Pharmaceutical and Medical Devices

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.

 
Continue Reading Massachusetts Appeals Court Overturns Jury’s Verdict in Pelvic Mesh Case

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
Continue Reading Massachusetts’ Supreme Judicial Court Upholds Record $63 Million Verdict in Children’s Motrin Case

A deadly Listeria outbreak has swept across the United States in recent weeks, sickening at least 29 people and taking the lives of three.  This latest tragedy is reportedly linked to the sale of commercially produced, prepackaged caramelized apples. If recent media reports are accurate, the situation highlights the devastation a single breach in sanitation protocol can thrust on an otherwise remarkable wholesale and retail food distribution system in the United States. The situation also serves to remind food growers, manufacturers, distributors and retailers alike that exposure to liability for food-borne illnesses today goes well beyond civil fines and damages and is increasingly subject to criminal prosecution.

Listeria outbreaks are rare but dangerous. In 2011, listeria in cantaloupes killed 33 people and sickened 147 in 28 states, according to the CDC. In 2012, 22 people were infected and four died in an outbreak attributed to a brand of ricotta cheese imported from Italy. Besides the potential civil suits, one of which has already been filed in connection with the caramel apple outbreak (James Raymond Frey, Individually and on behalf of the Estate of Shirlee Jean Frey, et al. v. Safeway, Inc., et al., No. CISCV180721 (Cal. Sup. Santa Cruz Co.)), food manufacturers should be aware of the unprecedented criminal prosecutions of food-industry defendants in multiple states.

In 2010 the U.S. Food and Drug Administration (FDA) began warning the food industry, that federal criminal laws would be enforced in the fooded safety industry, including the potential liability for food industry executives for the shipment of contaminated food, even though it was outside of the executive’s knowledge or consent. In light of the strict liability laws, U.S. v. Eric Jensen and Ryan Jensen resulted in Colorado’s Jensen brothers each serving  six months of home confinement in 2014 after pleading guilty to six of the “strict liability” federal criminal misdemeanors. The only evidence necessary was that the company distributed cantaloupes with the deadly pathogen; knowledge of the contamination was irrelevant.

Similarly, in United States v. Parnell, No. 13-cr-12 (U.S. Dist. Ct., M.D. Ga., Albany Div.) the food company employees are awaiting sentencing for “strict liability” misdemeanors because their contaminated eggs became part of interstate commerce. In addition, the recent jury trial and conviction of former Peanut Corporation of America (PCA) officers and managers has captured the attention of the entire food industry.

Most recently, criminal charges have been brought against the owners and employees of a pharmaceutical company linked to the deadly 2012 meningitis outbreak. Two of the fourteen arrested were the owners of the company, each of whom were charged with second-degree murder and racketeering in connection with the 64 deaths that resulted from the outbreak. The 131 count indictment alleges that the employees were aware that they were producing medication in an unsafe and unsanitary manner, yet distributed it anyway.

Although the requisite knowledge standard of those involved with the meningitis outbreak differs from the strict liability standard for those in connection with the listeria outbreak,
Continue Reading New Era of Criminal Prosecution For Those in the Food Safety and Pharmaceutical Industry

Plaintiffs, when faced with a legal bar to traditional negligence claims, frequently try to cloak them in new theories of liability. This tactic is reminiscent of dialogue in William Shakespeare’s play Romeo and Juliet, in which Juliet argues that the names of things do not matter, only what things “are” is truly important.

Trend

An upsurge in this practice took place following the Supreme Court’s decision in Pliva Inc., v. Mensing, 131 S.Ct. 2567 (2011), which held that state-law claims based on a failure to warn of the risks of a generic medication are preempted by federal law. New theories presented by plaintiffs included: (1) that generic manufacturers should have warned healthcare providers of (Metoclopramide’s) risks through means other than the product’s package insert, such as by way of a “Dear Doctor” letter; (2) that state-law liability can be predicated on duties that arise solely from the FDCA; (3) that state-law liability can be premised on an alleged duty to ask the brand-name drug manufacturer to make a labeling change; and (4) that a generic drug manufacturer can be held liable for failing to stop selling a drug with allegedly inadequate warnings.[i]

Recent Defense Ruling

Wyeth-Ayerst Pharmaceuticals, Inc. (“Wyeth”) recently beat back such an effort in Tersigni v. Wyeth-Ayerst Pharm., Inc., 2014 U.S. Dist. LEXIS 86993 (D. Mass. June 25, 2014).  Plaintiff Michael J. Tersigni filed suit on March 11, 2011 against Defendant Wyeth alleging that his primary pulmonary hypertension was caused by his use of its diet drug “Fen-Phen.”[ii]

The Fen-Phen Craze

During the height of the 1990s the market was flooded with diet and weight loss drugs to combat America’s increasing problem with obesity. One such weight loss drug was known as “Fen-Phen,” which was a pharmaceutical cocktail that combined phentermine and fenfluramine. [iii] This combination was not approved by the Food and Drug Administration (FDA), yet was prescribed by doctors across the nation.[iv] Fen-Phen worked by increasing serotonin levels in the brain which had a twofold effect – the consumer would feel satiated, while also experiencing a loss in appetite.[v]

Despite contentious debate about the safety of this pharmaceutical combination, dexfenfluramine, a derivative of the Fen-Phen cocktail and the active ingredient in “Redux,” was approved by the FDA in 1996.[vi]  Sales of the product were very strong, with nearly 2 million individuals taking dexfenfluramine in the U.S. alone.[vii]  An article published in The New England Journal of Medicine in August 1997, however, revealed that Fen-Phen led to a host of illnesses including heart valve problems and pulmonary hypertension.[viii]

Wyeth was the distributor and manufacturer of Pondimin, a version of fenfluramine that had been on the market in the United States since the early 1970s, as well as Redux.[ix]  Wyeth withdrew both of these products from the market in September 1997 following a request by the FDA. This led to a torrent of litigation in which thousands sought financial compensation due to medical conditions allegedly caused by consuming these drugs, including the case
Continue Reading What’s in a name? That which we call a rose by any other name would smell as sweet;

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