California is a beautiful, diverse state. It has everything from wide, sandy beaches to snow-capped mountains, deserts, thick forests, wide open spaces and massive cities. It also has laws and a court system that’s seen as friendly to those injured by prescription medications. And after a recent court decision, more people in other states may be heading there to try their product liability cases.

The California Supreme Court issued a decision in August which may encourage people harmed by prescription medications and medical devices from all over the country to file legal actions in the state. At issue is whether the state’s court system has jurisdiction over legal claims by people who’ve never been in California. In cases involving the drug Plavix, the answer was yes.

The eight lawsuits in question have 86 California residents and 592 people from 33 other states as plaintiffs. The defendant, Bristol-Myers Squibb, sought the dismissal of the claims by the 592 non-Californian plaintiffs.

Jurisdiction: The Power of a State to Hear a Legal Dispute

The question facing the court was whether state courts have jurisdiction over legal claims involving these plaintiffs. A key element to any civil case is whether the court has jurisdiction over the parties, whether it has the power to make decisions affecting those involved. The court decided that while the defendant’s “home” was not California, it also concluded that,

• Because of its “extensive contacts with California, encompassing extensive marketing and distribution of Plavix, hundreds of millions of dollars of revenue from Plavix sales, a relationship with a California distributor, substantial research and development facilities, and hundreds of California employees,”
• Jurisdiction over the non-California plaintiffs in state court was appropriate and consistent with Constitutional due process protections because these out of state claims arise from the same alleged conduct and actions which are the basis of those by the California plaintiffs.

The U.S. Constitution requires that government can’t take away property (such as a court ordering Bristol-Myers Squibb to pay plaintiffs’ damages) without due process of law. The defendant argued that having to litigate cases in California which originated in a number of other states is unconstitutional.

Why Do Plaintiffs Prefer California?

Why would 592 people from around the country want their Plavix legal claims litigated in a state where they may have never set foot?

• California state courts have a reputation as being more open to those suing drug makers.
• California’s consumer protection act offers better protections than other state laws.
• These are high stakes lawsuits and plaintiffs may be willing to put up with some practical inconveniences to benefit from any advantages they can get.

Defendant Prefers Other States

The defendant not only would prefer cases in states where plaintiffs would have a harder time proving their cases due to less favorable laws but there would also be practical advantages for Bristol-Myers Squibb:

• Having all these cases in one place saves resources for plaintiffs and their attorneys.
• If multiple cases are heard all over the country the Defendant may be better able to leverage its greater resources to be in a stronger position to defend itself and pressure plaintiffs into agreeing to a lower settlement.

This could be a win-win for plaintiffs. They may not only enjoy a better chance of winning their cases, or favorably settling them, but also take some time to visit California’s many famous sites. After a court room win plaintiffs (and their attorneys) could see Big Sur, Ghirardelli Square or do a tour of Hollywood.

Plavix is a blood thinning drug used prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. People who have taken the drug have alleged that Plavix has caused internal bleeding, heart attack, stroke, and cerebral hemorrhaging. Lawsuits allege that Bristol-Myers Squibb failed to warn patients and their doctors about the risks of taking the drug.

That is exactly what happened in one of the first important Depuy ASR Hip trials in California.

The Jury Trial

On March 8, 2013, a jury in Los Angeles Superior Court awarded $8,338,236.12 for a man injured by the failure of the Depuy ASR Hip. Loren Kransky alleged that the Depuy ASR hip components were negligently designed, that the components had a design defect, and that Depuy failed to warn him and his doctors about the potential risks involved in implanting the device.

After a five-week trial in 2013, the jury in the California case awarded Mr. Kransky $338,236.12 in “economic damages” and $8,000,000.00 in “pain and suffering” damages. Jurors in the case found that the device was defective at the time of sale, and that it injured the plaintiff. The jury found in favor of Mr. Kransky and awarded damages for medical costs and for emotional suffering and distress.

The jury did not award punitive damages to Mr. Kransky. The jury did not find that Depuy acted with fraud or malice, which prevented an award of punitive damages. Which was good for Depuy, as Mr. Kransky’s legal team aggressively argued for punitive damages in amounts that could have exceeded $100,000,000.00.

more The Appeal

After the jury verdict, Depuy filed a flurry of post-trial motions, which the trial court rejected. Depuy then filed appeal. Depuy argued several issues on appeal, but I want to focus on the most important defense argument: that the trial court made a fatal error when it prevented Depuy from entering evidence at trial that the U.S. Food and Drug Administration approved the Depuy ASR device for sale and marketing. Let me explain.

