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Maryland Court Continues Trend, Holding There Is No Duty To Warn For Household Exposure

Posted in Asbestos Litigation, Litigation Trends, Maryland Courts, Toxic Tort

The Maryland Court of Appeals unanimously ruled that Georgia-Pacific Corp. was not liable for illness involving a woman who was exposed to asbestos while doing her father’s laundry in the 1960s.

The Insurance Journal reported on the recent decision:

  • The Court of Appeals ruled that Georgia-Pacific Corp. was not obligated to warn relatives of the dangers of asbestos in the 1960s.
  • The hazard was not sufficiently known until federal regulations were issued in 1972 by the U.S. Occupational Safety and Health Administration.
  • The court’s ruling overturns a $5 million verdict.
  • Jocelyn Farrar had been exposed while doing laundry in the late 1960s and fell ill decades later.

In the decision, available on the website of the Maryland high court (pdf download), the Court explained that it rejected liability because:

  • There was no duty to warn persons such as Ms. Farrar, who was a “bystander of a bystander,” a person who never used the product and never directly came into contact with it.
  • The duty extends to those whom the supplier should expect to use the product or to third persons whom the supplier should expect to be endangered by its use.
  • Even if the danger was foreseeable, prior to 1972 OSHA regulations, it would have been difficult for the company to have provided a warning that could have avoided the danger.

The Maryland decision continues the recent trend in rejecting a duty in cases involving secondary exposure.  In 2012, California followed Ohio and joined the growing list of states which reject the defendant’s duty to an employee’s family member in “take home asbestos” cases. In an article featured in the DRI‘s Newsletter and published on May 9, 2014, co-authors Carter E. Strang and Karen E. Ross also noted the jurisdictions which have rejected secondary exposure claims.  Since their publication, California and Maryland have joined approximately nine other states in rejecting a duty in secondary exposure cases.  Another California court recently came to the same conclusion as the earlier California case in an unreported decision.

However, as Strang and Ross noted in their January 16, 2014 DRI article (pdf download), it is unclear how these cases will play out at the trial level, as a verdict of over $27 million was recently entered in California in a case involving take-home asbestos exposure.

As the National Association of Manufacturers noted, the Maryland Court of Appeals found:

“that there was skimpy knowledge at the time of the danger to household members from asbestos dust brought into the home, and that the company was unable to give warnings directly to such plaintiffs and the warnings would not have had any practical effect. “

Conclusion

Courts nationwide are increasingly rejecting the claims by plaintiffs and their attorneys that seek to impose duties far removed from the allegedly wrongful act.  Defense attorneys can and should seek to impose reasonable limits on the issue of duty to those instances in which harm is reasonably foreseeable to the alleged tortfeasor.  Raising appropriate defenses in cases involving “take home” claims “household” exposure, or secondary exposure is essential to the defense of toxic tort claims.

North Carolina Bankruptcy Court Limits Garlock’s Asbestos Liabilities and Ford Wants the Court Records Unsealed

Posted in Asbestos Litigation, Litigation Trends, Toxic Tort

Court Ruling

Background: Garlock Sealing Technologies, LLC (“Garlock” or “Debtors”) filed for Chapter 11 bankruptcy protection in June 2010.  Garlock had been an active asbestos defendant for its asbestos-containing precut gaskets, sheet gasket material, and packing materials.  In January, after extensive discovery and a trial held under seal, the Bankruptcy Court issued an opinion (pdf download) in which it estimated Garlock’s liability for present and future mesothelioma claims.  The Court adopted the Debtors’ estimate of $125 million despite the $1-$1.3 billion estimate of the representatives of current and future claimants (“Claimants”).

Estimation Analysis: In the past, bankruptcy courts have taken a variety of approaches to estimating liability for present and future claims, which has led to billions of dollars being set aside for claimants in asbestos bankruptcy trusts.  Here, Debtors requested that the Court follow a “legal liability” approach, in which the merits of claims are considered and an econometric analysis is conducted to determine the likelihood of recovery.  Meanwhile, Claimants requested that the Court follow a “settlement approach” based on extrapolating data from Garlock’s past settlements in the tort system.

