Angio seal class action lawsuit

Chapter Twelve Product and Service Liability Law
When consumers enter a store to purchase a product, they assume that the product will do the job the manufacturer claims it will do without injuring anyone, and the consumer may not be aware that each year more than 33.4 million injuries and around 28,200 deaths result from the use of products purchased in the United States. 1 Deaths, injuries, and property damage from consumer products incidents cost the nation more than $700 billion annually. 2 Estimates of the number of resultant product liability cases range as high as 1 million a year. Also, the verdicts for defective-product or product liability cases are increasing from year to year. The total of the five largest awards for product defect cases in 2009 was 52 percent larger than the total in 2008. In fact, the largest award from a 2009 product defect case amounted to around $300 million, from the Philip Morris tobacco case. Also, in 2008, only 1 of the 50 largest awards were the result of a verdict in a product defect case, but in 2009, 5 of the 50 largest judgments were awarded in product defect cases. 3

1 U.S. Department of Safety, http://www.yourlegalguide.com/defective-product-deaths/.

2 U.S. Consumer Product Safety Commission, www.cpsc.gov/about/about.html (accessed July 27, 2007).

3 John Cord, Product Liability Statistics & Trends, 2010. http://www.drugrecalllawyerblog.com /2010/01/product_liability_statistics_t.html.

Consequently, today’s businessperson is likely to become involved in some aspect of product liability litigation. This chapter discusses the most significant aspects of this area of law, known as product liability, to help the student function as a prudent consumer and businessperson.

Product liability law developed out of tort law, discussed in Chapter 10 . This chapter begins by introducing the three primary theories of recovery in product liability cases and the defenses raised in such cases. These sections are followed by an introduction to enterprise liability, a concept that has slightly broadened the potential reach of product liability cases. Closely related to product liability is service liability, discussed in the next-to-last section. The final section discusses global implications of product liability law.

Critical Thinking About The Law
Manufacturers owe a certain responsibility to consumers. Consumers should be able to reasonably use a product without its causing harm to them or others. After you read the following scenario, answer the critical thinking questions that will enhance your thinking about product liability law.

Katherine purchased a can of hair spray from her local drugstore. When she removed the cap from the hair spray can, the can exploded in her hands. She suffered third-degree burns on her hands and face and was unable to work for three months.

Katherine sued the hair spray manufacturer after she discovered that another woman had suffered an identical accident when using the same brand of hair spray. The jury awarded Katherine $750,000 in compensatory damages.

1. Katherine’s lawyer described a previous case in which an individual was injured because a product exploded. Two years earlier, a woman walking down a row of hair care products in a supermarket had been injured when three cans of hair spray spontaneously exploded. She lost her sight because of the explosion, and a jury awarded her $2.2 million in damages. Katherine’s lawyer argued that because the previous woman had been compensated, Katherine should be awarded $2 million in damages for her injuries. Do you think the earlier case is similar enough to Katherine’s case for Katherine to recover damages? Why?

Clue: How are the cases similar and different? How does the fact that Katherine purchased the product affect your thinking about the earlier case?

2. The manufacturer argued that because it places a warning on the hair spray cans, it is free from responsibility for injury. The can states, “Warning: Flammable. Contents under pressure.” The jury, however, ruled in favor of Katherine. What ethical norm seems to have shaped the jury’s thought?

Clue: Study the list of ethical norms in Chapter 1 . The manufacturer argued that it should not have to assume responsibility because the can has a warning. What ethical norm is consistent with offering greater protection for the consumer?

3. What additional information about this case would make you more willing to state your own opinion about the situation?

Clue: What information about the product would change your thinking about the responsibility of the manufacturer? For example, suppose that Katherine discovered that an identical accident had occurred with the same brand of hair spray. How might knowing the date that the similar accident occurred influence your thinking about Katherine’s case?

