September 2013

industrial talc powder

Background: 

Judge John A. Parkins, Jr. recently upheld a $2.8 million verdict awarded to the estate of a deceased 62 year old man in a mesothelioma case .  The Simmons firm represented Plaintiffs in this case against R.T. Vanderbilt (“Vanderbilt”).  Plaintiffs argued that Vanderbilt’s NYTAL industrial talc (pdf download) contained asbestiform materials and caused Mr. Galliher’s mesothelioma.  Vanderbilt argued that those asbestiform fibers could not cause mesothelioma.  At trial, Vanderbilt moved for a mistrial based on inadmissible testimony presented to the jury and judgment as a matter of law.  Judge Parkins denied the motion for a mistrial and reserved ruling on the motion for judgment as a matter of law.  Vanderbilt renewed its motions after trial and recently the Court denied both motions (pdf download).

Motion for New Trial:

Vanderbilt moved for a new trial based on the following evidence presented to the jury which it claimed was improper:

  • Plaintiffs failed to remove certain excluded hearsay testimony from the video testimony of a Vanderbilt employee regarding asbestos being present in the talc.
  • Dr. Barry Castleman inappropriately suggested that Vanderbilt spent $16 million “buying senators and lobbying the government.”
  • Dr. Castleman inappropriately referenced Johns Manville calling Vanderbilt “liars” regarding the marketing of its talc.
  • Sean Fitzgerald inappropriately relied upon ratios derived from an excluded report in his testimony.

Reasoning

Judge Parkins analyzed each of Vanderbilt’s arguments and determined they did not warrant a new trial.  Considering each claim individually, he found:

  • The Vanderbilt employee’s hearsay testimony was cured through a curative instruction.  Moreover, Vanderbilt had an opportunity to review the edited tape before it was shown to the jury, but did not find the mistake prior to its presentation to the jury.  The Court noted, “Vanderbilt took a calculated risk when it sent only one counsel to try the case.”
  • Dr. Castleman gave the $16 million statement in response to questions from Vanderbilt’s attorney.  The Court struck the testimony and instructed the jury to disregard it.  Ultimately, it determined that the testimony was not significant enough to warrant a new trial.
  • Dr. Castleman testified regarding the liars comment in response to questions from Vanderbilt.  The testimony comes directly from a paragraph in Dr. Castleman’s book, about which Vanderbilt specifically asked.  Vanderbilt’s argument largely fell on deaf ears because as the Court stated, “for no obvious reason Vanderbilt’s counsel decided to venture into the minefield.”
  • The Court determined the Fitzgerald testimony was cured through curative instructions.

Take-Away

Given the high standard for a new trial, the Court is unlikely to grant one unless the errors are egregious.  The Court will make every effort to cure prejudice during trial through curative instructions as it did here.  Finally, the Court appears to suggest that given the complexity of asbestos trials, the last minute nature of many evidentiary rulings inherent in these trials, and the time constraints of this trial (counsel had limited time to present the case), defendants should consider sending two trial counsel or rely more heavily on local counsel to assist with daily trial preparation.

Motion for Judgment as a Matter of Law:

Vanderbilt offered the following reasons the Court should grant judgment as a matter of law in its favor:

  • Plaintiffs failed to offer sufficient testimony that Mr. Galliher worked with or around the talc on a frequent and regular basis.
  • Plaintiffs failed to offer sufficient evidence that asbestiform fibers caused Mr. Galliher’s mesothelioma.
  • Plaintiffs failed to offer evidence that Vanderbilt was on notice of the dangers of asbestiform fibers giving rise to a duty to warn.
  • Plaintiffs failed to offer evidence that Vanderbilt’s warning was inadequate.

 Reasoning

Judge Parkins determined that the jury relied on reasonable record evidence to support its findings.  Plaintiffs offered several experts in support of their argument that asbestiform fibers in the talc caused Mr. Galliher’s mesothelioma and the jury relied on that testimony.  They also offered evidence that Mr. Galliher worked with the talc and that it contained a warning that said non-asbestiform.  Accordingly, the verdict was grounded in the evidence and Judge Parkins would not overturn the jury’s decision.

Take-Away

The Delaware standard for judgment as a matter of law after the jury returns a verdict is highly deferential to the jury.  Here, the pivotal issue was whether fibers in the talc could cause mesothelioma.  The best way to challenge scientific testimony in Delaware is through a Daubert challenge.  If a party’s witnesses and cross-examination of the other party’s witnesses is insufficient to convince a jury the science is inadequate, the Court is unlikely to overturn their finding.  Moreover, convincing a jury that a product cannot cause mesothelioma is a difficult proposition, when you cannot point the finger at another party as was the case here.

* Disclosure: Bill Larson served as Judge Parkins’ law clerk during the Galliher trial, but had no involvement in this decision. 

