Burns White Member Sheila M. Burke was selected to serve a three-year term on the Vincentian Home Board of Directors. The Vincentian Home is a continuing care retirement community that is part of the Vincentian Collaborative System, a not-for-profit Catholic healthcare and human services organization headquartered in Pittsburgh’s North Hills.
Burns White Member Sheila M. Burke was selected as one of the “2012 Most Powerful and Influential Women in Pennsylvania” by the National Diversity Council. Ms. Burke, along with other recipients, were honored Sept. 13 at the 3rd Annual Pittsburgh Diversity and Leadership Conference at Duquesne University.
Women recognized by the National Diversity Council for this award demonstrated leadership and a commitment to community service; a sustained record of accomplishments and/or contributions to their field of work; clout within their organizations in terms of significant impact on revenues, profitability and/or direction of the organization; and the highest ethical standards and professional excellence.
For more information on the council or the award, visit: http://www.nationaldiversitycouncil.org/.
By: T.H. Lyda, Esq. and Edwin B. Palmer, Esq.
The Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011. The FSMA is the most significant expansion of food safety requirements and the Food and Drug Administration’s (FDA) food safety authority in over 70 years. The Act charges the FDA with improving food safety and sets broad parameters for future regulation of the food industry. The focus of the FSMA is on preventing food safety problems, rather than taking more of a reactive approach to problems after they occur.
The FSMA imposes a number of requirements on individuals and entities that manufacture, process, pack, transport, distribute, receive or hold food and food products. The Act also grants the FDA increased authority to regulate food facilities and imposes new requirements for those facilities.
The overall purpose of the Act is to build a preventive food borne illness regime similar to that used by the United States Department of Agriculture (USDA). Under the FSMA, FDA food safety inspections will increase and the FDA is provided mandatory recall authority. Additionally, the FSMA imposes increased recordkeeping requirements on industry, as well as requires industry to identify possible causes of contamination and develop food contamination prevention plans for the future. The FSMA does not affect meat, poultry and egg products regulated by the Food and Drug Administration (FDA).
Despite its admirable intentions, major portions of the FSMA have not been enacted some 20 months after the statute was signed into law. Admittedly, the FSMA is a complex piece of legislation and the FDA has been tasked with authoring approximately 50 new rules, documents, reports and studies. Nonetheless, several regulations implementing the Act have been drafted and have been awaiting approval by the Office of Management and Budget since late 2011.
Until final regulations are published, food manufacturers are unsure of what the ramifications of the Food Safety Modernization Act will ultimately be. This blog post will provide a brief overview of the FSMA – where things currently stand, general requirements that food manufacturers and distributors can expect, and a brief discussion of what food manufacturers and distributors can do to prepare for the eventual enactment of the these regulations.
While many of the FSMA regulations have yet to be enacted, the FDA has certain new powers that have gone into effect. With the enactment of the FSMA, the FDA received authority to order mandatory recalls. Prior to the FSMA, the FDA only had mandatory recall authority on four types of products: infant formula, medical devices, human tissue products and tobacco products. In addition, it could only request that companies institute a voluntary recall of FDA-regulated products.
Under the FSMA, the voluntary recall procedure is still preferred and encouraged. However, if the responsible party declines to issue a voluntary recall within the time period requested by the FDA, the agency may order the responsible party to cease distribution of the food product and to notify all persons manufacturing, distributing or selling the article to cease all sales and distributions. The FDA is also granted the authority to impose civil and criminal penalties on a party that refuses to comply with a mandatory recall. The FDA’s enforcement authority provides a strong incentive for responsible parties to cooperate with the FDA and institute a voluntary recall when requested.
In addition to mandatory recall authority, the FDA issued a rule allowing the agency to administratively detain foods which the agency has reason to believe may be adulterated or misbranded. The FDA also has given itself the authority to suspend the registration of any regulated food facility if the food facility is producing food which, in the judgment of the FDA, presents a reasonable probability of causing serious adverse health effects or death.