Theories of Recovery in Product Liability Cases

Product liability law developed out of tort law. A glance at the three primary theories of recovery in product liability cases—negligence, breach of warranty, and strict product liability—reveals a relationship between product liability and tort law. A plaintiff usually brings an action alleging as many of these three grounds as possible.

Negligence

Plaintiffs in product liability cases have traditionally used theories of negligence. To be successful, the plaintiff must prove the elements of negligence explained in Chapter 11 : (1) that the defendant manufacturer owed a duty of care to the plaintiff, (2) that the defendant breached that duty of care, (3) that this breach of duty caused the plaintiff’s injury, and (4) that the plaintiff suffered actual, compensable injury.

The Privity Limitation

 An early problem with using negligence to recover for an injury caused by a defective product was establishing duty. Originally, a plaintiff who was not the purchaser of the defective product could not establish a duty of care and, thus, could not recover. This limitation was based on the concept of privity, which means that one is a party to a contract. In the earliest known product liability case, Winterbottom v. Wright, 4 the British court in 1842 established the rule that to recover for an injury caused by a defective product, the plaintiff must establish privity. In other words, before a manufacturer or seller of a defective good could owe a duty to the plaintiff, the plaintiff must have purchased that good directly from the defendant who manufactured it. Because plaintiffs rarely purchase goods from the manufacturer, few such suits were initially brought.

4 152 Eng. Rep. 402 (1842).

Gradually, especially in cases of defective food, courts began to eliminate the privity requirement, essentially abolishing it in the 1916 case of MacPherson v. Buick Motor Co. 5 In MacPherson, the court held the remote manufacturer of an automobile with a defective wheel liable to the plaintiff when the wheel broke and the plaintiff was injured. Judge Cardozo stated that the presence of a sale does not control the duty; if the elements of a product are such that it is harmful to individuals if negligently made, and if the manufacturer knows that the product will be used by someone other than the purchaser, then “irrespective of contract, the manufacturer of this thing is under a duty to make it carefully.” The holding in the MacPherson case, which was quickly followed by similar holdings in other states, eliminated the privity requirement, thereby allowing a negligent manufacturer to be held responsible for a defective product that caused injuries to someone with whom the defendant manufacturer had no contract.

5 217 N.Y. 382, 111 N.E. 1050 (1916).

Eradication of the privity requirement and the subsequent increase in the liability of producers and sellers reflected a shift in social policy toward placing responsibility for injuries on those who market a product that could foreseeably cause harm if proper care were not taken in its design, manufacture, and labeling. Increasingly, the courts indicated that defendants should be responsible for their affirmative acts when they knew that such actions could cause harm to others. Also, because the manufacturer and seller derive economic benefits from the sale and use of the product, it seemed fair to impose liability on them if they earned profits from a defectively made product.

Thus, abolition of the privity limitation opened the door for negligence as a theory of liability when people were injured because of a product manufacturer’s or seller’s lack of care. A number of negligent acts or omissions typically give rise to negligence-based product liability actions; these are listed in Exhibit 12-1 . We will discuss the most common ones: negligent failure to warn and negligent design.

Negligent Failure to Warn

 Most of the negligence-based product liability actions result from a failure to warn or inadequate warning. To bring a successful negligence case for failure to warn, the plaintiff must demonstrate that the defendant knew or should have known that, without a warning, the product would be dangerous in its ordinary use or in any reasonably foreseeable use. In determining whether a reasonable manufacturer would have given a warning in a particular situation, the courts frequently consider the likelihood of the injury, the seriousness of the injury, and the ease of warning.

