidistrict Litigation (JPML) granted the Plantiffs’ Motion for Transfer of Actions Pursuant to 28 U.S.C. § 1407 For Coordinated or Consolidated Pretrial Proceedings. The consolidated litigation will be named “National Prescription Opiate Litigation.” I will provide updates as this litigation progresses.

Depuy MoM Hip Implants: An Overview

Hip implants have been around for a long time. They can be made of various materials. Some older models use a polyethylene cup and a metal ball to create the artificial hip joint. While this combination works well, it’s not perfect. Engineers have looked for other materials to find a hip joint that can last longer with fewer adverse effects.

One attempted solution was to have both the cup and ball made out of metal, hence a metal-on-metal hip joint. However, the performance of these hip implants was even worse than joints that used polyethylene and metal. Problems with MoM hip implants included significant pain, bone loss, hip implant failure and metallosis.

As a result of these problems, thousands of lawsuits have sprung up, not just against Depuy, with its ASR and Pinnacle MoM implants, but other MoM hip implant manufacturers such as Biomet and Stryker. Many of the Depuy lawsuits have been consolidated into multi-district litigation, or MDL. A few initial bellwether trials involving the Depuy Pinnacle have resulted in massive verdicts against Depuy, which I wrote about here.

Basically, things have not been looking good for Depuy. And they just got worse.

more The Incriminating Documents

The Daily Telegraph recently published a story, based on internal documents recently made available, that show Depuy actually knew it had serious problems with its MoM hip implants for years. The company deliberately took steps to ignore the problems. The released documents include:

• A paper written by Graham Isaac, Ph.D., discussing problems with MoM hip implants.
• A letter from Dr. John F. Irving, MD, to Depuy’s head of US marketing (Paul Berman).
• Depuy corporate meeting minutes where Depuy executive met to discuss various topics, including MoM hip implants.
• Internal Depuy e-mail exchange discussing MoM hip implant problems.
• A July 2008 paper on the topic of MoM hip implant problems.

These papers are especially incriminating because they show what Depuy knew (or should have known) and when they knew it.

What Did Depuy Know?

In Dr. Graham Isaac’s paper, he explains how metal wear debris created from MoM hip joints were a serious problem due to poor design and manufacturing of the metal components. However, Dr. Isaac goes on to state that even with higher quality manufacturing and engineering techniques, the performance of MoM hip implants were still “as unpredictable as ever, working well for a period of time before suffering catastrophic breakdown…accompanied by a release of a large volume of debris.”

Dr. Isaac went on to conclude that metal-on-polyethylene hip implants performed significantly better than MoM implants. He also mentioned that using ceramics can produce hip implants that perform better than MoM hip implants.

In Dr. John Irving’s letter to Paul Berman, he spoke of his data collection which shows that Depuy’s MoM hip implants were dramatically underperforming other types of hip implants. When looking at metal-on-polyethylene hips from the last 10 years, Dr. Irving had a 1.2% failure rate, or eight revisions out of 660 hip implants.

Contrast this with Depuy’s MoM hip implants, where out of 262 implants, 31 required revision surgery. This was an 11.8% failure rate, almost 10 times that of the conventional metal-on-polyethylene hip implants.

As if that wasn’t bad enough for Depuy, Dr. Irving complained about Depuy’s “lack of attention and head-in-the-sand response to this problem.” Dr. Irving went on to state that “these products are harming patients,” that he “did not feel Depuy [was] doing enough to understand the extent of the Pinnacle MoM hip disease” and it would be “unethical to continue to market the product.”

And in 2010, when Depuy finally starting taking action with its MoM hip implants, there was an e-mail exchange among Depuy executives and experts acknowledging a “link to a failure pattern of the ASR XI to the Pinnacle with 36 mm heads when used with metal liners” and that “the problem may be widespread” with “evidence of metal on metal and ceramic on metal failings.”

There was also the recognition that when a hip implant failed, it was “sometimes catastrophic.” One of the e-mails ended with the belief that Depuy should “investigate and manage this growing problem.”

When Did Depuy Know?

So these internal documents go to what Depuy knew, but how long did Depuy know this? Corporate minutes show Depuy most likely knew of the MoM risks in 1995, over twenty years ago. One of the meeting’s attendees, Dr. Paul Peters, noted that Depuy needed “to be cautious of the legal/litigation issues and lawyers, etc…perception of metal debris and metal-ion release.”