Before making a determination, Judge George R. Hodges allowed Garlock to conduct additional discovery in 15 cases that it settled or took to trial.  Plaintiffs in these cases were represented by 5 major asbestos plaintiff firms.  In every case, Garlock found that evidence of alternative exposure was withheld.  The Court found on average pre-settlement disclosure of exposure to 2 bankrupt entities’ products, but after settlement those same plaintiffs made claims to an average of 19 bankruptcy trusts.  The Court found several occasions when lawyers misrepresented a plaintiff’s exposure history to judges and juries only to later file claims against trusts for products to which they had previously denied exposure.  Garlock has filed civil lawsuits against several plaintiff firms based on allegations of fraud.  For more details on the allegations and related litigation see the Court’s opinion and accounts from NPR, Forbes, and BusinessWeek.

While the Court recognized a comfort in relying on settlement history to estimate liability, it found in this case a “divorce” from that process was necessary and it adopted the Debtors’ approach and estimate.  The Court determined that the Claimants’ approach did not adequately account for cases in which exposure evidence was withheld and it did not take into consideration the cost of litigation as a driving factor in settlements.  The Court concluded that Garlock’s products were made of low potency chrysotile asbestos and generally Claimants had also been exposed to more potent amphibole asbestos from other manufacturers’ products.  Based on this alternative exposure and the fact that some claimants had never been exposed to asbestos from a Garlock product, the Court concluded Garlock should be responsible only for a small percentage of each claimant’s recovery and only if exposure actually occurred.

The Court adopted the analysis of Dr. Charles E. Bates of Bates White.  It found that $25 million was a reliable estimate of Garlock’s liability to its approximately 4000 current mesothelioma claimants, which is an average of $6,000 per claimant.  The Court also determined $100 million was sufficient to cover future claims based on Dr. Bates’ analysis.  News accounts expect Claimants to challenge these rulings.

Implications: Other entities want to know more about the evidence under seal.  Legal Newsline, which is owned by the U.S. Chamber Institute for Legal Reform, has moved for access to records of the alleged fraud described in the Court’s decision under the First Amendment.  The organization wants the Court to unseal the transcripts of its trial, so it can gather information regarding the plaintiffs’ alleged conduct in those asbestos cases.  Ford Motor Company joined the request last week and claimed that it may have been induced into inflated settlements in some of the cases in which Garlock conducted additional discovery.  If the Court releases the records, it will surely offer a glimpse into the practices of the asbestos plaintiffs’ bar.

Delaware Court Examines Admissibility of Epidemiology Experts in Product Liability Cases

Posted in Toxic Tort

Recently, the Delaware Supreme Court decided Tumlinson v. Advanced Micro Devices, Inc., No. 672, 2012 (Del. Nov. 21, 2013). This case provides a great example of the so-called “gatekeeper” function of the court when it comes to the admission of expert testimony in civil cases. More importantly, it provides context concerning the admissibility of expert epidemiological testimony under the Daubert standard in products liability cases. In Tumlinson, the Supreme Court affirmed a decision of the trial court that excluded an epidemiologist’s expert testimony on the ground that it failed to satisfy the reliability requirements of Delaware Rule of Evidence 702 and Del. R. Evid. 702.

The Facts

The defendant, Advanced Micro Devices, Inc. (“AMD”), a Delaware corporation with offices in several major U.S. and global cities, manufactures semiconductors used in computers. In 2008, the plaintiffs, who worked in AMD’s plants, filed suit against AMD based on their theory that chemicals used in the manufacture of AMD’s semiconductors caused birth defects in their children.

