Pharma Law Post

Pharma Law Post

California Defective Product & Drug Litigation

Albertson & Davidson, LLP Accepting California Low Testosterone and Low T Cases

Posted in Drug & Device Litigation, Litigation, Product Liability Litigation, Testosterone Therapy Litigation

Albertson & Davidson, LLP is now accepting California low testosterone and Low T cases involving men who have suffered heart attack, stroke, deep vein thrombosis (DVT or blood clotting), or pulmonary embolism while taking prescription testosterone products.

If you, or a family member, have been harmed while taking prescription testosterone products, click the link below and answer five simple questions. Then give us your name and phone number and we will contact you to discuss your case.

California Low Testosterone or Low T Questionnaire

These prescription testosterone products include low testosterone supplants AndroGel®, Androderm®, Axiron®, Bio-T-Gel, Delatestryl, Depo Testosterone, Fortesta®, Striant, Testim®, and Testopel®.

The journal PLOS ONE published a recent study that showed testosterone therapy in men over 65 doubled their risk of heart attack and tripled the risk of cardio events for men under 65 with pre-existing heart disease. Another recent study, published in the Journal of the American Medical Association (JAMA), raised similar concerns. Injuries can occur within 90 days of exposure via topical gel, transdermal patch, and/or buccal system (gum).

Medical prescriptions for low testosterone (or Low T) therapy have more than doubled since 2006. In 2011, 5.3 million testosterone prescriptions were written in the United States. Estimates show 13.8 million American men now experience the effects of lowered testosterone levels.

The FDA has taken note of these safety studies and the growing number of users. The FDA decided to reassess the safety issue of testosterone supplementation based in part upon the PLOS and JAMA publications. The FDA announced on January 31, 2014 that it is evaluating the risk of stroke, heart attack and death from testosterone products.

Men across the United States are being urged by aggressive marketing to seek treatment for not only symptoms of Low T but also low energy, sagging muscles, decreased libido, mood changes, and emotional injuries to name a few. These products are used by nearly 4 percent of men in their 60s, but only about half those men even had their testosterone levels checked before beginning therapy. Meanwhile, the FDA has approved testosterone products only for men with low testosterone levels who also have an associated medical condition.

A national leader with a track record of success against Big Pharma, Albertson & Davidson, LLP is accepting California law testosterone and Low T cases involving men who have been harmed by taking prescription testosterone products.

Two Recent Studies Indicate Testosterone Therapy Doubles Risk of Heart Attack and Triples Risk of Stroke—Testosterone Therapy Litigation Beginning in California Because Big Pharma Failed to Warn About Heart Attacks and Strokes Associated with Testosterone Therapy

Posted in Drug & Device Litigation, Litigation, Product Liability Litigation, Testosterone Therapy Litigation

Prescriptions for low testosterone (or Low-T) therapy have more than doubled since 2006. In 2011, 5.3 million testosterone prescriptions were written in the United States. It’s estimated that 13.8 million American men now experience the effects of lowered testosterone levels.

And Big Pharma companies are urging these men with aggressive marketing tactics to seek treatment for not only symptoms of “Low T,” but also low energy, sagging muscles, decreased libido, mood changes, and emotional issues, to name a few.

The largest Big Pharma companies that make and market Low T medical products are:

  • Abbvie, Inc. (a wholly owned subsidiary of Abbott Labs), which makes the name brand AndroGel® testosterone gel.
  • Elli Lilly and Company, which makes the name brand testosterone underarm gel Axiron®.

There are also a group of smaller Big Pharma companies that manufacture and sell prescription testosterone. They are:

  • Actavis, Inc., who markets Androderm®
  • Endo Pharmaceuticals, who markets Fortesta® Testosterone Gel
  • Auxilium Pharmaceuticals, Inc., who markets Testim Testosterone Gel
  • BioSante/Teva, who markets Bio-T-Gel

Two recent studies show that testosterone therapy in men over 65 doubled their risk of heart attack and tripled the risk of cardio events for men under 65 with pre-existing heart disease. Injuries can occur within 90 days of exposure from testosterone made of topical gel, transdermal patch, buccal system (gum), and injection.

