[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 ActosPradaxa, 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

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