Drug Recall Lawyer Blog

Here are the stories we're following:

• Levaquin: NJ.com reports that Levaquin manufacturer Johnson & Johnson may have paid millions in kickbacks to a large pharmacy for prescriptions to nursing home patients. The complaint was filed by the U.S. Attorney in Boston.
• Acetaminophen: An article published in the medical journal Thorax ScienceDaily reports that there may be a direct link between use of acetaminophen during pregnancy and child asthma.
• Twombly/Iqbal Statistics: The Federal Judicial Center has collected preliminary data on motions to dismiss before and after Twombly and Iqbal (hat tip: The Civil Procedure and Federal Courts Blog).
• Prempro: Bloomberg discusses Judge Ackerman's reduction of the Connie Barton punitive damages verdict (by 93%, from $75 million to $5.6 million) and added $1.2 million in interest to the jury's compensatory damages verdict of $3.7 million.

Happy Monday!

As you remember, Fosamax, Merck’s osteoporosis drug, is the subject of much litigation. The question presented is whether the drug causes osteonecrosis of the jaw, which is the death of jawbone tissue.

Judge Keenan, ruling over the federal Fosamax cases from his bench in the U.S. District Court for the Southern District of New York (Manhattan), decided that Merck was not entitled to dismissal of the Louise Maley case on the issue of specific causation (essentially, Merck argued that plaintiff could not prove that Fosamax caused her injury. This is different from general causation, which is the argument that Fosomax can cause injuries of this type). The plaintiff did not argue against dismissal of her strict liability and warranty claims, however. Her case will proceed on a failure to warn claim. See the Order (hat tip: Shearlings Got Plowed). The Maley case will go to trial on April 19, 2010.

So, Plaintiff Maley survived where Bessie Flemings could not—Judge Keenan dismissed her case (set for trial this month) last November on specific causation grounds.

In other Fosamax lawsuit news, Judge Keenan is set to select a replacement bellwether case shortly.

Judge Keenan is overseeing something like 700 lawsuits. As of last year, Merck had about 953 cases pending against them. Everything I have seen from these cases indicates that the plaintiffs have extremely meritorious claims. This is one litigation that I regret not getting into.

The Lancet has retracted [free subscription required] the 12-year old article connecting autism to MMR (measles, mumps and rubella) vaccinations. The Lancet stated:

Following the judgment of the UK General Medical Council's Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al1 are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were "consecutively referred" and that investigations were "approved" by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.

Click here for the original article, “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and
pervasive developmental disorder in children” (emblazoned with a bold, red typeface “RETRACTED”).

Here’s a summary of the posts on the internet and blogosphere:

Continue reading "In The News: Vaccines & Autism" »

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" »

Here are links to some stories we’re following:

• Hormone Therapy: New Philadelphia hormone therapy case proceeds to trial, and the plaintiff’s twin sister, who sits in the courtroom and took a different type of hormone therapy, did not have cancer. Both sides try to use it to their advantage
• Ortho Evra MDL: The judge addresses the issue of plaintiff ex parte communication with treating physicians (HT MassTortDefense Blog)
• Digitek: Bad news for some plaintiffs’ lawyers in the Digitek lawsuits (HT Overlawyered)
• Social Media and Drug Companies: Several drug companies have banded together to comment on the FDA’s proposed policies on promotion of medical products using the internet and social media (HT Pharma Marketing Blog)

Happy February!

We’ve been fielding questions lately about the cardiac stents that have been all over the news here in Baltimore. One of the inevitable questions is whether the stent is defective. There’s no indication that the stents implanted at St. Joseph Medical Center are defective—in fact, there is no evidence that the stents are of any particular brand or manufacturer. A few years back there was discussion about defective Johnson & Johnson Cypher Stents, which one Cleveland Clinic study showed to be four to five times more likely to cause blood clotting. The issue here is not one of defective stents, but rather medical malpractice.

Though it is outside the scope of this blog, it does touch close to home, happening here in Maryland. And, we’ve been fielding questions about these stents, so this is as good a forum as any. So, a little discussion.

Continue reading "St. Joseph’s Stents: Device Defect or Medical Malpractice?" »

The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:

• Issues related to predicate devices;
• Issues related to new technologies and scientific evidence;
• Issues related to practices CDRH has adopted in response to the high volume of 510(k) submissions; and
• Issues related to postmarket surveillance and new information about marketed devices.

The FDA receives over 3,000 510(k) submissions every year. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” After much backlash last year about FDA scientist/employee complaints about corruption, safety problems, conflicts of interest and budgeting, the Institute of Medicine (IOM) was called on to comprehensively study (to the tune of $1.3 million) the 510(k) process. That study is expected to be completed in March 2011, but this meeting is a companion to that study.
Conference Details:

• Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877
• Live webcast

Related documents:

• The FDA’s Press Release
• Notice of the Public Meeting
• Background information of 510(k) process
• Announcement of Institute of Medicine’s study of 510(k) process

This meeting is another good step the administration has taken to put patient safety first, and to rigorously watch over the medical device regulatory process.

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 Sandra Mazer Moss ruled in the Philadelphia hormone therapy cases that plaintiffs’ expert witness testimony was admissible, contrary to defendants’ assertions that the testimony was novel, and that the conclusions used by the experts relied on differential diagnosis. The Judge held that “I am not convinced by a preponderance of the evidence that differential diagnosis . . . is novel science.” FYI, differential diagnosis, a process of elimination, is a fundamental means of diagnosis taught by all medical schools. Therefore, the evidence will be admissible, and defendants may attack it in front of a jury.

The ruling applies to the majority of Philadelphia’s Court of Common Pleas hormone therapy cases. One new hormone therapy trial started yesterday, and another will commence next Monday.

Back in June (Statistics, Part I), we reported on the U.S. Department of Justice’s Civil Justice Survey of State Courts, covering 2005 state court trials. Though official statistics have not been released by the DOJ for 2006 to 2009, a recent Bloomberg article, Jurors Turned Against Companies in 2009 Product-Defect Cases, analyzes last year’s product liability verdicts through the lens of the recession and general consumer distrust of Big Business.

The reporter, Margaret Cronin Fisk, notes the following for 2009 product liability lawsuits (which were not limited to just state courts):

• The top 5 product defect verdicts were 52% larger in 2009 (at $620 million), as compared to 2008
• The largest 2009 product defect verdict was for $300 million (Altria’s Philip Morris was the defendant in tobacco litigation)
• 5 of the 50 largest verdicts in 2009 were for defective products (compared to only 1 in 2008)
• In 200, 10 of the 50 largest verdicts were for defective products.

In 2005 state courts, there were 346 product liability trials, 28 of which were for drugs or medical devices. Excluding asbestos cases, plaintiffs won 19.6% of product liability trials in 2005. Also interesting, is that in 2005, 10.2% of all tort cases in Philadelphia were product cases (this is a trend that likely continues, in large part because of the hormone therapy cases). The only other county with a higher percentage was San Francisco, at 12.7%.

I’d love to get my hands on the raw data used by the DOJ—it would be interesting to compare the largest product liability verdicts from pre-recession 2005 with those reported by Bloomberg for 2009. That data must be on the internet somewhere…