The FDA took note of the recent two studies and the growing number of men who use testosterone therapy. The agency has decided to reassess the safety of testosterone supplementation evaluating the risk of stroke, heart attack, and death from testosterone medical products.

Significantly, the FDA only approved testosterone products for men with low testosterone levels who also have an associated medical condition.

More to come on this story as it develops.

Off-label Promotion of Big Pharma Drugs Will Continue in the Current Regulatory Environment

Posted in Drug & Device Litigation, Litigation, Product Liability Litigation

In 2007, Bristol-Myers Squibb paid over $500 million to settle lawsuits for its unlawful promotion of one of its drugs. In 2009, Eli Lilly paid over $1.4 billion (yes that’s “b” for billion) for unlawful promotion of Zyprexa. In 2013, GlaxoSmithKline paid $3 billion (yes, again, “b” for billion) for unlawful promotion of various drugs. And now, Johnson & Johnson agreed last week to pay $2.2 billion for unlawfully promoting one of it’s best selling drugs, Risperdal.

What’s going on here? Why are all of these Big Pharma companies unlawfully selling their drugs? The answer is… money.  And it doesn’t matter how much these companies are fined by the Department of Justice, or how many lawsuits are filed by lawyers for the harms the unlawful promotion causes to patients; it doesn’t matter because these companies still make billions of dollars after paying the fines and the consumers they harm.

So how do these companies do this? Easy. They create a drug; any drug will do, and seek FDA approval of that drug. They go through extensive clinical studies to obtain the FDA’s narrow approval, which is put on a label for that drug. Then the FDA, to protect the public, says in its regulations that the drug company cannot promote the drug for anything other than it’s approved use. And companies are allowed to market their drug for on-label uses—but they cannot promote the drug for off-label uses.

Here’s where the gigantic loophole comes in. Doctors are allowed to prescribe drugs how they see fit for a particular patient. So, if a doctor believes a drug should be prescribed for off-label uses, there is no prohibition that keeps them for doing it. That’s where the drug companies come in. They promote the drug to the doctors to use for off-label uses. They promote these drugs in various ways, including, paying doctors to write prescriptions, paying key opinion leader doctors (so-called KOLS) to promote the drug to younger or less learned doctors, and paying researchers to write positive reviews in “peer reviewed” publications about off-label uses.

And while these drug companies face hefty fines from the federal government, state governments, and some lawyers, the companies still end up making millions, and in some cases, billions of dollars. The problem is that consumers and patients get hurt by the side effects of these off-label promoted drugs—in some cases, serious injury, including death.

Until the FDA begins to impose real and significant monetary fines against these companies, we’ll continue to see year in and year out a few billion here and there being paid in fines by these companies, while they continue to make many times over the amounts fined.

The Sympathetic Jury

Posted in Litigation, Product Liability Litigation, Vaginal Mesh Litigation

How many times have you heard a defense attorney say to potential jurors during jury selection that the jurors can’t feel “sympathy” for a plaintiff in rendering their verdict? The defense attorney usually follows this up with, “so Mr. Jones, you agree that you will not let the sympathy you feel for the plaintiff impact any award you might make in this case?” Then the defense attorney polls the entire jury pool with that same question over and over again.

As plaintiffs we need to address the issue of “sympathy” before the defense attorney attempts to precondition the jury into thinking there’s something wrong with having feelings or emotions during a jury trial. And we can do this because we get to go first in jury selection. That means we must be the ones to talk to them about sympathy and where it fits into a trial.

To do this, I start by talking to the potential jurors about things in the case they must award damages for (if we meet our burden of proof), and things in the case that they must never award damages for. I give them examples based on the elements in the verdict form that establish the things that California law allows money damages for. For example, I say “in a wrongful death case like this, California law requires damages if I prove to you that my client lost her child’s love, care, and companionship in a tragic incident. Mr. Jones, do you have any problem awarding money damages for the loss of a child.”

