Products Liability

May 5, 2009

Hydroxycut Recall

The FDA has warned users of weight loss drug Hydroxycut to stop taking the popular weight-loss product because of risk of severe liver damage. The Hydroxycut recall focuses us all for the zillionth time on FDA’s inability to sufficiently police so much as a high school prom. But they never do anything about it.

The FDA is officially in the “Britney Spears Zone” for just about everyone. If they accidentally approved heroin capsules tomorrow, the New York Times and the Washington Post’s editorial sections would light up for a week. Then it would be back to business as usual and nothing would change.

May 1, 2009

Botox Black Box Warning

by Ronald V. Miller, Jr.

The FDA announced that it will now require Botox and its progeny to provide a black-box warning. The FDA said the labeling is necessary to warn doctors and patients that Botox has potentially fatal complications, including problems with swallowing or breathing. The FDA has identified at least 225 reports of medical problems among patients treated with Botox and similar drugs.

If there was a stock available in 2004 called “The FDA Will Eventually Require Black Box Warnings for Botox But It Will Take Awhile”, I would have bought a ton. Unbelievably predictable.

March 4, 2009

Wyeth v. Levine!

by Ronald V. Miller, Jr.

Wyeth v. Levine!!!! Plaintiffs’ lawyers have seen drug (and medical device) injury victims take punch after punch. But in a huge win for patient safety, the Supreme Court upheld in a 6-3 ruling today that in a Vermont woman’s verdict against Wyeth for injuries she suffered after taking one of the drug maker’s medicines. Justice John Paul Stevens, writing for the majority, said FDA oversight of drug labeling doesn’t prevent the filing of state tort claims.

It is a little pathetic that this is a huge win. Gee, the law for the last 90 years will not be completely uprooted. Yippy! But the Drug and Device Law Blog predicted victory and those guys have been on the winning side of most everything lately. (A guest Drug and Device Law blogger also broke down the justices individually and predicted victory but I cannot find the post to link to it.) So I’ll admit I was more than a little scared. Now, I’m thrilled that even this conservative Supreme Court found decisively in favor of the Plaintiff.

The one downside: a loss may have mobilized Congress to act. This win in Wyeth v. Levine could ironically slow progress on a bill to overturn Medtronic v. Riegel.

September 8, 2008

Average Wrongful Death Verdicts for Females: Age Is More Than a Number

by Ronald V. Miller, Jr.

Interesting data from Jury Verdict Research on the median and average values of wrongful death cases where the decedent is female. The overall average compensatory award for wrongful death of an adult female over the last eight years in the United States is $2,990,032 ($1,102,976 is the median).

Age is a big variable when looking at median and average female wrongful death values. The average wrongful death verdict for a female between 18 and 24 is 2,990,032 ($1,102,976 median). For females between 30 and 39, women who are far more likely to have left behind children, the median wrongful death verdict escalates to $5,605,127 ($2,500,000 median). For women over 80, the average wrongful death verdict plummets to $1,314,241 (322,920 median).

I always find it maddening when insurance companies discount the value of human life in wrongful death cases because of the age of the decedent. If you are eighty years old and you are killed, those last 10 years of seeing your kids as adults, your grandchildren coming of age and everything else that comes with it are valuable years. But these numbers, regrettably, show that there is some logic to their thinking for how juries value wrongful death cases.

September 3, 2008

Plaintiffs’ Lawyer Are Committing Fraud and Defense Lawyers are Powerless to Stop It

by Ronald V. Miller, Jr.

The Mass Torts Blog, another defense lawyer blog brought to you by our friends at Dechert, posts on Labor Day about medical screening in mass tort cases. The allegations are basically that plaintiffs’ product liability lawyers are committing fraud when screening clients. Read the post for yourself and tell me that it is not a fair summary of what the post alleges.

It would be nice to have a more moderated voice coming from Dechert, a fantastic international law firm, as opposed to the defense lawyer version of Ann Coulter. But if what the Mass Tort Blog is saying is correct – that many plaintiffs who accepted settlements in the asbestos, silica, fen-phen, silicone breast implant, and welding fume litigations were fraudulent, manufactured claims – where were the defense lawyers to protect the defendants from this fraud?

Obviously, it was easy to make this determination, as Cardozo Law School Professor Lester Brickman had done in his study, which was relied upon in the Mass Torts Blog post. Were defense medical examinations a condition of settlement? Did they just blindly trust the plaintiffs’ lawyers? If this really is the case, shouldn’t we infer that all the defense lawyers who defended these cases committed legal malpractice?

August 25, 2008

Should Companies Be Required to Disclosure Expected Litigation Obligations in Product Cases?

by Ronald V. Miller, Jr.

The Wall Street Journal has an editorial with an anti products liability lawyer spin. No surprise. But what is surprising is that I agree with it.

Considering Enron and other business collapses that left stockholders holding the bag with no actual picture of the company’s financial condition, the Financial Accounting Standards Board wants to tighten standards. One requirement would make companies account for the potential cost of ongoing litigation not just regarding attorneys’ fees but regarding the actual value of the claims. The Wall Street Journal editorial says product liability lawyers will use the information to extort settlements and influence jury verdicts.