Before the start of the 2013 trial, Mr. Kransky filed a motion in limine asking the court to exclude evidence that the Depuy ASR device was approved by the FDA. Kransky argued that because the Depuy ASR hip hit the market under the abbreviated and less rigorous 510(k) process (which I’ve written about often), that mentioning FDA “approval” would confuse the jury and unfairly prejudice the Plaintiff’s case. The judge agreed, noting that the 510(k) was a limited review process which was not as rigorous as the comprehensive Premarket Approval process, and that it could confuse the relevant issues and consume too much time for a limited purpose.

On appeal Depuy hammered away at this decision by the trial judge, arguing that it was prejudicial to Depuy not to be allowed to present evidence that the FDA approved the device. On July 21, 2016, the California Second District Court of Appeal upheld the decision of the trial judge on this issue, writing that evidence of the FDA’s 510(k) device approval “was not relevant to, or had little probative value in, a Montana products liability design defect claim.” California Appeal Decision, July 21, 2016.

Although the appellate court in California was required to interpret Montana law for this appeal (because Kransky was a Montana citizen and first filed suit in Montana), I believe the decision is very important for all future cases because it shines a light on the rather easy road a medical device can travel to the marketplace under the limited 510(k) review process.

The Takeaway: Rejection of 510(k) as Valid “FDA Approval”

The Opinion should be read as a rejection of the defense “don’t blame me judge; the FDA approved our medical device.” The appeal’s court shut down that argument, clearly recognizing that Depuy chose to seek approval of the Depuy ASR hip through the much easier 510(k) process, which is inherently less credible than a full blown Premarket Approval (PMA) process. Because of the decision by Depuy to opt for the 510(k) process, the FDA had much less evidence to guide its ultimate decision to approve a device for sale. If Depuy wanted the full value and protection of “FDA approval,” Depuy should have put the ASR Hip through rigorous testing and clinical trials, which are required under PMA.

Depuy can’t have it both ways. It can’t choose a limited review process to get its ASR product quickly to the market, then when the device fails, defend itself by saying it received approval from the FDA. In California, the trial court and now the appellate court rejected that sleight of hand argument by Depuy.

Further Takeaway: Justice Delayed

But note the key dates in this case: Mr. Kransky received the Depuy ASR hip implant in 2007. He then suffered pain and high metal levels in his blood. By 2012 the device had to be removed. In 2013 Kransky won an $8.3 million jury verdict from Depuy. Now here we are, more than three years after the trial, and the appellate court has finally rendered a decision on Depuy’s appeal. Depuy can certainly attempt to appeal further, but the hope is that this decision ends the case and Depuy pays Mr. Kransky his money. After all, it’s been nine years since the defectively designed Depuy ASR hip was surgically implanted in his body. The man has suffered enough.

Finally, the hope is that with this appellate decision upholding a large jury award, Depuy will work more generously to resolve the remaining lawsuits over the Depuy ASR hip. We will see.

The case is Kransky (Ellis) v. DePuy Orthopaedics (Los Angeles Superior Court)

The Washington Lawsuit

States can sue companies on behalf of their injured citizens. If the state’s attorney general decides that a “bad act” is harmful to enough citizens, her office can file a lawsuit on behalf of the state and the group of people who were injured. It is an important consumer protection function provided by the states. This is what happened in Washington and California a few days ago. The Washington Attorney General reported that 11,728 transvaginal mesh products were sold (and implanted) in women in the state. The attorneys general in those states filed suit against Johnson & Johnson and made a series of chilling allegations against the company for its marketing of transvaginal mesh.

