September 2016

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A recent ruling in an asbestos-related case provides an important lesson for defendants in framing their defenses.

In Malone v. Air & Liquid Systems, et.al. (Report and Recommendation, C.A. No. 14-406-GMS-SRF (D. Del. Aug. 29, 2015)), a mesothelioma case pending in the U.S. District Court for the District of Delaware which involves allegations of asbestos exposure to several products at Ingalls Shipyard in Pascagoula, Mississippi, the court recently found summary judgment was appropriate for three defendants based on lack of evidence to support causation and the “bare metal defense.”  The court, however, rejected the defendants’ other arguments based on the “learned intermediary doctrine” and the “government contractor defense.”

U.S. Magistrate Judge Sherry R. Fallon confirmed that the well-established “frequency, regularity, and proximity” causation standard adopted by Mississippi courts in asbestos actions is a uniform standard regardless of the alleged asbestos-related disease.  The court recommended granting summary judgment for three defendants – Cummins, Inc. (“Cummins”); CBS Corporation f/k/a Westinghouse Electrical Corporation (“CBS”); and Foster Wheeler Energy Corporation (“Foster Wheeler”).[1]  In the recommendation, the court noted that “Mississippi courts have not distinguished between different asbestos-related diseases when applying the frequency, regularity, and proximity test.”  The court found the Malones’ argument that the factors should be applied “less rigidly” in mesothelioma cases unavailing, and that plaintiffs did not meet their burden to prove causation with respect to these defendants’ products.

Cummins, CBS, and Foster Wheeler each moved for summary judgment asserting as an additional ground the “bare metal defense.”  The “bare metal defense” shields from liability companies that did not manufacture or distribute asbestos-containing components which were incorporated into the manufacturer’s product after its sale.  In recommending summary judgment for each defendant, the court substantially followed its prior ruling in Dalton v. 3M Co., 2013 WL 4886658 (D.Del.), where the court found that “it is reasonably likely that the Supreme Court of Mississippi would follow the majority of jurisdictions that have refused to find defendants liable for other manufacturers’ asbestos products.”  The court rejected plaintiffs’ argument that Dalton is inapplicable where the use of an asbestos-containing product in association with the defendant’s product was foreseeable, where the defendant did not require its use.

While the court granted judgment as a matter of law to all three defendants based on defendants’ causation and “bare metal” arguments, the court rejected CBS’ argument that it was entitled to summary judgment based on the “learned intermediary doctrine” and CBS’s and Foster Wheeler’s argument that each was entitled to summary judgment based on the “government contractor defense.”  The court rejected CBS’s “learned intermediary” argument because, despite the fact that if offered evidence that the United States Navy was aware of the potential hazards associated with asbestos, it “offer[ed] no facts . . .  to support whether Westinghouse reasonably relied on the Navy to warn users like Mr. Malone . . .”  With regard to the government contractor defense, the court held that a factual issue concerning whether military specifications cited by plaintiffs were applicable to the Westinghouse turbines at issue, and thus whether the Navy required Westinghouse to create asbestos warning labels, precluded summary judgment on the government contractor defense.

Based on the court’s decision in Malone, defendants should take solace in the rejection, yet again, of a plaintiff’s argument for a less stringent causation standard in mesothelioma cases and the confirmation that yet another court adopts the majority approach to the “bare metal defense.”  The ruling also, however, illustrates that defendants should expect a tough go of it when arguing the “learned intermediary doctrine” and “government contractor defense” at the summary judgment stage in this jurisdiction.

The entire Malone decision can be found here.

[1]       The parties had fourteen days from the date of the Report and Recommendation to file written objections with the court.  Because no party filed written objections within that time frame, it is likely the court will accept the Report and Recommendation as its opinion on the matter.

Massachusetts Appeals Court
Massachusetts Appeals Court

On September 21, 2016, the Massachusetts Appeals Court upheld the grant of summary judgment to Johnson & Johnson (“J&J”), the manufacturer of the Ortho-Evra birth control patch at issue in the case of Niedner v. Ortho-McNeil Pharmaceutical, Inc., No. 15-P-1272, 2016 WL 5106479 (Mass. App. Ct. Sept. 21, 2016).  In so doing, the Appeals Court held that J&J had a duty to warn the decedent, but that it adequately did so.

Neidner involved the death of 17-year-old Adrianna Duffy, which resulted from blood clots allegedly caused by the Ortho-Evra birth control patch worn by Ms. Duffy.  Plaintiff claimed that she and Ms. Duffy had not been adequately warned about the increased risk of developing blood clots to those who use the patch.

In June, 2009, Ms. Duffy and her mother met with Ms. Duffy’s doctor to discuss birth control options. Ms. Duffy specifically asked her doctor about the Ortho-Evra patch, as she had previously taken an oral birth control pill but now wanted an easier birth control method. Id. at *1. Ms. Duffy’s doctor prescribed her the patch after this meeting and informed Ms. Duffy and her mother of the risks associated with using the patch, including that of blood clots. The prescription package filled by Ms. Duffy came with an insert from the manufacturer (J&J), as well as a leaflet from the pharmacy at which the prescription was filled, both setting forth the risks associated with the patch, including heart attack, stroke, and blood clots. After approximately three months of use, Ms. Duffy collapsed and died from a massive bilateral pulmonary embolus. Id. at *1.

