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Friday, April 5, 2013

Daniel Cummins: "A Maze of Uncertainty: PA Products Liability Law Remains in a Confusing State of Flux"

          As of the writing of this article in January of 2013, confusion is reigning in the Commonwealth of Pennsylvania on the uncertain issue of whether the Restatement (Second) of Torts or the different analysis set forth in the Restatement (Third) of Torts should be utilized in Pennsylvania products liability cases.  This uncertainty is the result of an ever-growing split of authority not only between the Pennsylvania state and federal courts, but also among, and even within, the different federal district courts across the Commonwealth.

          The situation has now spiraled downward to the point that litigants with cases pending in the Pennsylvania federal court system have to research whether the particular federal district court judge presiding over the case has previously issued a decision on the issue in order to determine which Restatement standard will be applied in that case.   While one Pennsylvania federal court judge has politely noted that this area of the law in Pennsylvania is in a “state of flux,”[1]   See Sikkelee v. Precision Automotive, Inc., 876 F. Supp. 2d 479, 489 (M.D. Pa. 2012 Jones, J.). another has more aptly described Pennsylvania products liability law as being “a maze of uncertainty.”[2]  See Samson v. Crown Equipment, 2:10-CV-0958, 2012 WL 3027989 (W.D. Pa. 2012 Hornak, J.). 

          Which standard is applied could make or break a case.  Although the Restatement (Second) favors strict liability concepts over negligence principles in the products liability context, the Restatement (Third) decreases the impact of concepts such as "intended use" and "intended user" and places a greater emphasis on the negligence principle of "reasonable foreseeability."   All of these changes in the Restatement (Third) arguably shift the balance in favor of manufacturer defendants in personal injury cases based upon allegations that a defective product was the cause of the injury.

          As noted below, under the current status of Pennsylvania products liability law, whether the case will be governed by the Restatement (Second) of Torts or the Restatement (Third) of Torts depends upon whether the case is in state or federal court, and if the case is in federal court, the answer may further depend upon which particular federal district court judge is presiding over the case.

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April 5, 2013 in Guest Blogger, Products Liability | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 26, 2013

Breaking: PA to Decide Between 2nd and 3rd Restatements on Products Liability

The order is here.


March 26, 2013 in Products Liability | Permalink | Comments (0) | TrackBack (0)

Sunday, March 17, 2013

Leslie Kendrick: "The Impossibility of Impossibility Preemption"

          When the Supreme Court hears oral argument in Mutual Pharmaceutical Co. v. Bartlett, it will embark on its third elaboration of “impossibility preemption” in the prescription-drugs context.  This line of cases is reshaping preemption doctrine, and it is doing so with little regard for a basic legal idea: the distinction between a property rule and a liability rule.

          The question at issue is whether it is “impossible” for prescription drug manufacturers to comply with both Food & Drug Administration requirements and state tort law.  State tort liability for design defect or failure-to-warn is predicated on a judgment that a drug or drug label was not designed safely.  But manufacturers generally cannot alter drugs or labels without FDA approval.  Thus, manufacturers argue, it is impossible for them to comply with both tort law and FDA requirements.

          The Supreme Court implicitly accepted this view in 2009’s Wyeth v. Levine, when it found no impossibility preemption of a failure-to-warn claim against Wyeth.  The Court rested this conclusion on the view that, under FDA regulations, Wyeth could have changed its drug’s warning label without prior FDA approval.  Wyeth thus could have avoided tort liability while complying with FDA rules. 

          This analysis was always dubious: labeling changes ultimately require FDA approval, and thus a manufacturer’s power to make unilateral changes is short-lived and mostly hypothetical.  But there soon arose a side effect which the majority in Wyeth, led by Justice Stevens, surely neither foresaw nor intended.  To the extent that the power to make unilateral changes exists at all, it is enjoyed only by brand-name manufacturers and not by makers of generic drugs.

          Thus when, in PLIVA, Inc. v. Mensing, the manufacturer of a generic drug made an impossibility preemption claim, the Court sprang the trap it had set in Wyeth.  If impossibility was avoided only to the extent that manufacturers could change their labels, then impossibility must exist with respect to generic drugs.