I then move to the issue of sympathy. I’m honest with the potential jurors and let them know that California law does not allow the jury to make a damage award based on their feelings of sympathy for my client. I tell the potential jurors that not allowing sympathy for my client makes perfect sense. The reason sympathy is not allowed as a basis for a damage award is because it is inadequate. That’s right—sympathy is inadequate, and the jurors must not make an award of money damages to my client based on how bad they feel for her. The reason sympathy is inadequate is because it’s charity—in other words, it’s not deserved. Its just jurors being “nice” to my client based on the sympathy they feel about her losing a child, etc.

I then tell the jurors that we are not here for sympathy or charity, but for only one thing “justice”—full justice, not partial justice. And the difference between charity and justice is that justice is deserved. Everyone is entitled to justice. I then point out the elements again in the verdict form and state that this is justice, not sympathy.

I close on the “sympathy” issue by saying we are not looking for robots to hear this case. If we only wanted robots we would put all the evidence into a computer, which would make a verdict based on zero emotion. I tell the jurors that they’ve all been training for this day since they started first grade. We are only asking them to use their common sense when evaluating the evidence in the case, and in no event are we asking them to have zero feelings when they hear or decide the case. We just don’t want them giving an award based on sympathy—we only want an award based on justice. “Mr. Jones, do you agree you will not make an award based on sympathy for my client? And Mr. Jones, if you feel sympathy for the defendant, do you agree you won’t give her a discount on damages because you feel sorry for her? Finally, Mr. Jones, you promise to follow California law and only award damages based on the things California law allows (if I meet my burden of proof)?”

I used this strategy in a recent jury trial. My associate who was with me said the defense attorney kept crossing things off on his legal pad. When the defense attorney got his chance in voir dire, he tried to talk about the “no sympathy” thing, but quickly became uncomfortable with it and moved on. Mission accomplished.

We can’t let defense attorneys attempt to precondition jurors with the idea that they can’t feel sympathy during the case. Of course the jurors can have feelings and emotions about the case. It’s our job to make sure we talk about the appropriate place for feelings, emotions, and even sympathy at trial.

Tort Reform Walking: How to Ask a California Jury for Money Damages

Posted in Litigation

There are multiple inputs of information required to obtain a full and fair jury verdict in a California civil case. But one input may be the most important—and that is asking the jury for money damages.

Jury Selection: This case is about the “money”.

We plaintiffs get to go first in jury selection. We need to make sure when we go first that we take away the distorted view of money damages that the defense will likely present to the potential jurors. We can count on two things being raised in defense voir dire in every case: first, the defense attorney will tell the potential jurors that this case is about “the money”, and, second, that the jurors cannot make a decision based on sympathy. Since we know the defense will do this, we must address these issues first. (In this post I’m only addressing money damages.)

You must be up front and tell the jury in voir dire that this case is about the “money.” Don’t run away from this concept. Don’t try to make it sound better than it is… because the truth is, this case is about the “money.” Once you’ve made sure to tell the potential jurors that this case is about the “money”, ask them questions like:

  • “California law will require you to associate “money” with the harms and losses my client has suffered. Anyone here going to have a problem associating “money” with my client’s losses?” When a juror says she will have a problem doing that, don’t shut her down. Thank her for the answer and ask her to tell you more about her response. Then once again, ask her if California law requires her to associate money damages with your client’s losses, can she do it in spite of her feelings? Ask if any other jurors feel like this juror does about “money” in a case like this.
  • The ask, “Do you think it’s important in our “justice” system, if someone hurts another person, the hurt person has a right, if they choose, to file a lawsuit and ask for “money” damages for their harms and losses?” Again, your job here is not to argue with the potential jurors, but to get them all talking about the concept of “justice” and “money”.
  • Then ask, “If the evidence supports a verdict in this case in the millions of dollars, anyone here have trouble allowing millions of dollars for the harms suffered?” Again, get the jurors talking. You should be talking 10 percent of the time, and the jurors should be talking 90 percent of the time. Don’t ever disagree with a juror. Always thank them for their candor and honesty.
  • The ask, “The law will only allow you to consider my client’s harms and losses in this type of case. The law will not allow you to consider whether the money will do any good, or bad things happen to us all, or whether the money will put my client on easy street. Anyone here have a problem with only considering my client’s harms and losses when deliberating this case? Do you all agree you will not consider things that California law does not allow you to consider in deliberations?”
  • “During deliberations, if one juror says ‘this will cause our insurance rates to go up’ or ‘the money won’t do any good’ or ‘money will put the plaintiff on easy street’, are you willing, as a juror in this case, to tell that one juror that the law does not allow the jury to consider those types of things? That the jury can only consider my client’s harms and losses when evaluating the “money” damages?”

Of course there are other concepts you want to cover in voir dire, and some judges allow more probing questions on “money” damages than others. So work with what the judge allows and the time permitted in voir dire to address “money” damages. Make sure the potential jurors understand this case is about the “money”, your client’s “harms and losses” only, and ultimately about “justice.”

Closing Statement: This case is about “justice”. 

Now in closing, you want to make sure the jurors understand that “money” damages equals “justice.” I say things like:

  • I remind the jurors of voir dire where they all “promised” they could associate “money” damages with my client’s losses, etc.
  • Then, I like to tell the jurors that we have been struggling for thousands of years with how to compensate someone who has been injured by another. I point out that some of the earliest writings of mankind (the Code of Hammurabi for example) have rules for compensating victims of personal injury. I then tell them that some of them may be more familiar with the Old Testament where that society stated if you injured another’s eye, then you lost your eye too. This is where we get the saying an “eye for an eye”, “tooth for a tooth”, “burn for a burn.” That’s how that society gave “justice” to someone who was harmed by the careless acts of another.
  • Then, I talk about the modern “eye for an eye”, which says “money” damages are how we give “justice” to someone who has been harmed by another’s careless conduct. I tell them money can never fully compensate my client for what happened, but that’s what “justice” requires, and California law requires “money” damages if we prove our case.
  • I point out that my client does not want to be there; does not want to ask the jurors for “money”. And if the jurors could render the ultimate verdict, we would only ask that my client be put back in the condition she was in before the harms were suffered. But since we don’t live in a world where we can go back in time to fix harms, we have to give “full and fair justice” for the harms my client has suffered.
  • If the “money won’t do any good” issue is strong in the case I give an example of Bill Gates owning a $50 million dollar racehorse. I say if Bill Gates, the richest man in the world, owned a $50 million dollar racehorse, and he asked someone to move the horse from California to Arizona for a race, and the person moving the horse didn’t follow appropriate rules for moving horses and the horse was killed, what are Bill Gates’ damages? I say we all agree the horse was worth $50 million dollars. Thus, we would give Bill Gates $50 million dollars—even though he doesn’t need $50 million because he’s the richest man on planet earth. But we give him $50 million anyway, because that’s what “justice” requires. And partial or incomplete justice is worse than no justice at all.

Once again, there are other concepts you must cover in closing statement (i.e. civil burden of proof, 9 of 12 jurors for each decision on the verdict form, your favorable facts and documents, etc.). But this is how I generally address money damages at trial. How many times have we heard the defense attorney get up in voir dire and closing statement and say, “this case is only about ‘money’”? If you do what I’ve suggested in this post, the jury will agree with the defense attorney—‘yes’ this case is about “money”—and they will render a full and fair verdict.

I recently used this strategy in a trial in San Bernardino County—Sloan v. Redmond—where the jury awarded $5.7 million for the death of my clients’ daughter who was killed in a DUI crash. I was honest with the jurors in voir dire and closing, stating that this case is about the “money.” The jurors agreed. We don’t need to shy away from our cases being about “money”, because “money” really means “justice” in a civil case. It’s our job to equate “money” with “justice.”

