Published By: Maxwell S. Kennerly, Esquire

Consumer Protection

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[Update: Drug & Device Law has also released their list of “best” cases, and so I have responded.]

First, a bow to my opponent. I reference the pharmaceutical company defense lawyers from Dechert at Drug & Device Law a lot here on this blog even though, as a plaintiff’s lawyer, I’m always on the other side from them (one might even say they’re on the wrong side of the law) because they write a great blog. They write detailed, passionate arguments about substantive issues of law, and they link liberally, involving others in the conversation. It’s not that I haven’t noticed you folks over at Weil Gotshal with your competing Product Liability Monitor (link nofollowed), but you need to add some hot sauce and link out if you want to roll with the big boys. Maybe it’s because Dechert’s in Philadelphia and Weil Gotshal’s in New York, or maybe it’s because we Philadelphia lawyers punch a little bit harder.

Now, on to the fight. Drug & Device Law has compiled their “Ten Worst Drug/Medical Device Decisions of 2011.” It must have been a Herculean task: from my perspective, you have to look really hard to find court decisions against the pharmaceutical and medical device industry. As I’ve written before, the deck is stacked against innocent people injured by these drugs and medical devices: it’s almost impossible to sue pharmaceutical companies for anything other than inadequate warnings on their labels (a claim that is itself in peril, even as drugs like Actos, Pradaxa, and Propecia warn of their minor risks but not their major risks), and it’s virtually impossible to sue implant and medical device manufacturers for anything other than violating FDA regulations.

Of course, none of the court opinions on the D&D Law list were really against the drug and medical device companies; no court ever rules that a drug company was negligent or that medical device company has to pay compensation. When a plaintiff “wins” a court decision, that really means the plaintiff gets a chance to prove their case in front of a jury. Instead, when drug and device companies complain about courts, it’s because they think the court should have dismissed the cases entirely, without a trial, without a word of testimony or a shred of evidence shown to a jury. The bulk of the cases cited by Drug & Device Law follow that pattern, with the defense lawyers complaining either that a court didn’t buy some preposterous defense theory or that a court didn’t let a company walk away scot-free after violating FDA regulations and hurting people.

Indeed, the D&D Law list of cases is revealing because of just how reasonable these “worst” court opinions are.  There’s been a lot of press lately about how more Americans are killed annually by prescription medication overdoses than car accidents; coincidentally, D&D Law’s “worst” decision of the entire year, DiCosolo, involved a consumer indisputably killed by a defectively manufactured prescription painkiller patch, and they argue we’re supposed to let the maker of that deadly product walk away from any accountability because the DiCosolo’s weren’t compulsive hoarders that held on to every used disposable product in their house? Because Janssen Pharmaceuticals failed to convince a jury of its ridiculous fentanyl fairy theory? What’s so wrong with letting a jury hear those factual arguments and deciding what’s true and what’s not, the way we’ve settled disputes since ancient times?

Let’s unpack a couple of these “worst” opinions and see just how bad they really are. 
Continue Reading The Unintentional Message Of The “Worst” Drug And Device Court Opinions

One of the more sobering parts of being a trial lawyer is reviewing intakes of potential cases. We routinely talk with people who have just lost a spouse or child or who have recently suffered an injury that will leave them permanently disabled. Many of these accidents happened in the course of activities we all know to have an element of danger, but many involve doing the same thing a million other people do every day. No one expects that giving their kid Motrin will cause a horrific skin disease or that their tap water might be so polluted that it’s flammable.

Now, a growing body of medical studies shows that acetaminophen (Tylenol in the US, Paracetamol everywhere else) is dangerous at far lower doses than previously believed. It’s been known for decades that acetaminophen overdoses cause liver damage (for example, “acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States,” and some estimates by the American Association of Poison Control Centers suggest more than 50,000 emergency department visits every year related to acetaminophen), particularly when combined with alcohol, but it was generally considered safe if taken at anywhere near the recommended amounts.

