Mass Tort Lawsuit Filed over Eliquis for Causing Fatal Internal Bleeding

The estate administrators for a New York man filed a product liability suit against Briston-Myers Squibb Co. and Pfizer Inc., charging that their drug blood-thinning drug Eliquis caused the internal bleeding that killed him.

Raymond Warme of East Hampton, NY, was prescribed Eliquis in April 2014 for atrial fibrillation. Within two months he began having gastrointestinal bleeding which led to his death.

The case, Dawn Dunn et al. v. Briston-Myers Squibb Co., case No. 156043/2017, is filed in New York Supreme Court. The plaintiffs are his daughter Dawn Dunn and his significant other Orla Troy.

Fraud and deceit by Big Pharma companies

The New York lawsuit says, “These representations were made by defendants with the intent of defrauding and deceiving decedent, the public in general, and the medical and healthcare community including decedent’s prescribing doctor, and were made with the intent of inducing [them] to recommend, dispense and purchase Eliquis, all of which evinced a callous, reckless, willful, depraved indifference to health, safety, and welfare of the decedent herein.”

Bristol-Myers and Pfizer’s wrongdoing started in 2010 with the Aristotle clinical study, calculated to get the drug approved by the FDA. During that study, the companies concealed side effects and didn’t report a death, subjects dropping out and dispensing errors, the complaint states.

Employees of the drugmakers also wrote an article published on Aug. 28, 2011, in the New England Journal of Medicine based on the study which the editor-in-chief found to be inaccurate and containing omissions, the suit says.

The FDA said on Feb. 9, 2012, that the companies showed “a pattern of inadequate supervision” and the agency pressed to get more information during the approval process, saying data was missing. The agency also said the label should mention the quality-control issues in the study, according to the suit.

On Dec. 28, 2012, the FDA approved Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation.

“Defendants overstated the efficacy of Eliquis with respect to preventing stroke and systemic embolism, failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Eliquis and that such irreversibility would have life-threatening and fatal consequences,” the suit says.

Two years later in 2014, more than 1,000 adverse event reports were filed with the FDA in that year alone, including at least 100 deaths, and more than 6,000 adverse event reports in 2015 consisting of hemorrhaging / gastrointestinal hemorrhaging. Yet the companies never strengthened their label.

Third Circuit Revives 5,000 Broken-Bone Cases in Fosamax Litigation

Edward Braniff of Simmons Hanly Conroy LLC in New York

The Fosamax ruling is good news for plaintiff attorney Edward Braniff of Simmons Hanly Conroy LLC in New York.

Handing plaintiffs a major success, the Third Circuit US Court of Appeals revived 5,000 product liability cases involving the osteoporosis drug Fosamax, ruling that federal preemption of state-law claims is a question of fact for a jury to decide, not a question of law for a judge.

The ruling in In re Fosamax Products Liability Litigation, Case No. 14-1900 et al, decided March 22, 2017, is a major setback for Merck and other Big Pharma companies that seek to torpedo patient claims in summary judgment motions, by arguing that:

  1. State-law failure-to-warn lawsuits are pre-empted by federal law
  2. When there is “clear evidence” that the FDA would not have approved a warning label that the plaintiffs claim is necessary.

On the other hand, the ruling is a boon to plaintiff lawyers who are striving to preserve their lawsuits against preemption attacks that have nothing to do with the merits of the case.

What is “clear evidence”?

The US Supreme Court Opinion created confusion about the preemption issue in Wyeth v. Levine, 555 U.S. 555 (2009). The ruling says that state-law failure-to-warn claims are preempted by federal law when there is “clear evidence” that the FDA would not have approved a label change. “This standard is cryptic and open-ended, and lower courts have struggled to make it readily administrable,” the Third Circuit commented.

Resolving the issue, the Third Circuit held that “The meaning of “clear evidence,” as Supreme Court usage confirms that the term is synonymous with “clear and convincing evidence.” The latter is a well-recognized intermediate standard of proof—more demanding than a preponderance of the evidence, but less demanding than proof beyond a reasonable doubt.”

Furthermore, the appeals court ruled:

  • Whether the FDA would have rejected a label change is a question of fact for the jury.
  •  At the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change.
  • A mass tort MDL is not a class action. Merck’s actual burden at the summary judgment stage was to prove that there is no genuine dispute in every single MDL case that plaintiffs’ doctors would have continued to prescribe Fosamax even if a fracture warning had been added to the Adverse Reactions section before May 2009.

The successful argument to the Third Circuit was made by plaintiff attorneys Edward Braniff of Simmons Hanly Conroy LLC in New York, Michael E. Pederson of Weitz & Luxenberg in New York, and Donald A. Ecklund of Carella Byrne Cecchi Olstein Brody & Agnello in Roseland, NJ.

Fosamax causes thigh fractures

Beginning in 2010, hundreds of plaintiffs filed personal-injury suits against the drug manufacturer Merck Sharp & Dohme, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures.

Each Plaintiff brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk of thigh fractures to Fosamax’s FDA-approved drug label. Many Plaintiffs also filed additional claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law.

Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law.

Fosamax is a treatment for osteoporosis, but plaintiffs claim that the drug actually increases the risk of thigh bone fractures. Plaintiffs claim that while stress fractures typically heal on their own, “some Fosamax users who develop insufficiency fractures have reduced bone toughness, and Fosamax prevents the normal repair of the fracture.” According to Plaintiffs, these patients may then go on to develop what are known as “atypical femoral fractures”: severe, non-traumatic, low energy complete fractures of the femur.

In 2013, Merck reached a separate settlement of $27 million with 1,200 Fosamax users who suffered necrosis of the jawbone.

Defective Product Class Actions: California Versus Florida

By William C. Ourand, Esq. • Newsome Melton, P.A. Reprinted from the Winter 2016 issue of The Trial Lawyer Magazine.

California has long been a common battleground for class action disputes. And there are many good reasons for this; most notably, California has a robust body of consumer protection law that lends itself well to class action litigation. In recent years, however, Florida has emerged as an ever-growing presence in the class action world, particularly with respect to automotive defect class actions. This trend, in turn, has given rise to a burgeoning body of Florida consumer protection law that has unique advantages and disadvantages when compared with California law.