Despite these developments, there is nonetheless considerable uncertainty and anxiety among regulated food companies as to what specifically will be asked of them under the FSMA regulations and when those regulations will go into effect. Regulations implementing the FSMA have been awaiting approval by the Office of Management and Budget (OMB) for more than nine months. The OMB is responsible for evaluating the proposed regulations’ effectiveness and consistency with administration policies. Among the rules currently awaiting OMB approval are:
Although there is considerable uncertainty as to what will specifically be required of food manufacturers and distributors, we can anticipate the general requirements that will be required by FSMA regulations. Under the FSMA, food companies will be required to adopt “Food Safety Plans.” More specifically, regulated food companies will be required to develop and closely follow the Hazard Analysis and Critical Control Point (HACCP) methodology.
Under a HACCP plan, a food processor would identify those hazards likely to affect the safety of its food (including the introduction of chemical, physical and microbiological contaminants) and then establish various critical control points where interventions could be made to prevent, reduce or control those hazards. There is no one-size-fits-all HACCP plan. Each food processor will have to identify and address a set of hazards that are unique to its facility and particular food products.
HACCP was first developed by Pillsbury in the 1960s as a quality control program governing the production of food for the United States space program. By the 1990s, the USDA required HACCP plans for all meat and poultry production in the United States. The FDA has required HACCP for all seafood production and the domestic juice industry for a number of years. Thus, we can expect that the FDA will ultimately require all food companies regulated by the agency to develop and closely follow their own HACCP plans. Specifically, companies will need to formally consider and identify all reasonably foreseeable food safety hazards; develop written plans addressing each of those hazards and closely follow those plans. As part of the HACCP process, companies will be expected to develop procedures to follow in the event a hazard is identified, including an assessment of the cause of the contamination, procedures for the disposal of the affected product, and written documentation of any corrective actions. Additionally, regulated food companies will be required to audit their HACCP plan to verify that the plan is working correctly.
When developing a formal HACCP strategy, companies should recognize that the plan will become a de facto FDA regulation of their particular food processing operation that must be strictly followed. Accordingly, all companies should strongly consider obtaining advice from industry consultants and lawyers when drafting their HACCP plans.
While no one knows precisely when FSMA regulations will be enacted, food producers can assess their facility risk based on the criteria identified in the FSMA, as well as the facilities of other companies, domestic and foreign, in their supply chain, and begin to develop plans to address those hazards.
Additionally food production companies should review their insurance policies. Questions to ask include:
Obviously, it is difficult to itemize in great detail every step that you should take to ensure compliance with the FSMA requirements as well as the continued safety and security of your food manufacturing process. This is particularly so when the food manufacturing process faces its own unique set of hazards. For a detailed review of your company’s policies and procedures, contact an attorney familiar with the federal, state and local regulations that apply to your particular situation.
T.H. Lyda is a Member of the firm and concentrates his practice in railroad, products liability, toxic tort, civil rights, professional negligence, medical malpractice defense and insurance defense litigation, with a particular interest in occupational disease litigation.
Edwin B. Palmer is also a Member of the firm and focuses his practice on the defense of products liability, toxic tort and occupational illness claims involving complex medical and scientific issues relating to exposures to solvents, diesel fumes, and other substances and the defense of repetitive stress injury matters.
Burns White Healthcare Litigator and Member Stuart T. O’Neal recently secured a dismissal of a defamation claim lodged against a large healthcare provider, as well as an individual executive from the same institution, facing alleged punitive damages. The claims for defamation, denied by the healthcare provider and the executive, were related to a former physician and department head, and brought on the physician’s behalf by his attorneys.
Michael J. Cremonese, Co-Chair of the Business Practices Group, along with other members of his team, were featured in an Aug. 24, 2012 Pittsburgh Business Times article examining the growth of the top ten law firms in the region. Click here to read the article.
By: Stephanie Solomon, Esq.