Recent studies suggest that’s not the whole story. Just a few weeks ago, a new study in the British Journal of Clinical Pharmacology found that “staggered overdoses,” in which patients repeatedly took amounts slightly higher than the recommended dosage, were the cause of a substantial portion of the hospital admissions for acetaminophen-induced liver damage, and could be more dangerous than individual overdoses, in part because staggered overdoses were harder to diagnose and treat.

In June 2009, the FDA’s Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee all voted in favor of:

  • Reducing the current dosage strengths of acetaminophen in nonprescription products to below 4 grams/day
  • Limit formulations of over-the-counter liquid doses of acetaminophen
  • Eliminating prescription acetaminophen combination products (e.g., oxycodone)
  • Requiring a boxed warning for prescription acetaminophen combination product

The FDA disappointingly didn’t act on most of that, and instead took eighteen months to take the weakest action it could:

On January 13, 2011, FDA announced that it is asking manufacturers of prescription acetaminophen combination products to limit the maximum amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit. FDA believes that limiting the amount of acetaminophen per tablet, capsule, or other dosage unit in prescription products will reduce the risk of severe liver injury from acetaminophen overdosing, an adverse event that can lead to liver failure, liver transplant, and death.

The size of the individual dosage unit was never the problem, though. As the Acetaminophen Hepatotoxicity Working Group for the FDA Advisory Panel found in its report, the problem was far more complicated than the pills being too big:

There is no single factor that leads consumers (also referred to as patients in this report) to develop acetaminophen-related liver injury. The contributing conditions for these cases are multi-factorial and require different interventions that attempt to address each factor. For example, when someone takes an amount greater than labeled, it is unclear whether it is a case of failing to read the directions, failing to understand the directions, failing to understand that severe liver injury can result from not following the directions or failing to realize that more than one of the medications used contained acetaminophen.

The Working Group concluded, “Thus, it is necessary to address all of these causes in attempting to prevent future cases, making clear directions conspicuous and easy to understand and making consequences of overdose unequivocally clear.” (Emphasis added.)

It’s not just the pill size. It’s not just the recommended maximum dosage. The core problem is that consumers and patients have learned, from years of Tylenol advertising and liberal use of acetaminophen by their parents, nurses, and doctors, that it’s a “safe” drug, like caffeine, that can be used every day and without much consequence unless you have a particular susceptibility to it or if you intentionally take way too much. Consumers look at recommended dosages like they do speed limits: you can use that amount without any problems, but try not to go too far above it. Problem is, if you did that with the 4 grams/day of acetaminophen guideline, you had a much higher risk of liver damage, even if you didn’t do it all the time. 
Continue Reading Courts Lag Behind Science In Recognizing How Regular Tylenol Use Causes Liver Damage

The pharmaceutical industry is plagued by the same problem as the entertainment industries: their business models are too reliant on blockbusters.  I’m certainly not the first person to notice that — even drug company CEOs have openly fretted about it — but the problem persists and grows each year. As the pharmaceutical consulting company L.E.K. pointed out a few months ago, “Blockbusters have become the centerpiece of the biopharma industry, growing from 16% of global drug revenue in 1995 to 35% in 2010.”

In the entertainment industry, the consequences of that reliance on blockbusters is merely a string of bad sequels to every hit movie and some unfortunate shark-jumping on television.  In the world of drug sales, though, it usually means a lot of people get hurt when a company fails to take a dangerous blockbuster drug off the market or update it with appropriate warnings.

Consider Propecia. Propecia is a 1 mg dose of finasteride, a drug originally used for the treatment of symptomatic benign prostate enlargement in 5 mg doses and marketed by Merck as Proscar. Finasteride, in turn, is a type II 5-Alpha reductase inhibitor that prevents the conversion of androgen testosterone to dihydrotestosterone (DHT).

In many ways, the mechanism of finasteride is quite simple: it inhibits the production of testosterone, a male sex hormone, and so it decreases the problems of high testosterone or testosterone sensitivity (male pattern baldness, prostate enlargement) while creating the same problems as if a man had low testosterone (decreased muscle mass and sexual function, impotence). The FDA-approved label for Propecia warns:

What are the possible side effects of PROPECIA?