Additional notes from the corporate minutes indicated that Depuy observed the following problems with MoM hip implants:

• Large volume of metal particles being released from the hip implants
• Metal ions being released into the body
• Poor wear results
• Metal scratches in the components taking the form of peaks and valleys (as opposed to just valleys, which would result in the hip implant lasting longer).

What Does All this Mean?

These documents appear to be from discovery in recent litigation concerning the Depuy Pinnacle hip implants, and they may have been used in Depuy Pinnacle bellwether trials. However, it’s somewhat unusual that these have been made public (by sources other than this website). The level of incriminating evidence contained in these documents is also quite unusual. If Depuy had all this information at its disposal more than twenty years ago, the injuries to patients who received the Depuy ASR and Depuy Pinnacle artificial hips in the years since then are particularly horrifying and egregious. I hope such bad publicity will further motivate Depuy to resolve its pending Depuy Pinnacle lawsuits as soon as possible.

*Note: The documents referenced and linked in this post are widely available from other news sources and were released prior to the publication of this article. The Daily Telegraph originally published “End Game” and other documents. I can not and do not verify the authenticity of these documents, nor can I confirm the truth of the statements made in the documents.

The Viagra litigation is ramping up. Last April the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation site in the Northern District of California for lawsuits alleging injury against Pfizer from the use of Viagra. Since then, the Viagra lawsuits have piled up in California federal court.

The U.S. Food and Drug Administration approved Viagra (sildenafil citrate) for sale in 1998. It set out to fix an intimate and unhappy problem: erectile dysfunction. One study indicated that thirty million men may suffer from erectile dysfunction. And it worked (I’ve heard). Millions of men standing on the sidelines were back in the game.

The reason I know it worked is because Viagra’s manufacturer, Pfizer, Inc., sold $1.8 billion dollars worth of the drug in 2013. Pfizer has self-reported that it has prescribed Viagra to 35 million men. All over the country and all over the world, those 30th wedding anniversary weekends were suddenly a lot more fun. And that’s a wonderful thing.

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Unfortunately, some of these men developed skin cancer. Melanoma is the most aggressive and most dangerous form of skin cancer. Melanoma develops when damage to skin cells triggers mutations that lead the skin cells to multiply rapidly and form malignant tumors. Many people think of melanoma as dark, asymmetrical moles, and in fact melanoma can develop from existing moles, but melanoma can also form directly on the skin. Melanoma has been estimated to cause over 10,000 deaths in the United States each year.

The problem is, men taking Viagra seemed to be developing melanoma at a greater rate than the general population developed melanoma.

The Master Long Form Complaint in the Viagra Litigation

The Master Long Form Complaint in the Viagra MDL sets out the narrative of the claims of men who developed melanoma after taking Viagra. I will bullet-point some of the important allegations:

• The Plaintiffs allege that Pfizer knew or should have known about the connection between Viagra use and melanoma, even going back to the late 1990s.
• Several studies linked Viagra use and the increased risk for melanoma.
• A 2014 study indicated an 84% increase in the risk of developing melanoma after taking Viagra, or worsening the effects of existing skin cancer.
• A 2016 study from Northwestern University reported “’a significant association with melanoma’ for users of sildenafil and tadalafil. Significantly, the study found a doubling of the risk for sildenafil.” (I write more about the science behind the connection between Viagra use and melanoma here.)
• Despite these studies, Pfizer continued to market Viagra aggressively (and you would think this medication would sell itself, given what it cures).
• Pfizer has marketed Viagra to younger men.
• Through the years, and through increasingly aggressive marketing campaigns, Pfizer did not warn users about the increased risk of developing melanoma.
• The general public and doctors who prescribe Viagra would not have known of the risks of taking Viagra.
• Pfizer knew or should have known that the drug posed a significant health risk to the men taking Viagra.
• The health risks of taking Viagra outweighs the benefits of using the drug, but Pfizer kept selling it anyway. After all, erectile dysfunction, while unpleasant, does not pose any health risks to men.
• Pfizer aggressively marketed and sold Viagra, for decades, and made a lot of money selling it.
• As a result of all these sales, consumers of the drug were placed at increased health risks.
• Many men developed melanoma.
• These men were seriously injured by taking Viagra. Melanoma is a serious health issue.
• Pfizer downplayed the risks through the manufacture and sale of Viagra.
• Pfizer did not mention any potential risks for developing melanoma in the medication label or package inserts.
• Pfizer did not mention any potential risk for developing melanoma in its advertising materials.
• As a result of Pfizer’s actions, the plaintiffs were injured.
• If doctors would have known of the risks, they would not have prescribed the drug.
• If patients would have known of the risks, they would not have taken the drug.

