This shows that the FDA is more interested in protecting pharmaceutical companies than patients. Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk. A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug. And allowing any… Continue Reading
Justinian
FDA won’t say which drugs on the market were approved based on fraudulent research
Posted in Drug Studies, FDA RegulationWashington court lets surgical robot lawsuit proceed
Posted in Surgical RobotsI knew there was a reason I got licensed to practice law in consumer-friendly Washington: A Washington state court yesterday denied Intuitive’s bid to throw out a lawsuit over the death of a patient operated on using the company’s da Vinci surgical system, according to court filings. The judge found the state’s product-liability laws require… Continue Reading
Pay to Delay vs. Generic Liability
Posted in Brand Name Liability, Legal IssuesSo, the Supreme Court will decide two interesting cases. The one below will decide whether or not a brand name manufacturer can simply pay generic companies not to bring generic drugs to market: WASHINGTON (AP) — Federal regulators are pressing the Supreme Court to stop big pharmaceutical corporations from paying generic drug competitors to delay… Continue Reading
AAJ on Generic Preemption
Posted in FDA Regulation, Generic DrugsHere’s a little more in-depth analysis of the generic drug argument before SCOTUS: Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process does… Continue Reading
Manufacturer of surgical robots discouraged training of doctors
Posted in Devices, Surgical RobotsJust imagine the sleazy sales manager who wrote the e-mail below” Company e-mails introduced in a lawsuit filed against Intuitive in Kitsap County, Washington, suggest salesmen lobbied hospitals to scale back doctor training. One manager’s e-mail lauded a salesman for persuading a hospital that five supervised operations were too many. In another, a manager told… Continue Reading
FDA Gives up on Graphic Cigarette Warnings
Posted in UncategorizedOn the one hand it’s disappointing to see them give up the fight. On the other, at least this won’t lead to a SCOTUS ruling that strips the FDA of more power. The fear of such a ruling is why I suspect the FDA gave up. (Reuters) – The government has dropped its push for… Continue Reading
More coverage of generic drug liability
Posted in UncategorizedMore on generic liability: During a one-hour oral argument justices questioned whether federal law, in this case the requirement that generics have same design as the name-brand version, prevents plaintiffs from making such claims under state law. Some justices signaled concern about juries making sweeping judgments about the effectiveness of drugs while others… Continue Reading
Hip Replacements More Likely to Fail in Women than Men
Posted in DePuy Hip Replacement, Stryker Hip ReplacementThis 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… Continue Reading
Mirena Class Action Lawsuit Update
Posted in Devices, MirenaI’ve had a few people ask me whether or not they can join the Mirena class action lawsuit. There actually won’t be a Mirena Class Action on behalf of women injured by the Mirena IUD. Instead, there will probably be a Mirena Multi-District Litigation, or MDL. A Mirena MDL will do what most people think… Continue Reading
Former FDA Chief Wants To Gut Clinical Trials
Posted in UncategorizedWhat 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… Continue Reading
Stryker Hip Implant Lawsuits On The Rise
Posted in Devices, Stryker Hip ReplacementHere’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… Continue Reading
Visit and Like our Facebook Page
Posted in DangerousDrugs.USFor someone with my background in tech, it’s kind of embarrassing that I haven’t been very engaged on Facebook. But, that’s no longer the case. We’ve had a Facebook page for a little while now, and today I put some effort into making it look a little more spiffy. More importantly, it now has its… Continue Reading
Sequester may or may not slow down approvals of generic drugs
Posted in Generic Drugs, PoliticsCould 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… Continue Reading
Our New Pharmacovigilance Specialist
Posted in DangerousDrugs.USI’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…. Continue Reading
Redacted Documents State that Bayer Does Not Believe Mirena Can Migrate After Insertion
Posted in MirenaWhile researching a potential Mirena lawsuit, I came across an interesting document filed in a Mirena lawsuit in South Carolina. In that case, one of the issues is whether a Mirena device can migrate after it has been implanted. The current medical literature makes it pretty clear that IUD’s sometimes migrate to other parts of… Continue Reading
More on the Alabama generics ruling
Posted in UncategorizedBehind a paywall, but still relevant: Business groups are urging Alabama’s highest court to reconsider its recent ruling that name-brand drug makers can be held liable for injuries caused by the generic versions of their products. Source: Generic-Drugs Court Decision Irks Businesses – WSJ.com
Waxman says that the Hatch-Waxman act does not preclude generic liability
Posted in Generic DrugsScalia 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,… Continue Reading
Brand-name drug makers are not happy about Alabama Supreme Court ruling
Posted in Brand Name Liability, Legal IssuesBack 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… Continue Reading
Will health insurance co be on the hook for hepatitis claims?
Posted in Lawsuits, Public HealthWay 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… Continue Reading
Prozac can cause low birth weight
Posted in Prozac Birth DefectsIn 2003, a study by Dr. Victoria Hendrick et al. titled “Birth outcomes after prenatal exposure to antidepressant medication” was published in The American Journal of Obstetrics and Gynecology, aiming to evaluate the risk for congenital malformations in infants whose mothers used antidepressant medication during pregnancy. Using many different parameters and studying different antidepressant drugs… Continue Reading
Paxil Tied to Birth Defects
Posted in Paxil Birth DefectsIn 2006, a research study by Bérard et al., a Canadian research team, titled “First Trimester Exposure to Paroxetine and Risk of Cardiac Malformations in Infants: The Importance of Dosage” was published in Birth Defects Research (Part B) that made several important conclusions about the safety of Paxil® use during pregnancy. In 1,403 infant-mother pairs… Continue Reading
Device used to treat patent foramen ovale recalled
Posted in Public Health, RecallsPatent foramen ovale (PFO) is a birth defect that occurs when then a hole between the right and left atria fails to close after birth. It is can be caused by maternal use of SSRI drugs during pregnancy. Anyone unlucky enough to have been born with PFO may now have just been dealt another blow:… Continue Reading
Will consumers once again be able to sue generic drug manufacturers?
Posted in Generic Drugs, PreemptionLongtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims. The ruling created a legal injustice for those injured by generic drugs. While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough… Continue Reading
2005 – Research Shows Paxil, Prozac Triple Risk for Neonatal Behavioral Syndrome
Posted in Misc. Drugs, Paxil Birth Defects, Prozac Birth Defects, Zoloft Birth DefectsPublished in a 2005 edition of the Journal of the American Medical Association, a study by Dr. Eydie L. Moses-Kolko et al., titled “Neonatal Signs After Late In Utero Exposure to Serotonin Reuptake Inhibitors,” reviews the danger posed to infants whose mothers used serotonin reuptake inhibitors (SRIs), a new type of antidepressant and anti-anxiety medication…. Continue Reading