I’m not worried about either of those outcomes no matter how many times the editorial uses the phrase “extort settlements.” But I think there is a risk of forcing a defendant to publicly estimate settlement and verdict values because I think it tips off product liability lawyers and creates a floor for the value of any mass tort claim. I also think the editorial is correct, that predicting the trajectory of long and complex litigation is inherently unscientific. Mass tort cases are like the stock market in that their values are always changing. A good trial outcome or even a good expert deposition in an MDL can increase or decrease the value of a case. I’ve been involved with mass torts from both sides and believe knowledge of the true value is rarely known even to the insiders until the advanced stages of the settlement process.

August 14, 2008

Wyeth v. Levine – August

by Ronald V. Miller, Jr.

The Wall Street Journal has a good article online about the preemption battle that is being waged the FDA’s bureaucrats in the courts and in Congress.

The last line of the article says that “Some drug companies are telling plaintiffs’ lawyers that if they settle their cases now, they won’t pay as much to the plaintiffs as they would have six months ago, before the Supreme Court announced that it would hear the Wyeth case. A lawyer negotiating a settlement with one drug maker said company executives told him it wants the ‘Wyeth discount.'”

I don’t think many cases will settle for a “Wyeth discount” because both sides seem to think they will win. I cannot imagine how the court could find that there is a conflict between state and federal law in drug cases because I think federal labeling requirements create a floor for state tort claims, not a ceiling.

June 30, 2008

Riegel v. Medtronic: Congress to the Rescue?

by Ronald V. Miller, Jr.

Since the Supreme Court’s disaster in Riegel v. Medtronic, I have been hoping and expecting Congress would step in to fix the Supreme Court’s ruling, because it was clear from the amicus briefs submitted in Riegel, from history, and from common sense, that Congress did not intend to prevent medical device tort claims. Yesterday, California Congressmen Henry Waxman and New Jersey Congressman Frank Pallone, along with 62 bipartisan supporters, introduced HR 6381, the Medical Device Safety Act. This bill would undo the wrong the Riegel does to medical device victims. We expect the Senate to offer a similar bill next month.

As the Wolf said in Pulp Fiction, we can’t start congratulating ourselves yet (I’m paraphrasing). This bill has not even made it out of a committee yet. But at least something is happening.

May 13, 2008

Stryker Hip Implants: More Reports of Problems

by Ronald V. Miller, Jr.

The New York Times ran an article yesterday aptly titled, “It Must Be Bob. I Hear His Hip Squeaking,” discussing people with hip implants, largely Stryker hip implants, who were told to try new ceramic hip implants. Its manufacturers promoted it and its sister implants as being more durable than the previous generation of hip implants. But their hips soon squeaked, raising concerns that the noises were not just embarrassing and uncomfortable, but forebode more serious problems with these hip implants. One patient has turned to YouTube to vent her frustrations with her Stryker hip implant.

The previous generation of hip implants, before 2003, had few problems with squeaking. The Times cited a Journal of Arthroplasty study which found that 10 patients out of 143 who received ceramic hips from 2003 to 2005, amounting to 7 percent, developed squeaking. Meanwhile, no squeaks occurred among a control group of 48 patients who received hips made of metal and plastic.

Last fall the FDA warned Stryker that it failed to take the steps needed to prevent squeaking and other problems. Many patients have had surgery to replace the squeaky hip implants. Many have hired lawyers to sue Stryker, arguing that these hips never should have introduced to the market without proper testing because, as it often happens, Stryker rushed to introduce its ceramic-on-ceramic titanium hip replacement onto the market to create a competitive advantage with its competitors.

December 4, 2007

Riegel v. Medtronic: The FDA Preemption Super Bowl

by Ronald V. Miller, Jr.

Today, the Supreme Court will hear arguments in Riegel v. Medtronic. The issue is whether the Food, Drug, and Cosmetic Act forecloses state law personal injury lawsuits for injuries from the design, manufacture, and labeling of a Medtronic medical device that the Food and Drug Administration initially granted a pre-market approval. This case is a product defect case involving a Medtronic balloon catheter that killed the patient but, this case could have ramifications for the Medtronic lead recall lawsuits that are being filed all over the country. [Update: “Could” is the understatement of the decade.] While technically this case focuses on a specific statutory provision, it would surprise no one if the Supreme Court’s holding provides a comprehensive framework for preemption that would apply to all drug and medical device cases.

Naturally, the Bush administration has lined up squarely behind the pharmaceutical companies. This is ironic because there is a strong presumption against preemption, particularly where the issue involves the individual states’ power to protect public safety and health.

The Supreme Court has consistently found that preemption of state law does not apply unless “the nature of the regulated subject matter permits no other conclusion” or “the Congress has unmistakably so ordained.” Chicago & N.W.Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 317(1981) (quoting Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142 (1963)).