Like all prescription products, PROPECIA may cause side effects. In clinical studies, side effects from PROPECIA were uncommon and did not affect most men. A small number of men experienced certain sexual side effects. These men reported one or more of the following: less desire for sex; difficulty in achieving an erection; and, a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men. These side effects went away in men who stopped taking PROPECIA. They also disappeared in most men who continued taking PROPECIA.

Most of that is known and to some extent foreseeable by Propecia users.  It’s similar to the symptoms of low testosterone because that’s pretty much what Propecia does: inhibit androgen conversion to testosterone.

But hormones are funny things.  The endocrine system is as complicated as the immune system, with the added complication of all the hormones working together in concert, and many of the glands responding to any changes in the system.  Tampering with the system often results in mild improvement in symptoms and then some drastic side effect. We saw that with estrogen plus progestin hormone replacement therapy: HRT was conventional wisdom in the medical industry throughout the late 1990s — due in no small part to Wyeth and Pfizer marketed the heck out of Prempro — until the Women’s Health Initiative trials in 2002 revealed a substantial increase in breast cancer, prompting a complete about-face in treatment for post-menopausal women.

Coming back to Propecia, the warning label in the United States didn’t mention until June of this year, but the warning labels in the United Kingdom have said for some time:

In addition, the following have been reported in postmarketing use: persistence of erectile dysfunction after discontinuation of treatment with PROPECIA; male breast cancer (see 4.4 Special warnings and precautions for use)

Propecia in Sweden and Italy has similar warnings. The big problem there — the persistence of sexual problems, even after stopping the medicine — has been known for years. The Wessells et al. study (“Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia“) found that 15% of finasteride-treated patients (more than double the placebo patients) had sexual adverse experiences arising from Proscar use, and that half of those had problems continuing even after they stopped taking Proscar.

Over time, others have followed up. Earlier this year, the Irwig et al. study confirmed (“Persistent Sexual Side Effects of Finasteride for Male Pattern Hair Loss“) what the Traish et al. study (“Adverse side effects of 5α-reductase inhibitors therapy: persistent diminished libido and erectile dysfunction and depression in a subset of patients“) had suggested: use of finasteride at their the Propecia or Proscar doses results in persistent sexual problems for a number of patients.

Merck responded in June of this year, by adding a new warning, the type of language by-of-and-for the drug manufacturer’s lawyers that I like to refer to as a “wink, nudge” warning:

In general use, the following have been reported: breast tenderness and enlargement; depression; allergic reactions including rash, itching, hives and swelling of the lips and face; problems with ejaculation; testicular pain; difficulty in achieving an erection that continued after stopping the medication; and, in rare cases, male breast cancer. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge. Tell your doctor promptly about these or any other unusual side effects.

The language used is, of course, designed to make doctors and consumers ignore the warning. “The following have been reported” indicates Merck doesn’t really believe Propecia causes any of them. Just in case consumers didn’t get that wink, nudge message, it’s emphasized again that these are all “unusual” side effects, not the side effects attributed to the drugs.

So, what gives? Why didn’t Merck update its U.S. labels back in, say, 2008, when it updated the Swedish warning? Why does the Propecia label still claim all instances of erectile dysfunction and decreased libido “went away in men who stopped taking PROPECIA?” Nobody these days thinks drug companies exist for the benefit of mankind — they’re all just profit-seeking enterprises that spend more on advertising than research — but many assume the companies at least worry about getting sued. 
Continue Reading Why Merck Still Doesn’t Warn About Propecia Causing Impotence

Another day, another multi-billion-dollar industry looking for a handout.

This time it’s the Wall Street hedge funds and venture capital funds — you know, the ones that talk “free market” but somehow always need government assistance — that have invested heavily in medical device manufacturers:

As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process. The push has alarmed patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”

The New York Times found that “people associated with funds that underwrite companies developing new devices and other health products have made more than $3.3 million in political donations to Republicans, Democrats and political action committees over the past five years.” Shocking, I know.

