Products Liability Prof Blog

R.I. Supreme Court Will Webcast Arguments in Lead Paint Nuisance Appeal

The much-anticipated oral arguments in the various appeals in Rhode Island v. Lead Industries Association will be webcast over the internet on May 15, 2008.  Arguments begin at 9:00 AM EDT.  At trial, the defendants were found liable on a public nuisance theory for abatement costs stemming from the use of lead-based paints decades ago.  Of the several issues on appeal, two are of particular interest:  (1) whether the manufacturing and sale of lead-based paint was, at the time, a public nuisance, and (2) the state's use of a contingent fee agreement with private counsel to prosecute the state's case.  Similar suits in other states have been rejected with courts essentially finding that a lawful activity, not known to be dangerous at the time of the activity, cannot amount to a public nuisance.  The second issue raises the essential question of whether counsel with a financial interest in the outcome of the litigation can maintain the degree of neutrality demanded by prosecutions in the public interest.

JDP

Second Circuit Rejects NYC's Nuisance Suit Against Gun Industry

The U.S. Court of Appeals for the Second Circuit has dismissed a public nuisance suit brought by New York City against gun manufacturers and wholesalers.  The court reversed the federal trial court's ruling that the case fit within an exception to the Protection of Lawful Commerce in Arms Act (PLCAA), a federal law enacted in 2005 to shield gun manufacturers and sellers from civil liability for the gun-related criminal actions of others.  The PLCAA contains an exemption for lawsuits alleging that a gun manufacturer or seller knowingly violated a state or federal statute "applicable to the sale or marketing of" firearms.  The plaintiffs argued that New York's second-degree criminal nuisance law was "applicable" to the sale or marketing of firearms.  The court disagreed, concluding that the word "applicable," when read in context, meant only firearms-specific statutes actually regulating the firearms industry.  The state's generally-applicable criminal public nuisance statute was not such a statute and therefore did not fit the exception in the PLCAA.  See the report in Product Liability Daily.

JDP

Trial Court Adopts Colacicco Preemption Ruling

Adopting the recent ruling by the Third Circuit in Colacicco v. Apotex, Inc., 521 F.3d 523 (3rd CIr. 2008), a federal trial judge in Illinois has ruled that the U.S. Food & Drug Administration's repeated rejection of a scientific basis for suicidality warnings on the prescription drug Paxil, preempted the plaintiff's state law failure-to-warn claim brought against the drug's manufacturer, SmithKlineBeecham (Mason v. SmithKlineBeecham Corp., C.D. Ill., No. 05-1252, 4/23/08).  Paxil is an antidepressant, one of several selective serotonin reuptake inhibitors (SSRIs).  The FDA has monitored the possible connection between SSRIs and suicide for nearly 20 years and has concluded that the suicide warnings desired by the plaintiff in Mason are without scientific basis and would therefore be false and misleading.  The plaintiff's state tort law claims that, without such warnings, the drug's labelling and use information were false and misleading directly contradicts the FDA's express conclusion to the contrary.  The plaintiff's information defect claim is thus preempted.  See the report in Product Liability Daily.

JDP

Consumer Product Safety Commission's "Safety Review" is Now Available

The Consumer Product Safety Commission's monthly electronic newsletter, "Safety Review," is now available.  Click here to see it.

MKS

$24.2 Million Verdict in Asbestos Suit Against Honeywell International

A Miami Herald article by Patrick Danner notes a Dade County jury verdict of almost  $24.2 million for Stephen Guilder in an asbestos suit against Honeywell International.  The plaintiff, a fifty-year-old surgeon, was exposed to asbestos when he worked on a farm as a teenager, repairing tractors and other farm equipment, where he was exposed to brake pads made with asbestos.  The plaintiff's theory was that exposure resulted in a rare, fatal type of cancer, peritoneal mesothelioma,.  The verdict was the largest compensatory damages verdict in a  Florida asbestos case involving a single defendant.  Honeywell International is the parent of Bendix, the brake maker. 

