Drug Recall Lawyer Blog

After eight hours of deliberations, a Montana jury found that a Breg infusion shoulder pump was defective and caused injury to an orthopedic surgeon.

Plaintiff's verdict? Not so fast. The jury found the product was defective but that the infusion pump conformed to the state-of-the-art design at the time it was sold. This can be fatal to a failure to warn claim.

The state-of-the-art defense under Maryland law in strict liability, failure to warn cases was explained in the landmark claim of Owens-Illinois Inc. v. Zenobia (which is best known for requiring actual malice for punitive damages in Maryland). Zenobia found that the manufacturer of a product, which is defective only because of the lack of an adequate warning, is not liable when the failure to warn resulted from an absence of knowledge of how dangerous the product was. Still, required knowledge is "knew or should have known" - it can be established by evidence that the risk should have been known because it was known in the scientific or expert community. This knowledge is called the 'state of the art' evidence.

Continue reading "State of the Art Defense" »

An article in the Ohio Columbus Dispatch reminds us that pain pumps are not just problematic for people with shoulder surgery. The article highlights the fact that pain pumps are not approved or safe to use next to any of the body's joints. The article focuses on college-age athletes who used a pain pump immediately following otherwise routine knee surgeries. Now, those athletes have difficulty sleeping and walking without pain, because the cartilage that used to pad the joint is now gone or significantly eroded. One patient said that her doctor told her she can't wear high heels or get pregnant because of the stress that will put on her weakened knee.

The lawsuits generally allege that manufacturers failed to warn doctors about the dangers of placing pumps near joints, and further allege that manufacturers encouraged that placement to orthopedic surgeons, who relied on that advice to the lifetime detriment of their patients. The manufacturers dispute the off-label claim, but many doctors have come forward to talk about how they were duped by medical device manufacturer's sales representatives.

Joint reconstruction and cartilage transplants are options for these patients, but it is extremely rare for them to recover 100%.

Pain pumps have been used with bad effects in shoulder, knee and even toe surgeries. The prime rule for patients is to refuse them anywhere near cartilage.

For more information on pain pumps, see our prior Drug Recall Lawyer Blog posts, and our main Pain Pump Website.

Here are this week’s stories:

• FDA: The FDA is changing the medical device approval process. See the FDA announcement (HT: Eye on FDA).
• FDA II: Little progress on more FDA independence and power in drug safety reviews (An appropriate lament by Tom Lamb).
• Heparin: Congressional examination into the contaminated Heparin debacle (HT: FiercePharma).
• Tylenol Recall: Seems we just went through this. Here’s another one, affecting infant/children Tylenol, Motrin, Zyrtec and Benadryl. See the recall notice.
• Pain Pumps: Drug and Device Law Blog’s view of the recent MDL denial.

Happy Monday!

Here are this week’s stories:

• Shoulder Pain Pump MDL Denied: The Judicial Panel on Multidistrict Litigation denied the plaintiffs’ request for consolidation in an Order. I disagree with the rationale).
• Hospira: Drug-maker Hospira received two FDA warning letters about manufacturing problems.
• Bayer Price-fixing: The Mississippi Supreme Court has overturned a trial court’s dismissal of a case alleging that Bayer inflated drug prices and “drove up the state’s Medicaid spending.” The attorney arguing the case told the Court that Mississippi lost over $1 billion because of Bayer’s fraud.
• YAZ: The LA Times has an article about the YAZ litigation and injuries. The picture’s caption says that “Studies have not found an increased risk with these pills”; though further in the article it acknowledges that “Research on the issue is divided . . . . some studies show a sixfold greater risk.”
• Kugel Mesh: Ron Miller reviews the recent trial.
• Epilepsy & Depression Drugs Linked to Suicide: A new study gives patients reason to talk to their doctors, especially about off-label uses of these drugs (HT: Drug Injury Lawyer Blog).

Have a great week!

