It’s finally here: Tincher v. Omega Flex, the Pennsylvania Supreme Court’s overhaul of strict liability. If you’re unfamiliar with the recent turbulence surrounding strict liability, check out this post of mine from July 2012, which will take you all the way from Webb v. Zern, 220 A.2d 853, 854 (1966) to Beard v. Johnson & Johnson, Inc., 41 A.3d 823 (Pa. 2012). Tincher is a foundational opinion, one that resets the landscape of strict liability and puts it on a more secure and coherent framework for the future.

The 137-page majority opinion written by Chief Justice Castille may become his magnum opus. It rises swiftly into the high politics of separation of powers (pp. 29–37), unearths the half-century-old foundations of strict liability in Pennsylvania (pp. 37–57), reviews the entirety of the precedent (pp. 57–74), explains the practical problems of the doctrine as used today (pp. 74–84), outlines the conceptual framework for strict liability (pp. 84–107), and charts the path forward (pp. 107–137).

It even quotes David Hume (p. 38) and includes a sly reference to Einstein’s dual theories of relativity (p. 110, criticizing the Third Restatement as having “general and special rules” for different types of products, rules that together fail to “state a general principle of liability consistent with the public policy that compensation is available for an injury caused by any type of defective product”).

The opinion is also unanimous, given that the whole court joined it, although Justice Saylor wrote and Justice Eakin joined a two-page “concurring and dissenting” opinion. Justice Saylor says that, if “left to [his] own devices,” he would adopt the product liability segment of the Third Restatement of Torts — an approach the majority opinion he joined eviscerated (pp. 33-37, 107-117), concluding it was “unmoored from guidance upon the broader legal issue,” making it at best “a superficially enticing option” that “risk[s] elevating the lull of simplicity to doctrine.” Slip op. at 116 (quoting Scampone). Frankly, I don’t see the incongruous ‘concurring and dissenting’ opinion having much impact going forward.

The majority opinion admits that it is part of an “incremental approach,” and that much lies ahead in “the development of strict liability law in Pennsylvania.” Slip op., p. 116. So let’s roll up our sleeves and figure out how to best apply the case going forward.

Predictably, the defense bar, the big corporate manufacturers, and the insurance companies have started claiming that Tincher actually adopted the Third Restatement by stealth, that this stunning reaffirmation of the purpose of strict liability and of the role of the jury as ultimate fact-finder is somehow favorable for them. See, e.g., Ballard Spahr, Morgan Lewis, and, of course, Drug and Device Law. We’ll come back to them.

Here are the five key points I’ve drawn from the opinion:
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Katie Colaneri at NPR / WHYY’s StateImpact has an excellent story on the new “light, sweet crude oil” trains rolling through Philadelphia these days. The development is part of a larger, North America-wide story about the surge in transport of oil by rail (see this Reuters story and this Joseph DiStefano story for background). On the one hand, it’s good news for our local economy: the trains are on their way to the refineries in South Philadelphia, which otherwise would likely lay dormant, with a corresponding economic loss. Presumably energy costs would go up as well if the trains weren’t used.

On the other hand, as Newsworks mentions, “these shipments are coming via the same type of train that derailed in Lac-Mégantic, Quebec, last July, leaving 47 people dead and reducing the downtown to smoldering rubble.” The blast radius was apparently twice the length of a football field, and afterwards even firefighters had to be excluded for more than a half-mile from the blast due to the intensity of the flames and the dangerous debris. (Map here.) Unsurprisingly, the Manitoba government just recently rejected plans to run a crude oil line near them.

The trains come from North Dakota, by way of Chicago, Albany, and New Jersey. As this PDF map from the Pennsylvania Department of Transportation shows, the CSX trains (the orange lines) roll down past Bustleton, Fox Chase, Cheltenham, North Philadelphia, then alongside the Schuylkill, through Center City (between Rittenhouse and University City), before curving off towards the refineries and the airport. An explosion equivalent to the Lac-Mégantic disaster in the Philadelphia metro area would produce a far greater loss of life, a catastrophe in every sense of the word.

So, what’s being done to make sure we’re safe? It seems nobody knows: 
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Do you think it’s fair to ask riding lawnmower manufacturers to pay for the medical care of children injured in riding lawnmower accidents? How about asking meat blender suppliers to compensate people injured by commercial blenders? Neither of these events happen all that often, and the cost would be passed on to consumers, making the question: would you mind paying a little bit more for your lawnmower to set up a fund for children who lost part of their leg, sometimes much more, after being run over by riding lawnmower? How about a little bit more for your hamburger in case the person blending the meat loses their hand when the blades unexpectedly keep spinning?

Sometimes, a court just plain gets it right, and Justice Nix of the Pennsylvania Supreme Court got it right 34 years ago in adopting strict liability in the Commonwealth of Pennsylvania:

The realities of our economic society as it exists today forces the conclusion that the risk of loss for injury resulting from defective products should be borne by the suppliers, principally because they are in a position to absorb the loss by distributing it as a cost of doing business. In an era of giant corporate structures, utilizing the national media to sell their wares, the original concern for an emerging manufacturing industry has given way to the view that it is now the consumer who must be protected.