The Plaintiffs’ Claims

From these allegations, plaintiffs bring many claims or “causes of action,” including:

1. Negligence 2. Unfair and Deceptive Trade Practices (Unfairness, Fraud, Unlawfulness) 3. Defective Design 4. Failure to Warn 5. Failure to Test 6. Breach of Express and Implied Warranties 7. Negligent Misrepresentation 8. Fraudulent Misrepresentation and Concealment 9. Fraud and Deceit; Willful, Wanton, and Malicious Conduct 10. Unjust Enrichment 11. Loss of Consortium 12. Survival 13. Wrongful Death 14. Punitive Damages

Pitched Court Battle Inevitable

Please remember: at this stage of the litigation, the allegations listed above are not yet proven. Pfizer has denied many of the allegations and will have the opportunity to defend itself, and intends to . . . vigorously. Pfizer is represented by Williams & Connolly, DLA Piper, and Kay Scholer, three of the most expensive defense law firms in the country. Look for a pitched court battle. Still, the scientific studies are mounting which point to a clear connection between Viagra use and the increased risk for melanoma. Please talk to your doctor if you are taking Viagra (or Cialis or Levitra); it may not be worth the risks.

I’ve written about Viagra and the Viagra litigation on this site. Check it out for more information.

There are many companies making different types of IUDs that work in different ways. Some use copper as the primary means of contraception while others use hormones. One of the most popular hormonal IUDs available goes by the brand name Mirena.

How Does the Mirena IUD Work?

Mirena is a hormonal IUD that is inserted into a woman’s uterus. Once inserted, the IUD continuously releases a small amount of the hormone levonorgesterel. The Mirena IUD is extremely effective and works primarily by preventing fertilization from occurring, rather than preventing implantation of the fertilized egg into the uterus.

Another advantage of the Mirena IUD is that it works for a long period of time (three to five years) without any intervention by the woman. And when the effective time period of Mirena passes or the woman decides she wants to try to get pregnant, the Mirena IUD can be removed and fertility restored. Because of these advantages, many women have chosen Mirena as their preferred form of birth control.

What’s Wrong with the Mirena IUD?

Despite its effectiveness as a contraceptive and its popularity, the Mirena IUD has caused some women to suffer from a variety of serious conditions, including the dangerous buildup of cerebrospinal fluid in the brain. This fluid buildup then causes an increase in intracranial pressure and can lead to severe headaches, ringing in the ears, nausea, blurred vision, neck pain, and blindness due to the swelling of the optic nerve.

Many women experience progressively worsening vision as the optic nerve swelling increases. Most of these symptoms are similar to those people suffering from a brain tumor. There are several names to describe this condition, including Pseudotumor Cerebri (PTC) and Intracranial Hypertension (IH).

Depending on the woman, the effects of PTC or IH can sometimes be reversed, but it often results in permanent damage to a woman’s vision. Even if the effects can be reversed, it usually takes years of maintaining normal intracranial pressure in the brain. As a result of these problems, many lawsuits against Bayer, the maker of Mirena, have recently emerged.

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It should be noted that there are other Mirena lawsuits against Bayer that were started earlier, but they allege different problems with the IUD, such as the uterine wall becoming punctured when the Mirena IUD migrates in the uterus. The lawsuits alleging fluid buildup and brain pressure (IH) are a recent development.

What’s the Status of the Mirena IH Lawsuits against Bayer?

Dozens of women who used Mirena and subsequently suffered from IH have sued Bayer, alleging that the hormone levonorgesterel has caused the buildup of fluid in the brain.

