

The Supreme Court has issued its long-awaited decision on whether or not state tort law claims are properly brought against generic manufacturers based on a duty to warn. Of note, the Court rejected a claim that the CBE ("changes being effected") or "Dear Doctor" letter mechanisms were available to the generic manufacturer. The Court further found that federal law only allowed for compliance with state tort duty that required stronger warnings if both the FDA and the brand-name manufacturer did the same. The Court found that this was a rare example of "impossibility preemption," where the manufacturer could not effectively comply with both state and federal law simulatneously.
In the case of a generic manufacturer, as well, whether or not the generic manufacturer was required to seek a change at the federal level was irrelevant, the Court found, because the tort duty assigned to it by the state was to present adequate warnings, which could only potentially be realized.
For the text of the decision, click here.
Category: Pharmaceuticals
Posted by: Anthony E. Abeln | Posted on: 7/11/2011 | Permalink & Comments
Entities that license their trademarks to other manufacturers may be held liable for injuries under the "Apparent Manufacture Doctrine." In a case of first impression, the Massachusetts Appeals Court in Lou v. Otis Elevator Company, 77 Mass. App. Ct. 571 (2010) affirmed a multimillion dollar jury verdict against the defendant asserting that a nonseller trademark licensor that substantially participates in the design, manufacturing, or distribution of the licensee's product, may be held liable as an apparent manufacturer. Although Massachusetts previously recognized the apparent manufacturer doctrine, the Lou ruling clarified its application of the doctrine as set forth in the Restatement (Third) of Torts.
Lou arose after a four year old Massachusetts resident was injured while riding an escalator in the People's Republic of China. The escalator itself was manufactured and sold by a foreign entity under a license from Otis Elevator Company ("Otis"). Based on agreements between Otis and the foreign entity, Otis agreed, among other things, to furnish (1) engineering and product design information; (2) production, installation and inspection methods; (3) quality standards; and (4) technical and managerial support. Rather than file suit in the People's Republic of China, Lou, through his parents, filed suit in Massachusetts.
In this case, Massachusetts adopted the apparent manufacturer doctrine as set out in the Third Restatement of Torts, which states that "One engaged in the business of selling or otherwise distributing products who sells or distributes as its own a product manufactured by another is subject to the same liability as though the seller or distributor were the product's manufacturer." Although Massachusetts previously applied the apparent manufacturer doctrine, it had not applied the doctrine to a nonselling entity outside of the distribution chain. In this case, the Appeals Court relying on case law from other jurisdictions, determined that there was no need for the apparent manufacturer doctrine to only apply to those who "participated directly as sellers in the chain of distribution." Thus, those trademark licensors who substantially participated in the design, manufacture, or distribution of the product may be held liable under the new standard set out by Lou.
Category: MM Blog
Posted by: Grace V.B. Garcia | Posted on: 2/9/2011 | Permalink & Comments
The Supreme Judicial Court 's Standing Advisory Committee on the Rules of Massachusetts Civil Procedure has presented a dramatic (if still only potential) revision of how expert testimony will be disclosed and presented under the Massachusetts Rules of Civil Procedure. This revision, (the "Proposed Rule"), which has not yet been recommended for adoption by the full Supreme Judicial Court, will force risk managers and defense attorneys to quickly adapt their practices regarding vital aspects in trial preparation and claim management.
Unlike current practice, the Proposed Rule requires that a party produce an expert report 90 days prior to the end of the discovery period if they carry the burden of proof on either a claim or on an affirmative defense. Importantly, the Proposed Rule states that the report must be produced not only if a "witness is one retained or specially employed to provide expert testimony in the case," but, moreover, a report by "one whose duties as the party's employee regularly involve giving expert testimony." Despite the language suggesting that this rule is limited to "the party's employee," there are no clear protections for reports produced by salaried or contract based in-house reviewers through this mechanism.
