Georgia federal court finds preemption of breach of warranty claim

Plaintiff’s counsel and defense counsel are equally guilty of the well-known and respected legal strategy called “throw everything against the wall and see if something sticks” strategy.  It starts with the complaint when Plaintiff’s counsel pleads every cause of action under the sun.  It is perpetuated when defense counsel pleads every affirmative defense in the known universe (including our favorite, laches).  Both are hoping, sometimes beyond hope, that when the issues are finally clarified, and both sides begin to determine what the case is actually about, they will have pled correctly.

Sometimes, though, it doesn’t work out that way.  In Haynes v. Cyberonics, Inc., No. 1:09-CV-2700-JEC, 2011 WL 3903238 (N.D. Ga. Sept. 6, 2011), Plaintiff Cloys Haynes sued the manufacturer of a device called a Vagal Nerve Stimulator, which had been implanted in his neck to control epileptic seizures.  He claimed that a few months after the device was implanted, he suffered various symptoms, including feelings of electric shock and tingling.  He also alleged that he suffered permanent left side neurological damage and chronic pain in parts of his body, including his throat and ear.  Ultimately, Plaintiff underwent surgery to remove the original device and replace it with a new, identical device. Problem for Plaintiff:  During the surgery to replace the device, a diagnostic test was performed on the original nerve stimulator. It was found to be normal.  No other testing was done.

Plaintiff’s original causes of action included strict liability, negligence, breach of warranty, punitive damages, and loss of consortium. Plaintiff later amended the Complaint to add a negligent manufacturing defect claim. He also sought attorneys fees for his troubles.

Just prior to the expiration of the discovery deadline, Plaintiff moved to have the case dismissed without prejudice.  Not surprisingly, the defendant opposed the motion and filed a motion for summary judgment, as well.  It also subsequently filed a motion to allow for supplemental briefing based on new preemption law in the 11th Circuit.  That motion was granted by the Court.

The Defendant based its summary judgment motion on the doctrine of preemption and asserted that all of Plaintiff’s causes of action failed in the face of this super-defense.  We’ve blogged about this defense before.  It’s awesome.  As the Court in this case noted, “[u]nder the doctrine of federal preemption, state laws that conflict with federal law are ‘without effect.'”  The Court also provided a very nice articulation of the test used in such cases:

In Riegel v. Medtronic, Inc., the Supreme Court determined that this express preemption clause will bar common law claims arising from injuries caused by FDA-approved medical devices in many circumstances. Tracking the language of the statute, Riegel set forth a two-pronged test for deciding whether state claims are preempted. First the district court must determine whether the federal Government has established requirements applicable to the device. If so, the court must then determine whether the plaintiff’s common-law claims are based upon state law requirements (1) that are “different from, or in addition to” the federal ones and (2) “that relate to safety and effectiveness.”
Plaintiff did not dispute that the nerve stimulator, as a Class III medical device, was subject to federal requirements for purposes of a preemption analysis.  It also conceded that, as a result, his design claim was preempted.  He didn’t concede, however, that preemption barred his other causes of action.
As to Plaintiff’s cause of action for manufacturing defect, a strict liability claim, the Court held that the claim was preempted:
Clearly, the FDA regulates the manufacturing practices of Class III medical devices.  Further, a manufacturer could comply with all FDA regulations, but nevertheless produce a product containing an unintended flaw or abnormal condition. That being so, by holding a manufacturer liable under such circumstances, Georgia law would be in the position of imposing requirements “in addition to” federal law.  Accordingly, [as] defendant argues, plaintiff’s strict liability manufacturing defect claim is therefore preempted.
Even if the claim were not preempted, the Court reasoned, Plaintiff had failed to provide any proof that the device was negligently manufactured.  He also failed to provide evidence that the symptoms and/or injuries he suffered were caused by the device.  (There’s that pesky lack of expert testimony thing again).
Plaintiff also argued that the device contained an inadequate warning, which is a design defect under Georgia law.  An inadequate warning may amount to a design defect and permit the imposition of strict liability.  However, because the FDA regulates content and appearance of prescription medical device labels, Georgia law would be imposing “requirements” that were “in addition to” federal regulations. As such, this claim was also preempted.
Plaintiff almost succeeded in surviving summary judgment on his negligent manufacturing defect claim.  As the Court noted, a “negligent manufacturing claim would not be preempted to the extent it relied on an allegation that the particular device had not been manufactured in accordance with the FDA’s pre-market approval process.”  However, although Plaintiff survived preemption on this claim, he failed to survive the summary judgment motion because he had failed to offer any evidence of any manufacturing defect claim. Oh, well.
The most interesting analysis in this case, however, centered on the issue of preemption in the context of a breach of warranty claim.  The Court stated, “Riegel did not address a breach of express warranty claim.  Nor has the Eleventh Circuit decided whether a breach of express warranty claim can be preempted by the MDA. Other federal courts remain divided over the issue.”
The Court held that preemption does apply in the context of a breach of warranty claim.  Its reasoning follows:
In any event, the express representation claims in this case would interfere with the FDA’s pre-market approval regime. Plaintiffs claim that defendant expressly warranted the stimulator to be “safe, and generally fit for use as an implanted stimulator,” when in fact the device was not safe.  In order to prove that defendant breached this warranty, plaintiff would need to show that the stimulator was not safe: a finding that would directly conflict with the FDA’s pr-emarket approval of the device as reasonably safe and effective.  Moreover, if these warranties were made in materials approved by the FDA in the pre-market approval process, then allowing a claim to proceed under Georgia law would subject defendant to state duties above and beyond the federal requirements.  Such a claim would fall within [the] preemption clause prohibiting state requirements that are in addition to, or different from, federal requirements.
Accordingly, the Court concluded that Plaintiff’s express warranty claim was also preempted.

BMW Enters Driverless Car Market

We here at Abnormal Use have blogged a few times now about Google’s attempt at a driverless car and the implications such a development might have on product liability law.  The question we posed to you, dear readers, is this:  when the law has developed around the [perceived] limits of technology, and that technology moves beyond that body of law, what happens?  When the driverless car crashes, who is responsible–can the owner of the car that caused the accident turn around and sue the manufacturer for a manufacturing or design defect? Read our prior posts for our thoughts on those general issues.

News alert: We may soon find out.  As recently reported by Wired, BMW is also testing a so-called “autonomous vehicle” and has outfitted a 5- series sedan with technology that enables the car to navigate heavy traffic, or in an emergency.  As such, the technology may not be intended to totally replace the driver, unlike the Google technology.  The BMW only takes over when driving becomes a chore: in a traffic jam.  The BMW is also not as well traveled as the Google car; BMW has put only 3,100 miles on its sedan’s odometer, while the Google car has more than 140,000.

The auto accident attorney in TX like Eric Ramos Law, PLLC says it’s further evidence that this is one direction in which automobile technology is headed, and product law must be prepared.  And yet, here is a thought: is the current state of product liability law already equipped to handle such a question?  The fundamental question of any products case is always this: what caused the injury or damage?  There are a number of possibilities – the design is bad, the manufacture of the particular product was shoddy, the owner failed to maintain the product, or it was simple operator error.  If we consider this the basic universe of theories, then is the law ready to handle the driverless car crash today?