          In Mutual Pharmaceutical Co. v. Bartlett, the Court is being asked to extend this analysis to preempt some suits against generic manufacturers for design defects.  And the United States, for its part, appears to ask the Court to feel free to endorse this rule for all design-defect claims, for both generic and brand-name drugs, on the theory that no manufacturer can alter the substance of its drug without FDA approval.  What started as a ground for rejecting preemption in Wyeth is now poised to eliminate virtually all tort liability for prescription drug manufacturers, all in the name of “impossibility.” 

          But if we know one thing about tort law, we know that it is not impossible to comply with it and FDA requirements simultaneously.  We know this because drug manufacturers have been complying with both since the passage of the Federal Food, Drug, and Cosmetic Act in 1938.   

         Moreover, anyone briefed in the most basic attributes of tort liability and FDA regulation can explain why.  Tort liability requires manufacturers to pay damages, not to alter their products.  A manufacturer may market a drug as approved while paying tort damages.  The manufacturer has other options, such as seeking to modify a drug or label, or developing improved products.  But it is entirely possible to change nothing and comply with both sets of laws.

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March 17, 2013 in Guest Blogger, Products Liability | Permalink | Comments (1) | TrackBack (0)

Tuesday, February 26, 2013

Pfizer Seeks Rehearing in Generic Liability Case

Forbes reports that Pfizer is asking the Alabama Supreme Court to reconsider its decision holding Pfizer liable for failing to warn a consumer who took a generic version of the drug Reglan.  The article points out the regulation, not litigation, may answer this one:

Meanwhile, though, the issue may be decided by the FDA. The agency recently disclosed plans to revise its regulations so that generic drugmakers can update product labeling and warn patients about risks associated with their drugs. If the FDA were to make such a change, generic drugmakers could be sued in state courts – if they become aware of evidence of serious side effects, but do not take action to update the product labeling (back story). 


February 26, 2013 in Current Affairs, Products Liability | Permalink | Comments (0) | TrackBack (0)

Monday, January 28, 2013

PA Judge Upholds $10M Children's Motrin Verdict

The Legal Intelligencer reports that Philadelphia Court of Common Pleas Judge Nitza Alejandro has denied Johnson & Johnson's McNeil-PPC's post-trial motions in a case involving over the counter Children's Motrin.  In the case, a jury awarded $10 million to a young girl who suffered Stevens-Johnson syndrome/toxic epidermal necrolysis after taking Children's Motrin.   The full story is behind a free registration wall.

Thanks to Lisa Smith-Butler for the alert.



January 28, 2013 in Current Affairs, Products Liability | Permalink | Comments (0) | TrackBack (0)

Tuesday, January 15, 2013

More on Stengel v. Medtronic (Ninth Circuit Preemption Decision)

Over at Torts Today, George Conk has commentary on Stengel v. Medtronic, the Ninth Circuit preemption decision reported here last week.  




January 15, 2013 in Products Liability | Permalink | Comments (0) | TrackBack (0)

Friday, January 11, 2013

Ninth Circuit Allows Failure to Warn Medical Device Case to Proceed

Muddling the preemption waters, the Ninth Circuit has ruled that a plaintiff can bring a state law failure to warn claim against a medical device manufacturer.  The court found the claim was not preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act.   A copy of the opinion is here.  The Recorder (via has more.

Thanks to Lisa Smith-Butler for the alert.


January 11, 2013 in Current Affairs, Products Liability | Permalink | Comments (1) | TrackBack (0)

Tuesday, November 27, 2012

PA: New Ruling on Products Liability Affirmative Defense

On Monday, the Supreme Court of Pennsylvania ruled that, in order to avoid liability, a defendant raising a claim of highly reckless conduct must plead and prove such claim as an affirmative defense.  The case, Reott v. Asia Trend, is here.

Thanks to Scott Cooper for the tip.


November 27, 2012 in Products Liability | Permalink | Comments (0) | TrackBack (0)

Tuesday, October 23, 2012

Meningitis Lawsuits

The Sunday Boston Globe contained an article by Jay Fitzgerald on the potential suits from the outbreak of meningitis linked to a Framingham drug compounding pharmacy.  Suffolk's Mike Rustad is quoted in the piece.