To support their claims, the plaintiffs retained an expert epidemiologist who concluded that the chemicals allegedly present in the AMD plant caused their children’s birth defects. AMD filed a motion in limine, wherein it argued that the epidemiologist’s opinion was unreliable because too many analytical gaps existed in her methodology to render a sound opinion. The trial court agreed.

Daubert Factor #1: Whether the expert’s opinion can be (and has been) tested.

The trial court first found that the expert’s opinion could not be tested because it lacked sufficient specificity. In this case, each of the plaintiffs’ children suffered birth defects that were very different in nature. The court observed that the epidemiologist was unable to identify which specific chemical or combination of chemicals caused the children’s different birth defects. The court further found that the expert did not distinguish between the differing work environments between the two plaintiffs or consider, specifically, how these different environments may have impacted the level of exposure.

Daubert Factor # 2: Whether the expert’s method has been subject to peer review and publication.

The court next considered whether the expert’s methods were subject to peer review and publication. The plaintiffs’ counsel argued that the expert’s opinion was peer reviewed because it was based on three studies that the expert synthesized before formulating her own conclusion. The court ruled that an expert’s opinion, even if based on the synthesis of peer reviewed studies, must demonstrate an independent indicia of reliability. The court found that there was nothing in the record to provide this independent reliability and, furthermore, the studies cited by the expert were produced in the context of other litigation and, themselves, unreliable.

Daubert Factor #3: Whether the methodology has attracted widespread acceptance within a relevant scientific community.

Finally, the trial court found that the epidemiologist failed to demonstrate that she relied on techniques that have gained acceptance in the scientific community. In reaching this conclusion, the court first observed that there are multiple scientific approaches that epidemiologists use to establish causation. Turning to the expert’s opinion, the court then found that she did not demonstrate that her opinion was the product of any of these accepted approaches. Specifically, the expert failed to detail her method of weighing the importance and validity of the data sources she used to form her opinion.

Take-Away:

When assessing the validity of an expert report, it is important to consider the factors highlighted above: does the report sufficiently state the scientific method used? Is the opinion based on reliable, peer reviewed sources? Does the expert consider objective data? Has the expert set forth each analytical step toward reaching his or her conclusion or has the expert ignored any consideration that might alter the opinion? As this lower court’s opinion and its affirmance by the Delaware Supreme Court demonstrate, the answers to these questions may determine the fate of your clients in complex product liability litigation.

Congresswoman’s Asbestos Lawsuit Emblematic of an Increasing Trend of Allegedly Asbestos-Related Lung Cancer Cases

Posted in Asbestos Litigation, Delaware Courts, Litigation Trends

Companies and insurers continue to experience an increase in the number of lawsuits they face, which involve Plaintiffs who allege that their lung cancer was caused by asbestos exposure, despite the fact that many of these Plaintiffs were longtime smokers.  The trend, which has emerged over several years, has gained nationwide prominence as highlighted by New York Congresswoman Carolyn McCarthy’s asbestos lawsuit.

Congresswoman McCarthy sued more than 70 companies alleging that their asbestos-containing products caused her lung cancer, despite the fact that she spent 30 years as a nurse and was a heavy smoker for more than 40 years, writes Daniel Fisher in Forbes. As Fisher notes, lung cancer claims in Madison County, Illinois and Delaware have more than doubled since 2010.

As Joe Nocera recently wrote in the New York Times, the upsurge in lung cancer cases appears to be driven by economic incentives.

The increase in lung cancer filings is notable not only because of the number of additional filings, but also because many of the injured parties are longtime smokers.  Congresswoman McCarthy, for example, reportedly “is such an avid smoker that she’s known around Capitol Hill for taking breaks ­between votes.

Marc C. Scarcella and Peter Kelso have recently published on the subject of the economic incentives of lung cancer cases.  Lung cancer filings in Madison County and Delaware have increased from less than 200 in 2000, to an estimated total for 2013 of more than 1,200.  The trend is especially notable given that smoking is likely a contributing factor in 90% of lung cancer cases, (pdf download).