9/11: The Passing of a Decade

Today marks the tenth anniversary of the 9/11 attacks on the United States.  Accordingly, we here at Abnormal Use and Gallivan, White, & Boyd, P.A. will take a moment to reflect on this solemn occasion.  There is no denying that we are a different country today than we were on September 10, 2001.  And yet we are also the same country – a place where we have the freedom to disagree with anyone about any subject, openly and in public.  Blogs like ours are not possible in many of the world’s countries, and we are thankful for the opportunity to express our opinions, and  read the opinions of others, in a forum that sparks lively and at times heated conversations.  We now have to take off our shoes before passing through metal detectors at the airport, and the purse searches at the ballpark are a little more thorough than they used to be.  But we are still free to disagree with one another and, for that matter, our government.  In that way, the attacks failed miserably to achieve their purpose. But on this day, on this anniversary of one of the greatest tragedies this nation has ever seen, we pause to reflect upon those who lost their lives that day and those who heroically came to the scene to respond to what had happened.  They and their families remain in our thoughts and prayers.

Montana Enhanced Injury Case Places Evidence of Seat Belt Usage Directly at Issue

In an enhanced or second injury case, the plaintiff claims that although the initial incident or accident caused him to suffer only minor injuries, the defective design and/or manufacture of a particular product caused him to suffer additional injuries.  The theory is that but for the negligent design or manufacture, the plaintiff would have walked away with only minor injuries.

This was the plaintiff’s theory of the underlying case at issue in Stokes v. The Montana Thirteenth Judicial District Court, — P.3d —-, 2011 WL 3304510 (Mont. August 1, 2011).  A man named Peter Carter was killed after being involved in a car accident during which the vehicle he was driving rolled over.  People around him did not have a c2c cpr training in london which is why they could not help him on time. Plaintiff Stokes filed a wrongful death and survival action on behalf of Carter’s estate against the car’s manufacturer (Ford), the rental car agency that rented Carter the vehicle (Overland West, Inc.) and the driver of the other car involved in the accident (Todd Durham).   Durham admitted that he caused the initial accident.  Stokes’ theory against the other two defendants was that “the initial impact caused only minor injuries, but the seat belt in the vehicle slackened and spooled out during the rollover, allowing Carter to be partially ejected from the vehicle and causing his fatal head injury.”  The case was brought on theories of negligence and strict liability against both defendants.

The fact that the plaintiff pleaded both negligence and strict liability in the case was problematic for the trial court, which didn’t think a jury was smart enough to distinguish between the two of them.  In Montana, evidence of seat belt use (or lack thereof) is admissible in product liability claims, but not in negligence claims.  So, “The court thus informed Stokes that if he planned on using evidence of seat belt use or non-use in his strict liability claims against Ford and Overland, he would be required to drop his negligence claims against all three defendants.”

So much for alternative pleading in Montana.

Stokes then petitioned the Montana Supreme Court for supervisory control, based on the fact that, basically, he should be permitted to assert both causes of action.  First, the Court considered whether or not the case was appropriate for the exercise of supervisory control.  Deciding in the affirmative, the Court then turned to the issue of whether evidence of seat belt use was precluded in either the strict liability or product liability cause of action.

The applicable Montana statute, The Montana Seat Belt Use Act, states that evidence of compliance or non-compliance with the mandatory seat belt law is not admissible “in any civil action for personal injury or property damage resulting from the use or operation of a motor vehicle,” and failure to comply with the seat belt use law does not constitute negligence.

Ford contended that all evidence of such use or non-use should be excluded, or that at the very least, such evidence should be inadmissible in the negligence cause of action.  Stokes had a different argument, modeled on the theories underlying negligence and product liability principles.  Citing a prior case, he argued that the statute “bars proof of seat belts in a claim for negligence,” where the focus is on the parties’ conduct, but “does not apply to product liability claims,” where the focus is on the condition of the product.

An interesting argument in most cases.  In this case, however, as the Court pointed out, the seat belt was placed directly at issue by the plaintiff’s claim that the seat belt system was defective, and caused the enhanced injury of the decedent after the initial accident.

With this in mind, the Montana Supreme Court held that evidence relating to Carter’s use of a seat belt was not prohibited under either cause of action, in the context of its bearing on the condition of the seat belt restraint system.  The Court did hold, however, that a limiting instruction for the jury was appropriate “to ensure the evidence is used only for this purpose.”