The report by the disclosed expert under the Proposed Rule must contain the following elements:
Although the Proposed Rule does allow for the protection of drafts of expert reports, it may weaken attorney-work product protections. The Proposed Rule permits discovery of "[a]ny communications that relate to compensation for the expert's study or testimony," of any communications that "identify facts or data that the party's attorney provided and that the expert considered in forming the opinions to be expressed;" and any communications that "identify assumptions that the party's attorney provided and that the expert relied upon in forming the opinions to be expressed." The proposed rule to some extent, echoes exisiting federal practice and are not new to practicing attorneys, but counsel should nevertheless begin to review their practices to protect the interests of their clients.
Category: MM Blog
Posted by: Anthony E. Abeln | Posted on: 12/17/2010 | Permalink & Comments
Recently, in Papdopoulos v. Target Corp., SJC 1059 (July 26, 2010), the Massachusetts Supreme Judicial Court significantly changed the law with respect to how snow and ice slip and fall cases are reviewed. No longer can such cases be defended based on whether the injury occurred as a result of a "natural" or "unnatural" weather condition, but rather now cases will be determined by whether the property owner fulfilled their obligation of reasonable care to maintain their property in a reasonably safe condition in view of all circumstances. Based on the change of law, which will be applied retroactively, it is anticipated that there will be significantly more snow and ice cases brought, and a decline of potential summary judgment motions, in this area.
Specifically, Papdopoulos held that a landowner has a duty "to act as a reasonable person under all of the circumstances including the likelihood of injury to others, the probable seriousness of such injuries, and the burden of reducing or avoiding the risk." In abolishing the distinction between natural and unnatural accumulations of snow and ice, the Court held that the new law does not add any burdens on a landowner, but only requires a landowner to continue its obligation to keep his property in a reasonably safe condition all year long. In determining whether the owner has kept his property in a reasonably safe condition with respect to snow removal, "it will depend on the amount of foot traffic to be anticipated on the property, the magnitude of risk reasonably feared, and the burden and expense of snow and ice removal." Thus, an owner of an apartment, house, store or building, may all have different obligations that they may have to fulfill in order to maintain their property in a reasonably safe condition.
Based on the Papdopoulos decision, defendants now have a greater burden to show that they have taken all of the necessary precautions in light of the potential risks. Landowners will not be able to rely on the open and obvious doctrine to avoid their responsibly. As such landowners may want to review any existing snow removal contracts or take proper measures to have such contracts in place to help shift the risk.
Not only do landowners want to reevaluate their wintertime weather procedures, but adjusters and defense counsel will have to evaluate these cases early on based on the new standard. Although summary judgment motions in negligence cases have historically been disfavored, the Papdopoulos decision has basically made all snow and ice cases too fact dependent to allow for summary judgment. Consequently, cases will need to be reviewed based on the standard to determine whether settlement or preparation for trial makes the most legal and economical sense.
Category: MM Blog
Posted by: Grace V.B. Garcia | Posted on: 8/9/2010 | Permalink & Comments
A new opinion by the First Circuit illustrates the growing impact of Bell Atlantic Corp. v. Twombly, 550
Gargano v. Liberty International Underwriters, Inc., No. 08-2287 (1st Cir. July 14, 2009) concerned an attorney's failure to give timely notice of a malpractice claim to his E&O carriers. Gargano had taken over a worker's compensation claim after his client fired the lawyer had worked on the case for four years. Gargano ultimately obtained a large settlement but only after assuring the state court that there were no liens on the file and that he had solely been responsible for the representation of his client. Predecessor counsel sued Gargano in 2005 and ultimately recovered a substantial judgment for the insured's fraud and misrepresentations.
Following the entry of the judgment in 2007, Gargano belatedly reported this claim to three professional liability insurers that had successively issued "claims made and reported" policies to him in 2005, 2006 and 2007. The insurers jointly moved to dismiss the insured's claims pursuant to Fed. R. Civ. P. 12(b)(6) attaching a copy of the underlying court judgment against Gargano. On the basis of these undisputed facts and the "claims made and reported" language in the insurers' policies, Judge Young dismissed the insured's contractual claim, along with his assertion of bad faith. These findings were affirmed by the First Circuit.