Azzarello v. Black Bros. Co., 391 A.2d 1020 (Pa. 1978). That’s the argument eminent torts professor William Prosser had been making for “strict liability” for decades. See, e.g. Prosser’s Strict Liability to the Consumer, 18 Hastings L.J. 9 (1966). The concept of strict liability was quite simple: whereas an injured person could always sue a manufacturer for negligence and then prevail by proving the manufacturer acted unreasonably by failing to guard against foreseeable harms, strict liability eschewed any question of the manufacturer’s conduct and instead focused on the product itself, making manufacturers liable for injuries caused by products that were so unsafe as to be “defective.”

The whole point of strict liability was, as explained by Azzarello, to make suppliers of surprisingly unsafe goods (i.e., goods that turned out to be more dangerous than consumers expected they would be) the insurer for accidents caused by the product. It’s a recognition that, in this day and age, consumer goods can contain a variety of risks that are more easily borne by the manufacturer, which made the decision to market the product, has better access to insurance, and can distribute the costs of these unexpected injuries on other consumers. In practice, strict liability is usually only successful where the product totally failed, resulting in catastrophic injuries. Consider some of the early strict liability cases, the ones characterized more as warranty cases than as the tort of strict liability:


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It’s no secret that pharmaceutical companies are among the more litigious businesses in America. Up until 2003, when Congress stepped in, the big drug makers had a good thing going: whenever the patent was about to expire on one of their blockbuster drugs, they would file a new patent for trivial modifications to the medicine, and thereafter would sue generic drug manufacturers claiming that the generic version of the old drug somehow infringed on the new patent.

Here’s the kicker: the big drug makers knew these patent infringement claims were frivolous, so they would enter into a “settlement” in which the big drug company — which nominally brought the case to recover monetary damages — would pay the generic company not to manufacture the generic drug anymore. Crazy, huh?

So crazy and so hopelessly anticompetitive that in 2003 Congress amended the Hatch-Waxman Act to force the major drug companies to report all of these “exclusive-payment” patent settlements to the Federal Trade Commission. The FTC still keeps an eye on them and keeps filing amicus briefs to make sure courts realize how damaging that practice is. As I’ve discussed before, some unions and health plans, stymied by the Illinois Brick decision precluding antitrust claims by indirect purchasers, have tried recovering the inflated health care expenses by filing unfair trade practices lawsuits.

The pharmaceutical companies are also not strangers to deceiving the federal government; over the past decade they’ve paid several billion dollars in qui tam cases, the result of brave whistleblowers exposing the fraud at great personal cost.

So pardon me if I don’t think that pharmaceutical companies deserve a special exception from the basic legal responsibilities we all have to one another just because they claim litigation is expensive or because they claim that always tell the FDA the truth. That sort of special treatment is what they’re trying to get with “tort reform” in the Pennsylvania legislature, and what they’re claiming they’re owed in the courts:

In questioning during oral argument Tuesday in Philadelphia, a state Supreme Court justice characterized the drugmaker Wyeth as asserting that there is enough protection for persons harmed by prescription drugs in federal regulation of the release of drugs onto the market, and limiting plaintiffs to lawsuits for drugmakers’ alleged failures to adequately warn of risks.

Plaintiffs are arguing in a case that could change the landscape of pharmaceutical products liability law in Pennsylvania that drugmakers can be sued for the negligent design defect of their drugs.

Questioning the plaintiffs’ lawyer, Justice Max Baer also said that Wyeth asserts that Pennsylvania would chill the manufacturing of prescription drugs if pharmaceutical companies can be sued for the negligent design defect of their drugs. He asked the lawyer to address why that may not be so.

The case, Lance v. Wyeth, arises from a primary pulmonary hypertension death allegedly caused by Redux, a hopelessly dangerous diet drug that causes a host of medical conditions which was yanked from the market for causing valvular heart disease. No one credibly disputes that the drug should never have been marketed or sold in the first place: it combined two drugs known to cause cardiovascular problems. Had Wyeth (now owned by Pfizer) properly tested it, they probably would never have sold it. Had they properly warned doctors and patients of the real risks, no doctor would have prescribed it and no patient would have taken it.

If dangerous drugs were automobiles with defective air bags (like Gaudio v. Ford Motor Co.), or rollover-prone all-terrain vehicles (like Smith v. Yamaha Motor Corp.) there wouldn’t be a question of the applicable law. Everybody — you, me, lemonade stands, multinational corporations, and everyone in between — has the same general legal duty to exercise reasonable care not to cause injuries to others. If we don’t exercise that reasonable care, we’re negligent, and we’re responsible to pay for the damage we cause.

That’s how the tort of negligence works. It’s quite simple.