Take a look at how thoroughly the Republican-controlled House of Representatives examined the issue:

Since February, four House panels have held hearings on the impact of F.D.A. procedures on device approval. At those sessions, 19 of the 26 listed witnesses were investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one. The list included no patients injured by a flawed device; one hearing in the Senate had a more varied witness list. Two weeks ago, four Democratic congressmen wrote to their Republican counterparts about the imbalance in the House testimony and suggested the hearings had failed to address potential dangers “if medical devices are not appropriately regulated.”

(Emphasis mine.)

Not one. A little over a year ago, Johnson & Johnson and the FDA announced the recall of nearly 100,000 defective DePuy hip replacement implants because the metal-on-metal bearings degrade and release metal shavings into surrounding tissues and patient’s bloodstreams, requiring revision surgery and treatment for blood poisoning, but the Republicans in Congress apparently couldn’t find a single person who felt strongly enough about that to testify.

Maybe Congress thought that was an exception and all the other medical implants are totally safe. So what about July of this year, when the FDA reported:

In October 2008, the FDA issued a Public Health Notification (PHN) to inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh, and to provide recommendations on how to mitigate risks and how to counsel patients.  Following the PHN, the FDA continued to monitor the outcomes of urogynecologic use of surgical mesh.  A search of the FDA’s Manufacturer and User Device Experience (MAUDE) database from the last 3 years (January 1, 2008 – December 31, 2010), identified 2,874 Medical Device Reports (MDRs) for urogynecologic surgical meshes, including reports of injury, death, and malfunctions.  Among the 2,874 reports, 1,503 were associated with pelvic organ prolapse (POP) repairs, and 1,371 were associated with stress urinary incontinence (SUI) repairs.

Just under 3,000 vaginal mesh problems because the surgical mesh eroded the vaginal wall causing painful sexual intercourse, infection, urinary problems, vaginal shrinkage, bleeding, and organ perforation, but the Republicans in Congress apparently couldn’t find a single person who felt strongly enough about that to testify.

Or maybe the Republicans in Congress didn’t want to hear what patients and their advocates might say: the FDA does too little to ensure medical devices are safe. The FDA needs more regulations, not fewer.

The Depuy ASR hip implant and transvaginal mesh implant debacles both had the same cause: the 510(k) clearance loophole. Under that loophole, if a medical device manufacturer can convince the FDA that the implant is “substantially equivalent” to something else on the market, then it’s approved, even without any actual testing to see if it’s safe or even useful.

It’s a bad idea, which is why the Institute of Medicine — which investigated 501(k) clearance at the request of the FDA — recommended the process be abolished. Consider this depressing section from the FDA’s safety update on transvaginal mesh placement:

Surgical mesh products are currently regulated as Class II devices and are reviewed under the 510(k) Premarket Notification Program.  The FDA’s premarket review of these devices has primarily focused on data supporting the adequacy of mechanical performance and material safety.  Bench and/or animal testing have been used to confirm that engineering specifications are met and that the mesh material is biocompatible.  Clinical performance data typically has not been used to support clearance for POP or SUI urogynecologic mesh products.

In other words, they just checked to make sure the transvaginal surgical mesh was made like normal surgical mesh. The FDA didn’t even bother to review “clinical performance data” on actually implanting the mesh to treat POP or SUI to see if it worked and if it was safe. It just made sure the vaginal mesh looked like surgical mesh and that was that. Those are the ‘overly burdensome’ regulations medical device manufacturers think are too stringent. There are Representatives and Senators who believe we need less FDA regulation?

There’s another important aspect to this debate: medical device manufacturers already have a special exemption from the negligence laws that apply to all the rest of us. Lowering FDA standards will make that special exemption even bigger.

