Fixodent Lawsuit Has No Teeth: Eleventh Circuit Court Affirms Dismissal On Daubert Grounds

On a roll recently, the Eleventh Circuit Court of Appeals has upheld the dismissal of a lawsuit filed against Proctor and Gamble brought by a woman claiming that she suffered from a neurological condition caused by Fixodent, a denture adhesive. The lawsuit was dismissed on the ground that Plaintiff could not prove causation because her experts were not reliable under Daubert

One of the main components of Fixodent is zinc.  Plaintiff alleged that the zinc blocked her body’s ability to use copper, leading to a neurological condition known as copper-deficiency myelopathy.  According to Plaintiff, she started to develop symptoms after using up to four tubes of Fixodent per week for eight years.

Plaintiff sought to prove causation primarily through four expert witnesses (all physicians), who would have testified generally whether Fixodent could cause copper-deficiency myelopathy. However, the trial court refused to allow such testimony, finding that Plaintiff’s experts did not use reliable methodologies because they failed to show any scientific evidence as to how much Fixodent must be used, and for how long it must be used, to cause a purported copper deficiency.  Moreover, the experts in question failed to show how long that copper deficiency condition must last in order to place someone at risk for developing copper-deficiency myelopathy.

The Eleventh Circuit Court of Appeals agreed with the district court’s decision to dismiss the case at the summary judgment stage.

The case is Chapman v. Procter & Gamble Distributing, LLC, — F.3d —- (11th Cir. September 11, 2014).

Up In Smoke: Eleventh Circuit Affirms Dismissal of Smoking Cases

Big Tobacco scored a big victory when the Eleventh Circuit upheld the dismissal of nearly 750 Plaintiffs’ cases because of defects in the complaint.  See 4432 Individual Tobacco Plaintiffs v. Various Tobacco Companies, Liggett Group, LLC, & Vector Group, Ltd (11th Cir. September 10, 2014). The defect stemmed from the fact that the law firm handling the case filed personal injury complaints on behalf of deceased smokers and deceased family members.  Of course, a deceased person cannot a maintain claim for personal injury.

The dismissed cases were brought in 2008 as part of 4,432 claims filed by a Jacksonville law firm.  The cases were filed individually after the Florida Supreme Court disbanded a state class action lawsuit and gave the plaintiffs one year to file individually.  The firm apparently did not have the time or the resources necessary to contact all of the class members but filed suits on their behalf to meet the deadline. In 2012, it was discovered that 588 of the smokers who had suits filed in their name were now deceased and 160 loss of consortium claims had been filed on behalf of dead family members.   The district court dismissed the cases and denied  leave to amend.  The court’s rationale for denying leave to amend was that the problems would have been avoided if the claims had been properly vetted in the first place.

The Eleventh Circuit upheld the decision not allow leave to amend the complaint.  The court refused to take mercy on the Plaintiff’s firm, who on appeal argued that the mistakes were the result of “unique logistical difficulties” involved in handling so many cases.   In reaching its conclusion, the court noted:

The solution to managing  these types of mass actions is surely not that the standard of care diminishes as the  number of cases grows. If we were to hold that plaintiffs’ counsel are entitled to substitution solely on account of the large volume of cases they filed, we would  invite the same result in every mass tort action.

Since the deadline to file is long gone, these cases are up in smoke.

English-Only Warnings: Adequate or Parsimonious?

Often at issue in products liability litigation is whether a manufacturer adequately warned consumers of the potential dangers of its product. Product warnings can be pictorial, but typically, they take the form of written statements printed on the product’s packaging or within its instruction manuals.  Often, these printed warnings are written only in English.  But as our country becomes more culturally diverse, questions arise as to whether English-only warnings are adequate.  Recently, in Farias v. Mr. Heater, Inc., No. 11-10405, 2011 WL 2354369 (11th Cir. June 21, 2012), the Eleventh Circuit touched on that very issue – somewhat. (Back in January 2011, we covered the lower court’s opinion.)