Exhibit 12-1 Common Negligent Actions Leading To Product Liability Cases

There is generally no duty to warn of dangers arising from unforeseeable misuses of a product or from obvious dangers. A producer, for example, need not give a warning that a sharp knife could cut someone. Similarly, some plaintiffs have argued that fast-food restaurants, like McDonald’s, are liable to consumers for consumers’ obesity-related health problems, because the restaurants failed to warn customers of the unhealthful attributes of fast food. In Pelman v. McDonald’s, the plaintiff alleged that McDonald’s failed to warn customers of the “ingredients, quantity, qualities and levels of cholesterol, fat, salt and sugar content and other ingredients in those products, and that a diet high in fat, salt, sugar and cholesterol could lead to obesity and health problems.” 6 In his decision dismissing the plaintiff’s claims against McDonald’s, Judge Sweet specifically stated that “this opinion is guided by the principle that legal consequences should not attach to the consumption of hamburgers and other fast food fare unless consumers are unaware of the dangers of eating such food.” * Because consumers know, or reasonably should know, the potential negative health effects of eating fast food, the plaintiff’s claim was dismissed. But if future plaintiffs can allege that McDonald’s food is dangerous in a manner not known to consumers, their claims may survive.

6 237 F. Supp. 2d 512 (S.D.N.Y. 2003).

A defendant may give a warning in a manner not clearly calculated to reach those whom the defendant should expect to use the product. If the product is to be used by someone other than the original purchaser, the manufacturer is generally required to put some sort of warning on the product itself, not just in a manual that comes with the product. If children or those who are illiterate are likely to come into contact with the product and risk harm from its use, picture warnings may be required.

Products designed for intimate bodily use, especially drugs and cosmetics, often give rise to actions based on negligent failure to warn because the use of these products frequently causes adverse reactions. When a toxic or allergic reaction causes harm to the user of a cosmetic or an over-the-counter drug, many courts find that there is no duty to warn unless the plaintiff proves that (1) the product contained an ingredient to which an appreciable number of people would have an adverse reaction; (2) the defendant knew or should have known, in the exercise of ordinary care, that this was so; and (3) the plaintiff’s reaction was due to his or her membership in this abnormal group. 7

7 W. Page et al., Prosser and Keeton on Torts (5th ed.) (St. Paul, MN: West, 1984), 687.

Other courts, however, determine negligence by looking at the particular circumstances of the case and by weighing the amount of danger to be avoided against the ease of warning. For example, in a 1995 case against McNeil Consumer Products Company, a jury awarded more than $8.8 million to a man who suffered permanent liver damage as a result of drinking a glass of wine with a Tylenol capsule. Although the corporation had known for years that combining a normal dose of Tylenol with a small amount of wine could cause massive liver damage in some people, the company failed to put a warning to that effect on the label. The jury did not accept the company’s argument that the reaction was so rare that no warning was necessary. 8

8 Benedict v. McNeil Consumer Products Co., 1992 WL 729052 (L.R.P. Jury).

Marketing of prescription drugs is unique because the manufacturer almost never communicates directly with the user; instead, it communicates with the physician who prescribes the drug. In these cases, the courts generally hold that drug manufacturers have a duty to provide adequate warnings to physicians to enable them to decide whether to prescribe the drug or disclose the risk to the patient. The manufacturer must warn the physician of any chance of a serious adverse reaction, no matter how small. Prescription drugs are frequently the subject of product liability cases, as described in Exhibit 12-2 .

Product

Case Status and Legal Claims

Avandia (prescription drug used to control blood sugar in Type II diabetics)

In May 2007, the New England Journal of Medicine released a study linking Avandia to a greatly increased risk of heart attack or heart-related death. The Food and Drug Administration (FDA) put out a safety alert and more research is being done on the safety of Avandia. The first law-suit as a result of this new information was filed in June 2007 and experts expect more to follow. As of May 2010, Avandia manufacturers made a $60 million settlement to end approximately 700 lawsuits; however,this was only the first settlement Avandia manufacturers are expected to make in regard to the drug's side effects.

Baycol (prescription drug to lower cholesterol)

Plaintiffs reportedly experienced rhabdomyolysis, a kidney disorder in which toxic muscle cells are released into the bloodstream. Patients can then develop fatal organ failure. Plaintiffs frequently bring claims of failure to warn or for a defectively designed drug. The manufacturer voluntarily removed Baycol from the market because of the legal claims it had spawned. As of January 2007, the court status update estimated that there were approximately 1,200 active cases. The status update also indicated that the manufacturer, Bayer, has settled 3,000-plus cases for more than $1.1 billion.