Ms. Niedner filed suit in October, 2010, alleging, among other things, that her daughter’s death was caused by her use of the patch and that J&J was liable for breach of warranty under the theories of design defect, failure to warn, and manufacturing defect. Id. at *1.  J&J filed a motion for summary judgment, arguing that the patch’s risks, including the increased risk of blood clots, were sufficiently disclosed. Id. at *1. A Superior Court judge agreed, allowing the motion, and plaintiff appealed.

Typically, a manufacturer has a duty to warn product users of dangers associated with the reasonably foreseeable use of its product.  Manufacturers of prescription drugs and medical devices are, however, generally excepted from that rule based on the “learned intermediary” rule, which provides that the manufacturer fulfills its duty by providing physicians with an adequate warning about the risks associated with its product. In these instances, the physician acts as the “learned intermediary” between manufacturer and consumer to ensure the patient understands the potential risks and benefits. In MacDonald v. Ortho Pharmaceutical Corp., however, the Massachusetts Supreme Judicial Court created a narrow exception to this rule for the manufacturer of oral contraceptives, which it held has a duty to directly warn not only medical professionals, but also the consumer, about the risks associated with birth control medications. Id. at *2. The Neidner court held that this same exception to the “learned intermediary” rule applies to birth control patches, such as the Ortho-Evra patch, and as such, J&J had a duty to warn Ms. Duffy directly of the risks associated with the use of the patch. Id. at *2.

The Appeals Court also held, however, that J&J had satisfied that duty.  It noted that the box of patches purchased by Ms. Duffy contained a pamphlet which explained the risks associated with its use and contained instructions to consult a physician concerning information contained in the pamphlet. Both Ms. Duffy and her mother read the insert, though neither then consulted with Ms. Duffy’s doctor. Among other topics, the pamphlet thoroughly discussed in multiple locations the risk of developing blood clots while using the patch, particularly in the lungs like those Ms. Duffy developed. Id. at *3. The Appeals Court found as a matter of law that the pamphlet adequately warned of the increased risk of developing blood clots that could result in death, and described these warnings as “plain, numerous, and comprehensive.” Id. at *4.

Lady JusticeOn September 13, 2016, the United States Court of Appeals for the Third Circuit partially reinstated a plaintiff’s claims that his decedent developed lung cancer as a result of asbestos exposure that he allegedly experienced from work in the vicinity of switchgear components manufactured by Westinghouse Electric Corporation, a predecessor to CBS Corporation.  In re: Asbestos Prods. Liab. Litig. (Frankenberger), — F.3d —-, 2016 WL 4750507 at *1 (3d Cir. 2016).

 

In Frankenberger, the plaintiff originally filed suit in the United States District Court for the Northern District of Indiana and the matter was subsequently transferred to the United States District Court for the Eastern District of Pennsylvania as a result of consolidation under a multi-district litigation (MDL-875).  Id. at *2.  Plaintiff alleged, via the decedent’s co-worker and expert testimony, that the decedent was exposed to asbestos as a result of: (1) maintenance performed on Westinghouse turbines that required the removal and installation of insulation that may have contained asbestos until 1973; and (2) maintenance and cleaning of Westinghouse switchgear that incorporated asbestos-containing components until approximately 1985.  Id.  Critically, plaintiff did not present evidence that the thermal insulation on the turbines to which he alleged the decedent was exposed was the original insulation supplied by Westinghouse or that Westinghouse supplied the insulation that was used to replace the original insulation.  Id.  In contrast, plaintiff produced evidence that the Westinghouse switchgear contained asbestos and released respirable fibers when cleaned and maintained.  Id.  Westinghouse moved for summary judgment arguing that plaintiff did not satisfy his burden of demonstrating that Decedent’s lung cancer was caused by exposure to Westinghouse products.  Id.  District Judge Robreno held that summary judgment was appropriate because there was no evidence that: (a) the decedent was exposed to asbestos-containing thermal insulation for which Westinghouse was responsible; and (b) the decedent was exposed to asbestos-containing dust from the Westinghouse switchgear.  Id. at *3.  Plaintiff appealed to the Third Circuit.  Id.

 

On appeal, the Third Circuit partially reversed the District Court and held that plaintiff presented evidence sufficient to present a question of material fact as to the decedent’s alleged switchgear exposure, but failed to demonstrate that Westinghouse was liable for the thermal insulation or even that the thermal insulation to which Decedent was allegedly exposed actually contained asbestos.  Id. at *4-5.  In analyzing plaintiff’s evidence, the Third Circuit applied Indiana’s causation standard, which requires that

 

A plaintiff . . . must produce evidence sufficient to support an inference that [the decedent] inhaled asbestos dust from the defendant’s product.  This inference can be made only if it is shown that the defendant’s product, as it was used during [the decedent’s] tenure at the job site, could possibly have produced a significant amount of asbestos dust and that the asbestos dust might have been inhaled by [the decedent].