In Farias, the plaintiff purchased two propane infra-red portable heaters manufactured by Mr. Heater, Inc.  One night, the plaintiff went to sleep with the two heaters running inside her home.  Because she neglected to close a valve on one of the propane tanks, her home caught fire, causing $300,000 in damages.  She filed suit against Mr. Heater and the retailer, asserting claims of strict products liability and negligent failure to warn.  The Spanish-speaking plaintiff alleged that the pictorial and English-language warnings were inadequate in alerting her of the dangers of using heaters indoors.  After Mr. Heater was awarded summary judgment on each of her claims, the plaintiff appealed.

The plaintiff acknowledged that Florida law did not impose an automatic duty to provide bilingual warnings.  However, she alleged that the warnings were inadequate because the pictures and English-text were inherently contradictory, inaccurate and ambiguous.  Further, she argued that English-only warnings were inadequate because Mr. Heater marketed the heaters to Miami’s Hispanic community.

The Eleventh Circuit was unpersuaded by either argument.

The  argued contradiction between the pictorial and English-language warnings is intriguing.  First, it is unclear how pictures and written text can be contradictory when the consumer lacks the ability to read the text.  If the written warnings were inadequate because they were not written in Spanish and, thus, could not be read by the plaintiff, it is illogical to assert that unreadable words contradicted with the pictorial warnings.

Second, the heater’s packaging contained six pictures depicting the appropriate usage of the product.  None of these pictures showed the heaters being used inside a home.  To accompany these pictures, the following warnings were printed on the box:

This heater is recommended for outdoor use only.

Always store propane cylinders outdoors in well-ventilated areas.

Not designed for use in living areas or small tightly enclosed spaces.

Propane heaters should be located outdoors during heater operations.

It is hard to envision any inconsistency between these written warnings and the pictures printed on the box.  However, the fact that the plaintiff was unable to read the English-language warnings leaves open the possibility that the pictures did not foreclose on the idea of using the heaters indoors.  Of course, the plaintiff had already conceded that Florida law does not require bilingual warnings.

As to the plaintiff’s second argument, the Eleventh Circuit found no evidence that Mr. Heater targeted the Hispanic community in its marketing.  As such, the Court did not find that the marketing efforts created a duty to provide bilingual warnings.  It would have been interesting to see how the Court’s analysis would have changed if Mr. Heater did so market the heater.  This may precluded summary judgment.

Unfortunately, due to some well-established Florida law on the subject, the Eleventh Circuit did not provide any thought-provoking jurisprudence on the necessity of bilingual warnings.  We here at Abnormal Use expect that the precedent will be challenged as we move forward.  While we doubt manufacturers will ever be required to print warnings in every language spoken in the United States, it isn’t far-stretched to assume they might be required to address the predominant ones.

Political Question Doctrine Bars Relief in Products Liability Action

As lawyers practicing in the neat little world of products liability, we sometimes become complacent with our narrow world, which is more often than not populated by familiar concepts like strict liability, state of the art, and warranty disclaimers.  We’re comfortable with these concepts.  We use them every day, and we can recite by name and sometimes even citation the cases that stand for those fabled and familiar principles. But every once in a while, a case comes along that requires us to leave our comfort zone and do what our law school professors challenged us to do: think outside the realm of the class in which we were sitting at that moment, and reach into concepts we (at least arguably) learned from other classes.

This was the situation facing the defense lawyers in the case Armedi v. BAE Sys., Inc., 1:10-CV-01557-JOF, 2011 WL 1707251 (N.D. Ga. Apr. 22, 2011).  The case involved the unfortunate death of Rebar Amedi, a civilian contractor working as a translator for the U.S. Army in Iraq.  Mr. Amedi was killed when the Mine Resistant Ambush Protected (“MRAP”) vehicle called a Caiman in which he was riding was struck by an improvised explosive device, commonly known as an IED.  According to the facts agreed to by the parties:

There were eight occupants in the passenger compartment of the Caiman which was designed to hold only six people. None of the occupants wore a seat belt and the doors to the compartment were not combat locked. The equipment stored in the MRAP was secured only by bungee cords and parachute cord, instead of ratcheting straps. Even though the passenger compartment was intact, the rear doors came off and it appears that Mr. Amedi was thrown from the vehicle and he sustained fatal injuries.