Google Crashes – Literally (More on the Driverless Car Dilemma)

Back in October, we blogged about Google’s new driverless car and used that new technology as a starting point to ask some poignant questions about how the law has failed, in general, to keep pace with the current speed of innovation.  Our specific question on that date was as follows:

As both the ABA Journal and The New York Times point out, the obvious question is this: Who is liable for an accident caused by a car that is driving itself – the person sitting in the driver’s seat of the car who isn’t actually driving, or the manufacturer of the driverless car itself?

At the time, there hadn’t yet been an accident caused by the software.  Well, now we have one.  As recently reported by friend of the blog Alan Crede of the Boston Personal Injury Lawyer Blog, Google’s brainchild caused an accident.  (For the record, Google’s position is that a human driver who overrode the software caused the accident).  Just as we did in our prior post, Crede used the Google Car opportunity to pontificate about larger legal questions facing the advent of fast-moving technologies.  We were, however, pleasantly surprised to see that Crede does not take the typical plaintiff’s attorney-approach to the issue, but rather argued that companies should not fear developing such cutting-edge technologies because of fears of liability.  Rather, Crede advocated for the imposition of liability on the owner or passive “driver” of the car itself, not the manufacturer.  In so doing, he argued:

Since, presumably, most accidents involving robot-driven vehicles will be due to some software error, perhaps the victims of robot car accidents will sue Google or other robot car manufacturers in product liability actions for selling defective products (defective software code). Such a system would insure that accident victims are compensated, but it would also mean that robot car manufacturers — the Googles, Fords and Toyotas of the world — would become the insurer of every car accident. Could any car manufacturer afford such a burden? Likely not.

It seems what we need therefore — in order to insure that the victims of robot-driven cars are compensated — is new legislation which would change the common law rules that govern car accidents. In particular, we need a system of compulsory auto insurance and a new legislatively-created rule that the owners of driverless cars are responsible for all accidents that they cause, regardless of whether they were piloting the car at the moment the accident occurred.

Such a change would replace our current negligence-based system of liability for car accidents with a strict liability regime that makes cars’ owners automatically liable for any damage caused by their cars, but it seems the only workable legal framework for a future of driverless cars.

GlA 180 Urban Edition 5dr auto review will prove why it is important to understand the current legal regime so that one can pick the right car.

Under the current legal regime, car manufacturers would have to insure every accident on their own, a burden that no company, even one as large as Google, can afford.

An interesting idea.  Thoughts?  Personally, I am not sure that this type of legislation is a good idea.  What happened to placing liability on the actual party at fault?  Ostensibly, the “driver” who is just sitting in the car isn’t at fault for the accident – maybe it was a software glitch that caused the accident.  Furthermore, who in their right mind would buy a car knowing that it would be their fault if the car causes an accident, even though they had no control over how it was designed?  Or am I sounding like a plaintiff’s attorney?  On second thought, don’t answer that last question.

A rose by any other name would smell . . . like a lawsuit.


According to a recent story at UPI.com, a Florida man is suing Winn-Dixie for $15,000 because he pricked his finger on a rose thorn, which was allegedly negligently, recklessly, and unforgivably left attached – to a rose!  In the suit, Plaintiff Charles Imwalle of Lake Mary, Florida claims that he suffered pain, disfigurement, medical bills and lost wages as a result of his encounter with the most delicate of flowers.  The suit also names Passion Growers, L.L.C. as the offending gardeners who ignorantly and negligently left the rose in its natural (though beautiful) state of unreasonable dangerousness.

Disfigurement?  Lost wages?  What was this guy, a hand model?

According to the UPI story, Mr. Disfigured’s lawyer declined to comment to the media.  But, thank goodness, we know from the pleadings what Mr. Disfigured’s lawyer thinks should have been done: there should have been antibacterial solution in the buckets in which the flowers were kept.  So, obviously, they’re claiming that the Plaintiff’s finger became infected.  Which begs the question: How long did this guy actually go without washing his hands?