Lynn v. Yamaha Golf-Car Co., Civil Action No. 2:10-cv-01059 (W. D. Pa. Aug. 16, 2012)
Pennsylvania state and federal courts have remained at odds with regard to the governing law in products liability actions since the Third Circuit Court of Appeals applied the Restatement (Third) of Torts: Products Liability §§ 1 and 2 in the controversial case of Berrier v. Simplicity Mfg., Inc., 563 F.3d 38 (2009), incorrectly forecasting the path Pennsylvania strict products liability law would take by mistakenly predicting that the Pennsylvania Supreme Court, if given the opportunity, would abandon the long-standing Pennsylvania precedent of following the Restatement (Second) of Torts § 402A. Why is this an issue? The answer: because whether the Restatement (Second) or the Restatement (Third) governs your case can be critical to the ultimate result. The Restatement (Third) of Torts: Products Liability §§1 and 2 incorporates certain negligence-based foreseeability concepts into the products liability analysis, arguably opening the floodgates as to the amount of “standard of care” and “risk-utility” evidence a jury may now hear. Dissimilarly, the Restatement (Second) of Torts § 402A’s rigid structure forbids a court to consider negligence principles.
The recent Western District decision in Lynn v. Yamaha Golf-Car Co., Civil Action No. 2:10-cv-01059 (W. D. Pa. Aug. 16, 2012) further precipitates this bizarre situation in which the law is different in Pennsylvania state and federal courts – and also amongst Pennsylvania’s federal district courts – on key issues. Thus, depending on the facts of your case, it is often in the interests of either Defense Counsel (in a pure strict liability design or manufacturing case where a state-of-the art defense may be argued), or Plaintiff’s Counsel (in a case where the Plaintiff is not using the product for its “intended use” or is not the “intended user” of the product) to remove the case to federal court if diversity jurisdiction can be established.
In Berrier, the Third Circuit Court of Appeals predicted that if given the opportunity, the Pennsylvania Supreme Court would change longstanding products liability law by adopting the Restatement (Third) of Torts: Products Liability §§ 1 and 2, thereby replacing § 402A of the Restatement (Second) of Torts. Berrier, 563 F.3d at 60. The Berrier decision was issued while the Pennsylvania Supreme Court considered making precisely that adoption in Bugosh v. I.U. North America, Inc. 942 A.2d 897 (Pa. 2008). However, following the Berrier decision, the Pennsylvania Supreme Court ultimately dismissed the appeal in Bugosh as being “improvidently granted,” leaving governing state law as the Restatement (Second) of Torts.
Since Bugosh, Pennsylvania district courts sitting in diversity have been faced with the decision of whether to apply the Restatement (Third) (and if so, what sections), or whether to apply the basic procedural legal doctrine set forth in Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938), which would require the application of Pennsylvania state law – i.e., the Restatement (Second) — while the Pennsylvania Supreme Court continues to “punt” on the issue. First, in the 2011 case of Schmidt v. Boardman Co., 11 A.3d 924, 940 (Pa. 2011), Justice Saylor noted the need to settle the inconsistencies but declined to rule directly on the issue, stating “[t]his case was not selected to address the foundational concerns, and, accordingly, the pathways to global resolution are not developed in significant detail in the briefing,” leaving the “present status quo in Pennsylvania to entail[] the continued application of Section 402A of the Restatement (Second).” Id. at 941. The Pennsylvania Supreme Court was given a second opportunity to end this “judicial volleying” once and for all in Beard v. Johnson and Johnson, 41 A.3d 823 (Pa. 2012). The Court “again recognized the continuing state of disrepair in the arena of Pennsylvania strict-liability design defect law,” however – it again also noted that the appeal at issue involved a “subsidiary issue.” Id. at 836. Thus, the Court refrained from entertaining the appellee’s request to consider adopting the Restatement (Third). Id.
The Third Circuit Court of Appeals ultimately reaffirmed that the Restatement (Third) should apply in Pennsylvania federal cases in Covell v. Bell Sports, 651 F.3d 357, 360 (3d Cir. 2011), a diversity suit involving the defective design of a bicycle helmet. Despite this decision, in the case of Sikkellee v. Precision Airmotive Corp., United States District Judge John E. Jones III of the Middle District of Pennsylvania nonetheless applied the Restatement (Second), opining:
[The] Third Circuit’s prediction in Covell is binding upon federal district courts sitting in diversity absent an affirmative indication from the Pennsylvania Supreme Court that it intends to retain the Restatement (Second) as the law in Pennsylvania. In our opinion, this indication was provided in Beard v. Johnson & Johnson, where the Pennsylvania Supreme Court took notice of the ‘continuing state of disrepair in the arena of Pennsylvania strict-liability’ law and nonetheless declined to take the opportunity to replace the Restatement (Second) with the Restatement (Third).