As Daniel Fisher noted in a follow-up article, despite her admitted 30-year smoking history, Congresswoman McCarthy denied that her lung cancer was caused by smoking.

Conclusion

With ever-increasing lung cancer lawsuits involving allegedly injured parties, zealous and thorough investigation and representation are even more important.  Determining the injured’ party’s smoking history is not only essential, but should be a critical and repeated theme woven throughout the defense of the case by defense attorneys.  Companies and insurers faced with lung cancer lawsuits involving alleged asbestos exposure must be vigilant regarding questionable claims.

Top 5: Changes to New Delaware Asbestos Standing Orders

Posted in Asbestos Litigation, Delaware Courts, Litigation Trends

Approximately a year ago Delaware Asbestos Judge John A. Parkins, Jr. asked the asbestos bar to recommend a revised Standing Order No. 1  (pdf download) and General Scheduling Order (pdf download) (“GSO”) to govern the ten asbestos trial settings in Delaware each year.  The endeavor was led by the ADR Master, David A. White, and then Judge Joseph R. Slights, III, who is now a practicing lawyer in Wilmington.  Judge Slights previously presided over the asbestos docket.  A year of negotiations led to joint proposed orders.  After a few minor changes, the Court issued the new orders earlier this month.  Transitioning to the new orders is still a work in progress, but it appears they will take full effect starting with cases scheduled for trial in February 2015.  Here are the Top 5 Changes you should know:

  1. The new standing order streamlines deadlines, while expanding the number of days in the GSO for most cases and providing an expedited track for exigent cases.  The new GSO has only 24 deadlines compared to 60 deadlines in the old GSO.  Unnecessary deadlines were removed and others were combined to allow for the more efficient processing of cases.  Under the prior GSO, discovery and pretrial took place over a 360 day schedule.  Now non-exigent cases will have a 420 day track and exigent cases, in which Plaintiffs provide certain discovery in advance of docketing for trial, can use “a spur” to jump into the GSO 320 days from trial.
  2.  New Standing Order No. 1 updates plaintiffs’ production requirements regarding claims forms.  Within 60 days of filing a complaint, plaintiffs must produce copies of all claims forms and all related materials.  In addition to bankruptcy trust proof of claims forms, plaintiffs must also produce applications for Social Security benefits, worker’s compensation benefits, military service benefits, and disability benefits.  Plaintiffs have an obligation to supplement these records up to the time of trial.  The new order expands plaintiffs’ production requirements and makes clear their ongoing obligation to produce these documents.
  3. The new GSO requires that the parties complete summary judgment fact discovery prior to the drafting of motions for summary judgment.  Practically speaking, the major change provided in this provision is that it allows plaintiffs an opportunity prior to motions for summary judgment to depose witnesses on which defendants plan to rely for those motions.  This provision should provide a more complete factual record for motions for summary judgment.
  4. For the second time in his tenure as Asbestos Judge, Judge Parkins moved summary judgment oral arguments earlier in the process.  Shortly after assuming the docket, he moved oral arguments from 30 days prior to trial to 60 days.  The goal was to give the Court time to rule on motions taken under advisement and the parties time to resolve claims prior to trial.  The new GSO calls for oral argument 100 days prior to trial.  The new oral argument date further accomplishes the Court’s goals discussed above and allows for motions to be heard prior to expert discovery, thus reducing transactional costs for all parties.
  5. The new GSO requires the parties be more prepared for trial at the pretrial conference which takes place 5 days before trial.  This provision is one of the few changes the Court made to the bar’s proposed order.  By the pretrial conference, the parties must now have completed all video depositions and provide proposed jury instructions and proposed verdict sheets.  The Court also now requires that all depositions read to the jury or played by video must be “reasonable” in length.  The Court further provided templates for the Court’s approved format for the Joint Pretrial Memorandum (pdf download) and Jury Screening Questionnaire (pdf download).