MKS

Texas Supreme Court Holds Defective Lighter Claim Preempted by Consumer Product Safety Act

In Bic Pen Corp. v. Carter, ___ S.W.3d ___ (Tex. 2008), decided April 18, 2008, the Texas Supreme Court held that a products liability design defect claim based on the use of a J-26 model BIC lighter was preempted by federal law. The case arose out of burns sustained by a six-year-old whose five-year-old brother accidentally set fire to her dress with the lighter. The jury found for the plaintiff, awarding three million dollars in actual damages and two million dollars in exemplary damages. The exemplary damages were reduced to $750,000, as required by Texas law. The Consumer Product Safety Commission adopted has adopted regulations requiring that disposal lighters be child-resistant and establishing a protocol for testing a lighter’s child resistance. Those regulations establish specific requirements for compliance. The J-26 lighter met the standards and the Commission issued a certificate of compliance for the lighter. The Consumer Product Safety Act contains both savings and preemption clauses. 15 U.S.C. §§ 2074(a) and 2075(a). The plaintiff argued that conflict preemption did not apply because of the savings clause. The Texas Supreme Court noted that two courts had considered the issue, with conflicting results. The Mississippi Supreme Court held in Frith v. BIC Corp., 863 So.2d 960, 967 (Miss. 2004) (en banc), that implied preemption should apply, while the United States District Court for the Southern District of New York rejected the preemption claim in Colon v. BIC, 136 F. Supp. 2d 196, 209 (S.D.N.Y. 2000). The Court considered and applied the policy analysis from Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), in arriving at its conclusion that the plaintiff’s claim was preempted:

Although Riegel addressed an express preemption provision, its policy analysis is likewise applicable here. . . Both the MDA provisions in Riegel and the CPSA provisions at issue here require products to go through safety testing before being released on the market. In both cases, a careful analysis of the provisions reveal that the testing is not merely a safety floor, but a balancing of factors that ensure the product meets carefully prescribed safety standards. Particularly here, where the Commission rejected the idea of more stringent standards, we agree that, under Riegel, a common-law tort claim could impose duties that conflict with the federal regulatory scheme and therefore would "stand as an obstacle to the accomplishment and execution of the full purpose and objections of Congress."

MKS

China Publishes New Draft Food Safety law

China published its new draft food safety law on Sunday on the website of the National People's Congress.  The draft law was submitted to the NPC Standing Committee in December of last year for the first hearing.  The draft makes producers of substandard food subject to fines, the confiscation of their incomes, and revocation of production certificates.  In more serious cases, producers could face prison terms ranging from three years to life.  Members of the public are being invited to make recommendations and submissions on the draft, until May 20, when the comments will be delivered to the NPC Standing Committee for further study.  [READ MORE]

MKS

Arkansas Supreme Court Reverses No Preemption Finding in Light of Riegel

In a February ruling, the Arkansas Supreme Court reversed a circuit court's grant of summary judgment in favor of a hearing device manufacturer holding that a design defect claim regarding the allegedly defective product, approved for marketing by the Food & Drug Administration, was not preempted by the Medical Device Amendments (MDA) under which such regulatory approvals are granted.  Less than two weeks later, the U.S. Supreme Court decided exactly the opposite in Riegel v. Medtronic, Inc., (169 L.Ed. 2d 892 (2008). When the defendant-manufacturer petitioined for reconsideration in light of Riegel, the Arkansas court reversed its earlier ruling in Despain v. Bradburn, (2008 Ark. LEXIS 233) and held that the state-law-based design defect claim was preempted.  A concurrence bemoaned the conclusion in Riegel that state common law claims are preempted by the MDA and expressed "dismay at the summary abandonment of venerable principles of state common law that have been developed over many generations."

JDP

U.S. Food & Drug Safety Officials Plan Office in China

The U.S. Food & Drug Administration is planning to open an office in China as early as May 2008 once final approval is given by the Chinese government.  The initiative is in response to the massive amount of Chinese goods imported into the U.S. and the impossibility of inspecting all such products for safety.  The goal is to improve product quality and safety at the point of origin.  Discussions of similar arrangements are underway with India and Mexico, also large importers of drugs or drug ingrediants.  See Gillian Wong's story for the Associated Press.