This article will begin by discussing recent class action cases pursued in Florida, will then move into a comparative analysis of the consumer protection laws governing class action suits filed in California and Florida, and will conclude by offering suggestions as to how to proceed when presented with the option of pursuing a class action involving consumers from each state.

Recent Florida Class Actions

Because each state has its own unique set of consumer protection laws and judicial precedent, is typically impossible to certify a national consumer fraud class in a product defect case. Accordingly, consumer advocates must pick and choose their battles wisely, as smaller states may not have a sufficient number of aggrieved consumers to help level the playing field through the class action mechanism. With a growing population of just under 20,000,000 people, Florida is one of the most populous states in the nation. It is unsurprising, then, that Florida courts, particularly the U.S. District Court for the Southern District of Florida, have become an increasingly common battleground for class action litigation.

Recent examples of major automotive consumer fraud class action cases filed in Florida include:

  • Batista v. Nissan North America, Inc., which involves an alleged defect that causes the continuously variable transmissions (“CVTs”) in certain Nissan Pathfinders and Infiniti QX60s to violently shake, impairing those vehicles’ ability to accelerate. The case was filed in the Miami Division of the Southern District of Florida in December 2014 by our firm in partnership with two other firms. The Court recently entered preliminary approval for a nationwide settlement class of all current and former owners and lessees of 2013–2014 Nissan Pathfinders and 2014 Infiniti QX 60s. Batista v. Nissan North America, Inc., Case No.: 1:14-cv-24728, D.E. 151 (S.D. Fla. 2016). 
  • Sanchez-Knutson v. Ford Motor Co., which involves an alleged defect that causes carbon monoxide to seep into the occupant cabin of certain Ford Explorers. In October 2015, Judge Dimitreleous of the Southern District’s Fort Lauderdale Division certified a class of all consumers who purchased or leased 2011–2015 Ford Explorers in Florida. In doing so, the Court accepted, “for purposes of class certification,” the plaintiff’s proposed “conjoint” damages model, which is “an analytic survey method used to measure customer preferences for specific features of products.” Sanchez-Knutson v. Ford Motor Co., 310 F.R.D. 529, 539 (S.D. Fla. 2015). The case was set to begin trial in early August 2016, but the parties reached a settlement agreement, which has been presented to the Court for approval. The proposed settlement would cover everyone who purchased or leased a 2011–2015 Ford Explorer in the United States. Sanchez-Knutson v. Ford Motor Co., 0:14-cv-6134, D.E. 416 (S.D. Fla. 2016).
  • Carriuolo v. General Motors Co., which involves an alleged misrepresentation as to the safety ratings for the 2014 Cadillac CTS. The Eleventh Circuit Court of Appeals recently affirmed the certification of a class of Florida consumers who purchased the vehicles, joining ranks with a growing number of circuits that have allowed for so-called “price premium” or “overcharge” classes even after the latest wave of SCOTUS decisions narrowly construing Rule 23. See Carriuolo v. GM Co., 823 F.3d 977 (11th Cir. 2016). This case is currently set for trial in early 2017. Carriuolo v. GM Co., Case No.: 0:14-cv-61429, D.E. 99 (S.D. Fla. 2016).

Additionally, Judge Moreno of the Southern District of Florida is currently presiding over the massive Takata airbag multi-district litigation (“MDL”). The consolidation of the MDL in Florida’s Southern District serves as a powerful testament to the Southern District’s ability to oversee complex litigation. Additionally, given the egregious nature of the exploding airbag inflator defect, it appears likely that the MDL litigation will generate favorable Florida consumer protection precedent.

The UCL And CLRA Versus FDUTPA

The primary statutes driving consumer fraud claims in California are the Unfair Competition Law (“UCL”) and the Consumer Legal Remedies Act (“CLRA”). Florida’s corollary law is the Unfair and Deceptive Trade Practices Act (“FDUTPA”). Although there is a far greater body of law construing the UCL and CLRA, recent FDUTPA decisions have staked out the boundaries of what constitutes a cognizable and classable FDUTPA claim. This portion of the article will summarize several key distinctions between these two bodies of law.

 FDUTPA Is Not Limited to Safety Defects

Most consumer fraud claims involving defective products revolve around an omissions theory—specifically, that the manufacturer failed to disclose a defect, and as a result, the consumer did not get what was paid for. For such a claim to be actionable under the UCL and CLRA, the plaintiff must show that the defendant was under a duty to disclose, which typically requires showing that the defect was “material.” The materiality inquiry, in turn, generally revolves around whether the defect poses a safety hazard. See Myers v. BMW of N. Am., LLC, 2016 U.S. Dist. LEXIS 140768 (N.D. Cal. Oct. 11, 2016); Lassen v. Nissan N. Am., Inc., 2016 U.S. Dist. LEXIS 139512 (C.D. Cal. Sep. 30, 2016).

In contrast, courts applying FDUTPA have specifically rejected a “safety hazard” requirement in omissions cases. See Matthews v. Am. Honda Motor Co., 2012 U.S. Dist. LEXIS 90802 (S.D. Fla. June 6, 2012) (rejecting the defendant’s argument that the plaintiff’s FDUTPA claim should be dismissed because the defect at issue did not pose a safety hazard, and explaining that the “argument derives from case law interpreting California’s consumer fraud statute . . . and FDUTPA is not so limited”). Instead, the plaintiff in a FDUTPA case must simply show that the defect diminishes the product’s value such that the failure to disclose the defect would be likely to mislead a consumer acting reasonably at the time of purchase. Id. As a practical matter, this distinction means that cosmetic defects—like paint discoloration and delamination—can form the basis for a valid FDUTPA claim, even if they could not meet the safety hazard analysis that often drives UCL and CLRA cases. Id.