These cases are very early in the litigation process and are currently in the procedural stages, such as consolidation and transfer to a central federal court district and evidentiary hearings. A hearing regarding a motion to consolidate and transfer is currently scheduled for March of 2017.

If you are a woman who has used the Mirena IUD and experienced any of the above mentioned symptoms, you may be suffering from intracranial pressure. You should see your doctor to determine if you have too much cerebrospinal fluid and learn how to treat it.

Let’s say you are a woman in your forties, and the mother of three children. After the birth of your third child you began to suffer from pelvic organ prolapse. This condition occurs when an organ like the bladder drops from its normal position and presses against the walls of the vagina. You go to your gynecologist, who recommends implantation of transvaginal mesh (TVM), the net-like plastic product that was marketed and sold as a solution to the problem of pelvic organ prolapse. You have the surgery. Soon you begin to suffer new and different pain and new health problems. You undergo three revision surgeries to remove all the pieces of the mesh. But after the revision surgeries you still suffer from pain and incontinence. You call an attorney, who files a lawsuit against the manufacturer of the TVM product. A few months into the litigation, your attorney explains that you now need an expert witness.

Your attorney is absolutely correct: you will need an expert witness in virtually all product liability cases. And a good one. And fast. If you do not have a qualified expert witness who can make the connection between your injuries and the failed product, then in the eyes of the court you do not have a case.

Your Most Important Witness

Expert witnesses are critical members of the team that is built to win your product liability case. In fact, other than your choice of attorney, the selection of the expert witness will be the most important decision you will make to help you win your case.

Expert witnesses are common in all kinds of litigation. In a simple car crash case, a treating doctor is almost always called to testify about the nature of the plaintiff’s injuries after the crash. In some car crash cases, a second expert witness will be called to explain why a car’s brakes failed, or why the car’s airbag did not deploy. Usually this testimony ends by showing causation, “and if the brakes did not fail, the driver would not have crashed into that oak tree and broken his arm.”

In a product liability case, the expert must be able to show causation, to make the connection between the failure of the product and the injuries the person suffered. If the injured person cannot show this causation through the testimony of a qualified expert witness, she cannot win her case. In the example at the top of this post, the expert will have to be able to testify that the new pains and the new health problems were medically caused by the failure of the mesh and the need for multiple revision surgeries.

But I’m getting ahead of myself.

more Finding a Qualified Expert Witness

Before an expert witness can testify as an expert, he or she must be qualified by the trial judge. You may have heard the name of this case before, but in most states the admissibility of expert testimony is governed by a Supreme Court case from the 1990s, Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). The Daubert standard requires a trial judge to scrutinize all potential expert witnesses before the expert is permitted to testify as an expert. If the expert is qualified by “knowledge, skill, experience, training, and education,” the expert will be allowed to testify if:

(1) the information provided by the expert will help the trier of fact to understand the evidence or determine a fact in issue;

(2) the testimony is based on sufficient facts or data;

(3) the testimony is the product of reliable principles and methods; and

(4) the expert has reliably applied the principles and methods to the facts of the case.

The qualification of an expert is one of the biggest battles that a plaintiff will face in litigation. The plaintiff’s lawyer will argue aggressively for the qualifications of the expert and the relevance of the expert’s testimony. The defense will argue just as aggressively that the plaintiff’s expert is unqualified, and that even if the expert is qualified, the testimony will not be helpful for the jury to understand the case. The trial judge will ultimately have to make the determination whether to permit the expert to testify. It is one of the key decisions the judge will make in a product liability case.

I can’t stress this enough: your expert witness is a vital part of your case. If the expert does not have proper education or credentials, or if the expert fails to provide convincing analysis of the connection between the failed product and the injuries, then the judge will reject the expert and the plaintiff will lose her case.

This situation happened recently in the Zimmer NexGen knee case. On the eve of the second “bellwether” trial, Judge Pallmeyer rejected the plaintiff’s expert and granted summary judgment for the defendants. Among other things, the judge concluded that plaintiff’s proposed expert has not “given the court sufficient basis to conclude that his opinion is reliable.” (Order, p. 17) After years of litigation, the plaintiff was out of court.