JDP

Restatement 3d, Products Liability - 10th Anniversary Symposium

The Brooklyn Law School is sponsoring a symposium on November 13 - 14, 2008, occasioned by the tenth anniversary of the Restatement (Third) of Torts - Products Liability.  The title of the symposium is "The Products Liability Restatement:  Was it a Success?"  A list of the distinguished speakers may be found on the law school's website at:  http://www.brooklaw.edu/news/Scheduled_Participants_Restatement.pdf.

JDP

New York Appellate Court Overturns Negligent-Design Verdict Against Tobacco Companies

A New York appellate court overturned a jury verdict in favor of a decades-long smoker who claimed that the tobacco company defendants negligently designed their products by continuing to produce cigarettes with higher levels of tar and nicotine than so-called "light" cigarettes.  A Manhattan jury had handed down a $3.4 million compensatory award to be evenly split between Philip Morris and Brown & Williamson, and a $7.1 million punitive award against Philip Morris.  The appellate court noted that New York law requires a plaintiff in a negligent design case to prove that the product created a substantial likelihood of harm and that it was feasible to design the product in a safer manner.  The majority held that, though it was technically feasible to manufacture "light" cigarettes, the plaintiff had failed to prove that regular cigarettes retained their "inherent usefulness" to consumers.  Unless the plaintiffs proved such "consumer acceptability" of light cigarettes with their different tastes and psychological effects due to lower tar and nicotine levels, they could not show that the alternative design was "feasible" and thus failed to make out a prima facie case of negligent design. See Noeleen Walder's story for the New York Law Journal.

JDP

FDA Drug Regulation Preempts Failure-to-Warn Claim

The U.S. Court of Appeals for the Third Circuit ruled that the Food & Drug Administration's long history of regulating anti-depressants and its explicit rejection of a suicidality warning for the drugs Paxil and Zoloft preempts state-law based failure-to-warn claims.  The divided and narrowly-tailored opinion is limited to circumstances in which the FDA has actively monitored the drug's risk and publicly rejected the need for the warning that plaintiffs argue state law requires.  The court did not decide whether preemption would be appropriate in other circumstances such as where the FDA had not rejected the substance of the warning sought or where the FDA had only stated its legal postition after the litigation had begun.  See Shannon Duffy's article for The Legal Intelligencer.

JDP

Eighth Circuit Applies Minnesota Statute of Repose To Bar Recovery for Damages Caused by Ventilation Fan

On April 7 the Eighth Circuit decided Integrity Floor Covering, Inc. v. Broan-Nu Tone LLC, No. 07-1824 (8th Cir. April 7, 2008) a case involving a claim for property damage to a building allegedly caused by a malfunctioning bathroom ventilation fan manufactured by the defendant.  The suit was brought more than ten years after the fan was installed, raising the issue of whether the Minnesota ten-year statute of repose, Minn. Stat. § 541.051 barred recovery because the claim arose "out of the defective and unsafe condition of an improvement to real property" or whether, or whether the  statutory exception in subdivision 1(d) for claims application to manufacturers or suppliers of "any equipment or machinery  installed upon real property" applied.  The statute applies to an "action by any person . . . to recover damages for any injury to property, real or personal . . . arising out of the defective and unsafe condition of an improvement to real property . . . brought against any person . . . furnishing . . . materials . . . ."  Minn. Stat. § 541.051, subd 1 (a) The court held that the statute covered Broan as a product manufacturer and that the exception for equipment or machinery installed upon real property did not exclude Broan because the fan, which was incorporated into the structure of the building, was ordinary building material.  The court acknowledged that the facts of the case presented a close issue, but that "the code-required interior bathroom ventilation fan is more analogous to the items Minnesota courts have found to be ordinary building materials."  The Eighth Circuit incorporated its opinion in Integrity Floor Covering in a companion case, Chicago Avenue Partners, Ltd. v. Broan-Nutone, LLC, No. 07-1784 (8th Cir. April 7, 2008), even though the fan in question in that case was not hard-wired into the buildling but was plugged in.  The court noted that the fan was connected to the buildling because it was nailed into a stud with a duct run to a hole in the roof or wall, and it required the services of someone familiar with wiring to complete the installation.