 

GranuFlo® and NaturaLyte® California Lawsuits on the Rise

Posted in GranuFlo and NaturaLyte Litigation, Product Liability Litigation

New product liability lawsuits being filed in California against Fresenius

There’s a new type of product liability lawsuit being filed by injured California patients who have been treated for kidney failure at Fresenius and third-party dialysis clinics who choose to use GranuFlo® and NaturaLyte®.

How dialysis works

California patients suffering from end stage kidney failure are treated with dialysis at these clinics, which removes toxins and excess fluids from the blood. The patient is connected to a dialysis machine that removes blood from the patient’s body, runs it across a membrane, and returns it to the body. As the blood runs across the membrane, a fluid on the other side, called dialysate which consists of purified water, an acid concentrate and bicarbonate concentrate, draws out and carries away toxins and excess fluids and supplements the blood with necessary electrolytes, such as sodium, potassium, calcium and magnesium.

Dialysis and the blood’s pH balance

The goal of dialysis is to restore the pH balance in the patient’s blood. The body naturally produces acid which normally functioning kidneys neutralize to prevent metabolic acidosis, a condition in which the blood contains too much acid. Most dialysis treatments accomplish this by including bicarbonate concentrate, a base, in the dialysate to buffer the acid in the patient’s blood.

Too much bicarbonate can cause heart attacks, strokes, and death

Patients are prescribed a specific amount of bicarbonate by their physicians to be delivered during the dialysis process. If a patient undergoing dialysis receives an excess of bicarbonate, metabolic alkalosis can occur. Metabolic alkalosis is a medical condition in which there is too much bicarbonate or base in the blood. If left untreated, metabolic alkalosis can lead to serious adverse health consequences, including heart attacks, strokes, and even death.

Allegations being made against Fresenius regarding GranuFlo® and NaturaLyte®

The allegations being made in the GranuFlo® and NaturaLyte® lawsuits boils down to these products delivering too much bicarbonate, resulting in heart attacks, stokes, and death in patients who are treated with these substances during dialysis.

Did Fresenius know about the higher levels of bicarbonate in GranuFlo® and NaturaLyte®?

What makes these cases worse, if true, is the allegation that Fresenius—the manufacturer of GranuFlo® and NaturaLyte®—had knowledge that these products delivered too much bicarbonate, but chose not to warn anyone about the dangers and risks to patients using these during dialysis.

Fresenius Internal Memos

For example, an internal memoranda concerning GranuFlo® Concentrate from Fresenius executives and medical staff dated December 7, 2000, authored by Dr. J. Michael Lazarus, head of the Fresenius Bicarbonate Committee stated that Fresenius clinics were not accounting for the increased amount of bicarbonate in GranuFlo® and NaturaLyte®. Additionally, in a series of memos from 2005 to 2008, Fresenius acknowledged the increased risk of death with the use of GranuFlo® and NaturaLyte®, yet continued to manufacture, distribute, market and sell GranuFlo® and NaturaLyte® to third-party dialysis clinics. During this time, it is alleged, Fresenius chose not to warn of the defects and increased risk of injury and death for patients using GranuFlo® and NaturaLyte® during dialyses. Finally, in an internal memo dated November 4, 2011, Fresenius noted that its own patients’ serum pre-dialysis bicarbonate levels had steadily increased form 2004 to 2011 which was during the time Fresenius was increasing the use of GranuFlo® and NaturaLyte® in their own clinics. 

The FDA issues a Class I recall of GranuFlo® and NaturaLyte®

In March 2012, the FDA issued a Class I recall of GranuFlo® and NaturaLyte®. A Class I recall is the most serious recall issued by the FDA. In its recall the FDA stated “This product may cause serous adverse health consequences, including death.”

Were any warnings given to patients?