Each week, we seem to be able to find a new ridiculous lawsuit brought by someone with less common sense than the last person.  And yet, this one might take the cake.  At least until next week.

“Well, Whaddya Think? Is It Ours?”

Every area of law has its particular discovery challenges, including products liability.  Quiz: How many times have you been out at the scene of an inspection, face to face with a destroyed ________ (fill in blank here: vehicle, boat, grill, house, et cetera), and asked the question of your client/engineer, “Well, whaddya think?  Is it ours?”  The question gets even trickier with component manufacturers.  “Well, did we sell that one inch piece of ______ in the destroyed ______?”

What a maddening area of practice, where you can go for months defending a case (or, for that matter, suing a manufacturer) and not even be certain the correct parties were involved.  In fact, you might actually resolve a case or two without ever having a definitive answer to that question. Ah, the perils of products cases!

That brings us to the relatively recent case of Fisher v. APP Pharmaceuticals, LLC, No. 08–CV–11047, — F. Supp. 2d —, 2011 WL 812277 (S.D.N.Y. March 1, 2011).  The case centered around the use of the drug heparin by the plaintiff’s decedent following elective heart surgery.  The plaintiff alleged that, rather than preventing blood clots as the drug was designed, the heparin actually caused the decedent’s blood to clot, which resulted in the decedent’s death of a heart attack. The personal representative of the decedent’s estate sued Hospira and John Doe Corporations asserting theories of strict liability/failure to warn, design defect, negligence, breach of warranty, negligent misrepresentation, fraud, and wrongful death.  Through two amendments to the original complaint, Plaintiff added APP Pharmaceuticals and Baxter Healthcare Corporation as defendants.

Motion to Dismiss Based on Lack of Product/Manufacturer Identification

Both APP Pharmaceuticals and Baxter moved to dismiss.  APP argued that the complaint failed to sufficiently identify the manufacturer of the heparin (the classic “it wasn’t me” defense, challenging Plaintiff to prove identity).  Baxter asserted that the complaint did not allege that Baxter’s product injured the decedent.

The Court cited the applicable pleading standards as follows:

Federal Rule of Civil Procedure 8(a)(2) requires a claim for relief to contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” While the Rule 8(a)(2) pleading standard does not require “detailed factual allegations,” it does require more than “labels and conclusions” or a “formulaic recitation of the elements of a claim.” In a New York products liability action, a plaintiff must prove (1) that the defendant’s product had a defect that rendered it unreasonably dangerous at the time it left defendant’s control and (2) that the defective product supplied by the defendant caused plaintiff’s injury.
The Court then reviewed the substantive allegations of the complaint, which alleged that “Defendants,” defined as APP, Baxter, and Hospira, manufactured heparin, which was administered to the decedent and caused his injury.  Motion to dismiss denied.  Not that Plaintiff had actually, truly identified the proper manufacturer – the Court simply decided that Plaintiff’s exclamation “It was one of you, I know it!” was sufficient.  [We will refrain from expressing our opinions about this so-called standard.]
Time Barred Claims

Defendants also argued that several of the claims were time barred, based on the late addition of the Baxter and APP defendants.  Plaintiff argued, of course, that the claims related back to the original complaint.  We all remember the relation back rule:

Plaintiff argues that the [second amended complaint] relates back to the original Complaint because the John Doe Defendants named in the original Complaint served as place-holders for APP and Baxter under New York Civil Practice and Rule 203(f). Under New York law this argument is only successful if the original pleading gave notice to the newly added parties. N.Y.P.L.R. 1024 and 203(f). It is Plaintiff’s burden to establish that “(1) both claims [arise] out of the same conduct, transaction or occurrence, (2) the new defendant is united in interest with the original defendant, and (3) the new defendant knew or should have known that, but for a mistake by the plaintiff as to the identity of the proper parties, the action would have been brought against him or it as well.”
The Court held that the discovery rule did not apply in this case.  First, the decedent was told that he was suffering from heparin-induced blood clots before he died and, therefore, Plaintiff could not say that the cause of the injury remained unknown or undiscovered.  As the Court so aptly put it, “Plaintiff relies on the argument that the discovery rule should apply in cases where the plaintiff does not know who caused the injury versus what caused the injury.”  Well said.  Accordingly, several of the causes of action were dismissed as being time barred by the Court.
The discovery rule is so important to products cases, where it is common to be faced with a piece of machinery, or a house, or a car, that has been totally destroyed by the incident at issue in the case.  When that happens, the burden to determine the proper defendants that designed, manufactured, and sold the product is often no small task.   As illustrated by this case, pharmaceutical litigation can also become a maze of several manufacturers, brand and generic names, and company spin-offs.  And let’s not forget the inevitable successor liability problem. But that’s a tale for another day.

Abnormal Interviews: Bob Dorigo Jones, Founder of the Wacky Warning Labels Contest

Today, we here at Abnormal Use continue our series, “Abnormal Interviews,” in which we conduct brief interviews with law professors, practitioners and other commentators in the field. For this latest installment, we turn to Bob Dorigo Jones, the Senior Fellow for the Center for America, the president of Michigan Lawsuit Abuse Watch, and the author of  Remove Child Before Folding, The 101 Stupidest, Silliest and Wackiest Warning Labels Ever.   Not too long ago, we wrote about his well known Wacky Warning Labels Contest.  Intrigued, we couldn’t resist requesting an interview, which he was kind enough to grant.

The interview is as follows:

1.  What was your inspiration for the Wacky Warning Label Contest?

In 1997, I heard about a Batman cape that actually came with a label warning, “Cape does not enable user to fly,” and that got me thinking about all of the obvious warnings we see in America. Most people have seen labels like that, and since they’re not only funny, but are there because of lawsuit abuse, we thought it would be a good way to spark a national conversation about the need for common sense legal reform.  It worked, and it’s been a great vehicle for educating the public about the larger lawsuit abuse issue and how it affects everyone from job providers and doctors to the Little League, Girl Scouts and soup kitchens that feed the poor.

2.  You’ve been doing the contest for 14 years.  What has been your favorite label submission from those years, and why?

One of my favorites is a warning label on a scooter that says, “This product moves when used.”  Well, of course, it does!  The manufacturer would probably be sued if it didn’t move.  Unfortunately, accidents often happen when kids are playing, so the manufacturer put this obvious warning on its products because, in America, if you make a product, you’re constantly looking over your shoulder for the next lawsuit. It’s sad, but it’s a fact of life now.  The next time you see one of those wonderful little silver scooters that kids all around America use, look for that label!

3.  Are there any products out there that do not have labels, but should?

I don’t know about products, but there’s a service that definitely needs a warning.  Every ad for plaintiff lawyers that appears in the telephone book or on television should have a label warning potential customers that there are often better (and by that, I mean more effective and less expensive) ways of solving disputes than lawsuits.  Many people who have legitimate grievances or injuries pay tens of thousands of dollars or much more to lawyers for problems that they could solve themselves or through mediation that might cost as little as $100 to $200.

4.  Have you noticed any recent trends in product labeling that you believe litigators should be aware of? If so, what are they?

One trend that troubles me is that labels are becoming so long and filled with so many obvious warnings that many people don’t read them anymore.  Certainly, there are many warning labels that aren’t wacky and that we all need to read, but there are also user guides that are so long that they have to come with a special key section just to explain the warning labels.  The Food and Drug Administration is well-aware of the problems caused by overwarning and therefore goes to great lengths, although they aren’t always successful, to keep warnings on medicines short and to the point.  I think this is wise.  People need to know about dangers that aren’t common sense.