Let’s look at some of the key allegations in the Washington State lawsuit. When I refer to “Defendants,” I mean Johnson & Johnson, Ethicon, Inc., and their related companies, who made and marketed several types of transvaginal mesh.

more Key Allegations:

1. Defendants misled consumers through informational and marketing materials that misrepresented the safety and effectiveness of transvaginal mesh. (Complaint, p. 7)
2. Defendants did not conduct human trials prior to the initial sale of transvaginal mesh. (p. 10)
3. Defendants destroyed the underlying data they claimed supported the safety and effectiveness of their original mesh products. (p. 11)
4. Defendants misrepresented the safety history of the transvaginal mesh to doctors. (p. 11)
5. Defendants made misrepresentations about the mesh directly to consumers through advertisements, brochures, and other marketing materials. (p. 11)
6. Defendants’ marketing materials failed to disclose the possible health complications from implantation of transvaginal mesh. These health problems include incontinence, defecatory dysfunction, dyspareunia (pain during sex), dysuria (pain while urinating), fistula, hematoma, hemorrhage, pain to partner during intercourse, permanent urinary dysfunction, recurrence, pain, UTI, urinary tract obstruction, vaginal scarring, and worsening incontinence. (p. 12)
7. Defendants knew about these mesh health problems but did not report this information. (p. 12-13)
8. Defendants’ Polypropylene Mesh Products present risk of chronic bacterial infection. These infections can occur years after the mesh was removed surgically. (p. 14)
9. Polypropylene mesh degrades and oxidizes in the body over time. This can cause a reaction in the body which can cause chronic inflammation. (p. 14)
10. The transvaginal mesh cannot be removed effectively when the medical device fails. (p. 15)
11. Transvaginal mesh implantation may also cause cancer in women. (p. 15)
12. Defendants knew about problems with sexual function and shrinkage at least as early September 2006, based on the discovery of a Johnson & Johnson internal document. (p. 15-16) Despite this knowledge, J&J sold thousands of mesh products after 2006.
13. Defendants falsely claimed that their transvaginal mesh products were “FDA Approved.” (p. 16) Rather, the mesh products were cleared under the 510(k) equivalency process. (p. 17) I have written about the 510(k) process several times in this blog.
14. Defendants failed to update informational and marketing materials. (p. 18)

Washington State’s Individual Claims Against J&J:

Washington State brought the following individual claims against Defendants:

1. Misrepresentation and Omissions Regarding Safety
2. Misrepresentations or Omissions Regarding Efficacy (the ability to produce a result)
3. Failure to Update Information Provided to Consumers

The State of Washington asked the court to “decree” (to determine, conclude) that Johnson & Johnson engaged in all the bad acts listed in the complaint. It also asked that the court find that J&J engaged in “unfair and/or deceptive acts” in violation of that state’s consumer protection laws. Washington then asked for a permanent injunction which would prohibit Johnson & Johnson from selling transvaginal mesh products in Washington. It also asked for civil penalties for every violation of state law. And finally, Washington asked for “restitution to consumers.”

The Complaint is captioned: State of Washington v. Johnson & Johnson, et al. (Wash. Super. Ct., King Cty.), and is worth reading if you have the time.

Meanwhile, in California

Kamala Harris, Attorney General for California, also filed suit on behalf of California on May 25, 2016. Attorney General Harris stated that Johnson & Johnson sold almost 800,000 pelvic mesh devices nationwide between 2008 and 2014. According to AG Harris, 42,000 mesh products were implanted in California women during this period. On behalf of the citizens of California, Harris sued Johnson & Johnson, alleging false advertising and deceptive marketing of its transvaginal mesh. The lawsuit alleges that J&J failed to inform patients and doctors of possible severe complications and misrepresented the frequency of these risks.

Johnson & Johnson’s Blanket Denial of Wrongdoing

Remarkably, despite more than a hundred thousand serious injuries, thousands of lawsuits, millions paid in jury verdicts and settlements, Johnson & Johnson still contends the mesh product is safe and is the preferred treatment for certain female health issues. According to the Wall Street Journal, Johnson & Johnson responded to the states’ lawsuit by stating, “the use of implantable mesh is often the preferred option to treat certain female pelvic conditions . . . .” As I’ve said before on this site, this blanket denial is a dangerous game for Johnson & Johnson to play, particularly when intentional misrepresentations are alleged.

The Takeaway

An injured person often feels powerless when facing a huge corporation like Johnson & Johnson. And rightly so. No individual, standing alone, can absorb a long legal fight in the same way that a multi-billion dollar corporation can. But when a state gets involved, the fight gets fair. California and Washington can bring the full power of the state to the legal fight against J&J. These lawsuits are therefore a huge step forward in protecting women against future pain and injury from transvaginal mesh. I will keep you posted on key developments in both cases.

Note: Again, I am no doctor. Please call your doctor if you have transvaginal mesh implanted in your body and you have concerns about your health. The information in this post comes mostly from the State of Washington’s lawsuit, which is a public document. I encourage you to review it carefully for further information.