FDUTPA Does Not Require Pre-Sale Awareness or Knowledge of the Defect

To “properly allege an actionable omission” under the UCL and CLRA, the plaintiff must allege “that the defendant knew of the defect at the time a sale was made.” Myers v. BMW of N. Am., LLC, 2016 U.S. Dist. LEXIS 140768, at *9 (N.D. Cal. Oct. 11, 2016). To meet the pre-sale knowledge requirement, plaintiffs often rely upon a combination of consumer complaints posted online, data from the National Highway Traffic Safety Administration (“NHTSA”), and technical service bulletins addressing the issue. See Butler v. Porsche Cars N. Am., Inc., 2016 U.S. Dist. LEXIS 114239 (N.D. Cal. Aug. 25, 2016). Of course, manufacturers do not always issue timely bulletins, and defects are not always well documented in NHTSA databases. Unfortunately, it can be difficult for the plaintiff— without access to discovery—to find other evidence to substantiate the defendant’s awareness of the defect. See Grodzitsky v. Am. Honda Motor Co., No. 2:12-cv-1142-SVW-PLA, 2013 U.S. Dist. LEXIS 33387, at *18 (C.D. Cal. Feb. 19, 2013) (granting the defendant’s motion to dismiss, and reasoning that the plaintiff’s references to online complaints and “speculative” allegations about the defendant’s pre-sale testing and internal data were insufficient to establish pre-sale awareness of the defect).

Conversely, “FDUTPA does not require [the defendant] to have subjective knowledge of alleged defects in order for [the plaintiff] to state a viable FDUTPA claim.” Gavron v. Weather Shield Mfg., 819 F. Supp. 2d 1297, 1302 (S.D. Fla. 2011). This is because Florida precedent makes it clear that, for purposes of FDUTPA, “a deceptive act occurs when there is a representation, omission, or practice that is likely to mislead the consumer acting reasonably in the circumstances, to the consumer’s detriment.” Id. (citations and quotations omitted). And as such, FDTUPA “focuses on whether an act is deceptive, not whether a defendant knew that the allegedly violative conduct was occurring.” Id.

The CLRA Has a Discovery Rule; FDUTPA Does Not

The UCL has a four-year statute of limitations, and the CLRA has a three-year statute of limitations. Cal. Bus. & Prof. Code § 17208; Cal. Civ. Code § 1783. California courts have extended the common-law discovery rule to both UCL and CLRA claims. See Philips v. Ford Motor Co., 2015 U.S. Dist. LEXIS 88937 (N.D. Cal. July 7, 2015). Under California’s common law discovery rule, a “claim accrues and the limitations period beings to run when a plaintiff has information of circumstances to put him on inquiry or if he has the opportunity to obtain knowledge from sources open to his supervision.” Id. (emphasis in original).

FDUTPA has a four-year statute of limitations. Fla. Stat. § 95.11(3)(f). And unlike UCL and CLRA claims, “[a] FDUTPA claim accrues at the time of purchase or lease of a product, not upon discovery of an alleged defect.” Speier- Roche v. Volkswagen Grp. of Am., Inc., 2014 U.S. Dist. LEXIS 59991 (S.D. Fla. 2014) (“It is well-settled there is no ‘delayed discovery rule’ applicable to FDUTPA claims.”). However, a plaintiff may still be entitled to toll the statute of limitations if he or she can plead and prove fraudulent concealment. See Licul v. Volkswagen Group of Am., Inc., 2013 U.S. Dist. LEXIS 171627, at *7 (S.D. Fla. 2013).

California Has a Catalyst Fee Statute; Florida Does Not

California law provides that “a court may award attorneys’ fees to a successful party against one or more opposing parties in any action which has resulted in the enforcement of an important right affecting the public interest….” Cal. Code Civ. Proc. § 1021.5. This statute is a codification of the so- called “catalyst fee” theory, which is an “exception to the general rule that each party to a lawsuit bears its own attorney’s fees.” Macdonald v. Ford Motor Co., 142 F. Supp. 3d 884, 890 (N.D. Cal. 2015). This statute allows the plaintiff to recover attorney’s fees if it is shown that the defendant issued a recall or undertook some other action in response to a UCL or CLRA class action. Id. Moreover, the statute applies to actions filed in both federal and state courts. Id.

Florida does not have a similar catalyst fee statute. Instead, FDUTPA simply contains a “prevailing party” attorney’s fee provision. Fla. Stat. § 501.2105(3). The courts have so far not expressly resolved the issue of whether a defendant must pay for the plaintiff’s attorney’s fees in a case where the defendant issues a recall to address a defect that is also the subject of pending FDUTPA class action litigation. In such circumstances, the defendant may argue that it should not be required to pay attorney’s fees on the grounds that the plaintiffs did not secure a final order on the merits. This argument would likely be premised on Supreme Court and other federal precedent construing prevailing party attorney’s fees provisions in various federal statutes. See Orlando Communs. LLC v. Cellco P’ship, 2015 U.S. Dist. LEXIS 103214 (M.D. Fla. July 22, 2015) (discussing Supreme Court precedent on whether and when a court may award “prevailing party” attorney’s fees). Given the difference in the nature and scope of the federal statutes addressed in that precedent, we believe that such arguments are incorrect, and would vehemently argue that fees should be awarded to ensure that the state law policy objectives underlying FDUTPA are achieved. However, this argument is more difficult to make than it would be in California due to the lack of a specific catalyst fee statute.

It Is Harder for The Defendant to Obtain Attorney’s Fees Under California Law

The UCL lacks any fee-shifting provision, and as such, a prevailing defendant must typically look to the CLRA if it wishes to seek attorney’s fees from the plaintiff. The CLRA, in turn, only permits the court to award “[r]easonable attorney’s fees … to a prevailing defendant upon a finding by the court that the plaintiff’s prosecution of the action was not in good faith.” Cal. Civ. Code § 1780(e). “Courts have uniformly constructed this language as requiring a subjective test.” Corbett v. Hayward Dodge, Inc., 119 Cal. App. 4th 915, 924 (2004). As explained by the courts, “good faith, or its absence, involves a factual inquiry into the plaintiff’s subjective state of mind.” Id. (emphasis in original). Accordingly, the defendant has the burden of establishing that the plaintiff acted in subjective bad faith in filing the lawsuit. Id.