Fen-Phen (Redux) (drug to treat obesity)

Some patients experienced heart-valve disease after using Fen-Phen to lose weight. In January 2004, a $3.75 billion trust was created as a settlement between patients and the drug manufacturer, American Home Products, to compensate patients injured by Fen-Phen use. Under the settlement agreement,eligible patients may be entitled to compensation, diet drug prescription refunds, and echocardiography screenings.

Paxil (antidepressant) (similar claims have been brought regarding Zoloft, another antidepressant)

Patients taking Paxil reportedly had withdrawal reactions and problems: anxiety, agitation, confusion, dizziness, fatigue, headache, insomnia, irritability, nausea, palpitations, sweating, sleep disturbances, sensory disturbances, tremor, and vision distortion. As of April 2004, there were about 1,500 Paxil withdrawal plaintiffs in more than 30 states. These cases were consolidated into multidistrict litigation. Plaintiffs frequently bring the following claims: intentional misrepresentation, fraud, negligence, strict liability, and breach of warranty. Paxil has also been linked to increased suicide risk in teens and has faced many lawsuits on that front.

Prempro (prescription drug to relieve menopausal symptoms)

Researchers determined that women taking Prempro were more likely to suffer breast cancer, stroke, heart disease, blood clots, and dementia. After this research, the FDA approved new labels emphasizing these increased risks; however, Prempro still remains on the market. Approximately 6 million women had been taking Prempro before the researchers announced the increased health risks associated with Prempro use. The first of the lawsuits against the manufacturer was heard in August 2006 and several suits have been found for the plaintiffs since then, with millions in damages awarded. In one court case in 2010, a woman was awarded $9.54 million; another case in 2007 yielded the astounding verdict of $134 million. As of 2010, many cases are ongoing.

Vioxx (NSAID, COX-2 inhibitor)

Vioxx is a painkiller marketed to treat pain from osteoarthritis. Vioxx has been linked to increased risk of heart attacks and strokes among users. In 2004, the manufacturer pulled Vioxx from the market in response to results of an FDA study. As of July 2007, the manufacturer still faced more than 27,000 lawsuits. A $4.85 billion fund was created by Merck, the manufacturer, to cover those suits. Specifically, a $4 billion fund was created to cover those who had suffered heart attacks after using the drug, and another $850 million fund for those who suffered strokes as a result of using the drug. As of 2010, many lawsuits are still pending.

Zicam (over-the-counter nasal gel to remedy the common cold)

Plaintiffs contend that after using Zicam, they lost their sense of smell and taste. Plaintiffs argue that the Zicam manufacturer knew or should have known about the potential dangers associated with the use of nasal medications containing zinc. Use of zinc can cause nerve damage. Furthermore, plaintiffs argue that the manufacturer failed to provide sufficient warnings to the users of the products even though the side effects of zinc compounds have been documented. In January 2006, the manufacturer settled with 340 plaintiffs for $12 million.

Accutane (drug intended to treat severe acne)

Accutane is an acne medication that was used by millions of people to treat severe acne. In 2009, it was linked to the emergence of inflammatory bowel disease in users of the acne drug who had had no prior health problems related to the disease. On June 29, 2009, Hoffmann-La Roche announced a nationwide Accutane recall. Since the June 2009 Accutane recall, six court decisions have resulted in about $56 million in damages being paid to users who contracted inflammatory bowel disease from using Accutane by Roche.

Fosamax (anti-osteoporosis drug)

The Journal of Oral and Maxillofacial Surgeons released a report in 2004 that linked Fosamax to osteonecrosis of the jaw (ONJ). The FDA swiftly issued warnings about the drug, distributed by Merck. ONJ causes the decay and subsequent death of the bone matter associated with the jaw.