October 23, 2012 in Current Affairs, Products Liability | Permalink | Comments (0) | TrackBack (0)

Saturday, October 6, 2012

Conk on Exploding Gas Cans, Products Liability, and Plaintiff's Misconduct

His coverage at Torts Today is here and he links to the NYT story (quoting Marshall Shapo and Frank Vandall).


October 6, 2012 in Current Affairs, Products Liability | Permalink | Comments (0) | TrackBack (0)

Tuesday, September 25, 2012

"Philly Regrets Flood of Cases"

The Wall Street Journal reports that mass tort filings in the Philadelphia Court of Common Pleas have "skyrocketed from 550 in 2008 to nearly 2,700 last year. The surge left an already busy court system buried in lawsuits and scrambling to repair the damage."    The article reports:

Also contributing to the surge of cases: the success of the Complex Litigation Center, a specialized Philadelphia court established in 1992 largely to handle the growing asbestos and pharmaceutical docket. The center adopted techniques that were designed to move cases through quickly, such as setting early trial dates, holding frequent meetings among the lawyers, and consolidating similar cases.

The Complex Litigation Center drew more mass-tort cases to Philadelphia. But until recently, it was largely able to manage its docket. Since 2008, the backlog of asbestos and pharmaceutical cases has shot up from about 2,600 to more than 6,100 through last month. Last year, 88% of the pharmaceutical cases were filed by out-of-state plaintiffs, according to the court.

The mess is now largely Judge Herron's to deal with. Since taking over as the administrative judge late last year, he has put into place several measures designed to reverse the trend—and to send a message to out-of-state lawyers to take their lawsuits to other courts. "Go elsewhere," he says, when asked to describe the message he is hoping to send to out-of-state lawyers. "There are a lot of really wonderful courts in the U.S., and you should make broader use of them."



September 25, 2012 in Current Affairs, MDLs and Class Actions, Products Liability | Permalink | Comments (1) | TrackBack (0)

Friday, August 17, 2012

PA: Is R3:PL the Law or Not?

This week, Amaris Elliott-Engel, of PA Law Weekly, wrote the first of a series of articles on tort law.  Her first piece is on the uncertainty in Pennsylvania products law.  Twice in the last 3 years, the U.S. Court of Appeals for the Third Circuit has opined that the Pennsylvania Supreme Court would adopt the Restatement Third (Products Liability).  However, the state Supreme Court has not directly addressed the issue, although there has been some provocative dicta and one instance in which the justices announced they had improvidently granted allocatur to consider whether section 2 of R3 should replace 402A of R2.  Thus, in general, state courts are applying 402A and federal courts are applying R3, though even among federal courts, some apply 402A.  As elsewhere, most plaintiffs' lawyers tend to prefer 402A and most defense lawyers tend to prefer R3.

Thanks to Scott Cooper for the tip.


August 17, 2012 in Current Affairs, Products Liability | Permalink | Comments (2) | TrackBack (0)

Monday, July 23, 2012

New Jersey Court Rejects Brand-Name Manufacturer Liability for Injuries Caused By Generic

Abnormal Use reports that a New Jersey Superior Court has rejected the "innovator liability" theory accepted by a California court in Conte v. Wyeth.  Under this theory, a plaintiff sues a brand-name manufacturer of a drug for injuries allegedly caused by taking the generic version of the drug.  To date, Conte is the only decision upholding this theory of liability.


July 23, 2012 in Products Liability | Permalink | Comments (0) | TrackBack (0)

Tuesday, May 1, 2012

Does Product Liability Makes Us Safer?

Kip Viscusi (Vanderbilt) recently pubished an article in Cato's Regulation, on "Does Product Liability Make Us Safer?"  The article is now available on SSRN.  The article concludes:

Rather than creating an environment to foster safer products, product liability law often has adverse consequences. Some of the problems stem from the inherent nature of product risk decisions and the function of tort liability, while others may derive from individuals’ cognitive limitations and inability to think properly about balancing risk and cost. Thus it would be both incorrect and an oversimplification to blame all the ills on the tort liability system. That system functions reason- ably well for many types of accidents, such as personal motor vehicle accidents. However, tort liability falls short with respect to products.  