As I’ve written before, it’s already particularly difficult to sue drug makers even for breaking federal law, and some courts are considering eliminating manufacturers’ legal duty to make safe drugs, leaving plaintiffs with a single potential claim, i.e. the “failure to warn” based on the drug maker not honestly describing how dangerous their drugs really are. 
Continue Reading Medical Implant Manufacturers Lobby For Even More Special Legal Treatment

[Update: the American Medical Association recently posted an article about how “off-label” marketing is so pervasive that many doctors don’t even know what the approved purposes of the prescription drugs and medical devices are, exposing them to malpractice liability.]

The pharmaceutical defense lawyers at Drug & Device Law, one of my favorite blogs to throw rocks at (we went Jersey Shore over the Wellbutrin litigation a year ago), are at it again, this time attacking a legal theory they refer to as ‘FDA regulatory informed consent.’ Although drug companies aren’t allowed to market drugs for any purpose other than those purposes approved by the Food and Drug Administration (it’s called “off-label marketing” and it’s blatantly illegal), the FDA permits individual doctors to prescribe FDA-approved drugs for any purpose, creating a disconnect between FDA approval and actual medical practice. The FDA doesn’t do anything to regulate what doctors prescribe; the closest it comes to informed consent are its regulations for clinical trials.

Under the theory of FDA regulatory informed consent, physicians should be required to tell patients if the physician is prescribing a medication for a use not approved by the FDA. Jim Beck at Drug & Device Law thinks it’s a bad idea, and wrote his post in response to a new law review article, “The Case For Legal Regulation Of Physicians’ Off-Label Prescribing,” 86 Notre Dame L. Rev. 649 (2011)(online copy here), by Philip M. Rosoff, a professor at Duke Medical School, and Doriane Lambelet Coleman, a professor at Duke Law School. As Beck notes, most courts don’t accept the explicit version of this — i.e., the requirement that a doctor specifically say the drug or medical device isn’t FDA-approved — but, as Beck doesn’t note, some courts get awfully close. See, e.g., DeNeui v. Wellman, No. 2009 U.S. Dist. LEXIS 114853, at *11–14 (D.S.D. Dec. 9, 2009)(“a jury must determine whether a reasonable person would attach significance to the off-label use of [the medical device] before deciding whether to undergo the surgery in this case”); In re Diet Drug Litigation, 384 N.J. Super. 525, 895 A.2d 480 (Law Div. 2005)(distinguishing Blazoski v. Cook, holding “While obesity is a serious condition, phen-fen is hardly its only cure. While phen-fen may have provided real benefits for those who took it, these patients were entitled to know of its risks. And it is certainly foreseeable that, if advised of the risks, they might well have chosen alternatives.”).

I’m unsurprisingly more on Rosoff and Coleman’s side. I’ll explain.

First, a little bit of background on the subject. As I’ve discussed before, intense lobbying by drug companies — including infiltration of the supposedly neutral legal research groups like the American Law Institute, which publishes the various Restatements — has whittled away at most of the potential claims against defective drug manufacturers. The law’s so hostile to patients that even doctors think it’s too protective of drug companies. (At the same time, those same companies have lobbied for absurd laws like the Prescription Drug User Fee Act that penalize the FDA if it doesn’t approve drugs quickly enough; unsurprising, that has made drugs less safe and more likely to be withdrawn.)

If you try to sue a drug company for inadequately testing or improperly designing a drug, the drug company will cite FDA approval and shout “pre-emption,” arguing that the FDA already signed off on the drug’s safety and efficacy and that the courts aren’t allowed to second-guess that — even if neither the FDA nor Congress said they meant to foreclose tort lawsuits. Defense lawyers call that dubious argument “implied pre-emption.”

Courts will too often buy those arguments; consider the lengths to which Judge Posner jumped to deny a toxic epidermal necrolysis / Stevens-Johnson syndrome victim a $3.5 million jury award. I’m not sure why he bothered with that long and winding factual argument, leaping from assumption to assumption and begging his own questions; he could have just said, “I’d prefer they lose” and be done with it.