In addition to their responsibility to pay for all negligently caused damages, everyone who sells products — again, from the lemonade stand to the multinational corporation — has “strict liability” for all damages caused by defective products. Consider that defective air bags case above:

[W]e will briefly review the history of products liability law and the crashworthiness doctrine in this Commonwealth. Our Supreme Court first adopted section 402A of the Restatement (Second) of Torts in Webb v. Zern, 422 Pa. 424, 220 A.2d 853 (1966). To state a section 402A products liability claim in Pennsylvania, the plaintiff must prove that the defendant sold a product “in a defective condition,” that the defect existed when the product left the defendant’s hands, and that the defect caused the plaintiff’s injuries. See, e.g., Hadar v. AVCO Corp., 886 A.2d 225, 228 (Pa.Super.2005). A product is “in a defective condition” when it lacks “any element necessary to make it safe for its intended use or possessing any element that renders it unsafe for the intended use.” Azzarello v. Black Bros. Co., Inc., 480 Pa. 547, 559, 391 A.2d 1020, 1027 (1978). Because the key inquiry in all products liability cases is whether or not there is a defect, it is the product, and not the defendant’s conduct, that is on trial. See, e.g., Hutchinson v. Penske Truck Leasing Co., 876 A.2d 978, 983 (Pa.Super.2005), affirmed, 592 Pa. 38, 922 A.2d 890 (2007).

Gaudio v. Ford Motor Co., 976 A. 2d 524 (Pa. Super. Ct. 2009)(remanding for trial a crashworthiness claim).

But Section 402A of the Second Restatement of Torts has a pesky “comment k” for defective drug cases which says:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . .  Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.  The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Defense lawyers contend that comment k promises pharmaceutical companies total and complete immunity from all potential theories of liability except for a narrow class of “failure to warn” claims. Wyeth argued that the sole question is “whether the risk information conveyed to prescribing physicians was sufficient to permit them to conduct an individualized risk-benefit analysis.”

Nonsense.

The plaintiffs in Lance were smart to hire Howard Bashman, friend of the blog, for their appeal, and his excellent opening brief and reply are both online. So, too, is the joint American Association for Justice and Pennsylvania Association for Justice amicus brief.

The briefs quite adequately cover Pennsylvania law on the subject, all the Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971)(a Jim Beasley case), Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807 (1984), and Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (1996) a drug liability law nerd could ask for.

Personally, I think two arguments should decide Lance v. Wyeth.
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If you were diagnosed with bladder cancer after using Actos and are reviewing your legal options, please see my Actos Bladder Cancer Lawyers page for patients. 

I wrote this post for my legal blog, which is ordinarily read by other lawyers. Patients looking for legal help should read the Actos page linked above. 

Personal injury law isn’t like running an ordinary business, not even an ordinary law practice, because of the risk involved in taking cases. Defective drug and consumer products lawsuits exemplify both extremes of our work: the cases are enormously expensive to pursue and require a tremendous amount of attorney time, but they also have the potential to be lucrative blockbusters.

Problem is, once a drug or product is shown to be unreasonably harmful by a study or a recall, there’s no way for us to know for certain what the courts will do with the lawsuits. We don’t roll the dice — it’s much more rational and systematic than that — but we have to play the odds. So it will be with Actos lawsuits: we believe the drug was inadequately tested and didn’t warn patients of the risks, and will vigorously pursue cases against their manufacturer, but the cases aren’t without considerable risk.

Consider the denture cream lawsuits. To paraphrase what I wrote last week while discussing asbestos lawyers, GlaxoSmithKline settled the vast majority of Super Poligrip claims, but Proctor and Gamble fought the Fixodent cases, resulting a judge dismissing one of the bellwhether cases on Daubert grounds.

One of the drug cases trial lawyers are pursuing these days involve Actos (pioglitazone), the best-selling Type 2 Diabetes drug in the world. The Associated Press recently wrote about the “wave of lawsuits” filed against Takeda Pharmaceuticals:

TRENTON, N.J. — The maker of the world’s best-selling diabetes drug is facing hundreds of lawsuits and likely a big sales drop as suspicion grows that taking the pill for more than a year raises the risk of bladder cancer. …

both the U.S. Food and Drug Administration and the European Medicines Agency have issued warnings about the cancer risk based on new research, but they have allowed sales to continue. Doctors are being told not to prescribe Actos for people who have or have had bladder cancer.

The warning will limit patient choices and could spell the end for a once-promising class of Type 2 diabetes drugs that debuted more than a decade ago amid heavy promotion.

An FDA warning that a popular drug increases the risk of any type of cancer or heart disease virtually guarantees the filing of thousands of lawsuits, and pioglitazone is no exception: it raises the risk of bladder cancer by more than 40%, or an “extra 28 cases a year for every 100,000 people taking it.” The irony is why Actos is so popular:

Actos, despite links to heart failure risk and other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. Avandia’s use was banned in the EU and sharply restricted here. Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.

Avandia’s restriction, of course, prompted its own wave of lawsuits, and GlaxoSmithKline has settled about 12,000 of them for around $700 million. Assuming the clients are on one-third contingent fee agreements, that’s over $200 million for the lawyers. I don’t say that to be critical; one of those firms, for example, recently spent hundreds of thousands of dollars on an antitrust action just to lose and then also get hit with almost $600,000 in costs. It’s a big-risk, big-reward kind of business, and one of the few elements of society keeping medical products safe in light of the broken clearance processes we have for new drugs and devices.

Which brings me to one of the lessons this episode has for lawyers trying to build a personal injury or product liability law practice.
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