As a preliminary matter, the First Circuit upheld the district court's consideration of the lower court judgment in the context of a Rule 12(b)(6) motion. While noting that courts do not ordinarily consider materials outside the complaint when reviewing a motion to dismiss, a narrow exception is permitted for documents the authenticity of which are not disputed by the parties, for official public records, for documents central to the plaintiff's claim and other documents that are referred to in the complaint itself. In this case, the court found that the superior court judgment fit squarely within this exception.
Turning to the merits of the insurers' defenses, the court observed that the underlying malpractice action, which involved a claim first made in 2005 and not reported until 2007, ran afoul of the "claims made and reported" language in each of the insurers' policies. As to Policy 1, the claim was received during the policy period but not reported until after it expired. As to Policy 2, the claim was neither reported nor received during the policy period. Finally, as to Policy 3, the claim was reported to the insurer during the policy period but received by the insured prior to the policy period.
Gargano argued that these terms should not be applied against him since he had never seen the policies and was unaware of their terms. (It is unlikely that any court would ever find such an argument to be credible when presented by a lawyer given the ubiquity of "claims made" terms in professional liability insurance policies.) Even so, the First Circuit found in this case that there was no basis in
Finally, in keeping with established principles of
There are several interesting aspects to this new opinion. First, it demonstrates the benefits of a Rule 12(b)(6) motion where the crucial facts supporting an insurer's defense to coverage may not be specifically pleaded in the underlying suit but are either undisputed or are contained in documents reference din the complaint. While reference to such extrinsic sources of proof would ordinarily have required a Rule 56 motion for summary judgment in the past, which many courts will not consider until later in a suit, a growing number of courts have adopted a more expansive interpretation of Rule 12(b)(6) in the wake of the U.S. Supreme Court's opinion in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007).
Gargano also affirmatively stifles the oft-repeated but baseless contention that an insured cannot be bound by terms in an insurance policy of which it was unaware. While this argument is effective in cases where exclusions or coverage limitations are new to a policy, as where they are added in a renewal policy without due notice to the insured, such an argument is ineffective where the provisions in question are neither ambiguous nor obscure or where the policy itself was in fact delivered to the insured's agent or broker.
Finally, Gargano is a useful reference case given that it involved a "perfect storm" of all of the permutations of trouble that an insured may face with "claims made and reported" language. For all of the foibles of
Category: Insurance
Posted by: Michael Aylward | Posted on: 7/21/2009 | Permalink & Comments
The Massachusetts legislature has dramatically changed the guardianship laws by enacting the Massachusetts Uniform Probate Code (MUPC) effective July 1, 2009. These changes significantly impact discharge planning from hospitals and admissions to long-term and skilled-care facilities.
HIGHLIGHTS INCLUDE:
Elimination of Guardianship of the Estate.
Limited Guardianships/Conservatorships favored over full guardianships.
Guardians do NOT have the authority to move a person to a nursing home without a specific Court finding that the admission is in the person's best interest.
How does this impact a hospital?
How does this impact a nursing home?
Health Care Proxy takes precedence over guardianship absent Court Order. A guardian may not revoke a Health Care Proxy.
Guardians do NOT have the authority to consent to treatment where a substituted judgment determination is required unless the Court issues findings, approves, authorizes and endorses a treatment plan in its Order or Decree.
The term "ward" is replaced by "incapacitated person" for guardianships and "protected persons" for conservatorships.
Some persons are excluded from serving as guardians.
This includes:
The District Court, not the Probate Court, has the jurisdiction to commit a person to a mental health facility.
Guardians are required to submit a report to the Court within 60 days of appointment and at least annually thereafter.
Counsel may be appointed on any guardianship matter, not just cases where substituted judgment or Roger's is applicable.
Category: Procedural Rules
Posted by: Kristen Lambert | Posted on: 7/3/2009 | Permalink & Comments
In Leavitt v. Brockton Hospital, Inc., (June 9, 2009), the SJC determined whether a hospital, and two of its registered nurses, owed a duty of care to an unrelated third party. The plaintiff was a police officer who was injured in a car accident while responding to the scene of a reported accident in which a medicated patient was struck by a car while walking home from the hospital after a procedure. The police officer argued that the hospital owed him a duty of care that was breached when it released the patient without an escort while the patient was still medicated.