It appears that Fresenius knew about the increased risks of using GranuFlo® and NaturaLyte® during dialysis, but chose not to warn doctors, clinics, and patients about these increased risks. We will report more on these cases as they are filed, and as we find out more during the discovery process.

More Good News Out of California’s Central District in the Vaginal Mesh Litigation

Posted in Product Liability Litigation, Vaginal Mesh Litigation

Some more good news came out of California’s Central District today in the vaginal mesh litigation mess. Federal Judge Philip S. Gutierrez remanded a mesh case back to California State court against the wishes of vaginal mesh manufacturer American Medical Systems, Inc.

Earlier in the year an injured California patient filed suit against American Medical Systems in California State court claiming significant injuries from the manufacturer’s vaginal medical device known as the MiniArc® Sling System. A few weeks later American Medical Systems removed the case the Federal Court claiming that the injured plaintiff did not have a right to file her case in state court.

American Medical Systems arguments were simple enough. It argued that the California doctors who implanted the MiniArc® in the patient were “fraudulently misjoined” in the State suit. It also argued that the case should be stayed and effectively punted to a West Virginia Federal Court.

But Judge Gutierrez disagreed with American Medical Systems’ arguments. He held that the case should not be stayed until it was determined that the Federal Court had jurisdiction over the case to begin with. Since Judge Gutierrez ultimately held that the Federal Court did not have jurisdiction, he did not stay the case. Rather, he sent it back to California where it belongs.

Thus far American Medical Systems has removed five cases from State court to Federal Court involving California patients. Of those five cases, three have been returned to State court. We are still waiting for one more decision to come down, and hopefully we will see that case remanded as well.

Some Good News and Not So Good News Out of California’s Central District Involving Transvaginal Mesh

Posted in Drug & Device Litigation, Product Liability Litigation, Vaginal Mesh Litigation

First, the good news. U.S. District Judge Josephine Staton Tucker remanded a vaginal mesh case back to California state court against the wishes of vaginal mesh maker American Medical Systems. You can see Judge Tucker’s order here.

And, second, the bad news. U.S. District Judge Audrey B. Collins decided not to remand a vaginal mesh case back to California state court. You can see Judge Collins’ order here.

Thus far, we’ve obtained federal court orders remanding three vaginal mesh cases to California state court, namely Goodwin, Lung, and Haston. You can see the Goodwin order above, the Lung order here, and the Haston order here.

There are still two cases that should be decided by the federal court in the next week or so. I’ll update that when it occurs.

The Central District of California Sends Another Invalidly Removed Vaginal Mesh Case Back to California State Court

Posted in Drug & Device Litigation, Product Liability Litigation, Vaginal Mesh Litigation

The vaginal mesh companies procedural gamesmanship continues to fail in the Central District of California. On Monday United States District Judge S. James Otero ordered a transvaginal mesh lawsuit back to California state court against the wishes of vaginal mesh manufacturer C. R. Bard, ruling that a California doctor was not “fraudulently misjoined” as a defendant in the original state court lawsuit. You can see Judge Otero’s order here.

This is a new (not so new now as it’s been copied by every defense firm who chooses to protect dangerous products made by vaginal mesh manufacturers) tactic where mesh companies unilaterally remove a state filed case to federal court claiming that the injured patient “fraudulently misjoined” the in-state doctor who surgically implanted the mesh.

But the “fraudulent misjoinder” doctrine does not apply in California or in the Ninth Circuit for that matter. But that doesn’t stop the vaginal mesh company defense attorneys from making this invalid claim.

The mesh company defense attorneys do this with the hope that the federal court will punt the “fraudulent misjoinder” issue to another federal court located in a far away venue, for example West Virginia. If that happens the West Virginia court is so busy dealing with thousands of other cases filed against the various transvaginal mesh companies, that it does not have time to rule on whether the mesh maker had the right to remove the case from state court to begin with. Voilà, the vaginal mesh company, if successful, just discounted the ultimate amount they’ll pay in damages to the injured California patient to pennies on the dollar.