Mr. Armedi’s widow brought suit against BAE Systems, Inc., BAE Systems Land & Armaments L.P.; and BAE Systems Tactical Vehicle Systems LP, on April 16, 2010, in the Superior Court of Fulton County, alleging product defect, negligence, and breach of warranty claims arising out of the death of Mr. Amedi.  The case was removed by the defendants, and they immediately filed a motion to dismiss not based on defenses they learned in products class, but based on the political question doctrine and the combatant activities exception to the Federal Tort Claims Act.

We will spare your digging through your home library for that dusty Con Law book, and remind you about the factors relevant to determining if a dispute raises a “non-justiciable political question.”  If only one of the factors is present, the court dismisses the case.  Those factors are:

1. a textually demonstrable constitutional commitment of the issue to a coordinate political department;
2. a lack of judicially discoverable and manageable standards for resolving it;
3. the impossibility of deciding without an initial policy determination of a kind clearly for nonjudicial discretion;
4. the impossibility of a court’s undertaking independent resolution without expressing lack of the respect due coordinate branches of government;
5. an unusual need for unquestioning adherence to a political decision already made; or
6. the potentiality of embarrassment from multifarious pronouncements by various departments on one question.
Likening the case to a prior 11th Cicuit Court of Appeals case on the same issue, the Court held that because the events which led up to Mr. Armedi’s death resulted directly from miltary decisions, including the use of MRAP vehicles, the timing of the convoy, and, as a prior-decided case articulated, “at the broadest level . . . the military’s decision to utilize civilian contractors in conducting the war in Iraq,” the case involved a non-justiciable political question, ”because to evaluate Plaintiff’s complaint would require the court to re-examine military decisions.”  After reaching this conclusion and dismissing the case on those grounds, it did not reach the question regarding the Federal Tort Claims Act.
To us, the most interesting part of the case was the use of a defense found outside the realm of products liability.  The product itself never became the issue in the case, despite the allegations levied against them by the plaintiff on products theories.  We are used to making procedural arguments that operate the same way, but we wonder if there are other long-forgotten classes we are under-utilizing in our products cases.   Who knows?  Maybe that third-year “law in movies” class could provide some novel defenses for cases in the future.

The Peanut Butter Products Liability Litigation Blues

As a defense lawyer, we are often place in the strange position of having to prove a negative. Sure, it’s supposed to be the plaintiffs’ burden to prove his or her case, and in theory, at least, everyone is innocent, er, not liable unless proven otherwise.

But we all know it doesn’t happen that way sometimes.

Take the recent case of the contaminated and recalled peanut butter. You remember all that, right? In 2007, ConAgra Foods peanut butter, marketed under the national brand Peter Pan and Wal-Mart store brand Great Value, were linked to several hundred cases of salmonella poisoning, and a massive recall was issued for the spreads. [Read more about that recall here.]

What followed this recall, dear readers? You guessed it! Massive amounts of litigation! So much, in fact, that it was all consolidated by the MDL Panel, at least for pretrial proceedings.

Since 2007, the slow wheels of justice have been turning. On March 23, the Northern District of Georgia ruled on ConAgra’s motion for summary judgment in In re ConAgra Peanut Butter Products Liability Litigation, 2011 WL 1060990 (N.D. Ga. March 23, 2011).

Not to get too graphic, but there are only a few ways to prove if a person has in fact contracted salmonella poisoning, or if they just have a nasty case of the stomach bug. You guessed it: they test one’s blood and other bodily fluids. The Court officially noted: “[T]hese samples are important in determining causation.” So, a number of plaintiffs stepped up to the proverbial plate and supplied samples. When some samples came up negative for salmonella poisoning, ConAgra moved for summary judgment based on lack of causation. Slam dunk, right?