FDUTPA, on the other hand, simply states that “[t]he trial judge may award the prevailing party the sum of reasonable costs incurred in the action plus a reasonable legal fee for the hours actually spent on the case as sworn to in an affidavit.” Fla. Stat. § 501.2105(3). Under this provision, “[o]nce a trial court has determined that a party is a prevailing party under FDUTPA, it then has discretion to award attorney’s fees and costs after considering various equitable factors….” Chow v. Chak Yam Chau, 640 F. App’x 834, 838 (11th Cir. 2015). Those factors include, but are not limited to, a consideration of whether the claim was filed in bad faith, or alternatively, whether the claim was frivolous even in the absence of subjective bad faith. Id.  

While California has been the traditional forum for class action disputes, emerging precedent from Florida and the Eleventh Circuit has shown that FDUTPA can be a very powerful tool for consumer advocates. As set forth above, courts applying FDUTPA have embraced the conjoint damages analysis, and have certified cases involving “overcharge” theories. Additionally, a comparison of California and Florida law reveals that FDUTPA may be the better choice in cases where the defect does not have a clear safety implication, or where there is a lack of public documentation to establish the defendant’s pre-sale knowledge of the defect. On the other hand, the UCL and CLRA may be better tools to employ in cases involving older products, where there is a chance that the defendant may issue a recall during the pendency of litigation, or where there is a higher likelihood that the defendant may prevail and request attorney’s fees from your client.

Risperdal Behind Massive Spike in Mass Tort Litigation

Risperdal-V2-headerBy Anjelica Cappellino. This article is reprinted from The Expert Institute.

There has been a huge spike in mass tort litigation due to the Johnson & Johnson medication, Risperdal, an anti-psychotic drug used to treat schizophrenia and other psychiatric disorders. Risperdal has been the center of litigation for years due to allegations that the drug causes breast tissue growth in young men, a condition called gynecomastia. This past year, however, Risperdal has accounted for over a third of all mass tort lawsuits pending in the Philadelphia Complex Litigation Center. Mostly comprised of individual suits rather than class actions, the verdicts may differ greatly, depending upon the evidence presented in each case. Due to the scientific and medical nature of the drug’s effects, experts in the field may strongly impact the verdict.

Risperdal’s Litigation History and Current Lawsuits

Risperdal has received a significant amount of attention dating back to 1994, when the drug first went on the market and Johnson & Johnson was accused of illegal marketing activities. In one of the largest health care fraud settlements in United States history, Johnson & Johnson was forced to pay more than $2 billion in penalties and settlements to state and government entities as a result of lawsuits relating to Risperdal and two other drugs, as well as civil and criminal complaints about their use. The Department of Justice stated Risperdal and two other Johnson & Johnson drugs were promoted for dementia patients, when Risperdal was approved only to treat schizophrenia. The Food and Drug Administration did not approve this use as safe and effective.

Deceptive marking actions are not the only claims against Risperdal.  The largest cause of action against the drug is that it causes men to develop gynecomastia. This breast development can have devastating and long-term effects on young men. At least 13,000 product liability claims involving Risperdal have been filed in courts around the United States, alleging that Johnson & Johnson was aware that the medication could cause gynecomastia, but concealed that information to the public.

Most of the current litigation is pending in the Los Angeles Superior Court and the Philadelphia Court of Common Pleas in Pennsylvania, where a small group of cases went to trial as part of a bellwether trial process. In February 2015, in one of the first cases to go to trial, a Pennsylvania jury awarded $2.5 million in damages to a 20-year old male plaintiff who had been using Risperdal since he was eight years old. A month later at the second trial, the plaintiff was not awarded any damages after a jury concluded that there was insufficient evidence that Risperdal caused his breast growth. However, the jury did find that the company provided inadequate safety warnings. In November of that same year, a separate jury in the same court awarded $1.75 million to another Risperdal user who developed breasts after taking the drug since age five. In July 2016, the largest award in Philadelphia Risperdal litigation was reached. A jury awarded a Tennessee teenager $70 million in damages after finding that Johnson & Johnson officials failed to warn the young man and his family that the drug could cause him to grow breasts. Most recently, in January 2017, Johnson & Johnson entered into a pre-trial settlement days before another Philadelphia trial, a case which would have been the seventh trial about Risperdal’s link to gynecomastia.

With more than 2,000 cases pending in the Complex Litigation Center of the Philadelphia Court of Common Pleas, and another 300 cases pending in Los Angeles Superior Court, litigation is far from over. The total number of mass tort cases pending in Philadelphia’s Complex Litigation Center at the beginning of 2017 has risen to its highest level in more than five years. Risperdal accounts for the second largest percentage of cases, making up more than 31 percent of Philadelphia’s mass tort docket. In 2016, there were 550 pending Risperdal cases, a 40 percent increase from the previous year.

How Have the Experts Weighed in?

Since the inception of the first lawsuit, expert witnesses were vital to the outcome of the case. David Kessler, a pediatrician and former Food and Drug Administration Commissioner, has been a vocal expert witness in the Risperdal litigation. Since 2012, Kessler has offered his expert services to plaintiffs as both a pediatrician and failure-to-warn expert, writing detailed reports about Johnson & Johnson’s promotion of Risperdal for non-approved uses in children. In 2015, Kessler testified in a Philadelphia trial that Johnson & Johnson knew as early as 2001 that Risperdal could cause gynecomastia in boys, five years before the company adding a warning about such a side effect on its label. The crux of most Risperdal cases is whether the company adequately warned the plaintiff of the drug’s side effects. Therefore, expert testimony like Kessler’s is indispensable in establishing that Risperdal did not contain adequate warnings of its possible side effects.

As plaintiffs often begin taking Risperdal in their youth, pediatricians have served as vital expert witnesses in explaining the effects of the drug on young males. Pediatric neurologists and endocrinologists have testified to explain how the drug affects the hormone levels and nervous system. Specifically, the drug stimulates the pituitary gland and elevates levels of prolactin, a hormone that is related to female breast development and lactation in nursing mothers.