MKS

New York Court Rules Circumstantial Evidence of Product Defect Inadequate

In Ramos v. Howard Industries, N.Y., No. 26, March 13, 2008), the New York Court of Appeals dimissed an electrical lineman's suit against an electrical transformer manufacturer for his failure to rule out causes of the transformer's explosion other than product defect.  Ramos first claimed that he had injured his back when he reached out of an aerial bucket while installing the transformer on a pole.  Two years later, he claimed that the transformer had exploded and knocked him over within the bucket.  By the time he described the explosion, the transformer itself could not be located for inspection or testing.

The court said that circumstantial evidence of a defect is enough to prove a product defective but that the plaintiff must prove that the product did not perform as intended and must rule out all other causes of the failure - the essential, traditional criteria for a res ipsa instruction to the jury.  Ramos would have to offer enough competent evidence to rebut any evidence of alternative causes but Ramos' expert's theory amounted to "pure speculation" from which no reasonable jury could conclude that all other causes of the transformer explosion were excluded.  Accordingly, the court upheld the trial court's grant of summary judgment to the defendant manufacturer.  See the Product Liability Daily report.

JDP

California Adopts Sophisticated User Doctrine in Failure-to-Warn Cases

The California Supreme Court unanimously held that the sophisiticated user doctrine applies in California, bringing that state's law into line with both federal law and the law in most states. Johnson v. American Standard Co., Cal. No. S139184, April 3, 2008, involved a claim by an air-conditioning technician that his lung disease was caused by exposure to phosgene gas released when the evaporators in air conditioning systems are serviced.  Johnson alleged that the defendants knew that phosgene gas forms when a commonly-used refrigerant is exposed to high heat, such as during welding, but failed to provide adequate warnings of that hazard.

American Standard argued that Johnson was a trained and certified professional who knew or should have known of an obvious risk widely known by industry technicians.  "Although manufacturers are responsible for products that contain dangers of which the public is unaware, they are not insurers, even under strict liability, for the mistakes or carelessness of consumers who should know of the dangers involved," according to the court.  A manufacturer is not liable to a sophisticated user of its product for failure to warn of a risk if the sophisticated user "knew or should have known of that risk."  The court conclulded that the evidence was clear that HVAC technicians knew or should have known of this risk and upheld the court of appeals dismissal of Johnson's claim.  See the Product Safety & Liability Reporter summary of the case.

JDP

Drug Companies May Be Liable for Off-Label Use of Third Parties' Generics

In a case of first impression in Pennsylvania, a trial judge has refused to grant the defendant drug companies' motion for summary judgment, ruling that those companies may be liable for money paid by patients to other drug companies making the generic equivalent of the name-brand drug if the class plaintiffs can prove their allegations that the defendants marketed that drug for off-label use.  See Amaris Elliott-Englel's article for The Legal Intelligencer.  Clark v. Pfizer, Inc., No. 1819, Philadelphia Co. Court of Common Pleas (June Term 2004) is a class action lawsuit in which the plaintiffs allege that Warner-Lambert Co. and its merger partner Pfizer fraudulently promoted Neurontin and its generic equivalent, gabapentin for uses not approved by the FDA.  Plaintiffs seek a refund of all money paid by those who purchased either the name-brand drug or the generic, including monies paid to third-party sellers of the generic drug.

The defendants argued that they never realized any profits from the sales by other manufacturers of the generics.  But the trial judge determined that it was foreseeable that the marketing of Neurontin for off-label use would increase the demand for the generic version of the drug.

JDP

Supreme Court Upholds Preemption Claim Under Medical Device Amendments

The Supreme Court made it harder for consumers to sue manufacturers of federally-approved medical devices when it ruled in Riegel v. Medtronic that many state common law claims are preempted by federal law.  Riegel was injured when a balloon catheter burst during a medical procedure.  He sued claiming that the device was defectively designed and that the manufacturer failed to warn of this risk.  Medtronic argued that the Food & Drug Administration's approval of this device, and its inability to change either the design or warnings without the agency's approval, put it in an untenable position if it was also subject to state-law-based product defect claims.  The federal district court ruled that these claims were preempted by section 360K of the Medical Device Amendments to the federal Food, Drug & Cosmetics Act, a result upheld on appeal by U.S. Court of Appeals for the Second Circuit.  The Supreme Court accepted the case for review and heard argument on it in early December 2007.  See Pete Yost's article for The Associated Press.