Here are the stories we’re following this week:

• Yasmin: Bayer is updating its European warning label after recent Swiss studies (HT: Tom Lamb)
• Direct-To-Consumer Drug Advertising: FDA proposes new regulations (HT: Mass Tort Defense Blog)
• Zicam: Update on the Zicam (nasal spray that may cause loss of sense of smell) MDL, pending in Phoenix (HT: Searcy Blog)
• Pain Pumps: California state judge cuts up pain pump claims (HT: Drug & Device Law Blog)
• Drug Companies: Three drug companies (Pfizer, Solvay, and Procter & Gamble) found to have breached the British Pharmaceutical Industry’s code of practice (HT: PharmaGossip)

Happy Monday!

Today in sunny San Diego, the Judicial Panel on Multidistrict Litigation (JPML) is hearing plaintiffs’ requests (see our blog post on the December 2009 petition) to convert the individual federal pain pump cases into one MDL, centralized before the District of Minnesota. See page 4 of the Notice of Hearing Session. Right now there are at least 104 federal pain pump cases proceeding in 28 distinct federal courts. The great majority of them are the same in numerous ways:

1. A pain pump was -placed into the intra-articular space following open or arthroscopic shoulder surgery.
2. The pump remained there for approximately 24-72 hours, providing post-surgical pain relief.
3. The patient, despite physical therapy, continued to have worsening shoulder pain beginning about three months after surgery.
4. Later x-rays, MRIs and surgeries show that the patients cartilage, located in the glenhumeral joint, has totally wasted away.

The defendants in the pain pump cases are the manufacturers of the pain pumps and, in some cases, the manufacturers of the anesthetic used in the pain pumps. Plaintiffs are proving that the pump manufacturers marketed their pumps to shoulder surgeons, telling them exactly how to place the pump’s catheter into the intra-articular space so the patient received maximum pain relief. However, the manufacturers never told doctors that the procedure was denied by the FDA three times for lack of safety data. And now, many patients cannot perform their jobs, cannot enjoy basic recreation (swimming, jogging, rock climbing, etc…), and even have difficulties sleeping because of the constant pain of bone-on-bone contact in their shoulder joints.

The goal of the motion (which was brought once before when the pain pump cases were brand new) is to bring the federal cases together before U.S. District Court Judge Tunheim in Minnesota. Judge Tunheim has been overseeing a large proportion of the pain pump cases in a sort of “mini-MDL” for some time, now. He has the experience with pain pump cases and the experience with MDLs to get the job done right. Consolidation would prevent duplicative discovery, and generally make the process of litigation more efficient. It is the right move, so we’re crossing our fingers that the JPML grants the petition.

For more information on Pain Pump lawsuits, contact us at 1.800.553.8082, or click here for an internet consultation.

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

Happy Monday!

A short article by FiercePharma, a monitor for the pharmaceutical industry, got me thinking about sales reps. The article, “Pfizer, Merck reps are tops to cardiologists,” summarized a poll of cardiologists sales representatives from the top pharmaceutical companies. Here they are, in order of “best to worst”:

• Pfizer
• Merck
• Schering-Plough
• AstraZeneca
• Novartis

Among the issues graded were product knowledge, understanding of doctors’ schedules, conduct, and samples. I don’t know how many pharmaceutical companies were graded—for example, is Novartis really bad, or were these the top five out of, say, 100 companies? At any rate, the article prompted me to think a little more about drug and device sales reps.

Continue reading "Sales Reps Can Be Important To Your Drug/Device Lawsuit" »

In the wake of last Friday’s $5.5 million verdict for a pain pump patient and his wife, the media has picked up the pain pump story. Interestingly, The New York Times has an article in the Sports section, “Studies Link Rare Ailment to Pain Pumps.”

The article is in the Sports section for good reason—many of the patients whose shoulders have been ruined by pain pumps were high school and college athletes. I’ve spoken with swimmers, volleyball players, and softball players. One bowhunter I spoke to told me how humiliating it was to be hunting with his buddies, using a crossbow while they used compound bows, simply because he no longer had the arm strength to pull back the bowstring.