In addition to Risperdal’s long-term effects on young men, the causal link between Risperdal and gynecomastia must also be established. As David Kessler previously testified in January 2015, he concludes that there is a connection. Kessler has pointed to a clinical trial, funded by Johnson & Johnson, that showed 3.8% of young males using Risperdal developed breasts. Kessler testified that the medication “probably or very likely” triggered the condition. Because gynecomastia is caused by elevated amounts of prolactin, experts have testified that if children’s levels of prolactin are monitored while on the medication, the development of gynecomastia can be more easily recognized, opposed to incorrectly attributing the side effects to weight gain.

In light of the growing mass tort litigation, the Philadelphia Court of Common Pleas is scheduled to convene a meeting on March 9, 2017 concerning its centralized docket of Risperdal claims. Although several plaintiffs have reached confidential settlements prior to trial thus far, there are thousands of cases that are still pending and there are no signs that litigation will slow down in 2017.

What Trial Lawyers Need To Know About The Exploding E-cigarette Epidemic

By William Ourand, Esq. • Newsome Melton, P.A. From the Summer 2016 issue of The Trial Lawyer magazine.

E-cigarettes have become a multi-billion dollar industry catering to millions of U.S. consumers. While the businesses behind these devices tout them as being a safe alternative to smoking traditional cigarettes, recent events have shown that these devices pose their own unique set of dangers.

The potential for these devices to cause catastrophic injury was recently highlighted by surveillance footage showing an e-cigarette exploding in a man’s pocket as he waited in line to check out at a convenience store. And this was not an isolated incident — a simple Internet search reveals pages of headlines about e-cigarette explosions resulting in catastrophic injuries.

The incredible profits being generated by the sale of e-cigarettes make it clear that these products are not going away anytime soon. Unfortunately, this means that unscrupulous businesses will continue to flood the market with defective devices. Past experience with dangerous consumer products, including the BIC lighter litigation from a few decades ago, has shown that the only way to force industry change and protect consumers is for trial lawyers to zealously pursue meritorious cases.

This article is intended to serve as a primer for anyone taking on such a case and will do so by analyzing the products themselves, the reasons why these devices are exploding, the current state of regulation for these devices, and finally, the legal theories and hurdles associated with pursuing one of these cases.

Why Are They Blowing Up?

E-cigarettes are battery-powered devices that mimic the sensation of tobacco smoking by releasing a vapor which resembles traditional cigarette smoke. The first e-cigarette was created in 2003 by Hon Lik, a Chinese pharmacist who invented the device in the hope that he could use it to quit smoking (it did not work — as of June 2015, he still smoked both e-cigarettes as well as traditional cigarettes). E-cigarettes exploded in popularity in the years that followed, and now constitute a $3.5 billion dollar industry. More than nine million American adults are estimated to use e-cigarettes. And more than three million middle and high school students used e-cigarettes in 2015, accounting for more than half of the 4.7 million middle and high school students who used at least one tobacco product that year.

The devices come in a variety of shapes and sizes, ranging from cigarette look-a-like “minis,” to midrange “vape pens,” and up to the large “advanced personal vaporizers.” All of the e-cigarette varieties rely upon a heating element that boils a liquid solution poured into the device. The liquid solution is often a combination of nicotine, flavoring, and various chemicals intended to improve the amount and flavor of the vapor produced.

The heating element in an e-cigarette requires a power source. This need is met, in turn, by the use of lithium ion batteries. And therein lays the problem. Lithium batteries contain flammable electrolytes. When these electrolytes are heated to their boiling point, the battery’s internal pressure can cause the battery to rupture, at which point the electrolytes will catch on fire. This dangerous propensity is magnified in the case of e-cigarettes because the batteries are installed at the end of the cylindrical devices, which are their weakest points. As such, when a lithium ion battery ruptures in an e-cigarette, the pressure builds quickly and causes the device itself to break apart. This in turn can cause a fragment of the e-cigarette container, or part of the lithium ion battery itself, to be propelled “like a high-powered rocket.”

E-cigarette explosions can be incredibly dangerous. Examples of media reports about injuries attributed to e-cigarette explosions from the year 2016 alone include:

  • A semi-truck driver who suffered facial injuries and crashed his truck after his e-cigarette allegedly exploded while he was driving
  • A woman who suffered severe burns and lost two teeth after her e-cigarette allegedly “exploded and caused her car to go up in flames”
  • A former professional soccer player who is now “unrecognizable” after an e-cigarette allegedly “exploded in his mouth” and “the product’s battery blew through his cheek”
  • A woman who suffered third-degree burns to her legs when an e-cigarette allegedly exploded in her pocket — she further claims that “the battery exploded with such force that it became lodged in her car’s dashboard”
  • A teenager who has been left completely blind in his left eye

Unfortunately, there is currently no source to turn to for accurate, up-to-date statistics as to e-cigarette explosions. The US Fire Administration previously reported that 25 fires had been caused by e-cigarette explosions between 2009 and 2014. However, as one media outlet has pointed out, “that list is based only on incidents reported by the media,” and “[g]iven that vaping’s seen a surge in popularity since then — last year, the CDC (Centers For Disease Control) reported a three-fold increase among middle-and-high school students alone — the number almost certainly is rising.” Indeed, “[a] quick Internet search shows at least a dozen explosions in 2015 alone.”

From the Unregulated “Wild, Wild West” to FDA Oversight

For more than a decade, the manufacture, distribution, and sale of e-cigarettes were completely unregulated, prompting officials from the Food and Drug Administration (“FDA”) to describe the e-cigarette marketplace as being “the wild, wild West.” Until very recently, it remained unclear as to which federal agency would even attempt oversight over the safety of the design and manufacture of the devices and their component parts, including the lithium ion batteries. While the Consumer Product Safety Commission (“CPSC”) took action to address the problem of exploding lithium ion batteries in hoverboards, the agency disclaimed responsibility for the similar danger posed by e-cigarettes, instead deferring to the FDA. The FDA, in turn, initially proposed to regulate the “health effects” associated with e-cigarettes in 2014. Notably, however, the 2014 FDA proposal lacked any language addressing the electronic components of the devices.