Asbestos Cases and Every Exposure Causation: Proper Expert Witness Preparation Is Essential In Any Jurisdiction

Posted in Asbestos Litigation, Litigation Trends

Judge's GavelCompanies around the country grapple with different standards of causation in different jurisdictions.  If recent trends continue, some jurisdictions may take a harder look at the “every exposure” theory of causation advanced by plaintiffs’ attorneys in asbestos litigation.

Pennsylvania has recently reaffirmed the “well established” concepts involving the requirements for substantial factor causation:

  • The each and every exposure theory may not be relied upon;
  • The plaintiff bears the burden of proof as to frequency, regularity, and proximity of alleged exposures
  • In cases involving dose-responsive diseases, expert witnesses must consider dose as a factor in their opinions;
  • De minimus exposure is not enough to establish substantial factor causation;
  • An individual analysis of the particular injured parties’ exposure history is required
  • Summary judgment is proper in light of de minimis exposures.

The recent Pennsylvania decision confirmed the Pennsylvania high court’s decision from 2012, in which the Court explained that

“Simply put, one cannot simultaneously maintain that a single fiber among millions is substantially causative, while also conceding that a disease is dose responsive”.

As Bryan Redding noted on the LexisNexis Legal Newsroom Litigation Blog, the Pennsylvania Court found that the single fiber theory offers a broad-scale opinion on causation to anyone who inhaled a single asbestos fiber above background levels, and in doing do, the plaintiff’s pathologist “did not use the language of a methodology or standard applied in the field of pathology.  Maddox’s testimony makes it clear that his opinion was grounded in risk assessment” which is not typically within the field of expertise of pathologists.  As such, defense attorneys should be attuned to the qualifications of the experts who may offer every exposure-based testimony.

The rejection of the every exposure theory appears to be a growing trend.  As Arlow M. Linton noted, courts in Rhode Island and Utah have also rejected the every exposure approach to causation in the past year.

Texas has required an analysis of the frequency, regularity, and proximity with defendant-specific evidence relating to the dose to which the plaintiff was exposed for several years now. Borg Warner decision pdf download. Not all jurisdictions have required such a rigorous causation analysis.  For example, Illinois courts are also required to consider the frequency, proximity, and regularity, but the Illinois courts allow plaintiff’s experts to offer opinions that every exposure is a substantial factor. Noland decision pdf download.

Similarly, the Supreme Court of California has set forth a rule requiring that trial courts take frequency, regularity and proximity into account, but lower courts in California have often applied this standard in manner in essentially the same manner as in Illinois.  Rutherford decision pdf download. Hernandez decision pdf download.

Take Away

Courts seem to be increasingly skeptical about the every exposure theory.  However, even in jurisdictions where existing case law does not require a diligent analysis of causation based on the duration, frequency and proximity of the alleged exposures, the same basic principles can still assist in the defense of the case.  Thorough expert discovery in particular is crucial for the defense of these cases.  Determining whether the plaintiff’s expert witnesses have any education or training on which they base their opinions and exploring the internal consistency of their opinions and their methodology is of the utmost importance.  Even in jurisdictions that allow experts to offer generalized conclusions that a single exposure is a substantial factor, courts should still require those experts to have a proper basis for that opinion.

Companies and insurers involved in asbestos litigation should be willing to undertake serious expert witness discovery, both offensively and defensively.  A comprehensive evaluation of the medical and scientific bases of the plaintiff’s case is more important now in light of these trends.

Delaware Judge Upholds $2.8 Million Verdict in Galliher Asbestos Trial

Posted in Asbestos Litigation, Delaware Courts

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. 

Social Media: #Discovery

Posted in Litigation Trends

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.

Massachusetts Court Finds Plaintiffs’ Claims Against Generic Drug Manufacturers Are Barred By Preemption

Posted in Massachusetts Courts, Pharmaceutical and Medical Devices

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.

Another Brick In The Wall Against Medical Monitoring Claims

Posted in Asbestos Litigation, Massachusetts Courts, Toxic Tort

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.