 

Id. at *4 (internal citations omitted) (ellipsis in original).

 

In analyzing the plaintiff’s claims related to the switchgear, The Third Circuit held that summary judgment was inappropriate because the plaintiff presented evidence that: (1) Westinghouse manufactured the switchgear; (2) asbestos-containing components in the switchgear deteriorated over time, thereby releasing respirable asbestos fibers; (3) the cleaning and maintenance of the switchgear caused these fibers to be released into the atmosphere; and (4) the decedent was present at the worksite when such release occurred.  Id. at 5.  Consequently, the Court held that a reasonable juror could conclude that Decedent’s lung cancer was caused by exposure to asbestos from the Westinghouse switchgear.  Id.

 

While the Court held that summary judgment was inappropriate on the switchgear claim, it conversely held that the plaintiff had failed to satisfy his burden of establishing exposure to thermal insulation which Westinghouse manufactured, installed, or supplied.  Id. at 4.  Furthermore, the plaintiff did not establish that the thermal insulation actually contained asbestos when the decedent was proximate to that insulation’s removal and installation.  Id.  As a result, plaintiff’s claims of exposure from the turbines could not survive summary judgment.  Id.

 

Frankenberger presents an interesting contrast in the Court’s treatment of a product identification defense as opposed to a defense based on causation.  With regard to the Westinghouse turbines, the Court applied the “bare metal” or “replacement parts” defense in granting partial summary judgment, holding that plaintiff produced no evidence that any insulation around which decedent may have worked was original to the turbines or was later manufactured or supplied by Westinghouse.  Thus CBS could not be held liable for any potential asbestos exposure associated with the turbine insulation.

 

In contrast, Westinghouse did not have such a product identification defense to plaintiff’s claims concerning its switchgears and was forced to argue causation.  Frankenberger, along with the Third Circuit’s recent decision in Haas v. 3M Co., 613 Fed. Appx. 191 (3d Cir. 2015) (reversing district court’s grant of summary judgment based on the plaintiff’s provision of evidence of exposure to asbestos-containing products manufactured by the defendant), seems to demonstrate, however, that the Third Circuit is becoming increasingly reluctant to grant summary judgment on the basis of causation—instead, it is more likely to find that a question regarding causation is a material issue of fact that should be determined by the jury.

 

The plaintiff was represented by Robert G. McCoy of Cascino Vaughn law offices.  CBS was represented by Christopher G. Conley of Evert Weathersby & Houff.  The Third Circuit panel consisted of Circuit Judges McKee, Ambro, and Scirica, with Judge Scirica delivering the unanimous opinion.

Gavel_editOn September 13, 2016, the Massachusetts Appeals Court decided Albright v. Boston Scientific Corporation by vacating a jury’s verdict in favor of Boston Scientific Corporation (BSC) and remanding the matter to the Superior Court for retrial. No. 15-P-633, 2016 WL 4736686 (Mass. App. Ct. Sept. 13, 2016).

By way of background, the Plaintiff, Diane Albright, sued BSC alleging that she suffered serious injuries following a March 2010 surgery in which she had a Pinnacle Pelvic Floor Repair device implanted to correct a pelvic organ prolapse. Id. at *1. That is, after Ms. Albright’s surgery she “developed painful bladder syndrome and other complications” due to the implant’s degradation. Id. at *2. BSC designed, manufactured, and marketed the device in question. Subsequently, Ms. Albright tried her case before a Middlesex County jury, which found in BSC’s favor with respect to Ms. Albright’s defective design and inadequate warning claims.

The plaintiff appealed arguing that the trial justice erred when she (1) excluded from evidence a medical application caution found within a 2004 and 2007 Material Safety Data Sheet (MSDS) concerning the polypropylene material used to form the mesh within the device and (2) prevented the jury’s consideration of two 2012 FDA letters to BSC. Id. at *1. The first letter ordered BSC to conduct a postmarket surveillance study of its Pinnacle devices. In its second letter to BSC, the FDA agreed to the postmarket surveillance study’s suspension following receipt of BSC’s representation that it planned to cease manufacturing and marketing the implant in the United States. Id. at *7.

After reviewing the trial court record, the appeals court agreed with the plaintiff’s position. It reasoned that the medical application caution “was relevant, material evidence for the limited purpose of showing that BSC, which had received the MSDS well before 2009, had notice or knowledge of the content of the caution.” Id. at *6. Thus, the medical application caution was not hearsay for the sole purpose of showing that BSC had notice or knowledge of the foreseeable risks associated with the Pinnacle implant. Id. Likewise, the appeals court concluded that the two FDA letters were admissible “for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial.” Id. at *7. Such a limited purpose use of the FDA letters, the court found, would constitute reasonable cross-examination to show bias or to rebut BSC witness opinion testimony.