Everybody Into The Digital PoolThere is little doubt that Facebook, LinkedIn, and Twitter have enhanced our ability to communicate with one another and express our ideas and feelings. These social networks—and countless others—make it easy to share photographs of our children at birthday parties, organize social events, or boast about our latest culinary creations. Often, we use social networking platforms to communicate our state of mind in real time (i.e., status updates). We expect that only our closest friends and family will be interested when posting a picture from last night’s party on Facebook or Instagram. It is a rare and litigious person, indeed, who understands that his or her status updates could be discoverable in a lawsuit.

In Romano v. Steelcase Inc., the Supreme Court of Suffolk County, New York granted a defendant’s motion to compel access to the plaintiffs’ social networking accounts. In doing so, the court reasoned that those “who place their physical condition in controversy may not shield from disclosure material which is necessary to the defense of the action … including a plaintiff’s claim for loss of enjoyment of life.” The plaintiffs posted images of themselves smiling outside their home to a publicly accessible Facebook page despite legal claims that they were restricted to bed by their injuries. The court found that, under such circumstances, “there is a reasonable likelihood that the private portions of [plaintiffs’ Facebook pages] contain further evidence” regarding their enjoyment of life.

Claims for personal injury, including products liability and complex tort actions, almost always demand relief for emotional pain and suffering. That being so, what defense litigation attorney would not cherish Instagram photos of the personal injury plaintiff dancing at a party? Employment disputes may also contain elements of emotional distress, suggesting discoverability of social network data. Certainly, a Tweet could be central to a defamation case. With so much of our lives online, it is hard to imagine many circumstances where social media evidence is not responsive to a narrowly tailored and reasonable discovery request.

The discovery rulings, much like the social networking sites, continue to develop. In July, the Southern District of Indiana decided that “tagged” photographs are discoverable (“Tagging” is a process by which a third party can take and post a photograph and digitally associate the photograph with the responding party, thereby making such photographs available on the responding party’s Facebook page).  The Employer Handbook: Facebook “tagging” adds a new wrinkle to social media discovery. Consequently, even the actions of third parties over which the responding party bears little control may be subject to a well-drafted and targeted discovery request.

Take Away

Of course, discovery of social networking data must have limits. Less than a year after the New York Supreme Court decided Romano, the court ruled that a demand to access a party’s social media account cannot amount to a “fishing expedition.” Caraballo v. City of New York. Generally, a discovery request is almost always successful when narrowly tailored and likely to result in admissible evidence. The information is, most often, rightfully discoverable provided that there is a factual predicate for the request. These discovery principles cannot change even though the types of information to which they are applied frequently do. For discovery request examples, see Sample Discovery Requests: Facebook and Social Media.

Generic Drugs

Written by Jonathan F. Tabasky and Kate B. Puccio

Massachusetts Superior Court Judge Bruce R. Henry recently dismissed a series of claims against several manufacturers of the generic drug Metoclopramide (“MCP”), against whom failure to warn claims was alleged.  See White v. Elsevier, Inc., Middlesex Superior Court Civil Action No. 11-04441.  In so doing, Judge Henry held that Plaintiffs’ state law claims were preempted by federal law which prohibited different labeling than that associated with corresponding brand-name drugs.

Physicians commonly prescribe MCP and its Brand equivalent Reglan to treat digestive tract problems. In support of their claim for liability, the Plaintiffs proffered evidence that long term use of the drug can cause tardive dyskinesia, a severe neurological disorder.  Documented side-effects have included involuntary muscle movements, tongue protrusions and the like. The Plaintiffs claimed that the warnings in place were too weak, and underreported the incidence of such side-effects.  In support of their claims the Plaintiffs argued that in 2009, the FDA ordered a black box warning, its strongest, which states: “Treatment with [Reglan/MCP] can cause tardive dyskinesia, a serious movement disorder that is often irreversible . . . Treatment with [Reglan/MCP] for longer than 12 weeks should be avoided in all but rare cases.” The Plaintiffs further alleged that these hazards were well known by the defendants before they started taking the drug, and had the black box warning been in place at the time they ingested same, they would have taken another drug, or limited the period during which they took the drug.

The Generic Defendants moved to dismiss the Plaintiffs’ claims pursuant to Mass. R. Civ. P. 12(b)(6), contending that the Plaintiffs failed to state a claim upon which relief may be granted because federal law preempts their claims.  In making this argument, the Generic Defendants relied upon Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a United States Supreme Court decision which addressed similar preemption issues concerning the same drug and many of the same generic manufacturers as in this case.

Judge Henry’s opinion contains a useful summary of the regulations governing the production and sale of generic drugs.  He noted that under federal law, “[a] brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label.” Conversely, ‘generic drugs’ can gain FDA approval simply by showing bio-equivalence to the brand-name drug that has already been approved by the FDA, and that the safety and efficacy labeling proposed is the same as the labeling approved for the [brand-name] drug (citations and ellipsis omitted). After this initial FDA approval, generic drug manufacturers have an ongoing federal duty of ‘sameness.’ A generic drug manufacturer that makes unilateral changes to strengthen a generic drug’s warning label would therefore violate the statutes and regulations requiring a generic drug’s label to match its brand-name counterpart’s.

