Products Liability Law In The Age of Nanotechnology: Understanding a manufacturer’s duty to warn, research, and test John C. Monica, Jr. Porter Wright.

Products Liability Law In The Age of Nanotechnology:

Understanding a manufacturer’s duty to warn, research, and test

John C. Monica, Jr.

Porter Wright Morris & Arthur LLPWashington, D.C.

International Congress of NanotechnologySan Francisco, California

November 2, 2006

“Magic Nano”

• Protective glass and bathroom sealant marketed in Germany earlier this year.

• Some customers alleged that they suffered “inhalation injuries” after using the product.

Inhalation Injuries?

• Some consumers were reportedly ill for up to four days after inhaling the product, with most improving within 12 to 24 hours.

• Twelve consumers were treated at hospitals, “and at least 6 of them . . . developed diffuse alterations of the chest radiography and fever, interpreted as toxic pulmonary edema.”

“Magic Nano” Reaction

• Kleinmann GmbH– Better conduct some testing.– Better recall product.

• Germany’s Federal Instutute for Risk Assessment (BfR)– Concluded no nano-material.

• Essentially a marketing device.

• Industry -- Feared Backlash.

False Alarm

Legitimate Consumer Questions

• What did the company know about the safety of nano-materials?

• What research/testing did the company do to determine whether its product was safe?

• What warnings and/or information were distributed with the product?

Restatement (Third) Torts, Product Liability, § 2

Even an otherwise flawless product is considered legally “defective” if: “the foreseeable risks of harm posed by the product could have been

reduced or avoided by the provision of reasonable instructions or warnings. . .”

What Does “Reasonably Foreseeable” Mean?

What Nanotechnology Health Risks, If Any, Are

“Reasonably Foreseeable?”

Foreseeability

• Scientific CausationHenley v. Philip Morris, Inc., 1999 WL 221076

(Cal. App. Apr. 6, 1999)

• Association– “Possible/Potential” Association

Garfinkle v. Bayer Corp., 779 N.Y.S.2d 71 (S.Ct. NY 2004)

– “Tending to Show” AssociationMiller v. Pfizer, Inc., 2000 WL 968792 (D. Kan. June 26,

2000)

“Tending to Show” Association

Miller v. Pfizer, Inc., 2000 WL 968792

(D. Kan. June 26, 2000)

• Less than a “reasonable probability.”

• Less than a “reasonable possibility.”

• Potentially even less than the FDA’s

“reasonable association.”

Reliance On Government

“FDA’s regulations and policies have always been driven by the most accurate science available. Petitioners, however, have provided no clear scientific justification for their claim that FDA must embark on a new regulatory system for nanotechnology. In fact, Petitioners’ citizen petition mischaracterizes the scientific issues associated with nanotechnology. When the full body of scientific understanding of nanotechnology is considered, it is clear that FDA’s existing regulatory authority is more than sufficient to ensure that medical and consumer products that utilize nanotechnology will continue to meet high standards of safety.”

Reliance On Government• Firms Should Perform Early Safety Testing On

Nanotech Products

Firms should make safety research on nanoparticles a priority in their product design processes, because the FDA's limited resources do not allow the agency to fully research the potential safety risks of nanotechnology, experts say. * * * Nanoscale materials may be capable of going places in the body that conventional materials cannot reach and of behaving differently due to their small size, said Stacey Lynn Harper of the Environmental Health Sciences Center's division of environmental and molecular toxicology at Oregon State University. "Current toxicology tools may not be adequate" to address this, she said. Still, there is no credible scientific evidence that nanomaterials as currently used pose a threat to human safety[.]

FDANews.com Devices & Diagnostics Letter Online, Vol. 33, No. 41 (Oct. 16, 2006)

Reliance on Government

• FDA Approval May Not Be Enough To Escape Products Liability– Many states have statutes that bar products liability

lawsuits against drug and medical device manufacturers who comply with the FDA’s drug label requirements.

– Courts have been increasingly willing to allow these suits to go forward, however:

• Levine v. Wyeth, 2006 WL 3041078 (Vt. Oct. 27, 2006) (holding that failure to warn claim relating to side effects of Phenergan via intravenous injection is not preempted)

Reliance on Government

• FDA Approval May Not Be Enough To Escape Products Liability

• Desiano v. Warner-Lambert & Co., 2006 WL 2846454 (2d Cir. Oct. 5, 2006) (holding that the FDA’s rule granting a drug manufacturer the ability to unilaterally strengthen warning labels without regulatory pre-approval does not preempt state failure-to-warn laws); c.f. 21 C.F.R. § 314.70(c)(6)(iii)(A).

Duty To Test/Research

“[A] manufacturer is held to the knowledge and skill of an expert . . . This means that it must not only keep abreast of scientific knowledge, discoveries, and advances, but, more importantly, test and inspect its product. . . . This duty to research and experiment is commensurate with the dangers involved. . . . A manufacturer may not rely unquestioningly on others to raise concerns about its product, but must instead show that its own conduct was proportionate to the scope of its duty.”

Wood v. Phillips Petroleum Co., 119 S.W.3d 870 (Tex. App. 2003)

Warren v. Sabine Towing and Trans. Co., 831 So.2d 517 (La. App. 2003)

Duty To Test/Research

“We appreciate that a manufacturer’s breach of its duty to test cannot, standing alone, suffice to impose liability on the manufacturer for a plaintiff’s injury. For liability to attach, there must be evidence that the manufacturer’s failure to test adequately led it to produce a defectively designed or dangerous product which in turned caused the injuries. In other words, a failure to test cannot be deemed the cause of injury if there is no defect or danger to be disclosed by testing.”

Stapper v. GMI Holdings, Inc., 2001 WL 1664920 (Cal. App. 1 Dist. 2001).

Duty To Test/Research

“’In fulfilling its duty, a manufacturer may not rest content with industry practice, for the industry may be lagging behind in its knowledge about a product, or in what, with the exercise of reasonable care, is knowledgeable about a product. . .’ a whole calling may have unduly lagged in the adoption of new and available devices. It may never set its own tests, however persuasive be its usages. Courts must in the end say what is required; there are precautions so imperative that even their universal disregard will not excuse their omission.’”

Frankson v. Brown & Williamson Tobacco Corp., 791 N.Y.S. 2d 869 (S. Ct. N.Y. 2004)

Duty To Research: Steps To Reduce Liability Exposure• Keep Current On All Research Into Health

And Safety Implications of Nanomaterials

• Conduct Tests On Products To Determine Exposure Risk By Consumers And By Your Employees

• Cultivate A Safety Culture Among Your Researchers, But Warn Your Employees To Be Careful About Speculative “Doom & Gloom” Predictions About Potential Risks

Questions?

John C. Monica, Jr.(202) 778-3050

[email protected]

www.nanolawreport.com

© 2006 John C. Monica, Jr. All rights reserved.