As a result of this health defect, the drug lost its patent protection in 2008 and is no longer one of Merck's most financially successful drugs. Furthermore, Merck has set aside millions of dollars to battle dozens of lawsuits over the drug. The suits have resulted in mistrials, and both successes and defeats for Merck.

Zyprexa (drug to treat schizophrenia) Seroquel (antipsychotic drug from AstraZeneca)

In 2005, it was determined that Zyprexa and Seroquel led to severe weight gain in those who took the drugs. The pronounced effects of the drugs associated with patients' weight put patients in danger of contracting diabetes, among other health issues related to weight gain. Lawmakers claim that manufacturers refused to release prior knowledge of the weight-gain side effect and thus improperly marketed the drug.

In 2005, the drug manufacturer Eli Lilly settled around 8,000 lawsuits, paying around $700 million to those patients affected by Zyprexa. AstraZeneca agreed to a $520 million settlement.

Ortho Evra (birth-control patch)

In 2006, clinical trial results that were released linked Ortho Evra to blood clots that could result in strokes. The drug, manufactured and distributed by Johnson & Johnson, comes in the form of a birth-control patch.

Lawmakers claim that Johnson and Johnson had prior knowledge of this side effect yet did not release the information to the public and left it out of the drug's advertising. Johnson & Johnson settled in court for $1.25 million in 2007.

Yaz (birth control)

At least 40 lawsuits popped up in 2009 against Bayer Pharmaceuticals because of its Yaz birth-control drug. The lawsuits claimed that inadequate information about serious side effects was released to the public through the marketing of the product. These side effects include, but are not limited to, heart attacks, stroke, gallbladder disease, and sudden death.

In fact, Yaz is the only birth control that contains both ethinyl estradiol and drospirenone, with the latter allegedly making the drug very dangerous. As of 2010, many of the lawsuits had been consolidated into large class action lawsuits and are pending in state courts from Florida to Ohio to New Jersey.

Exhibit 12-2 Prescription Drugs That Have Led To Product Liability Claims

Initially, almost all successful product liability actions based on negligence were for breach of the duty to warn. The range of successful actions was so limited because people believed that competition and an open market provided the best means for ensuring that products will have optimal safety features. Believers in the sanctity of the market feel that the manufacturer’s job is to see that the purchaser is an informed purchaser and is not deceived about the safety of a product. 9

9 R. Coase, “The Problem of Social Cost,” Law and Economics 3: 1 (1960).

Negligent Design

The foregoing attitude generally prevailed until approximately 1960, when the courts began, in a limited number of cases, to impose liability based on negligence in the sale of defectively designed products. Such liability is imposed only when a reasonable person would conclude that despite any warnings given with the product, the risk of harm outweighed the utility of the product as designed. Courts have found a wide variety of products to be negligently designed, including weed killers, gas stations, BB guns, airplanes, and traffic signs. One example of negligent design can be found in a 2010 case against Boston Scientific Corp.’s Guidant unit. The corporation was sued because it did not warn medical professionals and the United States Food and Drug Administration that some of the implantable heart defibrillators it was producing would short-circuit. The short-circuiting defects resulted in the deaths of many patients who had the medical device implanted. Furthermore, company officials had been aware of the defects for at least three years but refused to disclose the information. The corporation pled guilty and agreed to a settlement of $296 million. Thus, the design of the product was considered faulty, as the resulting deaths could have been prevented through the disclosure of the defects and spending resources on modifications and further testing.

In bringing an action for negligence in design, a plaintiff must generally prove that the product design (1) is inherently dangerous, (2) contains insufficient safety devices, or (3) consists of materials that do not satisfy standards acceptable in the trade.

Usually an action for product liability based on negligence is accompanied by a strict liability claim, which is easier to prove. With the growing use of strict liability and the broad range of defenses to negligence, negligence has become less important as a theory of liability.

