Children's MotrinThe Massachusetts Supreme Judicial Court has affirmed a record $63 million jury verdict against healthcare giant Johnson & Johnson for allegedly inadequate warnings about the health risks associated with Children’s Motrin. The facts underlying this remarkable verdict are undeniably tragic, but they also demonstrate just how important clear and comprehensive warnings are for product manufacturers. Further, as explained in more detail below, this case emphasizes that it is extremely difficult in Massachusetts for manufacturers to prove that the FDA would have rejected a plaintiff’s recommended warning change, a showing that the United States Supreme Court has suggested could shield a manufacturer from a failure to warn claim. With interest, Johnson & Johnson is currently liable for over $130 million to the plaintiffs.

The Case

In November 2003, seven-year-old Samantha Reckis took Children’s Motrin after showing signs of a fever. The popular pain reliever did not improve her condition. Instead, Samantha developed toxic epidermal necrolysis (“TEN”), a life-threatening skin condition that caused her to lose 80 percent of her lung capacity, 90 percent of her skin, and her vision. Since 2003, Samantha has undergone almost 100 surgeries, which have kept her alive.

Samantha and her parents sued Johnson & Johnson, the manufacturer of Children’s Motrin, for allegedly failing to provide adequate warnings about the risks associated with the drug. Specifically, the Reckis family claimed that Children’s Motrin should have included a warning that its use could result in a life-threatening condition. In February 2013, a Plymouth County jury returned a $63 million verdict in favor of the Reckis family.

The Appeal

Johnson & Johnson appealed the verdict, primarily arguing that the United States Supreme Court’s 2009 decision Wyeth v. Johnson & JohnsonLevine preempted the plaintiffs’ claims because the Food and Drug Administration (“FDA”) would have rejected the warning that the Reckis family argued should have been on Children’s Motion. In Wyeth v. Levine, the Supreme Court found that a drug manufacturer could still be liable for failure to warn even after the FDA had approved a drug’s warning label. However, the Court also indicated that if there was “clear evidence” that the FDA would have rejected a manufacturer’s proposed warning change, then the manufacturer would not be liable for failing to include such a warning.

In 2003, when Samantha Reckis took Children’s Motrin for her fever, the warning on the drug advised users to stop using it if an allergic reaction occurred, but did not mention TEN or that its symptoms could be a sign of a life-threatening condition. Thereafter, a group of citizens petitioned the FDA to revise the warning on pain relievers with ibuprofen, such as Children’s Motrin, to reflect that use of the product could lead to potentially life-threatening conditions such as TEN. The FDA rejected this petition and specifically noted that including disease names such as TEN would not be useful to consumers because most consumers would be unfamiliar with such terms. Johnson & Johnson argued that this rejection constituted clear evidence that the FDA would have
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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
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FMSA Moving Forward

In the future, we might look back at 2013 as the year the Food Safety Modernization Act (FSMA) finally got some teeth.  In January, the Food & Drug Administration (FDA) released two long awaited proposed rules, one aimed at food manufacturers and the other at farmers. A third rule is still in the drafting process and will require food importers to comply with United States standards through a stringent verification process.

It has been two years since President Obama signed FSMA into law, but these new rules proposed in January would be the first which actually give the FDA enhanced authority in its efforts to prevent food-borne illness. A major motive behind FSMA and the new rules is to allow the FDA to be proactive, rather than reactive, which, in turn, should lead to a tangible decrease in the number of food-related illnesses.  Presently, one in every six Americans suffers from a food-borne illness annually, with 130,000 requiring hospitalization and 3,000 dying each year.  As a result of these eye popping numbers, and increased media coverage, outbreak awareness and food litigation have exploded in recent years.   From the perspective of attorneys involved in food litigation, there are likely several ways which these new rules will impact current and future client.  Let’s take a closer look:

Rule #1, Manufacturers:

This rule will require food manufacturers to formulate a plan to prevent its food products from causing food-borne illness, as well as a plan to deal with any contamination or outbreak.  The rule also requires that the plan include a detailed strategy related to recall procedures.  Manufacturers will be required to document the plan and keep records to verify that their preventive steps are working. Furthermore, each plan will be evaluated by the FDA, and it will use the plan as a key factor in determining “high risk” facilities, which will be subject to increased inspections.  The new rule also grants audit power to FDA inspectors to confirm compliance with safety standards established in a plan.  Additional scrutiny by the FDA means more opportunity for a problem to be found, which could lead to increased future litigation. As such, compliance with the new rule is of paramount importance to any of your clients who manufacture a food product (which includes products originally manufactured in a foreign country). Your clients must be advised that a well-crafted, detailed plan is essential to both minimize risk of a contamination event, and to reduce the possibility of FDA scrutiny through audits and inspections. 

Also, it may sound obvious, but your clients must be instructed that going forward, they must comply with the plan at all times.  Having a plan is the first step, but that plan must be followed.  It is almost worse for your client to have a plan, if they do not comply with it.  After the rule is formally enacted, it is easy to envision how a plaintiff could exploit any inconsistencies or failure to comply with the plan that your


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Certified Gluten Free Lable

The Food & Drug Administration (FDA) is preparing to release a regulation on the labeling of “gluten-free” food by the end of 2012. Although the regulation will provide much needed guidance to consumers and food manufacturers, it will also establish a standard that food manufactures will need to follow in order to use a “gluten-free” label.  If food manufacturers use the “gluten-free” label without properly following the regulation, they could face lawsuits from consumers purchasing their products.