The question as to who would regulate the batteries in e-cigarettes was finally addressed on May 3, 2016, when the FDA announced the agency’s final rule construing the definition of “tobacco product” contained in the Tobacco Act of 2009. Under the final rule, the FDA’s regulatory authority includes not only e-cigarettes but also extends to the “components or parts” of the devices, including the batteries. The FDA specifically rejected the argument made by some commentators that the batteries were beyond the agency’s purview, explaining that it was “concerned about reports of exploding batteries.” The agency further clarified that lithium-ion batteries are properly subject to the agency’s authority where they are “co-packaged with other components or parts” of an e-cigarette, or “otherwise intended or reasonably expected to be used with or for the consumption” of e-cigarettes.

Although the FDA has now clearly stated that it has the right to regulate e-cigarette batteries, it remains unclear what the agency intends to do with its newly announced authority. The agency has stated that it is working on guidance, “which when final … will include FDA’s current thinking regarding compliance with existing voluntary standards for [e-cigarette] batteries.” However, others in Washington are calling for more urgent action. Senator Charles Schumer (D)NY succinctly summarized this point of view, bluntly stating that the FDA should “do its job and investigate why these cigarettes are exploding and force the e-cigarette manufacturer to prevent this from happening.” He further stated that the agency “should determine whether these vaping devices are flawed and require a recall if necessary, to make sure these explosions stop.”

To add to the uncertainty, businesses making a big profit from e-cigarettes promise to fight the FDA’s new regulatory authority in the judicial system. They have been successful in blocking the FDA’s attempt to regulate e-cigarettes in the past. In 2010, the U.S. Court of Appeals for the District of Columbia ruled that the FDA lacked authority to block the import of cigarettes under the Federal Food, Drug, and Cosmetic Act (“FDCA”). The Court reasoned that the FDA could only regulate “therapeutically marketed” tobacco products under its authority from the FDCA. However, the Court went on to observe that “the FDA has authority to regulate customarily marketed tobacco products — including e-cigarettes — under the Tobacco Act.” In light of this observation, the FDA is in a much stronger position to defend its new e-cigarette rule, which is based upon the Tobacco Act, than it was when it previously attempted to regulate e-cigarettes under the FDCA.

Factual And Legal Hurdles

At their surface, exploding e-cigarette cases resemble prototypical products liability actions: they revolve around poorly designed and manufactured products and include a significant warning component. As such, the causes of action to be advanced in such a case will include those pressed in other products liability cases: strict liability, negligence, failure to warn (pre and post sale), and breach of expressed and implied warranties. However, the unique nature of the e-cigarette marketplace creates a plethora of legal and factual hurdles which trial lawyers must be prepared to resolve.

At the outset, many of the usual parties to a products liability claim may prove difficult to track down, serve, and obtain a collectible judgment against in an e-cigarette case. The devices are typically sold by a store front or online retailer, often with some horrible name that incorporates a bastardization of the word “vapor,” that may very well have no assets other than the vape pens they are offering for sale. In such a scenario, the chances are slim that the sketchy storefront would have an insurance policy that would cover a products liability claim.

At the exact opposite end of the “chain of distribution” often sits a Chinese manufacturer. According to the Government Accountability Office, some industry experts estimate that up to 90% of e-cigarettes sold in the United States were imported from China. That is bad for products liability plaintiffs. Past experience has shown that Chinese defendants can be difficult, and at times impossible, to serve. Also, assuming service can be effectuated, any judgment obtained may be moot as the Chinese government may not be willing to recognize an American judgment.

There is a silver lining, however. Even assuming the retailer is a defunct storefront and the manufacturer is a Chinese entity that will thumb its nose at an American court, there remain other parties who may be found liable if the facts warrant. Such other possible defendants include the importer and component part suppliers. Several major brand-name manufacturers have their hands in the lithium-ion battery business and may prove viable defendants if the facts warrant. The necessary steps for pursuing an importer, including the proper arguments to make as to whether the importer should be treated the same as the manufacturer for purposes of legal liability, and the component part suppliers, are difficult but often not impossible tasks for skilled products liability attorneys to accomplish. And if pursued correctly and vigorously, these avenues of relief can open up pockets that are often more than sufficient to compensate clients for catastrophic injuries of the severest magnitudes.

Once the culpable parties are tracked down and brought into the lawsuit, the next hurdle will likely involve some type of “victim blaming” defense in the form of product misuse or alteration. One common refrain from the e-cigarette lobby has been that the products explode because of “user error.” The common theme of the “user error” defense is that the consumer has “overcharged” or improperly inserted the battery into the device. This defense seems feeble when one remembers the many other common consumer products that are subject to “overcharging” and similar misuse, but do not explode and maim consumers. For instance, it seems fair to say that the average consumer has left their cell phone plugged in and charging overnight without waking up to a live grenade in their bedroom the next morning. Additionally, this defense can be turned on its head as even industry insiders have recognized that the businesses profiting from the sale of e-cigarettes have not done enough to warn consumers about the dangers associated with the products’ lithium ion batteries.

E-cigarette defenders also like to point to modifications of the devices as the reason for explosions. It is no secret that the so-called practice of “vape modding,” which involves adding new hardware, batteries, or other components to an e-cigarette, has become incredibly popular within the e-cigarette industry over the past several years. In the legal setting, well-paid defense lawyers will try to use this to bar the courthouse doors, arguing that any such modification constitutes a “substantial alteration” of the product. If the facts of a case implicate a potential modification defense, it is important to anticipate such an argument and be prepared to rebut it, including by the development of expert proof that any modification did not cause or contribute to the incident. Similarly, it may be possible to rebut a modification defense by arguing that the particular modification at issue was reasonably foreseeable. This may be a particularly strong means of rebuttal given the immense popularity of modifications within the e-cigarette industry.

E-cigarettes have become the cornerstone of a multi-billion dollar industry that caters to millions of American “vapers.” Years of regulatory indifference led to a marketplace saturated with dangerous and defective devices that are literally blowing up in people’s faces, resulting in catastrophic injuries. Although the FDA has now signaled its intention to wade into this industry and begin regulating the devices, it remains to be seen what that regulatory oversight will ultimately look like. If past experience with similar product failures is any indicator, the only way industry change will be achieved is if trial lawyers from across the country take on meritorious cases and hold the responsible parties accountable before civil juries.