Your Expert Must be a Good Communicator

Choosing the right expert is very difficult. First, you must find a person with the right kind of expertise for the particular case. This expertise must be of a kind that will survive a motion to exclude the testimony by the defendants (such as a Daubert challenge). If your expert survives that scrutiny, he or she will still need to be able to communicate effectively with a jury. And those jurors will likely have almost no understanding of transvaginal mesh or pelvic organ prolapse (although they will know a lot about it by the end of the trial). Your expert must be able to communicate complicated medical or scientific terms in a simple way so that jurors will understand the concepts. This is no easy task. Your lawyer must talk to several potential experts before hiring one to testify on your behalf. My favorite experts are natural teachers. They can take very complicated subjects and explain them so that my teenage son can easily understand them. When that happens, you often win over the jury.

Experts don’t work for free. Every expert will charge the plaintiff for the time it takes to review the case file, analyze the information, write an expert report, and testify. Beyond that, the expert will have to be paid for travel expenses, hotels, and other costs. But if you find the right expert, the expense will easily pay off. Good luck.

Pregnancy brings with it many physical challenges, including nausea and vomiting which impact about 80% of pregnant women. It can range from being a minor issue to a potentially serious health risk, depending on the severity of the nausea and health of the mother. The drug Zofran is designed to limit nausea but it was not approved for use by pregnant women and it may cause birth defects. Although medical causation is not settled on the issue, many women who took Zofran during pregnancy gave birth to children with birth defects. Because of that potential link hundreds of lawsuits have been brought against the maker of Zofran, seeking compensation for the harm possibly done by the drug.

Intended Uses

Zofran (or ondansetron hydrochloride) helps prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that can trigger nausea and vomiting. It was originally designed to help cancer patients dealing with the side effects of chemotherapy but is also approved by the Food and Drug Administration (FDA) for those suffering nausea due to radiation therapy, anesthesia and surgery.

more Recent Medical Study

There are conflicting studies of the possible harmful side effects of Zofran but one 2014 article on the use of Zofran by pregnant women in the American Journal of Obstetrics & Gynecology made a strong recommendation against using the drug. Gideon Koren, MD, of the Motherisk Program at the Hospital for Sick Children and the University of Toronto wrote:

• The use of Zofran in the U.S. for nausea and vomiting during pregnancy increased from about 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues concerning fetal safety and FDA warnings about serious negative heart effects.
• A Danish study presented in August of 2013 showed the results of a study using the Danish birth registry covering 1997 to 2010 and 897,018 pregnancies. This study found a two-fold increased risk of heart defects in infants when their mothers used Zofran during their pregnancies, leading to an overall 30% increased risk of major congenital malformations.
• The FDA approved the use of a combination of doxylamine and pyridoxine in April 2013 specifically for nausea and vomiting during pregnancy. Since this safe and effective drug is available, there is no reason for women to be exposed to Zofran due to safety concerns for the mother and child.

Lawsuits Mounting

More than 200 lawsuits have been filed by plaintiffs claiming that their children were harmed by Zofran during pregnancy and that the manufacturer, GlaxoSmithKline (GSK), is to blame. These legal claims have been consolidated in federal court in Massachusetts. Plaintiffs claim the drug caused heart defects, cleft palates and other birth defects.

This isn’t the only issue involving Zofran that’s gotten GSK in trouble. The company agreed to plead guilty and to pay $3 billion to resolve criminal and civil liability due to their unlawful promotion of certain prescription drugs (including Zofran), its failure to report certain safety data and its civil liability for alleged false price reporting practices in 2012.

Part of the allegations was that GSK promoted some forms of Zofran for the treatment of morning sickness in pregnant women which is a use not approved by the FDA. GSK agreed to settle claims that it paid kickbacks to health care professionals to encourage them to promote and prescribe Zofran and other drugs. This resulted in $1.043 billion in false claims payments to the federal and state governments. The settlement money went to the federal government, several states, the District of Columbia and to plaintiffs involved in GSK whistleblower lawsuits.

GSK has shown it wasn’t afraid to bend the law when it comes to generating sales of Zofran. The drug may also be the cause of serious health problems for possibly thousands of children, leaving parents to care for them and pay a lifetime of medical bills.

If you believe your child has been harmed by Zofran and would like to learn more, the drug’s possible side effects and the growing litigation, feel free to call me so we can talk about your case, how the law may apply and your best options for obtaining compensation.