Apparently not.

The Court denied the motion for summary judgment without prejudice because “without the plaintiffs’ individual medical records, it is unclear when the sample was taken and whether there is a scientific or medical explanation–other than another illness–for a negative test. Therefore, ConAgra is not entitled to summary judgment before individual discovery on plaintiffs’ medical records is complete.”

We’re not sure exactly what the parties have been doing for the four years since this whole thing started, but apparently, the plaintiffs have not been trying to gather medical records or retain experts to satisfy their burden. Nevertheless, the Court granted them additional time to hold ConAgra hostage – otherwise known as “satisfy their burden” – in these cases.

When is a Product Sold? We Now Have the Answer!

Many months ago, we here at Abnormal Use discussed the critical question, “When does a bucket truck become a bucket truck?” At that time, we were discussing Campbell v. Altec Indus., Inc., 605 F.3d 839 (11th Cir. 2010) [PDF], which involved a plaintiff allegedly injured when a cylinder on a bucket truck owned by Georgia Power failed. The plaintiff sued not only the manufacturer of the truck but that of the lift cylinder, as well. The problem for the plaintiff, however, was the statute of repose, which limited the action to “ten years from the date of the first sale or use or consumption of the personal property causing or otherwise bringing about the injury.” If that seems unclear to you, well, the Eleventh Circuit wasn’t so sure about what it all meant, either. So, they certified the following question to the Georgia Supreme Court: Does the ten-year statute of repose begin to run when:

(1) a component part causing an injury is assembled or tested, (2) a finished product, which includes an injuring component part, is assembled, or, (3) a finished product, which includes an injuring component part is delivered to its initial purchaser?

Well, we finally have our answer. The Georgia Supreme Court recently issued its decision in Campbell v. Altec Indus., Inc., —S.E.2d—, 2011 WL 356110 (Ga. Feb. 7, 2011) [PDF]. The Court held that the statute of repose began to run on the action when the truck was delivered as new to its intended consumer (choice number 3 in the excerpt above, in case you are keeping track).
In coming to its decision, the Court relied heavily on statutory interpretation of OCGA section 51-1-11(b)(1), which imposes liability on a manufacturer “of any personal property sold as new property directly or through a dealer or any other person” when a person is injured because the manufacturer’s product “when sold by the manufacturer was not merchantable and reasonably suited to the use intended, and its condition when sold is the proximate cause of the injury sustained.” The Court reasoned that:
In crafting OCGA § 51-1-11(b), the General Assembly did not choose to begin the period of repose “on the date of the ‘first sale’ of a product by its manufacturer. [Rather, OCGA § 51-1-11(b)(2) ] provides that the period of repose commences on the date of the ‘first sale for use or consumption.’ The General Assembly could have chosen to begin the period of repose on the date that the product was last in the hands of the manufacturer, but it did not. The choice of “the date of the first sale for use or consumption” to trigger the running of the statute of repose is in keeping with OCGA § 51-1-11(b)(1)’s imposition of liability on a manufacturer who sells its product “directly or through a dealer or any other person” as new; regardless of any chain of middlemen, the end sale of the product as new is what brings the manufacturer within the ambit of OCGA § 51-1-11(b)(1), if the other conditions for imposing liability exist.

In so holding, the Court specifically overruled the prior decision of Johnson v. Ford Motor Co., 281 Ga. App. 166, 637 S.E.2d 202 (2006), which the Court called “wrongly decided.” The Court of Appeals had held in that case that the statute of repose began to run when a defective switch, the cause of the plaintiff’s injuries in that case, was installed in the Ford automobile (choice number 2 from the certified question above). Instead, the Campbell Court adopted the reasoning of Pafford v. Biomet, 264 Ga. 540, 448 S.E.2d 347 (1994), which drew the distinction between the sale of a product to “the individual who initially purchased a manufactured product for mere static retention in his inventory” and the individual who purchases the product and intends to actually use it. It is only when the purchase is made to the user that the statute of repose begins to run, because, in the words of the Pafford Court “it is that individual who is the intended beneficiary of the liability imposed” through the statute.