In short: under a variety of names (“implied preemption,” “learned intermediary,” “unavoidably unsafe product,” etc) the drug manufacturers routinely claim that FDA approval is the be-all, end-all of drug safety, and so no injured patient should ever be allowed to sue the manufacturer of an FDA-approved drug. It’s thus more than a little hypocritical for them or their lawyers to now claim that FDA approval is irrelevant to patients. It’s the sole reason they believe they’re entitled to special legal immunities not granted to other manufacturers.

Although every defective drug lawsuit these days alleges a variety of claims like strict liability, negligence, breach of warranty, and violations of consumer protection laws, in the end most of the prescription drug lawsuits tend to boil down to one type of claim: the “failure to warn” of a certain side-effect or problem with the drug. The Supreme Court held in Wyeth v. Levine that failure to warn cases could go forward, so patients’ lawyers have held on to that will all their might. All the big prescription drug cases these days — Accutane, Actos, Chantix, Darvon-Darvocet, Depakote, Fosamax, Plavix, Topamax, Yaz — are primarily failure to warn cases. The Accutane plaintiffs allege that Roche failed to warn about side effects like inflammatory bowel disease and birth defects. The Actos plaintiffs allege that Takeda failed to warn about an increased risk of bladder cancer. The Chantix plaintiffs allege that Pfizer failed to warn about the risk of depression and suicidal thoughts. Et cetera.

Lurking under the surface of many of these cases is the scourge of off-label marketing. You wouldn’t know it from Beck’s critique, but doctors and medical researchers have long fretted about off-label prescription. One study in 2006 found over 150 million off-label mentions by physicians each year — totalling over one-fifth of overall prescriptions — and found that three-quarters of those off label prescriptions had “little or no scientific support.”

Worse, many patients don’t know that doctors are allowed to prescribe drugs for unapproved and unsupported uses: “A 2006 poll suggests that much of the U.S. public is confused and ambivalent about off-label prescribing, with about half the respondents believing that physicians are permitted to prescribe drugs only for on-label indications and about half believing that physicians should be prohibited from prescribing drugs for off-label indications.” (Source).
Continue Reading Off Label Drug Use Should Be Regulated For Patient Safety

[Update: For the first time, the federal Environmental Protection Agency has released a report that finds a connection between fracking and groundwater contamination at a site in Wyoming. Unsurprisingly, natural gas companies have gone on the offensive about it. The report certainly helps strength plaintiffs’ claims arising from these types of claims, but they remain on the cutting edge of science, and thus are difficult to prove in court because our court system operates primarily off of long-standing scientific consensus, rather than novel, even if strongly meritorious, theories and evidence. Much will depend on what comes out of the EPA’s big report on the health hazards of fracking, slated for release in 2014.]

I’ll admit it: I find real estate law boring. On Monday, though, I saw an article about a an 1882 Pennsylvania case that touched upon gas deposits in the Marcellus Shale, a hot topic these days:

In 1882, the Pennsylvania Supreme Court announced a presumption that a reservation of “minerals” does not include oil absent evidence within the four corners of the deed of a contrary intent. Dunham v. Kirkpatick, 101 Pa. 36 (1882). In 1960, the Supreme Court announced that its decision in Dunham was a rule of Pennsylvania property law and that pursuant to the Dunham logic, a grant or reservation of “oil” would not include “gas” absent clear expression of the parties’ intent to do so. Highland v. Commonwealth, 161 A.2d 390 (Pa. 1960).

In Butler v. Charles Powers Estate, the Court of Common Pleas of Susquehanna County was faced with a similar claim that a reservation of “one half the minerals and Petroleum Oils” included the Marcellus Shale and, therefore, any gas contained therein. … On September 7, 2011, the Superior Court of Pennsylvania (at No. 1795 MDA 2010,  2011 PA Super 198) reversed and remanded Butler, ruling that the Plaintiffs should be given the right to develop a record in an attempt to prove: a) that the Marcellus Shale is a “mineral” and therefore within the reservation; b) that as unconventional gas, Marcellus Shale gas was not the type of natural gas contemplated in Dunham and Highland; and c) that shale may be more similar to coal than conventional oil and gas reservoirs, so that under Pennsylvania’s nearly unique position that coalbed methane is owned by the owner of the coal (see U.S. Steel Corp. v. Hoge, 468 A.2d 1380 (Pa. 1983)), the owner of the shale may own any gas contained therein.