Negligence per se

 As stated in Chapter 11 , violation of a statutory duty is considered negligence per se. This concept is used in negligence-based product liability cases.

When a statute establishes product standards, the manufacturer has a duty to meet those standards. A manufacturer that does not meet those standards has breached its duty of care. As long as the plaintiff can establish that the breach of the statutory duty caused injury, the plaintiff can recover under a theory of negligence per se.

Statutes that might be violated and lead to negligence per se actions include the Flammable Fabrics Act of 1953; the Food, Drug, and Cosmetics Act of 1938; and the Hazardous Substances Labeling Act of 1960.

Applying the Law to the Facts . . .

Let’s say that Rachel bought a sweater made of wool along with a mix of other materials. Rachel went to a bonfire with her friends and a small spark from the fire landed on her sweater, immediately causing it to burst into flames. If the manufacturer of Rachel’s sweater did not comply with the duties laid out in the Flammable Fabrics Act, what action could Rachel take against the sweater manufacturer? What would she need to prove to win her case?

Defenses to a Negligence-Based Product Liability Action

 All of the defenses discussed in the negligence section of Chapter 11 are available in product liability cases based on negligence. Remember that the plaintiff’s own failure to act reasonably can provide a defense. Depending on the state in which the action is brought, the plaintiff’s negligence will allow the defendant to raise the defense of contributory, modified comparative, or pure comparative negligence. If contributory negligence is proved, the plaintiff is barred from recovery. In a state where the defense of pure comparative negligence is allowed, the plaintiff can recover for only that portion of the harm attributable to the defendant’s negligence. In a state that follows modified contributory negligence, the plaintiff can recover the percentage of harm caused by the defendant as long as the jury finds that the plaintiff’s negligence was responsible for less than 50 percent of the harm. So, if a jury finds the defendant to be responsible for 60 percent of the plaintiff’s harm, the plaintiff could recover nothing in a contributory negligence state, but could recover damages for 60 percent of his or her injuries in a modified or pure comparative negligence state. If the defendant were only 40 percent responsible, however, the plaintiff would be able to recover 40 percent of his or her injuries only in the pure comparative negligence state and nothing in the other two.

Another defense available in product liability cases based on negligence is assumption of the risk. A plaintiff is said to assume the risk when he or she voluntarily and unreasonably encounters a known danger. If the consumer knows that a defect exists but still proceeds unreasonably to make use of the product, he or she is said to have voluntarily assumed the risk of injury from the defect and cannot recover.

In deciding whether the plaintiff did indeed assume the risk, the trier of fact may consider such factors as the plaintiff’s age, experience, knowledge, and understanding. The obviousness of the defect and the danger it poses are also relevant factors. If a plaintiff knows of a danger but does not fully appreciate the magnitude of the risk, the applicability of the defense is a question for the jury. In most cases, an employee using an unsafe machine at work is not presumed to have assumed the risk, because most courts recognize that the concept of voluntariness is an illusion in the workplace. Earlier, however, employees attempting to sue manufacturers of defective machines for injuries at work were defeated by this defense.

In many states, misuse of the product is raised as a defense in negligence- based product liability cases. To constitute a valid defense, such misuse must be unreasonable or unforeseeable. A defendant raising the defense of product misuse is really arguing that the harm was caused not by the defendant’s negligence but by the plaintiff’s failure to use the product in the manner in which it was designed and intended to be used.

Statutory defenses are also available to defendants. To ensure that there will be sufficient evidence from which a trier of fact can make a decision, states have statutes of limitations that limit the time within which all types of civil actions may be brought. In most states, the statute of limitations for tort actions, and thus for negligence-based product liability cases, is two to four years from the date of injury. Maine, however, has a six-year statutes of limitations. Kentucky, Louisiana, and Tennessee are the only states with one-year statutes of limitations. If the injured party is a minor, the statute of limitations does not start running until the injured party reaches age 18.

statute of limitations

A statute that bars actions arising more than a specified number of years after the cause of the action arises.

