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Justinian C. Lane is a personal injury attorney who focuses his practice on helping individuals injured by prescription drugs and medical devices.

This is from 02/18, but I forgot to post it back then.  Not sure what ramifications, if any, this will have for the various DePuy and Striker hip replacement lawsuits.  I’m certainly interested in speaking to anyone with a problem with their replacement hip regardless of gender.

CHICAGO — Hip replacements are slightly more likely to fail in women than in men, according to one of the largest studies of its kind in U.S. patients. The risk of the implants failing is low, but women were 29% more likely than men to need a repeat surgery within the first three years.

The message for women considering hip replacement surgery remains unclear. It’s not known which models of hip implants perform best in women, even though women make up the majority of the more than 400,000 Americans who have full or partial hip replacements each year to ease the pain and loss of mobility caused by arthritis or injuries.

“This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences,” said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families. “Research in this area could save billions of dollars” and prevent patients from experiencing the pain and inconvenience of surgeries to fix hip implants that go wrong.

Source; USA TODAY

What is the “revolving door” I’m always talking about?  It’s this.  The former head of the FDA now is in private industry and he’s proposing drastic cuts to the clinical trial process.  Yet no one complains.

The council’s report establishes an ambitious, yet reachable, national goal: doubling the current annual output of new medicines for patients. We believe existing evidence suggests this goal can be met by altering the FDA’s onerous clinical-trial requirements.

Source: FDA Reform Can Lift U.S. Economy – Bloomberg

Imagine if he went to work for a trial lawyer lobbying group and proposed allowing generics to update the warning label so consumers could sue them….

Here’s a news item about the various lawsuits being filed over Stryker hips.  My firm is evaluating cases right now for folks who received a Stryker hip.

More than 80 lawsuits have been filed in Bergen County against Stryker Orthopaedics by patients claiming that the Mahwah-based medical device maker sold them a defective hip implant that was later recalled from the market.

Source: Mahwah-based Stryker Orthopaedics faces hip implant lawsuits – NorthJersey.com

Could go either way.  Probably won’t have any effect on whether or not injured consumers can sue if they took generics.

Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011–known as sequestration–are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).

Source: FDA’s Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says | Bloomberg BNA

I’d like to introduce you to Jared Fink, who works for my firm as a Pharmacovigilance Specialist. What is a Pharmacovigilance Specialist, you ask? Well, every pharmaceutical company in the world has a team of folks who scour medical literature, the Internet, and other sources to look for signs that their drugs are causing harm. The men and women in those positions scour the medical literature and brief management on new and existing trends in product safety. They then prepare internal reports with candid assessments of whether they think a given study is important enough to merit further investigation. In other words, a Pharmacovigilance Specialist acts as the eyes and ears of a pharmaceutical company with respect to the medical community.

Jared does the same sort of work for us. He spends his days going through current and some not-so-current medical studies to determine what the risks are of drugs and medical devices on the market.  If he believes that a drug or device is more dangerous than the manufacturer lets on, he lets us know and we investigate whether or not we want to file lawsuits against the manufacturer of the drug or device.  And if we’re already sure we want to pursue a certain type of lawsuit, Jared helps us find the appropriate scientific evidence to back up our cases.

A big part of Jared’s job is summarizing lengthy and complicated scientific studies about drugs and medical devices. I don’t want all of his hard work to stay buried in our private network, so I have Jared blog about his findings. I think you’ll find that Dangerous Drugs has the most in-depth analysis of the science behind the lawsuits and most of that analysis comes from Jared. It’s important to me that Jared’s work is published on the open Internet because many of the studies he reviews are not published on the open Internet. Instead, they’re buried behind the pay walls of academic journals and are not accessible to the average citizen.   

Jared Fink graduated with honors from The College of Wooster, where he received a Bachelor’s of Arts in Philosophy. In addition to his senior thesis project titled “Authenticity and Art,” which resulted in a 96-page thesis with oral defense, as an undergraduate Jared managed genetics research for Dr. Amy Jo Stavnezer of the Neurology Department at the College of Wooster. For five summers, Jared worked in psychiatric research at the University of Michigan under Dr. Israel Liberzon, where his research focused on the neurobiological and genetic foundations for a number of psychiatric conditions.

I learn a great deal every time I read one of Jared’s blog posts, and I’m sure you will, too.

Scalia fans everywhere will cringe at the thought of using an amicus brief filed by Waxman on this issue, but setting that prejudice aside, this is kind of a big deal:

Here’s even more powerful evidence of Congress’s intent: a newly filed amicus brief filed by Senator Tom Harkin (D-Iowa) and Representative Henry Waxman (D-California, and, yes, the Waxman of Hatch-Waxman) in support of Bartlett. Harkin and Waxman, who are represented by Allison Zieve of the Public Citizen Litigation Group, say lawmakers’ intentions couldn’t be clearer. If Congress wanted federal regulation to preclude personal injury suits, it would have said so. It’s no accident that Congress did not, according to the brief.

“The notion that FDA regulation broadly pre-empts design-defect claims against prescription drug manufacturers finds no support in the text or purpose of the FDCA, runs counter to the … provision addressing product liability law and ignores more than 75 years of history in which damages suits and federal drug approval have co-existed,” the brief said. “Congress is well aware of its authority to pre-empt state damages actions, and with respect to prescription drugs, as with (over-the-counter) drugs, it has not done so. Moreover, in recent years, following litigation addressing whether federal regulation pre-empts state-law claims regarding injuries caused by drugs, both chambers of Congress have considered pre-emption of state-law claims concerning drugs. Yet Congress has taken no action to change the historical framework through which state law controls whether injured patients have a tort remedy.”

Source: Victim in SCOTUS generics case has powerful amici: Harkin and Waxman

Back in January the Alabama Supreme Court issued a ruling that enabled individuals who took generic drugs to sue the brand-name manufacturer.  Not surprisingly, the brand-name companies are not happy:

BIRMINGHAM, Alabama — Brand name makers of a drug used to treat acid reflux and other digestive problems today asked the Alabama Supreme Court to reconsider its January opinion that people who take generic equivalents of a drug can sue the brand name manufacturers.

The U.S. Chamber of Commerce, the Business Council of Alabama, and four other groups also filed court briefs today supporting that request, saying the court’s earlier ruling could have far-sweeping consequences on healthcare, as well as other industries, in Alabama.

Source: Brand-name drug makers ask Alabama Supreme Court to reconsider ruling that generic drug consumers can sue them | al.com

Way back in 2010, I wrote a blog post about the “prison rape” of one of the companies that manufactured the drugs improperly administered by Dr. Dipak Desai.  Now another defendant is on the hook:

Officials with Health Plan of Nevada knew in the late 1990s about Desai’s poor reputation after a doctor who was employed at one facility informed the company that Desai was cutting corners and compromising patient safety, Eglet said.

Source: UnitedHealth Unit Liable for Doctor’s Errors, Lawyer Says – Bloomberg

I’m actually much more open-minded about this defendant’s culpability.  If what the article says is true – the insurer had actual knowledge that the Dr. was a menace – it does raise serious questions as to why the insurer kept the doc on the approved list.  It will be interesting to see how the trial ends.