Drug Recall Lawyer Blog

Here are this week’s stories:

• Vioxx: See Shearlings Got Plowed for a quick summary of the Australian Vioxx trial. Good news.
• Defibrillator Battery Recall: 5,418 battery packs used in Lifeline AED and ReceiveR external defibrillators are recalled. See the FDA’s notice.
• Scientist-CEOs: Should pharmaceutical companies bring back the scientist-CEO business model?
• Kickbacks and Hip Implants: Read about a former umpire’s quest for justice when a hip implant fails, and he finds out about the moneyed relationship between his surgeon and the medical device manufacturer.
• Benicar: The Drug Injury Watch has a post on the possible dangers of Benicar.
• Motrin’s Phantom Recall: See Brian Nash’s blog for his take on the J&J recall.

Happy Monday!

Time to wake up and face the week! Here are the stories we’re following:

• Avandia: The U.K.’s Guardian blogs about GlaxoSmithKline’s potential $6 billion liability. @TomLamb and I are skeptical.
• Vioxx: Australian judge finds for plaintiff in defective drug lawsuit against Merck, though rules that Merck was not negligent. (HT: Pharmalot). Merck’s press release is here.
• FDA: The FDA is going to step up criminal prosecutions of corporate officials.
• Insulin Pump Defects: Insulin pumps have been beset by problems, spanning across the spectrum of manufacturers (HT: Drug Injury Lawyer Blog).
• 510k Approvals in February: See the list here.
• Direct-to-Consumer Advertising: BigPharma’s DTC advertising increased by a “paltry” 1.9% in 2009, but Pfizer leads the pack with $1.1 billion.
• BPA: Wisconsin is added to the list of states banning BPA in baby bottles and cups.
• Nerd Link of the Week: You’ll just have to click to find out…

Happy Monday!

Some interesting news to follow this week:

• Vioxx: The Pop Tort reports on how “lawsuits played a key role unearthing documents showing what lengths Merck went to cover up mounting evidence that patients taking Vioxx were experiencing a high number of heart attacks and strokes.” Now, Vioxx manufacturer Merck settles some shareholder lawsuits, and includes some proactive measures to protect against these abuses in the future.
• Benzene: The Accident and Injury Lawyer Blog reports on the dangers of benzene.
• Medical Radiation: Much continues to be written about radiation as it relates to diagnostic procedures, especially in the wake of the FDA’s newest guidelines. The Mass Tort Defense Blog opines that plaintiffs’ lawyers seeking medical monitoring for their patients may do more harm than good on the basis that it will increase radiation exposure. There is some logic to this, but shouldn’t patients be the ones to choose?
• Lipitor Whistleblower Lawsuit: FiercePharma reports on an amended complaint by a whistleblower, alleging that Pfizer unethically expanded its marketing base by ignoring cholesterol guidelines.
• Recall of Luer Access Devices: The FDA is posting recalls of Luer Access Devices, including certain lots of BD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems and certain lots of IV Extension Sets with BD Q-Syte™ Luer Access Device. These devices do not properly lock, causing leakage of intravenous materials or blood, or causing air emboli.
• Pain Pumps: This is a good graphic representation of the pain pump system

Some noteworthy news items to start your week:

• Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
• Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.
• FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
• Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

Here’s a list of some important stories we’ve been tracking.

• Boston Globe article probing the financial ties between Massachusetts doctors and Eli Lilly, a large drug manufacturer. “When the [drug] company provides the power point [for the doctor’s presentation], the risk of bias is even greater.”
• Seattle Post Intelligencer article examining the fatal overdose of a 15-year-old teen with autism. Michael Blankenship had a dental procedure and was given a Fentanyl Pain Patch. These are typically product liability cases, but it looks like Michael never should have received the patch in the first place, so Michael’s family has filed a medical negligence complaint.
• Drug Recall of specific lots of Infants’ and Children’s Tylenol (Johnson & Johnson) because of bacterial contamination.
• Update on Vioxx settlement: $4.85 billion.

Merck & Co. announced last week that they are settling third-party claims related to Vioxx. These are not the personal injury cases (cases by patients and their loved ones for heart attacks or other Vioxx injuries, most of which have already been settled for $4.85 billion), but rather these are lawsuits by unions and insurance companies against Merck, claiming that they overpaid for Vioxx in light of the drug’s risks.

The settlement, which has not been finalized but has been agreed to in principle, pays $80 million to settle 190 claims about the recalled drug. The document disclosing the settlement, Merck’s filing with the U.S. Securities and Exchange Commission, also revealed that the SEC’s formal probe of Merck surrounding Vioxx has ended. There are still outstanding third-party claims not involved in this settlement.

These third-party claims do not see a lot of play in the press. They are “faceless” claims by states, insurance companies, and other payers, none of whom suffer serious personal injuries. They are, however, becoming an invaluable component of drug litigation. It is one more hurdle for drug companies who put out dangerous drugs, and one more way to make sure the bottom line for defective or negligently marketed drugs is not as high as it otherwise would be. And, these are damages to taxpayers and members of insurance plans—one more reason we all have higher taxes and higher premiums.