But in this most recent case remanded back to state court, C. R. Bard’s (a mesh maker) strategy didn’t work in the Central District. Now the injured California patient’s case will be heard in front of a California jury.

Some more good news came out of the Central District of California a few weeks ago when United States District Judge John F. Walter ordered another transvaginal mesh case back to California state court. You can see Judge Walter’s order here.

In that case the defendant was American Medical Systems, who paid their defense attorneys—Reed Smith, LLP—to invalidly remove a case—Haston v. American Medical Systems, Inc.—from state court to federal court. Thankfully in Haston the federal court simply sent the case back to where it belongs—California state court.

American Medical Systems paid its attorneys—Reed Smith, LLP—to invalidly remove four other state-filed transvaginal mesh cases to federal court in late February 2013. The hearings on whether these cases should be sent back to the state courts are coming soon. I’ll provide an update when those cases are decided.

Federal Court Sends Vaginal Mesh Case Back To Riverside County Superior Court

Posted in Drug & Device Litigation, Product Liability Litigation, Vaginal Mesh Litigation

Some great news came down today from the Central District of California regarding a transvaginal mesh case that was recently removed to federal court by American Medical Systems, Inc.’s defense attorneys ReedSmith, LLP. Federal judge John F. Walter ordered the case back to the Riverside County Superior Court. (FYI, the picture to the right is not a picture a judge John F. Walter.)

The case—Haston v. American Medical Systems, Inc. (Case No. RIC 1218837)—was filed in Riverside County Superior Court in early late 2012. On February 27, 2013, American Medical Systems unilaterally removed the case to federal court (Case No. ED CV 13-00364-JFW OPx) alleging that the case could be removed based on diversity of citizenship between the plaintiff and defendant American Medical Systems, Inc.

But there was one glaring problem for American Medical Systems; the plaintiff and another named defendant–the doctor who surgically implanted American Medical Systems’ medical device into the plaintiff–were both California citizens, meaning the case did not qualify for removal to federal court.

But that didn’t stop American Medical Systems from unilaterally removing the case to federal court. American Medical Systems based its removal on “fraudulent misjoinder”of the defendant doctor relying on the so-called Tapscott doctrine that came out of the Eleventh Circuit in 1996. (FYI, we are in the Ninth Circuit in California.)

But the federal court wasn’t buying American Medical System’s unilateral removal to federal court. The federal court, without holding a hearing, remanded the case to California state court. The court based its decision on law school 101 analysis, as follows:

Federal courts are courts of limited jurisdiction, and federal jurisdiction must be rejected if there is any doubt as to the right of removal by American Medical Systems. Additionally, there is a strong presumption that the federal court does not have jurisdiction. Finally, American Medical System, the party invoking federal jurisdiction, bears the burden of demonstrating that removal to federal court was proper. Because the plaintiff and another defendant in this case (the implanting surgeon) were from California, American Medical Systems could not meet its burden of proof to have the case removed to federal court.

The federal court also dismissed American Medical Systems reliance on the Eleventh Circuit’s so-called Tapscott doctrine, based on Tapscott v. MS Dealer Serv. Corp., 77 F.3d 1353, 1360 (11th Cir. 1996). The court found that the claims by the plaintiff against the California defendant and the vaginal mesh company had a real connection to each other. The plaintiff’s claims involved serious bodily injuries that she suffered as a result of a defendant doctor (and California citizen) surgically implanting American Medical Systems’ medical device known as the MiniArc® Sling System. American Medical Systems designed, manufactured, marketed and distributed the MiniArc® Sling System to ostensibly help women suffering with stress urinary incontinence. Accordingly, the federal court found that American Medical Systems failed to demonstrate that the parties in the case were completely diverse.

This is the first of six cases that American Medical Systems removed to federal court in February 2013. I’ll update the other five cases as the various federal district courts decide our requests to remand.