“No Tolerance” for Drug Manufacturers Fabricating FDA Data Doesn’t Mean Much

As I've written before, as a legal matter, drug companies have it easy. Consider what drug company lawyers called their ten "best" court opinions of the past year, many of which involved courts re-writing laws to dismiss lawsuits brought by injured patients. In the notorious PLIVA v. Mensing case, a 5-4 Supreme Court tried its hardest to wash away any claims injured consumers could have against generic drug manufacturers by ruling that, as a matter of law, any lawsuit would conflict with the FDA's regulations — even though the Supreme Court couldn't point to any actual conflicting regulations, and even ... Continue Reading

Subrogation, Where Much Of The Hip Implant Settlement Money Will Go

We have a fair number of hip replacement lawsuits at the firm, so we follow all of the news related to them, including last week's article in the New York Times about "The High Cost of Failing Artificial Hips", which included a key point that hasn't received much attention in the press: In August, Mr. Dougherty underwent an operation to replace a failed artificial hip, but his pelvis fractured soon afterward. The replacement hip was abandoned and then a serious infection set in. Some of the bills: $400,776 in charges related to hospitalizations, and $28,081 in doctors’ bills. I can ... Continue Reading

The Most Unfair Prescription Drug And Medical Device Opinions Of 2011

A few days ago I reviewed the list of "worst" pharmaceutical and medical device liability court opinions of the last year as chosen by the defense lawyers at Drug & Device Law, so I feel obligated to follow-up on their post on the "best" prescription drug and medical device decisions. The short version is quite simple: drug and device companies really like activist judges legislating from the bench or overruling juries' factual findings. How else to explain the love for PLIVA, Inc. v. Mensing, in which the United States Supreme Court couldn't find a federal statute or regulation in support of ... Continue Reading

The Unintentional Message Of The “Worst” Drug And Device Court Opinions

[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 ... Continue Reading

Courts Lag Behind Science In Recognizing How Regular Tylenol Use Causes Liver Damage

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 ... Continue Reading

Why Merck Still Doesn’t Warn About Propecia Causing Impotence

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 ... Continue Reading

Medical Implant Manufacturers Lobby For Even More Special Legal Treatment

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 ... Continue Reading

Off Label Drug Use Should Be Regulated For Patient Safety

[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 ... Continue Reading

Where Are All The Pennsylvania Fracking Water Contamination Lawsuits?

[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.] I’ll admit it: I find real estate law boring. On ... Continue Reading

Pennsylvania’s Defective Drug Design Laws Hang In The Balance

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 ... Continue Reading