Almost as interesting as the Butler ruling — which, it could be argued, was very favorable to longtime Pennsylvania residents who might still hold some of these “mineral” rights and very unfavorable to the companies coming in for the natural gas “fracking” boom — was the author of the article, Russell L. Schetroma, of Steptoe & Johnson. There are two Steptoe & Johnson firms, but I didn’t know either to have expertise in Pennsylvania mineral rights law; that’s only happened since September, when they acquired the energy practice from a mid-sized firm near Pittsburgh, including Mr. Schetroma. As The Legal Intelligencer coincidentally reported the next day:

As the natural gas industry continues to expand its footprint in Western Pennsylvania, the region is quickly becoming a desired destination for energy and environmental attorneys.

Two Texas-based firms with relatively new offices in the Pittsburgh area recently brought aboard attorneys who moved either hundreds or thousands of miles to be on the groundfloor of Pennsylvania’s natural gas boom.

The article doesn’t even mention Steptoe & Johnson, but instead focuses on two other huge corporate firms racing to merge with small firms well versed in Pennsylvania real estate and environmental law. Even the lawyers (especially the lawyers?) are rushing to cash in on the Marcellus Shale natural gas boom.

The obvious group missing, though, are the trial lawyers, despite endless press and insurance company speculation that plaintiffs’ lawyers would be racing to file environmental contamination claims against oil and gas companies using hydraulic fracturing. After all, more than a year ago there was significant national press attention (Vanity Fair, New York Times) over contamination of water wells throughout Pennsylvania. That would, under ideal conditions, prompt government action to ensure the safety of residents, but the federal government has taken a pass — fracturing was exempted in 2005 by the intentionally misnamed Safe Drinking Water Act — and Pennsylvania’s own state government is, shall we say, highly inclined to take the gas companies’ side.

It would thus seem to be a perfect storm for lawsuits: the government has given multiple wealthy corporations almost carte blanche to engage in a dangerous process which can cause serious property damage and personal injury.

For all the discussion about environmental contamination caused by fracking in Pennsylvania, though, only a few lawsuits have been filed. I only know of two that have even passed the initial pleadings stage: Fiorentino v. Cabot Oil & Gas Corp. (reported by Reuters here) and Berish v. Southwestern Energy (reported by the NYTimes here). Both allege violations of Pennsylvania’s Hazardous Sites Cleanup Act (35 P.S. §§ 6020.101-6020.1305 (“HSCA”)), Negligence, Private Nuisance, Strict Liability, Trespass, and seek the establishment of a Medical Monitoring Trust Fund.

Both cases have survived the defendants’ motions to dismiss — the Fiorentino order is here, the Berish order here, and both are clear and well-written, and thus recommended reading even for non-lawyers — and are now in discovery. Fiornetino, arising from contamination in Dimock, has resulted in a settlement of the claim brought by the Pennsylvania Department of Environmental Protection to compel Cabot into paying to connect them to the main water systems, for methane mitigation systems, and for water treatment systems, but the plaintiffs’ individual claims for damages remain.

Seeing only two cases at the moment, neither of which has made it to any dispositive legal holdings or factual findings, the question, then, is: where are all the fracking water contamination lawsuits?

Continue Reading Where Are All The Pennsylvania Fracking Water Contamination Lawsuits?

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.
Continue Reading Pennsylvania’s Defective Drug Design Laws Hang In The Balance

The Executive Editor of the New England Journal of Medicine recently called the DePuy ASR hip replacement recall a “public health nightmare” and a prime example for why the FDA needs to fix the “510(k) clearance” loophole that allows the sale of certain medical devices — even implants — to be sold without any clinical data or testing. The Institute of Medicine, too, has recently recommended that 510(k) clearance be eliminated.