The SJC affirmed the trial court's order granting the defendant's motion to dismiss. In affirming the order dismissing the complaint, the SJC concluded that a medical professional does not owe a duty to a third person to control a patient (excluding a patient of a mental health professional) arising from any claimed special relationship between the medical professional and the patient. The court stressed, however, that this was not a failure to warn case. (The SJC had previously recognized in Coombes v. Florio, 450 Mass. 182 (2007) the liability of a third party in a situation where a physician had failed to warn a patient of the effects of prescribed medication.) Moreover, the SJC also determined that the police officer's injury was not "caused" by any action by the hospital because the injury fell outside the scope of foreseeable risk arising from any negligent conduct that would make the hospital's alleged misconduct tortious. The harm that the police officer suffered - injury from a collision not involving the patient - arose not from the "same general type of danger" (harm to the patient or to those injured by the patient as result of being released while medicated) that the hospital allegedly should have taken reasonable steps to avoid, but from "some other danger" (the collision between the police cruiser and another vehicle unrelated to the patient). The SJC also rejected the claim that the hospital was liable under the "rescue" doctrine. The court reasoned that not all injuries to rescuers are within the scope of foreseeable risk: the injury to the police officer was not the result of a risk that would have been anticipated to arise from the rescue.
The court's limitation of tort liability of medical providers to non-patient third parties would seem to extend to a situation where a third-party non-patient was directly injured by a medicated patient. The court, however, was direct in noting that this was not a "failure to warn" case. In addition, the court's decision is instructive on a procedural ground. Although causation is generally a question for a jury to decide, the court stated that the issue of causation could be determined as a matter of law where there is "no set of facts that could support a conclusion that the plaintiff's injuries were within the scope of liability". In addition, the court noted its adoption of the new, "stricter", standard of reviewing the adequacy of a complaint challenged by a motion to dismiss – factual allegations plausibly suggesting (not merely consistent with) an entitlement to relief are required.
Category: Tort Practice
Posted by: Tom Federico | Posted on: 6/10/2009 | Permalink & Comments
The Supreme Court granted certiorari in the case of Hertz Corp. v. Friend, Melinda, et al in an order dated June 8, 2009. The issue to be decided by the Court is whether, for purposes of determining principal place of business for diversity jurisdiction citizenship, a court can disregard the location of a nationwide corporation's headquarters - i.e., its nerve center.
Melinda Friend and John Nhieu filed a putative class action in California state court seeking damages for alleged violations of California's wage and hour laws. Hertz removed the action to the District Court. The putative plaintiffs filed a motion to remand and argued that Hertz was a citizen of California and that diversity of citizenship did not exist between Hertz and members of the putative class. The district court granted the plaintiffs' motion based on the court's conclusions that "a plurality" of Hertz' business activities occur in California and that "Hertz is not the type of litigant that diversity jurisdiction was designed to protect." Hertz sought review of the remand order by the Ninth Circuit. The Ninth Circuit concluded that the district court had correctly applied the circuit's "place of operations" test as articulated in Industrial Tectonics, Inc. v. Aero Alloy, 912 F.2d 1090, 1094 (9th Cir. 1990)("the 'nerve center' test should be used only when no state contains a substantial predominance of the corporation's business activities") and Toseo Corp. v. Communities for a Better Env't, 236 F.3d 495, 500 (9th Cir. 2001)(substantial predominance "requires only that the amount of corporation's business activity in one state be significantly larger than any other state in which the corporation conducts business"). In its order, the Ninth Circuit further refined this test in finding that no "policy concerns" justified taking California's population into account when determining whether a corporation's business activities in California were significantly larger than in any other single state.