Georgia Appeals Court Affirms $40M Jeep Fire Verdict

Attorney James E. Butler Jr. of Butler Wooten & Peak LLP in Atlanta, Georgia

Attorney James E. Butler Jr. of Butler Wooten & Peak LLP in Atlanta, Georgia

The Georgia Court of Appeals upheld a $40 million verdict in the death of a four-year-old boy who died when his family’s Jeep Grand Cherokee was rear-ended and burst into flames.

The court on Nov. 16 affirmed Decatur County Superior Court Judge Kevin Chason’s rulings in Walden v. FCA (Fiat-Chrysler Automobiles, formerly known as “Chrysler”). The case was tried last year, resulting in a $150 million verdict on April 2, 2015, which the judge reduced fo $40 million.

Remington (“Remi”) Walden, age 4, died in flames after the 1999 Jeep Grand Cherokee in which he was a passenger was rear-ended and the gas tank, which was located at the extreme rear of the car, burst. The ruptured tank caused a gas-fed fire that Remington could not escape.

Walden was the first case involving Chrysler’s rear gas tank cars to go to trial. Chrysler had managed to settle all others without trial.

The Grand Cherokee in which Remington was a passenger had a rear gas tank located only 11 inches from the back of the car and hanging 6 inches below the bottom of the car.

The Jeep where Remingon Walden burned to death.

The Jeep where Remingon Walden burned to death.

Plaintiffs claimed that Chrysler had known for decades about the dangers of that gas tank design and that a “midships” gas tank location – forward of the rear axle – was much safer.

Plaintiffs claimed that Chrysler had itself been warned repeatedly that its rear gas tank design was dangerous in rear impacts. Those warnings came from Chrysler customers who’d been in Jeeps with rear gas tanks that ruptured in rear impacts, from Chrysler’s own knowledge of real world collisions, and from Chrysler’s own engineers.

Chrysler admitted that the rupture of the gas tank caused the fire and that it could have put the gas tank on the 1999 Grand Cherokee in the “midships” position. Plaintiffs argued there was no evidence that a “midships” gas tank would have been punctured in this wreck.

17 other rear impact wrecks

Plaintiffs presented evidence that Chrysler knew about 17 other rear impact wrecks where Jeep rear gas tanks failed before Remington Walden died on March 6, 2012. One of them involved a crash in New Jersey in 1998, where a woman escaped her burning Jeep. On February 26, 1998 her mother, Norma Jean Friend, who owned the Jeep, wrote to Chrysler to warn it:

“In thinking about this afterwards, I can only imagine how horrible a situation it would be if a driver had to remove a child from a car seat, or could not get out of the car within moments.”

Two years and eight days later, Remington Walden, belted and in a booster seat, died from fire because no one could get him out fast enough.

“It is simply unbelievable that FCA continues to deny this design is defective – a design the industry has known for decades is vulnerable and can cause the most horrible kind of death and injury,” said Jim Butler.

“FCA’s briefs and oral argument were fundamentally dishonest,” he continued. “We are glad that the court saw through them.”

 

Texas Motorists Sues for Injuries Caused by Detonating Takata Airbag

Attorney Mo Aziz of Houston Selected for Texas Super Lawyers 2015

Mo Aziz of Abraham, Watkins, Nichols, Sorrels, Agosto & Aziz in Houston.

Texas attorney Mo Aziz of Abraham, Watkins, Nichols, Sorrels, Agosto & Aziz is representing Serena Martinez who was seriously injured on September 11, 2016, by the defective airbag system in her 2002 Honda Accord.

Cliff Walston and Josh Bowlin of Walston Bowlin, LLP are also part of Serena’s legal team.

The attorneys have filed suit in Harris County against TK Holdings, Inc., American Honda Motor Co., Inc., and related entities for the defective design, marketing, manufacturing, testing, and distribution of the vehicle and its accompanying airbag system. The lawsuit also names the driver of the vehicle who caused the collision as a defendant.

On September 11, 2016, Serena Martinez was involved in a motor vehicle accident in Katy, Texas. Upon impact, the ammonium nitrate in the airbag detonated, causing the inflator to fragment and metal shrapnel to be forced through the airbag. The metal fragments struck Serena in the chest and arm, causing severe lacerations.

airbag

When the airbag detonated, metal fragments struck the plaintiff in the chest and arm, causing severe lacerations.

Takata airbags are defectively designed because they use ammonium nitrate as an airbag propellant. Ammonium nitrate is dangerously unstable and highly sensitive to temperature changes and moisture. It has been known for decades that ammonium nitrate goes through thermal cycling that leads to its degradation and makes it more susceptible to detonation.

Unfortunately, I expect to see more fatalities and serious injuries caused by exploding ammonium nitrate inflators,” according to Mo Aziz who also represented the family of Houston teenager Huma Hanif. Huma was killed by an exploding airbag inflator earlier this year.

Takata Sued In Texas Ammonium Nitrate Explosion

Airbag ComponentHouston attorney Mo Aziz of Abraham, Watkins, Nichols, Sorrels, Agosto & Friend is representing Rene De Los Santos Olveda, who was seriously injured in the August 22, 2016 ammonium nitrate truckload explosion near Quemado, Texas. The lawsuit was filed against TK Holdings, Inc. and Takata de Mexico, S.A. de C.V. The suit is also requesting access to the blast site and all physical evidence, some of which has been retrieved by Takata, as well as access to Takata’s Monclova manufacturing facility to investigate quality control practices.

According to Mr. Aziz, “A temporary restraining order is necessary at this time to gain access to the blast site and conduct crater analysis. Takata has been at the blast site since early last week and based on news reports has been confiscating evidence.”

In the early hours of August 22, a truck hauling Takata airbag inflators and propellant to its warehouse in Eagle Pass, Texas crashed and exploded. The explosion destroyed a nearby home and vehicle, killing one woman and injuring several other people, including Rene De Los Santos Olveda. Due to Mr. Olveda’s proximity to the blast, he sustained a blast induced concussion and has suffered permanent hearing loss.