In the meantime, 93,000 patients are stuck with defective ASR hip replacement implants with a shocking replacement rate: 21% revision rate at 4 years (up to 35% if all currently known painful implants progress to revision) to 49% at 6 years. Other hip replacement devices have a revision rate of 12% to 15% at 5 years. DePuy Orthopedics is negligent and they know it; they spend about a quarter billion dollars every four months dealing with the product recall and the litigation associated with it.

We have an active DePuy hip replacement recall practice around here, so we follow the litigation closely, and yesterday’s report by Reuters discussed one of the more disturbing turns lately:

In a highly unusual move, DePuy has hired a third party — Broadspire Services Inc, which manages workers compensation and other medical claims on behalf of insurance companies and employers — to administer patient claims for out-of-pocket medical costs associated with the recall.

The move has prompted debate among industry and legal experts. Some see it as an efficient way to outsource a process that is unrelated to making artificial hips. Others see it as a way for J&J to limit payments while gaining control of medical records and other material that could be used against patients in court. …

To critics, DePuy’s handling of its hip implant recall is designed to save money by potentially settling claims with patients before they fully understand their legal rights, or the likely cost of their hip-related medical costs in the future.

Indeed, that’s exactly what Johnson & Johnson (which owns DePuy Orthopedics) and DePuy are trying to do: manipulate patients and their treating physicians outside of the appropriate court processes.
Continue Reading DePuy Tricks Hip Recall Patients Into Losing Legal Rights

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.
Continue Reading Lawyer Branding And The Race For Actos Bladder Cancer Clients

One thing you learn as a personal injury lawyer is that many everyday products are far more dangerous than you thought. Until I became a lawyer and began screening cases and receiving calls, I hadn’t a clue that Children’s Motrin could cause Stevens-Johnson Syndrome.

Tylenol is another example. I’ve used acetaminophen safely for years without a problem, and I thanked my lucky stars for it when 1,000mg of the stuff brought me back from the delirium caused by a 104+ fever. Every week, though, approximately ten people die and one-thousand are sent to the emergency department by acetaminophen overdosing.

Which brings us to In re McNeil Consumer Healthcare, Marketing & Sales Practices Litigation, 10-md-02190 (E.D. Pa.). The Amended Complaint is available on RECAP. The claims arise from a string of recalls of various children’s and infant’s Tylenol, Motrin, Zyrtec, and Benadryl prompted by FDA investigations that uncovered some ugly problems, like:

155. In May and June of 2009, the FDA discovered that from April through June 2008, McNeil had used microcrystalline cellulose, an ingredient used in liquid adult and children’s Tylenol products, that had been potentially contaminated with a gram negative bacteria, Burkholder cepacia.

***

160. Beginning in approximately the Fall of 2008, McNeil began receiving reports regarding musty, moldy odors emanating from McNeil Tylenol pills manufactured at its Las Piedrad, Puerto Rico facility.
161. McNeil did not fully investigate these reports for approximately one year notwithstanding McNeal’s obligation to notify the FDA of such reports within three days.
162. Only after the FDA insisted that McNeil conduct a thorough investigation was it discovered that the odor was the result of contamination by a product called 2,4,6-Tribromoanisole (“TBA”), a pesticide used on the wooden pallets that stored and
transported packaging materials for the medications.

***

169. In April of 2010, McNeil recalled approximately 40 types of children’s and infants’ products manufactured at its Fort Washington, Pennsylvania plant because of filth and contamination, including acetaminophen, cellulose, nickel and
chromium particulate contamination, involving McNeil’s liquid infant and children’s products including Tylenol, Motrin, Benadryl, Zyrtec and Tylenol Infants’ Drops.

You can read the first “Form 483” reports generated by the FDA here. Obviously something went very wrong with the McNeil compliance process, prompting recalls, an unknown amount of physical injury, and economic loss to the many consumers who bought those products (including myself).

The Amended Complaint was just dismissed, with leave to amend against Johnson & Johnson and McNeil.Continue Reading Recalled Product Lawsuits Getting Harder, Children’s Tylenol Edition