May 1, 2012 in Products Liability, Scholarship | Permalink | Comments (0) | TrackBack (0)

Thursday, April 19, 2012

9th Circuit Preemption Case of Interest

On Monday, the Ninth Circuit issued its decision in Stengel v. Medtronic, Inc., No. 10-17755, slip op. [pdf]. The case involved a Medtronic pain-pump that the plaintiff alleged caused his paraplegia. The Ninth Circuit upheld dismissal based on Reigel v. Medtronic, Inc., 552 U.S. 312 (2008), and also denied plaintiffs' "failure to report" claim under implied preemption.

Drug & Device Law has a thorough examination of the opinoin. Arizona Central also has a report.


April 19, 2012 in Products Liability | Permalink | Comments (0) | TrackBack (0)

Friday, March 9, 2012

Philly Asbestos Verdict Challenged

The Legal Intelligencer reports on a variety of issues raised by the plaintiffs in a post-trial motion challenging a defense verdict in Webber v. Ford Motor Co.   In particular, plaintiffs' counsel alleges that the verdict form was the result of ex parte contact by defense lawyers and the supervising judges in Philadelphia's Mass Torts Program.

Thanks to Lisa Smith-Butler for the alert.


March 9, 2012 in Current Affairs, Products Liability | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 28, 2012

Asbestos Claims from Malta reports the heirs of dockyard workers in the tiny Mediterranean country of Malta filed asbestos-liability claims in New York against American companies that made products used aboard U.S. Navy ships.

The dock workers were exposed to the asbestos when the Navy ships were brought in for service and repairs. Although the exposure came as long as 40 years ago, some of the worker died only recently. Mesothelioma cancer, which is caused by the asbestos exposure, can linger for up to 50 years before it shows any symptoms.

According to Maltatoday, the leading news service in Malta, up to 400 workers or their families have filed claims through the United States court system.

Thanks to Cary Sklaren for the tip.


February 28, 2012 in Products Liability | Permalink | Comments (0) | TrackBack (0)

Thursday, February 16, 2012

Maybe Not the Best Place for That Gauge

Gawker presents a somehow-not-fictional air gun with the air pressure gauge in what might be called...not an ideal location.  Check it out.  I'd say it's exam-worthy, except the counterarguments would be a bit weak.


February 16, 2012 in Products Liability | Permalink | Comments (0) | TrackBack (0)

Friday, January 20, 2012

Burger King, Spit, and Emotional Damages in Products Liability

A suit over a burger, spat upon by an employee of Burger King, resulted in the Ninth Circuit certifying a question to the Washington Supreme Court.  Plaintiff developed an uneasy feeling after receiving a Whopper with cheese.  When he lifted the bun, he saw a "slimy, clear and white phlegm glob" on the burger.  The glob was tested and was a DNA match with one of Burger King's employees, who pled guilty to felony assault.  Plaintiff claims ongoing emotional distress.  The district court granted judgment on the pleadings to Burger King.  On appeal, the Ninth Circuit certified the following question:  “Does the Washington Product Liability Act permit relief for the emotional distress damages, in the absence of physical injury, caused to the direct purchaser by being served and touching, but not consuming, a contaminated food product?”
The case is available here.  (Link has been fixed)
Thanks to Susan Raeker-Jordan for the tip.

January 20, 2012 in Food and Drink, Products Liability | Permalink | Comments (0) | TrackBack (0)

Monday, December 26, 2011

Omitting Claim for Economic Damages Pays Off - $10M Verdict in Segway Fall Case

The Connecticut Law Tribune reports on an interesting trial strategy in a Segway fall case:

In the case of former Southern Connecticut University student John Ezzo, [Robert B.] Adelman and his partner, Neil Sutton, decided to take a calculated risk. They omitted any claim for treatment costs, lost income or future earnings.

Instead, they only focused on the pain and suffering “non-economic” damages, and the alleged recklessness of Segway Inc., the maker of two-wheeled, scooter-like vehicles that carry riders in an upright position.

The focus on non-economic factors paid off handsomely, in the form of a $10 million verdict on Dec. 14. The jury found Segway acted recklessly when its employees failed to provide Ezzo with a helmet during a test drive. “It’s a unique, almost never-seen-before strategy,” said a lawyer for Segway, which is currently attempting to get the verdict reduced or thrown out.

Thanks to Lisa Smith-Butler for the alert.


December 26, 2011 in Current Affairs, Products Liability | Permalink | Comments (0) | TrackBack (0)