Drug Recall Lawyer Blog

In an article about what the FDA does not tell you, Smart Money tells us that 90% of medical devices approved by the FDA go through what is called a "510(k)" which allows device manufacturers to skip testing a device before putting it on the market if there is already a "similar device available."

I'm not saying necessarily that every medical device that has the slightest modification should have to jump through the full FDA approval process. I think few people are really saying that. The question is simply where do we draw the line and it seems fairly clear that we are drawing it in a way that makes it far too easy on medical device manufacturers.

The FDA recently took a shot at making the 510(k) device clearance process "more predictable and smarter" but has not made any real progress. Again, I understand their trepidation. We want to get products with slight improvements on the market quickly. I just think we have to (1) better define what qualifies for 510(k) and (2) intensify the requirement - something in the middle of full blown testing and "bring it on through."

Stryker's CEO Stephen MacMillan was on Squawk Box this morning talking about the President's speech and Stryker's recent boost in profitability. He looked like a nice guy, he really did. I was on the treadmill so I did not get what prompted the joke but in response to something Joe Kernen said, MacMillan said that next time he would bring with him a really good hip replacement (or words to that effect).

The comment underscored to me how in the world of big business, litigation is just one piece of a very large puzzle. I would think MacMillan would be a little more sensitive about the fact that just a few years ago they had to recall Stryker hip implants to the point where he wouldn't have thought it a joke. But Stryker has settled most of those cases and clearly moved past it.

I don't know what my point is, really. I'm not even saying the joke was inappropriate. The whole thing just struck me as odd.

Johnson & Johnson’s fourth-quarter profit fell 12% and projected lower than expected earnings in 2011. One big reason: J&J recorded a $922 million charge for the cost of defending and paying claims in the DePuy ASR hip recall lawsuits.

I don't think $922 million is going to be enough to cover the Depuy and Pinnacle hip lawsuits. But it does give an indication that J&J is starting to put money aside to deal with cost of the recall.

If J&J wants to increase profitability, it has to get back to the basics of making great products. It is easy to forget, J&J was once the gold standard in the industry. It has a long way to dig itself out of the hole it created.

The FDA announced that PGxHealth's Vilazodone (Viibryd) has been approved for treatment of major depression. Vilazodone is yet another serotonin reuptake inhibitor with a few other pharmacaclogical twists.

No matter what you think of the SSRIs, they have been battle tested for a long time. When you combine the regulatory environment with drug companies looking for a quick score, you have to look somewhat skeptically at the safety and efficacy on any new antidepressant. But, hopefully, this drug works well for those who have struggled to get relief from the antidepressants currently on the market.

According to the drug's manufacturer, PGxHealth, the approval was based primarily on two eight-week clinical trials comparing vilazodone with placebo. The drug was also tested in a 52-week uncontrolled study with efficacy results similar to those seen in the randomized trials.

Vilazodone's label will include a boxed warning and about risk of suicidal thinking and behavior in patients younger than 25 years-old.

• Hospitals to put doctors' relationships with pharmaceutical companies under the microscope (The Denver Post). Of course, they have been saying this for years. But I never see anyone actually pull out this microscope. Five years from now, I will link to a similar article suggesting the dawn of a new era. Hopefully, they will be efficient with their time and just cut and paste this article.
• Aggressive drug marketing and resultant prescribing causes harm to patients (Emax health). Aggressive drug marketing is not good for patients. Another "haven't we seen this before?" study.
• Research and Markets: Allergan - SWOT Framework Analysis (Business Wire)
• Ask Not For Whom the Drug Tolls (Intermex Financial). “If Huckleberry Finn and Tom Sawyer were in a school in Massachusetts today, they’d be drugged with Ritalin, according to many psychiatrists and other experts.” I guess the question is whether that would be a bad thing. I'm not sure one way or the other. (Using the word "drugged" certainly baits the answer.) I could probably offer more insight if I had read Huck Finn instead of the Cliff Notes. They should have put a warning about this in ALL CAPS.

Continue reading " Today's Stories and Links " »

The Oregon Attorney General John Kroger announced today that a lawsuit has been filed claiming that Johnson & Johnson should not have left its defective Motrin on the market.

The allegations are problematic for J&J. The lawsuit claims that instead of coming clean, J&J planned a "phantom recall" by quietly pulling the defective product.

Again, I appreciate Oregon's view. But the real end game is stopping and punishing drug and medical device companies when they are putting the public in real danger as opposed to selling a product that smells bad. I think there may be a forest for the trees problem.

• High Court To Hear Case Over ‘Data Mining’ Of Drug Prescription Data (Liberal, Political News & Candidate). I'm in the minority I know but I really don't care that much about data mining of pharmaceutical drugs prescriptions, on Facebook or anywhere else.
• Health care bill ends pre-tax purchases of aspirin and other non-prescription drugs (Politi fact)
• FCSO targets Rx abuse (Forsyth News)
• Doctors rapped over narcotics prescriptions (The Chronicle Herald)
• Four file lawsuit against Vancouver pain clinic (The Columbian). I understand these cases, I really do. The problem is, when it comes to narcotic prescriptions it takes two: a prescribing doctor and a patient who is taking the medication. In many cases, both bear responsibility and, in my opinion, the patient often bears the bulk of the responsibility.
• The Drug and Device Law Blog reports on the granting of cert in a pharmaceutical drug company First Amendment case. I personally don't think James Madison was thinking about Johnson & Johnson when he was writing that little diddy up.
• Weight loss product Synerate recalled (CTV News)
• Child safety: New registration system alerts parents to vital recalls (Sun Sentinel)
• Tamale Recall Initiated Over Allergen Concerns: USDA (The epoch times)
• Antibiotic Maker Recalls Underweight Tablets (Medical News)
• Rocks Organic recalls blackcurrant squash (Safer Food, Better Business)

Continue reading " News Roundup " »

The New York Times reports that the number of ER visits from patients misusing or abusing prescription drugs almost doubled over the last five years.

Doubled. You read so many statistics these days. It is mind numbing to the point where incredible statistics like this get glossed over in the next 3 hour news cycle. I read the article and I still have no idea how this could be. We need the Freakanomics guys to figure this out.

• Natco seeks Pfizer nod for drug clone (The Economic Times)
• Medicare patients get added benefits in 2011 (The Tennessean)
• Cocaine vaccine works in mice; human tests possible (North County Times)
• Pfizer enters R&D pact with Santaris Pharma (Trading Markets)
• XOMA soars on deal with French drug company. CPEX Pharma climbs on takeover offer. Positive ID surges on deal with Siemens (2010 BioMed Reports)
• Vending Machines for Medicine (KFYR-TV North Dakota's NBC)
• Regulators Propose Remedy for Medication Misuse (FairWarning)
• Tucson Health: Why did the UA College of Medicine earn an "F" for conflict-of-interest?
• Jury Awards $7 Million in Medical Malpractice Verdict in New York (New Jersey Medical Malpractice Lawyers).
• Alabama court to hear lawsuit against Pfizer drug (Market News & Analysis)
• Willamette Shelling Product Recall (Los Angeles Defective Product Attorney)

Too often, drug companies choose profits over people. I'm sure this statement is true. But the cousin of this argument, drug companies make too much money, I think is flawed.

A story I just read underscores why drug companies can charge $200 for a pill that costs $.05 to make and still be charging a fair price. Inspire Pharmaceuticals suffered an awful setback for both the company and for cystic fibrosis patients when its experimental treatment for cystic fibrosis failed to improve patients' health in a critical study of the treatment's safety and efficacy. Their stock fell, good people will probably lose their jobs, and cystic fibrosis patients continue to look to the next horizon for better treatment options. There are a lot of losers for every drug that is not a hit and not just the pharmaceutical company that will have no profits from which to draw for their next experimental treatment.

Why make this point on the Drug Recall Lawyer Blog? Because I think it is important to identify the real problem. When we say these drug companies just make too much money, the fallacy of this argument bleeds into the real truth: businesses in general have a tendency to put profits ahead of people and we need effective watchdogs of personal injury lawsuits and government regulation to level off the tendency. This does not mean most businesses do this. Most businesses and most drug companies do the right thing. But too many do the wrong thing and those folks need to be watched like hawks. A big company like Johnson & Johnson has divisions that are like companies. Some are great and some are not so good.

But railing against pharmaceutical companies profits is general as opposed to specific examples of individual companies putting profits ahead of safety is not productive and is just plain wrong. I think I can prove this. If you think drug companies are too profitable, go buy some pharmaceutical stocks on the NYSE. If you don't, they are not too profitable.

Our lawyers are investigating NuvaRing lawsuits. NuvaRing is a small inter-vaginal device inserted by the user once a month to prevent pregnancy. NuvaRing's manufacturer sells NuvaRing on the premise that its regime is easy compared to the traditional birth control pill that has to be taken every day.

NuvaRing releases the hormones estrogen and progesterone into a woman's body. The concern is that at high levels these hormones can cause cardiac problems and blood clotting, specifically, the formation of an embolus - a blood clot that can cause pulmonary embolisms. NuvaRing lawsuits contend that NuvaRing's manufacturer failed to provide proper and full information as to the safety of the NuvaRing to the FDA, which regulates the sale of the NuvaRing.

Continue reading " NuvaRing Lawsuit " »

Consumer Reports Poll: Only One-Fifth of Americans are Aware They Purchased a Recalled Product (PRNewswire-USNewswire). This is a real problem but who knows how to solve it?

Harris Teeter recalls ground beef

Health care reform 101: What kicked in Jan. 1? (Health News and Scoops)

Common Dangerous Drug Interactions

Continue reading " Drug/Device/Product News " »

Some Johnson & Johnson shareholders are blaming the company for not complying with federal regulations that led to the scores of product recalls we saw from J&J in 2010, and have filed a lawsuit against the company in U.S. District Court in Trenton, New Jersey.

Certainly, 2010 was an awful PR year for Johnson & Johnson as the company had a large number of recalls, including some that really caused hardship to their customers (DePuy hip replacements come to mind).

But you can't pitch this in terms of "even Johnson & Johnson stockholders are turning on the company" because this is just one group of stockholders. I think I may have some J&J stock. I could go out and file a shareholder derivative lawsuit. Of all of the cuts to J&J last year, and there were plenty, this one is one of the shallowest.