Sikkelee v. Precision Automotive Corp., No. 4:07cv00886, 2012 WL 2552243, at *9 (M. D. Pa. July 3, 2012).
The recent Western District Lynn decision comes on the heels of the Middle District Sikkelee decision, reaching the exact opposite conclusion. In Lynn, District Judge Hornak hinged his decision on the fact that “the Pennsylvania Supreme Court in Beard did not affirmatively disavow the premise of the Covell decision, along with the principle that the Third Circuit’s predictions regarding Pennsylvania state law are binding on this Court absent a decision of the Pennsylvania Supreme court expressly to the contrary.” Lynn, at *12.
The Lynn case arose from an accident involving two teenage girls who were riding a Yamaha golf cart on residential roads in their neighborhood. Id. at *1. Yamaha’s primary defense was that their use of the cart was not an “intended use,” nor was the young driver an “intended user.” Id. at *10. Applying the Restatement (Second), Judge Hornak noted that Yamaha’s arguments may be valid; however, under the Restatement (Third) they are irrelevant, given that the Restatement (Third) employs the concept of “reasonable foreseeability.” Id. at *17. The application of the Restatement (Third) clearly inured to the Plaintiffs’ benefit, in refusing to restrict recovery only to users or consumers by allowing Plaintiffs’ claims to proceed to trial.
For now, it appears that the decision regarding which restatement should apply will continue to be made on a case-by-case basis by each judge in every federal case in Pennsylvania until the Pennsylvania Supreme Court rules squarely upon the issue. Therefore, it’s critical to the initial case analysis that any attorney with a pending federal strict products liability case or a pending state court case where federal removal is achievable understands the facts of that case before determining whether the Restatement (Second) or the Restatement (Third) best supports their argument.
PITTSBURGH, Aug. 16, 2012 — Burns White Transportation Associate Shanicka L. Kennedy was named as one of this year’s 40 Under 40 by Pittsburgh Magazine and the Pittsburgh Urban Magnet Project for her commitment to shaping the Pittsburgh region and making it a better place for everyone.
For nearly 20 years, Ms. Kennedy, an advocate for the underprivileged, has worked in various roles that have allowed her to make a significant impact on the personal lives of youths and adults in the Pittsburgh region. Highlights of her current involvement include:
Selected from a nomination pool of more than 220 candidates, this year’s 40 honorees under the age of 40 were chosen by an independent panel of judges comprised of former winners, business professionals and civic leaders. Nominees were evaluated on their level of passion, commitment, visibility, diversity and overall impact on the Pittsburgh region. All recipients will be featured in the November 2012 issue of Pittsburgh Magazine and recognized at an awards event on Nov. 2 at the Wyndham Grand Pittsburgh Downtown.
For the full list of the 2012 40 Under 40 award recipients, visit here.
Associate Nicholas D. Varischetti was recently appointed to serve a three-year term on the La Roche College Board of Trustees, effective October 2012-October 2015. In this capacity, Mr. Varischetti will be responsible for contributing toward the quality education and financial health of the college through his work on the Buildings & Grounds and Institutional Advancement Committees.
Construction Group Co-Chair Michael Cremonese and Associate Andrew Fuga authored an article in The Legal Intelligencer’s construction law supplement published on Aug. 7. Titled “Professional Negligence vs. Negligent Misrepresentation,” the article takes a look at the increasingly blurring lines of demarcation between professional negligence and negligent misrepresentation claims brought against design professionals. Click here to read the article in full.
Jeffrey D. Roberts and Patrick C. Booth penned an article about the questions directional drilling raises in relation to surface estates for the July 31, 2012 print edition of The Legal Intelligencer. Read the full article here.