Because the Plaintiffs alleged that the Generic Defendants’ duty to warn could have been satisfied by “Dear Doctor” letters or other modes of communication, Judge Henry noted that the Code of Federal Regulations definition of labeling to include almost every conceivable communication, including but not limited to: brochures, booklets, literature, references published (for example, the Physicians’ Desk Reference, drug information supplied by the manufacturer, packer, or distributor).  He also noted that the Mensing decision held that “Dear Doctor” letters fell within the definition.

Judge Henry concluded that the Plaintiffs’ negligence, breach of warranty, fraud and consumer protection claims arose out of the claim that Reglan/MCP labeling was inadequate. Judge Henry found, however, that the Generic Defendants could not change the labeling of MCP as to do so would have deviated from the labeling of their brand-name Reglan counterparts in violation of federal law.  For the same reasons, the Generic Defendants could not disclose additional safety information to the medical community by “Dear Doctor Letters” or other means. Therefore, just as in Mensing, federal law preempts the plaintiffs’ claims because it is impossible for the Generic Defendants to comply with both their duties to warn under Massachusetts law and under federal law.

The White case is continuing against brand defendant, pharmacy defendants, and patient education monographs (PEM) defendants.  Updates regarding this important case will follow in the near future.

Brick Wall

United States District Court Judge Mark L. Wolf recently denied the “medical monitoring” claims of a putative class alleging beryllium exposure. This is the first decision addressing medical monitoring claims in Massachusetts since the landmark Donovan ruling in 2009, and strengthens the restrictions on such claims.

Medical monitoring claims, a relatively modern addition to tort law, seek monetary damages for medical testing required after toxic exposure. States increasingly allow medical monitoring claims to proceed. However, a divide remains between courts which require evidence of physical injury and those which require only evidence of increased risk of injury. In Donovan v. Philip Morris USA Inc., 455 Mass. 215 (2009), Massachusetts’ highest court ruled that medical monitoring claims are allowed, as long as evidence of physiological, or “subcellular,” changes are present.

In Donovan, plaintiffs sought to represent a class of symptom-free smokers and asked the court to order medical monitoring. Philip Morris sought dismissal of the medical monitoring claims based on the lack of injury to any of the plaintiffs. On the question of whether medical monitoring claims are valid under Massachusetts law, the U.S. District Court certified the question to the Supreme Judicial Court.

The primary dispute: whether plaintiffs must establish physical injury to sustain their claims, or merely an increased risk of injury. The SJC ruled that plaintiffs can sustain a medical monitoring claim in Massachusetts by proving seven elements, including: “[exposure] to a hazardous substance that produced, at least, subcellular changes that substantially increased the risk of serious disease, illness, or injury.” Donovan at 226. The requirement of “subcellular,” or physiological, changes was a departure from the law of many other states. While the Donovan decision confirmed that medical monitoring claims could be brought in Massachusetts, it also restricted such claims to plaintiffs who had suffered actual physical damage.

Fast forward two years. This past June, U.S. District Court Judge Mark L. Wolf granted a defendant summary judgment in the first medical monitoring decision to be addressed in Massachusetts since Donovan. In the consolidated cases of Betucchy, et al. v. Raytheon Co. (1:10-cv-11652) and Genereux v. Hadric Laboratories Inc. (04-cv-12137), plaintiffs sued Raytheon for, among other things, medical monitoring costs associated with exposure to beryllium at Raytheon’s Waltham facility. Their complaints alleged that Raytheon’s improper handling of the chemical increased their risk of developing Chronic Beryllium Disease (“CBD”). None of the members of the putative class exhibited any signs or symptoms of CBD, and none had received abnormal results on the BeLPT, the test for that disease.

Raytheon moved for summary judgment, claiming that the plaintiffs failed to produce any evidence of the “subcellular change” required by the SJC in Donovan. In granting Raytheon’s motion, Judge Wolf examined the plaintiffs’ only evidence: the testimony of plaintiffs’ expert. The expert could not conclude that any of the plaintiffs suffered subcellular changes, nor did he find that any plaintiff had abnormal BeLPT tests. Finally, he had testified that increased exposure to beryllium does not necessarily lead to subcellular change, but only an increased risk of subcellular change.

Judge Wolf ruled that the plaintiffs’ expert’s opinion did not meet the “subcellular change” requirement established by the SJC. He acknowledged that the SJC had left open the possibility of cases in which subcellular change would not be required. However, the claims in this case could not be considered as such because plaintiffs’ complaints specifically alleged “subcellular changes to [their] persons.” In addition, Judge Wolf upheld the SJC’s reasoning that the “subcellular change” requirement acts as a check on plaintiffs’ ability to seek medical monitoring merely on the basis of increased risk of harm. The requirement of physiological change, in other words, ties the modern doctrine of medical monitoring in with traditional elements of tort law: physiological changes establish the  element of injury and damages.

The Take Away

While the trend has been for courts to allow medical monitoring claims, defendants must utilize well-reasoned opinions, such as Betucchy to push for clearly-defined restrictions on such claims, such as a requirement that plaintiffs demonstrate some physical harm, even if that harm consists of only subcellular changes.