This ruling means that a manufacturer of a defective component part will not be able to avoid liability to an injured plaintiff when the end-product simply sits on the retailer’s shelf for a long time before being sold to the user, effectively shortening the statute of repose. The decision does not undermine a plaintiff’s burden to prove that the product is actually defective, or that the allegedly defective product proximately caused his or her injuries; it simply closes the procedural loophole that Johnson created.

Being an Expert Expert Doesn’t Make You an Expert

You know him well. He is the professional expert. No matter the issue, the case, or the product, there he is, opining that your client’s product is unreasonably dangerous, and unquestionably caused the plaintiff to suffer personal injuries, psychological damage, and lost income. In fact, as soon as you see this expert’s name at the top of the report, you can recite its contents, eyes closed and one hand tied behind your back.

Not so fast. In Beam v. McNeilus Truck and Manufacturing, Inc., 697 F. Supp. 2d 1267 (N.D. Ala. 2010), the Northern District of Alabama considered the defendant’s motion to exclude the testimony of Dr. L.D. Ryan, a mechanical engineer and professional expert, as to the defectiveness of the design of a garbage truck. The case involved an accident in which the plaintiff’s decedent, a garbage collector, fell or stepped off of the riding step of a garbage truck and died as a result of his injuries. The central issue of the case was whether the truck was defectively designed with regard to the riding steps.

The court carefully considered Dr. Ryan’s qualifications, noting that “Plaintiff’s expert . . . has little or no experience in the world of refuse collection, road-vehicle design generally, or garbage truck design specifically.” Furthermore, although Dr. Ryan had watched “three hours of videos on ‘YouTube,’ he has no training or experience in designing waste-hauling routes” and has no knowledge “about the history or evolution of rear-loading garbage-truck designs.” In fact, the court stated, the “mere fact that Dr. Ryan is a licensed engineer is, in and of itself, insufficeint to qualitgy him as an expert in this case.”

The court’s harshest criticism of Dr. Ryan’s so-called qualifications, however, was reserved for his status as the professional expert. The court made several references to the fact that Dr. Ryan had acted as an expert in hundreds of cases. In fact, the court devoted an entire footnote to Dr. Ryan’s career expertise, opining that “Dr. Ryan has been involved in hundreds of cases invovling a variety of products, and his testimony has been at issue in a number of those cases,” and providing a list of some of those cases.

With no actual expertise on the subject of garbage truck design, the court excluded Dr. Ryan and his reports. Without expert testimony as to the defective design, the plaintiff could not make her case, and therefore the defendant’s motion for summary judgment was also granted.

Bravo, Northern District of Alabama. Abnormal Use salutes you. Next time, plaintiffs, make sure your expert does more than watch YouTube.

Georgia vs. Texas

No, this post is not about college football. (Spring practices have just gotten under way at most colleges around the country and unfortunately for this blogger, August can’t get here soon enough!) Today’s post is a reflection upon the recent Georgia and Texas cases dealing with the learned intermediary defense (previous discussed individually on this site here and here). Specifically, I wanted to highlight a key distinction in how each court analyzed the doctrine.

In Dietz v. Smithkline Beecham Corp., No. 09-10167, 2010 WL 744273 (11th Cir. March 5, 2010) the court was interpreting Georgia law and correctly focused on the proximate cause between the decedent’s death and the adequacy of the warning provided to the physician. Dietz at *2-3. The court’s analysis was that the court, when applying the doctrine, must first look to the adequacy of the warning that was given. Id. at *2. The court cited to well-established Georgia case law that states that if the warning is adequate, the analysis ends and the plaintiff is barred from recovery. Id. In Dietz, the evidence was that the decedent’s physician testified that regardless of whether he knew about the increased risk of suicide with the use of Paxil, he still would have prescribed the drug to the decedent. Id. As such, the court reasoned that the Plaintiff could not establish proximate cause since the alleged failure to warn did not have an effect on the decision to prescribe the drug.

