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
Category Archives: Legal Issues
Subscribe to Legal Issues RSS FeedPay 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
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
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
Actos Lawsuit Discusses History of Actos and Bladder Cancer
Posted in Actos & Bladder Cancer, Drugs, LawsuitsOn September 9th of 2011, an Actos bladder cancer lawsuit was filed by an Actos lawyer in the United States District Court for the Eastern District of Louisiana. The lawsuit was filed on behalf of a Louisiana husband and wife. The husband developed bladder cancer after using Actos for a number of years. The Actos… Continue Reading
Drug Company Was "Prison Raped" At Hepatitis Trial
Posted in Jury VerdictsThe editorial below discusses the $1 billion dollar verdict against drug companies Teva and Baxter. Said one lawyer requesting anonymity, “The defense counsel will get absolutely railroaded by Judge Walsh, and when I say railroaded, I mean prison raped.” Those of us out here in the cheap seats were under the impression hepatitis was spread… Continue Reading
Solicitor General Files Brief in Pliva v. Mensing, Rejects Preemption
Posted in PreemptionA little late, but better than never. Especially since the Solicitor General agrees that failure to warn lawsuits against generic manufacturers are not preempted by the FDCA: The court of appeals correctly rejected petitioners’ contention that respondent’s failure-to-warn claims are categorically preempted by the FDCA, and its decision is consistent with the decision of the… Continue Reading
Vermont Federal Court Embraces Conte, Holds Brand-Name Manufacturer Liable
Posted in Brand Name LiabilityHere’s a hypothetical for you: A patient goes to see a doctor about chronic heartburn. The doctor thinks Reglan might be a good choice, so the doctor goes to the Physicians’ Desk Reference and reads the label for Reglan. That label was written by Wyeth, which was the brand-name manufacturer of Reglan. Based upon what… Continue Reading
$257 Million Dollar Verdict In Risperdal Lawsuit
Posted in Jury Verdicts, Misc. DrugsThis is not a good year for Johnson & Johnson. Johnson & Johnson lost a $257.7 million jury verdict in Louisiana for making misleading claims about the safety of the company’s Risperdal antipsychotic drug. * * * * The jury found 35,542 violations of the state’s Medical Assistance Programs Integrity Law and imposed a penalty… Continue Reading
Big Pharma Could End Mass Tort Litigation, But It Is More Profitable To Get Sued
Posted in LawsuitsThat sounds crazy, I know. But here’s my logic. The vast majority of pharmaceutical lawsuits are brought under what’s called a failure to warn theory of liability. Failure-to-warn lawsuits allege that a manufacturer of a drug didn’t accurately inform a plaintiff about the risks associated with taking a specific drug. If the manufacturer does give… Continue Reading
Another Wyeth Preemption Case Goes to the Supreme Court
Posted in PreemptionBruesewitz v. Wyeth looks like it will be the Wyeth v. Levine of vaccine lawsuits: Erwin Chemerinsky, a liberal scholar, and Kenneth Starr, a conservative, may appear to be the Oscar and Felix of constitutional law, but they’re also friends and, perhaps surprisingly, share essentially the same view in one, increasingly hard-fought area of constitutional… Continue Reading
Allergan’s $600 Million Dollar Headache
Posted in FDA Regulation, Off Label MarketingDrug marketing 101: The FDA approves drugs for specific ailments. Drug companies may not market the drug to treat any other type of ailment. If they do, it’s called off-label marketing and it is illegal. Drug marketing 201: It’s often very profitable to engage in off-label marketing, because the fines you pay are less than… Continue Reading
Will the FDA Finally Get Subpoena Power & Recall Authority?
Posted in FDA Regulation, PoliticsDid you know that the FDA doesn’t have subpoena power? That’s the power to make a company hand over a document. Every single attorney in the U.S. can subpoena a document from a pharmaceutical company, but the FDA (which is supposed to regulate pharmaceuticals) doesn’t have that power. Citing a recent spike in pharmaceutical recalls,… Continue Reading
Small Settlements In Seroquel Lawsuits
Posted in LawsuitsThe fact that the average plaintiff will receive $10,000 doesn’t surprise me. These were very, very difficult cases to prove. There are many causes of diabetes, and it’s pretty tough to prove that Seroquel is what caused it. AstraZeneca Plc agreed to pay $2 million to settle more than 200 cases over its antipsychotic drug… Continue Reading
FDA Launches New Website To Show Safety Information Of New Drugs
Posted in FDA RegulationThis is a great step towards greater transparency: WASHINGTON — The Food and Drug Administration launched a website Tuesday where patients and health care professionals can find safety information about recently approved drugs and vaccines. On the Postmarketing Drug Safety Evaluations site, the FDA plans to share what it has learned about the safety of… Continue Reading
CVS Sued for selling expired products
Posted in LawsuitsJust goes to show you that you should always check expiration dates – even if you buy from reputable vendors. Connecticut Attorney General Richard Blumenthal said Monday that his office is suing a unit of CVS Caremark Corp. for allegedly selling expired over-the-counter drugs and other products in its stores in Connecticut. In a statement,… Continue Reading
FDA plans to speed reviews and visit China
Posted in FDA RegulationI agree that visits to China should be at the top of the FDA priority list. I’m not sure about increasing the speed of drug reviews, though, unless that speed increase comes from increased staff. Asking existing staff to do more in less time is a recipe for another Vioxx disaster. NEW YORK (Reuters) –… Continue Reading
FDA employees will receive training at Duquesne University
Posted in FDA RegulationThese employees are charged with reviewing applications to market new drugs. Obviously, the more training they get, the better. (And if you didn’t know, it’s pronounce Dookane.) Duquesne University will have a hand in the training of federal employees charged with reviewing pharmaceuticals, as part of a consortium of schools that won a two-year $652,000… Continue Reading
Class Action for Those Who Purchased Complete MoisturePlus
Posted in LawsuitsUnfortunately, I had the opportunity to view some of the evidence against AMO in this case. That evidence included graphic depictions of those who have lost their eyes or been forced to undergo eye surgery due to infections developed while using this solution. (shudder) Here’s some news about a class action lawsuit relating to the… Continue Reading
Drugmakers Seek FDA Seal of Approval for Internet
Posted in FDA RegulationThis sounds like a fantastic idea to me. WASHINGTON, Nov 9 (Reuters) – A drug industry group on Monday urged the U.S. Food and Drug Administration to adopt a universal safety symbol for Internet content containing FDA-approved information about a medicine or medical device. The proposal from the Pharmaceutical Research and Manufacturers of America, which… Continue Reading
FDA Taking Interest In Link Between Gadolinium and Nephrogenic Systemic Fibrosis (NSF)
Posted in FDA Regulation, Misc. DrugsI think I first learned about the link in early 2008. Nice to see the FDA taking an interest. WASHINGTON, Nov 17 (Reuters) – Some contrast agents used with magnetic resonance imaging scans appear to carry a higher risk of a potentially fatal skin disease than others, U.S. drug reviewers said in documents released on… Continue Reading
FDA Considering Outsourcing Core Functions
Posted in FDA RegulationAs if that wasn’t bad enough, they’re considering outsourcing them to a group with strong ties to the pharmaceutical industry. Sounds like a bad idea to mw. WASHINGTON (Dow Jones)–The U.S. Food and Drug Administration is considering outsourcing decisions about the effectiveness of antibiotics, according to Rep. Rosa DeLauro (D., Conn.). "It is very troubling… Continue Reading