For purposes of diversity jurisdiction, the circuit courts have created four different tests to determining a corporation's principal place of business: (1) the Seventh Circuit's "nerve center test," which focuses on locating the corporation's "brain," and ignores all other business operations as irrelevant; (2) the Ninth Circuit's "place of operations test," which focuses on the locations of the corporation's business operations, while generally ignoring its nerve center; (3) the Third Circuit's "center of corporate activities test" which focuses on finding the center of day-to-day corporate-wide activity and management, with the locations of other business activities being relevant, but less important, factors; and (4) the Fifth, Sixth, Eighth, Tenth and Eleventh Circuits' "totality of the circumstances test" which hinges on no particular facet of corporate activities, but rather on the company as a whole, including its character, business purpose, nerve center, management center and locations of operations.
In its petition for writ of certiorari, Hertz argued that a test for determining a corporation's principal place of business for purposes of diversity jurisdiction should be guided by: (1) the ordinary meaning of those words, i.e., the most important, consequential or influential place of business in comparison to all others; (2) the underlying purposes of diversity jurisdiction, e.g., protecting out-of-state citizens against the bias of local tribunals and promoting the free flow of commerce; and, (3) Congress' expressed reasons for adding the principal place of business provision to 28 U.S.C. § 1332(c)(1), i.e., "a simple [and] practical" method for readily determining the existence of jurisdiction, which also allows judges to protect against "frauds and abuses of federal jurisdiction by corporations which are primarily local in character." It argued that the place of operations test, "reduces a corporation's nerve center to an afterthought, does not comport with the ordinary meaning of the statute, is not tailored to address the 'evil' which prompted Congress to amend the statute, and is inconsistent with the underlying purposes of diversity jurisdiction".
Category: Procedural Rules
Posted by: Tom Federico | Posted on: 6/9/2009 | Permalink & Comments
In Dee v. PCS Property Management, Inc. ___ Cal. App.4th ___ (5/28/2009), a tenant brought suit against her landlord stemming from stemming from her exposure to mold in her apartment. On appeal, the plaintiff challenged the trial court's exclusion of proposed expert testimony that her numerous ailments, ranging from an increased risk of cancer to fibromyalgia, were caused by her exposure to mold. The Court of Appeals upheld the trial court's exclusion of this expert testimony where the plaintiff's experts had relied on unsupported assumptions and inadmissible blood and brain tests.
One of the plaintiff's experts, Gary J. Ordog, acknowledged that no mycotoxin was found in the plaintiff's unit at the time she was living there. Specifically, Ordog admitted that trichothecene, aflatoxin, and satratoxin were not identified on the premises at the relevant time period. Based on section 801 of the California Evidence Code, the trial court excluded evidence of a causal connection between toxic mold and cancer. "[H]is testimony at the 402 hearing . . . was conclusive that he has no sufficient evidence of a causal connection." The court excluded Ordog's proposed testimony on a causal connection between toxic mold exposure and cancer, brain damage, reproductive harm, and future birth defects based on section 801. The court further concluded that Ordog's testimony lacked foundation because there was no proof "that the inhalation of mycotoxins caused her injury." The court explained that it "listened carefully to Dr. Ordog, and I [concluded] that what occurred was in the main speculation, and when it wasn't speculation, it was 'I know it when I see it,' and 'I know it based on my experience'; and we don't know what that experience was."
Category: Procedural Rules
Posted by: Tom Federico | Posted on: 6/3/2009 | Permalink & Comments
An agreement between two subcontractors on the construction project which permitted one subcontractor to use another subcontractor's scaffolding did not fall under the dictates of G.L. c. 149, §29C. and the indemnity agreement contained therein was thus enforceable. Although the parties to the agreement were subcontractors on a construction project, the court noted that the subcontractors had no contractual relationship aside from the indemnity agreement. The statute contemplates the existence of a construction contract between the parties. (The reference in the agreement to the construction project was insufficient to bring the agreement within the dictates of c. 149, §29C).
Thomas LeBlanc v. Walsh Bros., Inc., 2008 Mass. Super LEXIS 109
Category: Construction Law
Posted by: Tom Federico | Posted on: 5/19/2009 | Permalink & Comments