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QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.
Which of the following statements is incorrect?
A. These are all examples of product liability.
B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.
C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.
D. It is now harder to include multiple plaintiffs in a class-action lawsuit.
E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.
ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.1 DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.
The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”2 Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.
At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.
Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.
The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.
Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”
There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.
In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.3 He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.
The California Supreme Court went beyond the law of contracts and negligence by introducing the notion of strict liability, which centers on whether a product is defective and unreasonably dangerous. It holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs.
“Defective” is usually defined as product quality that is less than what a reasonable consumer expects. It can be a design, manufacturing, or marketing defect, the latter instance typically showing up as a failure to warn. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.
Product liability lawsuits commonly involve pharmaceutical products and medical devices. Recent examples are suits against Pfizer over Lipitor’s alleged role as a cause of diabetes and against Johnson & Johnson over its talcum products purportedly causing ovarian cancer.4
When the same product injures multiple plaintiffs, they may band together to file a common legal action against the manufacturer. This is called a class-action suit, and will proceed if it is certified to satisfy four prerequisites: numerosity, commonality, typicality, and adequacy.5 A class-action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.
A recent U.S. Supreme Court decision has, however, put a damper on class-action suits by tightening the jurisdictional requirement.6
The case involved Bristol-Myers Squibb, which was sued in California by several hundred individuals from 33 states for injuries from the platelet inhibitor Plavix (clopidogrel). The issue was whether non–California residents could sue in that state for injuries incurred elsewhere.
In a 8-1 decision, the U.S. Supreme Court held that California courts did not have specific jurisdiction to hear the claims of nonresidents without identifying an adequate link between the state and the nonresidents’ claims, as they weren’t prescribed Plavix in the state, didn’t buy or take the drug there, and weren’t injured by the drug there.
Finally, note that, should a doctor fail to warn an injured patient of a known medication risk, the patient may have a claim against the doctor – but usually not against the drug manufacturer. This is termed the “learned-intermediary doctrine.” The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps and in its package insert and the Physician’s Desk Reference. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
Such lawsuits fall in the common category of medical negligence and lack of informed consent, and are not considered a product liability action.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.
2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.
3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).
4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.
5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.
6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).
QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.
Which of the following statements is incorrect?
A. These are all examples of product liability.
B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.
C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.
D. It is now harder to include multiple plaintiffs in a class-action lawsuit.
E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.
ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.1 DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.
The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”2 Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.
At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.
Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.
The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.
Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”
There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.
In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.3 He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.
The California Supreme Court went beyond the law of contracts and negligence by introducing the notion of strict liability, which centers on whether a product is defective and unreasonably dangerous. It holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs.
“Defective” is usually defined as product quality that is less than what a reasonable consumer expects. It can be a design, manufacturing, or marketing defect, the latter instance typically showing up as a failure to warn. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.
Product liability lawsuits commonly involve pharmaceutical products and medical devices. Recent examples are suits against Pfizer over Lipitor’s alleged role as a cause of diabetes and against Johnson & Johnson over its talcum products purportedly causing ovarian cancer.4
When the same product injures multiple plaintiffs, they may band together to file a common legal action against the manufacturer. This is called a class-action suit, and will proceed if it is certified to satisfy four prerequisites: numerosity, commonality, typicality, and adequacy.5 A class-action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.
A recent U.S. Supreme Court decision has, however, put a damper on class-action suits by tightening the jurisdictional requirement.6
The case involved Bristol-Myers Squibb, which was sued in California by several hundred individuals from 33 states for injuries from the platelet inhibitor Plavix (clopidogrel). The issue was whether non–California residents could sue in that state for injuries incurred elsewhere.
In a 8-1 decision, the U.S. Supreme Court held that California courts did not have specific jurisdiction to hear the claims of nonresidents without identifying an adequate link between the state and the nonresidents’ claims, as they weren’t prescribed Plavix in the state, didn’t buy or take the drug there, and weren’t injured by the drug there.
Finally, note that, should a doctor fail to warn an injured patient of a known medication risk, the patient may have a claim against the doctor – but usually not against the drug manufacturer. This is termed the “learned-intermediary doctrine.” The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps and in its package insert and the Physician’s Desk Reference. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
Such lawsuits fall in the common category of medical negligence and lack of informed consent, and are not considered a product liability action.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.
2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.
3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).
4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.
5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.
6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).
QUESTION: A groundskeeper alleges he developed terminal lymphoma from the use of the weed killer Roundup. A homeowner injures his leg while using a lawnmower. One thousand litigants allege Lipitor caused them to develop diabetes. A patient sues his doctor for a serious allergic reaction to an antibiotic.
Which of the following statements is incorrect?
