On the topic of conflicts of interest, our clients and those who do research for them are under constant scrutiny and encounter an ever-escalating call for disclosure of every dime of research money, speaker money, consulting money, etc. Not all conflicts though boil down to money. And the sole, and obsessive, focus on financial disclosures makes us question whether what is being sought is “context,” as often asserted in defense of witch-hunt (more…)

The Third Circuit issued an important medical monitoring decision yesterday. Sheridan v. NGK Metals Corp., 2010 WL 2246392 (3d Cir. June 7, 2010). Although this case does not involve a drug or a device, several rulings should prove useful to lawyers who handle drug and device cases. To get the key points of this hot little decision in your hands quickly, we’ll cut right to the chase without Monty Python clips, exercises in alliteration, (more…)

This blog welcomes guest posts, particularly by other defense counsel. We’re just as lazy as the next guy.

This is a guest post by John A. Tartaglia III, of the Renzulli Law Firm, on attempts in Congress to strip manufacturers of FDA premarket approved medical device manufacturers of their hard-won preemption defense. He gets all the credit and all the blame for what follows.

Take it away, John:
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Good tidings and great cheer. Merry Christmas, Happy Hanukkah, Kool Kwanzaa, Super Solstice – whatever holiday you’re celebrating. What is there to celebrate? Well, for the moment we can all celebrate our top ten favorite drug and medical device decisions of 2009. While we don’t have a Supreme Court star at the top or our tree this year (Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), isn’t drug/device), there are still (more…)

It’s that time of year. Yeah, we know, it’s neither new nor original to do top ten lists – but it’s still fun. Except when it isn’t.

How much fun can it be to review all those times in the past year when we’ve been kicked in the teeth? That’s right. Here are our top (or should we say bottom) ten worst prescription drug/medical device decisions of 2009.

True, there are still a (more…)

Thanks to a newspaper reporter of all people for this tip – John Ellement of the Boston Globe. The case involved, Donovan v. Philip Morris (go here and click on, first, “slip opinions” and then “Supreme Judicial Court” and finally “opinions”), is a cigarette case, and since both of our firms represent tobacco companies we’re limited in what we can say. So we’ll concentrate on the elements of the “medical monitoring” cause of action that (more…)

The American Conference Institute is again sponsoring its annual Drug and Medical Device Conference in New York City in December.

This year’s conference will be held from December 8 to 10 at the Millennium Broadway Hotel.

Here’s a link to the conference website, which in turn links to the conference brochure.

ACI is offering readers of this blog a $200 discount off the conference price. Mention the “Drug and Device (more…)

Companies that provide medical malpractice insurance tend to be pretty large and pretty sophisticated.

It’s thus not surprising that the way they handle most of their business makes a lot of sense to us: They hire lawyers on a “wholesale” basis, asking law firms to defend a high volume of medical malpractice litigation for relatively low rates. The insurers win some cases and lose others, but, overall, the companies presumably maximize (more…)

We’re not surprised that physicians invest in medical devices companies.

Legendary investor Peter Lynch said, “Buy what you know.” Surgeons who implant medical devices know . . . medical devices.

Sometimes those surgeons invent the devices. Sometimes the surgeons simply learn about the devices and believe they’re good products.

Not surprisingly, surgeons sometimes choose to invest in companies that manufacture medical (more…)

Off-label use — using a drug or medical device for an indication other than that set forth in the FDA-approved label — poses tricky legal issues.

Off-label use is entirely legal: The FDA doesn’t regulate the practice of medicine, so physicians can use drugs or devices for any appropriate purpose, approved by the FDA or not.

But if the physician is later sued for malpractice, a lay jury may give disproportionate weight to the (more…)