Continue reading "The Media’s Take On Pain Pumps" »

Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:

• Direct-to-Consumer Advertising: FiercePharma lists the top ten drugs for percentage of web-based traffic from DTC ads. YAZ is seventh, even “better” than Viagra.
• Radiation Therapy Malpractice: Pat Malone reports on the dangers of technology, training and procedures in radiation therapy: “Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions.”
• FDA Chastises GE: The FDA warns GE that its website for Visipaque is misleading. Visipaque is a drug used with x-rays to provide clearer images, and the FDA reports that there is no data showing it to be safer than other contrast agents. GE is currently facing lawsuits on it’s MRI contrast dye, Gadolinium.
• Meridia: Tom Lamb and the Drug Injury Watch report on a possible Meridia drug recall.
• Glaxo and Merck Disclose (Hide?) Payments to Doctors: The TortsProf Blog cites a story about Glaxo and Merck publicizing the money they give to doctors. The blog reports that the disclosure lists were “difficult to locate.”
• Hormone Therapy: Bloomberg reports that a judge denied Pfizer’s attempts to forcibly remove a YouTube video on hormone therapy, posted by Plaintiffs’ attorneys. The judge did, however, require the attorneys to rename the video and indicate it was not a news segment (which was obvious from watching the video). See the video here.

Happy Tuesday!

On Friday, an Oregon state court jury determined that I-Flow Corporation (through Kimberly Clark, its parent company as of late last year) owes Matthew and Krista Beale $5.5 million for defects associated with their On-Q pain pump. The pain pump is a device used after surgery to continuously administer anesthetic (usually bupivacaine or ropivacaine-type drugs) for a few days. I-Flow heavily marketed the drug for use in the shoulder joint after arthroscopic shoulder surgeries (SLAP tear repairs, rotator cuff tears, etc…), despite numerous rejections by the FDA for that indication, because of a lack of safety information. The anesthetic used in these pumps is toxic to cartilage cells, and exposure of even one day can completely destroy the shoulder cartilage, which cannot regrow or heal itself.

Like so many other patients who received the pain pump, Mr. Beale will have to endure at least one shoulder reconstruction surgeries, potentially permanent loss of mobility, and likely constant pain in his shoulder. Mr. Beale is a 38-year old father of four. The verdict was $4.225 million to Mr. Beale, and $1.275 million to Mrs. Beale.

This is simply the first of many plaintiffs’ verdicts. There are numerous pain pump manufacturers, including Stryker, Breg and McKinley Medical. There are very few things that can cause this type of injury, making the pump an easy suspect to rule in. Furthermore, the regulatory behavior of the device manufacturers clearly indicates that they did not have the right to market the pumps for this off-label use. However, they ignored the risks and promoted the pump directly to orthopedic surgeons, who relied on the manufacturers for their expertise.

See other Drug Recall Lawyer Blog posts on pain pumps, or refer to our pain pump website for more information.

Judge Tunheim of the U.S. District Court for the District of Minnesota denied the pain pump defendants’ motion to transfer one of eighteen pain pump cases (the Ivey case) before that court on Monday. The motions’ practice was among the best we have seen for motions to transfer venue. Kudos to Rob Jenner, Yvonne Flaherty, Irwin Levin, Greg Laker and Jeff Gibson, the attorneys handling Plaintiffs' case.

Here are the key facts, as argued by the pain pump defendants:

Continue reading "Motions To Transfer Venue In Pseudo-MDL Cases" »

Two days ago, plaintiffs in several shoulder pain pump cases filed a renewed petition for transfer, consolidation and/or coordination in an MDL (MultiDistrict Litigation). The 82-page motion (with exhibits) was made before the Judicial Panel on MultiDistrict Litigation. The last petition was denied on August 11, 2008.

You can see a copy of the petition here.