5.  What do you think these labels tell us about our collective mindset in this country, if anything?

After reading all of the labels in this country that warn us about the obvious, people might think Americans are idiots.  I’m not that cynical.  We’re smart people, and by the way, we’re not anymore likely to hurt ourselves using a product than a person in any other country.  However, these labels do tell us that Americans have a litigation problem and that a certain segment of the population is willing to overlook personal responsibility and sue someone else when they injure themselves.  Even worse, a certain segment of the judicial profession is willing to allow these lawsuits in their courts.  My hope, by working with the Center for America, is to increase public awareness of this problem and help create a collective mindset that is unwilling to accept abuse of the civil justice system any longer.

6.  What do you say to consumer advocates and lawyers who believe these types of labels are necessary?

I ask them why there isn’t any evidence that Americans are better off for all of these warnings.  People in other advanced, industrialized countries like Germany, France, Japan and Australia aren’t being warned like we are that a scooter moves when used, but they aren’t piling up injuries faster than we are.  How do I know?  Because reporters from those countries have come here regularly to interview me and have told me so.  They don’t understand why we put up with the lawsuits that lead to these obvious warnings.  So where’s the benefit?  The only ones benefiting are the personal injury lawyers who now make so much money that they can run ads on TV all day long when legitimate product makers can’t even afford to do that.

Beyond that, I say to the so-called consumer advocates and personal injury lawyers that America is worse off today because of all of the fear they have created in our lives.  Many product makers have refused to bring consumer-friendly products to market because they fear being sued.  This is true in many areas, but it is worst in the area of medicine.  The long warning labels they’ve made necessary on drug packaging are bad enough, but when a mother dying of cancer has to leave her children to go to another country to get medicine that’s not available here because of America’s litigation problem, we have to say, “Enough is enough!”

7.  What do you believe is the best – or the funniest – pop culture depiction of a product label or products liability issue?

One of the funniest things I’ve ever seen is a spoof commercial for a product called “Happy Fun Ball” that aired on “Saturday Night Live” several years ago.  It has a warning that takes up about 90 percent of the commercial and is probably where America is heading if we don’t get a handle on our lawsuit problem.  If you’ve never seen it, I would highly recommend it. Also, one of the funniest books I’ve ever read about frivolous lawsuits was written by a former producer at “Saturday Night Live.”  James Percelay wrote a book called Whiplash! that is the first book you should get after you buy Remove Child Before Folding, The 101 Stupidest, Silliest and Wackiest Warning Labels Ever!

BIOGRAPHY: Bob Dorigo Jones, who serves as Senior Fellow for the Center for America, is the author of the bestselling Remove Child Before Folding, The 101 Stupidest, Silliest and Wackiest Warning Labels Ever. He is the host of a new national radio/Internet commentary, “Let’s Be Fair.” He has also appeared on dozens of national and international TV and radio programs, including NBC Nightly News, ABC News’ 20/20, BBC WorldNews, FOX News, and CNBC.  He also serves as president of Michigan Lawsuit Abuse Watch (M-LAW), a Center for America partner organization. Prior to joining CFA and M-LAW, Dorigo Jones served on the staff of the Michigan House of Representatives. He received a B.A. in economics and political philosophy from James Madison College at Michigan State University.

Jurisdiction of Federal Court Determined by Distributor Liability Analysis

For defendants in products liability actions, the issue of distributor liability is a maddening, state-by-state patchwork of different rules and laws.  The same conduct by one distributor of a product across many states may make it liable for any injuries caused by the product in one state, yet immune from liability in another.  Not only can the role of the distributor be crucial from a liability perspective, but it often has jurisdictional implications as well.  This was the case in Martin v. Medtronic, Inc. and Saracare Corp., 5:11-CV-144/RS-CJK, 2011 WL 2473318 (N.D. Fla. June 22, 2011). The issue was the plaintiff’s motion to remand, i.e. whether the Northern District of Florida had jurisdiction to hear the case at all based on diversity of citizenship.  The plaintiff had sued Medtronic, Inc. and Saracare Corporation on products liability theories, including strict liability, after the death of her decedent allegedly caused by a defective insulin pump.