A. These are all examples of product liability.
B. If successful, the groundskeeper may be awarded hundreds of millions of dollars in damages.
C. The homeowner has a cause of action against the manufacturer, even if it’s a borrowed lawnmower from a neighbor.
D. It is now harder to include multiple plaintiffs in a class-action lawsuit.
E. The “learned intermediary doctrine” immunizes the drug manufacturer from liability for a patient’s allergic reaction.
ANSWER: A. Johnson v. Monsanto was a recent case in San Francisco that resulted in a verdict for the plaintiff to the tune of $289 million.1 DeWayne Johnson, a 46-year-old groundskeeper, had developed non-Hodgkin lymphoma after using the weed killer, Roundup, to treat the school grounds, sometimes spraying the herbicide for several hours a day. Mr. Johnson alleged that Roundup’s active ingredient, glyphosate, is a known carcinogen, and that Monsanto, its manufacturer, failed to provide appropriate warning regarding this dangerous product.
The judge in the case allowed into evidence internal emails and experts’ warnings, as well as a critical 2015 position paper of the World Health Organization’s international agency for research on cancer, which classified glyphosate as “probably carcinogenic to humans.”2 Yet the herbicide, used widely in households and in commerce, is registered in 130 countries and approved for use on more than 100 crops. It was the first such case involving Roundup.
At trial, the jury unanimously found that Roundup was a substantial contributing factor in causing Mr. Johnson’s malignancy, that Monsanto failed to warn him of its health hazards (marketing “defect”), and that it knew or should have known that its product was unreasonably dangerous. The main portion, $250 million (of the $289 million award), was awarded as punitive damages.
Tort damages are of two types: compensatory and punitive. The former is to compensate the victim for past and future losses such as wages and medical expenses, pain and suffering, and/or emotional distress. On the other hand, punitive damages, also called exemplary damages, are awarded where there is a reckless, willful, or wanton disregard of the obvious risk of harm.
The case is currently under appeal. Meanwhile, another Roundup trial will soon take place in St. Louis, and the company is facing a class-action suit in U.S. district court in San Francisco, as well as several thousand claims in state courts throughout the country.
Johnson v. Monsanto is a typical product liability action. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”
There are basically three legal theories in a product liability claim: negligence, breach of warranty, and strict product liability. The latter is the most favored by plaintiffs, as there is no need to prove fault or warranty.
In a seminal case in 1963, William Greenman was injured when he used a power tool that was given to him as a gift.3 He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer, as he did not make the purchase himself.
The California Supreme Court went beyond the law of contracts and negligence by introducing the notion of strict liability, which centers on whether a product is defective and unreasonably dangerous. It holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs.
“Defective” is usually defined as product quality that is less than what a reasonable consumer expects. It can be a design, manufacturing, or marketing defect, the latter instance typically showing up as a failure to warn. “Unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.
Product liability lawsuits commonly involve pharmaceutical products and medical devices. Recent examples are suits against Pfizer over Lipitor’s alleged role as a cause of diabetes and against Johnson & Johnson over its talcum products purportedly causing ovarian cancer.4
When the same product injures multiple plaintiffs, they may band together to file a common legal action against the manufacturer. This is called a class-action suit, and will proceed if it is certified to satisfy four prerequisites: numerosity, commonality, typicality, and adequacy.5 A class-action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.
A recent U.S. Supreme Court decision has, however, put a damper on class-action suits by tightening the jurisdictional requirement.6
The case involved Bristol-Myers Squibb, which was sued in California by several hundred individuals from 33 states for injuries from the platelet inhibitor Plavix (clopidogrel). The issue was whether non–California residents could sue in that state for injuries incurred elsewhere.
In a 8-1 decision, the U.S. Supreme Court held that California courts did not have specific jurisdiction to hear the claims of nonresidents without identifying an adequate link between the state and the nonresidents’ claims, as they weren’t prescribed Plavix in the state, didn’t buy or take the drug there, and weren’t injured by the drug there.
Finally, note that, should a doctor fail to warn an injured patient of a known medication risk, the patient may have a claim against the doctor – but usually not against the drug manufacturer. This is termed the “learned-intermediary doctrine.” The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps and in its package insert and the Physician’s Desk Reference. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
Such lawsuits fall in the common category of medical negligence and lack of informed consent, and are not considered a product liability action.
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at siang@hawaii.edu.
References
1. DeWayne Johnson v. Monsanto Co., Superior Court of California, County of San Francisco, Case No. CGC-16-550128, June 18, 2018.
2. The Monsanto Papers: Roundup (Glyphosate) Cancer Case Key Documents & Analysis. Available at usrtk.org.
3. Greenman v. Yuba Power Products Inc., 377 P.2d 897 (Cal. 1963).
4. “Defective and unreasonably dangerous,” Internal Medicine News, Nov. 4, 2014.
5. “Class-action lawsuits,” Internal Medicine News, April 1, 2015.
6. Bristol-Myers Squibb Co. v. Superior Court of California, 582 U.S. ____ (2017).