An increasing number of people in the U.S. follow a gluten free diet.  Gluten is a protein contained in grains such as wheat, barley, rye and triticale.  Packaged Facts, a Maryland based research firm, estimates that U.S. retail sales of gluten-free products in 2010 was $2.3 billion dollars, up from $1 billion dollars in 2006.  The firm projects retail sales of gluten-free food to reach $2.6 billion in 2012, and $5.5 billion in 2015.

Although the recent increase in dollars spent in the gluten-free market presents opportunities to businesses, it also presents risks.  People choose to follow a gluten-free diet for a variety of reasons, and some individuals require that food they consume be prepared in a completely gluten-free environment. If individuals with Celiac disease consume gluten, they may suffer symptoms ranging from gastrointestinal issues to neurological problems and cancer (PDF download). According to a 2010 study, 10% of gluten-free consumers purchase gluten-free products because they or a member of their household have Celiac disease or an intolerance to gluten, wheat or other ingredients. Scientists estimate that approximately 18 million Americans have some degree of gluten sensitivity. This requires that businesses take food labeling and food handling procedures seriously.

Confusion over what is gluten and what type of special handling is required to comply with a “gluten free” label has made the universe of food labels confusing to both gluten-free consumers and manufacturers.  Food labels range from being marked “gluten-free,” “made with no gluten ingredients,” and “manufactured in a gluten-free environment.” Currently, a company can label a product as gluten-free regardless of whether the food has been tested for the presence of gluten.

McDonalds received a great deal of negative publicity in 2006 when the company admitted that the fries they had previously claimed were gluten-free, are actually prepared with an oil that uses hydrolyzed wheat bran.  After an outcry from gluten-free consumers, McDonald’s removed fries from their list of gluten-free options and began labeling them as containing the allergen wheat. Although lab results indicated that no gluten was present in the fries, McDonald’s has not relabeled the fries as gluten-free (and appears to no longer have a gluten-free list at all) possibly out of fear of more lawsuits.

The FDA has twice opened the comment period for the public to weigh in on the agency’s proposed rule on how to label food as gluten-free. The proposed rule may require, among other criteria, that food bearing the claim of gluten-free cannot contain 10 parts per million (ppm)
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Genetically modified organism lemons

California’s Secretary of State recently announced that the California Right to Know Labeling Initiative will be Proposition 37 on this November’s state ballot. If passed, this initiative would require labeling by food manufacturers of any genetically modified organisms (GMOs), also known as genetically engineered organisms (GEOs).

GMOs made their first public appearance in 1994, when a tomato became the first genetically engineered product sold. Since then, GMOs have become increasingly more common in everyday products. In fact, the Grocery Manufacturers of America estimates that approximately 70 to 75% of processed foods available in U.S. grocery stores contain a GMO.   Furthermore, the FDA, which oversees product labeling requirements, considers GMOs to be “generally regarded as safe” (GRAS) and does not require that they be identified on product labels.  Nevertheless, despite nearly two decades of main stream retailing, it seems that the American public remains largely unfamiliar with the both the benefits and commonality of GMOs, as well the scientific community’s support for their safety.

How will Prop 37 impact the food manufacturing industry?

Should California vote in favor of Proposition 37, the imposition of similar labeling requirements is likely to follow in other states around the country.  As a result, manufacturers will likely experience increases in operational costs, as they are forced to adjust their manner of handling and preparing their products to account for GMOs.  Furthermore, food companies will also see increased legal costs,  because increased labeling requirements would also increase the potential for litigation, namely false-labeling class actions, which are becoming increasingly more common.  These class actions are not only costly to defend, but also harmful to a food company’s brand.

Where will these impacts manifest?   

  • Food producers will need to implement a system for maintaining separate inventories of product, so as not to mix the GMOs and non-GMOs.
  • Companies will be forced to amend their HACCP plans to address the handling of GMOs.
  • Overhead may increase as a result of inconsistent GMO labeling requirements nationally.
  • Companies will be forced to choose between having one label which adheres to each state’s requirements and utilizing different labels depending on the state in which the GMO containing product will be sold.
  • In response to potential consumer backlash against products containing GMOs, food manufacturing companies may need to raise the price of their products, discontinue certain brands, or engage in costly marketing campaigns to ensure future profitability.
  • Increased labeling requirements would also increase the potential for litigation in the form of false-labeling claims.

In business, smart companies aim to do business ethically and place the health and safety of their consumers first; they have the ability to meet goals while still complying legally with an ever-changing legislative landscape.

What are smart companies in the California food industry doing to prevent consumer backlash and insulate themselves from potential lawsuits in a post-Proposition 37 market?

  • Communicating: In-house counsel and litigation counsel should be having frequent conversations regarding the short and long impact of this initiative. Great litigation firms not only understand


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