“We know from other litigation that Takata has manufactured off-spec ammonium nitrate in the past and shipped it to customers. Ammonium nitrate that is low in density is more susceptible to detonate and is classified as an explosive,” said Mr. Aziz.

Mr. Aziz serves on the Plaintiffs’ Steering Committee in the West Explosion Litigation Explosion that devastated the City of West in 2013. He also represents the parents of 17-year old Huma Hanif who was killed on March 31, 2016, by the defective ammonium nitrate airbag system in her vehicle that was manufactured by Takata.

“Disasters such as West, Texas, the Takata airbag fatalities, and now Quemado, Texas highlight the dangers of ammonium nitrate,” said Mr. Aziz.

To learn more about the lawsuit, contact Mo Aziz at 832-868-4198 or maziz@abrahamwatkins.com or Jessica Dean at 713-226-5131 or jdean@abrahamwatkins.com. To learn more about Abraham, Watkins, Nichols, Sorrels, Agosto and Friend, contact the firm at 713-222-7211 or visit www.abrahamwatkins.com.

$33.8M Verdict for Fall Through Defective Skylight

Mark A. Haney

Mark A. Haney is a member of the National Trial Lawyers Top 100 Trial Attorneys.

A Texas jury awarded $33.8 million to a worker who fell through a defectively designed skylight that was too weak to support foreseeable human loads.

Plaintiff Steven Landers fell through the skylight and suffered a broken leg, arm, ribs, punctured lung, and back injury. He required amputation of the lower right leg after months attempting to save the leg, and had a 5-level back fusion to repair his back.

Attorneys Mark Haney of Puls Haney Kaiser, PLLC and Pat Gallagher of Haslam & Gallagher, P.C., both in Fort Worth, Texas, recovered the damages after a 10-day trial.

Steven Landers

Steven Landers sits with one of his children, Colton, 2, at his Fort Worth home. Photo by Ron T. Ennis of the Star-Telegram.

Fell 35 feet

The fall took place in an industrial building on September 18, 2010. Plaintiff fell 35 feet to a concrete floor. Landers, age 34, is married with three children.

The defendant is one of the nation’s largest manufacturers of skylights and has installed millions of them. OSHA records show that reported falls through skylights average about 45 per year.

The case is Steven Landers v. Wasco Products, Inc., 48th District Court, Tarrant County, Texas. Hon. David Evans presiding.

 

 

 

 

Xarelto Multidistrict Litigation Proceeds as Case Filings Increase

Blood Thinner

Case filings are gradually increasing in the Xarelto blood-thinner mass tort litigation.

The drug, which was originally approved by the FDA in 2011, was a popular alternative to other more traditional anticoagulants, largely because it required no drastic dietary alteration, little monitoring, and no adjustment to dosage. It has since received negative attention in the legal world, with more than 3,124 complaints filed or transferred into the multidistrict litigation docket.

Harmful Side Effects Experienced by Users

Multidistrict litigation (MDL) refers to a special federal legal procedure designed to speed the process of handling complex cases, such as air disaster litigation or complex product liability suits. MDL is helpful in mass tort cases like this because it allows attorneys to participate in discovery and litigate common factual issues efficiently and effectively for their respective clients.

Xarelto (Rivaroxaban) is a prescription anticoagulant medication that prevents the formation of blood clots by blocking certain clotting proteins in blood. Three additional indications of use for Xarelto are:

  • Used in people with atrial fibrillation (heart rhythm disorder) to reduce the risk of stroke caused by a blood clot.
  • Used to prevent/treat deep vein thrombosis (DVT) and pulmonary embolism (PE).
  • Used to reduce the risk of the formation of blood clots in the legs (DVT) and lungs (PE) after hip or knee replacement surgery.

Defendants in the MDL include Bayer Healthcare, the designer and manufacturer of Xarelto. Janssen Pharmaceuticals (a Division of Johnson & Johnson) currently sells Xarelto in the United States pursuant to a licensing agreement with Bayer. Plaintiffs involved in the MDL have suffered various harmful side effects, including:

  • Gastrointestinal Bleeding,
  • Intracranial Hemorrhage,
  • Hemorrhagic and Other Severe Internal Bleeding,
  • Stroke, &
  • Death (due to one of the aforementioned injuries).

In January 2015, the U.S. Judicial Panel for Multidistrict Litigation consolidated MDL 2592 in the Eastern District of Louisiana (New Orleans) before The Honorable Eldon E. Fallon. Four bellwether trials have been selected and are slated to occur in early 2017. MDL developments will continue to be reviewed in monthly status conferences.

Bellwether trials are an increasingly common phenomenon in U.S. legal practice. Bellwether trials are especially common in MDL practice. In MDL cases, it is not practical to prepare every case for trial. For efficiency, several matters are selected as bellwether cases and prepared for trial. They are then settled or tried and the results are used to shape the process for addressing the remaining cases.

A bellwether trial is designed to be a value ascertainment function for settlement purposes or to answer troubling causation or liability issues common to a universe of claimants. For the tried cases to achieve these purposes, they must be similar and representative of all cases.

Case Filings Continue to Rise

Philadelphia has experienced a significant increase in Xarelto case filings in recent years. From March to October 2014, only a handful of cases were filed each month, the most being five in September 2014. However, in November 2014, the number spiked with 19 new cases filed. In December 2014, 26 cases were filed, followed by 17 in January 2015, 37 in February, and 50 in March.

Philadelphia is not the only state that has experienced a sharp increase in Xarelto MDL. In Louisiana, 2,800 suits were combined by the JPML as MDL No. 2592. Pennsylvania has also merged 550 plaintiffs’ cases to form a mass tort litigation program in the Philadelphia Court of Common Appeals. The majority of the cases consolidated into MDL No. 2592 allege that the drug places patients in danger of sudden and catastrophic bleeding events. Additionally, MDL plaintiffs claim that the makers of the drug concealed the negative traits of Xarelto through unsound business practices, while touting its positive attributes to the public.

The first bellweather trial is scheduled for February 6, 2017.