States also have statutes of repose , which bar actions arising more than a specified number of years after the product was purchased. Statutes of repose are usually much longer than statutes of limitations; they are often at least 10 years, and frequently are 25 or 50 years. Statutes of repose may seem unduly harsh on consumers who may be injured as a result of a latent defect in a product. In contrast, to make the manufacturer liable in perpetuity may be unduly harsh on manufacturers and sellers, because of the resulting uncertainty about possible liability. Those who worry about the seller’s liability, however, should remember that the older the product is, the more difficult it will be for the plaintiff to prove negligence on the part of the defendant.

statute of repose

A statute that bars actions arising more than a specified number of years after the product was purchased.

A defendant may use the state-of-the-art defense to demonstrate that the alleged negligent behavior was reasonable, given the available scientific knowledge existing at the time the product was sold or produced. In a case based on the defendant’s negligent defective design of a product, the state-of-the-art defense refers to the technological feasibility of producing a safer product at the time the product was manufactured. In cases of negligent failure to warn, the state-of-the-art defense refers to the scientific knowability of a risk associated with a product at the time of its production. This defense is valid in a negligence case because the focus is on the reasonableness of the defendant’s conduct. Nevertheless, demonstrating that, given the state of scientific knowledge, there was no feasible way to make a safer product does not always preclude liability. The court may find that the defendant’s conduct was still unreasonable because even in the product’s technologically safest form, the risks posed by the defect in the design so outweighed the benefits of the product that the reasonable person would not have produced a product of that design.

state-of-the-art defense

A product liability defense based on adherence to existing technologically feasible standards at the time the product was manufactured.

An earlier section showed that failure to comply with a safety standard may lead to the imposition of liability. An interesting question is whether the converse is true: Does compliance with safety regulations constitute a defense? There is no clear answer to that question. Sometimes, however, compliance with federal laws may undergird a defense that use of state tort law is preempted by a federal statute designed to ensure the safety of a particular class of products. The following case illustrates one situation in which the Supreme Court had to determine whether a corporation could be found guilty of product liability after the company had complied with federal regulations, or whether the federal regulations preempted state product liability law.

Case 12-1 Mutual Pharmaceutical Company, Inc. v. Bartlett

United States Supreme Court 133 S. Ct. 2466 (2013)

In 1978, the federal Food and Drug Administration (FDA), approved the nonsteroidal anti-inflammatory pain reliever sulindac, sold under the brand name Clinoril. The FDA also approved its labeling, which included warnings of potential side effects. When the company’s patent expired, other companies, including Mutual Pharmaceutical Company, produced generic versions of the drug. As required by federal law, the companies selling the generic drugs used the exact same labels as approved for the original drug, without any modifications.

Karen Bartlett was prescribed Clinoril for shoulder pain, and the pharmacy filled the prescription with the generic form of the drug manufactured by Mutual Pharmaceutical. Shortly after starting to use the pain reliever, she developed an acute case of toxic epidermal necrolysis. As a consequence, she became severely disfigured and nearly blind. The label had not warned of the potential for toxic epidermal necrolysis, although subsequently, however, the FDA recommended changing all NSAID labeling to contain a more explicit toxic epidermal necrolysis warning.

Bartlett sued Mutual Pharmaceutical Company under the New Hampshire state design-defect law. A jury found in her favor and awarded her over $21 million in damages. The First Circuit Court of Appeals affirmed the decision, finding that neither the FDCA nor the FDA’s regulations preempted respondent’s design-defect claim. It distinguished PLIVA, Inc. v. Mensing, a previous Supreme Court case holding that failure-to-warn claims against generic manufacturers are preempted by the FDCA’s prohibition on changes to generic drug labels, by stating that generic manufacturers facing design-defect claims could comply with both federal and state law simply by choosing not to make the drug at all.

Mutual Pharmaceuticals appealed to the U.S. Supreme Court.

Justice Alito

We must decide whether federal law preempts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID). New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings.