Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Category Archives: Legal Issues

Subscribe to Legal Issues RSS Feed

FDA won’t say which drugs on the market were approved based on fraudulent research

Posted in Drug Studies, FDA Regulation

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

Pay to Delay vs. Generic Liability

Posted in Brand Name Liability, Legal Issues

So, 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 Drugs

Here’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 Issues

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… Continue Reading

Will consumers once again be able to sue generic drug manufacturers?

Posted in Generic Drugs, Preemption

Longtime 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

Drug Company Was "Prison Raped" At Hepatitis Trial

Posted in Jury Verdicts

The 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 Preemption

A 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

Big Pharma Could End Mass Tort Litigation, But It Is More Profitable To Get Sued

Posted in Lawsuits

That 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 Preemption

Bruesewitz 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

Small Settlements In Seroquel Lawsuits

Posted in Lawsuits

The 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 Regulation

This 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 Lawsuits

Just 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 Regulation

I 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 Regulation

These 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 Lawsuits

Unfortunately, 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 Regulation

This 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. Drugs

I 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