Continue reading "Renewed Motion for Pain Pump MDL" »

Some items of interest while you eat turkey sandwiches for lunch, today:

• Class-1 recall of Stryker’s Navigation System II: 23 of these units are potentially faulty. The device is a computer-aided surgery platform that performs hip, spine, knee, neuro and ENT surgeries. The computer may not work properly, which could lead to serious injury or death. Stryker is also a manufacturer of shoulder pain pumps.
• Second bellwether Fosamax case dismissed:
  Judge Keenan (S.D. New York) dismissed the second of three Fosamax bellwether cases last week because of lack of specific causation (proof that Fosamax caused her injury, which is different from general causation—proof that Fosamax can cause these types of injuries). The third case is set for an April 2010 trial.
• Making drug safety information more accessible to patients: discusses the labeling of drugs, and whether those labels are sufficient for detailing drug efficacy and safety issues (hat tip to Tom Lamb at www.DrugInjuryWatch.com).
• AstraZeneca performs its own Seroquel study—surprised at what they found? Dr. Paul Woolf, a paid consultant who has received more than $216,000 from AstraZeneca, intends to testify that he reviewed AstraZeneca’s 2004 study on Seroquel, and that it shows the drug does not significantly affect blood-sugar levels. See our other blog posts on Seroquel and the findings of other studies (including AstraZeneca’s own covered-up research).

Happy Monday!

After reviewing some of the myriad reports detailing the chondrolysis (loss of cartilage) from patients following routine arthroscopic shoulder surgery, the FDA is now mandating that the manufacturers of local anesthetics (for example, bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine) place specific warnings on their drugs.

The FDA's notice to healthcare providers states:

The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics.

Specifically, healthcare providers are warned against using these drugs in pain pumps for continuous intra-articular infusion of local anesthetics after orthopedic surgery. The warning is not limited to shoulder surgery.

The requirement that drug manufacturers place appropriate warnings on their drugs is a significant step forward, and bolsters the position of plaintiffs in pain pump cases around the country. In many of those cases, the pain pump manufacturers and the manufacturers of the anesthetic drugs have been sued. The anesthetic manufacturers are disclaiming liability, saying that they have no responsibility for how their drugs are used. Clearly, the FDA thinks otherwise.

Stryker and many of its executives have been indicted on charges of wire fraud, conspiracy to defraud the United States Food and Drug Administration, distribution of a misbranded device, and making false statements to the FDA. The charges were made by the U.S. Attorney’s Office for the District of Massachusetts.

Continue reading "Patterns Of Behavior: Stryker Encourages Off-Label Use" »

Last week, Kimberly-Clark Corporation and I-Flow Corporation announced their agreement for the sale of I-Flow to Kimberly-Clark. News reports reveal that the transaction is valued at $276 million. I-Flow has net sales of over $1 billion, and has always had the largest market share of the pain pump business. However, there have long been concerns about I-Flow’s financial viability, specifically with regard to the shoulder pain pump litigation. It was disappointing that the press release did not mention the impact to pending litigation, or the degree to which that litigation affected the transaction. However, it appears that there is a shareholder lawsuit brewing over the expected sale.

For our money, the sale is a good thing. First, Kimberly-Clark, though having low medical device experience, is a reputable company that will hopefully steer I-Flow in the right direction (away from the mismanagement and dollar-focused predecessors). Second, it means that there may be some assets available so injured patients don’t end up being left with only I-Flow’s parking lot…

For more on Pain Pumps, see our website.

Ask any pharmaceutical or medical device lawyer—one of the biggest problems in tackling these cases is product identification (sometimes referred to as PID). As an example, in the gadolinium MRI cases, it can take months (or longer) to go through and determine (1) whether the patient had gadolinium used for any particular MRI or MRA scan, and if so then (2) what brand of gadolinium was used. The brand is important because the lawsuit must identify a proper defendant.

Continue reading "Tracking Defective and Recalled Drugs and Medical Devices" »