In seemingly direct contrast, the court in Centocor, Inc. v. Hamilton, No. 13-07-00301-CV, 2010 WL 744212 (Tex. App. – Corpus Christi March 4, 2010, no pet h.), in its creation of an exception to the learned intermediary doctrine, did not end its analysis with a determination of the adequacy of the warning. In Centocor, the evidence was that the Plaintiff’s physician that originally prescribed the drug at issue, Remicade, testified that he warned her of the potential risk of developing a lupus-like syndrome. Centocor at *6. As such, it would appear that the physician warned the Plaintiff of the exact risk that was the basis for her lawsuit–she developed a lupus-like syndrome after taking the drug. Instead of ending the analysis with the initial physician’s testimony, the court then went into a long discussion about advertising techniques of drug companies and the theoretical underpinnings of the doctrine.

In this blogger’s opinion, the Centocor court should have ended its analysis when it found that the Plaintiff’s physician provided her with a warning about the risk of developing a lupus-like syndrome. Based on the doctor’s testimony, any potential proximate cause link between use of the drug and any warning would have been severed. I, along with others, am left to wonder how a physician’s direct warning of a potential risk can not, as a matter of law, be an adequate warning and thus invoke the doctrine?

Paxil and The Learned Intermediary Defense

The learned intermediary defense appears to be alive and well in the State of Georgia. For years it seems that drug companies have been able to rely on the venerable learned intermediary defense to avoid liability in personal injury cases brought by plaintiffs that have obtained their products through a physician prescription. The defense has recently come under scrutiny in light of the marketing attempts by drug companies that intended to inform the public about their products. The trial lawyers’ bar seems to be asserting that the advertisements by the drug companies are attempts to provide warnings to the public.

Last week the U.S. Court of Appeals for the Eleventh Circuit considered the defense. In Dietz v. Smithkline Beecham Corp., No. 09-10167, 2010 WL 744273 (11th Cir. March 5, 2010), the court upheld the trial court’s grant of summary judgment in favor of the defendant. In Dietz, the plaintiff brought a wrongful death claim in which the surviving spouse claimed that her husband’s suicide was proximately caused by his use of Paxil. Id.at *1. The plaintiff actually brought the claim under three theories: strict liability, negligence and breach of warranty. Id. The defendant raised the learned intermediary defense, an affirmative defense under Georgia law. Id.

The facts in Dietz were that the plaintiff’s husband had visited his family physician with “anxiety, depression, insomnia, and stress, but expressed that he had no suicidal ideation.” Id. His physician prescribed him to take Paxil as well as a sleep aid, Ambien. Id. Eight days after obtaining his prescription and after he began to take the drug, he committed suicide. Id.

The decedent’s family physician testified during a deposition that the decision to treat the decedent with Paxil was an appropriate decision and that even after reviewing the results of an updated prescription information sheet, there was nothing that about the new information that would have made him decide to not prescribe Paxil to the decedent. Id. *2. The Dietz court reviewed the long-standing doctrine of the learned intermediary defense:

[T]he manufacturer of a prescription drug … does not have a duty
to warn the patient of the dangers involved with the product, but instead has a
duty to warn the patient’s doctor, who acts as a learned intermediary between the
patient and the manufacturer. The rationale for the doctrine is that the
treating physician is in a better position to warn the patient than the
manufacturer, in that the decision to employ prescription medication …
involves professional assessment of medical risks in light of the physician’s
knowledge of a patient’s particular need and susceptibilities.

Id. at *1 (internal citations omitted). The court then went on to hold that the plaintiff could not establish that the defendant’s alleged failure to warn the physician about the increased risk of suicide associated with Paxil proximately caused the decedent’s death. Id. at *3. The court’s decision hinged upon the doctor’s testimony that even after reviewing the new prescription drug information sheet and the warnings mandated by the U.S. Food and Drug Administration, he still would have prescribed the drug. As such, the learned intermediary (decedent’s physician) had an adequate warning and the potential chain of causation proffered by plaintiff was severed.