JDP

Third Circuit Certifies Strict Liability Bystander Recovery Case to Pennsylvania Supreme Court

Berrier v. Simplicity Manufacturing, Inc., No: 05-3621 (3d Cir. Jan. 17, 2008), arose out of injuries sustained by a four-year-old Ashley Berrier when her grandfather inadvertently backed over her foot while mowing his lawn with a riding mower manufactured by the defendant.  Her foot was ultimately amputated as a result of the accident.  Her parents sued Simplicity on their own behalf and as her parents and guardians, alleging strict liability and negligence claims based design defect and inadequate warning theories.   The case was filed in the Pennsylvania Court of Common Pleas and removed to the United States District Court for the Eastern District of Pennsylvania.  Simplicity moved for summary judgment on both claims.  In granting the defendant’s motion for summary judgment, the trial court in the case expressed “grave doubts as to the logic of preventing an innocent bystander from recovering for injuries caused by an allegedly defective product, particularly when the American Law Institute, through the Restatement (Third) of Torts:  Product liability, has retreated from the very genesis of the ‘intended user’ doctrine.”   The court nontheless felt constrained to follow Pennsylvania law in Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003) (holding that a child who started a house fire with a butane lighter was not an intended user), which limits liability under a strict liability theory to intended users of a product.  Berrier v. Simplicity Corp., 413 F.Supp.2d 431, 432 (E.D. Pa. 2005).

In its review of Pennsylvania law the Third circuit was “persuaded that the proper scope of strict liability remains unresolved where a bystander, who is neither a ‘user’ nor a ‘consumer’ of an allegedly defective product, is injured when that product is being used as intended.”   The court certified the following question to the Pennsylvania Supreme Court:

Whether, under Pennsylvania law a plaintiff minor child may pursue a strict liability claim for injuries caused by a riding lawnmower, where that child is neither an intended user nor consumer of the mower.    See Pennsylvania Department of General Services v. United States mineral Products Co., 899 A.2d 590 (Pa. 2006); Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003); Riley v. Warren Manufacturing, 688 A.2d 221 (Pa. Super. 1997).

MKS

Tobacco Control Legal Consortium Newsletter Overview of Light Cigarette Lawsuits

The latest issue of Legal Update, the Tobacco Control Legal Consortium newsletter, is now available at www.tclconline.org. The issue includes the Legal Consortium’s most recent law synopsis, Light Cigarette Lawsuits in the United States: 2007, an overview of light cigarette litigation and its mixed record in state and federal courts to date.  The synopsis was written by attorneys at the Consortium's Massachusetts affiliate, the Public Health Advocacy Institute at Northeastern University School of Law. 

MKS

Teflon Paste Failure-to-Warn Claim Preempted by Medical Device Amendments

In yet another case, a court has ruled that a failure to warn claim regarding a Class III medical device is preempted by the FDA's approval of the product for sale.  In Mathis v. E.I. dupont De Nemours & Co., W.D. La., No. 06-0825 (1/16/08), the plaintiff claimed that she was injured by a Teflon paste used to treat her vocal chords paralyzed because of earlier thyroid surgery.  The product manufacturer moved for summary judgment arguing that Mathis' failure to warn claim was preempted.  In granting the defendant's motion, the court noted that the FDA had imposed device-specific requirements on the product, including requirements for the information to be included in the product's labeling and warnings, and that the warnings could not be modified without FDA approval.  To say that the warnings were inadequate or that additional or different warnings were required under state law would be imposing state requirements "different from or in addition to" those imposed by the FDA and thus, the court concluded, were preempted under 21 U.S.C. section 360k(a) of the Medical Device Amendments to the Food, Drug & Cosmetics Act.

JDP