For diversity purposes, the plaintiff was considered to be a citizen of Florida; Medtronic was a citizen of Minnesota; and SaraCare a citizen of Florida.  No diversity, right?  For all of you with recent memories of law school (which are, alas, distant memories for us), you will understand that the correct answer is always, “Well, it depends!” (For all of you readers who do have recent recollections of law school, be forewarned:  This is also always the right answer in “real life” legal situations, as well). Whatever the case, the jurisdictional question hinged on whether or not SaraCare was a “sham defendant,” in which case the Court would not consider its citizenship for diversity purposes (meaning that there would be diversity after all).  And, since SaraCare was alleged to be a distributor of the insulin pump, the Court’s jurisdictional analysis focused on the potential liability of SaraCare as a distributor. As the Court summarized:

Generally, strict liability extends to those in the “distributive chain” including “retailers, wholesalers, an d distributors.” Strict liability is applicable to distributors of medical products. Strict liability, however, does not generally apply to doctors or hospitals that use a defective medical device incidental to their services.  Similarly, strict liability does not apply to pharmacists who simply dispense prescription drugs and play no role in their preparation.
In this case, SaraCare performed two functions:  first, it confirmed that the letter of necessity met the guidelines of the decedent’s insurance company for reimbursement, and second, it took the order for the pump and routed it to a Medtronic distributor.
The Court determined that SaraCare’s actions were more akin to a traditional distributor than a pharmacist and held that “because Plaintiff claims the pump malfunctioned, the traditional medical device line of strict liability cases governs.”  As such, the strict liability claims could be maintained against SaraCare, and it was determined not to be a sham defendant.  With SaraCare remaining in the case, no complete diversity existed, and the case was remanded to state court.

The Fight Over Avastin

On June 29, 2011, a panel of the Food and Drug Administration rejected the drug Avastin for use in the treatment of end-stage breast cancer.  Manufactured by Genentech, a subsidiary of Roche, the drug has been approved for the treatment of other types of cancer, but as recently reported by NBC Nightly News, the panel believed that the drug is not effective, and the side effects too serious, for the treatment of breast cancer.  A final decision will come from the FDA in a few months.

As can be imagined, this action has brought a firestorm of criticism of the FDA.  Because the drug will still be on the market, it will be possible, perhaps, for doctors to prescribe the drug “off-label” for breast cancer, but of course, insurance companies won’t pay for it if it’s not approved for the specific disease for which it is prescribed.

But, as FiercePharma reports, it appears that Avastin will not be dropped from Medicare coverage, no matter what the FDA decides down the road, and the decision could have grave consequences for the FDA down the road:

Indeed, House Republicans are promising to make Avastin an issue during next week’s hearings on the reauthorization of FDA’s user-fee funding provisions. House Energy and Commerce Committee Chairman Fred Upton says he has “grave” concerns about FDA’s review of the data on Avastin, the Wall Street Journal reports, and aides are saying that either he or another member will raise those concerns at Thursday’s hearing.

Read the referenced Wall Street Journal article here.  Stay tuned.  If indeed the full FDA precludes usage of Avastin for the treatment of breast cancer, it will present many questions for the manufacturer, which will undoubtedly know that doctors may still be prescribing it for use as a treatment for the disease.  Of course, manufacturers of all sorts of drugs know that their medication is prescribed off-label, but this will be a much higher profile case than most.  Will that knowledge hurt the manufacturer if any defects are alleged?  We will have to wait and see.  Preemption is always a good argument in drug cases, but what preemption would there be if the FDA did not approve the drug for use for this particular disease?